advanced medical technologies

Tissue Engineering and Cell Therapy 2009-2018

2010-04-08T07:08:00.000-07:00

Tissue Engineering and Cell Therapy 2009-2018

This blog has moved

2007-01-31T07:41:00.000-08:00

The "advanced medical technologies" blog of MedMarket Diligence's Patrick Driscoll has moved to a new address in the blogosphere: http://mediligence.com/blog.

Please visit us, and thank you Blogger.

Tags: medtech

Amniotic stem cells good, but not embryonic replacement

2007-01-09T14:42:00.000-08:00

As reported in the Washington Post and other sources, researchers at the Institute for Regenerative Medicine at Wake Forest University and Children's Hospital (Boston) have shown that stem cells from amniotic fluid can be differentiated into brain cells, bone cells, muscle, fat, blood vessels and liver cells, demonstrating the kind of pluripotentiality that has previously marked one of the real distinctions between embryonic and adult stem cells. Moreover, the amniotic stem cells demonstrated a kind of stability (resisting formation of tumors) that is better than embryonic stem cells.

Quick to pounce on and deflate the balloon of embryonic stem cells as the only solution, some opponents of embryonic stem cell research (e.g., Richard Doerflinger of the U.S. Conference of Catholic Bishops, who notes,"This is wonderful news," for offering the benefits of stem cells without destroying embryos). They have a valid point, but one that is limited by the fact that no stem cell type is likely to be perfect for all applications and that in reality a continuum of stem cell types exists, with a comparable spectrum of advantages. George Daley of Harvard, notes that amniotic stem cells "are not a replacement for embryonic stem cells."

As Charles Darwin said, "a scientific man ought to have no wishes, no affections, -- a mere heart of stone." The science of determining the clinical application of different stem cell types needs to be carried out in a way that is less fraught with hope and expectation of specific outcomes for or against the value of embryonic stem cells for specific applications. The field remains characterized more by wishes and affections than science.

Tags: medtech, embryonic, stem-cells

Medtech Startups: Stealth, Location, and Platform Tech

2007-01-02T13:50:00.000-08:00

Medical Technology Startups Identified in the December 2006 MedMarkets (subscribers only).

In the December 2006 issue of MedMarkets, I note in my MedMarket Outlook column the common tendencies in the formation of medical technology startups in 2006. It should come as no surprise that central to many (though certainly not all) were the premises of stealth (staying under the radar), location (where are startups concentrated, as if it should be any surprise), and platform technologies, among others.

Here, for reference (or late Christmas present), are the companies identified in the December issue.

Company	Principal(s)	Location	Product/Technology	Founded
Carticept Medical, Inc.	(Domain Associates, New Enterprise Associates)	Alpharetta, GA	Development and sales of therapeutically related medical devices	2005
Forcept, Inc.	John Maroney	Menlo Park, CA	Assisted cautery/cutting systems for performing transvaginal hysterectomy	2005
Internal Fixation Systems, Inc.	Steve Hernandez	Medley, FL	Orthopedic implants (e.g., bone screws)	2006
I-Therapeutix, Inc.	William H. Ransone II	Waltham, MA	Hydrogel sealant for use in ophthalmic surgery	2006
iCardiac Technologies, Inc.	Mikael Totterman, CEO	Rochester, NY	ECG-based cardiac diagnostics and medical devices	2006
NBI Development, Inc.	Undisclosed	Chicago, IL	Spinal neuromodulation devices	2006
Optmed, LLC	Alain Klapholz	New York, NY	Developing "innovative medical technologies"	2006
Safe Surgery Technologies LLC	David Michelson	Cheyenne, WY	Capsulotomy cutting device	2006
TriReme Medical, Inc.	Eitan Constantino	Pleasanton, CA	Apparatus and methods for delivering prostheses to luminal bifurcations	2005
Vertebral Technologies, Inc.	Jeffrey Felt, CEO	Minnetonka, MN	Biocompatible polymers for joint restoration in the spine	2005

Carticept Medical, Inc. (Alpharetta, GA; http://carticept.com [under construction])
Forcept, Inc. (Menlo Park, CA; no URL)
Internal Fixation Systems, Inc. (Medley, FL; no URL)
I-Therapeutix, Inc. (Waltham, MA; http://itherapeutix.com)
iCardiac Technoloigies, Inc. (Rochester, NY; http://icardiac.com)
NBI Development, Inc. (Chicago, IL; http://nbidevelopment.com [under construction])
Optmed, LLC (New York, NY; http://optmed.net)
Safe Surgery Technologies LLC (Cheyenne, WY; no URL)
TriReme Medical, Inc. (Pleasanton, CA; no URL)
Vertebral Technologies, Inc. (Minnetonka, MA; no URL)

Tags: medtech, startups

FDA Panel Assesses Drug-Eluting Stents and Clotting

2006-12-07T13:10:00.000-08:00

Questions about whether the risks of clotting, heart attacks and death are higher for patients with drug-eluting stents compared bare stents are the subject of a two-day panel by the FDA. The questions center on whether and how long patients with the drug-eluting stents should stay on anti-clotting drugs such as Plavix. In a worst case scenario, the elevated risks, which the FDA does believe exists, could ultimately sabotage a $5 billion market for the devices.

Principal players (with a bevy of newcomers waiting in the wings) Boston Scientific and Johnson & Johnson have different spins on the risk. Boston Scientific "acknowledges a slight increase in clotting associated with its drug-coated stent, the Taxus," but the company asserts that there is no corresponding increased risk of heart attack or death. Johnson & Johnson argues that the risk of clotting, heart attack or death is equivalent for drug-eluting and bare stents.

The question of increased risk of clotting will certainly influence approvals of pending drug-eluting stents from Medtronic, Abbott and others.

Detailed coverage of the drug-eluting stent market is provided in the October 2006 issue of MedMarkets (subscribers).

Tags: medtech, stents

Orthopedic Biomaterials Global Market

2006-12-06T10:36:00.000-08:00

Orthopaedic devices are a major contributor to the global medical device market, accounting for almost $26 billion in 2006, and with a growth rate that reflects growth in the medical sector overall. The table below gives a market growth projection for the five years 2007-2011.

	Worldwide Sales ($millions)	Growth (%)
2006	25,764	--
2007	27,122	5.3%
2008	28,562	5.3%
2009	30,989	8.5%
2010	31,708	2.3%
2011	33,425	5.4%
CAGR '06-'11	5.3%

Orthopaedic Biomaterials
The current valuation of the orthopaedic biomaterials segment is around $5 billion, representing over 17% of the orthopaedic total. It is also estimated that this market segment will grow at 10-12% a year, that is more than double the rate for the overall orthopaedics market. At this rate the biomaterials segment will achieve a value of $9.5 billion by 2011 and will represent 28% of all orthopaedic product sales.

The global market for orthopedic biomaterials is analyzed in a new report from MedMarket Diligence (www.mediligence.com).

Tags: medtech, orthopedic

Global Growth in Refractive Surgery

2006-11-30T08:42:00.000-08:00

Shift in use of refractive types, growth by country...

Refractive surgery is performed using a number of surgical techniques, each designed to minimize the patient’s dependence on eyeglasses and contact lenses. Although there are many options to improve refractive error making it a complex field for the surgeon, while at the same time offering a broad range of options to treat each patient’s unique needs, some approaches will grow at a greater rate while other refractive surgery options will be cannibalized by these faster growing techniques or they will be relegated to serving the needs of niche populations. For those techniques that serve a particular niche population, manufacturers will struggle with how to maintain visibility for these sub-population therapies while ensuring that clinical competence will be maintained at a level to allow the surgeon to deliver the outcomes that are feasible.

Numerous factors come into play as the market for refractive surgery evolves:

Clinical Outcomes – documented clinical advantage will not only encourage physicians to embrace new approaches to refractive surgery, it will help clinicians to determine the subset of patients that are most likely to benefit by one technique over another.

Physician Education – the speed with which surgeons can be trained on the new techniques

Access – how rapidly will the market adopt the technology that is necessary to perform the procedure and how quickly will the market be penetrated

Patient Education – the ability of physicians and marketing efforts by manufacturers to inform patients of various options

Cost – Significant differences in price to the patient as well as cost associated with training and equipment by physicians and ambulatory care centers

Reimbursement – insurers willingness to pay for such procedures will continue to be a factor in a patient’s decision to undergo refractive surgery

The net effect is that custom LASIK will soon constitute a dominant share of refractive procedures.

Globally, the U.S. dominates the market for refractive surgery products, but strong growth is evident in many countries.

Tags: medtech, ophthalmology, refractive, LASIK

Orthopedic Biomaterials Market Segment Growth

2006-11-29T11:51:00.000-08:00

The worldwide market for orthopedic biomaterials -- allografts, synthetic bone substitutes, bone growth factors, polymers, ceramics, etc. -- is growing steadily due to a concurrent evolution of surgical procedures, the emergence of innovative products and a dynamic and growing patient population. Select segment growth in this worldwide market is shown at right.

Data drawn from forthcoming MedMarket Diligence report, "Emerging Trends, Technologies and Opportunities in the Markets for Orthopedic Biomaterials, Worldwide." (publishing Nov/Dec 2006)

Tags: medtech, orthopedic, biomaterial

Drug-Eluting and Bioabsorbable Stents

2006-11-04T09:36:00.000-08:00

>> See updated coverage of drug-eluting and bioabsorble stents on the current blog at mediligence.com/blog.

From October 2006 MedMarkets

Developers of Cardiovascular Drug-Eluting and Bioabsorbable Stents

Company	Stent	Drug	Status
Abbott Vascular	BVS (bioabsorbable)	Everolimus	ABSORB first-in-man clinicals began 3/06
	Xience V (distributed by Boston Scientific as Promus)	Everolimus	CE Mark 1/06; European launch 10/06; U.S. launch expected 2008
	ZoMaxx	Zotarolimus	Development discontinued 10/06
Avantec Vascular	Duraflex	Pimecrolimus	In development
Beijing Lepu Medical Device	Ton Xin Partner	Sirolimus	Launched in China 11/05
Biosensors International	Axxion	Paclitaxel	CE Mark 7/05
Biosensors International	BioMatrix	Biolimus A9	In trials; expects CE Mark in 2006
Biotronik	Absorbable Metal Stent (AMS)	Completely bioabsorbable magnesium alloy	In clinicals (PROGRESS)
Blue Medical Devices	Melissa	Melatonin	In clinicals (NOBLESSE)
Boston Scientific	Taxus Express2	Paclitaxel	CE Mark 1/03; FDA approval 3/04
Boston Scientific	Taxus Liberté	Paclitaxel	CE Mark 9/05; FDA approval expected 2006
Conor Medsystems	Corio	Pimecrolimus	GENESIS trial began 5/06
	CoStar	Paclitaxel	CE Marked 2/06; U.S. launch expected 2007/2008
	CoStar II (bioabsorbable polymer)	Paclitaxel	In clinicals
	SymBio	Pimecrolimus and paclitaxel	GENESIS trial began 5/06
Cordis (J&J)	Cypher	Sirolimus	CE Mark; FDA approved; U.S. launch 4/03
	Cypher Neo (for smaller arteries)	Sirolimus	U.S. launch expected 2007
	Cypher Select	Sirolimus	CE Mark in 2003
	Cypher Select Plus	Sirolimus	International launch (outside U.S., Japan) 9/06
CorNova	Chronoflex DES	(Undisclosed)	In development
Devax	Axxess (bifurcated)	Biollimus A9	Clinicals (DIVERGE) began 6/06
DISA Vascular	Stellium	Paclitaxel	Clinicals to begin 2007
Endovasc-TissueGen	(Undisclosed; fully resorbable)	Prostaglandin E-1 antirestenotic	In development
Estracure	(Undisclosed)	17-(beta)-estradiol	In clinicals
JW Medical Systems	Excel (bioabsorbable)	Rapamycin	U.S. Phase IV clinicals began 6/06
Medtronic	Endeavor	Zotarolimus	CE Mark 7/05; U.S. launch planned 2007
MicroPort Medical	Firebird (cobalt alloy polymer)	Sirolimus	Approved in China 2003
MIV Therapeutics	(Undisclosed)	(Undisclosed)	Vascore Medical (acquisition agreement announced 9/06) stents to carry MIVT coatings
OrbusNeich	Cura (bioabsorbable polymer)	Sirolimus	In clinicals (Singapore)
OrbusNeich	Genous Bio-engineered R Stent (bioabsorbable)	Coated with antibody that captures patient’s own endothelial progenitor cells	CE Mark 8/05; HEALING III trials began 2006, 9-mo. results expected 1Q07
Relisys Medical Devices	(Undisclosed)	Paclitaxel	In clinicals
REVA Medical	REVA Medical Resorbable Stent	Balloon-expandable, drug-eluting polymer	First-in-man trials to begin 2006
Sahajanand Medical Technologies	Infinnium	Paclitaxel	CE Mark 12/05
	Infinnium Bioabsorbable	Paclitaxel	In clinicals (SIMPLE registries)
	Supralimus (bioabsorbable)	Sirolimus	In clinicals (SERIES)
Sorin Biomedica Cardio	Janus Flex	Tacrolimus	CE Mark; launched in Europe 2/06
Terumo	Nobori	Biolimus A9	Clinicals began 6/05; product launch expected late 2006
Translumina	Yukon ChoiceDES (polymer-free)	Rapamycin	International launch 4/06
Vascular Concepts	ProNova	Sirolimus	Available internationally
X-Cell Medical	Ethos	17-(beta)-estradiol	In clinicals (ETHOS); to incorporate SurModics’ Bravo polymer matrix per 9/06 licensing agreement
Xtent	Custom NX	Biolimus A9	In clinicals; European launch expected 2007, U.S. in 2009
Source: MedMarket Diligence, LLC

Tags: medtech , stents , drug-eluting

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Can We Handle the Pace of Technology Development?

2006-10-25T16:34:00.000-07:00

(From October 2006 MedMarkets)

From time to time, when I am looking at current developments to gauge the future of medical technology markets, certain common threads seem to be seen suggesting a theme, if not a legitimate trend, encompassing them all. Each of the developments may be noteworthy on their own, but if part of an overall trend, the developments become supportive evidence.

Explosive New Technology
The emergence of evidence that drug-eluting stents correlate to some significant degree with increased risk of late-stage restenosis demonstrated that the technology that suddenly produced at $5 billion market for J&J, Boston Scientific and now others (see "Drug-Eluting Stents Vie for Market Share With Innovation, Acquisitions" in this issue, page 1) was not as perfect as cardiologists (or investors) would have hoped. One might be inclined to grant a little forgiveness on the part of both manufacturers and clinicians in their zeal for the new technology, given the incontrovertible data on the restenosis associated with bare metal stents and the overwhelmingly positive short term data that drug-eluting stents dramatically reduce restenosis. But the zeal did extend beyond the direct clinical benefit of anti-restenosis. It extended to the support for a huge medical device market—encompassing angioplasty and stents—that was arguably at risk of renewed competition by coronary artery bypass grafting, which has seen device market development of its own (beating heart bypass, percutaneous technologies, even robotics) to retake the market for treatment of coronary artery disease. Neither patients seeking better outcomes, nor clinicians seeking secured caseload, nor manufacturers seeking increased revenue had particular incentive to challenge the long-term outcomes of drug-eluting stents. Those who did raise such yellow flags were not well received.

Business Week Online (Science & Technology, October 9, 2006) noted the case of Dr. Renu Virmani of the cvpath Institute (Gaithersburg, MD) who, at a meeting in Paris in 2004, tried to inject a level of restraint in the enthusiasm for drug-eluting stents. She believed, based more on (what turned out to be valid) instinct than on a large body of hard clinical data, that the drugs used to prevent restenosis would in fact only delay restenosis or lead to other problems, such as clots. By all accounts, her message was not well received. Now, with the benefit of hindsight and hard clinical data, even clinicians and manufacturers are acknowledging the higher risk of blood clots associated with drug-eluting stents. However, one can't help but feel the implicit tendency among all stakeholders to minimize the significance of this increased risk while noting, of course, that more data needs to be collected.

We can go out on a relatively short limb here and assert that virtually every new technology will be overused in the short run. For medical technologies, the primary limiter is contraindication, and until a sufficient body of clinical data is produced to flesh out the contraindicated population, there will be little limitation in a new technology's growth. The alternative is untenable, that a new technology not be approved until such volume of data is produced by numbers of cases and long term follow up to fully elucidate all the risks. The FDA, of course, would be the remaining voice for restraint, but its voice is virtually drowned out by clinicians, manufacturers and patients who clamor for the new technology.

Radically New Technology
In a recent report issued by the Woodrow Wilson Center's Project on Emerging Nanotechnologies, Michael Taylor, former deputy commissioner for policy at the FDA and now a professor at the University of Maryland, notes that the FDA is severely constrained by budget limitations such that it is wholly ill-prepared to regulate nanotechnologies. Taylor notes that, with upwards of 320 products with nanomaterials already on the market, and with over 200 drugs and medical devices incorporating nanotechnology in the pipeline, the FDA needs to be authorized by Congress to collect more safety data and perform more post-marketing surveillance. Moreover, the agency simply needs more funding to hire staff and develop expertise that is as good or better than the nanotech industry that it will be expected to police.

Nanotechnology is a radically new technology or, rather, technologies. The definition of nanotechnology, framed as it is simply by the size the of products (or their components), lends itself to an incredibly diverse set of technologies (see past MedMarkets issues //Dona??//) that will exceed FDA’s abilities to address safety and efficacy. By some estimates, the U.S. government has already invested $1.3 billion in nanotechnology initiatives and private industry has added another $1.7 billion, as testament to the benefits that are expected to emerge. If, as was already noted, the FDA had limited ability to provide effective restraint in the growth of drug-eluting stents, a market for which it arguably already has adequate expertise, then what might one expect for nanotechnology?

The examples of drug-eluting stents and nanotechnologies centered on limitations with the FDA in constraining the emergence of technologies to protect patients, and while regulation of medical technologies by the FDA must certainly become more effective (read, more aggressive) to accompany the aggressive development of medical technologies, the best regulation of medical technologies cannot occur without the effective management of the downside of medical technologies by manufacturers themselves. The recent history of manufacturers not taking the long view of their products (e.g., Guidant, Merck) is evidence enough for products that aren’t characterized by rapidly growing or radically new technologies. The range, types and potential impact of new technologies poised to enter the marketplace (i.e., beyond nanotechnologies) is truly breathtaking and without some level of judicious restraint applied to the pace of their introduction, the past examples of repercussions from technologies too aggressively introduced will pale in comparison.

Tags: medtech, FDA, nanotechnology, stents

Technologies and that Highlight Advances and Precipate Even More

2006-10-05T13:49:00.000-07:00

September 2006
MedMarket Outlook: Technologies that Highlight Advances and Precipitate Even More

Product developments with the potential to dramatically alter the landscape of both patient care and manufacturer market shares are numerous. They take many forms, from pure device, biotech or pharmaceutical to endless combinations of them all. Device technologies also represent a unique platform for health care delivery beyond simple device, drug-coated or other device hybrids.

In any industry, there are many wildcard technologies --- innovations envisioned to enable radical solutions to problems, thereby turning current markets on their heads. The medical technology industry is not only no exception, but is as good an example of this as any. Here we consider examples for illustration:

Implantable Wireless Biosensors
The University of Rochester Medical Center and an associated startup (Physiologic Communications LLC) is working on producing implantable wireless biosensors that will be integrated with living cells in order to detect and report on localized physiologic and chemical changes. Moving beyond the idea of implantable miniature drug delivery chips (e.g., MicroCHIPS), these devices will be hybrids of devices and cells such that the cells remain viable as a component of a miniature electronic chip. Localized physiologic conditions can be monitored -- the presence of specific proteins, ion concentrations or changes -- or in the technology's more advanced potential therapeutics can be delivered directly or the biosensor can trigger delivery by other localized devices (e.g., a defibrillator or pacemaker). The devices also hold potential for in vitro drug testing in order to test new drug candidates prior to animal or human trials.

The ability to integrate devices with biologics and, indeed, viable cells has profound implications for technology development, particularly because the end result of doing so is to compensate for some of the inherent limitations of medical devices:

Medical technology is eminently invasive. Just as laparoscopy was a radical improvement over traditional open surgery due to its ability to greatly reduce invasiveness, the advent of implantable technologies, which might ultimately be implanted via catheter, syringe or other relatively non-invasive techniques, if only for diagnostic or monitoring purposes, harbors the potential to similarly reduce the invasiveness of medical technologies.
Medical technology, and devices in particular, is an arm's length proposition. Once a medical device is implanted, it is largely hidden. If the device can be revealed real-time by integrating sensors with cells as well as the device itself, then the resulting knowledge by the clinician (and the manufacturer) can enable multiple improvements in the device's performance. This would include optimizing placement of the device during implantation (e.g., to augment fluoroscopic guidance), alerting to changes in status of the device or the device's environment to alert the clinician to impending device failure, change in patient status requiring intervention or other local changes.
Medical technology is symptom-oriented. Medical devices are innately crude -- this is not to detract from their sophistication of design, but metal, polymer or even more advanced material construction is frequently designed to, at best, minimize inflammation or other clinical sequellae. Understanding the nature of the device’s environment with which it actively or passively interacts is paramount to improving device performance.

The erosion of the differences between devices, drugs and biologics is furthered by advances of those described above. Wireless, living cell biosensors may soon have the capacity to be "aware of" and respond to local physiologic conditions by administering therapeutics or other intervention.

Non-invasiveness versus Minimal Invasiveness
Despite the best intentions of drugs, biotech and medical devices, it frequently becomes necessary to intervene with a surgical solution. Laparoscopy and thoracoscopy have already demonstrated that surgery can be made drastically less invasive. However, even the minimal invasiveness of "keyhole" surgery is still invasive and can therefore be improved upon.

Minos Medical (Irvine, CA) has trademarked a procedure called "APPENDOECTOMY", an approach to appendectomy involving endoscopic access to the appendix and its removal via the colon. This and other endoscopic technologies have come about as a result of the logical course of technology evolution that produced laparoscopy and endoscopy --- improvements in endoscopic visualization, flexible endoscopy and the developments in surgical instrumentation deliverable through endoscopic channels.

Minos Medical's Appendoectomy is one of several procedures being developed in surgical endoscopy under the heading, "Natural Orifice Transluminal Endoscopic Surgery" or "NOTES". Minos is also developing procedures for cholecystectomy and hysterectomy, two other high volume surgeries.

Given the number of diseases in the gastrointestinal tract, NOTES represents a formidable potential for the continued evolution of surgery away from invasiveness.

Analogously, cardiovascular applications are similarly evolving away from invasive surgical procedures such as traditional coronary artery bypass graft (CABG) to percutaneous interventional procedures and even to percutaneous CABG (originally developed by TransVascular, Inc., acquired in 2003 by Medtronic).

The balance of care is shifting away from traditional surgery toward laparoscopic, endoscopic and percutaneous procedures, a trend driven by innovations that enable procedures to be done less invasively or non-invasively and with competitive outcomes. Healthcare is thereby shifting away from surgeons and toward gastroenterologists, interventional cardiologists and other non-surgical specialists, a fact enabled by and of great interest to manufacturers.

Ultimately, however, true non-invasiveness is an achievement that may well not be possible with any type of medical technology at all, but only with orally, nasally, topically or other non-syringe administered drugs.

Removing the veil
Gaining a more intimate picture of structures and processes at the cellular level and below is another advance that will augment the ability of health care to understand and intervene. In September, Nikon Corporation held its "Small World" international light microscopy photo competition, with this year’s winning image of the nuclei of a mouse colon cells, a picture taken by Dr. Paul Appleton, of the University of Dundee (UK). The picture was selected due to its originality, visual impact and, in particular, its informational content, which was that it was judged to help elucidate regulation of cellular changes and their involvement in the development of colon cancer.

The inability to directly see processes at the cellular and molecular levels has been, in some ways, the catalyst for truly innovative experiments that elucidate structure, function, dynamics, causality and other answers in medical science. But, with so many advances in imaging technology (X-ray, MRI, SPECT, etc.), combined with increased understanding (from other technologies) of the nature of cellular and molecular processes, a multitude of discoveries must be pending in medical science that will remove the veil from healthy and pathological processes and open the doors to treatments -- drug, biotech, device and others -- that we have not yet envisioned.

We have highlighted in past MMO columns that discoveries in medical sciences and advances in the development of more effective treatments are increasingly coming as a result of synergy gained between multiple scientific disciplines, as well as through the contribution of information technologies that can reveal what is significant, even when we are not looking for it. But it is the aggressive development of seemingly unrelated innovations that not only produces new treatments -- even cures -- but also furthers the trend toward more and greater advances.

URLs
Medtronic, Inc. -- Minneapolis, MN; http://medtronic.com
Minos Medical, Inc. -- Irvine, CA; http://minosmedical.com

Physiologic Communications, Inc. -- Rochester, NY; http://physiocomm.com (under construction)

Tags: medtech, medical technology

Startup Medtech Companies, September 2006

2006-09-26T06:44:00.000-07:00

Startup Companies Identified in September 2006 MedMarkets

Company	Principal(s)	Location	Product/Technology	Founded
AcelRx	Thomas A. Schreck	Portola Valley, CA	Drug-device technology for treatment of breakthrough pain	2006
Amaranth Medical, Inc.	Guy Heathers, Charter Life Sciences	E. Palo Alto, CA	Bioresorbable drug-eluting stents	2006
Arbel Medical Ltd.	Didier Toubia, CEO	Yoknean, Israel	Cryosurgical ablation technology	2006
CardioInsight Technologies, Inc	Warren Goldenberg, CEO	Cleveland, OH	Electrocardiographic imaging of the heart's electrical activity	2006
Minos Medical, Inc.	Bradley J. Sharp, CEO	Irvine, CA	Minimally invasive (HIFU) surgical systems for appendectomy, cholecystectomy and hysterectomy	2006
nContact Surgical, Inc.	John P. Funkhouser, President & CEO	Morrisville, NC	Intraoperative tissue coagulation devices	2005
OmniMedics, Inc.	Alan Cohen	Newton, MA	Cardiac device	2006
Sirion Therapeutics, Inc.	Philippe Boulangeat, Chief Business Officer	Tampa, FL	Therapeutic ophthalmology compounds and other products	2006

AcelRx, Inc. (Portola Valley, CA; http://acelrx.com [under construction])
Amaranth Medical, Inc. (East Palo Alto, CA; no URL)
Arbel Medical Ltd. (Yoknean, Israel; http://arbel-medical.com [under construction])
CardioInsight Technologies, Inc. (Cleveland, OH; http://cardioinsight.com)
Minos Medical, Inc. (Irvine, CA; http://minosmedical.com)
nContact Surgical, Inc. (Morrisville, NC; http://ncontact.us)
OminiMedics, Inc. (Newton, MA; http://omnimedics.com)
Sirion Therapeutics, Inc. (Tampa, FL; http://siriontherapeutics.com)

U.S. diabetes prevalence to double by 2050

2006-09-08T13:10:00.000-07:00

In the September issue of Diabetes Care, Dr. K. M. Venkat Narayan and colleagues from the CDC's Division for Diabetes Translation write that by 2050 a full 12% of the U.S. population, or 48.3 million people, will have
diabetes (link). Moreover, if the rate of diabetes in the U.S. population continues to rise, the prevalance by 2050 will be even higher.

Further, the rates of growth in prevalence will be disparate. Minorities will face a significant added burden, with prevalence among whites doubling by 2050, while the prevalence among African-Americans will triple and the number of Hispanics with diabetes will increase almost six-fold. Diabetics aged 65-74 will triple and those over 75 will increase five-fold.

Given the associated costs of diabetes and its complications, this data adds to a steady chorus of support among clinicians for better screening, diagnosis and management of diabetes.

Tags: medtech, diabetes, insulin, glucose

Bioengieering the end of medical devices (well, eventually)

2006-09-06T13:49:00.000-07:00

The use of bioengineered tissues is often considered for organ regeneration and regeneration of other macro structures (ears, pancreas, etc.), but it seems clear from recent research that a wealth of applications of bioengineering will be realized on smaller scales. Why players in the medtech industry should consider this is that some applications have the potential to preempt entire device industries. Culling just a few examples I found today on bioengineering applications limited to cardiology shows this pretty clearly.

Bioengineering could replace pacemakers. In the September 5 article of Circulation, it was shown that delivery of a bioengineered cell-surface protein to the cardiac tissue of pigs could effectively regenerate the sinoatrial (SA) node, the principal site for controlling heart rhythm.

Discovery of new gene that stimulates the growth of natural bypasses. Researchers at the Max-Planck Institute for Heart and Lung Research in Germany identified a gene responsible for inducing the formation of collateral vessels, which bypass blocked arteries. Further, researchers were able to demonstrate an ability to enhance the growth of the collateral vessels, or "natural bypasses", in order to improve the results of surgical interventions or, perhaps one day, preempting surgery entirely.

The heart can heal itself. Additionally reported at the World Congress of Cardiology in September, it has been discovered that mammalian hearts possess a reservoir of stem cells that contribute to the formation of new vessels and myocytes during the course of the organism's lifespan and that, further, it may ultimately be possible "to induce the stem cells residing in the heart to migrate to the sites of damage forming new vessels and myocytes."

Hammering away as I do on my theme that discoveries in the biological sciences hold eminent potential to preempt the symptoms-oriented treatment provided by devices, but that biotech inevitably underestimates the developmental hurdles in doing so, it is clear that the potential offered up here in bioengineering cardiac tissue is very likely as understated as are the challenges.

Tags: medtech, biotech, bioengineering

The Intellectual Property Yardstick

2006-08-24T22:01:00.000-07:00

Out of curiosity, since I see Medtronic so frequently on patents and patent applications, I decided to take a one month snapshot, from July 25 to August 24 (today) of patent applications referencing the phrase "medical device" and examine it for the patent assignee company or other company reference. Here's what came out:

Medtronic's dominance (38 patents for medical devices in one month) of the intellectual property game is pretty astounding. It begs the question of how a player can hope to dominate the market without having some technological advantage, and whether pursuing a campaign of patent strength will correlate with success in the market.

These are just questions.

Medtech analysis test drive

2006-08-23T07:29:00.000-07:00

We've added a new feed to our list of rss/xml feeds on medical technology content. The new feed is entitled, "Sample content from the medtech reports of MedMarket Diligence, LLC." Here, we will regular post excerpts and other sample data from the library of medical technology market reports we have published (or are about to publish). We want our audience to get a feel for what the detail is in these 200+ page reports.

The xml link is here.

Tags: medtech

Energy-Based Devices in General Surgery

2006-08-22T09:24:00.000-07:00

The dynamic market for energy-based devices used in general surgery is growing steadily with compounded annual growth rates of 12% projected for the short term. This market includes devices based on ultrasonic, radio frequency (RF), light, thermal, hydromechanical, cryogenic and microwave technologies.

The popularity of ultrasonic devices is due in large part to the fact that they do not utilize heat when sealing tissues, thus effectively eliminating smoke from the operating room. This can reduce costs for hospitals as the absence of smoke eliminates the need for smoke evacuation systems. Meanwhile, the lack of smoke also improves the surgeon’s line of vision. Also to their benefit, ultrasonic surgical instruments combine cutting, grasping and coagulation into one tool set, thus further reducing cost while also reducing surgical time as there is no longer a need for intraoperative instrument exchanges. Lastly, patient safety is enhanced because with ultrasonic systems, there is no electric current passing though the patient’s body, which can result in lateral tissue damage.

The second largest segment in the market for energy-based devices used in general surgery comprises devices based on RF energy, which (like laser systems) rely on thermal welding to achieve tissue coagulation. RF devices comprise roughly 27% of the overall market for devices used in general surgery. Growth in this market segment is being driven by the introduction of new technologies into the marketplace.

Thermal energies, which are used most often in surgeries to treat benign prostatic hyperplasia (BPH) and menorrhagia, also have application in general surgery, however, less than 5% of the market is devoted to these systems. Newly developed hydromechanical (based on water-jet technology), cryogenic, and microwave systems also are being introduced into the market, thus further fueling market growth in devices designed for general surgery.

Many developments have occurred among the manufacturers in this dynamic market over the last several months.

(Further details in August 2006 MedMarkets.)

Tags: startup, medtech, ablation

August 2006 startup medtech companies

2006-08-16T16:27:00.000-07:00

These are the startup companies we identified and have published in the August 2006 issue of MedMarkets.

Artisan Therapeutics, Inc. -- Framingham, MA; no URL
Andrew Tehnologies, Inc. -- Haddonfield, NJ; http://andewtechnologies.com [under contruction]
Nitric BioTherapeutics, Inc. -- Brisol, PA; no URl
Recovery Science, LLC -- Hollywood, MD; no URL
SurgiQuest, Inc. -- Fairfield, CT; no URL

Source: MedMarkets, August 2006, MedMarket Diligence, LLC

Tags: startup, medtech, obesity, surgery, wounds

Biomaterials Stimulating Orthpedic Growth

2006-08-14T15:07:00.000-07:00

The total world market for all orthopedic devices and materials was worth $20 billion in 2005 and is growing at annual rates in the range 7-10%; the US accounts for almost half the market overall. A major contributor to the market, both in terms of size and growth, is orthopaedic biomaterials. This segment contributed $4.6 billion (23%) to the global orthopaedic market in 2005 and furthermore is growing considerably faster than the market overall, with a predicted CAGR in the region of 15% over the next five years. The buoyant performance of this sector is due to a combination of several factors, including demographic and lifestyle changes, the emergence of new types of biomaterials offering significant improvements in performance, the premium prices associated with novel high-tech products, and evolving attitudes among orthopaedic surgeons.

From August 2006 issue of MedMarkets and forthcoming MedMarket Diligence report #M625.

Tags: medtech, orthopedic, biomaterials

Artificial Pancreas for Diabetes: The Closed Loop Pump/Monitor

2006-07-25T16:59:00.000-07:00

Two of the most important milestones in the development of products for the treatment of diabetes include the development of the completely non-invasive glucose monitor and the "artificial pancreas", or closed loop system that monitors blood glucose and administers insulin to produce a homeostatic-like control of glucose. Both systems represent areas of tremendous development activity, driving work at multitudes of companies and other institutions due to the chronic nature of diabetes and the high cost of complications arising from inadequate glucose control. Noninvasive glucose monitoring -- being pursued through development of near infrared detection, interstitial fluid measurement, laser lancing and other methods -- has long been foremost due to the comparative challenges presumed to exist for closed loop monitor/infusion pump. However, given the seemingly no-less-daunting task of achieving noninvasive and reliable monitoring technologies, while continuous monitoring and external and implantable infusion pump technologies rapidly evolved, the prospects for the artificial pancreas have grown.

At the 66th Scientific Sessions of the annual American Diabetes Association meeting, there was considerable focus on efforts to develop the artificial pancreas. Rather than summarize those efforts myself, I instead provide this excellent review by Andrew B. Muir, MD, on Medscape.

The possibility remains for stem cell research to enable pancreatic cell transplant or similar cell based therapies, since the restriction on federal funding is regressive but destined to succumb to more enlightened consideration of the issue -- science and ethics -- than is possible with the current administration.

Tags: medtech, diabetes, glucose

Local Market Volume of Medical/Surgical Procedures

2006-07-19T13:04:00.000-07:00

I continue my discussion of our use of the Medicare 100% file and other datasets to serve specific needs of medical product manufacturers.

As I mentioned, the Medicare 100% file is large (measured in gigabytes) unwieldy and, as anyone who has purchased raw data from the U.S. government can attest, the file is not constructed in the most convenient format to allow simply queries, summaries or other processes that will reveal meaninful insights. And, given the cost, the need for HIPAA-related disclosure agreements to be signed,m the dataset is not quite amenable to data analyst with occasional interest or need in purusing it. Lastly -- and this goes for all reimbursement or discharge survey datasets -- whatever logic may govern the coding systems (DRG, ICD-9 and CPT4) used in this data, the reality of how clinicians fle claims and how survey data is collected can result requires that working with claims-based and survey-based datasets be done by someone with experience in these issues.

Now you might understand why the question, "So if this is in the public domain, how is your product in any way unique?" causes me to take a breath before answering.

MMD has joined with Medical Technology Partners (MTP) to capitalize on MTP's use of these large datasets, which have been acquired for reimbursement consulting, to use them for answerng very technology-specific and facility-specific questions raised by medical product manufacturers.

Tags: medtech, hospitals, utilization data

Top Volume Hospitals by DRG, ICD-9

2006-07-18T16:57:00.000-07:00

[The data we offer, and discussed below, includes data on the top volume hospitals by DRG or ICD-9. We drive the data reports from the 100% Medicare file (a very big, unwieldy file that is impractical to work with unless you have the resources and need to work with it). This is the 2005 volume of actual claims filed at each facility. Not estimates.]

We had no idea when we started offering clinical utilization data to medical product companies seeking data in support of new product introduction, etc., that we would have such a positive response to the offer of providing the data on the top volume hospitals with claim data on the DRG or ICD-9 codes of interest. It was really overwhelming. MMD (MedMarket Diligence) looked at the types of questions being asked, and the purposes being put to the data, by the typical medical product company client -- VP, President, Director, Product manager -- and realized that while on the high end of needs ("what products should we be developing?" or "what companies should we acquire?") the questions were adequately answered by U.S. aggregate data on total volume, with trends, payer segmentation, reimbursement amounts, and the like, but on the "low" end we were not helping clients enough.

By low end, I mean answering questions about "where should I send my sales reps tomorrow?." Well, how about looking at the hospitals in any geographic territory that have the highest volume utilization, measured by patient discharges and the specific diagnoses or procedures currently or potentially using the company's products?

After we started adding this to quotes, we sudddenly realized that hospital-specific data was in very big demand.

There are a lot of other aspects to working with this data, making sense of it and delivering it the right way. In subsequent posts, I'll describe that a little further, but don't have time now.

I have two more quotes to get out before day's end.

Tags: medtech, hospitals, utilization data

Technologies in Treatment of Stress Urinary Incontinence

2006-07-17T16:59:00.000-07:00

Bulking Agents for Stress UI

One important weapon in the arsenal of noninvasive or minimally invasive therapies for Stress Urinary Incontinence (SUI) comprises bulking agents—injectable substances that expand the intrinsic sphincter of the bladder, allowing it to withstand greater pressures.

There are several companies exploring or developing bulking agents for SUI (see chart). For many of these, the technology was initially designed as a therapy for treatment of wrinkles or other dermal defects, gastroesophageal reflux disease (GERD), wound care, drug delivery or other therapy.

Treatment for urinary incontinence ranges from pelvic muscle rehabilitation to behavioral therapies and pharmacologic therapies. Beyond that, surgical therapies exist and are becoming increasingly less invasive. Minimally or even noninvasive interventional therapies are extremely attractive to both young and old patients; younger patients don’t want to be slowed down by an open surgery while many older patients may not be strong enough to undergo such.

The latest therapies being developed to treat SUI involve bulking agents, sling or urethral supports, and even stem cell therapies, among other procedures.

At least 13 million Americans suffer from urinary incontinence, a condition that is far more frequent in women than in men. In the general population between the ages of 15 and 64, 10%–30% of women are affected, compared to only 1.5–5% of men. At least 50% of all nursing home residents have urinary incontinence, 70% of whom are women.

The Agency for Health Care Policy & Research estimates that $16.4 billion is spent annually on incontinence-related care: $11.2 billion for community-based programs and at home, and $5.2 billion in long-term care facilities. In addition, $1.1 billion is spent annually on disposable products for adults.See MedMarkets, July 2006 issue.

Tags: medtech, incontinence, implant

Spine Surgery Market Development at a Pivotal Stage

2006-07-10T15:58:00.000-07:00

[See also "Spine Surgery Worldwide, 2008-2017." Published March 2008. See link.]

Coverage in the July 2006 issue of MedMarkets includes an overview of the U.S. and worldwide spine surgery market (excerpt below).

Treatments for disorders of the spine – ranging from degenerative disc disease, kyphosis, diskitis, spinal stenosis, spondylolysis/spondylolisthesis and others – stand at a crux between multiple options. Spinal fusion (lumbar and cervical) will be on the rise for a few short years before disc replacement/repair and other approaches will have begun to penetrate significant caseload. Competitors in the market for spine surgery products face a combination of opportunity and risk that will result in big rewards for some and only brief rewards for others.

Worldwide Spine Surgery Market, 2003-2009

Source: MedMarket Diligence, LLC, Report #M501, "Worldwide Spine Surgery Market." Note: This report has been updated, January 2008, with report #M510, "Spine Surgery Worldwide, 2008-2017." See link.

Treatments for these disorders range from the non-surgical and inexpensive (bed rest) to complicated surgeries designed to excise tissue and halt vertebral segment motion (spinal fusion). “Back trouble”—especially among aging baby boomers and the elderly—is in no imminent danger of decline. Consequently, the spine-related osteobiologics market in the U.S. will undergo steady growth for the next decade. Although certain treatments and technologies currently enjoying a robust market share will likely be replaced by those now in development, older men and women will seek the best treatment alternatives available to help them maintain an active lifestyle.

Over the past two decades, the worldwide spine industry has grown dramatically, with annual revenues in 2004 estimated at about $3.4 billion. Disorders or conditions located in the lumbar area of the spine account for the majority of these revenues.

Tags: medtech, spine, orthopedic

Timescale of nanotechnology materials/components and application development

2006-07-04T09:06:00.000-07:00

Nanotechnology Biomedical Application Development Timescale

Source: MedMarket Diligence, LLC, from "Micro- and Nanomedicine: Technologies, Applications, Industry, and Markets Worldwide," report #T625. Published May 2006.

Tags: nanotechnology, nanotech, mems, nanomedicine

Drug delivery and nanotech

2006-07-03T08:51:00.000-07:00

Nanotech products are being developed to improve delivery of drugs with poor solubility. It is estimated that 40-50% of newly developed drugs have solubility problems. Sales of drugs with poor solubility and low bioavailability totalled $72 billion in 2003, up from $64 billion in 2002. The total world market opportunity for nanotech-derived drug delivery products and services was estimated at $290 million in 2005 (0.6% of the total drug delivery market, valued at more than $43 billion). This is predicted to grow at a CAGR of 50% to reach $8.8 billion by 2015, or over 5% of the total drug delivery market.

Many nanotech research projects are devoted to improving drug delivery and targetting in cancer. The oppurtunity is considerable. The total cancer chemotherapy market in 2005 was estimated at $10 billion, including plain and DDS (drug delivery system) products. The DDS market share was 20% in 2000; this is forecast to grow to 80% by 2010. The cancer market itself will grow as the over-65 population in developed countries increase from 12% in 2000 to 20% in 2020.

From MMD's May 2006 report, Micro- and Nanomedicine.

Tags: nanotech, nanotechnology, drug delivery, medtech, cancer

Endovascular Technologies Drive AAA and TAA Stent-Graft Market

2006-06-23T16:57:00.000-07:00

Stent-Grafts for AAA will represent a $1 billion market in less than five years.

Endovascular aortic repair (EVAR) is one of the most significant technological advances in vascular surgery over the last decade and continues to show promise as a less-invasive alternative to conventional surgery in treating patients with abdominal aortic aneurysms (AAAs) or thoracic aortic aneurysms (TAAs). As manufacturers make ongoing refinements to endovascular devices for aneurysm therapy, the estimated 2.7 million aortic aneurysm patients in the United States have more treatment options available than ever before. Although aneurysms are far less common than heart attacks, they are also far more fatal. According to the National Center for Health Statistics, roughly 15,000 patients die annually from ruptured aortic aneurysm, and this number may be low because the condition can be overlooked easily in a standard autopsy. Ruptured abdominal aneurysm is currently the 13th leading cause of death in the United States. In fact, as many as 2 of 3 patients with an AAA rupture die prior to reaching the hospital. Even with open surgery, there is an average 48% mortality rate associated with patients having a ruptured AAA. AAAs typically enlarge slowly and without symptoms, making them difficult to detect. However, detecting AAAs early and repairing them can decrease the death rate by one-sixth. TAAs are also under-diagnosed because most patients are asymptomatic. The incidence of TAA in the United States ranges from 15,000 to 30,000.

Rapid Market Growth Expected
The endovascular stent-graft market will continue to expand rapidly for a number of reasons. One primary driver comprises increasing numbers of patients who will select this less-invasive procedure over the traditional open surgery with its longer recovery periods and higher rates of complications. In addition, the aging population will continue to expand, putting more people at risk for aneurysm. It is estimated that 5%–7% of those over age 65 has an AAA. Finally, implementation of screening programs will detect a greater number of cases of aortic aneurysm, thus leading to an increase in the number of endovascular stent-graft procedures. The chart on page 1, “Worldwide Market for AAA Stent-Grafts,” illustrates this growth. The first endovascular aortic grafts were available for use in the United States in 1999. Now there are four AAA endografts that are FDA-approved and available commercially in the United States for EVAR: Cook’s Zenith AAA, Endologix’ Powerlink, Medtronic’s AneuRx, and Gore’s Excluder. Gore is the only company with a TAA endograft (the Gore TAG) on the U.S. chart, “Developers of Endovascular Grafts for Abdominal and Thoracic Aneurysm Repair”). TAA endografts show great potential, not only for the treatment of TAA but also for other anomalies of the thoracic aorta, such as acute and chronic dissections, penetrating ulcers and traumatic injuries. U.S. research institutions are serving as clinical trial sites for next-generation aortic endografts made of synthetic fabrics. Boston Scientific’s TriVascular Enovus AAA and the Terumo/Vascutek Anaconda are examples of investigational endografts that incorporate new design features, taking into account varying patient morphology. market; other manufacturers’ devices are in development and/or are available outside the United States. TAA endografts show great potential, not only for the treatment of TAA but also for other anomalies of the thoracic aorta, such as acute and chronic dissections, penetrating ulcers and traumatic injuries. U.S. research institutions are serving as clinical trial sites for next-generation aortic endografts made of synthetic fabrics. Boston Scientific’s TriVascular Enovus AAA and the Terumo/Vascutek Anaconda are examples of investigational endografts that incorporate new design features, taking into account varying patient morphology.

Looking Ahead
The rate of EVAR should increase rapidly within the next decade with the advent of promising technologies such as lower-profile devices that allow percutaneous delivery and endostapling devices that offer increased durability as well as the ability to treat short, angulated necks. Imaging modalities used with EVAR also will continue to improve, providing greater accuracy for screening, as well as procedural and post-procedural surveillance needs.

Tags: medtech, aortic-aneurysm, stent, stent-graft

Meanwhile, American Medical Systems Corners a Market

2006-06-20T16:56:00.000-07:00

Company Steadily Secures the Urogenital Treatment Market
The acquisition of Laserscope by American Medical Systems Holdings this month for $715 million adds a certain punctuation to AMSH's steadily growing presence in the field of urogenital medicine or, as the company refers to it, "pelvic health." Lest there be any doubt, AMSH has been on a Tyco-like drive of acquisitions that have garnered it a clear lock on urogenital markets. In May 2006, the company acquired Solarant Medical, a maker of minimally invasive therapies for stress urinary incontinence. In April 2006, AMSH acquired BioControl Medical for its implantable electrical stimulation technology, which the company will use to develop its own incontinence treatment technology. In 2004, the company acquired TherMatrx, the developer of an office-based thermal treatment for BPH, In 2003, the company acquired CryoGen, the developer of cold technology for treatment of menorrhagia, and the company also acquired erectile dysfunction technologies from Endocare in 2003...the list goes on.

While Boston Scientific and Medtronic fight tooth and nail in both the courts and the markets to gain turf in the cardiovascular device industry, we watch with interest as AMSH has steadily purchased its own plot of real estate in the urogenital arena, a field that while putatively overshadowed by cardiology, represents a hugely attractive area of upside potential, and growing less crowded all the time.

Tags: medtech, urogenital, urology, bph, prostate, incontinence

Megatrends in Medical Technology

2006-06-16T13:56:00.000-07:00

(June 2006 MedMarket Outlook in MedMarkets)

Megatrends in Medical Technology
Aside from other trends in the medical product industry we've addressed previously in MedMarket Outlook, such as the dissolution of boundaries between device and pharmaceutical technologies, the increasing integration of information and information technologies with medtech, and the rise of "holistic research" (aka "systems biology") that recognizes the value of studying pathology with a multidisciplinary scientific approach, there are specific overarching trends and forces that are changing medical technology and the markets for them on a grand scale.

Stem Cell Research
The debate about stem cell research was no more likely to end as a result of President Bush's restriction on federal funding as it was that the established cell lines would be sufficient or appropriate for research (they weren't) or that the case would abate (as they have not) for the use of stem cells in the treatment of diabetes, Parkinson's, spinal cord injury or other disease and disorders. Here, we make no ethical case for or against embryonic or somatic stem cell research --- the debate is likely to become wholly moot in a matter of time --- we only comment on the inevitability of the science moving forward one way or another. In June, Harvard University's Harvard Stem Cell Institute confirmed that two projects focused on cloning to produce embryonic stem cells will move forward under private funding. The projects employ the same general type of research, somatic cell nuclear transfer, that is underway at the University of California at San Francisco and at the University of Connecticut's Center for Regenerative Biology. Aside from these approaches, a cursory review of the state of cell research in general and stem cell research in particular will reveal that researchers have both the innovation and the willingness to pursue cell therapeutics that lead to treatments heretofore not possible. It seems fairly certain that, looking back at progress in the development of the range of cell therapies, the Bush administration's federal funding restriction will be seen to have produced a momentary hitch rather than the obstacle it was originally portrayed as producing.

Nano- and Microscale Juggernaut Forces
There are as many different functions -- maybe even more -- being provided by technologies designed around nanoscale or microscale level as there are different types of these technologies. The sole criteria for technologies grouped into the nano and micro categories is size. Aside from their size, there is then little common among these technologies, which represent an incredible array of devices, molecules, materials and other products that achieve functions not possible on the macro scale, even if one only considers nano- and microscale medical applications. These range from products that are largely nanoscale materials (e.g., silver nanoparticles as antimicrobials in wound management) to those providing functions such as artificial retinas, cancer diagnostics, drug delivery and biosensors. As an industry, nanotechnology (more so than MEMS, which has found considerable realized success) has been plagued by a combination of inflated promise and underestimated technical hurdles, but while MEMS (microelectromechanical systems) has found bigger initial commercial success, nanotechnology has begun scoring commercial success that will ultimately result in markets that will eclipse MEMS products by orders of magnitude.

Open Surgery in Decline, or the Rise of the Minimally Invasive, Less Invasive, Interventional, Percutaneous and Other Alternatives to Surgery
Often stated, but never emphasized enough, is the compelling drive for treatments (that were all too recently delivered exclusively via surgery) to be associated with, or replaced by, ever-decreasing invasiveness. Device manufacturers have well established records for producing devices that not only minimize the trauma of surgery (e.g., laparoscopy) but also promise to make open surgery obsolete (e.g., percutaneous procedures like coronary anastomosis). Driving this trend is the persistent recognition that "collateral damage" in achieving clinical outcomes is unacceptable, whether from the perspective of the physician seeking to optimize results, the healthcare system seeking to minimize the costs of healthcare (or optimize revenue streams by being able to market the latest less-invasive techniques) or the patient seeking to minimize the impact of surgery on his/her busy lifestyle.

Disease State Centered Marketplaces
Certain technologies in certain clinical areas remain the predominant if not exclusive option for treatment in those areas. However, in 2006, any legitimate competitive analysis of a market considers a multitude of different technology types. Case in point: any treatment for coronary artery disease will of necessity consider the competitive threat of bare versus eluting stents, angioplasty, atherectomy (waning but not gone), products for identification/treatment of vulnerable plaque, traditional coronary artery bypass, MIDCAB, OPCAB and other bypass variants (e.g. robotics), percutaneous bypass, atherosclerosis-reversing drugs and others. Compelling arguments must be created through the intrinsic advantages of new technologies in order to secure sought-after shelf space in the cost-fixated healthcare system armamentarium.

Materials Science Creating/Upending Markets
Underlying a stunning number of new technologies, from biodegradable/resobable stents, cellular scaffolds and a wide arrange of other implant types are the advances in materials sciences that are leading to the ability to engineer implants that now go well beyond providing solely structural roles. Driving these advances are the needs to improve upon the function of implants as static, inert devices that do not fully reflect the in situ need upon implantation, fail to adapt to changing conditions or otherwise do not provide the functions that optimize the end results of the implants' use. Whether by impregnation with different substances or by the nature of the implant material employed, implants have improved considerably in being able to not induce an anti-inflammatory response, to provide anti-microbial function to the device, to minimize formation of blood clots and to avoid the effects like restenosis of vasculature following interventional procedures. With the need for implants frequently changing at some point after their implantation, more devices -- biodegradable/bioresorbable stents, matrices/scaffolds for tissue engineering and others -- are being developed that are either resorbed completely by the body or just enough to be expelled in whole or in part once their purposes have been served. Lastly, materials science and implant engineering in general have also been able to simply produce implants that are more easily deployed through tortuous twists in vessels or through narrow channels in endoscopic devices. Expectations are that more complex functions will be served by implants as a result of these trends and forces in development, from the increasing sophistication of drug delivery in various passive and active forms, to the ability of implants to respond via biofeedback to changing conditions in situ, and to providing increasingly sensor-like functions. Increasing demands are being made of the medical product marketplace -- cost, competitive technologies, financial performance of public companies, etc. -- but it seems clear that these demands are driving the proliferation of technologies that indeed satisfy them, sometimes with each advance creating ever greater demand in an endless progression. It also seems apparent that this "technology burst" is taking place simultaneously with the increasingly strident need for healthcare costs to get under control. The focus in the U.S. Congress on the need for Medicare reform, and reform in the U.S. healthcare system overall (up to an including the increasing drive toward universal healthcare), is gaining greater intensity and may well yield more than nominal changes to the system. The medical product industry is likely to both respond to these changes and facilitate solutions that we can scarcely imagine even now.

Tags: medtech, nanotech, mems, stem-cell

Categories on medtech companies tracked

2006-06-08T15:43:00.000-07:00

Not a great picture, I know, but this is partly due to technology limitation (mobile phone pic sent to go@mobile.com). But this is a screenshot of the one of the database data entry forms used in our internal company database, which in turn is used to track medtech companies (and other entities (e.g., VCs, providers, etc.) active in medtech. The categories include technology type (biopharm, device, pharm, biotech), major clinical applications (cardio dx, cardio tx, surgery, orthopedics, cell therapy, tissue engineering, patient monitoring, minimally invasive therapies, etc., etc.). We also segment by manufacturer, distributer, healthcare provider, etc.

Tags: medtech, companies, healthcare expenditure

Wasted Medicine: A Mantra

2006-06-07T16:05:00.000-07:00

A report in the June 7 issue of the Journal of the National Cancer Institute (see article in Medical News Today):

Screening for cancer can find tumors that might not otherwise have been diagnosed in a person's lifetime, a situation called overdiagnosis. Overdiagnosis wastes health care resources. Tests and treatment resulting from overdiagnosis can lead to substantial toxicity and even premature death in patients.

I find this interesting, unsurprising and largely irrelevant. First, I have to note that I was struck with the use of the term "overdiagnosis", which I would expect to be a term used to describe an exhausted physician. I'm certain the authors intended to mean something akin to "false positives".

It is unsurprising in that I expect clinical practice to occasionally result in instances where there appears to be a problem that, under further evaluation, turns out not to be a problem. The alternative is to miss the problems, resulting in pain and/or death.

It is largely irrelevant because, in lieu of technology or clinical practice that is perfectly accurate and precise by never missing pathology and never mistaking normal tissue from abnormal, we must err on the side of false positives -- excuse me, overdiagnosis. Do we want to minimize the wasted use of our precious healthcare dollars? Are these non-trivial differences between accurate and inaccurate diagnoses? Who can argue against these questions?

A marketing manager was questioned by a new boss about a promotion to get registrants to a conference, and the boss questioned why the brochures were sent out to so many people. The manager responded, "Tell me who will attend the conference, and I'll only send brochures to them."

How is cancer really any different?

Tags: medtech, cancer, healthcare expenditure

Guidant Warning Letter Never Sent Over Concern of "Undue Alarm"

2006-06-07T12:50:00.000-07:00

The New York Times reported today that in January 2005 Guidant drafted a letter warning doctors about a short circuiting defect in its Contak Renewal and Contak Renewal 2 defibrillators, but never sent the letters to doctors over concerns the letter would cause "undue alarm" and result in procedures to remove potentially faulty devices, and that such procedures would be associated with higher risk than simply leaving the debrillators in place. The letter and other documents were unsealed by a Texas judge overseeing a product liability lawsuit.

Of course hindsight is 20/20. With what Guidant (now Boston Scientific) knows now, there is no question (at least in my mind) that failing to send the letter, and instead sending the "product update" letter, was ill-conceived. The subsequent recalls and class action lawsuits caused a reveral of fortune for Guidant, knocking billions off the price tag of its sale to Boston Scientific.

If there was indeed real concern about the risk of explantation being higher than the risk from faulty defibrillators, then that is precisely what should have been communicated. It is difficult to conceive that Guidant calculated the potential fallout from the letter and deemed it to be greater than the fallout of not disclosing the defibrillator defects. In this day and age, in which every misstep by manufacturers is magnified with crystal clarity, it is an absolute obligation to understand the impact of product liability.

Tags: medtech, defibrillator, Guidant, FDA

MEMS and Nanotech in Medicine

2006-05-30T07:00:00.000-07:00

In initiating our report on "Micro- and Nanomedicine", which details the full spectrum of products, technologies and markets in the application of MEMS and nanotech to medical use, I elected not to approach this as an update of the report we did in 2003, for several reasons. First, I was able to draw on very qualified resources for the current report, and was particularly interested in the analysis capitalizing on this by having an "unbiased" view of the market. Second, the market continues to be driven heavily by R&D, which by its nature results in a rapid flux in the players, the nature of their nanotech/MEMS initiatives and the actual status of development.

Since our prior analysis, a very great deal has changed in the fields defined by those corporate, academic and government entities pursuing medical development of nanotech and MEMS. We currently profile about a 100 companies, but there are easily 4-fold more that one might consider for profiles given the number of companies and their current or potential involement in micromedicine or nanomedicine.

Tags: nanotech, nanotechnology, nanomedicine, micromedicine medtech

Unnecessary Surgery and Throwing the Baby Out with the Bathwater

2006-05-19T17:09:00.000-07:00

Here's another reference from BusinessWeek today, "Bypass that Operation", on the same vein about doctors who don't know what they are doing, including performing unnecessary surgery. It suggests that many if not most of 400,000 bypass surgeries and 1 million angioplasties are unnecessary.

While I find fault with the general tone of this article, glorifying Dr. David Eddy, his brilliance and his blunt challenge to healthcare that it needs better proof for the efficacy of its treatments, because the tone of this article blithely understates the fact that there is a clinical basis for the decisions doctors make, some patients actually do get better by the treatments prescribed, and wholesale dismissal of physicians' education and training may have less to do with the facts than it does with Dr. Eddy's ego and BusinessWeek's need to make brash statements to gain attention. This is not to say that I do not believe there are flaws in the process, but there is little justification for the kind of criticism that the BW article. What bothers me most about this article is that its sensationalistic approach to the subject and its flippant consideration of clinical practice on a grand scale trivializes the benefits of medicine and medical technology to patients.

By the way, in 2003, I was diagnosed with coronary artery disease, with blockage at 90% in one artery. While Dr. Eddy may thrive on the debate challenging the value of angioplasty and stenting ("mesh tubes" are not angioplasty, BusinessWeek), I know that however true it may be that some "cheaper alternative" might have done as well as angioplasty/stenting, there was no such alternative at the time. I am alive now. Replicate my experience with all others similarly diagnosed and that is precisely the reason for the high utilization of angioplasty/stenting. BusinessWeek's cursory analysis failed to consider such an obvious driver.

Tags: medtech, stent, angioplasty, evidence-based medicine

"Medical Guesswork" Exposing the Ugly Truth

2006-05-19T10:16:00.000-07:00

I have always had a rather sanguine understanding of medicine, having been sensitized to its practical limitations for most of my life. Having been the son of a general surgeon and the nephew of a pediatrician, I saw many aspects of medicine that have tempered my thinking about treatment alternatives in the medical device industry. For this reason, when I came across the article in the May 29, 2006, issue of BusinessWeek Online, asserting that healthcare professionals really know little about which treatments actually work, I found agreement with the idea, and in some cases strongly so, but in other cases I felt the premise misses a few big boats.

From BusinessWeek: "The problem is that we don't know what we are doing," says Dr. David Eddy (the"mathematician and health-care economist" who coined the term "evidence-based medicine"), arguing that, bluntly, there isn't very much of this in healthcare today. Further, according to BusinessWeek, "even today, with a high-tech health-care system that costs the nation $2 trillion a year, there is little or no evidence that many widely used treatments and procedures actually work better than various cheaper alternatives."

The point at which I agree with this is that physicians have always been given wide latitude in determining therapeutic choices, by virtue of their education, their consideration of many different variables affecting patient condition and the suitability of any given treatment. What drives the physician's decision-making is the availability of a reimbursible therapeutic option that specifically addresses the clinical problem to address the medium term need of the patient. By "medium term" I mean the need to solve the problem now, get the patient back on their feet and keep them that way not in any permament sense, but in a medium term sense. Does any cardiothoracic surgery think CABG is a permenent solution? Perhaps long term, but not permanent. Does any interventional cardiologist believe even a drug-eluting coronary stent is a permanent solution? Perhaps more likely to be permanent than bare stents or angioplasty alone, but certainly not permanent. So, doctors are applying the available therapeutic option for the longest solution that is viable. There are many stakeholders interested in the more expensive option -- medical product manufacturers, physicians, even patients (who want the high-tech quick-fix). There are not many stakeholders advocating for cheaper options -- perhaps HMO's --- but who is listening to them?

However, medical devices and drugs are already aggressively evaluated for their efficacy against controls, so the premise of this article, however well-founded, overstates the case when it comes to the use of medical products. The upshot of this article otherwise is to suggest that the upward spiraling U.S. healthcare costs are attributable to expensive treatments alone, when indeed the focus should be on clinical decisions themselves. Physicians are the ones who have been given the latitude to apply them or not, and until they have a different incentive system or until the evidence is much stronger for alternative treatments, absolutely nothing will change.

Tags: healthcare, health-care, treatment, evidence-based medicine, medtech, medical device

Endoscopic GERD Treatment

2006-05-17T12:40:00.000-07:00

Market shares for key players supplying GERD devices in the U.S. are shown in the chart at right.

Gastroesophageal reflux disease (GERD) is a growing problem affecting approximately 5% of the population. An estimated $10 billion is spent on GERD in the United States each year. It is primarily treated with medical therapies (e.g., proton pump inhibitors, or PPIs) for the majority of patients who present. For the remainder of the patient population (approximately 20%) who do not respond satisfactorily to PPI therapy, surgery or one of a variety of innovative endoscopic therapies that treat GERD are the next best alternatives. For some patients, neither palliative drug regimens nor major surgery are attractive options. Trends indicate that this market is moving towards GI endoscopic therapies as less invasive therapies continue to evolve and enter clinical studies. In 2006, the GI endoscopic anti-reflux device market is expected to be $10 million and by 2011 the market is expected to reach $50 million.

Related Tags: GERD, reflux, endoscopy, Medical-technology, medtech

Nanotech Hype versus Actual

2006-05-15T15:52:00.000-07:00

The potential for nanomedicne, the medical application of nanotechnology, is vast, as has been pronounced almost endlessly since it was conceived. However, already on the market in the United States are wound dressings that exploit the antimicrobial properties of nanocrystalline silver, and nanotech-based products for drug delivery, materials technologies and other nanomedical applications are indeed real and in clinical trials now. Many ompanies are developing a diverse range of nanotechnology types for applications including biopharmaceuticals, drug delivery, materials uses, and sensors & diagnostics. These select applications represent just a small sample of the possibilities being pursued, but also represent uses that have made noteworthy progress toward commercialization, a very elusive aspect of the often overstated nanotechnology industry. The unique traits of nanoparticles, fullerenes and other nanoscale structures that either represent novel types of biopharmaceuticals or allow coupling to therapeutic agents for more effective (e.g., localized) drug delivery have lended themselves to development by many companies. Here are examples:

Avidimer Therapeutics

Introgen Therapeutics

BioSanté Pharmaceuticals

ImaRx Therapeutics

One very common use of nanotechnology, under development at many companies and institutions, is as a means to develop unique materials with properties similar to, or even identical to, other naturally occurring or synthetic materials, but with distinct advantages afforded by the materials. Examples:

Angstrom Medical

MIV Therapeutics

...many others

Nanotech-based sensors and diagnostics represent a middle ground, in development terms, between nanotech-as-materials and therapeutic nanotech devices, and many companies are focusing efforts in this area, including:

Biophage Pharma

Orion Integrated Biosciences

...more

We adddress the nanotechnology/MEMS industry, reviewing the technologies, applications and their status for companies in a range of applications of nanomedicine and micromedicine in the May 2006 MedMarkets. Related Tags: nanotech, nanotechnology, nanomedicine, Medcial-technology, medtech

Organ Printing

2006-05-04T13:46:00.000-07:00

The process of engineering tissues is advancing to the point where researchers actually consider such possibilities as organ printing. The formation of organs proceeds, at least in principle, on the formation of tubes, which then fuse after incubation in a bioreactor. It was described this way in Wired.

Of course, organ complexity in terms of differentiated morphogenic function, shape, etc., will complicate the ability to produce organs that can even be considered for clinical trial. Hence, exceedingly optimistic assessments of when organ printing may reach trials are at least five years away (ten years is probably pushing it).

However, the ability to form the simple structures like sheets in bioengineered skin grafts or fill voids for regeneration of bone through extracellular matrices is already an established skill (see Tissue Engineering, Cell Therapy & Transplantation).

There are many, many questions to be answered, and many hurdles crossed, before bioartificial organs can be produced at the push of a button, but the possibility of success is just the sort of stimulant that feeds entrepreneurs (and drains VCs).

Related Tags: bioengineering, Medtech, Medical, Medcial-technology

Diabetes complications

2006-05-03T06:43:00.000-07:00

Long term studies, performed with the goal of capturing more data that will enable more confident conclusions, sometimes become moot when more recent studies eclipse their premise.

In the May issue of the Journal Diabetes, researchers at the University of Pittsburgh Graduate School of Public Health reported on the Pittsburgh Epidemiology of Diabetes Complications (EDC) Study's findings (see press release) that long term complicatons including heart disease and eye disease have not improved over the past 25-30 years for type 1 diabetes juveniles and adolescents treated at Children's Hospital of Pittsburgh between 1950 and 1980.

Now, I certainly respect long term studies, because arguably there are far too few of them and far too many studies that are not only too short term, but also too narrowly focused to reveal all the implications of treatment options. Short term data is awfully compelling, especially if you are a manufacturer seeking marketing approval or just a market edge.

But long term data can lose much of its relevance when it is eclipsed by more recent research that also passes the "long-term" test. Clearly, the EDC study is undercut by the Diabetes Control and Complications Trial conducted from 1983 to 1993, which showed very clear improvement in the risk and severity of complications associated with eye, kidney and nerve disease when Type 1 diabetes had their glucose more tightly controlled:

Eye disease
76% reduced risk

Kidney disease
50% reduced risk

Nerve disease
60% reduced risk

Now, even though patients in the DCCT trial were not expected to have heart-related problems at the beginning of the trial, since they were on average only 27 years old, cardiograms, BP and blood fat were assessed during the trial, revealing at the end of the trial that those with tight glycemic control had significantly lower risk of developing high cholesterol, a significant indicator of risk for developing heart disease.

Therefore, one must seriously question findings of a type 1 study that did not specifically factor the level of glycemic control in a consideration of heart disease or eye disease risk. Almost as significantly, the patients included in this study were type 1 individuals who, at the latest, were patients 13 years before the end of the DCCT trial.

Further, in discussion of the findings, it is noted that "many of the guidelines currently used for managing type 1 diabetes are derived from what we know about people with type 2 diabetes. We need to recognize that they are two different conditions with different processes involved. Therefore, some of the complications we see in type 2 diabetes do not occur in type 1 and vice versa."

I am struggling to not be harshly critical of statements like this. Type 1 and Type 2 are well known to be starkly different, the only common denominator being a problem of one sort or another with insulin and therefore the need to keep an eye on blood glucose (again, the omission of the level of glycemic control being a glaring omission).

Fast forward to today (read "modern technology"). A type 1 diabetic diagnosed in 2006 faces an order of magnitude difference in treatment than one diagnosed between 1950 and 1980. Research should therefore focus on what we know now, and how we can enhance treatment, rather than what we knew almost 60 years ago.

-------
As a matter of obligation, I must note that my 11 year old daughter has type 1 diabetes, having been diagnosed over four years ago. So yes, maybe I'm biased, but I'm also extremely well informed on this topic. Her most recent HbA1c was 7.4.

Related Tags: diabetes, Medtech, Medical, Medcial-technology

Cardiovascular Drug-Eluting Stent Developers, Products, Status

2006-04-27T11:31:00.000-07:00

Developers of Cardiovascular Drug-Eluting Stents

Company	Stent	Drug	Status
Abbott Vascular Devices	ZoMaxx	Zotarolimus	In clinicals; ZOMAXX II trial approved 6/05
Avantec Vascular (Goodman)	Duraflex	Pimecrolimus	In development
Biosensors International	BioMatrix	Biolimus A9	In trials; Expects CE Mark in 2006
Boston Scientific	Taxus Express2	Paclitaxel	CE Mark 1/03; FDA approval 3/04
Boston Scientific	Taxus Liberté	Paclitaxel	CE Mark 9/05 (launched 1/05); FDA approval expected mid-2006
Conor Medsystems	CoStar	Paclitaxel	CE Marked 2/06
Conor Medsystems	(Next-generation CoStar)	Pimecrolimus	Pimecrolimus licensed from Novartis in 3/06; Testing two devices: one loaded with pimecrolimus and another with both pimecrolimus and paclitaxel
Cordis (J&J)	Cypher	Sirolimus	CE Mark; FDA approved, U.S. launch 4/03
Cordis	Cypher Select	Sirolimus	CE Mark in 2003
Cordis	Cypher Neo	Sirolimus	In development
CorNova	(Undisclosed)	(Undisclosed)	In development
Devax	Axxess Plus (bifurcated)	Biolimus A9	In clinicals (positive first-in-man data reported 11/05)
DISA Vascular	Stellium	Paclitaxel	In development
Estracure/Medivas/Picarus	(Undisclosed)	17-(beta)-Estradiol	In development
Guidant	Xience V	Everolimus	CE Mark 1/06; European launch pending
Medtronic	Endeavor	Zotarolimus	CE Mark 7/05; U.S. launch planned in 2007. RESOLUTE trial began 12/05
Occam International (subsidiary of Biosensors International)	Axxion	Paclitaxel	CE Mark 7/05
Relisys Medical Devices	(Undisclosed)	Paclitaxel	In clinicals
Sahajanand Medical Technologies (SMT)	Infinnium	Paclitaxel	CE Mark 12/05
Sorin Biomedica Cardio	Janus Flex	Tacrolimus	CE Mark; launched in Europe 2/06
Terumo	Nobori	Biolimus A9	Clinical trial launched 6/05
X-Cell Medical	Ethos	17-(beta)-Estradiol	In clinicals
Xtent	Xtent	Biolimus A9	In clinicals; European launch planned in 2007, U.S. in 2009

Note: CV Therapeutics and MIV Therapeutics (among others) are developing coatings for coronary drug stents.

Source: MedMarket Diligence, LLC

Related Tags: Medtech, Medical, Medcial-technology

More Drug-Eluting Stents Nearing Market; Biotech Market Progress -- April MedMarkets

2006-04-26T11:52:00.000-07:00

In our April issue of MedMarkets, we cover the current and forecasted market for drug-eluting stents, considering the pending introductions of a number of competitors to established players J&J and Boston Scientific. We also look at the hard successes of biotech in bringing products to market and the growing success the industry is having in once again attracting invesment. Below is our outline of coverage:

Biomedtech, Combo Technologies Bolster Growth in Device Markets
Flurry of Cardiovascular Drug-Eluting Stents Nearing Market
MedMarket Outlook: Opportunities in Common Technology Threads
Early Stage Companies:

Intraoperative Determination of Tumor Margin
All -Polymer Hip Implant European Trial
Ultrasound-Assisted, Transdermal Insulin Delivery

Early Stage Company Financings: Active Implants, AngioScore, Aptus Endosystems, BlueBelt Technologies, CryoFluor Therapeutics, Ultradian Diagnostics
Recent Medtech Startups
Biotech Update: Carbon Nanotube Scaffolding Fosters Proliferation of Bone Cells
Drivers: California Judge OKs Stem Cell Research Agency
Leading Clinical Edge:

Measuring EPCs: A new Test for Heart Disease?
Artificial Nuscle Stronger Than Natural Muscle
"Neuro-chip" Leads to Improved Communication
U.K. Researchers to Produce Wound Monitor
Online (HTML) Only:

Articular Cartilage Paste Grafting Shows Promise
New Knee Repair Technique Introduced
Stent-Graft Improves Aneurysm Repair
Better Outcomes with Less-Invasive AAA Repair
CRT Devices Linked to Better Outcomes
Esophageal Stenting Found Effective

Developments

ISSYS Awarded Patent for Wireless Sensors
WorldHeart's LVAS Enters Key Phase in Animal Testing
Sorin to Launch Cobalt Chrome Carbostent
ATS Announces First Implant of Annuloplasty Ring
Medtronic's AAA Stent Receives FDA Approval
FDA OKs DexCom's Glucose Monitoring System
FDA Clears Bone Graft Product
Regeneration Technologies Launches New Implant
Online (HTML) Only:

MicroCHIPS Develops Wireless Drug-Delivery System
Cordis to Develop Cardiac and Vascular Institute
Nanogen Receives Clearance for CHF Test
Crestor Reverses Heart Disease
Biomet for Sale?
Orthopedic Companies Promote Knee Implants for Women
Pioneer Surgical, Encelle to Work on Spinal Fusions
FDA Approves St. Jude Closure Device
Protege by ev3 Receives FDA Approval

Related Tags: Medtech, Medical, Medcial-technology

High Growth Medical Technologies -- Add'l Opportunities

2006-04-25T13:47:00.000-07:00

Last week, I wrote the white paper, High Growth Medical Technologies, based on looking at different technologies I have seen and believe have excellent prospects for growth in the near term. I have since edited the white paper to not only clean up some typos but to also add a section on additional opportunities and to add a set of conclusions I see based on the nature of high growth technologies (where/how they derive, etc.). Nothing earth-shattering, but a few useful insights.

In the white paper, I also make reference to the Institute for Systems Biology, which I became aware about some time ago and for which I have great respect. This is the institute founded by Leroy Hood. In any event, I only made passing mention of this institute, but urge readers who aren't already aware of this multidisciplinary approach to biology to drill down further.

Related Tags: Medtech, Medical, Medcial-technology

CMS Medicare Cuts for Cardiac Devices Won't Fly (This Time)

2006-04-21T09:53:00.000-07:00

The proosal by CMS to reduce by up to 30% the reimbursement to hospitals for cardiac devices arises from a compelling need to reduce the clearly high costs associated with these devices (stents, defibrillators, etc.). Given the size of the proposed cuts, however, and their impact on device makers and hospitals, their negative reaction (see Boston Globe) was anything but surprising. The reality is twofold: the proposal will get scaled back moderately to significantly before a final rule, likely in October, and this CMS proposal is only the first shot fired in a volley regarding device costs. As I noted in my publisher's letter in the April MedMarkets, device manufacturers and healthcare systems alike have to recognize that the writing is on the wall.

Nanotech/MEMS in medicine (nanomedicine) companies

2006-04-20T13:24:00.000-07:00

This is preliminary(!) list of the companies involved in nanotech and/or MEMS with at least a minimum level of activity in applying the technologies to medical applications. This list was updated from a previous report by MMD, but still may included a number of companies (not yet edited out) who ultimately were unable to sustain the rampant, rabid optimism needed to drive investment in support of R&D in this area. We also will likely have a moderate to significant number of additional companies profiled.

Advanced Photonic Systems GmbH

Amersham Biosciences Corp

Anson Nano-Biotechnology Company Ltd

Aphios Corp

Aquamarijn MicroFiltration BV

Avidimer Therapeutics

Biocristal Ltd

Biodelivery Sciences International

Bio-Gate Bioinnovative Materials GmbH

Bionova Inc

Biophan Technologies

Biospectrum

C Sixty

Capsulation Nanoscience AG

CardioMEMS Inc

Digital BioTechnology Co Lts

DIOLAS Diodenlaser GmbH

Fairfield Sensors Ltd

Flamel Technologies SA

Genencor International

HealPlus International Inc

IGI Inc

ImaRx Therapeutics Inc

iMEDD Inc

Improvita Health Products Inc

Insert Therapeutics Inc

JenLab GmbH

JR Nanotech plc

Kereos Inc

Kliendieck Nanotechnik

Liplasome Pharma A/S

Magforce Applications GmbH

MagnaMedics GmbH

ManoMedica Inc

Micralyne Inc

Micromet AG

Micronics Inc

MicroTec Geselschafft fur Mikrotechnologie GmbH

MIV Therapeutics Inc

Molecular Profiles

Nanobac Pharmaceuticals Inc

NanoBio Corp

Nanobiotics

Nanobiotix

Nanocarrier Co Ltd

Nanocopoeia Inc

Nanogate Technologies

Nanogen Inc

NanoMed Pharmaceuticals Inc

Nanomix Inc

NanoPharma AG

Nanostream Inc

Nanosyn Inc

Nanotherapeutics Inc

Nanovax Inc

Newco Surgical

NOSE

Novosom AG

Nucryst Pharmaceuticals

Nutralease Ltd

Petnet Pharmaceuticals Inc

Pharmosol GmbH

Precision Optics Corp

Psvidia Ltd

Silex Microsystems AB

Skyepharma plc

Solubest Ltd

Spherics Inc

Spire Corp

Spinelix

Starpharma Pooled Development Ltd

Tecan Group Ltd

The report is about a week away, depending on how much additional content we feel meets the "absolutely-have-to-include-this" test. Related Tags: Nanotechnology, MEMS, Nanotech, Medical, Nanomedicine

Drug-Eluting Stents Update; plus Biotech Progress and Milestones

2006-04-19T16:55:00.000-07:00

The April 2006 issue of MedMarkets updates the market for drug-eluting stents. We also review the status of the biotech industry, considering a report from Ernst & Young (Beyond Borders: The Global Biotechnology Report) and other data on this ever-optimistic industry. (BTW, I found it particularly curious that the E&Y report referred to this year as the 30th anniversary of the biotech industry -- having once worked for one of the first biotechnology companies, Collaborative Research, which was founded in 1961, later named Genome Therapeutics and now known as Oscient Pharmaceutials, I guess biotech just measures time differently.)

Coverage in the April MedMarkets is outlined (and will be updated) on our archives page.

Lastly, thank you for those comments received on our all-too-brief, but apparently well received, "High Growth Medical Technologies" white paper. We are considering updating and expanding it in the near future.

Related Tags: Medical, Advanced Medical, Medtech, Medical Technology

High growth medical technologies

2006-04-13T16:12:00.000-07:00

The most rewarding aspect of tracking medical technology markets is witnessing the innovation that emerges as entrepreneurs device solutions to healthcare problems that sometimes providers didn't know exist (or at least couldn't put their finger on).

We put together a small white paper looking at some of the high growth medical technologies we see for the next few years, and probably beyond.
Related Tags: Medical, Advanced Medical, Medtech, Medical Technology

Diabetes markets (Type I & II)

2006-04-11T16:37:00.000-07:00

The market for products worldwide in the management of diabetes is the subject of an analysis done by MMD at the end of 2005. While a plethora of studies are available on markets for diabetes-related products, our analysis succeeds uniquely by looking at both established and developing technologies with a more critical eye and doing so in a global analysis.

Worldwide Diabetes Market 2004

Medications	$15,000 million
Diagnostic devices	$8,000 million
Insulin therapy devices	$275 million
Insulin pumps	$1,000 million
TOTAL	$24.3 billion

This $24 billion global market -- big enough as it stands -- represents only the tip of the potential market iceberg, for several important reasons.

For the majority of Type 2 diabetes, the adult onset segment, is an undiagnosed, untreated population

A huge pent-up demand exists for improved treatment due to the need for frequent testing (finger pricks) and insulin administrations (pen/syringe)

A huge payer demand exists for effective treatment (read high patient compliance) that reduces the incidence of costly complications

Advancements in diagnosis OR treatment that lead to (pick one) improved quality of life or reduced rate of complication leading to even a modest increase in the penetration of the Type 2 undiagnosed will be a huge boon to the market

So, the technologies being pursued with aggressive energy include:

minimally invasive glucose monitors (optical coherence tomography, ultrasonic, measurement, infrared, etc.)
closed loop pump/monitor systems ("artificial pancreas")
stem cells ("cure")

It is very diffiicult to discern between those analyses of the diabetes market that are largely driven by spreadsheet formulas and those that both grind out the hard numbers and apply real insight to determine the defensible timing and impact of technology developments.

Our intention and our belief is that our hard work has produced the latter.

Bioengineered bladders

2006-04-10T10:19:00.000-07:00

News came out last week (published in Lancet) on the successes achieved by well-known researcher Dr. Anthony Atala, professor at the Wake Forest Institute of Regenerative Medicine, in the development of pediatric bladders engineered from patients' own cells.

The development of bioengineered organs, which faces many technological hurdles but also holds tremendous promise, was part of our report, Tissue Engineering, Cell Therapy and Transplantation, published in 2005. There is lengthy waiting lists for organs of all types, and even those patients who are lucky enough to receive transplanted organs are then faced with the ongoing requirement to take immunosuppressive drugs to prevent rejection.

Dr. Atala envisaged the solution, but was stymied in bringing it to reality and is only now, after some 16 years of research, succeeding in being able to harvest the right patient cells, culture them ex vivo to grow from one million cells to 1.5 billion cells, apply them to a protein scaffold and reimplant them back in the patients.

Dr. Atala is on the Board of Directors for Tengion (http://www.tengion.com), a company developing the technology. From Tengion's website:

Tengion’s technology of creating a neo-organ, such as a neo-bladder, starts when a surgeon sends the patient's biopsy to Tengion. Tengion's scientists identify and multiply the patient's own healthy progenitor cells, and then place these cells on a structure that is shaped like the needed organ or tissue (a bioresorbable scaffold). The resulting neo-organ becomes ready for implantation after a period of maturation. The surgeon then implants the neo-organ in the patient's body, where it integrates with the rest of the body and becomes functional. By contrast, the current therapy for urinary bladder reconstruction, Augmentation Cystoplasty, dates from the 1890’s and is associated with acute and chronic risks and complications.

Organ replacements are a ripe area of development in the field of tissue engineering and cell therapy (again, see our report). The intrinsic value of bioengineering tissues/organs from the patient's own cells is unquestioned, given the organ shortages, the need for immunosuppressants and other constrains of organ donation, as noted.

What makes Dr. Atala's success noteworthy is that tissue engineering of this type is among the most promising of medical technologies insofar as its ability to dramatically change treatment options for serious diseases. The initial tissue engineering successes were limited to less complex anatomical structures, such as skin, but has been expanded to include bone, cardiac tissue and other tissues with more complex functional and structural roles. Moreover, Dr. Atala's work is like the "rising tide that floats all boats," in that the process of isolating the appropriate cell types, optimizing their conditions for growth and applying them to scaffolds or matrices to form the transplantable organ structures can be replicated by researchers focused on other organ types.

Startup Medtech Companies

2006-04-07T16:14:00.000-07:00

These are recent startups I am reporting on in the April issue of my newsletter. As always, there's no guarantee (or endorsement on my part) that any of these will succeed:

Company	Principals or Investors	Location	Technology	Founded
BeneChill, Inc.	MedVenture Associates, Prospex Medical	San Diego, CA	Non-invasive cooling technology for treatment of cerebral ischemia	2005
Bioasssessments, LLC	Peter Hyde, Christopher Hyde	Elkton, MD	Real-time angiotensin monitor for salt sensitivity	2006
Neotract, Inc.	New Enterprise Associates	Palo Alto, CA	Surgical urological devices	2005
NeuroLife Noninvasive Solutions	Daniel McChesney, MD	Pittsburgh, PA	Noninvasive device to accurately monitor brain pressure	2006

The newsletter is described here. The coverage in back issues is detailed here.

advanced MEDICAL technologies

2006-04-07T13:26:00.000-07:00

Am I the only one who gets frustrated when finding that most references to "technology" are limited only to discussions of computers? I know it's a combination of the investment industry (which in this respect seems remarkably lazy) seeking to simplify the world so that it can post prognostications without using many words . . . "technology stocks are up on positive news from Microsoft."

But for the love of Thomas Edison, technology isn't only computers! It's bridges, medical devices, rockets, medical devices, automobiles, medical devices...

What are you going to get more excited about, a piece of hardware that can ultimately only handle or transfer information in some unique way, or a medical device that saves a life or even just dramatically improves it?

People innately don't undestand medicine and they can't be faulted for it. At the same time, it is inherenly in the interest of physicians to mystify the science. Instead of saying, "your child is bleeding from the lungs and we don't know why," they say, "your child has a confirmed diagnosis of idiopathic pediatriac pulmonary hemorrhage".

But there is good information out there, and it's getting better just as the healthcare consumer is yearning for it. Now, I'm pretty healthcare savvy, but when people call me up and ask what I think of some obscure symptom, I suggest (after telling them to call their DOCTOR) they take a look at WebMD. As for sites that are less, consumer-oriented, I like sites like MedGadget, for the fact that the site's authors are (apparently) a group of young MDs and that this leads them to a youthful enthusiasm for new stuff, even an appreciation of the technologies' missteps (see Patently Silly which I came across awhile back and recently saw on MedGadget's site) and others. If you're in the medical product industry, however, I absolutely have to recommend my own site, MedMarket Diligence.

Micro and nanotech medicine

2006-04-07T12:14:00.000-07:00

We're working on finalizing this report. It shouldn't be a surprise to anyone who has looked at the nanotech "industry" over the past couple years (we did a report three years ago) that it is the most hyped, promise-filled industry that has kept forestalling investors and any other interested parties from seeing concrete successes. Producing a report on this subject that achieves even the least resemblance to realistic timelines or realizable potential demands a diligent, critical eye to filter out the unlikely-to-ever-be-fulfilled potential.

Having said that, even the most conservative analyst would have to look at this industry and recognize that, REVENUES ASIDE, the industry is exploding with activity. The number of companies pursuing applications in nanotech and MEMS is huge. When you then distill the content down to focus only on those in the medical arena, the numbers are still huge.

There is revenue, too, and it is growing steadily toward that hockey stick upward shot that will take place, well, I'm not saying yet... We're still applying our analysis and tracking multiple technologies approaching the launch pad.

* * *

Micro- and Nano-Medicine: Technologies, Applications, Industry, and Markets Worldwide

April 2006

Report #T625

· 250 pages · 45 Exhibits · 72 Company Profiles · Pub. Date April 2006 · Report #T625

The Report will be a detailed assessment of the products and technologies under development in the nanometer scale and micrometer scale levels with clinical applications, and an assessment of the market potential for products/technologies to be successfully commercialized for use in clinical practice within a ten year forecast period. This assessment will identify the technological, market, regulatory or other hurdles to be crossed en route to commercialization. The report will provide particular emphasis in detailing the current activities and status of product development at active companies. The analysis will be directed toward revealing specific opportunities for current or hopeful competitors.

Our VC tracking URLs

2006-03-29T07:44:00.000-08:00

These are some of the VC and other sites we track to keep an eye on new investments and new technologies in order to identify formation of new medtech companies.

http://www.atvcapital.com/portfolioGroup.php?id=9

http://www.aperturevp.com/portfolio.htm

http://www.arcapita.com/corporate/current/current-healthcare.html

http://www.canaan.com/portfolio_life.html

http://www.carecapital.com/companies.asp
http://www.dpbioventures.com/

http://www.domainvc.com/Portfolio.asp?Filter=A
http://www.frazierhealthcare.com/portfolio/index.asp
http://www.goldenpineventures.com/portfolio.htm
http://www.herculestech.com/portfolio/portfolio.asp?CompanyID=3225&IndustryID=15

http://www.denovovc.com/portfolio/index.html
http://www.wispartners.com/

http://www.kpcb.com/portfolio/portfolio.php?lifescience

http://www.lifescienceangels.com/content.php?cid=1013
http://www.magicvc.com/portfolio/index.html

http://www.masonwells.com/Portfolio.htm

http://www.massmedic.com/members_primary.htm
http://www.nea.com/PortfolioCompanies/Healthcare/Devices/index.cfm?&SA=1

http://www.nlvpartners.com/portfolio.html#medical
http://silk.nih.gov/public/cbz2zoz.@www.sbirsttr.fy2006.txt
http://www.northbayangels.com/pages/DealsDone.jsp

http://www.onset.com/portfolio/index.html

https://www.pequotventures.com/portfolio/healthcare.html

http://www.pitango.com/portfolio.asp

http://www.polarisventures.com/Portfolio/ViewBySector.asp#

http://www.pwcmoneytree.com/moneytree/nav.jsp?page=industry
http://www.prismventure.com/portfolio/lifescience.asp
http://www.radiusventures.com/healthcare_industry.asp
http://www.tvmvc.com/site/lsportfolio.php
http://www.threearchpartners.com/html/portfolio.html
http://www.tmvp.com/Portfolio.html
http://www.tricardia.com/

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Startups Redux

2006-03-21T15:33:00.000-08:00

In my previous post, I went generous and added the startups I planned to include in our March publication. I hav subsequently realized I was being too generous, as I keep finding out that many people in the medical product industry are clamoring for new technology/ideas, but (partly because of the interest) the small medical technology companies are increasingly inclined toward stealth. SOOO, it behooves me to try to recoup the costs I have incurrent in my hard-earned effort at ferretting out these little company gems. So, I've published a compilation of the startups I have identified who have been founded from January 2005 to March 2006.

As good readers of this blog (sigh), I will be more than happy to reward you with occasional free listings of those companies.

See the new Startup report/listing described here.

Some new startups (wink)

2006-03-15T12:10:00.000-08:00

Normally, I would not do this (add subscription content to this blog), but I thought I would drop a list of some new companies (from my Startups table in MedMarkets that I publish every month). Here are the ones from the upcoming March issue. For reference, my goal is to find companies that have been founded in the past month (not when they say they were founded, but when their corporate filings were done -- a harsher measure of how "new" they are). Sometimes I'll go a little farther back and publish on companies who have done an exceptional job at staying in stealth mode, but who have suddenly become apparent to me. If they are new to me (I am constantly looking), then maybe my customers haven't heard of them either.

Company	Principal	Location	Product/Technology	Founded
Aragon Surgical, Inc.	Onset Ventures	Palo Alto, CA	Surgical device platform designed to reduce OR time	2005
EpiTeK, Inc.	Jean Paul Rasschaert	Pittsburgh, PA	Minimally invasive device to prevent strokes in atrial fibrillation	2004
i25tech, Inc.	John Dunning, President	Santa Fe, NM	Undisclosed device for treatment of a variety of diseases	2005
Keramed, Inc.	Yichieh Shiuey	Cupertino, CA	Device for facilitating corneal transplantation	2005
Oringen, LLC	John Krusinski, President & CEO	Tallmadge, OH	Liquid crystal sensor for bacteria and viruses	2006
Transtimulation Research, Inc.	Jiande Chen	Oklahoma City, OK	Intestinal pacing for obesity	2005

Aragon Surgical, LLC — Palo Alto, CA; no URL
EpiTeK, Inc. — Pittsburgh, PA; http://epitek.com (under construction)
i25Tech, Inc. — Santa Fe, NM; http://i25tech.com (under construction)
Keramed, Inc. — Cupertino, CA; http://keramed.com (under construction)
Oringen, LLC — Tallmadge, OH; no URL
Transtimulation Research Inc. — Oklahoma City, OK; no URL

Cartilage paste, devices, commerce and optimism

2006-03-09T12:03:00.000-08:00

In the healthcare arena, I keep finding it amazing how so many technologies that are different in so many ways are changing the definitions of what constitutes a medical device. I came across this article on cartilage paste in March issue of Arthroscopy: Journal of Arthroscopy–Related Surgery. Now, while this is not a new technology, it does represent the kind of marriage of technologies that happens frequently these days in the medical field. I then came across details of a Tallmadge, OH, company called Oringen, which has licensed a technology (from Northeastern Ohio Universities College of Medicine and Kent State University) to be developed into a liquid crystal sensor for detection of bacteria and viruses (Pathogen Detection Systems of Boulder, Colorado, has also licensed the technology).

I am not an obligatory cheerleader for technology, because I really do believe that in the U.S. we have spent far too much on healthcare without it producing the intended or necessary improvements in quality of life. Too frequently, "innovations" have just resulted in higher premiums for us all. However, when you consider the steady progression of materials technologies, nanotechnologies, cell/tissue engineering technologies, the development of drug/device hybrids and other technologies, it becomes difficult to imagine a clinical problem that isn't destined to be solved by medical technology. This may be wildly optimistic and ignore the lessons of history, but this sense of optimism is the driving force (that, and its associated commercial success!) behind the great diversity of medical technologies being pursued in different applications.

And the winner is...

2006-01-25T07:26:00.000-08:00

In a final move that seemed (at least in the eyes of some industry analysts) as likely to be designed to increase J&J's price tag for the acquisition of Guidant as it was an actual competitive bid, Boston Scientific had this month upped its bid to $27 billion ($80 per share), and when the midnight (January 24) deadline passed without J&J responding with another offer, it now appears likely that the winner in this bidding war will be Boston Scientific. Guidant has accepted Boston Scientific's offer and terminated the agreement to be acquired by J&J. For its part, J&J issued a statement saying, "it had determed not to increase its last offer for Guidant Corp., because to do so would not have been in the best interest of its shareholders."

Confidence is high in the likelihood of BSX making a success of this, given the related deal with Abbott (to acquire Guidant's vascular business), the fit with Boston Scientific and, at least in general, the relative value of the acquisition price tag and the Guidant revenue streams and balance sheets. But one has to give pause to this and consider several points:

J&J is as experienced in acquisitions as any monolith out there and it viewed the $27B price tag as too high. Do they know something that BSX doesn't?
BSX and J&J have been bitter rivals in the DES market and one can't help but wonder if the rivalry hasn't clouded BSX's judgment, making this little more than a pyrrhic victory for BSX. A loss for J&J does not equate with a win for BSX.
The combined BSX/GDT business now has $12 billion in debt, a hefty burden that can only be lightened by market performance (oh yes, see "Guidant Defibrillator Recalls").

It's very hard not to think back to the Time/Warner acquistion of AOL, and in that case Time/Warner did not have a competitor who balked at the value of the deal, and we all know how well the AOL acquisition worked for T/W.

Guidant ping pong

2006-01-12T08:03:00.000-08:00

In the latest turn in the burgeoning bidding war over Guidant between J&J and Boston Scientific, Guidant on Wednesday accepted J&J's $23.2 billion acquisition offer, but Boston Scientific has indicated it is not yet walking away from the deal. Moreover, Guidant has expressed to Boston Scientific that it is willing to consider additional talks and a better offer, and it is entirely likely that Boston Scientific will, given the $14 billion in funding available to them from banks who have agreed to help finance the deal.

Both sides appear prepared to really go to the mat on the deal, which further supports the likely significance of "winner's curse", in which the ultimate acquirer ends up paying more for the deal than they should. Already, J&J has offered to pay $1.9 billion more than it offered in November, when it had then dropped the price to $21.9 billion as a result of the recalls that, in J&J's views, had effectively reduced the value of Guidant. Of course, the $1.9 billion premium does not reflect any added Guidant value, but instead represents the price J&J is attempting to pay to take Boston Scientific out of the game.

One has to wonder, in this high stakes poker game, if one or both players recognizes that the goal is not to acquire Guidant but to make the other pay more than necessary while improving the likely terms to acquire the alternative ICD player, St. Jude.

Growth in Bone Graft Substitutes

2006-01-06T11:56:00.000-08:00

The bone graft substitutes market, comprised of synthetic bone graft substitutes, demineralised bone matrices (DBMs), and bone morphogenic proteins (BMPs) is the subject of a report we have added from a well regarded U.K. based analyst, Dr. Nelesh Patel. The report details products, applications, companies and the associated markets in the U.S. and in major Western European countries. The report is described here.

Nanomedicine material science to structural engineering

2006-01-02T07:36:00.000-08:00

In our December '05 issue of MedMarkets, we addressed applications, products and companies developing nanotech and MEMs (microelectromechanical machines) in medicine. There we address applications and companies focused on nanomedicine developments in biosensors, pacemakers, implantable pumps, personalized medicine, drug delivery, cancer therapeutics and diagnostic systems.

From a macro view, it is worthwhile to step back and look at the migration of nanotechnologies from the more purely materials science, in which nanoparticles or nanosurfaces are developed to provide properties intrinsic to such small scale, toward structurally engineered products at the nanoscale, including nano products that provide the more complex sensor-type performance or even beyond, with specialized structural and functional components.

By comparison to a prior analysis that we provided on nanotech and MEMs, this developmental trend has become more pronounced, illustrating the growing sophistication of the science. In our current analysis, a limited, but fairly representative sample of companies suggests the following current distribution of the essential functional characteristics provided by the nanotechnologies being developed, as measured by the simple frequency of companies:

particle/surface: 64%
analysis: 8%
functional structure: 28%

By "particle/surface", we mean products that are nanoparticle, nanoparticle coating or other products based simply on nanoscale materials.

By "analysis", we mean products designed to reveal structure or function at the nanoscale level, rather than products that are themselves nanoscale or that provide analytical (e.g., sensor-based) functions at the nanoscale.

By "functional structure", we mean those products that are themselves nanoscale in simple or complex structure (i.e., beyond surface coating) providing functional performance beyond nanoparticles as materials.

In this, we have seen, even in the past two years, an impressive increase in nanotechnologies in the functional structure category, the most advanced of nanotechnology development. Indeed, the predominant types of nanotech products, both in nanomedicine applications and in the broader applications, fall in the area of particle and/or surface-based nanotechnologies, in which there is little or no performance of nanotech beyond that provided materials science. In nanomedicine, this particle/surface category, even cursorily surveyed, stands at 64% of the nanotech companies.

This is not to say that nanotech development necessarily has as its endpoint (in ultimate market potential) the development of complex nanostructures. Tremendous market potential may well reside in nanotech as surface coatings (let's remember what coatings did to the stent market), whether for devices or for pharmaceuticals. Impirically, there are more challenges in the development and testing of complex nanostructures than in the development of nanosurfaces. But there may also be nanoscale applications of complex nanostructures that we have envisioned neither technologically nor from a market potential.

If there is a take home message (sorry to have taken so long to get here), it is that the survival-conscious device manufacturer has recognized that nanotech is an area that it cannot afford to ignore. Over the next 1-2 years, witness the number of developmental, investment or other deals involving device companies and nanotech companies.

Stealth medical technologies

2005-12-21T07:04:00.000-08:00

The need to keep innovation under wraps until it has been allowed to develop enough to maximize the value is driving more and more companies to eschew any kind of promotion until they are actively seeking investment to formally bring the technologies out into the open as part of market introduction.

At least by our anecdotal evidence -- in the number of companies who we identify (by corporate filing or otherwise) but who have successfully avoided disclosing the nature of their technology anywhere.

There is a change in the dynamics at work here. It is doubtful that it is a diminution of hubris among entrepreneurs that is undercutting self-promotion, since pride is the trait that sets them out on their own in the first place. It is instead the result of at least two forces: (1) tacit recognition that with funding comes insidious influence to be studiously avoided until absolutely unavoidable and (2) tacit recognition that the hunger is great enough for new technologies that the innovator can take greater risk in funding from the 3F's before seeking formal investment at market introduction.

Of course, we have ways of piercing the stealth veil, and we're getting better at doing so.

St. Jude must be next

2005-12-08T08:24:00.000-08:00

St. Jude Medical is number 3 in the rhythm management market, behind Guidant (#2) and Medtronic (#1), so when either J&J or Boston Scientific lose out in the grab for Guidant as their new rhythm management acquisition, where are they going to look next? It’s not likely to be Medtronic, with a $70 billion market valuation.

What is St. Jude’s stock price likely to do?

The door is still open for BSCI on Guidant

2005-12-07T14:23:00.000-08:00

Following the surprising (but not shocking) offer yesterday by Boston Scientific to buy Guidant for $25B, upping the deal by $3.4B over J&J’s renegotiated deal, Guidant is agreeing to cooperate with Boston Scientific’s review of Guidant as a precursor to finalizing the $25B offer. This could be viewed as Guidant simply going through the motions, but since J&J has indicated that it still sees $21.5B as “full and fair value” for the deal (see NYT today) and J&J Chairman William J. Weldon’s statement as such did not mention Guidant shareholders, it’s a fair bet that in short order there will be a sweetener added to the deal, lest Guidant shareholders demand more.

Even though the burden on Boston Scientific would be extreme, quadrupling its debt burden, the opportunity to jump into the $10 billion pacing/defib market would give it a boost it needs. Although Taxus has doubled the company’s earnings in each the last four quarters, the company’s stock price has slipped by 42% as investors have been itching for the company to come up with the next big thing after Taxus.

Even without Guidant in the picture, I have every reason to believe Boston Scientific and J&J are both developing and looking for just such a thing.

Boston Scientific Rebuffed? on Guidant

2005-12-06T10:17:00.000-08:00

Boston Scientific’s offer of a $3.4B premium to buy Guidant over J&J’s offer was initially rebuffed today by Guidant, who signalled that it was opting to stick with the newly reworked $21B+ deal with J&J. Boston Scientific clearly recognized the market value of picking up Guidant (at J&J’s expense), even with the stent divestitures that would have been mandated. Guidant shareholders will vote on the deal in 1Q 2006.

(It appears likely, however, that Guidant may well consider the Boston Scientific offer. An additional $3.4 billion should more than cover the legal costs of getting out of the J&J deal (!).)

Boston Scientific and J&J remain in a pitched battle over share in the drug eluting stents sector, which will be joined in the next 1-2 years by not only Guidant, but Medtronic, Abbott and a healthy list of others.

TCT data

2005-11-28T12:05:00.000-08:00

We report in the November issue of MedMarkets on trials, products and competitor activity at this year's TCT meeting. A great deal of the drug-eluting stent data from the trials demonstrates no appreciable difference between J&J's Cypher and Boston Scientific's TAXUS stents. There are differences in efficacy, some very supportable in the trial data, but there are also differneces essentially in marketing. Boston Scientific has taken the aggressive share-protection step of coming up with its "Taxus Stent Assurance Program" (from our November issue):

In an unusual move—and after a recent decline in market share due to a perception that Cypher has a safer profile—Boston Scientific offered a guarantee in the form of its “TAXUS Stent Assurance Program.” If any patient receiving a TAXUS Express2 stent requires reintervention due to in-stent restenosis during calendar year 2006, the company will provide a replacement stent at no charge.

We also cover embolic protection, a big market that has been developing for some time, and may soon be growing at a much faster clip.

Medical product industry investment making a turn

2005-11-22T07:57:00.000-08:00

Healthcare product (medical device and biotech) investment, like all investment in the past four years, has been pinched, but not so much as one might believe. The total investment has been relatively stable, and in fact has increased recently in the both the aggregate and for medical devices specifically. What is more the case with investment in the post-9/11 and post dotcom era is the conservative shift in that investment, notably a shift in investment from earlier or expansion stage of company development to later stage investments. We’ve talked about this before. (Perhaps the most telling aspect over the past four years has been that MedMarket Diligence experienced a big increase in information purchased from the investment community, apparently no longer satisfied solely with their own research.)

The conservative shift is waning, however. We’ve read the tea leaves and see signs (numbers of deals, size of the deals, and numbers of startups forming) that opportunity-hungry investors are ready to take more chances.

Expect the following to happen in 2006 – barring any unforeseen global event (let’s be safe, but let’s also live our lives!). Aggregate investment in healthcare products will take a healthy jump, with a measurably bigger share going to medical devices, and investment will shift back upstream in the development cycle. Many more deals, at bigger average investments (i.e., $10 million each).

The ideal author

2005-11-18T10:24:00.000-08:00

I’ve often been asked what makes a good author of the reports we publish. My answer comes as the result of the truth having been pounded into me repeatedly over the past 20 years (I have lots of scar tissue).

The ideal author has:

10-20 years in the industry about which they will write
Experience in that industry in senior management or VP/Director level roles in marketing/sales or business development
Diligence research capabilities to ensure that 99% of the market is considered, not 80% or 70%
Demonstrable analytical skills to prioritize the relevance of data (i.e., wade skillfully through the BS), identify important trends (besides the “aging population”), reveal opportunities (I have to force even the best to do this), and otherwise give insightful conclusions.
Good-to-excellent writing skills. It doesn’t matter if they can research among the best if they can’t put it in words. I can and will edit extensively to bring out the best, but the content has to be good enough to start with so that I’m not writing reports for authors.
Acceptable computer skills. It’s maddening to have an author who has skills 1-5 above, but doesn’t know how to back up his/her files, doesn’t run anti-virus software or is running Windows 95.
Je ne sais quoi: At some point during my initial interview with an author, I can identify whether the author has that certain “something” that I want or has that certain “something” that I know will prohibit them from doing a good report. My instincts have proven themselves in the long run.

This is a REAL challenge. If I am going to publish studies that will command the prices they do, it’s imperative that the authors fit the bill. If I have to compromise on any of these, I know I will pay for it (one way or another) in the long run. I have therefore learned to take it on the chin and decline prospective authors when the truth is plain to me.

Who doesn’t fit this bill:

Anyone who says, “I’ve always wanted to write. I think it will be fun.” You’d be surprised how often this comes up.
Almost anyone with the letters PhD behind their name. Don’t get me wrong, I’ve had a couple great PhD authors, but among the worst prospects were those with this degree. The failing is simply the tendency toward ivory tower thinking and the lack of direct industry experience or relevant analytical skills in business.
Anyone who says, “Now where do I get the market data to do this report?”
Technical writers (convinced though they may be about how well qualified they are)
Medical marketing brochure writers (certain they may be that brochure experience = report authoring skill)
Anyone who has written for specific other report publishers ---- [censured by lawyer].

I could go on, but it’s too exasperating to think how often I have to say no.

Novel technologies in diabetes management

2005-11-17T12:26:00.000-08:00

A glimpse of newer technologies in diabetes management (from http://www.mediligence.com/rpt-d500.htm).

Pancreas transplants
Islet cell transplants
Stem cell developments
Antibody treatment
Vaccines
Genetic approaches (genetic testing, SiRNA)
Novel drugs (DDP-IV Inhibitors, NN-14, Rimonabant)
Continuous glucose monitoring (electroenzymatic sensor, optical sensor, carbon nanotube sensor)

Aggressive medtech development in lieu of perfect solutions

2005-11-16T23:05:00.000-08:00

In reviewing a past report we produced on the management of obesity, which was addressed more recently in our October issue of MedMarkets, I was struck by the proliferation of companies pursuing surgical device solutions to obesity. These include variants of the gastric band approach, which simply reduces gastric capacity. The market for these devices has burgeoned in the past couple years, and is expected to grow aggressively. Why? For one, the stigma of obesity is fading as it is being viewed in the popular press more as the result of pathology than character flaw. This has opened the floodgates to people seeking a surgical solution. Reimbursement (not my forte) has at least not been an impediment. But why all the device development? This is a classic device-centric pathology; the stomach is a structure whose capacity can be readily reduced through gastric banding, it is a relatively simple surgical procedure and produces the immediate effect of reducing intake of food. This is, of course, also the rapid adoption phase of a market, and it is difficult (short of available long term data on approved devices – especially since most devices are not approved in the

U.S.

, yet) to see the downside.

It would be misguided of me to not acknowledge that devices are rarely (ever?) perfect solutions to pathology. But, I also recognize the tremendous potential for devices to achieve solutions that increasingly raise the barrier to the development of biotech/pharma/biopharm solutions to pathology, because devices, imperfect or limited in functional performance or fit with the premise of “rational therapeutics” though they may be, they are available now and are achieving solutions sine qua non.

Technologies among newly identified startups

2005-11-16T13:28:00.000-08:00

Newly identified companies developing advanced technologies in medical/surgical applications:

» Medical device based treatment for obesity (Newport Beach, CA)
» Treatment of intervertebral disc via conduits to restore nutrient/waste exchange (San Jose, CA)
» Beating heart bypass technology (Fullerton, CA)
» Diagnostic device to detect arteriosclerosis (Misgav, Israel)
» Surgical and percutaneous treatment of cardiac valve and CHF (Ft. Lauderdale, FL)
» Undisclosed minimally invasive surgical technology (Menlo Park, CA)
» Image guidance for open liver surgery (Nashville, TN)
» Surgical device (Menlo Park, CA)
» Dialysis on a microchip (Cambridge, MA)
» Surgical product development of implants, instrumentation and surgical devices (Mission Viejo, CA)
» Endoluminal platform technology for gastroenterology and uro/gyn (Ayer, MA)
» Fluorescence spectroscopy for diabetes screening (Albuquerque, NM)

Company details in the November MedMarkets.

J&J Can Absorb Guidant

2005-11-16T11:54:00.000-08:00

Johnson & Johnson has already demonstrated an incredible propensity to acquire and aborb companies, managing them at arms length and making them succeed. That J&J and Guidant renegotiated their deal, at $4B less than originally negotiated last year, speaks volumes about J&J's ability to "absorb". I was frankly surprised to have to wait until Tuesday (Nov. 15) to learn that a new deal had been struck following the Friday announcement that the original deal was not going to fly. Guidant's recall woes can be dealt with (if you're J&J). The underlying asset base and technology portfolio is sound. J&J will certainly come out of this with a new foothold in pacemakers plus $4 billion extra cash. We give an update on the latest developments in our November MedMarkets.