Cardiovascular Drug-Eluting Stent Developers, Products, Status

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

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

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)

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

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

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

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)

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.

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


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


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


4. 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

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

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

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

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.