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:
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    • 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:
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    • 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:
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        • 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
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    • 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:
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        • 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

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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.

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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.

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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.

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

  1. A huge pent-up demand exists for improved treatment due to the need for frequent testing (finger pricks) and insulin administrations (pen/syringe)
  2. A huge payer demand exists for effective treatment (read high patient compliance) that reduces the incidence of costly complications
  3. 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
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” as if by their multisyllabic discourse they have gotten a firm handle on the problem.

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.