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
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
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.
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.
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
Aquamarijn MicroFiltration BV
Biodelivery Sciences International
Bio-Gate Bioinnovative Materials GmbH
Capsulation Nanoscience AG
Digital BioTechnology Co Lts
DIOLAS Diodenlaser GmbH
Fairfield Sensors Ltd
Flamel Technologies SA
HealPlus International Inc
ImaRx Therapeutics Inc
Improvita Health Products Inc
Insert Therapeutics Inc
JR Nanotech plc
Liplasome Pharma A/S
Magforce Applications GmbH
MicroTec Geselschafft fur Mikrotechnologie GmbH
MIV Therapeutics Inc
Nanobac Pharmaceuticals Inc
Nanocarrier Co Ltd
NanoMed Pharmaceuticals Inc
Petnet Pharmaceuticals Inc
Precision Optics Corp
Silex Microsystems AB
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.
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.
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).
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
Insulin therapy devices
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:
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.
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:
Tengionâ€™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 1890â€™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.
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.