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
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
- BioSantÃ© 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
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
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).
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.
Developers of Cardiovascular Drug-Eluting Stents
|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|
|Taxus Express2||Paclitaxel||CE Mark 1/03; FDA approval 3/04|
|Taxus LibertÃ©||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,
|Cordis||Cypher Select||Sirolimus||CE Mark in 2003|
|Cordis||Cypher Neo||Sirolimus||In development|
|Devax||Axxess Plus (bifurcated)||Biolimus A9||In clinicals (positive first-in-man data reported 11/05)|
|DISA Vascular||Stellium||Paclitaxel||In development|
|Guidant||Xience V||Everolimus||CE Mark 1/06; European launch pending|
|Medtronic||Endeavor||Zotarolimus||CE Mark 7/05;
|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
|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,
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
- FDA Approves St. Jude Closure Device
- Protege by ev3 Receives FDA Approval
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.