Meanwhile, American Medical Systems Corners a Market

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.

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Megatrends in Medical Technology

(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.

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Categories on medtech companies tracked

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.

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Cardiovascular Drug-Eluting Stent Developers, Products, Status

Developers of Cardiovascular Drug-Eluting Stents

CompanyStent DrugStatus
Abbott Vascular DevicesZoMaxxZotarolimusIn clinicals; ZOMAXX II trial approved 6/05
Avantec Vascular (Goodman)DuraflexPimecrolimus In development
Biosensors InternationalBioMatrixBiolimus A9In trials; Expects CE Mark in 2006
Boston ScientificTaxus Express2PaclitaxelCE Mark 1/03; FDA approval 3/04
Boston ScientificTaxus LibertéPaclitaxelCE Mark 9/05 (launched 1/05); FDA approval expected mid-2006
Conor MedsystemsCoStarPaclitaxelCE Marked 2/06
Conor Medsystems(Next-generation CoStar) PimecrolimusPimecrolimus licensed from Novartis in 3/06; Testing two devices: one loaded with pimecrolimus and another with both pimecrolimus and paclitaxel
Cordis (J&J)CypherSirolimusCE Mark; FDA approved, U.S. launch 4/03
CordisCypher SelectSirolimusCE Mark in 2003
CordisCypher NeoSirolimus In development
CorNova(Undisclosed)(Undisclosed)In development
DevaxAxxess Plus (bifurcated)Biolimus A9In clinicals (positive first-in-man data reported 11/05)
DISA VascularStelliumPaclitaxelIn development
Estracure/Medivas/Picarus(Undisclosed)17-(beta)-EstradiolIn development
GuidantXience VEverolimusCE Mark 1/06; European launch pending
MedtronicEndeavorZotarolimusCE Mark 7/05; U.S. launch planned in 2007. RESOLUTE trial began 12/05
Occam International (subsidiary of Biosensors International)AxxionPaclitaxelCE Mark 7/05
Relisys Medical Devices(Undisclosed)PaclitaxelIn clinicals
Sahajanand Medical Technologies (SMT)InfinniumPaclitaxelCE Mark 12/05
Sorin Biomedica CardioJanus FlexTacrolimusCE Mark; launched in Europe 2/06
TerumoNoboriBiolimus A9Clinical trial launched 6/05
X-Cell MedicalEthos17-(beta)-EstradiolIn clinicals
XtentXtentBiolimus A9In 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, LLCRelated Tags: , ,

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:
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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
  •  
    • 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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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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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.

Our VC tracking URLs

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/
http://www.usvp.com/home.html

http://www.devicelink.com/links/venture.html
http://www.versantventures.com/portfolio.html
http://www.wfdventures.com/index.html

Novel technologies in diabetes management

A glimpse of newer technologies in diabetes management (from http://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)