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LEAD STORIES |
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At TCT, New Studies Support Drug-Eluting Stents
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After experiencing a serious downturn caused by concern over possible links between drug-eluting coronary stents and late-term thrombosis, the market for such products has been steadily recovering throughout 2008. That trend toward recovery received another boost in October, with the release of new studies reported at the Transcatheter Cardiovascular Therapeutics Conference (TCT) in Washington, DC.
Stone |
The clinical studies revealed at the conference generally concluded that drug-eluting stents are safe and do not increase the incidence of major adverse cardiac events as compared with bare-metal stents. More importantly, the TCT studies generally affirmed the long-held belief of interventional cardiologists that drug-eluting stents are significantly more effective than their bare-metal counterparts for combating restenosis, or reclogging of the artery.
“These results provide definitive evidence that drug-eluting stents are superior in efficacy to bare-metal stents and have a comparable safety profile at one year,” said Gregg W. Stone, MD, professor of medicine and the director of research and education at the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical Center. [More] New FTC Exemption a Boon to Healthcare Providers, Pharmaceutical Companies, and DME Suppliers
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Winslow
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At the end of August, the Federal Trade Commission announced amendments to its telemarketing sales rule. The new amendments prohibit all prerecorded telemarketing sales calls, but create a limited exemption specifically for calls subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In this issue, Daniel B. Winslow and James Kossuth of the law firm of Duane Morris LLP (Boston) explain how the new exemption came about—and what it will mean to medtech companies.
The exemption should come as a great relief to healthcare providers, durable medical equipment suppliers, and companies that make calls on their behalf. Without the exemption, medical device manufacturers, pharmaceutical companies, and health-related providers would have been effectively barred from using the latest technology to contact customers or patients. Such a prohibition would have hobbled industry efforts to recall products, issue reminders or warnings about medicines, or even to check on the health and welfare of customers in areas affected by natural disasters. [More] Shopping for Value
Brennan |
Recent visitors to New York’s Fifth Avenue or San Francisco’s Union Square have noticed the large number of foreign tourists shopping, snapping up bargains in (to them) cheap U.S. dollars. Economists attribute the crowds of eager tourists to a combination of the strength of foreign currencies versus the dollar, and a reduction in domestic buyers due to the poor U.S. economy.
Much the same is happening in the healthcare technology marketplace: foreign investors are finding many attractive values in U.S. companies. In this issue, James R. Brennan, managing director of VirtualCDO (Great River, NY), an M&A and corporate development advisory firm, discusses how foreign investors are moving in to seize on acquisition opportunities in the U.S. medtech marketplace—and what that trend portends for 2009. [More]
VC Confidence Hits All-Time Low
Cannice |
A recurring measure of confidence among West Coast venture capitalists has confirmed what every market watcher already knows: market conditions look pretty bleak in every direction. According to the Silicon Valley Venture Capitalist Confidence Index for the third quarter of 2008, confidence among VCs registered 2.89 on a 5-point scale (with 5 indicating high confidence and 1 indicating low confidence). This reading fell from the previous quarter’s reading of 3.07 to a fourth consecutive new low since the index began in Q104, and indicates a continuing downtrend in venture capitalists’ confidence.
The index report is prepared quarterly by Mark V. Cannice, PhD, associate professor of entrepreneurship and the executive director and founder of the entrepreneurship program at the University of San Francisco. The report is based on an ongoing survey of San Francisco Bay Area and Silicon Valley venture capitalists. The index measures and reports the opinions of professional venture capitalists in their estimation of the high-growth venture entrepreneurial environment in the San Francisco Bay Area over the next 6–18 months. [More]
Midwest Healthcare Start-Ups Attract Record Level of Venture Investment
Shah |
In spite of the spreading financial crisis affecting economies around the world, venture capital firms are still finding attractive investment targets among early-stage medical device companies in America’s heartland. During the third quarter of 2008, in fact, medtech companies captured more than half of the venture dollars invested in Midwest life sciences start-ups.
During the quarter, Midwest healthcare start-ups reported a record-breaking $455 million in new investments, according to the Midwest Health Care Venture Investment Report. The report was released In October by BioEnterprise (Cleveland). “Despite the broader economic downturn, Midwestern healthcare start-ups continue to attract record levels of venture,” said Baiju R. Shah, president of BioEnterprise. [More]
Analysis: PTO Should Deny Abbott’s Patent Extension for Rapid-Exchange Technology
Portnow |
At the beginning of July 2008, Abbott Cardiovascular Systems Inc. (ACS), a division of Abbott (Abbott Park, IL), received FDA premarket approval to commercialize its long-anticipated Xience V everolimus-eluting coronary stent system. Shortly thereafter, the company filed an application for a patent term extension on its key patent for rapid-exchange catheter technology. If ACS’s application is granted, it would extend the company’s monopoly almost three years—until May 24, 2011—enabling it to continue preventing other medical device manufacturers—most notably, Medtronic—from using the technology.
In this issue, Doug Portnow, Annie M. Rogaski, and Mark D. Barrish of the law firm of Townsend and Townsend and Crew LLP (Palo Alto, CA) explain the importance of Abbott’s patent on rapid-exchange technology—and why the company’s application for an extension should be denied. [More]
Industry Organizations Unite to Define Massachusetts Gift Ban
Sommer |
The so-called ‘gift ban’ passed by the Massachusetts legislature at the end of July has kept the medical device industry buzzing for several months. In anticipation of the final shape of the implementing regulations, industry watchers have kept themselves busy with speculation about the effects of the legislation. According to Tom Sommer, president of the Massachusetts Medical Device Industry Council (MassMedic), representatives of the association have met with state public health and economic development officials throughout the past several months to express concerns with the restrictions contained in the new law.
Those efforts were expanded at the beginning of October, when Sommer joined with chief executives of industry associations AdvaMed, the Medical Device Manufacturers Association (MDMA), and the Medical Imaging Technology Alliance (MITA), to compile a list of industry-specific issues and recommendations relating to implementation of the gift-ban law. The recommendations were delivered with a letter to Department of Public Health Commissioner John Auerbach, whose office is now reviewing the law and developing the implementing regulations. [More]
Supply-Chain Survey Reveals Key Industry Concerns
Hook |
A survey to find out more about how healthcare companies are handling key supply-chain issues was recently conducted by UPS (Atlanta, GA), a global provider of healthcare logistics and transportation services. Targeting top supply-chain decision makers in the pharmaceutical, medical and surgical device, and biotech industries, the 2008 “UPS Pain in the Healthcare (Supply) Chain Survey” found that global market access is emerging as the area companies need the most help addressing.
“Capitalizing on new global market opportunities amidst an increasingly competitive industry landscape requires changes in supply-chain and business strategies,” said Bill Hook, UPS vice president for healthcare logistics. “It’s crucial that companies have the supply-chain flexibility to respond to changing market conditions in order to capture new market share and navigate the many complexities associated with global market access.” [More]
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| OCTOBER 2008 CONTENTS |
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At TCT, New Studies Support Drug-Eluting Stents
New FTC Exemption a Boon to Healthcare Providers, Pharmaceutical Companies, and DME Suppliers
Shopping for Value
VC Confidence Hits All-Time Low
Midwest Healthcare Start-Ups Attract Record Level of Venture Investment
Analysis: PTO Should Deny Abbott’s Patent Extension for Rapid-Exchange Technology
Industry Organizations Unite to Define Massachusetts Gift Ban
Supply-Chain Survey Reveals Key Industry Concerns
INDUSTRY IN BRIEF
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INDUSTRY IN BRIEF |
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At the beginning of October, NewCardio Inc. (Santa Clara, CA), announced that it had opened a new sales and client services office in Princeton, NJ. NewCardio is a cardiac diagnostic and services company focused on the development of a proprietary platform technology to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram. The company’s development-stage software and hardware products and services are intended to improve the diagnosis and monitoring of cardiovascular disease.
Luminex Corp. (Austin, TX) and BD Diagnostics–TriPath (Franklin Lakes, NJ), have announced the signing of a development and supply agreement. Under the terms of the agreement, BD Diagnostics–TriPath will develop, market, and sell new biomarker-based diagnostic tests for certain cancers using Luminex’s multiplexing xMAP technology platform. BD develops technologies for cervical cancer screening, as well as innovative diagnostic products for the detection of cancer. The Luminex xMAP technology is a proprietary multiplexing platform that enables scientists to conduct multiple, simultaneous tests on a single patient sample.
In mid-October, Cohera Medical Inc. (Pittsburgh) announced that it had secured $16.1 million in a Series B financing for the ongoing development of TissuGlu, a novel surgical adhesive for sprayable application in plastic surgery. Cohera’s products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible, and fully resorbable. The financing, which was led by Bradford Capital Partners, included participation from existing investors led by Kern Whelan Capital LLC. The angel financing provides the company with sufficient capital to advance TissuGlu into clinical trials, which are expected to begin early next year.
T2 Biosystems Inc. (Cambridge, MA), a privately held company developing the first portable medical diagnostic products that combine nanotechnology and miniaturized magnetic resonance technology, announced in October that it had raised $10.8 million in a Series B financing. Proceeds from the financing will be used to accelerate the development of T2 Biosystems’ rapid diagnostic platform. T2 Biosystems was founded in 2006 by renowned researchers from the Massachusetts Institute of Technology, Harvard University, Harvard Medical School, and Massachusetts General Hospital. In the Series B round, the company’s initial investors, Flagship Ventures, Polaris Venture Partners, and Flybridge Capital Partners were joined by new investors Partners Healthcare and In-Q-Tel. T2 Biosystems previously closed a $5.5 million Series A financing in 2006.
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CALENDAR |
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November 3–4: Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices, Costa Mesa, CA.
November 6: Doing Business in India. Webcast.
November 6–7: Japan: Regulatory Filing Requirements and Compliance Processes for Life Sciences, Malvern, PA.
November 7: Customer-Centric Marketing for Medtech Marketers, Waltham, MA.
November 12: Faster Route to Market with Japanese Standards, Web seminar.
November 13–14: 2008 Regulatory Strategy Forum, Orlando, FL.
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