Medical Device Link.

Despite the recent credit crunch, there were several notable diagnostics and medical device private equity transactions in 2007, some of which were announced in the prior year. Going forward, large deals of this nature will be harder to finance. In this article, Richard S. Cohen, a principal at the Walden Group Inc. (Tarrytown, NY), takes a look at these and other top 2007 medtech deals, as well as the M&A outlook for 2008. [More]

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The pact can be broadly divided into two major activities: special oversight for a specified trial group of medtech products, and enhancement of overall cooperation between HHS-FDA and SFDA. In this article, Ames Gross and John Minot discuss the provisions of the agreement and what they mean in practice for the medtech industry. Gross is president and founder of Pacific Bridge Medical (Bethesda, MD), and John Minot is an associate at the company. [More] 

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Medtech IPOs Maintain Pace in 2007 

Ubl

On January 29, the House Committee on Energy and Commerce’s subcommittee on oversight and investigations held a hearing in relation to its ongoing investigation into the adequacy of the efforts of FDA to protect the American public from excessive risks from prescription drugs, medical devices, and other matters. During the hearing, the subcommittee considered the findings of a recent report from FDA’s science board, FDA Science and Mission at Risk. The report concluded that FDA cannot fulfill its mission because its scientific base has eroded, its scientific workforce does not have sufficient capacity and capability, and its information technology infrastructure is inadequate. The report attributed the deficiencies to soaring demands on FDA and the fact that the agency’s resources have not increased in proportion to those demands.

“The Food and Drug Administration has long been considered the world’s standard bearer for safety, but critical steps must be taken to ensure that continues in this period of limited resources and additional responsibilities,” said Stephen J. Ubl, president and CEO of industry association AdvaMed (Washington, DC). [More]

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Europe to Benefit from U.S. Consumer Demand for Home-Use Diagnostic Testing

Burnell

The market for home-use diagnostics is set to take off as a result of the continuing trend toward consumer-driven healthcare. This new growth is expected to rival the size of the existing $7 billion global market in home-use diagnostics, which is currently dominated by pregnancy tests and glucose monitors. In this article, author Simon Burnell describes the conclusions of a two-part report by Cambridge Consultants (Cambridge, MA, and Cambridge, UK) indicating that Europe may be the first to benefit from the consumer diagnostics revolution—even though key drivers for the explosion of the market will come predominantly from the United States.

The Centers for Medicare and Medicaid Services (CMS; Baltimore) reported that healthcare spending growth in the United States accelerated slightly in 2006, increasing 6.7% compared to 6.5% in 2005, which was the slowest rate of growth since 1999.

Xtent Inc. (Menlo Park, CA), a developer of customizable drug-eluting stent systems, has submitted its application for CE mark approval of its Custom NX drug-eluting stent system. Following CE mark approval, Xtent plans to begin European sales of the system in the second half of 2008 through partnerships with leading regional distributors. The company is also continuing its work with FDA to fulfill the necessary requirements to gain approval to start a pivotal trial of the Custom NX system.