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LEAD STORIES
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Medtech M&A Picks Up the Pace

Abbot's Capek says the acquisition of AMO strengthens and expands Abbott’s medical device business. |
For some time now, industry analysts have been predicting that with significantly lower valuations brought on by the protracted economic downturn, a number of medtech companies would become increasingly attractive as acquisition targets—particularly to larger players with strong balance sheets. Taking a look at recent medtech M&A activity over the last two months, reality may now be in sync with the forecasts.
During those two months such industry stalwarts as Johnson & Johnson Inc. (J&J; New Brunswick, NJ), Abbott (Abbott Park, IL), Boston Scientific Corp. (Natick, MA), Medtronic Inc. (Minneapolis), and St. Jude Medical Inc. (St. Paul, MN) have all made acquisitions that either added complementary products to their portfolios or took them into a new market segment.
While not all blockbusters, billion-dollar deals were announced by Abbott, with its acquisition of Advanced Medical Optics Inc. (AMO; Santa Ana, CA) and J&J, which added Mentor Corp. (Santa Barbara, CA) to its deep and diverse line of medical products and devices. [More]
Why FCPA Compliance Is Critical to Medical Device Manufacturers that Do Business Internationally

Booher |
The once little-enforced U.S. Foreign Corrupt Practices Act (FCPA) has claimed its fair share of headlines recently. The record for fines and penalties under the FCPA was shattered in December 2008 when Siemens announced that it settled FCPA charges with the government for $800 million. No letup is expected in 2009 either; in January, the Los Angeles Times reported that government officials had advised that enforcing the FCPA is the second highest priority for the Department of Justice (DOJ), behind only combating terrorism.
The requirements of the FCPA are often not intuitive. Business activities and practices that are often considered routine when seeking or retaining business from private parties may result in government investigations when they involve a “foreign official.” In this article, attorneys Ross Booher and Taylor Phillips examine the implications of the FCPA on a device company’s compliance program and share how to ensure that your company has the best controls in place to prevent even inadvertent violations.[More]

Keltjens |
AngioDynamics Appoints New President and CEO
AngioDynamics Inc., whose products include radiofrequency ablation and irreversible electroporation resection systems, has appointed Jan Keltjens as president and CEO. Keltjens, an executive with more than 20 years of medical industry leadership experience, will take the reins effective March 1, 2009. The 51-year-old Keltjens will succeed Eamonn Hobbs, a cofounder of AngioDynamics who has led the company for the past 21 years. Hobbs will become vice chairman of the company’s board of directors. [More]
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| INDUSTRY IN BRIEF |
Boston Scientific Corp. said that it has settled two intellectual property lawsuits and agreed to stand down on three others with Medtronic Inc. The medical device maker said the lawsuits involved disputes over interventional cardiology and endovascular repair devices. Boston Scientific said that while the terms of the settlements remain confidential, the agreements would not have a material impact on financial results.
Aethlon Medical (San Diego) has completed a first-in-man study of a medical device to treat human immunodeficiency virus (HIV). In the study, an HIV-infected individual completed a 12-treatment study of the Aethlon Hemopurifier. The device targets the clearance of all circulating strains of infectious HIV. The principal investigator of the study reported that all 12 treatments were completed without any observed adverse events and that the patient felt increased energy and appetite.
Tibion Corp. (Moffett Field, CA), which focuses on bionic devices for the mobility impaired, said it had received a license from the California Food & Drug Branch to manufacture medical devices. The company has developed the PowerKnee, a wearable bionic device for the leg, which it says assists with muscle strength. Obtaining the license is a milestone toward the device’s commercialization, says the privately held firm.
Getinge AB has settled Federal Trade Commission charges that its proposed $865 million acquisition of rival Datascope Inc. (Montvale, NJ) would be anticompetitive and would violate federal antitrust laws. Under the settlement with the Commission, Datascope is required to divest its endoscopic vessel harvesting (EVH) product line to an FTC-approved buyer within 10 days of the date that the deal is consummated. Datascope has proposed to sell the assets to Sorin Group USA Inc.
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