Healthcare Industry News:  NPWT 

Devices Litigation Wound Care

 News Release - January 27, 2006

BlueSky Wins Key Ruling in Second Markman Hearing

CARLSBAD, Calif., Jan. 27 (HSMN NewsFeed) -- BlueSky Medical Group Inc. announces that the Federal District Court has issued its Ruling on the November Markman Hearing in Kinetic Concept Patent Suit against BlueSky Medical. In its ruling the court construed certain terms of US Patents Nos. 5,636,643 and 5,645,081. BlueSky Medical believes that the court ruling is consistent with a favorable view to BlueSky's desired position. The court made a key distinction in interpreting claims associated with the type of cover.

Separately, BlueSky has requested the FDA clarify its recent safety alert on "Vacuum Assisted Wound Closure" issued in November of 2005 (FDA show #45, November 2005). The increased number and severity of adverse events on the Morykwas Approach, including deaths that are being reported while patients are using the competitor's product, is of concern to BlueSky. The company would like to ensure that there is a clear distinction between the competitor's product and the BlueSky Versatile 1(TM) Wound Vacuum System and the Chariker-JeterŪ Wound Sealing Kits. Adverse events and additional information on Negative Pressure Wound Therapy can be viewed at http://www.NPWT.com or http://www.accessdata.fda.gov/psn/transcript.cfm?show=45.

BlueSky Medical filed in February of 2005 an antitrust counterclaim and is seeking substantial recoveries for damages caused by KCI's business practices and has recently added additional claims and allegations that KCI has interfered with BlueSky Medical's business opportunities and made disparaging statements concerning its products. KCI, for example, wrote to the FDA and requested that the 510(K) for the Versatile 1(TM) product be overturned.


Source: BlueSky Medical

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