CARLSBAD, Calif., Jan. 27, 2006 — 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-Jeter(R) 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.
