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MacroPore Biosurgery Successfully Completes 6-month Clinical Evaluation
Corporate-news announcement sent by DGAP.
The sender is solely responsible for the contents of this announcement.
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MacroPore Biosurgery Successfully Completes 6-month Clinical Evaluation of Bone
Repair Implants
San Diego/Königstein, Ts., August 15, 2003. MacroPore Biosurgery, Inc.
(Frankfurt Stock Exchange: XMP) announced today that twenty-one patients have
successfully completed a 6-month assessment evaluating the performance of the
new Faster Resorbing Polymer (FRP) bioresorbable implant system. Developed by
MacroPore Biosurgery as an extension of its Craniomaxillofacial/Neurosurgical
(CMF/Neuro) product line, the FRP system consists of bioresorbable protective
sheets and screws designed for bone repair applications where rapid healing is
expected.
The successful clinical outcomes is pursuant to the completion of a 12-month
clinical evaluation designated as a milestone worth $5 million to MacroPore
Biosurgery in accordance with the terms of the asset purchase agreement entered
into September 2002 with Medtronic.
“This 6-month evaluation marks the half-way point to reaching our milestone for
the clinical outcomes,” stated Christopher J. Calhoun, CEO of MacroPore
Biosurgery. “We are very confident that the 12-month evaluation will also have
successful results and expect the milestone payment to be triggered by December
2003.”
Bioresorbable polymer implants contour to the anatomy, maintain significant
strength during the critical healing period, and are naturally resorbed. As a
result, the traditional use of metal devices for craniofacial and neurosurgical
fixation is progressively being replaced with bioresorbable polymer devices.
“The bioresorbable technology of the new FRP system brings tremendous benefits
to the pediatric patient population undergoing complex craniofacial and
neurosurgical procedures,” stated Steve R. Cohen, MD, co-principal clinical
investigator and pediatric reconstructive plastic surgeon. According to Cohen,
“In pediatric and adult applications where bone healing occurs quickly, the
rapid biodegradation of the FRP system, and its surgeon friendly design, makes
it the system of choice.”
The data collected indicates that the FRP system is comparable in safety and
efficacy to the CMF/Neuro fixation systems developed by MacroPore Biosurgery,
then sold to Medtronic in 2002. The FRP system products are cleared by the FDA
for craniofacial and neurosurgical applications.
MacroPore Biosurgery, Inc. is a leader in the design, development, and
production of bioresorbable polymer implants for use in a variety of surgical
applications and is pioneering advancement of regenerative medicine for surgical
therapies using adult stem cells derived from adipose (fat tissue). Some
products designed for use in spine, neurosurgical, and musculoskeletal surgeries
are distributed by Medtronic, while other products designed for soft tissue are
distributed through our direct US sales force and an international distribution
network. MacroPore Biosurgery is traded on the Frankfurt Stock Exchange in
Germany under the symbol ‘XMP’. For further information please visit the web
site www.macropore.com.
MacroPore Biosurgery Disclaimer
This press release may include forward-looking statements regarding events and
trends which may affect MacroPore Biosurgery’s future operating results and
financial position. Such statements are subject to risks and uncertainties that
could cause MacroPore Biosurgery’s actual results and financial position to
differ materially. These risks and uncertainties are described (under the
heading “Risk Factors”) in our 2002 Annual Report which is available on our web
site. MacroPore Biosurgery assumes no responsibility to publicly release the
results of any revision of forward-looking statements to reflect events, trends
or circumstances after the date they are made.
end of message, (c)DGAP 15.08.2003
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WKN: 940682; ISIN: USU553961025; Index: NEMAX 50
Listed: Geregelter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin-
Bremen, Düsseldorf, Hamburg, Hannover und Stuttgart
150904 Aug 03
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