Macropore Inc. IR-Pages
MacroPore Biosurgery Receives FDA Clearance for its HYDROSORB(TM) Spine System
Ad-hoc-announcement transmitted by DGAP.
The issuer is solely responsible for the content of this announcement.
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MacroPore Biosurgery Receives FDA Clearance for its HYDROSORB(TM) Spine System;
the First and Only Resorbable Spine System with Radiographic Visualization
Properties
San Diego, CA, Aug 3, 2004 – MacroPore Biosurgery, Inc. (Frankfurt: XMP) today
announced that it has received FDA Clearance for a radiographically identifiable
version of its HYDROSORB(TM) Spine System, which is the first and only
resorbable spinal plate and screw system to include a radiopaque marker. It will
allow physicians to visualize and monitor the position and placement of plates
and screws over time without obstructing the view of the healing bone.
The HYDROSORB(TM) Spine System is indicated for use in spinal fusion procedures,
in conjunction with traditional rigid fixation, as a means to maintain the
relative position of weak bony tissue such as autografts. The radiopaque
component of the HYDROSORB(TM) Spine System contains beads of barium sulfate.
Barium sulfate is an inert material, commonly used by physicians as a contrast
agent in x-ray examinations, which is safely eliminated from the body intact.
end of ad-hoc-announcement (c)DGAP 04.08.2004
Issuer’s information/explanatory remarks concerning this ad-hoc-announcement:
“The HYDRSORB(TM) Spine System is the first resorbable spine product that can be
visualized radiographically” said Todd Lanman, M.D., Assistant Clinical
Professor, University of California, Los Angeles, Division of Neurosurgery.
“With its introduction, physicians are now able to confirm the proper placement
of the HYDROSORB(TM) plates and screws both intra-operatively and
postoperatively, while alleviating concerns about leaving a permanent device
behind.”
“The introduction of the HDYROSORB(TM) Spine System with radiographic visibility
represents another evolutionary step in our resorbable spine and orthopedic
technologies, which provides additional rationale for the adoption of these
products by the medical community,” said Sharon Schulzki, Chief Operating
Officer, MacroPore Biosurgery. “The clearance with the radiopaque marker is the
latest example of how we are extending our competitive position in the
resorbable market, which is further augmented by the proprietary manufacturing
process and pending intellectual property.”
MacroPore Biosurgery’s entire family of HYDROSORB spine and orthopedic implants
are made from a polylactide (PLa) resorbable technology platform that provides
temporary support while bone healing takes place. The material then naturally
resorbs into the body over time. As with the entire HYDROSORBTM product line,
the radiographic HYDRODSORBTM Spine System products will be manufactured by
MacroPore Biosurgery and distributed exclusively through Medtronic Sofamor Danek
(MSD).
About MacroPore Biosurgery, Inc.
MacroPore Biosurgery (Frankfurt: XMP) is focused on the discovery, development
and commercialization of regenerative medicine technologies. We have two
technology platforms, bioresorbable technology and regenerative cell technology.
Our surgical implants, derived from our bioresorbable technology, represent one
of the latest advancements in spine and orthopedic medicine. They are
manufactured by us and distributed exclusively through Medtronic Sofamor Danek.
Within our regenerative cell technology program, we are developing a system to
isolate autologous, homologous-use, regenerative cells. Simultaneously, we are
generating scientific knowledge through internal research to support the
clinical use of these cells. Our most advanced research and development program
is in the repair of cardiovascular tissues that are damaged after a heart
attack. We are also researching applications in bone repair, spinal disc
regeneration, and cosmetic and reconstructive surgery. For further information
please visit our web site http://www.macropore.com.
Cautionary Statement Regarding Forward-Looking Statements
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 2003 Form 10-K annual report for the year ended
December 31, 2003, 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.
For further information, please contact: MacroPore Biosurgery, Inc., Stefanie
Bacher, sbacher@macropore.com, Phone +1 858 458 0900, Fax +1 858 458 0994.
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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
040800 Aug 04
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