28.08.2007 20:00:00
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Wright Medical Group, Inc. Announces Launch of PRO-DENSE(TM) Injectable Regenerative Graft
Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical
device company, today announced U.S. and international release of
PRO-DENSE™ Injectable Regenerative Graft, a
progressive new bone graft substitute that has demonstrated unique and
highly favorable metaphyseal bone healing properties compared to
autograft in preclinical studies.
A proprietary, patented composite of calcium phosphate and sulfate,
PRO-DENSE™ Graft employs a unique, tri-phasic
resorption profile providing the biologic environment to allow the body
to quickly and reliably regenerate dense new bone. Extensive animal
testing found that new bone regenerated by PRO-DENSE™
Graft was of greater density and greater compressive strength at 13
weeks than the new bone regenerated by autograft, which is widely
considered to be the "Gold Standard”
for bone grafting. Additionally, the testing revealed that the bone
voids treated with PRO-DENSE™ Graft formed new
bone at a faster rate than autograft.
"Our pre-clinical model suggests that the
resultant bone repair properties could be a significant step ahead of
currently available synthetics and DBM products,”
said Thomas Turner, D.V.M., Assistant Professor at Rush University
Medical Center in Chicago and principle investigator for the
pre-clinical model.
Receiving FDA clearance in February 2006, the PRO-DENSE™
Graft was released in a controlled fashion to select institutions to
confirm human effectiveness over a 17-month period. "This
has been a very controlled product release,”
stated John T. Treace, Vice President of Marketing for Wright’s
Biologics. "Extra time and resources were
invested in order to generate strong clinical experience prior to our
full-scale commercial release. Based on experience from 17 months of
human use at top orthopaedic centers, we are confident that PRO-DENSE™
Graft will deliver our customers worldwide results yet to be seen with
conventional bone grafts.”
According to Joseph Borrelli, Jr., M.D., Chairman of Orthopaedic Surgery
at UT Southwestern Medical Center in Dallas. "In
my clinical practice, PRO-DENSE™ appears to
be an excellent synthetic autograft substitute that may ultimately lead
to better patient outcomes through its ability to lay down dense bone
fast.” Another clinical investigator, J.
Tracy Watson, M.D., Chief, Division of Orthopaedic Traumatology at St.
Louis University, explains, "I could tell by
the early radiographic results that this material demonstrated a unique
response, behaving differently than other alloplastic graft materials I
have used previously for similar metaphyseal defects. The new bone
regenerated was very impressive with active remodeling demonstrated
throughout the healing period. We now have many patients treated with
this material well out over a year, and this phenomenon has been
consistent in all these cases.”
PRO-DENSE™ Injectable Regenerative Graft is
the latest addition to Wright’s
market-leading biologics franchise, which includes products such as
GRAFTJACKET® Regenerative Tissue Matrix,
OSTEOSET® T Medicated Bone Graft (not
available in U.S.), the ALLOMATRIX® line of
demineralized bone matrix products, MIIG® X3
Injectable Graft, and the CANCELLO-PURE™ line
of Sterile Xenograft Bone Wedges.
About Wright
Wright Medical Group, Inc. is a global orthopaedic medical device
company specializing in the design, manufacture and marketing of
reconstructive joint devices and biologics. The Company has been in
business for more than 50 years and markets its products in over 60
countries worldwide. For more information about Wright Medical, visit
our website at www.wmt.com.
Safe-Harbor Statement This press release contains "forward-looking
statements” within the meaning of Section 27A
of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. All
statements made in this press release, other than statements of
historical fact, are forward-looking statements. Forward-looking
statements reflect management’s current
knowledge, assumptions, beliefs, estimates, and expectations and express
management’s current views of future
performance, results, and trends. The Company wishes to caution readers
that actual results might differ materially from those described in the
forward-looking statements. Forward-looking statements are
subject to a number of risks and uncertainties, including the factors
discussed in the Company’s filings with the
Securities and Exchange Commission (including the Company’s
annual report on Form 10-K for the year ended December 31, 2006 under
the heading, "Risk Factors”
and its quarterly reports), which could cause the Company’s
actual results to materially differ from those described in the
forward-looking statements. Although the Company believes
that the forward-looking statements are accurate, there can be no
assurance that any forward-looking statement will prove to be accurate.
A forward-looking statement should not be regarded as a representation
by the Company that the results described therein will be achieved. The Company wishes to caution readers not to place undue reliance
on any forward-looking statement. The forward-looking statements are
made as of the date of this press release. The Company assumes no
obligation to update any forward-looking statement after this date.
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