Healthcare Industry News: demineralized bone matrix
News Release - August 28, 2007
Wright Medical Group, Inc. Announces Launch of PRO-DENSE(TM) Injectable Regenerative GraftBreakthrough in Metaphyseal Bone Grafting Technology Now Available to Surgeons Worldwide
ARLINGTON, Tenn.--(HSMN NewsFeed)--Wright Medical Group, Inc. (NASDAQ: WMGI ), a global orthopaedic medical device company, today announced U.S. and international release of PRO-DENSE(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) line of Sterile Xenograft Bone Wedges.
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.
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.
Source: Wright Medical Group
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