Orthovita Announces Presentation of Clinical Results Evaluating Vitagel™ Surgical Hemostat in Reducing Blood Loss During Primary Unilateral Total Knee Arthroplasty
MALVERN, Pennsylvania, Monday, April 11, 2011 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce that Michael Bloomfield, M.D., of Cleveland Clinic, presented results of a study entitled “Prospective Randomized Evaluation of a Collagen/Thrombin and Autologous Platelet Hemostatic Agent During Total Knee Arthroplasty” on Friday, April 8, at the 29th Annual Meeting of the Mid-America Orthopaedic Association in Tucson, Arizona. Wael Barsoum, M.D. and Alison Klika, M.S. of the Cleveland Clinic, Cleveland OH, served as the principal investigators of the study.
The prospective, double-blind, randomized 100-patient study evaluated the ability of Vitagel™ Surgical Hemostat (Vitagel), a microfibrillar collagen, thrombin and autologous plasma composite hemostatic agent, to reduce blood loss during primary unilateral total knee arthroplasty. In this study, standard hemostasis with Vitagel was found to reduce blood transfusions following primary total knee arthroplasty as compared to standard hemostasis alone (electrocautery). Key findings were:
• Transfusion requirements were significantly lower in the Vitagel group (0 blood transfusions in the 50-patient Vitagel arm compared to 5 transfusions in the 50 patient control arm; p=0.007).
• There was a trend toward higher hemoglobin levels in the Vitagel group starting on the second postoperative day; this trend achieved significance by the fourth day (10.0±1.0 vs. 8.8±1.1; p=0.01).
• No adverse events were attributed to the use of Vitagel.
Antony Koblish, President and CEO of Orthovita, stated, “This study represents an important resource for surgeons seeking options to minimize bleeding and the need for transfusions associated with joint replacement surgery. As a novel biomaterials company, Orthovita is committed to substantiating the use of products like Vitagel based upon clinical evidence.”
Dr. Bloomfield received the Mid-America Orthopaedic Association E. W. Johnson, Jr., M.D. Physician-In-Training Award for his contribution to the study.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
