- The proportion of complete wound closure was 63.0% (29/46) for vCPM and 18.2% (10/55) for dHACM (p < 0.0001) for all treated wound types
- Mean size for closed wounds was 9.4 cm 2 for vCPM versus 2.1 cm 2 for dHACM group (p=0.0201)
- For all non-closed wounds in the vCPM group (n = 17), reductions in both surface area and volume indicate clinical improvement. In contrast, there was no clinical improvement observed in the non-closed dHACM population (n = 45) based on an overall increase in wound dimensions after treatment with dHACM
- Kaplan-Meier probability of complete wound closure by week 12 was 74.3% for vCPM and 19.0% for dHACM
About the StudyThe study population (N = 79) was comprised of two subject groups, dHACM (n =39) and vCPM (n = 40), and represent distinct and consecutive sets of patients that were managed at Bozeman Health Deaconess Hospital- Wound and Hyperbaric Center with either graft for the purposes of wound closure and do not reflect a subset of either population. All male and female patients over the age of 18 years of age, receiving at least one application of either dHACM or vCPM between February 2014 and March 2016 with at least one follow up measurement were eligible for analysis. Consistent with the terms and conditions dictated by the Health Insurance Portability Act of 1996 (HIPPA), de-identified information was obtained from the electronic health record database for the purposes of a retrospective comparative effectiveness analysis between the two human placental products. Osiris Therapeutics, Inc. partnered with a biostatistics research organization as well as a consultant from the Department of Applied Mathematics and Statistics at The Johns Hopkins University to perform the blinded independent data analysis. About Grafix Grafix is a cryopreserved placental membrane comprised of an extracellular matrix (ECM) rich in collagen, growth factors, and viable cells native to the tissue. Grafix is processed using Osiris' proprietary technology; it is flexible and conforming and designed for application directly to hard-to-treat acute and chronic wounds, including but not limited to diabetic foot ulcers, venous leg ulcers and thermal burns. Grafix is a Human Cells, Tissues, and Cellular Tissue Based Product (HCT/P) as defined in 21 CFR part 1271 and Section 361 of the Public Health Service Act. About Osiris Therapeutics Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing, and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world's first approved stem cell drug, the company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine - including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO 4 ®, Cartiform ®, Grafix ®, and Stravix ™. Osiris, Grafix, Cartiform, and Stravix are trademarks of Osiris Therapeutics, Inc. BIO 4 is a trademark of Howmedica Osteonics Corp. More information can be found on the company's website, www.Osiris.com. (OSIR-G) Forward-Looking Statements This press release may contain forward-looking statements. These forward-looking statements may generally be identified by the use of the words "may," "will," "expects," "anticipates," "believes," "estimates," and similar expressions, and involve a number of risks and uncertainties. For a variety of reasons, actual results may differ materially from those described in or contemplated by any such forward-looking statement. Examples of forward-looking statements may include, without limitation, statements regarding the anticipated efficiencies and advantages of products or services. Consequently, the reader is cautioned to consider all forward-looking statements in light of the risks to which they are subject.
For additional information, please contact:Diane SavoieOsiris Therapeutics, Inc.(443) 545-1834 OsirisPR@Osiris.com