Healthcare Industry News: Grafix
News Release - January 20, 2017
Osiris Therapeutics announced a Comparative Effectiveness Study on the Use of Two Human Placental Membranes in Wound Management is Available Electronically in a Peer-Reviewed JournalCOLUMBIA, Md., Jan. 19, 2017 -- (Healthcare Sales & Marketing Network) -- Osiris Therapeutics, Inc. (OSIR) announced today that the study “A Comparative Outcomes Analysis Evaluating Clinical Effectiveness in Two Different Human Placental Membrane Products for Wound Management” has been published in the peer-reviewed journal Wound Repair and Regeneration and is available online (http://bit.ly/comparativeoutcomes). This is the first comparative effectiveness study to report on the clinical outcomes associated with the use of different placental wound care products once broadly implemented in the clinical setting.
The a priori specification of the research question focused on the clinical outcomes in two nonrandomized past patient cohorts receiving wound treatment with either a viable intact cryopreserved human placental membrane (vCPM) (Grafix®; Osiris Therapeutics, Inc., Columbia, MD), or a dehydrated human amnion/chorion membrane (dHACM) (EpiFix®; MiMedx Group Inc., Marietta, GA) as an adjunct to standard of care, as evidenced through a single-center electronic database. A total of 79 patients with 101 wounds were analyzed: 40 patients with 46 wounds received vCPM and 39 patients with 55 wounds received dHACM. Both subject groups represent consecutive sets of patients treated by either graft. Treatment cohorts were equal, as there were no statistical differences in the baseline patient characteristics, wound characteristics or etiological distribution of wound types between the two groups.
Highlights of the Study Results:
- 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 cm2 for vCPM versus 2.1 cm2 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 Study
The 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.
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 BIO4 ®, Cartiform®, Grafix®, and Stravix™. Osiris, Grafix, Cartiform, and Stravix are trademarks of Osiris Therapeutics, Inc. BIO4 is a trademark of Howmedica Osteonics Corp. More information can be found on the company's website, www.Osiris.com. (OSIR-G)
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Source: Osiris Therapeutics
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