Healthcare Industry News:   diabetic foot ulcer 

Devices Regenerative Medicine Wound Care

 News Release - April 24, 2014

Grafix(R) Pharmacoeconomic and Scientific Characterization Studies Featured at the 2014 Spring Symposium for Advanced Wound Care

COLUMBIA, Md.--(Healthcare Sales & Marketing Network)--Osiris Therapeutics, Inc. (OSIR) announced today that results from both a pharmacoeconomic evaluation and a scientific characterization (cryopreservation versus non-cryopreservation) of Grafix® will be presented at the 2014 Spring Symposium on Advanced Wound Care (SAWC) in Orlando.

The pharmacoeconomic evaluation study focuses on the economic advantages that Grafix provides using claims data, including discharge information from over 6.9 million patients (DRG Summary for Medicare Inpatient Prospective Payment Hospitals) and clinical data from Osiris’ multi-center, randomized, controlled clinical trial evaluating the safety and effectiveness of Grafix in patients with chronic diabetic foot ulcers (DFU). The trial demonstrated overwhelming efficacy of Grafix when compared to conventional care (62% vs. 21%, p=0.0001). Performed by the Division of Health Care Policy and Research at the University of Colorado Anschutz Medical Campus, the cost benefit study highlights the overall cost savings of healed ulcers versus non-healed ulcers in the DFU trial. Mean cost savings for a healed ulcer was $20,622.00, which represents a 47% cost savings over the course of the 12-week trial compared to non-healed ulcers (p

“Treatment costs alone do not reflect the actual costs to the healthcare system when addressing the clinical condition of DFUs. A holistic estimation of costs needs to include patient medications and outpatient procedures, as well as much more expensive inpatient hospitalizations,” said Eugene J. Nuccio, Ph.D., Assistant Professor at the University of Colorado Anschutz Medical Campus. “The cost comparison presented reflects this more comprehensive and inclusive estimation of costs associated with healing vs. not healing a DFU for the patients in the clinical trial.”

The scientific characterization study demonstrates that a cryopreserved human amniotic membrane has enhanced activity relative to a non-cryopreserved human amniotic membrane, for improved wound closure potential. The cryopreservation process is able to effectively protect the natural components of the amniotic membrane, including the three-dimensional tissue matrix architecture, growth factors and cells. In comparison to non-cryopreserved membrane, the cryopreserved membrane demonstrates significantly higher (p

The 27th Symposium for Advanced Wound Care (SAWC) Spring Conference is held from April 23th to 27th. The meeting is the leading wound healing conference in the country and is the official meeting site of the Association for the Advancement of Wound Care (AAWC). Visit Osiris at SAWC Booth 1329.

About the Trial (Protocol 302)

Protocol 302 is a single-blind, randomized, controlled multi-center trial evaluating the efficacy and safety of weekly applications of Grafix for the treatment of chronic diabetic foot ulcers. A total of 131 patients were enrolled at 19 leading wound care centers across the United States. Patients between 18 and 80 years of age with confirmed type 1 or type 2 diabetes and chronic diabetic foot ulcers on the dorsal or plantar surface of the foot were randomized to Grafix or control dressings at a 1:1 ratio. Ulcers had to be present for at least 4 weeks prior to randomization and between 1 cm2 and 15 cm2 in size. Patients were excluded from the trial if the ulcer decreased with more than 30% during the one week screening period. Patients received treatment weekly for up to 12 weeks. The primary endpoint measures complete wound closure by 12 weeks as determined by the investigator and are confirmed using an independent, blinded Wound Core Lab. Secondary endpoints include complete wound closure rates for those patients that complete all scheduled treatments, time to wound closure, number of applications, proportion of patients achieving at least a 50% reduction in wound size by day 28 and number of re-occurrences. Patients randomized to the control group who did not heal within 12 weeks entered a cross-over arm for evaluation in an additional 12 week open-label treatment with Grafix.

About the Pharmacoeconomic Study

The pharmacoeconomic (PE) study applied a rigorous PE model to the clinical data obtained from Protocol 302 and was designed to compare per patient estimated total health care costs during the trial. Five cost categories were identified including treatment costs based on wound size matched to available graft size, medications using data from the CMS National Average Retail Price (NARP) report, clinical procedures delivered in the outpatient setting, and adverse event, serious adverse events and hospitalizations including discharge information from over 6.9 million patients assigned to specific Diagnosis Related Groups (DRG) using the Agency for Healthcare Research and Quality (AHRQ) DRG Summary for Medicare Inpatient Prospective Payment Hospitals. Trial event data from the 97 participants were combined and evaluated for cost effectiveness.

About Osiris Therapeutics

Osiris Therapeutics, Inc. is the leading stem cell company, having developed the world’s first approved stem cell drug, remestemcel-L for graft versus host disease. Osiris’ products include Grafix® and Ovation® for acute and chronic wounds, Cartiform®, a viable cartilage mesh for cartilage repair and the latest addition to Osiris’ line of products, OvationOS™, a viable bone matrix. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution. Osiris has developed an extensive intellectual property portfolio to protect the company's technology and commercial interests.

Osiris, Grafix, Ovation and Cartiform are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, (OSIR-G)

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as "anticipate," "believe," "continue," "ongoing," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project" or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our ability to successfully navigate these requirements; the success of our product candidates in development; status of the regulatory process for our product and product candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for marketed Biosurgery products (including Grafix, Ovation, OvationOS and Cartiform) and Biosurgery products under development; our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to address medical needs; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available products, to meet demand; our costs to comply with governmental regulations; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and potential products; and results of our scientific research. Additional risks and uncertainties related to the sale of our ceMSC assets and the related transactions contemplated by the Purchase Agreement with Mesoblast include typical business transactional risks, the risk of changing relationships with customers, suppliers or employees, the risk associated with the disposition of our ceMSC assets and the increased relative dependence on and importance of our other business including our Biosurgery business, the risk that we may not be able to fully benefit from the transactions through milestone payments or royalties, payment risks, including the risk associated with receipt of equity as consideration, in lieu of cash, and the risk of dependence on others to achieve results upon which milestone or royalty payments to us are conditioned. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled "Risk Factors" in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

Source: Osiris Therapeutics

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