Osiris Therapeutics, Inc. Announces An Addition To Its Wound Care Portfolio, Truskin

TruSkin is a viable human skin allograft

COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ:OSIR), the leading cellular regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, announced today the launch of TruSkin, a cryopreserved, living skin allograft.

“Osiris is committed to developing products that address unmet medical needs”

TruSkin has been developed to provide healthcare professionals a new option for treating large, chronic wounds in the Hospital Outpatient, Private Office, and/or Surgical Settings, where allograft options are limited and reimbursement pressures are high. Specifically in the HOPD setting, it has become common to relegate product usage to those products that are under their assigned bundled payment amounts. Currently, patients with larger wounds are limited in the offerings of advanced skin substitutes. Osiris’ strategy is to provide a larger-sized, high quality graft that fits within the Medicare bundled payment amounts to ensure that providers have an Osiris product option despite wound size. Osiris’ large TruSkin allograft will ensure that physicians have a larger-sized, high quality graft for patients regardless of wound size.

Standard industry processing and cryopreservation methods for skin allografts were optimized by Osiris to maximize post-thaw cell viability. Characterization studies demonstrate that the new proprietary TruSkin process maintains key structural and functional properties of fresh skin allografts to promote proper wound closure. Consistent with its evidence based approach, Osiris plans to introduce a robust scientific and clinical program for TruSkin, including multiple randomized controlled trials, comparative studies, case studies, and clinical and scientific posters and abstracts.

“Osiris is committed to developing products that address unmet medical needs,” said Alla Danilkovitch, Ph.D., Chief Scientific Officer. “This new skin allograft, TruSkin, provides structural and functional properties similar to fresh skin that are essential for the repair of chronic wounds in patients.”

About TruSkin

TruSkin is a split-thickness, cryopreserved skin allograft that is offered by Osiris to address unmet medical needs of chronic wounds. TruSkin retains the extracellular matrix, growth factors, and endogenous living skin cells of native tissue, making it an alternative to fresh skin allograft. TruSkin is optimally meshed to cover more wound area than competing skin allografts, while still allowing for proper wound drainage. TruSkin can be used to repair acute and chronic wounds, including but not limited to: diabetic foot ulcers, venous leg ulcers, pressure ulcers, surgical wounds, and wounds with exposed bone and tendon. TruSkin will be available in multiple sizes and have a 5-year shelf life when stored at or below -40°C.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is the world leader in researching, developing and marketing cellular regenerative medicine products that improve the health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, Osiris works to further advance the medical field. Osiris’ research and development in biotechnology focuses 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, a viable bone matrix, Cartiform®, a viable osteochondral allograft, Grafix®, a cryopreserved placental membrane and TruSkin, a viable human skin allograft.

Osiris, Grafix and Cartiform are registered trademarks of Osiris Therapeutics, Inc; TruSkin is a trademark of Osiris Therapeutics, Inc. BIO4 is a registered trademark of Stryker Corporation (NYSE: SYK). More information can be found on the company’s website, www.Osiris.com. (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 biologic drug 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 biologic drug candidates and marketed Biosurgery products (including Grafix, BIO4, Cartiform and TruSkin); our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to treat disease; 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. 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.

Contacts

Osiris Therapeutics, Inc.
Amanda Badillo, 443-545-1834
OsirisPR@Osiris.com

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