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 Stravix™, a cryopreserved human placental tissue designed to address surgical needs for soft tissue repair.
The two billion dollar U.S. soft tissue reinforcement market consists of utilizing grafts for the surgical treatment of a broad range of indications1. While synthetic grafts have been traditionally used, biologic tissue grafts have offered better results with fewer post-operative complications. It is broadly published that surgical reconstruction procedures benefit from products that provide structural support, and reduce scarring and inflammation. Placental tissues as a cover have such properties;2 however, the majority of the currently used placental products are dead, dehydrated amniotic membranes lacking sufficient tensile strength and activity. Stravix was developed as a pliable allograft cover with tensile strength that is ten times greater than amniotic membranes alone and designed to offer durability, elasticity, and conformability for surgical procedures.3,4 In addition, Stravix retains the properties inherent to the native fresh tissue as a result of Osiris’ proprietary cryopreservation process, BioSmart®.
“Osiris plans to collect scientific and clinical data supporting the use of Stravix,” said Alla Danilkovitch, Ph.D., Chief Scientific Officer. “The ideal allograft should not only preserve the original characteristics of the tissue beneficial for natural repair but also have properties and ease of application needed for complicated surgeries; Osiris has achieved this with Stravix.”
Stravix is a viable cryopreserved human placental tissue comprised of amniotic and connective layers of umbilical tissue that has been developed as a cover specifically for surgical procedures. It retains native components of the tissue including collagen and hyaluronic acid rich extracellular matrix, cytokines, fibroblasts, growth factors, viable endogenous mesenchymal stem cells and epithelial cells. Stravix conforms to the site of injury, requires minimal preparation prior to use and is stored at -75°C to -85°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 BIO4 ®, a viable bone matrix, Cartiform®, a viable osteochondral allograft, Grafix®, a cryopreserved placental membrane, TruSkin™, a viable human skin allograft and Stravix, a durable placental allograft.
Osiris, Grafix and Cartiform are registered trademarks of Osiris Therapeutics, Inc.; TruSkin and Stravix are trademarks 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)
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, TruSkin and Stravix); 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.
1 Statistics from iData
2 Cooke, M., et al. “Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/ chorion tissue.” Journal of Wound Care 23.10 (2014).
3 Giancarlo, Pennati, et al. “Biomechanical properties of the human umbilical cord.” Biorheology 38 (2001).
4 Jabareen, Mahmood, et al. “Relation between mechanical properties and microstructure of human fetal membranes: An attempt towards a quantitative analysis.” European Journal of Obstetrics & Gynecology and Reproductive Biology 144 (2009).