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Press Release

Peer-reviewed Publication on the use of Grafix® Prime for Outpatient Management of Complex Wounds with Exposed Bone, Tendon, Muscle, Joint, and Hardware


Posted on: 31 Oct 16

COLUMBIA, Md., Oct. 31, 2016 (GLOBE NEWSWIRE) -- Osiris Therapeutics, Inc. (NASDAQ:OSIR), a leading regenerative medicine company focused on developing and marketing products for wound care, orthopaedics and sports medicine, announced today that a new peer-reviewed manuscript by Kazu Suzuki, DPM, CWS, Surgeon, Certified Wound Care Specialist, “Viable intact cryopreserved human placental membrane for a non-surgical approach to closure in complex wounds” has been published in the Journal of Wound Care and available on line

A 10-month, single-center effectiveness review was conducted on the clinical outcomes in patients treated with Grafix® for complex wounds characterized by exposed bone, tendon, muscle, or hardware. Wounds were managed with routine standard of care in addition to serial applications of Grafix®. Wound types included chronic wounds, surgical dehiscences and pressure ulcers. The average baseline wound area and duration at presentation were 17.5 cm2 and 11.2 weeks, respectively.

Study Highlights:

  • All cases resulted in granulation over the exposed structures followed by complete wound re-epithelialization without the concomitant use of negative pressure wound therapy (NPWT), hyperbaric oxygen therapy, or surgical intervention
  • The mean time to closure was 10 weeks with a mean graft use of 8.1 grafts
  • The mean 4-week percentage of wound area reduction was 62.5 %.  There were no adverse events attributed to the use of Grafix®

Dr. Suzuki remarked, “This shows that complex wounds with exposed bone, tendon, joint, and hardware can be reliably managed with this viable cryopreserved amniotic membrane graft, allowing patients to achieve wound closure on an outpatient basis. This is in contrast to the more invasive surgical methods requiring inpatient hospitalization and donor site morbidity, such of autologous skin grafting and flap procedures.  I believe that it is beneficial for both patients and providers to have multiple treatment options.”

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 BioSmart™ 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.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, 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®, TruSkin ™ and Stravix™.

Osiris, Grafix, Cartiform, TruSkin and Stravix are registered trademarks of Osiris Therapeutics, Inc. and BIO4 is a trademark of Howmedica Osteonics Corp.  More information can be found on the company's website, www.Osiris.com.  

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 the anticipated efficiencies, advantages, or cost-savings of products or services, as individual results may vary depending on circumstances, means of use, costs of goods or services, and other factors.  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.  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.

GlobeNewswire
globenewswire.com

Last updated on: 01/11/2016

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