Osiris wins positive review from BCBSA for Grafix

Osiris Therapeutics said today the Blue Cross Blue Shield Association gave the company’s Grafix a positive review when used to treat individuals with diabetic lower-extremity ulcers.

Gravix is a cryopreserved placental membrane designed as a wound cover for patients with chronic wounds, and can conform and be applied directly to acute and chronic wounds, the company said.

Columbia, Md.-based Osiris said the BCBSA found sufficient evidence for meaningful improvements in net health outcome during testing.

“We would like to thank the Blue Cross Blue Shield Association for their thorough review of Grafix for diabetic foot ulcers. As we continue to expand our products’ scientific and clinical data portfolio, we look forward to providing the evidence exchange with additional data in the near future,” CEO Dwayne Montgomery said in a press release

Earlier this month, the company said it that results from a study of its Grafix in patients with complex chronic diabetic foot ulcers indicated a 96.3% rate of 100% granulation at 16 weeks, with a mean time to 100% granulation of 6.8 weeks with 6.8 applications of Grafix.

The company reported no adverse events related to the Grafix, and a 92.3% mean percentage area reduction fo all wounds at 16 weeks.

“Complex wounds and patients with other significant illness are normally excluded from prospective clinical studies because they are so difficult to treat, and yet they are frequently encountered by wound care professionals in their clinics. This study demonstrates that Grafix can be effective in this patient group and considered in the management of such serious wounds,” Montgomery said in prepared remarks.

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