|BioTime Submits CE Mark Application for European Approval of Renevia®|
“Submission of the CE Mark application establishes an important
The CE Mark application was based on Renevia® successfully meeting its primary endpoint with treated patients retaining approximately 100% of transplanted volume at six months. In addition to strong product performance at 6 months, treated patients retained an average 70% of the transplanted volume at 12 months and 64% at 18 months. All Renevia® transplants were shown to be generally well tolerated and there were no device-related serious adverse events noted during this trial.
In combination with the U.S. investigator-led trial, we believe we can build upon the European trial data with additional appropriate clinical evidence to expand the potential utility of Renevia® and enter other geographies, including the U.S.
Renevia® is an investigational medical device that is being developed as an alternative for whole adipose tissue transfer (fat grafting) procedures. Renevia® is part of the Hystem® hydrogel family of proprietary injectable matrices, being developed as devices for wound management, cell and drug delivery.
Premvia™ is indicated for the management of wounds including: partial-thickness, full-thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh’s surgery, post-laser surgery, podiatric wounds, wound dehiscence, abrasions, lacerations, second degree burns, skin tears, and draining wounds.
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