BioTime, Inc. (BTX) Tuesday said it has received notice from the FDA's Center for Devices and Radiologic Health that Premvia has been cleared for marketing as a Class II medical device.
Premviais the first FDA-cleared member of BioTime's HyStem family of hydrogels, which are designed to mimic the natural structures of the human body's extracellular matrix.
According to the FDA clearance, the product is indicated for the management of wounds including partial thickness, full-thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers and donor skin graft sites.
Separately, the company reported a wider second-quarter loss attributable to shareholders of $9.55 million or $0.16 per share, compared to $7.55 million or $0.14 per share last year.
Total revenues fell to $1.11 million from $1.22 million.
The stock, which closed at $2.84 on Monday, fell 10.2 percent in pre-market trading.
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