Biotechnology company BioTime has obtained clearance from the FDA’s Center for Devices and Radiologic Health for its Premvia, to market it as a Class II medical device.
Premvia is claimed to be the first FDA-cleared medical device from BioTime’s HyStem family of hydrogels, which are developed to mimic the natural structures of the human body’s extracellular matrix.
Premvia can be used for the management of wounds, including partial thickness, full-thickness, tunneling wounds and pressure ulcers.
It can also be used to treat 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.
BioTime chief commercial officer William Tew said the company intends to complete the review and implementation of the requisite quality and manufacturing documentation in advance of introducing the product to the market.
"Additionally the Company will undertake selected clinical studies to further refine the target market niches, and following that, will lay our final plans for associated marketing initiatives and strategies," Tew added.
BioTime plans to start pivotal trial of HyStem’s another product Renevia in the later part of the year.
The company is seeking a CE Mark for the use of Renevia in combination with cells for the purpose of lipotransfer in the treatment of HIV-related lipoatrophy.
In addition, BioTime is in the process of developing HyStem technology to use in formulating different products manufactured from pluripotent stem cells using the firm’s PureStem technology.