The Food and Drug Administration’s (FDA) Centre for Devices and Radiologic Health has granted clearance to BioTime to market its Premvia as a class II medical device.
Premvia is the first FDA-cleared member of the company’s HyStem family of hydrogels, which are designed to look similar to the natural structures of the human body’s extracellular matrix.
The device is intended to manage wounds, including partial thickness, full-thickness, tunnelling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers and donor skin graft sites, as well as 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: “We plan to rapidly 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.
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“HyStem-based products such as Premvia and Renevia are anticipated to provide the company with opportunities for significant near-term revenue, while balancing the long-term opportunities created by the company’s pluripotent stem cell technology platform, which provides the potential for the industrial-scale manufacture of all of the cellular components of the human body.
“Together, these matrices and cellular building blocks provide a combination of technology platforms that we believe can lead the industry in the revolution underway, commonly called ‘regenerative medicine’.”
UCLA Clinical Professor and UCLA / AAFPRS facial plastic surgery fellowship co-director Gregory Keller said: “Premvia utilises unique patented technology that allows the cross linking of collagen and hyaluronic acid and is compatible with cells and tissues.”
The FDA clearance of Premvia will provide BioTime with a foundation for the development of even more advanced bioactive and cell-matrix combination products, the company said.
The pivotal trial of Renevia is expected to start later this year in Europe, where the company is seeking a CE Mark for the use of Renevia in combination with cells for lipotransfer in the treatment of HIV-related lipoatrophy.
The company is also in the process of developing HyStem technology for use in formulating a number of products manufactured from pluripotent stem cells using its PureStem technology.
The combination products of HyStem-based hydrogels with PureStem cell lines will require future human clinical trials.