FDA Clears Premvia™ Hydrogel Scaffold for Regenerative Indications

Bioactives and Cell matrix company BioTime, Inc. says its Premvia™ hydrogel tissue substitute has been cleared for marketing as a Class II medical device.

Background

Premvia™ is 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.

The HyStem® family of hydrogels are unique biomaterials that are designed as matrices and scaffolds in medical device, tissue engineering, and regenerative medicine applications. HyStem® hydrogels are already distributed and sold worldwide by BioTime and its distributors for pre-clinical research.

The FDA clearance indicates Premvia 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.

Physician comments

“Premvia™ utilizes unique patented technology that allows the crosslinking of collagen and hyaluronic acid and is compatible with cells and tissues,” remarked Dr. Gregory Keller, MD, FACS, Clinical Professor at UCLA and co-director of the UCLA/AAFPRS facial plastic surgery fellowship. “I am excited by the prospects of using Premvia™ in treating wounds resulting from a number of the approved indications in general aesthetic and reconstructive surgery.”

Company comments

“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,” said William Tew, Ph.D., BioTime’s Chief Commercial Officer.

“HyStem®-based products such as Premvia™ and Renevia™ (the latter anticipated to begin its pivotal clinical trial in Europe later this year) 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.’”

Source: BioTime, Inc., Business Wire

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