BioTime, Inc. today announced that it has initiated the development of two new products based on its HyStem® hydrogel technology platform.
The first of these new products is ReGlydeTM, a cross-linked thiol-modified hyaluronan hydrogel for the management and protection of tendon injuries following surgical repair of the digital flexor or extensor tendons of the hand. The product is intended to be applied in the vicinity of the repaired tendon via a syringe or similar device immediately prior to closing of the surgical area. Separation of the tendon from surrounding tissue has been shown to significantly reduce post-surgical adhesions that can lead to complications such as restricted finger mobility and flexibility. BioTime believes that the flowable and in-situ gelling capability of ReGlydeTM could provide an advantage over the existing technology which is in the form of a sheet causing difficulty in application in what is often a small compartment after surgery.
The second new product, PremviaTM, is a HyStem® hydrogel formulation of cross-linked thiol-modified hyaluronan and thiol-modified gelatin for the management of wounds including partial and full-thickness wounds, ulcers, tunneled/undermined wounds, surgical wounds, and burns. Due to its high water content, PremviaTM is able to donate water molecules to the wound surface and to maintain a moist environment at the wound bed, which is critical for wound healing. Additionally, the biodegradable matrix provides a scaffold for the cellular infiltration and proliferation as well as capillary growth needed to promote healing. There is significant competition in the wound healing dressing space, however, one advantage that PremviaTM appears to have over most other technologies is the ability to flow into the wound and cross-link, or change from a flowing liquid to a semi-solid gel consistency, in-situ, thereby providing a moist environment to every part of a wound which a traditional covering cannot.
Both ReGlydeTM and PremviaTM are expected to be regulated as medical devices in the United States. BioTime has initiated for these development-stage products the requisite studies for marketing approval, including ISO 10993 biocompatibility studies and animal studies to demonstrate safety and efficacy for a 510(k) application to the Food and Drug Administration. BioTime may be required to provide human clinical data demonstrating safety and efficacy for approval as a medical device if the FDA determines that marketing approval should not be granted on the basis of a 510(k) application.
PremviaTM is also intended to serve as a foundation for the further development of bioactive wound healing products that could deliver biological factors or cells to accelerate wound healing. PremviaTM may face a different level of regulatory approval for those uses.
Significant quantities of the components common to ReGlydeTM and PremviaTM have been manufactured under cGMP conditions, therefore, BioTime will have cGMP quantities of both products available for its pre-clinical investigations and the initiation of human clinical use if FDA approval for marketing is obtained.