DALLAS — February 4, 2014 — TissueGen® Inc., developer of a groundbreaking biodegradable fiber format for drug delivery, had a significant year in 2013 marked by strengthened relationships with key players in drug delivery and medical device industries. The company rolled out its first commercially available product in Q2 and ended the year by moving to a state-of-the-art facility that will enable manufacturing of high quality products consistently meeting exact medical standards.
In its new location, TissueGen will benefit from an on-site certified clean room and extrusion room facilities. These enhanced capabilities will be essential as the company continues to focus on commercialization of its proven technology for advanced drug delivery and sustained therapeutic release. Additionally, TissueGen will apply for ISO 13485 certification this year to further enhance the value delivered to its material provider customers.
Earlier in 2013, TissueGen announced its first commercially available product, ELUTE™ biodegradable drug-loaded fiber, including pharmaceutical loaded fibers and growth factor loaded fibers. The company’s patented core technology includes fiber extrusion at room temperature, thereby preserving the biological activity of incorporated drugs and therapeutic agents-expanding the selection of drugs that may be directly incorporated into implantable medical devices.
“2013 was a major year for TissueGen as we moved from R&D to full commercialization of our core technology,” said Christopher Knowles, President and CEO of TissueGen. “We are focused on building strong relationships with industry partners and medical device customers who value TissueGen as a material provider for the implantable medical device market. We now offer a streamlined manufacturing process to deliver our novel biodegradable drug-loaded fiber materials to the medical device industry. Having an industrially clean lab environment with an ISO 7 certified cleanroom will enable our engineers to perform advanced nanoparticle development and to deliver high quality fiber products.”
TissueGen announced a marketing partnership with Biomedical Structures (BMS) in 2013. BMS, as a recognized world leader in medical textiles, can utilize TissueGen’s drug-loaded fiber platform to develop biomedical textile structures designed for drug delivery within the body. Because TissueGen’s novel technology enables engineering of devices with both pharmaceutical composition and mechanical properties such as size, shape, and porosity specific to each application, a single structure can satisfy both physical and pharmaceutical performance requirements.
The company participated alongside BMS at four leading industry tradeshows, including MD&M West, MD&M East, BIOMEDevice Boston and AMI’s Medical Grade Polymers 2013 where they presented a joint session entitled “Medical Fabrics & Drug-Loaded Fibers: New Frontiers in Material Selection.” TissueGen also continued to build upon its intellectual property portfolio in 2013, including new patents and patents pending.
“We are well-positioned for continued growth and success in the new year as we diligently focus on developing fibers for an expanding field of medical applications,” added Knowles.
Posted February 4, 2014
Source: TissueGen Inc.