TissueGen’s ISO13485:2003 certification; record growth driven by ELUTE fiber

Dallas, Texas – TissueGen Inc., developer of ELUTE fiber, controlled, sustained drug delivery from bioresorbable fiber, has been awarded ISO13485:2003 certification following significant investment in its quality management system and upgrades to its research, development and production infrastructure. Following a banner year for the company marked by its strongest annual revenue to date and significant personnel growth, the company moved ELUTE fiber development and manufacturing to an ISO Class 7 cleanroom facility in 2015. ELUTE fiber is now developed and manufactured to support compliance with FDA cGMP requirements for manufacturing drug product.

To drive continued growth for ELUTE fiber applications in 2016, TissueGen has expanded its team by 150% over the last 12 months, with notable appointments including:

• Brent Crow, Ph.D., promoted to head, special programs, now leading the company’s development of platform technologies for ELUTE fiber applications;
• Jennifer Seifert, Ph.D., who joined the company in 2015 to lead application of ELUTE fiber for the treatment of spinal cord injuries and is now serving the company as director, research, and development;
• Biomedical engineer Nicholas Mucha joining the R&D team as research scientist; 
• Michelle Locke joining in January as manager, quality, and regulatory affairs;
• Principal Scientists Paul Hubbard, Ph.D., Alpesh Patel, Ph.D., and Paul Sood, Ph.D., joining and significantly expanding the company’s expertise in protein, polymer, and pharmaceutical drug delivery technologies; and
• Andreas Sauerbrey, MD, and Richard W. Snyder II, MD, joining the company’s scientific advisory board with industry-leading expertise in the fields of orthopedic and cardiovascular medicine, respectively, to guide the company’s development of ELUTE fiber for clinical application. 

TissueGen anticipates continued personnel growth in 2016 to further advance development of ELUTE fiber applications for pharmaceutical, therapeutic, and medical device customers. 

The company is also very pleased to announce the launch of its newly redesigned website presenting TissueGen’s roadmap for development of ELUTE fiber-based pharmaceutical and biologic delivery products for advanced drug delivery, nerve regeneration and tissue engineering.  

“ELUTE fiber enables our pharmaceutical, therapeutic and medical device customers to develop innovative products for FDA submission and clinical application. We demonstrated our commitment to quality in 2015 with ISO13485:2003 certification, ISO Class 7 clean room installation, and investment in key personnel,” said Christopher Knowles, CEO, TissueGen. “With the launch of our redesigned website, continued investment in our talented development team and plans to expand manufacturing capacity for ELUTE fiber – we’re just getting started.” 

About TissueGen
TissueGen Inc. is the developer of ELUTE fiber, a groundbreaking bioresorbable fiber format for advanced drug delivery, nerve regeneration, and tissue engineering. TissueGen has more than four decades of cumulative experience in extruding bioresorbable polymer fibers with broad drug delivery capabilities. ELUTE fiber can directly replace standard fibers used in bioresorbable textiles currently on the market and provide significantly improved clinical outcomes by delivering therapeutic agents directly at the site of the implant. By delivering pharmaceuticals and biologics at the site of implantation, ELUTE fiber enables medical devices to guide the body’s healing and regenerative processes.

Source: TissueGen Inc.