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30th March 2016, Dallas, TX

TissueGen receives certification after investing in its quality management system

Tailored for devices that require both mechanical and pharmaceutical support, ELUTE fibre is ideal for tissue scaffolds and stents, the company reports. © TissueGenTissueGen, a developer of ELUTE fibre, a controlled, sustained drug delivery from bioresorbable fibre, 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 fibre development and manufacturing to an ISO Class 7 cleanroom facility in 2015.

ELUTE fibre is now developed and manufactured to support compliance with FDA cGMP requirements for manufacturing drug product, the company reports.

Team expansion

To drive continued growth for ELUTE fibre applications in 2016, the company has expanded its team by 150% over the last twelve months, with notable appointments. TissueGen anticipates continued personnel growth in 2016 to further advance development of ELUTE fibre applications for pharmaceutical, therapeutic, and medical device customers.

Brent Crow, PhD, was promoted to Head, Special Programs, now leading the company’s development of platform technologies for ELUTE fibre applications. Jennifer Seifert, PhD, who joined the company in 2015 to lead application of ELUTE fibre for the treatment of spinal cord injuries, is now serving the company as Director, Research and Development. Biomedical engineer Nicholas Mucha joined the R&D team as Research Scientist, and Michelle Locke joined in January as Manager, Quality and Regulatory Affairs.

Also, Principal Scientists Paul Hubbard, PhD, Alpesh Patel, PhD, and Paul Sood, PhD, joined and significantly expanded the company’s expertise in protein, polymer, and pharmaceutical drug delivery technologies. Finally, Andreas Sauerbrey, MD, and Richard W. Snyder II, MD, joined 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 fibre for clinical application.

New website

The company is has also launched its newly redesigned website presenting TissueGen’s roadmap for development of ELUTE fibre-based pharmaceutical and biologic delivery products for advanced drug delivery, nerve regeneration and tissue engineering.

“ELUTE fibre 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 fibre—we’re just getting started.”

TissueGen

TissueGen has more than four decades of cumulative experience in extruding bioresorbable polymer fibres with broad drug delivery capabilities.

According to the company, ELUTE fibre can directly replace standard fibres 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.

TissueGen has received prestigious industry recognition, including the 2015 R&D 100 Award in the Market Disruptor Service category and the ITMA Future Materials Award for Most Innovative Small Company. The company will exhibit ELUTE fibre at the upcoming MD&M East tradeshow in New York in June.

www.tissuegen.com

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