“Our company saw a strong fit with ARMI|BioFabUSA when we attended the Institute’s launch in July of 2017,” said Peter Gingras, President & CEO of Viscus Biologics, LLC. “Although at times the whole Regenerative Medicine (RM) industry can be overhyped, we see real and incremental developments in tissue replacement starting with wound care and tissue to repair defects in the short-term horizon.”
The Ohio-based company designs, manufactures, and delivers innovative components and medical devices with the objective to positively impact the health and well-being of patients around the world.
Given the nature of the company’s products, quality is of paramount importance in the culture and operation of their mission to guide the actions and ensure safe and effective devices for humans.
Viscus Biologics received its ISO 13485 certification in April 2016. ISO 13485 certification certifies that the holder of the certificate has demonstrated compliance to the medical device quality management system standard from the International Organization for Standardization (ISO).
“We support our partners from the earliest stages of innovation and concept development through manufacturing, commercialization, and beyond,” noted Gingras.
The company specializes in xenograft materials. They research, develop, and manufacture medical devices with unique physical properties and biologic performance. The current product platform line includes AlloMEM, a human peritoneal tissue; XenoMEM for wound management; and FibermarX™ tissue marker for marking soft tissue for subsequent x-ray, CT scans, and mammography imaging.
“A goal of the whole Regenerative Medicine community should be to create the entire manufacturing system from raw materials, such as collagen, through to tissue and organs with new good manufacturing processes (GMP),” Gingras said. He continued, “Clinical grade collagen will be necessary in sheet and powder forms as well as soluble collagen for additive manufacturing, and we all need to help define the FDA/GMP practices from the outset.”
Gingras noted a program at Stanford University in BioDesign as a good place to watch when formulating an ecosystem strategy. “There the ‘problem-centric’ method is used to come to solutions. Not unlike the mission of ARMI | BioFabUSA, BioDesign students learn to appreciate not only the engineering aspects of a problem, but also the needs and desires of the patients, doctors, hospitals and health care systems, among others.”
Novel wound care, orthopedic, cardiovascular, and general surgery products are all in the pipeline for Viscus Biologics based upon allograft or xenograft tissues.
“Our close relationship with our sister company, Aran Biomedical in Ireland, offers our partners an integrated approach to the development of products that combine biologic materials based on extracellular matrices with synthetic materials,” he noted.
For more information, visit Viscus Biologics' Site here!