FDA Cleared Carbohydrate Polymer Boosts Bone Healing

A biotechnology startup spun off from the University of California at Davis, called Molecular Matrix Inc., has received Food and Drug Administration 510(k) clearance for a carbohydrate-based polymer that can help injured bones heal and regrow.

Osteo-P, a synthetic bone graft substitute, supports and guides the growth of new bone. The biomaterial is later resorbed and replaced with the patients’ own bone during the healing process. With the 510(k) FDA clearance, Molecular Matrix will now be able to take Osteo-P to market.

“This is yet another meaningful milestone for UC Davis and our technology commercialization efforts,” said Dushyant Pathak, Ph.D., M.B.A., associate vice chancellor of Technology Management and Corporate Relations, and executive director of Venture Catalyst at UC Davis. “Our focus on innovation and technology commercialization is a direct reflection of its being one of the most tangible ways in which the university can fulfil its mission of public benefit and societal impact.”

For Charles Lee, Ph.D., the founder of Molecular Matrix and an assistant adjunct professor in the Department of Cell Biology and Human Anatomy at the UC Davis School of Medicine, the FDA clearance marks an exciting turning point for the company UC Davis helped him found in 2011.

“What began as an idea from UC Davis has reached all the way to FDA clearance,” Lee said.

Lee received his B.S. in microbiology and Ph.D. in comparative pathology and did his postdoctoral work at UC Davis. He became fascinated by stem cells as an undergraduate when he had an internship with Alice Tarantal, Ph.D., professor of pediatrics and cell biology and human anatomy in the UC Davis School of Medicine, and the associate director of the UC Davis School of Medicine Stem Cell Program. Tarantal gave him a line of stem cells to culture.

“I fell in love with those cells,” Lee said. “That’s how I got into stem cell biology. There was nothing else I wanted to do than study and research them.”

The stem cells he worked with were grown in a single layer, but Lee began thinking about new ways to grow them.

“Stem cells behave much differently when they are grown in an aggregate as opposed to a monolayer,” Lee said. “But building up stem cells is not easy. It requires a scaffold—a matrix or structure—to help support the cells to grow into an organoid.”

Lee wanted to use a carbohydrate, a sugar, for scaffolding.” I wanted it to be degradable and nontoxic, to not affect stem cells in any way,” he said.

The invention he came up with, a hyper-crosslinked carbohydrate polymer technology, provides a platform for stem cells to grow both in vitro and in vivo. “We chemically crosslink the carbohydrate molecules to build a massive structure. It’s crosslinked so much that it can hold its shape under heat and pressure” Lee said.

For its first clinical launch, Molecular Matrix focused on creating a polymer product to help bones regrow without stem cell transplantation. “Bone is a good place to start,” Lee said. “It is simpler to regenerate than other organic systems.” The company plans to release the product for single-patient use as early as mid-March.