Tissue Regeneration Systems, a startup with offices in Kirkland, WA and Ann Arbor, MI, has raised $4.6 million to see if it can come up with a product to make life a little easier for patients who need significant bone replacement as part of complex facial and jaw surgeries.
The company has picked up its Series B financing from Venture Investors of Madison, WI and Ann Arbor, MI, as well as the University of Wisconsin, University of Michigan and a State of Michigan venture capital matching fund, said CEO Jim Fitzsimmons. TRS has now raised about $7 million since its founding in 2008, Fitzsimmons said.
The idea at the company, based on research at the University of Michigan and University of Wisconsin, is to help the body regenerate bone. TRS is developing a an implantable scaffold designed to be strong like metal to support weight-bearing stretches of bone in the face and jaw, but resorbable—meaning it eventually goes away and leaves natural bone in its place. The long-term plan is to develop the material for craniomaxillofacial (CMF) surgery, in hopes of coming up with an alternative to metal plates and bone grafts, in which surgeons harvest bone from the hip or the fibula and engraft it in the face or jaw, creating complications and multiple surgeries.
“Our goal is to develop products we implant and allow the patient to be restored to full function in one operation, and keep their fibula,” Fitzsimmons says.
Fitzsimmons is well known in the Seattle-area medical device community. He’s the former CEO of Archus Orthopedics, a spinal device company that raised $60 million in venture capital before being shut down in 2009 when investors soured on the spine implant market because of long, expensive clinical trials required, and concerns about whether insurers would pay in full for the products. He also founded Scout Medical Technologies, a medical device incubator that hatched a couple of other companies still in business—Kirkland, WA-based Cardiac Dimensions and Redwood City, CA-based EndoGastric Solutions.
TRS has run a series of large animal studies with its material, and has submitted a pair of applications to the FDA for approval. If it can win those approvals, the company should be in position to seek a larger amount of venture financing necessary to pursue other iterations in its product lineup, manufacture them, and sell them to a specialized part of the orthopedics market, Fitzsimmons says.
The total market is thought to be worth about $600 million, and while established players like Stryker, Medtronic, Biomet and Johnson & Johnson have offerings in the craniomaxillofacial market, TRS’s market research says the market is small and specialized enough that a small company can be successful, Fitzsimmons says.
TRS has remained a “virtual” company with just four full-time employees, although Fitzsimmons said the founders remain engaged. The founders are Scott Hollister, a professor of biomedical and mechanical engineering at the University of Michigan; Frank La Marca the director of the surgical spine program in the neurosurgery department at the University of Michigan School of Medicine; William Murphy, an associate professor of biomedical engineering as well as orthopedics and rehabilitation at the University of Wisconsin; and Stephen Feinberg, a board-certified oral and maxillofacial surgeon and professor at the University of Michigan School of Medicine.