Growth factor: UM spinoff aims to use mesh to create bone

It sounds futuristic: Tissue Regeneration Systems Inc. is in the business of using a biodegradable polymer mesh to grow new bone and replace the titanium implants now in use. But the future isn’t so far off.With a fresh round of venture capital funding, including $500,000 from a new state of Michigan fund, and animal trials winding down, theUniversity of Michigan spinoff hopes to be in the market late next year or in 2015 at the latest.TRS, based at UM’s North Campus incubator, has received $2.25 million in its second round of VC funding, including $500,000 from the Pure Michigan Venture Match Fund, a deal theMichigan Economic Development Corp. will announce this week. The Pure Michigan fund was approved by theMichigan Strategic Fund board last February; the investment in TRS was part of the first round of six investments the fund will announce. (See fact box at right.)TRS uses a biodegradable polyester polymer called polycaprolactone to serve as spinal implants, to mend cracks or fill in voids in broken bones, to repair broken orbital sockets and for facial reconstruction. The polymer is formed as a mesh and coated with growth factors that encourage a patient’s own bone to grow over and through the mesh. As the bone grows, the polymer eventually dissolves. The company will soon make the transition from being an incubated startup to an actual manufacturer, said CEO Jim Fitzsimmons, which will include finding space of its own, buying manufacturing equipment and hiring more employees to go with the four it has. The market opportunity is to replace implants created by companies like New Jersey-basedJohnson & Johnson, Minneapolis-basedMedtronic Inc. and Kalamazoo-based Stryker Corp. One eventual option for TRS to return a profit to its investors would be to sell the company to one of those medical device manufacturers.
Market opportunities
Titanium is stronger than the bone that surrounds it, which can cause degenerative problems. And if it is used in children, it must be replaced as the child grows. No replacement of TRS material would be needed in children because by the time they had grown, it would have dissolved, TRS officials said. The company hopes one potential lucrative market will be facial reconstructions on injured war veterans — using computer modeling to make the reconstructed face as much as possible like the face before it was injured. TRS, which employs four people, has completed successful trials on rhesus monkeys at the National Dental Centre of Singapore and is conducting trials on pigs at the University of Illinois. The trials are funded through three small-business innovation research grants totaling $1.2 million from the National Institutes of Health.In 2011, TRS received a $245,000 grant from the U.S. Health and Human Services Qualified Therapeutic Discovery Program.The company has filed two requests, called 510(k) submissions, with the U.S. Food and Drug Administration for approval to begin selling its products. One use is as a general filler of voids in bones; the other is specifically to fill cracks or voids in bones of the head.Company officials expect FDA approval by the end of the year. If granted, TRS can go to market without need for time-consuming and expensive human trials.
A 510(k) submission claims that a product is as safe and effective as legally marketed devices on the market.While there are no polycaprolactone products in the bone repair and replacement market, it has been widely used in industry and biotech and has been approved by the FDA for a variety of applications in the human body, including coating drugs and as a suture material.
Source:Tom Henderson