March 03, 2008   Maker of device for wrist breaks gets FDA approval By Loralee Stevens, Staff Reporter - North Bay Business Journal Santa Rosa, CA - (March 3, 2008) – Sonoma Orthopedic Products has received FDA approval for its first product in just 22 months and with less than $6 million in capital, launching the company into a new phase of growth. The company, founded by orthopedic product developer Charles Nelson and a team of orthopedic surgeons, is bringing to market a minimally invasive device to promote the healing of wrist fractures. “About one out of six fractures seen in emergency rooms are wrist, or distal radius, fractures,” said Mr. Nelson, Sonoma Orthopedic’s chief operating officer. In anticipation of marketing the device and a series of others now in development, the company has brought on as CEO Glen Coleman, previously president of U.S. marketing and sales with Wright Medical. The company was able to obtain 510K approval by showing its EnsplintRx Fixation Device is equivalent to FDA-approved products. “I’ve watched the development work on this new intramedullary device and I believe it will add a significant new treatment option in the care of distal radius fractures,” said Kai Mazur, M.D., lead clinician of the development team for Sonoma Orthopedic. Insurers are expected to welcome the product, which represents an advance over invasive wrist surgery. A complicated break necessitates the cutting of tendons, ligaments and muscles and use of plates and casts to immobilize the joint during healing. Even a simple break requires a cast. “Twenty-one percent of traditional methods for treating broken wrists have fair to poor results,” said Mr. Coleman. “The bone doesn’t heal straight or the patient never recovers full mobility.” The SOP device is placed through a small incision into the hollow cavity inside the bone. Casting isn’t needed and physical therapy can begin immediately, he said. The product will be manufactured at the company’s facilities in Larkfield. Sonoma Orthopedic will sell and distribute the device itself for this first launch, said Mr. Nelson. “Our current location will be adequate for this year and part of 2009,” he said. After that, Sonoma Orthopedic, now at 20 employees and growing, will seek larger quarters in Sonoma County. The company received two rounds of funding, in May 2006 and May 2007. Each series was for approximately $3 million. MedVenture Associates of Emeryville led the most recent round. Previous investors EDF Ventures, Asset Management Company, Halo Fund and angel investors also contributed. Mr. Nelson said SOP is working on its capital models and needs and has not yet reached a conclusion about new funding. It’s also working on pricing models for the new product. About 50 employees are expected to be added to the staff within the next two years. “We’re going to be moving a lot faster this year,” said Mr. Coleman. “Our next product will most likely be announced in six to eight weeks. We’re hiring now and that will pick up once revenues are coming in.” In addition to Mr. Coleman, who joined the staff in October of 2007, Sonoma Orthopedic has hired a clinical specialist to start supporting and training physicians in the use of the devices. Operations, quality and regulatory affairs staff are already in place, according to Mr. Nelson. For contact information, visit www.sonomaorthopedics.com.   < Back to Press Coverage