Sonoma Seals $12M For Fracture Devices
By Brian Gormley
4/21/2009
Sonoma Orthopedic Products Inc., whose implants help wrist and clavicle fractures to heal, has raised a $12 million Series C to expand rollout of its first two devices and to launch new products.
New investor Split Rock Partners led the round, which closed on March 24. Return investors Asset Management Co., EDF Ventures and MedVenture Associates also participated in the financing, which Chief Executive Glen Coleman said would last through 2011. The Santa Rosa, Calif., company has now raised a total of $25 million since forming in 2005. Its valuation is undisclosed.
Sonoma Orthopedic uses its WaviBody technology to make flexible implants that are inserted in an inner bone cavity called the intramedullary canal. Once inside, the device becomes rigid and secures the fracture in its anatomical configuration. The approach, an offshoot of the minimally invasive procedures used for cardiovascular disease, enables surgeons to treat fractures through incisions in the bone.
The company applies this platform to difficult fractures, and last year secured 510(k) clearances for implants aimed at two hard-to-treat conditions: distal-radius, or wrist, fractures, and fractured clavicles.
Physicians traditionally have treated wrist fractures with casts or, if severe, with bone plates. Sonoma Orthopedic's distal-radius fracture device can help patients in both groups, though the most serious cases still require plates, Coleman said. Surgeons insert the device - which can be removed, if needed - in an outpatient procedure. Patients then wear a splint afterward.
Since clavicle fractures are so hard to treat, physicians often let them heal on their own; patients are typically given a brace or a sling to keep their shoulder steady, Coleman said. Since the resulting bone union is often poor, however, surgeons are searching for new options, he said.
Once Sonoma Orthopedic's clavicle implant is placed inside the bone canal, grippers on the device are expanded, locking the implant to the medial and lateral bone fragments. Surgeons then place a screw through the stainless-steel hub to further secure the lateral bone fragment.
Competitors include Wright Medical Technology Inc., which sells Micronail, an intramedullary implant for distal-radius fractures, and Johnson & Johnson's DePuy Orthopedics unit, which markets the Rockwood Clavicle Pin.
Coleman, a former Wright Medical executive, said the candy-cane shape of his company's wrist implant makes it easy to deploy in arched bones. Meanwhile, the product's grippers hold it firmly in place. As a result, physicians can deliver consistently good results, Coleman said.
To help with marketing, Sonoma Orthopedic is conducting a clinical trial that will enroll about 50 distal-radius fracture patients. In this study, it hopes to show that patients not only get better results than they would with traditional techniques, but that they also get them sooner. Strong clinical data are important, since hand surgeons are a conservative group, Coleman said.
Of its two products, the clavicle device, which targets a relatively open market, is drawing the strongest sales so far, Coleman said, though he declined to give specifics. Sonoma Orthopedic is concentrating its marketing on Western states and plans to make its way east over the next two to three years. Its goal is to build trust in devices springing from its WaviBody platform.
"It's more important for us to go slow and build some early adoption than to sprinkle products across the country," said Coleman, adding that he plans to introduce a new fracture-repair device each year. The company is developing devices for upper- and lower-extremity fractures, he said.
Split Rock Managing Director Dave Stassen has joined the board of Sonoma Orthopedic, which has 26 employees.