CEO: Kevin Sidow
Based: Hayward, CA
The scoop: Moximed is shooting to change the standard of care for patients with knee osteoarthritis (OA) with its KineSpring Knee Implant System. Normally, patients with OA try to get by with pain medication and knee braces before opting for joint-altering surgery. Moximed's product targets patients with mild and moderate knee OA whose pain is worsening but aren't ready for arthroplasty, or total knee replacement.
The company's KineSpring device is implanted in the knee and can reduce pressure on the joint by as much as 13 kg. And unlike other implants, the device does not require any bone, ligament or cartilage to be removed.
Moximed has already gained traction for its knee implant system in Europe, where the device is CE marked and has been used in more than 1,000 patients. And the company's KineSpring is attracting attention from investors. In May, Moximed raised $33 million with firms such as Vertex Venture Holdings, New Enterprise Associates and Gilde Healthcare Partners contributing funds.
The company is running two clinical trials concurrently in the U.S. and Europe for its implant, both of which started in 2012. The 24-month SOAR study is looking at the device's efficacy in 110 patients in the U.S., while a 24-month GOAL study is evaluating the implant against more invasive surgery in 225 patients.
What makes Moximed Fierce: Moximed's knee implant addresses "an area of massive, unmet need," CEO Kevin Sidow told FierceMedicalDevices. Although chronological age plays a role in who receives the company's device, physiological age is also a key factor, Sidow said. Older adults are increasingly active, and there's a "glaring need" for devices that can preclude invasive surgeries, he added. KineSpring lowers the pain threshold and allows individuals with its implant to maintain their day-to-day lives and hobbies.
"The economics are there on a global basis," Sidow said. "We think over the next few years, people will recognize it as significant and a big contributor to orthopedics."
What to look for: With the latest financing under its belt, Moximed will continue to refine its product and develop a next-generation version of the implant, Sidow said. The company expects to score a CE mark for its next-generation device sometime during the next 6 months and plans to do a postmarketing study of the device in European markets. Moximed will also launch a study for the device in the U.S., but it will be a pilot feasibility study aimed toward FDA 510(k) clearance. "The clinical data is baking," Sidow said.
Meanwhile, the company is "talking to a couple of people interested in developing collaborations with us that go beyond investment," Sidow said. Without revealing any specific details, he said funding from those deals would support additional clinical studies, including for therapies adjacent to KineSpring's focus.
"We think the impact in this pre-arthroplasty space will be massive, and frankly, will be as big someday as the arthroplasty space," Sidow said. "It won't happen overnight, but ultimately there will be a paradigm shift to something you can remove and not burn bridges to those other therapies that are more invasive."
-- Emily Wasserman (email | Twitter)
Startup Moximed gets $33M to gain FDA approval of early stage osteoarthritis knee implant