New funding fuels device makers' push for FDA approval - MedCity News

Moximed’s MISHA knee system

Medical device company moximed has been working for almost 15 years on its signature product, the implantable knee shock absorber.

Backed by $40 million in new funding announced Tuesday, the Fremont, Calif.-based company hopes to secure approval for the product by next year from the U.S. Food and Drug Administration, according to Moximed CEO and co-founder Anton Clifford.

“I believe so deeply in what we do. Not only is it the right thing to do, but it provides a huge benefit,” Clifford said in a phone interview. “I’m excited to try to bring that to patients.”

Moximed’s device, called the MISHA Knee System, targets knee osteoarthritis patients between the ages of 33 and 64 who have exhausted traditional medications, such as corticosteroid injections or weight loss, but are not ready for joint replacement. The device, which is implanted on an outpatient basis, fits under the skin but does not require cutting bones or harvesting ligaments. Clifford touts the fact that this is the first implantable device of its kind.

A Moximed study to be published in September shows the system can reduce pain, improve function and potentially delay the need for total knee replacement in some patients. Clifford described the results as better than expected, but declined to provide details ahead of publication.

The new funding, a Series C round led by Advent Life Sciences, will support the company as it works to secure FDA approval and build infrastructure to market and sell the device. The latter will involve a heavy dose of training for orthopedic surgeons and salespeople, according to Clifford.

“I personally believe that education is a big part of it,” Clifford said. “We are bringing a first-of-its-kind implant to the orthopedic surgery community.”

He expects surgeons to embrace the device as a mid-range alternative to joint replacement in younger, active patients. Clifford believes that insurers can be convinced because the device can reduce the cost of treatment patients who suffer from regular pain or are limited in their abilities. He estimated that about 9 million people suffer from knee OA symptoms who would benefit from something less than joint replacement.

“We recognize that there will still be fluctuations, so just the status quo will be the biggest competition we have,” Clifford said. “That’s where education comes in.”

Moximed developed a version of the device, called the KineSpring System a few years ago and was ready to seek FDA approval for this device. However, early positive results from MISHA convinced the company to focus on this version, Clifford said. “This is the product we want in the market.”

In addition to the investment from Advent Life Sciences, the $40 million Series C round includes backing from New Enterprise Associates, Future Fund, Vertex Healthcare, Gilde Healthcare, GBS Venture Partners and Morgenthaler Ventures, with debt financing provided by Runway Growth Capital .

Investors stepped in $50 million during a Series C round in 2017 and $33 million in 2015.

“Working people who have osteoarthritis of the knee have been waiting for a solution that falls between conservative care and eventual joint replacement,” Dr. Shahzad Malik, general partner of Advent Life Sciences, said in a statement. “Moximed has the potential to fill this gap in knee OA treatment with the MISHA Knee System, and we are excited to continue to support Moximed’s efforts to change the treatment paradigm for millions of Americans.”

Photo: Moximed

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