Moximed’s MISHA Knee System
medical device company Moximate For nearly 15 years, it has been tinkering with its signature product, an implantable shock absorber for the knee.
Backed by $40 million in new funding announced on Tuesday, the Fremont, Calif.-based company hopes to secure approval from the U.S. Food and Drug Administration by next year, according to Moximed CEO and co-founder Anton Clifford. Product approval.
“I have no doubts about what we’re doing. Not only is it the right thing to do, but it’s bringing huge benefits,” Clifford said in a phone interview. “I’m excited to bring it to patients.”
Moximed’s device, called the MISHA Knee System, targets knee osteoarthritis patients aged 33 to 64 who have exhausted traditional treatments, such as corticosteroid injections or weight loss, but are not yet ready for joint replacements. Implanted on an outpatient basis, the device fits under the skin but does not require cutting any bone or harvesting any ligaments. Clifford touted it as the first implantable device of its kind.
A study by Moximed to be published in September suggests the system can reduce pain, improve function and possibly delay the need for total knee replacement in some patients. Clifford said the results were better than expected, but declined to provide details ahead of release.
The new funding, a Series C round led by Advent Life Sciences, will support the company’s efforts to gain FDA approval and build the infrastructure to market and sell its devices. According to Clifford, the latter will include substantial education for orthopaedic surgeons and commercial payers.
“I personally think education is a big part of that,” Clifford said. “We are bringing first-of-its-kind implants to the orthopedic surgery community.”
He hopes surgeons will embrace the device as a middle ground for alternative joint replacements for younger, active patients. Clifford thinks insurers can be persuaded that the device could lower treat Patients with constant pain or limited ability. He estimates that approximately 9 million people suffer from knee OA symptoms that would benefit from a lack of treatment for joint replacements.
“We do recognize that there will still be hesitations, so maintaining the status quo will be our biggest competition,” Clifford said. “That’s where education comes in.”
Moximed has developed a version of the device, Called KineSpring System a few years ago and is preparing to seek FDA approval for the device. However, Clifford said early positive results from MISHA persuaded the company to focus on that version instead. “That’s what 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.
investor input $50 million in Series C financing in 2017 and $33 million in 2015.
“Office workers with knee OA have been waiting for a solution between conservative treatment and eventual joint replacement,” Dr. Shahzad Malik, general partner at Advent Life Sciences, said in a statement. “Moximed has the potential to pass The MISHA Knee System fills this gap in knee OA treatment, and we are excited to further support Moximed’s efforts to transform treatment paradigms for millions of Americans.”
Photo: Mosimed
