The MISHA Knee System is an implanted shock absorber created to ease pain, maintain function, and provide a treatment option that is capable to delay arthroplasty
Moximed announced the results of the Calypso Study that evaluated the MISHA Knee System. (Credit: Angelo Esslinger from Pixabay)
Medical device company Moximed announced that its MISHA Knee System showed the superiority of its primary endpoint, reduced pain scores significantly, and improved function scores of participants in the Calypso Study.
The MISHA Knee System is an implantable shock absorber (ISA) designed to ease pain, maintain function, and provide a treatment alternative that may delay arthroplasty.
The Calypso Study evaluated the safety and effectiveness of the implantable shock absorber at multiple centres. A total of 81 participants took part in the trial in which Moximed’s implant was compared with high tibial osteotomy (HTO) for the treatment of symptomatic osteoarthritis.
Moximed CEO Anton Clifford said: “In our investigational device exemption (IDE) study, the MISHA Knee System was compared to the high standard set by high tibial osteotomy, a well-established orthopedic procedure.
“To demonstrate superiority against an established procedure, with proven results, is a great outcome for patients.”
The company reported that the MISHA Knee System was superior to high tibial osteotomy (HTO) at two years.
In the results, the medical device firm found that its knee system showed a composite success rate of 85.6%, in comparison to HTO, which scored 65.5%.
Moximed’s implantable shock absorber continued to show superiority on all secondary endpoints. These included the Knee Injury and Osteoarthritis Outcome Score (KOOS)-derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and function ratings, which improved after three months and at 24 months, respectively.
David Diduch from the department of sports medicine at the University of Virginia, University of Virginia presented the findings of the Calypso Study.
Diduch said: “These clinical findings are exciting because they demonstrate that the joint-preserving implantable shock absorber has the potential to provide significant benefits compared to high tibial osteotomy. Over 90% of the patients receiving the MISHA Knee System experienced substantial, clinically meaningful pain relief and functional improvement.
“Without cutting bones or permanently modifying the joint, patients with knee OA may soon have a treatment option that allows them to return to their active lives.”