The company develops components made of a Polyimide material, MP1, originally developed for the aerospace industry. The material, being thermoset, combines unusual toughness, self-lubrication, excellent friction and wear durability, resistance to fatigue, creep and impact, and provides a longer lifespan of articulating implanted components.
Preclinical and clinical studies conducted by the company indicated that the liner characteristics almost totally prevent wear debris, and the little debris formed did not penetrate the bloodstream nor cause inflammation.
A pilot study under Ethical Committee approval of 100 cases has been conducted in New Zealand; 28 cases with about one year’s successful follow up and two cases with eight years’ excellent follow-up clinical results, including satisfying histological results of one recently retrieved implant. A CE Mark and ISO 13485 were granted in 2011.
MMATech CEO and Regulatory Affairs professional Simha Sibony said that the company is happy with the study results showing that the MP1 achieved safety and efficacy.
"There is a growing interest in the company and its technology. The innovative new material improves life quality and extends it by an estimated 25-30 years. It enables, for the first time, the THR procedure to be performed on young people and is safe since it does not wear, and is totally inert and compatible to body systems," Sibony added.
MMATech will be opening an investment round to further develop its technology, extend the clinical study to knee tibial component and submit the total hip system with MP-1 acetabular component to the FDA.
