TEL AVIV, Israel, June 18, 2014 /PRNewswire/ --
MMATech Ltd, developing an acetabular liner for total hip implants, produced with a revolutionary, novel, advanced, low-friction and wear-resistant polyimide material, will be opening an investment round after excellent clinical results in recent pilot studies.
Due to a constant increase in human life expectancy, more people require Total Hip Replacement surgeries, a field generating billions of US$ per year with more than a million THR surgeries worldwide annually. One of the major problems with the current materials used for THR is the high wear created between the articulating components that could lead to significant complications including inflammation around the implant and extreme pain, which require revision surgery within 10-15 years.
In case of metal implants, the metal ions and wear debris absorbed by the tissues enter the bloodstream and might cause carcinogenic and toxic effects. Thus, there is a constant striving to find more durable and inert materials.
MMATech Ltd develops components made of a revolutionary 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.
"I'm very happy with the study results showing that the MP1™ achieved safety and efficacy," said Simha Sibony, CEO of MMATech and Regulatory Affairs professional. "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."
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.
Efrat Kaduri | Efrat@ofirpr.co.il | +972-4-9535030
SOURCE MMATech Ltd