OMNIlife science, Inc., is very pleased to announce that it has entered into an exclusive U.S. distribution agreement with Societe d'Etudes Recherches Fabrication (SERF)-Dedienne Sante of France for its NOVAE® Dual Mobility Acetabular Cup System. OMNI intends to begin distribution of this product in the USA as soon as U.S. FDA approval of the product is achieved.
"Gaining the distribution rights to SERF's NOVAE® line of Dual Mobility Acetabular Cups will allow OMNI to provide its customers with access to large head hip articulation technology that is free from the risk of metal ION release. The SERF Dual Mobility Cup System has a successful clinical history of over 30 years with outstanding implant longevity and extremely low complication rates. Combining this Ion Free, Large Head Dual Mobility Acetabular Cup technology with OMNI's advanced Apex Modular™ and K2 Modular hip stems as well as the new Apex ARC™ Tissue Sparing Hip Stem systems will, upon FDA approval, provide OMNI with the ability to compete against the Metal on Metal large head acetabular cup technology of our competitors without the risks that have recently been associated with Metal on Metal bearing surfaces," said George Cipolletti OMNI's president and CEO.
Nik Nikolaev, Chairman of Orthopaedic Synergy, Inc., the holding company that owns OMNIlife science, Inc. and Enztec, Ltd., states, "Our distribution arrangement with SERF is in keeping with our philosophy of providing the best technology to our customers whether developed in house by our own family of companies or by partnering with very high quality manufacturers such as SERF-Dedienne Sante."