EAST TAUNTON, Mass., March 10 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(TM) and K2 Modular hip stems as well as the new Apex ARC(TM) 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."
About OMNIlife science, Inc.
OMNIlife science, Inc. was founded in 1999 as an organization committed to the design, manufacture and distribution of high quality orthopaedic devices. Our corporate headquarters are located in East Taunton, Massachusetts. Our products are prescribed by orthopaedic surgeons for their patients who require total joint replacement. OMNI is ISO 13485 certified and its products are FDA cleared and CE approved. OMNI is emerging as a leader in modular hip stem technology and total knee replacement systems. We continue to challenge the design and functionality of our products based on continued advances in reconstructive surgical techniques, anatomic and biomechanical data, as well as input from surgeons. Our corporate strategic objectives include continued growth through line extensions to our hip and knee product offerings as well as the introduction of new products that will complement our current product portfolio and allow us to provide new clinical options for our customers.
About SERF-Dedienne Sante
SERF-Dedienne Sante is a French medical implant Company with a long experience in the design, manufacturing and distribution of orthopedic and dental implants. Headquartered near Lyon-France, the Company has two manufacturing plants in Lyon and Montpellier. Since 1973, SERF-Dedienne Sante has pioneered several important developments in orthopaedic and dental technology, the most successful being the Dual Mobility Acetabular Cup Concept invented by Pr. Gilles Bousquet in the mid 1970's and which is currently generating a tremendous interest from the orthopedic community based upon excellent widely published long term clinical results. The Company is ISO 13485 & ISO 9001 certified and its products are CE marked. Thanks to its invaluable experience, flexibility, dynamic R&D and competitive manufacturing, SERF-Dedienne Sante is now expanding its strong European position to North America and Asia Pacific markets.
SOURCE OMNIlife science, Inc.