The CE Mark clears AxioMed for commercialization of the Cervical Disc into the European, Asian, Latin American, and Australian, where it is TGA approved, markets.
BOSTON (PRWEB) March 14, 2019
AxioMed announced today the issuance of the CE Mark approval for their viscoelastic disc replacement. The CE Mark approval was received as a result of an accredited Notified Body assessment of the company’s complete portfolio of biocompatibility and biomechanical cervical disc testing and supporting clinical data regarding the viscoelastic AxioMed technology.
AxioMed first received CE Mark in 2009 before moving operations from Cleveland, OH to Boston, MA and is preparing for a full global launch in 2019. The CE Mark clears AxioMed for commercialization of the Cervical Disc into the European, Asian, Latin American, and Australian, where it is TGA approved, markets. AxioMed is an ISO 13485:2016 certified manufacturer of the AxioMed Lumbar and Cervical Discs.
About AxioMed LLC
AxioMed was founded to advance the standard of care for patients with degenerative spine conditions by progressing spine technology beyond fusion and first-generation artificial discs. Led by an experienced surgeon team and utilizing patented viscoelastic polymer technology, AxioMed has developed the next generation of artificial discs. AxioMed completed its U.S. IDE for the Lumbar Disc with over five years of clinical follow-up.
KICVentures, the parent company of AxioMed, is a private investment company founded in 2005 by Harvard-trained Orthopedic Surgeon & Professor Dr. Kingsley R. Chin, who brings unique experience at the intersection of medicine, business and information technology. KICVentures is equipped with a strong advantage in identifying niche healthcare opportunities, and is headquartered in Boston, Mass.