ApiFix receives Australian regulatory approval

Editor’s note: The Therapeutics Goods Administration (TGA) is the Australian government body that oversees the regulation of therapeutics.

The ApiFix spinal implant receives TGA certification.

ApiFix received TGA certification through its distributor Orthotech Pty. Ltd. to begin marketing the ApiFix system in Australia for the treatment and correction of Adolescent Idiopathic Scoliosis (AIS) using an innovative, minimally invasive surgical approach. TGA is the Australian government body that oversees the regulation of therapeutics.orthotech logo

The ApiFix system represents a breakthrough treatment for Adolescent Idiopathic Scoliosis (AIS) as it is a minimally invasive, non-fusion spinal implant system which dramatically improves the quality of life of patients who undergo scoliosis surgery. Additionally, it saves hospitalization and OR time, and is considerably more cost-effective than current scoliosis surgery.

“Incorporating the ApiFix system into our portfolio of products fits our mission to bring exceptional, unique, state-of the-art orthopedic products into the Australasian market. The ApiFix system provides game-changing technology for AIS patients and surgeons alike and we’re proud to include them in our suite of products,” commented Sam Scott-Young, Managing Director of Orthotech.

Standard scoliosis surgical correction is a highly invasive, lengthy procedure involving a long recovery period, and resulting in a rigid spine due to fusion of the vertebrae. The ApiFix approach brings an ingenious solution with its minimally invasive, non-fusion spinal implant system, inserted in a short procedure, followed by a brief recovery period, and maintains spine flexibility.

ApiFix CEO Eran Feldhay, M.D., remarked: “The certification for the ApiFix product by the TGA through our distribution partnership with Orthotech allows us to expand our reach and provide treatment for AIS patients in Australia too. We look forward to working with a company like Orthotech who are committed to innovative orthopedic solutions for their customers.”

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