ApiFix Reaches 100-Patient Milestone

Editor’s note: News about the ApiFix milestone appeared on PRNewswire and other media outlets.

The Company expands its European clinical sites to treat children and adolescents who have scoliosis with its minimally invasive, non-fusion device

ApiFix, Ltd. announced that the company’s ApiFix® system has now been used to correct scoliosis in 100 patients, with a first case at the Paul Gerhardt Diakonie Hospital in Berlin, Germany. The 100th case was Dr. Miguel Alquiza’s first time implanting the ApiFix system. It took about an hour with excellent results, leaving the surgical team enthusiastic about the device.

Hear from ApiFix patients.

The ApiFix system is a minimally invasive, fusionless spinal implant system for the correction of Adolescent Idiopathic Scoliosis (AIS). Traditional surgical correction is a highly invasive procedure involving fusion, which results in a rigid spine, compared to the ApiFix system, which can be implanted with a minimally invasive procedure, does not require fusion, and retains flexibility of the spine.

ApiFix has opened new European clinical centers in Italy, Germany and France in the first half of 2016. The Paul Gerhardt Diakonie Hospital in Berlin is one of the newest German centers that has started twork with the ApiFix system. The 100-patient clinical experience in Europe and Israel now includes 12 sites in nine countries, with the earliest patients being over four years out post operatively and excellent results overall. The Company expects to double the number of cases by the end of 2017.

ApiFix’s U.S.-based Chairman, Ted Bird commented, “I am very happy with the progress being made by the ApiFix team in managing the controlled clinical release in Europe and Israel since receiving a CE Mark in December 2012. The Company has also made great progress on preparing a submission to the FDA for a Humanitarian Device Exemption (HDE) clearance in the United States after receiving approval from the agency for this pathway last year.”

Apifix principals will attend the annual meeting of the Scoliosis Research Society (SRS) in Prague, Czech Republic, 21-23 September to present the ApiFix system, clinical cases, and their follow-up to potential users from all over the world.

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