ApiFix said today that it won a humanitarian device exemption from the FDA for its MID-C implant for treating pediatric scoliosis.
The Boston-area company said the minimally invasive deformity correction device’s August 23 approval covers patients with progressive adolescent idiopathic scoliosis.
“FDA approval of ApiFix’s MID-C system is a significant achievement for our company,” CEO Paul Mraz said in prepared remarks. “But more importantly, it makes a notable treatment advancement available for patients and their families who want FDA approved alternatives to permanent spinal fusion. Our MID-C System addresses a significant unmet clinical need for a motion-preserving alternative to spinal fusion and is a viable treatment option for progressive scoliosis in a select group of AIS patients.”
“The FDA rigorously evaluated data from patients treated with ApiFix’s MID-C system since 2012 to demonstrate the safety and probable clinical benefits of our lessinvasive, non-fusion deformity correction system,” added co-founder & CMO Dr. Yizhar Floman.
“We are grateful to FDA for this approval and we are excited to be in a position to offer a game-changing alternative to young patients in the United States,” co-founder and CTO Uri Arnin said in a release. “Since forming the company in 2011, it has been our mission to positively change the lives of scoliosis patients forever. This HDE approval brings us much closer to achieving that goal.”