ApiFix

ApiFix Ltd. develops and markets the ApiFix MID-C (Minimally Invasive Deformity Correction) System, a posterior dynamic deformity correction implant for adolescent idiopathic scoliosis (AIS). The system centers on a patented unidirectional, self-adjusting rod that functions as an "internal brace," combined with motion-preserving polyaxial joints. It is implanted on only one side of the spine through a posterior approach, which the company describes as less invasive than fusion and other fusionless procedures. Most curve correction is achieved during the index procedure, with the self-adjusting rod permitting additional post-operative correction over time and accommodating further growth, allowing treatment of both skeletally immature and skeletally mature adolescents. The implant is removable. Reported procedure characteristics include an approximately two-hour operation, hospital discharge in one to two days, and return to school within about two weeks.

The company positions the procedure as filling a gap between bracing, which may be ineffective, and spinal fusion, which is permanent. In the United States the ApiFix MID-C System is authorized as a humanitarian use device for AIS; the labeling states that effectiveness for this use has not been demonstrated and restricts sale to physicians. The U.S. indication covers single curves classified as Lenke 1 (thoracic major) or Lenke 5 (thoracolumbar/lumbar major) with a Cobb angle of 35 to 60 degrees reducing to 30 degrees or less on lateral side-bending radiographs, and thoracic kyphosis below 55 degrees (T5–T12). The outside-the-U.S. indication is similar but covers Cobb angles up to 60 degrees. Contraindications include non-idiopathic scoliosis, excessive thoracic kyphosis, malignancy or infection history, spinal cord abnormalities, neurological deficit, and poor bone quality; patients are advised against contact or high-demand sports.

ApiFix Ltd. is a wholly owned subsidiary of OrthoPediatrics Corp. (Nasdaq: KIDS), a company focused on pediatric orthopedics, and the ApiFix website lists OrthoPediatrics' Warsaw, Indiana address. Trademarks used by the company include ApiFix, The Internal Brace Option, and Refuse to Fuse.

Founding story

Yizhar Floman, M.D., is identified as a co-founder and served as Chief Medical Officer. The Trendlines Group was the company's founding investor and largest shareholder, with Trendlines Chairman and CEO Todd Dollinger also serving as chairman of ApiFix.

Business model

ApiFix commercializes an implantable spinal device and associated surgical procedure, sold on the order of a physician and performed by trained surgeons at hospitals and clinics. The company supports adoption through surgeon resources, a provider directory, and clinical evidence materials, and operates as a subsidiary within OrthoPediatrics' pediatric orthopedics portfolio.

Revenue is generated from sales of the implantable MID-C System components, which are single-use sterile devices sold by or on the order of a physician.

Traction

More than 1,100 AIS patients have been treated with the ApiFix procedure since the first case in April 2012, representing over ten years of clinical experience. At the time of the 2016 financing, more than 100 operations had been performed, with the earliest patients four years post-surgery. Published retrospective studies report mean major curve correction of 46% (47 degrees pre-operatively to 25 degrees at final follow-up), with 82% of patients at a final Cobb angle of 30 degrees or less and 18% undergoing revision surgery in one series; a separate growth-modulation study reported significant curve reduction across Risser groups with four revisions and no conversions to fusion. The company has also initiated a post-approval registry tracking safety and probable benefit for five years post-implantation.

Latest developments

The ApiFix MID-C System is authorized in the United States as a humanitarian use device for AIS, and the company operates as a wholly owned subsidiary of OrthoPediatrics Corp. Cumulative experience exceeds 1,100 treated patients over more than ten years, and a post-approval registry is collecting five-year safety and outcomes data.