ApiFix News
17 articles
OrthoPediatrics Spotlights Award-Winning ApiFix® Technology at IMAST
OrthoPediatrics Corp.s ApiFix System has been named the Gold Winner of the 2022 Medical Design Excellence Awards. The company showcased its award-winning technology at the 2022 International Meeting on Advanced Spine Techniques (IMAST). OrthoPediatrics also highlighted other products, including the RESPONSE Scoliosis System, FIREFLY Pedicle Screw Navigation Guides, and 7-D Image Guided Surgery technology. The ApiFix System offers a non-fusion alternative to adolescent idiopathic scoliosis surgery and has the potential to disrupt the continuum of care for scoliosis treatment. OrthoPediatrics acquired ApiFix Ltd. in April 2020. The ApiFix system has FDA and CE Mark approvals and is available in multiple countries.
PartnersExpand
OrthoPediatrics buys Israeli co ApiFix for at least $67m
OrthoPediatrics Corp. has acquired ApiFix, an Israeli scoliosis treatment device company. The acquisition will allow OrthoPediatrics to fill a major treatment gap and potentially avoid fusion surgery. ApiFix has developed a minimally invasive deformity correction system for non-fusion treatment of progressive adolescent idiopathic scoliosis. The MID-C system, approved by the FDA, provides permanent curve correction while retaining spine flexibility. OrthoPediatrics will pay 934,768 shares of common stock and $2 million in cash, with additional milestone payments and earn-outs over four years. The total additional payments could be at least $30 million. The acquisition is expected to contribute to the growth of non-fusion procedures. The event occurred on April 2, 2020.
Acquisition
FDA approves ApiFix MID-C system for progressive AIS - MedTech Innovator
Israeli medical devices manufacturer ApiFix has received FDA approval for its minimally invasive deformity correction system for the treatment of progressive adolescent idiopathic scoliosis. The MID-C system, which is a motion-preserving alternative to spinal fusion, allows for permanent curve correction while retaining spine flexibility. The FDA approval is a significant achievement for ApiFix and provides an FDA-approved alternative treatment option for patients and their families. The MID-C system works as an internal brace with a self-adjusting rod mechanism and enables additional post-operative correction over time.
CustomersPartners
ApiFix Receives FDA Approval to Commercialize MID-C System for Motion-Preserving Deformity Treatment of Progressive Idiopathic Scoliosis in Adolescents
ApiFix Completes Financing to Prepare for Commercial Efforts in the United States
https://www.marketwatch.com/press-release/apifix-surpasses-250-scoliosis-patients-treated-and-six-year-follow-up-of-earliest-cases-2018-10-02
Canadian surgeon performs 1st ApiFix scoliosis surgery in North America: 4 key insights
Dr. Ron El-Hawary performed adolescent idiopathic scoliosis surgery using the ApiFix procedure at the IWK Health Centre in Halifax, Canada. The IWK Health Centre is the only facility in North America to offer the procedure. The ApiFix System, which uses one rod with flexible joints, provides an alternative to spinal fusion surgeries and may allow for more postsurgical spinal mobility. Dr. El-Hawary is the chief of orthopedics at the IWK Health Centre and an associate professor at Dalhousie University Faculty of Medicine in Halifax.
Customers
Ontario teen has 'no more pain' after new scoliosis surgery, but Halifax surgeon urges caution CBC News
The IWK Hospital in Halifax is offering a new spinal surgery called the ApiFix procedure, which has the potential to dramatically change the way children with scoliosis are treated. The surgery involves using a flexible device developed in Israel that attaches to the spine with screws, allowing for continued flexibility. The surgery is less invasive and takes less time than traditional fusion therapy. The results of the surgery have been positive so far, with patients experiencing improved quality of life and increased participation in physical activities. The surgery has not yet been approved in the United States, but surgeons across North America are closely watching the results.
Customers
ApiFix Ltd. Announces New Leadership - Ortho Spine News
ApiFix Ltd., a portfolio company of The Trendlines Group Ltd., announced the appointment of Ed Roschak as Chairman of the Board and Paul Mraz as President and CEO. ApiFix provides minimally invasive non-fusion solutions for the treatment of spinal scoliosis. Roschak previously served as President and CEO of Ellipse Technologies, which was acquired by NuVasive for $410 million. Mraz brings 25+ years of spine and orthopedic medical device experience. The appointment is expected to help ApiFix expand in the U.S. and European markets as it finalizes its application for FDA clearance.
Management Changes
ApiFix Signs Distribution Agreement in Canada;Completes First Cases in North America at IWK Health Centre Hospital, Halifax
Medical device company ApiFix Ltd. has signed an exclusive distribution agreement in Canada with Joint Solutions Alliance Corp (JSA), a national Canadian medical device and services distribution organization. The agreement allows ApiFix to penetrate the North American market and deliver their non-fusion spinal implant system for the correction of Adolescent Idiopathic Scoliosis (AIS) to more patients around the world. The ApiFix system aims to improve the quality of life for scoliosis patients and reduce costs and recovery time associated with standard scoliosis surgery. The company has CE clearance and is already marketed in several countries.
Partners
The ApiFix Spinal Implant Receives TGA Certification - Ortho Spine News
ApiFix, a portfolio company of The Trendlines Group, has 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. The certification allows ApiFix to expand its reach and provide treatment for AIS patients in Australia. The ApiFix system is a breakthrough treatment for AIS, offering a minimally invasive, non-fusion spinal implant system that improves the quality of life for patients and is more cost-effective than current scoliosis surgery. Orthotech is committed to innovative orthopedic solutions and is proud to include ApiFix in its suite of products.
Partners
ApiFix Closes Spanish Distribution Deal with Acuna-Fombona
Medical device company ApiFix has signed an exclusive distribution deal in Spain with Acuna-Fombona, a distributor of Spain and Portugal. ApiFix has developed a minimally invasive, non-fusion spinal implant system for the correction of Adolescent Idiopathic Scoliosis (AIS). The distribution deal will help ApiFix expand its presence in Europe and offer its products to Spanish AIS patients. The deal is seen as a growth-positive move for the company.
Partners
Scoliosis correction for kids just got much less invasive
ApiFix, an Israeli company, has developed an internal brace for adolescent scoliosis. The device has been used on 110 patients in Israel and eight European countries and is close to receiving approval from the US FDA. ApiFix is completing a $5 million investment round led by B. Braun. The device, which requires only two screws and a one-hour minimally invasive procedure, allows patients to maintain flexibility in their spine. The company plans to market the device in additional countries and hopes to become the standard treatment for up to 60% of adolescent scoliosis patients. ApiFix will file for FDA approval early this year and expects approval within a year.
CustomersInvestment
Israeli spinal implant co ApiFix raises $5m
Israeli spinal implant company ApiFix has raised a $5 million Series B investment round. B. Braun Melsungen Aesculap division has invested $2.8 million in the latest financing round. ApiFix is disrupting the scoliosis device market with its minimally invasive, non-fusion spinal implant system. The global market for ApiFix is over $1.15 billion. ApiFix received CE Mark approval in 2012 and is marketing its device in Europe. The funding round will support ApiFixs FDA submission and expansion of clinical and commercial activities in Europe. B. Brauns investment positions ApiFix for accelerated growth and brings their substantial experience to ApiFixs board of directors. B. Braun and Trendlines have a partnership for co-investment and collaboration in the development of new technologies and products.
Investment
ApiFix system reaches 100-patient milestone - Spinal News International
The ApiFix system has been used to correct scoliosis in 100 patients, with excellent results. ApiFix has opened new clinical centers in Europe and expects to double the number of cases by the end of 2017.
CustomersExpand
Startup invents ratchet to correct adolescent scoliosis
Israeli startup ApiFix has developed a ratcheting device for the treatment of scoliosis. Unlike traditional surgery, the ApiFix device retains the spines flexibility and involves a minimally invasive procedure. The device is suitable for non-severe scoliosis cases and gradually corrects the curvature of the spine through specific spinal exercises. ApiFix has received European CE mark approval and is used in several European countries. It has also received approval from the Israeli Health Ministry and is in the process of obtaining FDA approval in the United States.
Customers
ApiFix Scoliosis Correction Ratchet Gets EU CE Mark (w/video)
ApiFix, a company based in Misgav, Israel, has received European regulatory approval to market its ratcheting spinal correction implant. The implant is designed for adolescent idiopathic scoliosis and consists of a ratchet that spans between two screws implanted into the spine. ApiFix successfully completed a pilot clinical trial in Europe, demonstrating the implants safety and success in correcting the curvature. The company achieved impressive results within about three months. With the CE Mark, ApiFix can now commercially distribute its innovative treatment system for scoliosis.
Customers
