MISGAV, ISRAEL: The Trendlines Group Ltd. announced on Wednesday that its portfolio company ApiFix Ltd., a leading scoliosis correction company and one of Trendlines’ ten most valuable companies, received regulatory approval from the United States Food and Drug Administration (FDA) to commercialize its MID-C System for motion-preserving deformity treatment of progressive adolescent idiopathic scoliosis (AIS).
The FDA announced its approval of ApiFix’s MID-C System via social media.
AIS is the most common type of scoliosis and affects 2%-3% of the population between ages 10 to 21. Generally, AIS curves progress during an adolescent’s rapid growth period and, while most curves slow their progression significantly at the time of skeletal maturity, some deformities, especially curves greater than 50o, continue to progress during adulthood.
FDA approval will enable ApiFix to begin selling its device in the United States. The MID-C System has had CE approval in Europe since December 2012 and more than 300 surgical procedures have been completed, including a number of implantations in Singapore.
In a press release by the company, ApiFix CEO, Paul Mraz said, “FDA approval of ApiFix’s MID-C system is a significant achievement for our company….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.”
Chairman and CEO of The Trendlines Group, Todd Dollinger commented: “We are extremely proud of this achievement by ApiFix. Since the establishment of ApiFix in 2011, we have identified strongly with the company’s mission of positively impacting the lives of young patients with scoliosis. This will now be possible in the United States, following the company’s clinical successes in other countries around the world.”
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