For reasons not completely understood in the medical world, some children over the age of ten suffer from a side curvature of their spine, known as Adolescent Idiopathic Scoliosis (AIS). According to Scoliosis & Spine Associates, three to five percent of adolescents have some form of scoliosis.
Symptoms of scoliosis include back pain, leg length discrepancy and uneven hips. Patients with AIS may have one shoulder higher than the other and visible curving of the spine to one side. Progressive scoliosis, left untreated, can result in significant deformity.
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ApiFix is an Israeli company developing a minimally invasive correction system for adolescent patients with a curvature of the spine of over 40 degrees.
Currently, although there are procedures available for very young children with scoliosis, there is no similar treatment for grown AIS patients on the market, ApiFix says. In addition, traditional treatment models for AIS are usually invasive surgeries that can leave complications and side-effects.
ApiFix might be able to offer a new solution that is less invasive, thereby reducing the risk of full-blown surgery.
Allowing the body to adjust
Uri Arnin, co-founder of ApiFix tells NoCamels that the problem with the conventional surgery is that “the physician is trying to fix the spine that has built itself in a deformed shape for many years, at one time, which is very difficult.”
The ApiFix system incorporates a miniature ratchet mechanism that captures incremental corrections performed by the patient in the corrective direction. The deformity correction process is spanned over several months to allow the soft tissues to accommodate any minor correction.
ApiFix uses only two screws and a small expandable rod in between. The contraption is inserted through a small incision. A patented control mechanism enables the surgeon to access a control feature that can lock or un-lock the ratchet system at any time.
Arnin says: “After the operation, as the patient does spontaneous bending to the corrective direction, a miniature ratchet mechanism incorporated in the system to capture any minor correction. The soft tissues are then allowed to accommodate the correction along time. The patient gets accustomed to the new position, and the process is then repeated in a step-by-step process, over several months allowing the body to get adjusted.”
Currently, according to Arnin, conventional surgery involves fusing an average of 10 spinal levels using many screws, in a six-hour procedure that can cost up to $100,000.
Clinical trials in Europe
ApiFix, was founded in 2010 by Uri Arnin and Prof. Yizhar Floman, and is backed by The Trendlines Group, an Israeli seed stage investment group. Arnin has over ten years of experience in the spinal field and was inventor and CTO of Impliant Inc., along with Spine21 Ltd. Floman is a leading Israeli spine surgeon and chairman of the Israel Spine Centre at Assuta Hospital. He is also the President of the Israel Spine Society and is a member of the Scoliosis Research Society, the international Society for the Study of the Lumbar Spine, the Spine Society of Europe and the North American Spine Society.
ApiFix is currently undergoing clinical trials in Europe.
According to Arnin, “our timing is tied to budget and once we have additional funding it will take one year to be on the market. We are looking to complete the first cases, and based on the outcome of the clinical cases, we will raise additional money to get approval and then the device can be commercialised.”