After performing complex surgery to correct a leg-bone deformity in a 15-year-old from Jerusalem, pediatric orthopedic surgeon Dr. Eitan Segev explained to the patient and his parents that they now faced a critical responsibility.

The boy’s leg would be stabilized in an external fixation device fitted with struts (rods) that must be turned a certain amount by hand several times per day for about a month to promote proper positioning, growth and healing.

These manual adjustments are tricky, and if not done correctly the patient can suffer pain and even repeat surgeries, he told them following the procedure at Tel Aviv Sourasky Medical Center’s Dana-Dwek Children’s Hospital on January 25, 2018.

But for the first time in his long career, Segev was able to offer an alternative: The young patient could be the first human to try a “smart” robotic external orthopedic fixation system from Israeli startup OrthoSpin.

The OrthoSpin system makes precise pre-programmed adjustments of the fixation device automatically and continuously without human intervention. Integrated software enables the surgeon to chart patient progress remotely and, if necessary, quickly adjust the treatment regimen.

The boy and his parents agreed to give it a try.

“We took x-rays every week and saw the system was working accurately,” says Oren Cohen, CEO of OrthoSpin, a portfolio company of The Trendlines Group in Misgav, northern Israel.

At the end of the regimen, the teenager was beaming.

“At his last treatment, he said, ‘Oren, see how my leg looks normal!’” Cohen tells ISRAEL21c.

Segev, a member of the company’s advisory board, said he looks forward to the smart system’s routine integration in orthopedic treatment.

“The OrthoSpin system allows for objective measurement, ease of use, and provides more peace of mind for the patient and family,” the surgeon said.

$800m market

In March, Cohen presented a working prototype of the OrthoSpin device at the annual conference of the American Association of Orthopedic Surgeons in New Orleans and met there with key companies such as J&J.

Two years previously, he’d presented the concept for the device at the AAOS meeting and confirmed that the system met a major unmet need.

The extremity fixation market — primarily external fixation devices — is estimated at $800 million. Conditions necessitating such treatment include bone disease, sarcoma (a type of cancer) and injury.

“There is good interest in our company and we expect to get funding from one of the big players to refine the prototype and continue with clinical trials,” Cohen reports.

Because the system is external to the body, such trials are not required for regulatory approval from the US Food & Drug Administration.

“We are doing trials for our own validation and marketing purposes,” he says. “Within 18 months of getting funding we hope the product will become commercial.”

The funding also would be used to develop a companion physician interface app enabling the orthopedic surgeon to monitor progress and collect a range of data from the smart system without any need for the patient to come for weekly checkups and x-rays as is required with the manual regimen.

Founded in 2014 by medical-device veterans Liraz Shlomoff (Trimaco Surgical, Carevature) and Yoni Epstein (InnoLap Surgical, Deep Breeze), OrthoSpin set itself the goal of introducing the first advance in the trauma market for external fixation in the past 20 years, says Cohen.

“Physicians are looking for innovation to make the system more automated. Two big industry players tried to do it unsuccessfully and we took a different approach,” says Cohen, whose background includes a degree in electrical engineering from the Technion-Israel Institute of Technology and senior management positions at Neuronix, Medtronic, Spectrum Dynamics, Qualcomm and Primesense.

For the 15-year-old Jerusalem patient, the precise adjustments of OrthoSpin’s system resulted in a less painful process due to smaller, more incremental changes – in this case, an eighth of a millimeter in movement – which also is expected to reduce soft tissue damage during the rehab process.

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