OrthoSpin completes successful first in human

Editor’s note: News of the OrthoSpin FIH appeared in OrthoSpine News and Yahoo! Finance.

Successful first in human for OrthoSpin’s robotic external orthopedic fixation system

OrthoSpin announced that it successfully completed a first-in-human (FIH) case for its smart, robotic external fixation system for the treatment of an orthopedic deformity. The patient was a 15-year-old suffering from deformity of the tibia. The deformity caused shortening of the leg and a limp, limited his daily activity, had the potential to disrupt his growth, and had aesthetic consequences. Pediatric orthopedic surgeon Dr. Eitan Segev, of Tel Aviv Sourasky Medical Center’s Dana-Dwek Children’s Hospital, performed surgery to correct the deformity, which was followed by external fixation with the Taylor Spatial frame using OrthoSpin’s smart automatic control system.

OrthoSpin system

The SmartStrut™ external fixation system developed by OrthoSpin automatically and continuously adjusts according to the prescribed treatment regimen – without patient or caregiver involvement. Photo: Studio Imaginet

Meet OrthoSpin CEO Oren Cohen and see a working prototype of the OrthoSpin smart external fixation system at the AAOS Annual Meeting in New Orleans, Louisiana, 6-10 March 2018.

Instead of conventional manual adjustment of the external fixator, the OrthoSpin system makes pre-programmed adjustments automatically and continuously — without the need for patient involvement. Integrated software enables physicians to chart patient progress and, if required, quickly adjust the treatment regimen. Physicians receive real-time feedback on computers or mobile devices to ensure that the prescribed course of treatment is followed. Using the system also eliminates the need for weekly x-rays to check status. 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 are expected to reduce soft tissue damage.

OrthoSpin CEO Oren Cohen remarked, “We are extremely pleased with the results of our FIH case. OrthoSpin’s innovative system has the potential to change the outcomes of these types of orthopedic treatments. Following the first patient, we will conduct additional trials and submit for regulatory clearance during 2018 in order to bring our product to market. OrthoSpin’s future plans are to enable the physician to collect many other treatment parameters due to the capabilities of the smart system.”

Dr. Segev, commented, “The OrthoSpin system allows for objective measurement, ease of use, and provides more piece of mind for the patient and family. We look forward to its routine integration in orthopedic treatment.”

Chairman and CEO of Trendlines, Todd Dollinger added, “We are very proud of this important achievement for OrthoSpin. The company has the ability to bring an automatic external fixation device to market that will significantly improve treatment and quality of life for the benefit of both patients and physicians.”


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