OrthoSpin has won FDA 510(k) clearance for its robot-assisted external fixation system for orthopedic treatments.
Misgav, Israel-based OrthoSpin’s system is designed to automatically make pre-programmed adjustments to eliminate manual adjustments and patient training while reducing the need for follow-ups. The system could change the outcomes of orthopedic treatments such as bone lengthening, setting complex fractures and correcting deformities, according to the company.
OrthoSpin raised $3 million for the external fixation system in a July 2018 funding round led by Johnson & Johnson (NYSE:JNJ).
“Receiving FDA clearance is an exciting achievement for us,” OrthoSpin CEO Oren Cohen said in a news release. “We were thrilled at the efficient, fast process. Our robotic struts eliminate the need for manual adjustment, improve patient compliance and the process is expected to be less painful. OrthoSpin’s system can monitor biomechanical parameters, and in the future will enable the device to automatically send real-time updates to physicians for following patient progress. This allows fine-tuning of the treatment regimen, if necessary, including a personalized treatment plan for each patient.”
“OrthoSpin’s achievement makes us very proud,” added Todd Dollinger, CEO of Trendlines Group (SGX:42T; OTC:TRNLY), an investor in OrthoSpin. “We look forward to continuing to participate in their progress in improving orthopedic treatment and outcomes,”
Shares of TRNLY were down -1.5% at $2.89 per share in early-morning trading today.
