ExtremitiesRegulatoryRobotics

OrthoSpin Ltd. Receives FDA Regulatory Clearance for its G2 System

YOKNEAM, Israel, Jan. 25, 2021 /PRNewswire/ — OrthoSpin Ltd. (“OrthoSpin”), announced today that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its second generation, robotic, digitally enabled external fixation system for orthopedic treatments.

External fixation devices are a common treatment choice for bone lengthening, setting complex fractures, and correcting deformities. Patient compliance challenges and a lack of real-time feedback for physician follow-up present substantial challenges. Currently, effective treatment necessitates that patients manually adjust fixation devices daily, requiring complicated patient training. This may cause adjustment errors and non-compliance, potentially resulting in poor clinical outcomes.

The Company has completed initial clinical cases in the U.S. and Israel with the FDA-cleared OrthoSpin Generation 1 system which makes pre-programmed adjustments automatically without the need for patient involvement. Integrated software enables physicians to chart patient progress and, when required, immediately adjust treatment programs. The second-generation system represents a technological leap forward as it is more user friendly, covers all strut range sizes, and is lighter by 20%.

“We are very excited to launch the Generation 2 OrthoSpin system,” said Dr Assaf Dekel, Active Chairman of OrthoSpin. “We believe that robotic automation will revolutionize the hexapod bone deformity market and we are proud to play a part in this transformation.”

Future applications, such as the ability to follow and modify treatment plans via smart phones and cloud-based AI algorithms treatment plans based on computerized historical data, have the potential to play an increasingly prominent role in medicine and healthcare.

The OrthoSpin G2 system is approved in Israel and-cleared for use in USA and can be used with the DePuy Synthes MAXFRAME™ Multi-Axial Correction System.  

About OrthoSpin

OrthoSpin was founded in December 2014 to offer a new robotic, digitally enabled external fixation system for orthopedic treatments. OrthoSpin Ltd. is a portfolio company of  The Trendlines Group Ltd. (“Trendlines”)  (SGX: 42T;OTCQX: TRNLY), traded on the Singapore Stock Exchange (SGX: 42T) and in the United States as an American Depositary Receipt (ADR) on the OTCQX International (OTCQX: TRNLY).

For further information: 
Oren Cohen, CEO OrthoSpin  
oren@orthospin.com 
Phone +972-54-334-2651   

SOURCE OrthoSpin

Print Friendly, PDF & Email
Tags

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

Related Articles

Back to top button
Close