OrthoSpace Completes Enrollment for InSpace™ U.S. Pivotal Study

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The study is evaluating the use of InSpace for the treatment of full thickness massive rotator cuff tears.

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We are pleased to report that the InSpace clinical study has reached full accrual as targeted, owing to the strong interest of our investigators and patients in the novel and minimally invasive technology.

OrthoSpace Ltd. (“OrthoSpace” or “the Company”) today announced that enrollment for the U.S. pivotal study evaluating the use of the InSpace™ biodegradable balloon spacer to treat full thickness massive rotator cuff tears (RCTs) has been completed. The prospective, single-blinded, multi-center, randomized, controlled, pivotal IDE study enrolled 184 subjects at 21 sites in the U.S. and Canada.

“We are pleased to report that the InSpace clinical study has reached full accrual as targeted, owing to the strong interest of our investigators and patients in the novel and minimally invasive technology,” said Heather Neill, OrthoSpace’s Vice President of Clinical Operations. “We are grateful to our investigators and their research teams, as well as study participants for their contributions to this clinical study.”

Massive, irreparable rotator cuff tears are associated with severe pain and disability. The InSpace System is deployed in the subacromial space between the acromion and the humeral head, allowing smooth gliding and frictionless movement between the two bones and emulating the function of the original bursa. The arthroscopic procedure typically requires less than 10 minutes to perform.

Nikhil Verma, M.D., Principal Investigator on the study and Professor and Director, Division of Sports Medicine at Rush University Medical Center commented, “Massive rotator cuff repairs represent a major unmet clinical need, and I am pleased to support the development of new technologies for this patient population, which often has few other treatment options.” Dr. Verma continued, “We look forward to presenting clinical results upon completion of follow-up and data analysis.”

As of today, all 184 enrolled participants have been treated and commenced follow-up. Of these, 25 subjects have completed their month 24 follow-up visit. Per the study protocol, a composite primary endpoint to evaluate the safety and effectiveness includes an improvement in Western Ontario Rotator Cuff Index (WORC) and the American Shoulder and Elbow Surgeons (ASES) by week 6 from baseline and maintained at month 12 post-operatively. Participants will also be followed for safety that includes any subsequent secondary surgical interventions (SSSI) in the index shoulder and Serious Adverse Device Effects (SADEs), through month 12 post-operatively.

“Concluding enrollment in our pivotal study is a significant milestone for OrthoSpace as we pursue U.S. market commercialization for InSpace, our innovative technology for the treatment of symptomatic rotator cuff tears,” said Itay Barnea, CEO of OrthoSpace. “We are looking forward to working with the FDA as we move toward data analysis and submission to the agency, which we are projecting for 2Q19.”

About OrthoSpace Ltd.
OrthoSpace is a privately held medical device company located in Caesarea, Israel. The Company's product, InSpace, is an orthopedic biodegradable balloon system that is simple, safe and a minimally invasive method that addresses unmet clinical needs in rotator cuff repair. InSpace is CE Marked and commercialized in Europe, Israel and several countries in Asia and Latin America. OrthoSpace has been granted an Investigational Device Exemption (IDE) to conduct a pivotal human clinical study of the InSpace System in the United States.

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Itay Barnea
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