OrthoSpace Announces the Enrollment of the First Canadian Subjects in the InSpace™ Pivotal Study

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The first Canadian patients are enrolled to the InSpace™ study at Ottawa Hospital in Ottawa, Ontario.

OrthoSpace Announces Publication of Positive Results for the InSpace System in the Treatment of Massive Rotator Cuff Tears

OrthoSpace

The InSpace™ System is currently being evaluated in a prospective, single-blinded, multi-center, randomized, controlled study that will enroll up to 184 patients in North America.

OrthoSpace Ltd. (“OrthoSpace” or “the Company”) today announced that Ottawa Hospital in Ottawa, Ontario has begun enrolling patients in the ongoing pivotal study of the InSpace™ System for the treatment of massive rotator cuff tears (MRCTs). Peter Lapner, MD, FRCSC, principal investigator at Ottawa Hospital, is the first to enroll subjects in Canada.

"Our team is thrilled that we are the first center in Canada to start accruing to the InSpace study, which represents a novel, minimally-invasive treatment for patients with massive rotator cuff tears," Dr. Lapner commented. "As a hospital dedicated to supporting innovative therapies and improving patient care, we’re looking forward to the continued enrollment of Canadian patients in this study."

OrthoSpace expects to activate the second Canadian site at Fowler Kennedy Sport Medicine Clinic under direction of Robert Litchfield, MD, FRCSC and the third Canadian site at St. Joseph’s Health Care in London, Ontario, where George Athwal, MD, FRCSC will act as Principal Investigator. Dr. Athwal stated, "Thousands of patients with massive rotator cuff tears live with debilitating pain. With limited treatments available, we are excited to begin the InSpace study at St. Joseph’s, the results of which could open up new surgical options to address this unmet clinical need."

"We are proud to be initiating enrollment at three of the leading orthopedics hospitals in Canada and to be collaborating with Dr. Lapner, Dr. Athwal and Dr. Litchfield," said Itay Barnea, Chief Executive Officer of OrthoSpace. "This planned expansion for the InSpace study will contribute to more robust data as well as expand surgeon knowledge and experience with the device."

The InSpace System is currently being evaluated in a prospective, single-blinded, multi-center, randomized, controlled study that will enroll up to 184 patients in North America. It is designed to assess the safety and effectiveness of the InSpace device, a biodegradable balloon spacer implanted arthroscopically in the sub-acromial space and intended to relieve pain and improve function in patients with MRCTs. Eligible patients are at least 40 years of age, have imaging-confirmed, full-thickness MRCTs and have documented failure of conservative therapy, in addition to meeting other criteria. Enrolled subjects are randomized to undergo arthroscopic implantation of the InSpace System or arthroscopic partial repair of MRCTs.

The InSpace System is CE Marked in Europe and Israel and investigational in the U.S. and Canada. Details for the clinical study, including participating institutions and complete eligibility requirements, are available at ClinicalTrials.gov under identifier NCT02493660.

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 and Israel and has been granted an Investigational Device Exemption (IDE) to initiate a pivotal human clinical study of the InSpace System in the United States.

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Itay Barnea
OrthoSpace
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