Enrollment of 184 patients at 19 North American sites is on track to be completed by the end of 2017, demonstrating a brisk pace of patient accrual and ongoing momentum for this technology as the Company prepares its FDA marketing submission.
CAESAREA, Israel (PRWEB) January 17, 2017
OrthoSpace Ltd. (“OrthoSpace” or “the Company”) announced today that it has surpassed the midway point for patient enrollment in its U.S. Investigational Device Exemption (IDE) pivotal study of the InSpace biodegradable balloon system for the treatment of massive rotator cuff tears. Enrollment of 184 patients at 19 North American sites is on track to be completed by the end of 2017, demonstrating a brisk pace of patient accrual and ongoing momentum for this technology as the Company prepares its FDA marketing submission.
“Patient interest in the InSpace device for massive rotator cuff repair is accelerating, and our investigator teams, who recognize the potential value of this device, remain committed to meeting enrollment targets and the continued collection of high-quality data,” commented Nikhil N. Verma, M.D., of Rush University Medical Center and the Principal Investigator for the study. “The treatment of massive, irreparable rotator cuff tears remains a challenge for physicians and patients, and we are optimistic that, upon marketing approval by the FDA, the InSpace device will provide a valuable, simple and safe option for pain relief in this patient population.”
The study is a randomized, single-blinded, controlled study that compares the InSpace System to conventional repair or partial repair of full-thickness massive rotator cuff tears. Patients will be followed for adverse events and other safety measures. The study’s primary efficacy outcome is the change in the Western Ontario Rotator Cuff Index (WORC), which assesses patient-reported quality-of-life metrics, at 12 months post-operatively when compared to baseline. Secondary outcomes measures include changes in American Shoulder and Elbow Surgeons (ASES) scores, changes in Constant shoulder outcome scores and changes in Quality of Life (as measured by the EuroQOL [EQ-5D-5L] five dimensions questionnaire) at up to two years of follow-up.
InSpace is currently commercially available outside of the United States and has been implanted in over 10,000 patients in 15 countries. Details for the U.S. pivotal 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.