OrthoSpace announced that the enrollment of the first three patients in its US Investigational Device Exemption (IDE) pivotal study.
The study is a 184 patient randomized, single blinded control study that compares the Company’s InSpace biodegradable balloon system to conventional repair or partial repair for the treatment of full thickness massive rotator cuff tears.
While InSpace is currently commercially available outside of the United States and has been implanted in over 5,000 patients in 15 countries, today’s announcement marks the first time the balloon has been implanted in the US.
Edwin J. Rogusky MD and Paul R. Sensiba MD performed the procedures earlier this week at University Orthopedics Center in State College, Pennsylvania. After these first three surgeries they said, "We are honored to be a part of this study and to initiate clinical study enrollment. The data to date has demonstrated InSpace’s safety and efficacy, and we look forward to contributing to the US dataset to facilitate InSpace’s entry into the US Market."
Nikhil N. Verma MD, of Rush University Medical Center, is the Primary Investigator of the study, and he commented, "Having heard about promising results with the use of this technology from our colleagues abroad and having seen the procedure in Europe, I am looking forward to leading this talented group of US surgeons in completing this pivotal study that will hopefully allow us to bring this innovation to the US."
"InSpace addresses a current unmet medical need for my patient population: a simple, minimally invasive way to treat massive rotator cuff pathology, with limited recovery time for the patient."
Enrollment in the study is ongoing, and patients are being recruited at multiple sites across the country.
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 the Company has begun a pivotal human clinical study of the system in the US.