|OrthoSpace's InSpace--Courtesy of OrthoSpace|
Outside of surgery, physicians can do very little to treat severe rotator cuff tears. Israeli company OrthoSpace is aiming to offer a new treatment option. It's raised an $8 million venture round led by Healthpoint Capital that will finance a pivotal, U.S. trial for the company's biodegradable balloon system InSpace.
The device implantation usually takes less than 10 minutes and it is deployed using minimally invasive techniques such as arthroscopy or mini-open surgery. InSpace is already CE marked and has been used in over 5,000 procedures over the last five years--this round is expected to help the company expand into a global marketplace.
Orthopedic device player Smith & Nephew ($SNN), as well as TriVentures are existing investors that participated in the financing.
"InSpace offers a treatment for patients who currently have few options in the continuum-of-care for rotator cuff injury," OrthoSpace CEO Itay Barnea said in a statement. "The technology addresses a large and growing market segment with limited treatment options."
The system is designed to create a physical barrier between tissues in the subacromial space, acting as a spacer between the acromion and the humeral head. This allows the two bones to move more freely without friction and emulates the function of the original bursa, a small fluid-filled bag that sits between these shoulder bones but is no longer fulfilling its purpose for these patients.
The device can be deployed under local or general anesthesia and in hospitals or clinics.
About 75% of patients treated with InSpace improved on a measure of shoulder pain and function known as the Total Constant Score (TCS) in data with follow-up as long as 5 years, according to the company. In one study of 47 patients, 69% of patients reported an improvement of at least 20 points in their TCS at 6 months. There were two safety-related events, one of device displacement and another of removal due to actual deterioration in shoulder function after the procedure.
OrthoSpace was founded in 2009 as part of startup incubator Xenia. It was a spinoff of another company, BioProtect, which had developed a balloon to separate healthy tissue from an enlarged prostate during radiation treatment to protect it. It has raised a total of more than $16 million, according to an article in the Israeli newspaper Globes.
"What sets us apart is that we answer to the needs of a large group of patients who are classified as 'chronic'--people who are relatively old, with poor tissue quality, which causes them to react less well to invasive procedures such as tendon repair and shoulder replacement," Barnes told Globes.
He continued, "We are not attempting to fix anatomy that can no longer be fixed, rather to provide a tool that relieves the patient from pain, and helps him or her undergo physiotherapy and rehabilitation."
- here is the release
- and the Globes story