Canada-based ARC Medical plans to evaluate its fluid medical devices, JOCOAT and IPCOAT, for the prevention or reduction of adhesions following orthopaedic, gynaecological, and abdominal surgeries.
“Radiolabel data from preclinical studies shows that JOCOAT and IPCOAT, when injected into the surgical area, flow and the polymer in the liquid medical devices forms a temporary, physical barrier film that covers all the tissues and organs, thereby preventing or reducing the formation of surgical adhesions throughout the entire surgical area,” said the company’s CEO Dr Chris Springate in an interview with Clinical Trials Arena.
A systematic review found that the formation rate of adhesion after abdominal surgery and obstetric and gynaecological surgery were 54% and 51%, respectively. The study also found that the laparoscopic surgeries reduced the adhesion formation rate by 25%. Adhesions following abdominal and gynaecological surgeries can have long-term effects such as chronic pain, small bowel obstruction and infertility. Adhesion following orthopaedic surgeries can result in pain and limited movement of the corresponding joint.
Both JOCOAT and IPCOAT have the same polymer in them, with the JOCOAT being a more concentrated 10mL device for use in orthopaedic surgeries while IPCOAT is a less concentrated device for gynaecological and abdominal surgeries.
Dr Springate noted that in a well-accepted preclinical model of gynaecological and abdominal surgical adhesions, IPCOAT was more effective in preventing or reducing adhesion formation compared with three of the current top competitors, including a film, because ARC’s IPCOAT liquid medical device covers the whole surgical area, whilst the film can only reduce adhesion formation on the area it is applied to. Furthermore, ARC’s liquid medical device is easier to administer through small ports during laparoscopic surgeries compared with mesh devices.
ARC plans to conduct an orthopaedic clinical trial on its own, said Dr Springate. The proof-of-concept trial will be conducted in Canada and enrol approximately 40-60 patients. The participants will be randomised 1:1 to receive either JOCOAT or normal saline control. According to Dr Springer, the company chose normal saline as a placebo control as it is indistinguishable from the JOCOAT and there is no standard of care to prevent surgical adhesions in Canada, Europe, and the US.
ARC plans to seek partnerships in Japan and Europe to conduct clinical trials evaluating IPCOAT in abdominal and gynaecological indications, said Dr Springer. It is anticipated that the Japanese partner would conduct a clinical trial evaluating IPCOAT against the standard of care in the country, mesh devices, said Dr Springate.
“Dependent on the outcome of partnering and financing activities, ARC and its partners may start their gynaecological clinical trial in Europe, the orthopaedic clinical trial in Canada and both the abdominal clinical trial and the smaller gynaecological clinical trial in Japan, in 2025,” said Dr Springate.
The ARC IPCOAT liquid medical device was found to be safe and well tolerated in a Phase I clinical trial with 76 health volunteers. The study evaluated IPCOAT against a placebo control of Ringer's lactate. The maximum tolerated dose was up to and including 3mL IPCOAT per kilogram in body weight. The trial also found that IPCOAT showed no interaction with the commonly used anticoagulant for venous thromboembolism prophylaxis, enoxaparin sodium.
