SafeHeal Receives Breakthrough Device designation for Colovac Endoluminal Bypass Sheath

Colovac device promises significantly improved patient recovery after colorectal surgery

Tampa, FL – June 7, 2024 – SafeHeal™, a leading innovator in the field of digestive surgery, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to investigate the use of Colovac™, a groundbreaking endoluminal bypass sheath. Colovac is intended as an alternative to temporary diverting ostomy for patients undergoing colorectal resection. Breakthrough Device designation guarantees priority regulatory review, interactive and timely communications with FDA, and FDA senior management engagement in the regulatory process. The Colovac endoluminal bypass sheath is a less-invasive alternative to temporary diverting ostomy, the current standard of care for patients undergoing colorectal resection. Diverting ostomy is applied prophylactically to most patients today undergoing a low anterior resection (LAR) and anastomosis. The ostomy temporarily diverts the stool away from the healing anastomosis to the outside of the body and into an ostomy bag. In most cases, the ostomy is needed only until the rectum has healed, and then it can be reversed, typically after 2-9 months. The eventual reversal of the ostomy requires another operation, with a second hospital stay and recovery period. In some cases, the ostomy may not be reversed and remains permanent. In addition to the potential surgical complications associated with ostomy procedures, patients may experience an impact to their quality of life due to social isolation, reduced physical activity and/or intimacy.

Colovac is an alternative to diverting ostomy, designed to eliminate the need for a temporary stoma in most patients, thereby improving patient recovery and quality of life by eliminating stoma related complications including permanent stoma and eliminating the physical and emotional burden associated with stoma management and care.

Colovac has been successfully studied in over 60 patients in the U.S. and Europe.

To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the program is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment and review while maintaining regulatory standards for pre-market approval. With Breakthrough Device Designation, SafeHeal’s Colovac device could become available as a new treatment option sooner for people affected by colorectal disease.

Every year approximately 500,000 patients undergo low anterior resection surgery, defining the opportunity for the Colovac device to significantly improve patient outcomes and recovery.

The Colovac device is anchored above the anastomosis using a stent combined with an innovative vacuum-based mechanism. Colovac is placed endoluminally and is fully reversible. Once in place, the implant covers the colon down to the anus. It remains in place until the body’s natural healing and tissue repair processes are complete (approximately ten days), after which it is removed during an endoscopic procedure, without the need for a second surgical intervention. This enables patients to resume their normal life without the stigma and complications associated with ostomy devices.

SafeHeal SAS, headquartered in Paris, France, and its wholly-owned U.S. subsidiary, SafeHeal Inc., is a clinical-stage medical device company which develops Colovac, a device invented by a French digestive surgeon, Dr. Charam Khosrovani, to obviate the need for a digestive ostomy in patients undergoing colorectal surgery. Colovac is a flexible bypass sheath intended to reduce the contact of fecal content at the anastomotic site following colorectal surgery. The device is placed endoluminally and is fully reversible. The device remains in place for 10 days, until the body’s natural healing and tissue repair processes are complete, after which it is removed during an endoscopic procedure without the need for a second surgical intervention. This enables patients to resume their normal life without the stigma and complications associated with an ostomy procedure.  Colovac is an investigational device, not currently available for sale.