SafeHeal

SafeHeal SAS, a clinical-stage medical device company headquartered in Paris, was established in 2015 to address a critical unmet need in colorectal surgery. The company was founded by a team including Dr. Charam N. Singular, a practicing colorectal surgeon, and is led by CEO Karl-Andre Tjagur. The impetus for SafeHeal's creation stemmed from the significant clinical and economic burdens associated with anastomotic leaks, a severe complication following colorectal surgery where the surgical connection between intestinal segments fails. This complication often necessitates the creation of a temporary diverting ostomy, a procedure that significantly impacts a patient's quality of life and incurs substantial healthcare costs.

The company's core focus is the development and commercialization of the Colovac device, a single-use, endoluminal bypass sheath designed to protect the anastomosis during the critical healing period. Colovac is introduced endoscopically after the surgical procedure and positioned to cover the anastomotic site. It works by diverting the fecal stream away from the vulnerable area, thereby preventing leaks and the subsequent need for a diverting stoma. The device is designed to remain in place for approximately 10-14 days, after which it is removed non-surgically during an outpatient procedure. This approach aims to allow the anastomosis to heal securely while the patient maintains normal intestinal function, thus avoiding the physical and psychological trauma of an ostomy bag.

SafeHeal operates within the medical technology market, specifically targeting colorectal surgeons and hospitals performing colectomy procedures. Its business model centers on the sale of the disposable Colovac device to these healthcare providers. The value proposition is twofold: for patients, it offers the prospect of avoiding a temporary ostomy, leading to a faster recovery and improved quality of life; for healthcare systems, it presents a potential for significant cost savings by eliminating the expenses associated with creating, maintaining, and reversing a stoma, as well as managing its complications. The company has secured significant funding to advance its clinical trials and pursue regulatory approvals, including a €18 million Series A financing round in 2017 led by Sofinnova Partners and a subsequent €40 million Series B round in 2021 co-led by Bpifrance and Panakès Partners.

Keywords: colorectal surgery, medical device, anastomotic leak, ostomy prevention, Colovac, endoluminal bypass, surgical device, clinical stage, colectomy, MedTech