SafeHeal has pulled in €35m ($39.7m) in Series C equity financing to validate its Colovac endoluminal bypass system.
The oversubscribed funding round was led by Solar Eclipse and included participation from new investors, including Gideon Strategic Partners and M&L Healthcare. Existing investor Sofinnova Partners also participated.
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Colovac is designed to prevent anastomotic leakage following colorectal surgery, in which the colon (large intestine) is connected to the remaining rectum after a portion of the rectum has been removed. The system is, therefore, positioned as a less-invasive approach to eliminating the need for stoma bags in most patients who have undergone colorectal resection versus temporary diverting ostomy, the current standard of care (SoC) for colorectal resection, a procedure most undertaken in colon cancer patients.
Having received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) in 2021, the France-headquartered company said it will use the funds to support the completion of its SAFE-2 IDE pivotal study of Colovac and proceed with commercialisation activities.
SafeHeal president and CEO Chris Richardson commented: “This capital raise places SafeHeal in an excellent position to continue our momentum toward FDA approval and commercialisation of Colovac.”
The efficacy of Colovac, which was granted a breakthrough device designation from the FDA last year, has already been studied in some depth. In SafeHeal’s preliminary SAFE-1 study, completed in three European centres in 2017, the sheath demonstrated 100% protection of colorectal anastomoses in 15 patients.
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By GlobalDataColorectal cancer is the third most diagnosed cancer in the US. The American Cancer Society estimates there will be around 107,000 new cases of colon cancer and around 46,950 new cases of rectal cancer diagnosed in the US in 2025.
March was US Colorectal Cancer Awareness Month. An aggressive cancer, CRC has a survival rate of just 11%-13% when diagnosed at stage 4. According to GlobalData analysis, in vitro diagnostics (IVD) tests such as Guardant Health’s Shield blood test are a necessary means of bridging the screening gap, and that by ensuring that the process of obtaining a CRC diagnosis is more accessible and patient-friendly, physicians will be able to catch cancers earlier, as in stages 1 or 2 when survivability is 79%-92%.
