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Ostomy Bag Articles & Analysis

4 news found

SafeHeal obtains CE-mark for Colovac, its novel endoluminal bypass sheath

SafeHeal obtains CE-mark for Colovac, its novel endoluminal bypass sheath

At the end of 2018, SafeHeal concluded its successful first-in-human clinical study in fifteen patients, with results demonstrating that Colovac can successfully obviate the need for a diverting ostomy for the majority of patients undergoing colorectal surgery. ...

BySafeHeal


SafeHeal Completes First-in-Human Clinical Study of Endoluminal Bypass Sheath

SafeHeal Completes First-in-Human Clinical Study of Endoluminal Bypass Sheath

The single-arm 15-patient study was aimed at evaluating the safety and efficacy of Colovac in the protection of colorectal anastomosis in adult patients who were scheduled to receive a diverting ostomy, following colorectal surgery. During the study phase, patients received a Colovac implant for two weeks, in place of a diverting ostomy. ...

BySafeHeal


SafeHeal closes €6.0 million financing round led by Sofinnova Partners

SafeHeal closes €6.0 million financing round led by Sofinnova Partners

Mar 23, 2018 – This financing allows for the execution of the company’s clinical and regulatory market access program. SafeHeal, an early-stage medtech company specialized in digestive surgery and focused on the development of the Colovac device, announces today that it has closed a €6 million Series A financing round led by Sofinnova Partners. Based in ...

BySafeHeal


SAFEHEAL starts first-in-human and CE-mark clinical study of endoluminal bypass sheath with the potential of replacing ostomy

SAFEHEAL starts first-in-human and CE-mark clinical study of endoluminal bypass sheath with the potential of replacing ostomy

Jan 29, 2018 – The study will evaluate safety and efficacy of the Colovac bypass device for ostomy-free anastomosis protection following colorectal surgery SafeHeal, a leading innovator in the field of digestive surgery and developer of the Colovac device, announces today that it has enrolled the first five patients in its CE mark study. The Colovac device is a unique ...

BySafeHeal

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