SafeHeal develops Colovac, an innovative solution for the protection of digestive anastomosis, designed to reduce anastomotic complications and to obviate the need for diverting ostomies for patients undergoing colectomy.
The Colovac device is meant to enable patients to resume their normal life after a colorectal surgery, without having to bear an artificial anus and wear an ostomy pouch.
SafeHeal, reshaping digestive surgery.
Anastomotic (point of surgical connection) leakage after a colorectal resection is associated with significant mortality and morbidity. Symptomatic anastomotic leakage occurs in 5 to 10% of all colorectal resections, and in more than 10% of anterior resections. Thus, there is a clear and unmet need for a way to improve the patient’s recovery and quality of life by reducing leakage, associated complications and the need for repeat operations.
Many patients receive a diverting ostomy receive a diverting ostomy in order to let the anastomosis heal. The colon is deviated towards a bag placed on the abdomen. Although the anastomosis typically heals in one or two weeks, the ostomy remains for two to six months, if not longer.
Afterwards, the patient returns for another surgical operation to reverse or takedown the ostomy.
The whole process is debilitating for the patient, costly, and prone to frequent complications.
Patients need a way to quickly recover from their colectomy, without a diverting ostomy
Physicians need a way to avoid anastomosis complications and better treat their patients
Medical insurances need a way to reduce surgical interventions and costs while maximizing patient outcomes
Colovac is a flexible bypass sheath which protects the anastomosis by isolating it from feces. It aims to minimize post-operative complications such as staple-line leakage.
Colovac is intended for delivery during both open and laparoscopic procedures. It is anchored above the anastomosis using an innovative vacuum-based mechanism, seamless, minimally invasive and 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 (which takes approximately 2 weeks), after which it is removed manually without the need for a second surgical intervention.
The Colovac device has been tested on over 80 pigs including a randomized pig study. These extensive pre-clinical experiments successfully evaluated the safety and usability profile of Colovac.
SafeHeal is currently finalizing and validating the design of its Colovac prototypes in order get ready for clinical trials.
SafeHeal is the first company created and incubated by MD Start, a medtech accelerator developing innovative medical devices based on inventions from physicians. It is currently funded by MD Start and Sofinnova Partners.
SafeHeal is laureate of the Worldwide Innovation Challenge 2015 edition (Concours Mondial de l’Innovation - Phases 1 and 2) and of the iLab grant program, which foster talent and bring out future champions of the French economy.
SafeHeal was also elected as the most promising and innovative investor conference MedTech start-up at Biovision 2016, was a finalist for the global Medtech Innovator 2016 competition.
Finally, SafeHeal is a 2016 recipient of the Charles Foix grant which rewards innovations aimed at improving the quality of life of elderly people.
SafeHeal is based on the invention of a French surgeon, Dr. Khosrovani and managed by a team of serial entrepreneurs experienced in product development, validation and launch in the field of gastroenterology and surgery.
Charam is a digestive surgeon trained in Paris in academia and practicing in a private clinic in Avignon. He invented the Colovac device and has filed two patents to protect his idea.
Karl is a senior executive with more than 25 years of experience in managing international business operations, combining capital equipment and medical devices in both large and small company environments. Karl played a key role in successfully launching several innovative medical devices and technologies in his previous positions.
Regulatory / Clinical / Market Access
Cécile is a biomedical engineer and experienced program manager in medtech start-ups in the early phases of their clinical experience. She is leading the regulatory, clinical and market access efforts for SafeHeal.
Anne is a biomedical engineer and seasoned medtech entrepreneur, having already supervized the development, clinical validation and commercial launch of innovative medical devices in the fields of endoscopy and surgery.
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