PARIS–(BUSINESS WIRE)–BariaTek Medical, a privately held medical device company dedicated to the development of minimally invasive endoscopically delivered solutions to treat obesity and diabetes, founded by Truffle Capital, announced it has initiated enrollment of patients in its First-in-human clinical trial in both Australia and Uzbekistan, and has successfully performed its first-in-human implantation.
Obesity is a chronic and debilitating disease affecting more than one billion people worldwide. It bears a tremendous economic burden to healthcare systems surpassing that of cardiovascular diseases and cancer and its prevalence is increasing worldwide. It often leads to diabetes, high blood pressure, heart disease and reduced life expectancy.
Bariatric surgery currently remains the most effective approach to treat obesity and limits the resulting complications, but surgery is poorly perceived, alters anatomy permanently, is costly, and can result in severe adverse events. Obesity pharmaceutical therapies could provide an effective alternative solution for some patients, but they are very expensive and poorly tolerated in many, resulting in their cessation and corresponding regain of the lost weight. Furthermore, they could be associated with multiple under-reported side-effects and off-label prescriptions. As for available minimally invasive endoscopic solutions, they enjoy variable safety but lack efficacy.
BariaTek Medical’s product candidate, the BariTon™, is a soft, atraumatic, reversible implant that is delivered via a simple endoscopy through the mouth within a few minutes and in an outpatient setting. It consists of a gastric part and an intestinal part, thereby having a dual effect: reduced food intake and calorie absorption. The BariTon™ is expected to be the first implant of its kind to potentially mimic the efficacy of sleeve gastrectomy and bypass surgery1 and offer superior safety, ease of use, reversibility, and lower cost.
Dr. Abdurashid Abdukarimov, Principal Investigator, Bariatric Surgeon at the Center of Surgery in Tashkent Uzbekistan who has led the first human implant said: “I am extremely pleased with the outcome of this first-in-human implantation. The endoscopic procedure was smooth, and the patient recovered very rapidly. She was back at work the day after she was discharged. I would like to thank the support of the BariaTek medical and engineering team, who made the trip to our center, and we look forward to the next steps in this groundbreaking first-in-human study.”
Dr. Adrian Sartoretto, Principal Investigator, Bariatric Endoscopist and Director of the BMI Clinic in Sydney Australia said: “The daily life of patients suffering from obesity can be difficult and associated with multiple comorbidities if not treated optimally. The BariTon™ device meets a growing demand for a more innovative, minimally invasive, effective, and reversible solution and we look forward to evaluating its safety and efficacy in our center.”
Dr. Thierry Manos and Dr. Christophe Bastid (Marseilles, France), Bariatric Endoscopists and co-inventors of the BariTon™ said: “We were delighted to participate in this first-in-human implantation. The procedure went according to plan and we look forward to the outcome of this clinical study.”
Youssef Biadillah, CEO of BariaTek Medical said: “Obesity is a global pandemic and none of the therapeutic options available today is optimal. We are thrilled about the prospect of bringing our highly differentiated solution, the BariTon™, to obesity gastroenterologists and surgeons and to patients worldwide. More patients need to be treated and carefully monitored and close interactions with regulatory agencies and payors need to take place, to draw conclusions on its safety, efficacy, indications and market potential.”
About BariaTek Medical
BariaTek Medical, based in Paris France, is a privately held medical device company dedicated to the development of minimally invasive endoscopically delivered medical devices to treat obesity and limit its complications. BariaTek Medical was founded by Truffle Capital, a premier life science venture capital fund (Paris) and founder (or co-founder) of multiple MedTech and Biotech companies such as Abivax (NASDAQ & Euronext : ABVX), Carmat (Euronext: ALCAR), Carbios (Euronext ALCRB), Vexim (acquired by Stryker), Symetis (acquired by Boston Scientific), Caranx Medical, Artedrone, EvextaBio and Affluent Medical (Euronext: AFME).
1 Sleeve gastrectomy is a surgical procedure consists of removing a large part of the stomach; Bypass bariatric surgery consists of both removing a large part of the stomach and shunting part of the intestine.
Contacts
Primatice
Armand Rigaudy – armandrigaudy@primatice.com / 07 88 96 41 84