In February 2024, BariaTek Medical announced that it had successfully performed the first-in-human implant of the BariTon™, an endoscopically delivered implant that consists of a gastric and an intestinal part, thereby both reducing food intake and calorie absorption - mimicking the mechanisms of sleeve gastrectomy and gastric bypass surgery. Bariatric News talked to Youssef Biadillah, Chief Executive Officer at BariaTek, about the limitations of current surgical and endoscopic options to treat obesity, the potential of the device…
“Although bariatric surgery is known to be effective for weight loss, it does have several limitations. Firstly, surgery is complex and can lead to serious adverse events. Secondly, surgery is poorly perceived by the patients because it is highly invasive and is a permanent alteration to their bodies. The fact that 1% surgical candidates have surgery show that there is a reluctance from patients to have surgery. Obesity pharmaceutical therapies will 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, such as intra-gastric balloons, they enjoy variable safety but lack efficacy,” said Biadillah. “We know what the mechanisms of bariatric surgery are and therefore why surgery is effective. So, how can we mimic the mechanisms of surgery but through an endoscopic procedure that does not alter the body, a procedure that can be completely reversible if you remove the device and which can be done in few minutes in an outpatient procedure?”
In January 2021, founded by Truffle Capital and a few obesity experts, working in conjunction with Drs Thierry Manos and Christophe Bastid (Marseilles, France), Biadillah began to develop an endoscopic implant that could mimic the effects of sleeve gastrectomy and bypass surgery, but without the need for highly-invasive, complex surgery and the inherent risks that come with it. The result was the BariTon™ Device a soft, atraumatic, reversible implant that is delivered endoscopically through the mouth in approximately 20 minutes in an outpatient setting. The BariTon™ consists of an inflatable gastric part that occupies space in the stomach and slows down gastric emptying, meaning the patient eats less and feels full longer. The BariTon™ also includes an intestinal liner that diverts the food to a more distal part of the bowels preventing absorption of nutrients and calories in the proximal bowels and inducing malabsorption and a lower calorie intake.
“The device sits by geometry: The intra-gastric portion sits proximal to the pylorus, and the proximal part of the liner sits distal to the pylorus, so the device anchors naturally around the pylorus. It is like an hourglass sitting in a keyhole. During the implantation procedure the intestinal liner is released first, followed by the release of the intragastric portion. Inflation of the intragastric portion is then performed through a dedicated port within the delivery system and the implant intended position is validated via a standard endoscope before the implant is released and the delivery system is retrieved.” he explained. “Importantly, the BariTon™ can be retrieved at will once therapeutic objectives are achieved. To do that, a regular endoscope is inserted through the mouth and using standard tools, the BariTon is deflated, grabbed, and retrieved from the patient within few minutes.”
The first patient who received the device in January 2024, is part of a larger human feasibility study in which 20 patients are expected to be recruited in Australia and Uzbekistan.
“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,” commented the study’s co-Principal Investigator, Dr Abdurashid Abdukarimov, a bariatric surgeon at the Center of Surgery in Tashkent, Uzbekistan. “I would like to thank the support of the BariaTek medical and engineering team, who made the trip to our centre, and we look forward to the next steps in this groundbreaking first-in-human study.”
The primary outcome of the ongoing human feasibility study is safety and the secondary outcomes are the change in weight (total body weight loss), body composition evolution (%fat mass), metabolic profile (HbA1c, insulin), heart rate, blood pressure, blood lipid levels, liver function, pancreas function, kidney function, inflammation, among others.
“The daily life of patients suffering from obesity can be difficult and associated with multiple comorbidities if not treated optimally,” added Dr Adrian Sartoretto, a bariatric endoscopist and Director of the BMI Clinic in Sydney, Australia, and the study’s co-Principal Investigator. “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 centre.”
In this human feasibility study, all patients will be followed up to one year.
“Once we have sufficient data from this ongoing human feasibility study, we plan to continue our discussions with the US, EU, and Australian regulatory agencies to start a large multi-centre clinical study in select centres in the US and the EU in 2025,” concluded Biadillah. “We expect the study to include about 200 patients towards regulatory approval and commercial launch sometime in 2027.”