The FDA has approved an USGI Medical’s Investigational Device Exemption application to conduct a pivotal study of its POSE2.0 incisionless procedure for primary obesity. The clinical trial, known as INSPIRO (Incisionless Suture Plications (POSE2.0) In a Randomized Obesity Study), will evaluate up to 186 participants at as many as seven US sites and potentially other international sites.
POSE2.0 uses USGI Medical’s Incisionless Operating Platform (IOP) to strategically place durable Snowshoe Suture Anchors in gastric tissue to both shorten and narrow the stomach. The procedure provides volumetric gastric restriction, like that achieved by a surgical sleeve gastrectomy, without surgically removing part of the stomach. Patients treated with the POSE2.0 procedure typically return to normal activities and lifestyles faster, compared with traditional laparoscopic and open abdominal surgery.
Dr Barham Abu Dayyeh, Mayo Clinic (Rochester, MN), is expected to lead the new INSPIRO pivotal study as Principal Investigator. Dr Erik Wilson, Medical Director of Bariatric Surgery at the University of Texas McGovern Medical at Houston, will serve as Co-Principal Investigator.
Abu Dayyeh also served as Principal Investigator of the previously completed pilot study of POSE2.0 of 40 patients at four clinical centres that evaluated weight loss in adults suffering from obesity (body mass index [BMI] 35-40 kg/m²) who have an obesity-related comorbidity, such as diabetes or hypertension.
“The FDA’s action is another important milestone for USGI, and we are excited to move forward with a pivotal study to further validate POSE2.0’s safety, durability and effectiveness in treating primary obesity,” said Arnold Podgorsky, Interim CEO of USGI Medical. “We appreciate the FDA’s support as we look to advance this potentially life-changing treatment option in the United States, which has already helped thousands of patients in other countries. This procedure holds promise, as it could prove to be a cost-effective, less burdensome therapeutic option with value added over existing pharmaceutical and surgical approaches. “Marketing in the US would be a game-changer for USGI, its investors and the doctor-patient community.”
The Incisionless Operating Platform, including the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors, has both CE Mark and US 510(k) Clearance for tissue approximation. The safety and effectiveness of the device has not been established in the US so as to permit marketing for the treatment of obesity. The device is considered an investigational device in the US and is thereby limited by Federal law to investigational use for obesity treatment.