The FDA has acknowledged the successful completion of a pilot study of USGI Medical’s incisionless, endoscopic gastroplasty procedure, known as POSE2.0, which 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. Completing the pilot study lays the foundation for future regulatory submissions to enable marketing of POSE2.0 devices in the US.
The pilot study, which included four sites and 40 US patients, was led by Dr Barham Abu Dayyeh from the Mayo Clinic (Rochester, MN), who served as Principal Investigator. Investigators evaluated patients’ safety, weight loss and other effectiveness factors. Patients received lifestyle and nutritional care through the primary endpoint of one year.
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 to traditional laparoscopic and open abdominal surgery.
The IOP, 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.
“As a pioneer in incisionless weight loss procedures, this acceptance marks an important milestone for USGI in validating the safety, durability and potential effectiveness of POSE2.0® devices for primary obesity,” said Arnold Podgorsky, CEO of USGI Medical. “It also reflects our ongoing collaboration with leading bariatric specialists from around the world. We look forward to advancing a US pivotal study for a primary obesity indication and continuing to build value for our shareholders.”