USGI Medical Receives FDA Approval to Expand US Pilot Study Evaluating Incisionless Weight Loss Procedure – POSE 2.0

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June 8, 2020

USGI Medical, Inc, (USGI) a cutting-edge company advancing incisionless endoluminal procedures, announced that the Food and Drug Administration (FDA) approved the expansion of a US- pilot study of the Company’s non-invasive, endoscopic procedure, known as POSE 2.0, designed to evaluate weight loss for adults suffering from obesity with a body mass index (BMI) of 35 to 40 kg/m² and an obesity-related comorbidity, such as diabetes or hypertension.

USGI Medical states POSE 2.0 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 amputating part of the stomach.  Patients treated with the POSE procedure typically return to work in just one to two days without any scars or signs of surgery.

During the first stage of the US pilot study, Principal Investigator, Professor Barham Abu Dayyeh, MD, MPH at the Mayo Clinic (Rochester, MN) treated five patients with the POSE 2.0 procedure. Participants in the Investigational Device Exemption (IDE) study are evaluated for weight loss and other efficacy assessments and receive lifestyle and nutritional care through the primary endpoint of one year.

Dr. Abu Dayyeh commented, “This procedure is very reproducible. It’s quite impressive how every patient receives the same new smaller stomach configuration throughout the series contributing to ease of use and consistent positive results.”

To date at the midpoint follow-up of 6 months, patients treated with the POSE 2.0 procedure achieved on average 12.5% total body weight loss (TBWL). All patients responded to treatment with a clinically meaningful TBWL >5% and 60% of patients achieved TBWL >13%. Thus far, all patients are fully satisfied with their outcomes to date and no adverse events were reported during both the procedure as well as throughout the 6-month follow-up.

Given the promising results obtained so far, on April 14, 2020, USGI Medical, Inc. received approval from the FDA for expansion of the pilot study to 4 US institutions and 35 US subjects.

Mr. Carlos Babini, CEO of USGI Medical stated, “We are most pleased with reaching this milestone and continuing our commitment to safe and effective outcomes for patients undergoing the POSE 2.0 procedure.  We look forward to progressing towards a US-based pivotal study and FDA submission for an obesity indication for our label.”

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