SAN CLEMENTE, Calif., June 18, 2020 (GLOBE NEWSWIRE) -- 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.
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.”
About Obesity
Obesity is a chronic health condition and is associated with serious health risks, including heart disease, stroke, type 2 diabetes, hypertension, dyslipidemia, gastroesophageal reflux disease (GERD), nonalcoholic fatty liver disease (NAFLD), sleep apnea, and certain types of cancer. According to the Center for Disease Control and Prevention (CDC), the prevalence of obesity among U.S. adults today is approximately 40%, a rate that has grown significantly over the preceding decades, putting financial strains on the U.S. healthcare system with annual medical costs totaling more than $150 billion in U.S. dollars. Obesity has also been identified by the CDC and others as a high-risk factor for severe illness from COVID-19.
About USGI Medical, Inc.
USGI Medical is committed to the development of technologies to enable Incisionless Surgery – the treatment of diseases through the natural passageways of the body. USGI's Incisionless Operating Platform (IOP) provides physicians the operating platform and specialized tools they need to perform procedures through a patient's mouth or other natural orifices. USGI has demonstrated the capability to suture GI tract tissue reliably and durably without an incision, opening the way to a new generation of treatments for a wide variety of acute and chronic diseases. Operating through the body's natural orifices offers promise for less pain, shorter hospital stays, reduced risk of wound infection along with no external scarring from abdominal incisions – and is rapidly becoming an option demanded by patients and healthcare providers. USGI offers surgeons and gastroenterologists the tools they need to offer millions of potential patients a less invasive option to surgery. For more information, go to http://www.usgimedical.com/.
The Incisionless Operating Platform, including the g-Cath EZ Delivery Catheter with Snowshoe® Suture Anchors, has both CE Mark and US 510(k) Clearance. As a treatment for obesity, however, the safety and effectiveness of the device has not been established in the United States. The device is considered an investigational device in the United States and is thereby limited by Federal Law to investigational use for this application.
For Further Information:
Media Contact:
Glenn Silver
Lazar-FINN Partners
glenn.silver@finnpartners.com
+1 646 871 8485
Corporate Contact
Arlene Heider
1140 Calle Cordillera
San Clemente, CA 92673
aheider@usgimedical.com
(949) 369-3890 x 1200
Source:
USGI Medical, Inc.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f5c3f1cd-c7bd-4cbb-a9e9-2c89667b3aa8