• 02 Feb 2024
• Admin
• News Article

USGI Medical gets US FDA nod to conduct pivotal study of POSE2.0 incisionless procedure for primary obesity treatment

USGI Medical, Inc, a pioneer in developing technologies to enable Incisionless Surgery – the treatment of diseases through the natural passageways of the body - announced that the US FDA has approved an Investigational Device Exemption (IDE) 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 potetially other sites outside the US.

“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 US 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.”

There is a growing body of clinical data underscoring the positive impact that weight loss has on a range of comorbidities. Endoscopic gastric remodeling is an emerging approach that does not require the removal of the stomach, thus increasing access for more patients desiring less invasive options.

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.

Barham Abu Dayyeh, MD, MPH, of Mayo Clinic (Rochester, Minn.), is expected to lead the new INSPIRO pivotal study as Principal Investigator. Erik Wilson, MD, Medical Director of Bariatric Surgery at the University of Texas McGovern Medical at Houston, will serve as Co-Principal Investigator.

Dr. Abu Dayyeh also served as Principal Investigator of the previously completed pilot study of POSE2.0 of 40 patients at four clinical centers 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.

“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,” added Podgorsky. “Marketing in the U.S. would be a game-changer for USGI, its investors and the doctor-patient community.”

Obesity is defined as abnormal or excessive fat accumulation that presents a risk to health. A body mass index over 30 is considered obese. A relatively small and simple reduction in weight, for example, of around 5%, can improve patient outcomes and may act as a catalyst for further change, with sustainable weight loss achieved through a series of incremental weight loss steps. According to the Center for Disease Control and Prevention, the prevalence of obesity among US adults today is approximately 40%, a rate that has grown significantly over the preceding decades, putting financial strains on the US healthcare system with annual medical costs totaling more than $150 billion in US dollars.