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FDA approves expansion of POSE2.0 US pilot study evaluating incisionless weight loss procedure

Thu, 06/25/2020 - 08:45
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The FDA has approved the expansion of a US- pilot study of the USGI Medical’s non-invasive, endoscopic procedure, known as POSE2.0. The study is designed to evaluate weight loss for adults suffering from obesity with a BMI35-40 and obesity-related comorbidities, such as diabetes or hypertension. The FDA approval, based on the promising results obtained so far from the first stage of the study, means the pilot study will be expanded to four US institutions and 35 US subjects.

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 amputating part of the stomach. According to the company, patients treated with the POSE procedure typically return to work in just one to two days without any scars or signs of surgery.

“POSE2.0 is fundamentally different than POSE1.0. POSE1.0 anatomically reduces the gastric fundus and place a horizontal line of plications in the distal gastric body. POSE2.0, on the other hand, places synchronised plications on the greater curvature of the stomach starting at the level incisura and extending to the proximal body, which produces a small food reservoir in the fundus with a tubular configuration of the remainder of the stomach that is significantly shorter than the native configuration (Figure 1),” said Principal Investigator of the study, Professor Barham Abu Dayyeh from the Mayo Clinic, Rochester, MN. “These anatomic manipulations of POSE2.0 seem to impact the physiology of the stomach (both accommodation and emptying) and result in significant improvement in satiety and satiation, which when combined with a life-style programme produce a total body weight loss of about 17% at one year. Given the durability of the POSE2.0 plications, the favourable effects of the procedure are expected to last for years. Furthermore, compared to POSE1.0, the procedure is technically easier and more efficient to learn and perform, with an average procedural time of about 30 minutes.”

Figure 1: Illustration showing the differences between the POSE1.0 and POSE2.0 procedures
Figure 1: Illustration showing the differences between the POSE1.0 and POSE2.0 procedures
 

During the first stage of the US pilot study, Professor Abu Dayyeh 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.

To date at the midpoint follow-up of six months, patients treated with the POSE2.0 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 six-month follow-up.

Professor Abu Dayyeh then explained how the POSE2.0 procedure differs from other bariatric endoscopic procedures such as endoscopic sleeve gastroplasty (ESG). He said that both endoscopic sleeve gastroplasty and POSE2.0 offer significant advantages over other endoscopic bariatric and metabolic removable devices in that they offer higher and more-durable weight loss.

“We are investigating mechanistic physiologic differences between POSE2.0 and ESG, and preliminary work suggest that both techniques are complementary and effective. Furthermore, this work is pointing out that different baseline physiologic measurements, such as gastric emptying can help select high-responders to either POSE2.0 or ESG, thus ushering in the era of personalised procedural selection based on physiology to maximise weight loss success and minimise unfavourable symptoms.”

“ POSE2.0 is the most durable gastric-plication platform on the market; thus, we anticipate that the favourable weight loss effects of POSE2.0 last for years compared to other competitive suturing and plication platforms”, added Carlos Babini, CEO of USGI Medical. “This impressive durability is due to the unique and consistent serosal healing that our platform offers. USGI has ten-year human clinical durability on file (Figure 2).”

Figure 2: Serosal healing
Figure 2: Serosal healing
 

The study researchers believe that the POSE2.0 plications are exceptionally durable as demonstrated by upper GI x-rays and endoscopies performed at 12 months after the procedure demonstrating that all plications are intact. The POSE plication is designed to distribute the force of the plication over a larger surface area afforded by the baskets design and create fibrosis and fusion of the muscle layer and serosa at the plication site. Thus, animal and human studies of these plications demonstrated long-term durability.

“The fact that the procedure is minimally invasive, anatomy preserving, and associated with quick recovery and return to regular activities within a couple of days after the procedure, I believe will drive patients’ interest,” added Professor Abu Dayyeh. “Furthermore, the patient's quality of life is improved because of the lack of unfavourable symptoms associated with the POSE2.0 procedure, such as GERD or dysphagia. Additional advantages include the decreased risk of micronutrients deficiencies as the GI tract anatomy is preserved; thus, not necessitating any long-term replacement therapy.”

After the completion of the US IDE expanded study, the researchers are hoping this data combined with prospective protocol-driven multi-centre data they are gathering on the POSE2.0 procedure from Europe and the Middle East will allow the company to conduct an efficient US pivotal trial for an obesity indication for the procedure.

“We are most pleased with reaching this milestone and continuing our commitment to safe and effective outcomes for patients undergoing the POSE2.0 procedure,” said Mr Carlos Babini, CEO of USGI Medical. “We look forward to progressing towards a US-based pivotal study and FDA submission for an obesity indication for our label.”

The Incisionless Operating Platform, including the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors, has both CE Mark for use in Primary Obesity (POSE) and Obesity Repair (ROSE) procedures as well as US 510(k) Clearance for use in Obesity Repair (ROSE) procedures. As a treatment for obesity, however, the safety and effectiveness of the device has not been established in the US. The device is considered an investigational device in the US and is thereby limited by Federal Law to investigational use for this application.