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USGI completes study enrollment, secures $9M credit facility

July 16, 2014 - Medical Device Daily

The U.S. obesity epidemic is a source of frustration in the medical community because despite current treatment options there is still a rather sizable gap of patients who are eligible for bariatric surgery but refuse to consider that option out of fear and social stigmas.

The good news is that there are new medical device options in the pipeline that could go a long way toward bridging that gap. One such option comes from USGI Medical (San Clemente, California), a company developing an incisionless, endoscopic weight loss procedure. USGI recently completed enrollment in its U.S. pivotal study, dubbed the ESSENTIAL trial, and the company also just received a senior secured credit facility of up to $9 million agented by GE Capital’s Healthcare Financial Services business, with EW Bank participating as a syndicate partner.

The funds will be used to support additional European studies of the company’s outpatient weight loss procedure and will also help USGI build on its commercial operation outside the U.S., prove the benefits of the platform in other applications, and begin preparations for a future U.S. launch of the procedure, known as POSE (Primary Obesity Surgery, Endolumenal).

The trial is one of the largest multi-center, randomized, sham-controlled studies of an endoscopic procedure for weight loss ever conducted, according to USGI Medical. A total of 332 patients at 11 sites across the U.S. are participating in the study and there was so much demand for the study that the company reached its enrollment limit ahead of schedule and had to turn people away, John Cox, COO of USGI, told Medical Device Daily. He said the company had originally expected to complete enrollment in the U.S. trial in August, but the “demand was amazing.”

USGI received the nod from FDA to launch the head-to-head pivotal study comparing the POSE procedure to primary bariatric surgery last October. Physicians participating in the study used the company’s g-Cath EZ suture anchor delivery catheter to place tissue anchors across folds of tissue in strategically-located parts of the stomach to reduce its size and ability to stretch to accommodate a meal. The g-Cath, which is used extensively for general, non-obesity indications, is proven to create a durable, healed fold in the stomach, according to USGI.

The POSE procedure has been performed on more than 2,500 patients, mostly in Europe, and is performed entirely through the mouth without any incisions through the abdomen. The company said many patients return to work without any bandages or signs of surgery within two to three days.

Patients enrolled in the study will be followed for weight loss and other efficacy endpoints for a year and receive a total of at least two years follow up and nutritional care, the company said. The study will form the basis of the company’s premarket approval application with the FDA for a weight loss indication in the labeling for the g-Cath EZ delivery catheter with Snowshoe suture anchors. All of the components of the company’s Incisonless Operating Platform currently have FDA clearance for other indications and CE mark.

“The sham-controlled ESSENTIAL trial was designed to generate the highest-quality data possible for a procedure. If the outcomes from the POSE procedure are positive and consistent with smaller trials, it could mean that tens of thousands of patients may have an incredibly compelling option to consider if they’ve struggled to lose weight with diet and exercise, but aren’t candidates for or are not prepared to accept the risk of traditional bariatric surgery,” said Thomas Lavin, founder of The Surgical Specialists of Louisiana and the lead investigator in the study. “Based on preliminary studies of the POSE procedure conducted in Europe, we believe that this new approach may help patients feel full sooner during meals, improving satiety and reducing hunger cravings so they can control their portions, consume fewer calories and lose weight.”

Lavin told Medical Device Daily that when his center began recruiting for the study the demand was “incredible,” which was expected because of the incisionless nature of the procedure and the fact that it was potentially an outpatient procedure that allowed patients to get back to work and their normal routine quickly without ever having to disclose that they’d had surgery.

Cox said the company was surprised at just how important the privacy issue was for patients. That revelation became clear even as the procedure was introduced in Europe. “They didn’t want to have to tell their co-workers and family members that they had a procedure,” he said. “There is still a stigma associated with being overweight and obese, which is unfair . . . there is a treatment gap that exists between diet and exercise and the human story, what’s lost in these patients is associated with that stigma,” Cox said. He added that the POSE procedure gives patients the ability to get back on the right track, control their hunger, and lose a substantial amount of weight without having to disclose that they had surgery.

Lavin said there’s a long-held misconception that it’s just “eat less, move more.” People don’t understand the underlying genetics and pathology of obesity, he said. As a bariatric surgeon and a national proctor who helps train other surgeons for weight loss procedures, including laparoscopic gastric bypass and gastric banding, he knows there’s more to it, for many patients, than diet and exercise alone.

“What people don’t understand is without surgery almost everything else is short term,” Lavin said. The reason for that, he added, is partially genetics and also how a person is raised from birth through adolescence. “You body starts to learn and once you’re 20 years old and you’re overweight . . . it’s almost unheard of for a person to lose weight and keep it off without some kind of surgical intervention.”

That’s because of the way our body’s fat cell memory works and the hormones that are produced by fat cells that send a message to the brain, after a person begins to lose weight, that lowers metabolism and stimulates appetite.

“People don’t understand, we have real hormones that affect our behavior,” Lavin said. He used the example of going to the grocery store hungry as opposed to going after a big lunch. Grocery shopping while hungry typically leads to buying more food than you actually need, while grocery shopping on a full stomach is more likely to lead to getting only the items that you went there to buy.

Previously, Lavin said, the only long-term durable option was through a surgical means, such as laparoscopic gastric bypass. The POSE procedure introduces an option for the patients that are choosing not to have surgery, either because they don’t qualify or because of the social stigma. One thing that sets this procedure apart from other types of bariatric surgery, he said is the fact that the procedure itself is done entirely on the stomach without altering the patient’s GI tract or re-sectioning parts of their anatomy. Rather, the procedure is designed to create folds of tissue in certain parts of the stomach, reducing capacity so that it takes longer between meals before the onset of hunger.

The company has seen positive results with the procedure in Europe. In one study, patients treated at a center in Spain reported feeling full faster and less hungry between meals after undergoing the POSE procedure. A year after the procedure, patients had lost 62% of their excess weight, on average or over 19% of their total body weight. In Europe, the procedure is generally performed in an outpatient setting.

The studies done in Europe also have generated positive safety data for the procedure, Lavin noted. “In the right hands, it’s extremely safe,” he said. He added that for doctors already trained on endoscopic surgery, the learning curve for the POSE procedure is “very short.”