51.5 F
Laguna Hills
Thursday, Mar 28, 2024
-Advertisement-

USGI Cleared for Trial on Weight-Loss Devices

San Clemente-based USGI Medical Inc. is moving along with development of its less-invasive devices for weight loss.

USGI, which has raised some $95 million in venture capital funding during its 12-year history, got clinical approval earlier this month from the Food and Drug Administration to start a clinical trial that will determine the safety and effectiveness of its incision-less endoscopic weight-loss procedure.

The company is going to enroll about 350 subjects at up to nine centers across the U.S.

“It’s amazing news—the main thing to take out of that is that over the past year or so, the FDA has really been working with startup companies and presented more realistic bars in terms of efficacy outcome,” said Chief Executive Scott Moonly.

Clinical Data

USGI reported clinical data from a pair of studies done in Barcelona on its procedure in August during the 18th World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, which took place in Istanbul.

“We’ve been silent for a few years about what we’ve been doing and what our data looks like,” Moonly said.

The latest data “clearly represents what we feel is absolutely the best data for endolumenal therapy for the treatment of obesity,” he added.

USGI’s procedure includes an endoscopic access device, an endoscopic grasper, a catheter with suture anchors, and a tissue grasper.

The company’s website says the procedure “addresses many of the challenges of endolumenal surgery, providing surgeons the tools they need to cut, sew and manipulate tissue through the narrow confines of the body’s natural lumens.”

Lumens, in anatomical terms, are the inside spaces of structures such as arteries or intestines.

USGI is looking at potential patients for its clinical trial with body mass indexes of between 30 and 40, according to Moonly.

“It’s a more expanded set of patients,” he said.

The company, which has about 32 workers, is working on its clinical trial during a time when statistics have shown that a majority of American adults are considered overweight or obese.

Realize, Lap-Band

“Most people try diet and exercise, and I think most people fail at diet and exercise, especially over a long period of time,” Moonly said. “Right now, in the U.S., you’re effectively limited to full-blown bariatric surgery or getting a Lap-Band or the competitive product by Johnson & Johnson, the Realize band.”

Lap-Band is a product of Irvine-based Allergan Inc., which has said it plans to divest the device in the wake of declining sales.

Moonly noted that Lap-Band and Realize are used on patients in the 30-to-35 BMI range, while bariatric surgery has historically been reserved for morbidly obese patients.

USGI is some years away from commercializing in the U.S.; it currently sells devices in Spain. Moonly declined to give a revenue figure for the company.

“I think a safe estimate would be 2016” for the company to submit data from its domestic clinical trial to the FDA, Moonly said. “We hope to do better than that.”

Moonly said he expects the procedure to be cash-pay early on, noting that the company hasn’t had problems finding patients in Spain who are willing to pay cash.

“Initially in the United States, it will be cash-pay, but given the importance of this disease state to our country (and) the total healthcare expenditures of our country, reimbursement is going to have to be addressed,” he said.

Moonly has been the device maker’s chief executive since November 2011, succeeding company cofounder Eugene Chen.

Chen and former USGI President Vahid Saadat cofounded USGI in 2001 with funding from San Francisco-based investor Alta Partners.

Moonly was previously with Johnson & Johnson Development Corp., J&J’s venture capital arm, which also invested in USGI.

“I was one of those people doing the funding, venture capital investments on behalf of Johnson & Johnson,” said Moonly, who also had served as a USGI board member since 2009. “I really got to see inside of the company.”

USGI assembles its devices at its headquarters in San Clemente.

Want more from the best local business newspaper in the country?

Sign-up for our FREE Daily eNews update to get the latest Orange County news delivered right to your inbox!

-Advertisement-

Featured Articles

-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-

Related Articles

-Advertisement-
-Advertisement-