USGI Medical expects that its latest infusion of $19.5 million in cash and debt will enable it to complete a U.S. pivotal trial and to submit for FDA approval. The pivotal trial is currently in the follow-up phase; the financing will also enable a crossover study of patients who previously had received sham treatment in the trial.
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| The Snowshoe Suture Anchor--Courtesy of USGI Medical |
The financing will also support the commercialization of its obesity tools in Europe and the Middle East.
The startup's device enables endoscopic access for surgeons to place tissue anchors across folds of tissue in particular portions of the stomach to reduce its size and ability to stretch. This is done using its g-Cath, which is already used for general, non-obesity indications. This would be the first endoscopic suturing technology approved to create a durable, healed fold in the stomach, according to the company.
"For every surgical patient in the U.S., there are 100 or more overweight or obese Americans on the sidelines today with no realistic option. The key to unlocking this market is an intervention that is a simple, outpatient procedure that offers a positive risk/cost/benefit proposition," Guy Nohra, chairman of the board of USGI and managing director of Alta Partners, said in a statement.
USGI got the go-ahead from the FDA in October 2013 for a pivotal trial. This is the largest multicenter, randomized, sham-controlled study of an endoscopic procedure for weight loss, the startup said at the time. USGI completed enrollment for the study in July; it includes 332 patients at 11 U.S. centers.
European data for the first 22 patients that were followed for 12 months after the procedure had an average excess weight loss of 62% with a total body weight loss of 19%. More than 2,500 patients have already undergone the procedure. All the components of the USGI Incisionless Operating Platform have previously been FDA-cleared and CE-marked for other indications.
The financing includes a second $4.5 million debt tranche with GE Capital as an agent. This brings the total raised this year by USGI to $36 million in equity and debt.
Concluded Alta's Nohra, "We founded USGI in our offices and are excited to see the company entering this new phase of accelerated commercial penetration into the EMEA as they also prepare for a potential launch of this important and game-changing procedure in the U.S."
USGI is not alone in aiming for an FDA-approved obesity device. EnteroMedics just garnered the first FDA not for an obesity device in over a decade for its neurostimulator. And several other obesity device companies with varying approaches are aiming to complete pivotal U.S. data and submit to the FDA within the next year or two.
- here is the release