|TransPyloric Shuttle--Courtesy of BaroNova|
Obesity treatment devices have been in the regulatory spotlight in 2015 with two approvals for balloon-based devices and another for a neurostimulator. That makes for a total of 5 FDA-approved obesity devices--including the two banding devices that were already approved.
Now, BaroNova, a Goleta-CA based startup, has raised a $36.5 million to conduct a U.S. pivotal trial for yet another device-based weight loss approach--the TransPyloric Shuttle (TPS), an endoscopically placed device that is intended to enhance feelings of fullness and delay gastric emptiness, thereby inducing weight loss.
"BaroNova's TPS has been shown to help patients lose as much weight with a durable, endoscopically placed device as with today's more invasive surgical alternatives. This round of financing is an important step toward the goal of providing millions of obese patients with a safer and effective alternative for weight loss," said Dr. Gregory Grunberg, Managing Director of Longitude Capital, in a statement. Delos Capital led this latest financing, with Longitude as the co-lead and participation from existing investors Lumira Capital Partners, Onset Ventures and Sante Ventures.
In an earlier clinical trial of the device, after 6 months, treated patients with a BMI of 30-50 kg/m2 had lost about half of their excess weight on average. Patients at the lower end of that range with 30-40 kg/m2 lost an even higher average amount of their excess weight at 58%.
"With this financing, we are well positioned to fund the development of the TPS, a product that has previously demonstrated the potential for compelling weight loss," added Hugh Narciso, founder and CEO of BaroNova.
The FDA already has given the company the go-ahead for the U.S. pivotal trial, which will be known as ENDObesity II Study. It's intended to support a PMA submission to the FDA, with the first subject slated to enroll before year end.
"We believe that its differentiated technology may address an important need and, thereby create significant value," concluded Delos Managing Partner Henry Chen.
- here is the announcement