ReShape Medical, which is developing a balloon system to combat obesity, notched a significant victory in its path to commercialization, CEO Richard Thompson told MassDevice.com today.
Regulators at the FDA waived a requirement that the San Clemente, Calif.-based company appear before an advisory committee for its premarket approval application, Thompson told us. That removes a significant amount of uncertainty from the arduous PMA process for the ReShape Duo device, he said.
Medical device advisory panel meetings are typically convened at the FDA’s request for 2 key reasons: Premarket submission advice and/or regulatory issues. The panels, which are made up of members of the medical community, are typically held over 2 days and feature presentations from sponsors and FDA representatives. The FDA is not bound by its panels’ decisions when approving a product, but often follows their lead.
"I consider [bypassing the advisory panel] to be a major risk reduction for the company, as well as a schedule reduction," Thompson told us.
ReShape, which filed its PMA application last June, is on pace to get a decision from the agency during the 1st half of 2015, he said. A positive decision would clear the pathway for a U.S. launch of the obesity balloon system.
The ReShape Dual Balloon system is designed to be inserted endoscopically and remain in the stomach for 6 months. The balloon takes up space in the stomach and helps patients feel full. While the stomach-filling balloons are in place, patients are counseled by healthcare professionals on nutrition, exercise and behavior modification to help them develop a healthier lifestyle, according to ReShape.
Last fall ReShape released results from its Reduce US pivotal trial that it said showed patients with the device lost 2.3 times more weight than patients using just diet and exercise.
The Duo, which has been available commercially in Europe since 2007, is a non-reimbursed cash procedure.
Thompson told MassDevice.com that the company is likely seek another round of financing on the private markets to fund commercialization. In February, the company closed on nearly $7 million through existing internal investors, according to a filing with the federal Securities & Exchange Commission. ReShape Medical has raised more than $46.5 million since its inception.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.