A San Clemente-based medical device maker cleared a big regulatory hurdle and landed on a faster track to commercialization.
ReShape Medical Inc. received permission last week from the Food and Drug Administration to bypass a requirement to appear before an agency panel to obtain premarket approval for its dual-balloon weight-loss device.
The FDA uses advisory panels of between 10 and 20 experts on matters such as premarket medical device approvals. The agency is not bound by the panels’ recommendations—but it frequently follows their lead.
Final Decision
ReShape expects the agency to make a final decision on the device by the end of June—a period that has been sped up by the drop of the panel requirement.
“Our estimate is that it takes three to six months off the schedule when you don’t have to do a panel meeting,” said ReShape Chief Executive Richard Thompson.
He took the FDA’s move as a validation of his company’s research and development.
“It means that people at FDA who are responsible for reviewing our application are comfortable enough that the data that we provided showing the safety and effectiveness of our product is sufficient for them to make a determination without getting outside opinions,” Thompson said last week from New York, where he was meeting with potential investors. “That’s a pretty big vote of confidence—they really don’t need help in evaluating.”
ReShape, which has received more than $46.5 million in financing since 2007, expects to announce another round close to the time it receives regulatory approval, Thompson said. The company’s investors include SV Life Sciences in San Francisco and Menlo Park-based New Leaf Venture Partners and U.S. Venture Partners.
Balloon
ReShape’s balloon is inserted endoscopically into a patient’s stomach to assist in weight loss. It stays in the stomach for six months, takes up space, and helps patients feel fuller.
The procedure is designed for people who have a body mass index of 30 to 40, which is classified as medically obese.
Counseling on nutrition, exercise, and behavior modification is also part of the treatment, which ReShape refers to as “the ReShape Integrated Dual Balloon System.”
“We’re not just about selling the balloon—we’re selling a procedure that lasts a full year,” Thompson said.
The device is approved in Europe and has sales, but ReShape declined to give numbers.
Cash Pay
It is a cash-pay procedure that ReShape officials say is an alternative to more invasive weight-loss surgeries.
Thompson said that the device has already received preapproval from Orlando, Fla.-based CareCredit, a unit of Stamford, Conn.-based Synchrony Financial that finances various healthcare procedures.
Thompson said he believes the company’s device could be covered by insurance at some point, provided that it shows sustained weight loss after it is removed from the patient’s stomach.
“The proof that we’ll need to provide is sufficient, lasting benefit to the weight loss,” he said. “In other words, that the patients just don’t gain all the weight back.”
ReShape has 25 workers now and is preparing for commercialization, including steps to ensure the ability to go ahead with manufacturing the device if the FDA approves it.
“Now, the volumes have to get significantly larger,” Thompson said. “Scaling up for manufacturing is a focal point for us—we’ve had to hire more assemblers. We’re starting to hire more people in management and more engineers.”
ReShape also is building its sales and commercial unit up for the device’s launch, he said.
Panel Prep
Thompson said FDA panels are challenging to prepare for and take months of preparation in order to properly present device evidence.
He also said they present a “scheduling problem” because of the need to make sure that all of the proper experts are available to meet in Washington, D.C., for the panels, which are typically held over a two-day period.
ReShape has several Orange County device veterans among its management and board ranks. For example, the company’s chairman, Kenneth Charhut, is a former executive of Baxter International Inc.’s cardiovascular division, which evolved into Irvine-based heart valve maker Edwards Lifesciences Corp.
