CEO: Richard Thompson
Based: San Clemente, CA
The scoop: No new medical device has been approved by the FDA to treat obesity in more than a decade. And no effective weight-loss treatments are available in the U.S., aside from surgery. In postapproval data from the EU, the ReShape Integrated Dual Balloon System provided weight loss that was almost equivalent to that achieved via Lap-Band. Patients lost 42% of excess weight in a 6-month period; the commonly cited expectation for Lap-Band, the least effective type of surgery, is about 50%. But the ReShape device doesn't require surgery; it can be inserted and removed in a physician's office.
What makes ReShape Medical Fierce: Any advance in major obesity treatment in the U.S. is likely to be greeted with a great deal of relief, as obesity and its associated ailments weigh more heavily every year.
|ReShape Integrated Dual Balloon System|
Insurers have become much more open to reimbursement for surgical options, including Lap-Band, despite the fact that the Lap-Band is removed within a few years about half of the time, often due to complications. That experience could make them more open to reimbursing for ReShape's balloon device. ReShape has a shot to be the first significant treatment that is noninvasive (unlike surgical options) and nonsystemic (unlike drugs, which are likely less efficacious). But side effects and long-term efficacy could prove to be stumbling blocks.
The startup's president and CEO, Richard Thompson, said that the reinforced behavior modification aspect of its device translates into sustained weight loss, although repeat usage isn't out of the question. The system is only intended to remain inflated in the stomach for 6 months.
"The most important aspect of our product is that, unlike some of the other devices being contemplated, the patient gets immediate feedback after consuming only a very small meal," he said. "The patient is always getting positive feedback; if you eat less, you will weigh less."
"We see a pretty effective retention of long-term weight loss. In many other devices, the mechanisms work under different schemes and patients continue to eat normally. They are just denied calories; nothing caused them to learn new behaviors," Thompson concluded.
Devices aiming for the U.S. market include a vagal-nerve stimulator from EnteroMedics that received a mixed FDA panel review; a gastric liner from EndoBarrier; a stomach size-reducing suture catheter placed endoscopically from USGI Medical; and a stomach-draining device from Aspire Medical.
What to look for: ReShape submitted a PMA in July and hopes to get an FDA approval in the first half of 2015. It hasn't publicly disclosed the pivotal data the PMA is based on; it only revealed that the trial met its primary endpoints. Given the placebo-controlled structure of the trial and the infectious enthusiasm of the EU trial leader, the results are not expected to be quite as robust as the EU data released in August.
ReShape will present the U.S. pivotal REDUCE trial results at Obesity Week in November, where it will also present data on repeat use of the device. ReShape's Thompson thinks that its timeline could translate into 18 to 36 months of lead time before competitive weight-loss devices start hitting the market.
On an FDA approval, Thompson said ReShape would reevaluate its status as a private company; the company recently received a $4 million cash infusion and expects to have more by year end and an additional, undisclosed amount upon FDA approval. Investors include New Leaf Venture Partners, SV Life Sciences, US Venture Partners and Venture Investors. -- Stacy Lawrence (email | Twitter)
ReShape targets U.S. approval as EU study shows major weight loss
In obesity device race, ReShape lines up with FDA