Earlier this year, MD+DI reported there were some significant changes occurring in the obesity treatment market. The latest change in the space is the addition of BAROnova’s weight-loss product to the U.S. market.
The San Carlos, CA-based company won a nod from FDA TransPyloric Shuttle (TPS) device, a non-surgical obesity treatment technology for patients with a body mass index of 30 to 40kg/m2. BAROnova said the device is approved for up to one year of treatment, during which time patients undergo lifestyle modification counseling to help develop and maintain healthier habits.
The TPS device is delivered and retrieved endoscopically and relies on its mechanical structure to maintain its shape to keep it in the stomach as opposed to traditional inflatable intragastric balloons. The constructed TPS is the size of a small peach (~5.6 cm in diameter), 85% to 90% smaller than the fluid-filled balloons.
Once in stomach, it is designed to slow the passage of food, so patients feel full sooner and stay full longer. The 12-month treatment duration is twice as long as intragastric balloons currently approved in the U.S. The longer treatment duration potentially allows patients the opportunity to achieve more durable lifestyle changes and health benefits.
"FDA approval is a significant milestone for the company," Lian Cunningham, M.D, PhD, Senior Vice President of Clinical Affairs and Regulatory Affairs of BAROnova, said in a release. "The TPS device is unique in its treatment efficacy and duration. Further validation of potential comorbidity benefits, like cardiometabolic improvement observed in the pivotal study, during the post-market phase may translate to important advantages in achieving healthcare coverage for the TPS device in the future. We look forward to bringing this new technology to patients and physicians."
As mentioned earlier, there have been some pretty significant shifts in the weight-loss treatment-by-device market in the past few months.
Just a few short weeks ago, Obalon Therapeutics – another significant player in the obesity treatment space, announced it would eliminate 50% of its staff as it moved to a new selling model. The San Diego, CA-based company then went on to retain Cowen as an independent financial advisor to assist in exploring financial and strategic alternatives.
GI Dynamics has been making has a good measure of progress with its EndoBarrier technology over the past few months. This is significant because the Boston-based company has been struggling to get the device on the market in the U.S. and has even had approval suspended in Europe.
The EndoBarrier is designed to treat obese patients with Type 2 diabetes by creating a barrier between food and the wall of the small intestine. The company said this changes the metabolic pathways by controlling how food moves through the digestive system.
In February, GI Dynamics won a nod from FDA and the Institutional Review Board to launch another pivotal trial of the EndoBarrier. (GI Dynamics’ first pivotal trial was halted in 2015, after four cases of hepatic abscess were found among the 325 patients enrolled in the study.)
The approval of the 2019 pivotal trial came about a month before GI Dynamics touted promising data from the UK’s National Health Service EndoBarrier study that showed a significant reduction in HbA1c, weight, liver fat, and cardiovascular disease risks as well as a reduction in the need for insulin in some patients.
And in late 2018 two rivals ReShape Medical and Apollo EndoSurgery took part in a deal that would allow for a product swap of sorts in late 2018.
In the transaction, Apollo said it would sell its surgical product line, which includes the Lap-Band adjustable gastric banding system to its rival San Clemente, CA-based ReShape Medical. In addition, ReShape decided to sell its intra-gastric balloon line to Austin, TX-based Apollo. The transactions are worth about $17 million.