FDA approves BAROnova’s TransPyloric Shuttle for weight management in adults with a BMI of 30-40 kg/m2 – May 1, 2019

Up to 12-month use of endoscopically-delivered device, which delays gastric emptying; Follows results from ENDObesity II: 9.5% vs. 2.8% body weight loss (TPS vs. sham) in 12 months

FDA has approved BAROnova’s TransPyloric Shuttle (TPS) for weight management in adults with a BMI of 30-40 kg/m2, for up to 12 months of use.

The endoscopically-delivered device sits at the bottom of the stomach to block food movement and delay gastric emptying. TPS is the size of a “small peach” (~5.6 cm in diameter), making it ~85%-90% smaller than fluid-filled gastric balloons, which can only remain in the stomach for six months.

Approval was based on positive results from BAROnova’s phase 3 ENDObesity II study (n=302), which demonstrated 3.4x greater average weight with the TPS compared to the sham-control group (9.5% vs. 2.8%, p<0.0001). Two-thirds of those treated with TPS lost ≥5% of their body weight, and 40% lost ≥10%.

Notably, the TPS is the second non-surgical and non-pharmacologic device approved by FDA this month for obesity, the first being Gelesis’ Plenity – a hydrogel capsule taken orally with lunch and dinner that rapidly absorbs water in the stomach and mixes with food to expand ~100x and give a feeling of satiety.

As we’ve heard from KOLs, factors to drive greater update of obesity treatment could include improvements in safety, cost, BMI indication range, simplicity, and ease-of-use. As a device applied and removed endoscopically, the TPS does not enter the bloodstream, avoiding many concerning side effects of pharmacotherapy. On balance, however, a relatively high 10% of ENDObesity II participants had the TPS removed prior to 12 months, and other devices – namely gastric balloons – have their own safety concerns.

As we see it, potential headwinds for the TPS could be cost and the BMI indication range; indicated for 30-40 kg/m2, the product is not differentiated from other anti-obesity agents. For comparison, one of the main draws of Plenity to KOLs was its indication down to a BMI of 25 kg/m2, making it an enticing option for improving insulin resistance and in certain demographics with lower average BMIs.


--by Peter Rentzepis, Ann Carracher, and Kelly Close