BAROnova, a venture backed company developing technologies to treat obesity, said it has submitted a premarket approval (PMA) application to FDA for its TransPyloric Shuttle (TPS) device, a non-surgical treatment option for obese patients.
The TPS device is an intragastric implant that is trans-orally placed into the stomach during a standard endoscopic procedure. The device was designed to reside in the stomach for 12 months before being removed with another endoscopic procedure. During those 12 months, the device works to delay gastric emptying, a frequently used mechanism for weight loss that helps patients feel full much quicker during meals.
“While the device resides in the stomach, it works to slow the passage of food from the stomach into the intestine by intermittently blocking and releasing the pylorus,” says David Thrower, president and CEO of BAROnova. “This is called delayed gastric emptying, which is a known mechanism for weight loss. It helps people feel full more quickly and for a longer period of time when compared to eating without the device. The TPS also does not alter the patient’s anatomy, and therefore preserves future treatment options.”
Thrower said the safety and effectiveness of the device has been evaluated in a multicenter clinical trial called the ENDObesity II study. Now that the study has been completed, the company plans to reveal the clinical findings in November at a week-long conference in Nashville known as Obesity Week — however, the company said the device was evaluated for a 12-month treatment period and demonstrated promising results. Thrower said there could also be the potential for the technology to extend beyond a 12-month period, providing a long-term treatment option unlike anything else currently on the market.
“Longer treatment duration is likely important to patients to help keep the weight off after the device is eventually removed,” Thrower said. “There are currently multiple treatments for obesity, but the most comparable current treatment is with a set of products called balloons from companies like Apollo Endosurgery and Obalon. These devices are generally thin skins delivered into the stomach via the esophagus, which are then inflated into a balloon shape with a gas or fluid. In the U.S., balloons are only approved for up to six months. If approved, we will be the only comparable gastric device in the U.S. approved for 12-month residence in the stomach, which could lead to greater and more durable weight loss for patients.”
According to the company’s PMA application, the device will be indicated for patients with a defined co-morbidity and body mass index (BMI) from 30-34.9. Any other obese patients with a BMI between 35-40 will also be eligible for the implant. With obesity rates continuing to rise in the United States, Thrower said the new TPS device could play a pivotal role for patients who seek non-surgical solutions that can treat obesity. However, technologies like the TPS device are not the only important factor when it comes to treating obesity.
“It’s important to note that technological innovation with devices like the TPS is only one part of the solution,” Thrower said. “Obesity is a huge public health issue in this country, however, very few obesity treatments are covered by insurance. In fact, none of the obesity treatments currently approved in the U.S. are covered by insurance companies. This has to change in order to address this urgent medical need in our society. Otherwise, even though good treatment options like the TPS device may exist, only a very limited number of patients will be able to afford them.”
Thrower said that without regulatory approval, the TPS device remains unavailable to patients for the time being. The company remains optimistic that with recent clinical data, BAROnova will be able to work with FDA to obtain approval and begin to market the device.