Christina tried a dieting and practice beforehand. The weight always dropped, but then increased again, especially after she gave birth to her son in 2022.
She hoped that the new class weight loss medications may finally offer something different. Obesity treatments such as Vegs And Zepbound has just arrived on the scene helping people lose weight with unprecedented ease. But the price of these GLP-1 drugs has made them unaffordable. Christina health insurance will not cover the cost.
Desperate for another option, Christina signed up for a clinical trial that promised a few months of blockbuster weight-loss therapy, followed by the possibility of something more. (Christina, a Texas woman in her early 50s, asked that her last name not be used to protect the privacy of her weight-loss treatment.)
This something more was not another injection or pill, but a one-time procedure using a new medical device. And instead of targeting the stomach or the brain, he focused on the gut itself: reprogramming how a part of the upper intestine known as duodenumprocesses nutrients and regulates metabolism.
This approach, performed using a minimally invasive endoscopic device, is designed to help people who want to stop taking GLP-1 medications. The goal is to capture the benefits without the high costs, weekly injections or lingering side effects. And in 2026, the first company to develop such a device will most likely seek permission for its use in patients.
“We are creating a new therapeutic area,” says Harith Rajagopalanco-founder and CEO of this company, Fractile healthbased in Burlington, Massachusetts.
Reset metabolism for a long time Weight loss
You can think of these systems as a middle ground between medications and bariatric methods. operation. An endoscope is a thin, flexible tube equipped with a camera and a guidewire that guides a catheter into the digestive system. Doctors send instruments down the throat so they can examine and change the intestines from the inside out, remodeling the intestinal tissue and recalibrating its response to food without making a single cut. The procedure takes about an hour and patients usually go home the same day.
To understand how the treatment works, you must first understand what happens to your gut over years of unhealthy eating. As diets high in sugar and fat bombard the duodenum, its lining becomes inflamed and its normal signaling pathways are disrupted. Mucosal cells in tissue grow abnormally and propagate these maladaptive changes, establishing a dysfunctional pattern that causes food cravings, weight gain, and insulin resistance.
The Fractyl device overcomes these ingrained changes. It works by deliberately damaging tissue and using near-boiling water to burn diseased cells in the intestinal lining. The natural healing process then begins, creating a fresh layer of healthy tissue and restoring proper metabolic control.
“You'll see regrowth in about two weeks, and this continues until the mucosa looks quite normal,” says Alan Cherringtonphysiologist at Vanderbilt University School of Medicine and consultant to Fractyl.
Preliminary results from a clinical trial that Christina joined called 1 study leftindicate that the procedure works as intended to stabilize post-GLP-1 weight. therapy. Three months after stopping Zepbound, study participants who received the Fractyl treatment generally maintained their weight at a stable level or continued to lose weight, while those who received the sham treatment saw their scale numbers rise steadily.
The results are “honestly better than I expected,” says one of the doctors leading the study. Shelby Sullivangastroenterologist and obesity specialist at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
Sullivan cautions against drawing sweeping conclusions given the small number of participants and short follow-up period. But anyone watching the field won't have to wait long for clearer answers. “By six months,” she says, “we'll know for sure whether it works or not.”
New generation devices for the treatment of obesity
If the six-month data demonstrates sustained weight maintenance (full trial results are expected in 2026), then Fractyl intends to seek regulatory approval to market what could be the first device specifically approved for post-GLP-1 weight management.
But Fractil is far from alone in striving to achieve this therapeutic goal. EndogenexThe company, based in Plymouth, Minnesota, uses a flexible, expandable printed circuit board to deliver pulsed electric fields directly onto the wall of the duodenum to burn off problem cells. Meanwhile, TeCureV South KoreaAnd Aqua Medicalin Pleasanton, California, use lasers and radiofrequency heated water vapor, respectively, to achieve similar remodeling of the intestinal mucosa.
“At the end of the day, you can do the same thing in different ways,” says Pishamol Jirapinobariatric endoscopist at Brigham and Women's Hospital in Boston and co-founder Bariendoa network of 10 non-surgical weight loss clinics around the world. United States. While ongoing research may clarify differences in efficacy and safety, Girapino (who consults for Fractyl) expects performance characteristics such as ease of use and procedure time to play a critical role in determining the drug's popularity among practitioners.
Time to market is also critical and Fractyl, which is currently the market leader, is expected to deliver the first large-scale clinical results. These findings from the study, led by Sullivan, could set the tone for a whole class of new device-based obesity treatments aimed at preserving the benefits of GLP-1 drugs, the Endogenex CEO said. Stacey Pugh. “If they are successful, it will open the field wide,” she says.
Alternative Post-GLP-1 devices
Not everyone is convinced that duodenal resurfacing is the right way to go. Last year, a new weight loss device called Reboot this – although not approved for use in post-GLP-1 drug settings – inserts a sleeve-like pad into the duodenum that physically prevents contact between food and the intestinal wall. However, this device must be removed within a year, providing only a temporary solution.
Other endoscopic approaches target the stomach: One of the widely used today stitches are placed to fold the stomach and reduce its size, while another, more experimental method burns stomach tissue that regulates the secretion of hormones that stimulate appetite.
These gastric-targeted methods may offer a logistical advantage given the relative reliability and availability stomach, explains Andrew Stormis an endoscopist at Wake Forest University in Winston-Salem, North Carolina. “The duodenum is paper thin compared to the stomach, which is like a thick neoprene bag,” he says.
Regulatory approval for Fractyl will allow the company to directly market its post-GLP-1 weight maintenance product. Boston Scientificcreator most widely used gastric stapling deviceshe is not legally allowed to do so unless she takes part in a new round of clinical trials. And this difference may give duodenal treatments a marketing advantage. But Storm, who advises Boston Scientific and also participated in trials of the Endogenex system, raising concerns about the complexity of duodenal therapy. “It just creates a whole different level of complexity for the endoscopist, which I think will impact scalability,” he says.
Maintain hard-won progress
For patients like Christina, the debate over stomach versus duodenum or one company's device versus another is largely academic. What's important to her is that the 50 pounds she lost on Zepbound (nearly 20 percent of her body weight) are still there, and she attributes that stability to the Fractyl device. Since the study is randomized and blinded, it is possible that she actually underwent a sham procedure. But Christina is pretty sure she got the real thing.
Her reasoning is based on small but revealing moments, such as when her husband was cooking the burnt ends of smoked pork emitting that rich aroma that would once have sent it straight to the table. “It smelled very nice, but I had no desire to eat it,” says Christina.
Experiences like Christina's hint at the tantalizing promise of a long-term drug-based solution to weight loss, but medical device development requires more than anecdotes. With critical trial results on the horizon, the coming year could determine whether these devices remain promising prototypes or become proven tools in the next era of obesity treatment.
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