Closely held Aqua Medical is advancing therapy for gastrointestinal (GI) and metabolic diseases—including Type 2 diabetes—using its disruptive, transoral, outpatient vapor-based endoscopic ablation platform.
“Our goal is to change the course of Type 2 diabetes with our unique, non-surgical Radiofrequency Vapor Ablation (RFVA) System that is a true platform technology designed to treat multiple GI diseases and prevent GI cancers. We are FDA-cleared for ablation in the GI tract, but not yet for diabetes,” Lloyd Mencinger, president and CEO of Aqua, says in an interview with BioTuesdays.
With a rich background in the healthcare and medical device space, Mr. Mencinger brings decades of experience to Aqua. His leadership roles at Boston Scientific, Baxter Healthcare, Tenet Healthcare, and Edwards Lifesciences lend deep expertise in global commercialization, business development, and minimally invasive endoscopic ablation therapies to the company. His proven track record in scaling med-tech innovations and leading international teams supports Aqua’s growth and clinical impact strategy.
Mr. Mencinger explains that the company’s RFVA System is a single-use, through-the-endoscope, circumferential ablation catheter that attaches to a standard endoscope. Radiofrequency energy converts saline into heated vapor at the catheter tip, which is released under direct endoscopic visualization to achieve precise and uniform ablation. “Steam is a difficult medium to control but it’s the perfect ablation agent because it has very high energy and can achieve uniform coverage in the irregularities of the bowel,” Mr. Mencinger says. “Our proprietary algorithm delivers vapor in a tightly regulated way—produced at the catheter tip for real-time control and safety. That’s why we’re more advanced than any other technology out there.”
He notes that the RFVA System offers multiple interchangeable catheters for different sections of the GI tract, potentially enabling physicians to treat a range of conditions with the same platform. Procedures are fluoroscopy-free, avoiding patient exposure to X-rays, and designed for outpatient or ambulatory settings. Aqua’s technology is intended to be simpler and faster than existing GI management techniques, making it accessible to a broader base of physicians. “The other competitors’ systems are very large, cumbersome, and challenging for physicians to manipulate—typically some even requiring fluoroscopy.”
Aqua’s lead indication is Type 2 diabetes, a condition affecting more than 38 million Americans, with an additional 98 million living with prediabetes. Globally, more than 640 million adults are projected to have the disease by 2030. Despite the availability of more than 60 pharmacologic treatments for diabetes, including oral agents and injectables, none can halt or reverse the disease. “Type 2 diabetes is a global epidemic. And a big concern is that if patients stop their medication, the disease returns,” Mr. Mencinger points out. “What we’re doing is downstaging the disease—we’re actually reversing the metabolic clock.”
Aqua’s procedure, called Proximal Intestinal Mucosal Ablation (PIMA), targets the mucosal lining of the duodenum and proximal jejunum—tissue regions shown to play a critical role in glucose homeostasis. The approach builds on decades of bariatric surgery data revealing that bypassing the small intestine can resolve diabetes, often within days of surgery. “The small bowel is far more complicated than we used to think it was and is a key element in addressing Type 2 diabetes,” Mr. Mencinger contends. “Our procedure attempts to mimic the metabolic effects of gastric bypass but without surgery. It’s a 40-minute outpatient procedure, minimally invasive, with very little post operative pain.”
The company recently completed a 66-patient clinical study in Chile that demonstrated compelling results. Patients experienced an average reduction of more than two percentage points in hemoglobin A1C levels, matching the metabolic benefits seen with gastric bypass and exceeding those achieved by other device-based competitors. “We’re thrilled with these results,” Mr. Mencinger says. “We’ve seen outstanding safety and tolerability, no serious adverse events, and dramatic metabolic improvement. It’s truly a game changer.”
Aqua’s clinical and procedural advantages are significant. The company’s device treats four times the length of intestine compared with competing systems—covering between 50 and 70 centimeters rather than the 12 to 15 centimeters typically achieved by other devices. The RFVA System delivers higher treatment energy for more complete tissue coverage while maintaining safety and comfort, and the procedure time remains the fastest in its class. Because the system passes directly through the endoscope, it can be used in ambulatory centers by a wide range of GI physicians, dramatically expanding access and reducing procedural complexity.
While Aqua’s current focus is Type 2 diabetes, the company is also advancing its RFVA platform for oncology prevention. “In Barrett’s esophagus, we can ablate precancerous tissue and potentially prevent progression to esophageal cancer—one of the fastest-rising cancers in the U.S.,” Mr. Mencinger asserts. “In pancreatic cysts, vapor ablation could potentially prevent transformation to pancreatic cancer, one of the most lethal malignancies.” Aqua’s technology is already FDA 510(k) cleared for GI ablation in Barrett’s esophagus, and has received Breakthrough Device Designation for the treatment of Type 2 diabetes.
Following the success of its international study, Aqua received its Investigational Device Exemption (IDE) from the FDA and plans to launch a 20-patient pilot study across four U.S. centers, including the University of North Carolina, Mayo Clinic, Hoag Hospital, and Honor Health. The company anticipates enrolling its first patient in early 2026.
“We’ve achieved all this progress with just $31 million—remarkably capital-efficient,” Mr. Mencinger emphasizes. “With our two-pronged strategy—diabetes and Barrett’s esophagus—we’re addressing enormous markets with validated clinical data and a scalable platform.”
He adds that Aqua’s leadership team brings deep experience across GI endoscopy, medical devices, and metabolic disease management. The company holds 27 issued patents and 34 pending, protecting its proprietary vapor generation and delivery technologies.
“At Aqua Medical, we believe gastrointestinal diseases—including cancers—will eventually be preventable and manageable with our innovative through-the-endoscope ablation interventions,” Mr. Mencinger concludes. “We are working to make our technology faster, easier, and clinically more effective than other approaches. We’re not just managing Type 2 diabetes—our path is toward reversing it.”
The PIMA procedure and RFVA system are investigational and are not approved for sale in the United States or other markets. Safety and effectiveness have not been established.
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