Latest news with #Endogenex
Medscape
09-05-2025
- Health
- Medscape
Endoscopic Procedure Shows Promise in Type 2 Diabetes Care
A novel investigational endoscopic procedure targeting the duodenum appears beneficial in improving glycemic parameters in people with type 2 diabetes (T2D). In a new dose-finding study, the re-cellularization via electroporation therapy (ReCET, Endogenex) improved insulin sensitivity, beta-cell function, and other glycemic parameters at 12 and 48 weeks in 51 individuals with T2D. 'The findings suggest that duodenal mucosal and submucosal recellularization are key therapeutic targets in type 2 diabetes management,' said Barham Abu Dayyeh, MD, director of Interventional Gastroenterology at Cedar-Sinai Hospital, Los Angeles, in a presentation at Digestive Disease Week (DDW) 2025. The outpatient technique is based on pulsed electrical fields, or electroporation, which do not use heat. 'It's nonthermal regeneration, not just ablation. It's regeneration of the duodenum as a treatment target that could potentially modify type 2 diabetes,' Abu Dayyeh told Medscape Medical News . Separately at DDW, Abu Dayyeh presented results from an artificial intelligence–based analysis of duodenal biopsies from 111 individuals with T2D and 120 control individuals without diabetes, demonstrating distinct mucosal features associated with metabolic disease, significant inflammation in the deep mucosa and submucosa with increased fibrosis, and gut-barrier dysfunction. The authors termed this set of abnormalities 'diabetic duodenopathy.' Abu Dayyeh likened the duodenum to a 'conductor' of the 'dysfunctional orchestra' of metabolic disease that includes T2D. 'It's tasked with integrating signals from the food that we eat and from our microbiome and communicates that metabolic response to downstream organs like the pancreas, liver, and adipose tissue.' Currently, he said, 'We use treatments that work downstream on components of this dysfunctional orchestra. So we work on the violinist and the flute player, but we do not go upstream to say maybe there's an opportunity to put the orchestra conductor back in synch…We manage blood glycemia by lowering it, rather than looking at upstream disease-modifying targets that could reverse the course so you require less insulin and less medication.' Abu Dayyeh envisions the ReCET procedure as an option for people struggling to control T2D with standard medications, or for early use to avoid or delay medications, particularly insulin. But it won't replace medications. 'On the contrary, I see it as enhancing and complementing medications,' he said. Asked to comment, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, Cleveland, told Medscape Medical News , 'Diabetes is a heterogeneous disease complex with numerous pathophysiological derangements. Although diabetic duodenopathy can be seen in some patients with diabetes, that wouldn't explain the entire story behind diabetes pathogenesis in all people with diabetes. In a subgroup of people with duodenal involvement in their disease process, endoscopic procedures targeting the duodenum may play a role in the future.' Glycemic Parameters Improve Following ReCET Procedure The new study, called REGENT-1, was a multicenter, open-label, single-arm dose escalation of three levels of energy delivery in patients who had T2D for 10 years or less with A1c levels 7.5%-11% despite the use of one or more noninsulin glucose-lowering medications. Procedural success, defined as treatment of at least 6 cm of duodenum, was achieved in 100% of participants. From a baseline A1c of 8.6%, there were dose-response drops at weeks 12 and 48 by energy delivery, with significant reductions at week 48 of 1.00 and 1.70 percentage points, respectively, among the 18 who received the middle dose and the 21 given the highest dose. Body weight also dropped in all three groups in a dose-response way, from 1.2% with the lowest to 6.2% with the highest energy delivery. In mixed-meal tolerance testing, glucose area under the curve, homeostatic model assessment for insulin resistance, sensitivity index, beta-cell function, and disposition index (a measure of beta-cell response to insulin resistance) were all reduced from baseline at 48 weeks after ReCET, reaching statistical significance with the highest energy dose. There were no device- or procedure-related serious adverse events. Based on a literature search, Abu Dayyeh found that modern glucagon like peptide-1 receptor agonist medications have a stronger effect than ReCET or Roux-en-Y gastric bypass (RYGB) on beta-cell function (increases by 239% with semaglutide and 314% with tirzepatide vs 50% with ReCET and 74% for RYGB). However, ReCET procedure produced superior results for both insulin sensitivity (+487% for ReCET and +326% for bypass vs 30% and 62%, respectively for semaglutide and tirzepatide) and disposition index (+1032% for ReCET, +667% with tirzepatide, +642% for RYGB, and +367% for semaglutide). Aminian commented, 'The findings of this single arm clinical trial are promising. The next step is to incorporate a blinded control group who undergoes an endoscopy without any therapeutic intervention.' In fact, such a study is underway. Results of 'a multicenter, randomized, double-blind, sham-controlled study for assessing the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (ReCET)' are expected in late 2026. In the meantime, Amanian said about the current findings, 'I'd argue that the observed improvement in diabetes parameters can be related to more intensive medical therapy during follow-up in this single arm study.' In the trials, the procedure takes 30 minutes to an hour to perform. However, as the technology improves, 'the vision of this is to be a 20-minute outpatient procedure eventually,' Abu Dayyeh said. He envisions that eventually the procedure will become as accessible as colonoscopy is now, and that primary care physicians and endocrinologists would similarly refer patients to a gastroenterologist or surgeon to have it done. 'They do the procedure and send your patient back, hopefully with a less complex management strategy, so you could manage them more efficiently without escalating care.' Abu Dayyeh is a co-inventor of the ReCET procedure, with the technology licensed by the Mayo Clinic. He is a consultant for and/or reported receiving research support from Boston Scientific, Olympus, Medtronic, Metamodix, BFKW, Apollo Endosurgery, USGI, Endogastric Solutions, Spatz, and Cairn. Aminian had received grants and personal fees from Medtronic and Ethicon. He serves as a consultant for Medtronic, Ethicon, and Eli Lilly.
Yahoo
07-05-2025
- Health
- Yahoo
Endogenex reports results on ReCET system for type 2 diabetes management
Endogenex, a company focused on developing medical devices for type 2 diabetes management, has shared results from its REGENT-1 clinical study during the Digestive Disease Week (DDW) 2025 event held in San Diego, US. The study evaluated the safety and feasibility of the Endogenex pulsed electric field system (ReCET system) in the US and Australia. The system is an investigational endoscopic outpatient procedure that employs non-thermal energy to address inflamed and dysfunctional tissue linked to type 2 diabetic duodenopathy. This treatment aims to regenerate healthy cells in the mucosal and sub-mucosal layers of the duodenum, which plays a crucial role in metabolic processes. Endogenex CEO Stacey Pugh said: 'The REGENT-1 study continues to deliver promising results, reinforcing the ReCET System's potential as a transformative treatment for type 2 diabetes. 'We have known for some time that the duodenum plays an important role in type 2 diabetes, and these new data– along with other cutting-edge analyses being presented here at DDW – illuminate and reinforce the duodenum as a novel target in the treatment of type 2 diabetes.' The findings from the REGENT-1 Australia study indicated notable enhancements in insulin sensitivity and beta cell function at 12 weeks. Improvements sustained at 48 weeks in a dose-responsive manner, indicating the 'durability' of the treatment, according to the company. The study reported a procedural success rate of 100%, with no serious adverse events related to the device or the procedure, according to the company REGENT-1 study lead author Dr Barham Abu Dayyeh said: 'These findings reinforce that the duodenal mucosa and submucosa are critical therapeutic targets for advancing type 2 diabetes treatment and disease management. 'These results lay the groundwork for further studies, and we are eager to expand the clinical evidence base.' In June 2024, Endogenex closed an oversubscribed Series C financing round, securing $88m to complete the ReCET clinical study. "Endogenex reports results on ReCET system for type 2 diabetes management" was originally created and published by Medical Device Network, a GlobalData owned brand.
Reuters
07-05-2025
- Health
- Reuters
Health Rounds: Procedure that delivers electric pulses to intestine improves type 2 diabetes
May 7 (Reuters) - (To receive the full newsletter in your inbox for free sign up here) High-voltage electrical pulses to the upper region of the small intestine in a minimally invasive procedure can significantly improve type 2 diabetes, researchers reported at the Digestive Disease Week, opens new tab meeting. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The magnitude of improvement is comparable to the diabetes benefits seen with gastric bypass weight loss surgery, particularly in patients who receive the highest-dose electrical pulses, the researchers said. 'This first-of-its-kind study demonstrates that non-thermal pulsed electric field energy treatment of the duodenum can significantly and durably improve... insulin resistance and beta cell function,' the main body processes involved in type 2 diabetes, Dr. Richard Pratley of the AdventHealth Diabetes Institute in Orlando, Florida, who worked on the study, said in a statement. As nutrients move from the stomach into the small intestine, the cells of the duodenum play a crucial role in glucose regulation. Typically in type 2 diabetes, the duodenum is inflamed and dysfunctional. Delivery of the electric pulses triggers the body to regenerate healthy cells that can help control blood sugar levels. The 51 mostly overweight or obese patients with type 2 diabetes who participated in the trial of the Endogenex Pulsed Electric Field System known as ReCET, showed significant improvements in insulin sensitivity and pancreas beta cell function at 12 weeks, with improvements persisting at 48 weeks, the researchers reported. Patients also had significant improvements in blood sugar control and body weight. The researchers are now testing the procedure in a pivotal trial in overweight individuals with type 2 diabetes inadequately controlled by non-insulin glucose-lowering medications. While the current studies are looking at blood sugar control and weight loss, study leader Dr. Barham Abu Dayyeh of Cedars-Sinai in Los Angeles said the treatment is likely to also work for type 2 diabetes in patients who are not overweight. 'We believe any patient who has type 2 diabetes, is struggling to maintain control of their disease, and is progressing toward (needing multiple diabetes medications) or insulin will be target candidates,' he said. PROCEDURE FOR PREVENTING PANCREATITIS DOESN'T WORK A common surgery done to prevent pancreatitis does not actually work, a new study has found. About one in 10 people are born with a condition called pancreas divisum, in which pancreas ducts fail to fuse properly. While often asymptomatic, it can sometimes be a factor in recurrent pancreatitis, a serious and painful condition. Retrospective studies have suggested that a minimally invasive surgery called endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) eases acute pancreatitis in 50% to 70% of such patients. However, ERCP itself can cause acute pancreatitis in 10%-20% of patients and may instigate other issues later, such as scarring of the pancreas opening, which may lead to other symptoms, study leader Dr. Gregory Cote of Oregon Health & Science University said in a statement. Despite the known risks of the procedure, until now there have been no trials comparing miES to a sham procedure. At the Digestive Disease Week meeting, his team reported on 148 patients with pancreas divisum and an average of three previous episodes of pancreatitis who were randomly assigned to undergo miES or a sham procedure. During a median follow-up of 33.5 months, there was no statistically significant difference in the number of patients who had another bout of acute pancreatitis. There were also no differences in numbers of patients who reported pancreas-related pain more than a month after the procedure or who developed chronic pancreatitis, diabetes, or inadequate production of digestive enzymes by the pancreas. The findings are 'actually quite extraordinary when you consider that many doctors have advocated for this procedure for decades,' Cote said. 'Guidelines currently recommend/acknowledge pancreas divisum as a risk factor for pancreatitis, and suggest ERCP as a treatment. These guidelines are likely to change based on this study,' he said. He added that some patients with conditions such as a narrowing or blockages of the pancreatic duct might still benefit from ERCP. Patients with those conditions were not included in this study. VASECTOMY RARELY FAILS, BUT SEMEN ANALYSIS SHOULD BE PERFORMED Vasectomy failure is very rare but happens more often than previously believed, researchers reported at the American Urology Association annual meeting, opens new tab in Las Vegas. They said a post-vasectomy semen analysis to ensure that sperm is not present should become routine. Reviewing nearly half a million vasectomies performed between 2007 and 2021, they found a post-vasectomy pregnancy rate of 2.26 for every 1,000 patients observed for one year after the procedure. Historically, the pregnancy rate had been roughly 1 in every 2,000 patients observed for a year. Vasectomy failure rates were highest during the first four months after the procedure, at 4.7 pregnancies per 1,000 per year. Pregnancy rates were lower in patients with older partners and when procedures had been performed more recently. After taking patients' risk factors into account, the researchers saw an increased risk of failure when the doctor performing the vasectomy was not a urologist, when the procedure was done in a doctor's office, or when a semen analysis was not performed after the procedure. (This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays)
