Endogenex has raised $50 million in venture capital financing to complete the development of its minimally invasive procedure for Type 2 diabetes and bring its tech to the FDA.
The fundraising comes shortly after the company delivered initial clinical study results showing its pulsed electric field system met its safety goals and led to metabolic improvements in HbA1c, fasting glucose levels and body weight.
Founded in partnership with the Mayo Clinic, Endogenex has been targeting the upper section of the small intestine, the duodenum, with a treatment that aims to reset inflamed and dysfunctional tissue linked to Type 2 diabetes and the gut’s ability to regulate blood sugar, appetite and digestion.
Its procedure delivers pulsed electric fields to the inner mucosal layers of the organ through an endoscopic electrode array, eliminating poorly functioning cells and stimulating regeneration without potentially damaging heat. The approach previously obtained a breakthrough designation from the FDA.
Earlier this month, the Minneapolis-based company announced the publication of 48-week results from proof-of-concept programs in the U.S. and Australia. More than 70 participants with poorly controlled Type 2 diabetes underwent the procedure, with a 100% technical success rate.
One group of 31 patients—who received a double application from a second-generation, higher-energy device—saw an average HbA1c reduction of 1.5 percentage points over 48 weeks, as well as weight losses of about 5.4 kilograms, amounting to about 5% to 6% of their body mass.
At the same time, glucose monitoring data showed their time in a healthy range increased from 55.8% to 82.1%. The trial results were published in the journal Diabetes, Obesity and Metabolism.
The injection of $50 million will help fund Endogenex’s pivotal trial, ReCET, which is now enrolling patients. The proceeds, led by new backer Arboretum Ventures, come as part of an extension to a 2024 series C round that had raised $88 million.
“This financing puts us in a strong position to complete our pivotal study and take the ReCET System through FDA approval,” Endogenex CEO Stacey Pugh said in a statement.
“Type 2 diabetes continues to take a heavy toll on patients, providers, and the healthcare system. Even with the best available therapies, including GLP-1 receptor agonists and SGLT2 inhibitors, the disease often continues to progress,” Pugh added. “We believe that is because an important part of the disease has gone untreated: the gut. By restoring the duodenum to a healthier state, we aim to help patients do more than manage their symptoms. We want to potentially alter their disease progression, and this funding moves us meaningfully closer to that goal.”
A separate company also chasing ways to reline the duodenum, Fractyl Health, previously showed its thermal Revita rejuvenation procedure could deliver durable HbA1c benefits out to two years.
However, Fractyl would later pivot away from pursuing an indication in Type 2 diabetes, and, after layoffs, instead directed its research toward obesity and a procedure for maintaining weight loss in people taking GLP-1 drugs.
