Endogenex has raised $50m in funding, setting the company up with sufficient funds to complete a pivotal trial of its type 2 diabetes (T2D) treatment and support a regulatory filing for the endoscopic system with the US Food and Drug Administration (FDA).
The Series C extension financing round was helmed by new lead investor Arboretum Ventures. Existing investors also participated, building on Endogenex’s previous $88m Series C fundraise, to a total $138m. Since its founding in 2002, the company has raised a total of $1bn capital from equity and venture financing.
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The Minnesota-based company’s ReCET system is an endoscopic catheter that uses non-thermal pulsed electric fields to treat inflamed tissue and encourage cell regeneration in the duodenum. By targeting the duodenum tissue’s mucosa and submucosa, ReCET is intended to restore proper metabolic signalling from the gut to improve metabolic function, insulin resistance, and blood sugar control in T2D patients.
An evolving body of evidence suggests that inflammation of the duodenum, the first part of the small intestine immediately beyond the stomach, disrupts the gut’s ability to sense and communicate with the organs that regulate blood sugar, appetite, digestion, and metabolism. This research indicates that inflammation of the duodenum may be responsible for worsening or contributing to the root cause of T2D.
Endogenex’s latest funding tranche will support the completion of its ReCet trial (NCT06267391). The study, which obtained an investigational device exemption (IDE) from the FDA in 2024, is evaluating the safety and effectiveness of endoscopic intestinal re-cellularisation therapy in T2D patients who are inadequately controlled on non-insulin glucose-lowering medications.
Endogenex’s CEO, Stacey Pugh, noted that even with the application of therapies such as SGLT2 inhibitors, which treat T2D by forcing the kidneys to remove excess glucose through urine, the disease often continues to progress.
Pugh said: “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.”
On the pharma side, the efficacy of GIP, glucagon-like peptide 1 receptor (GLP-1R) and glucagon triple hormone receptor agonists are being assessed to reduce T2D patients’ average blood sugar levels (A1C). Flagship drugs include Eli Lilly’s Mounjaro (tirzepatide) and Novo Nordisk’s Ozempic (semaglutide).
In a recent data readout from the Phase III TRANSCEND-T2D-1 study (NCT06297603), Eli Lilly’s triple hormone receptor agonist, retatrutide, led to an A1C reduction of between 1.7% and 2.0% after 40 weeks in patients with T2D with inadequate glycaemic control with diet and exercise alone, versus 0.8% with a placebo.
