Endogenex™ Secures $88M Series C Funding for ReCET™ System Trial in Type 2 Diabetes

Endogenex, a clinical-stage medical device company based in Minneapolis and committed to enhancing outcomes for individuals with type 2 diabetes, has announced the successful closure of an oversubscribed Series C financing round amounting to $88 million. This significant influx of capital will be directed towards completing the pivotal ReCET Clinical Study, an initiative approved under an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA).

The Series C funding saw the participation of new investors such as Hatteras Venture Partners, Lumira Ventures, and Orlando Health Ventures, alongside a strategic lead investor whose identity remains undisclosed. Existing investors, including Intuitive Ventures, Longitude Capital, Mayo Clinic, and Santé Ventures, also took part in this funding round.

Stacey Pugh, CEO of Endogenex, expressed enthusiasm about this development, highlighting the vital role the funding will play in advancing their mission to transform diabetes care. According to Pugh, the funding will facilitate the completion of the pivotal clinical study, which is a crucial step towards providing a groundbreaking solution for patients with type 2 diabetes. She emphasized the evolving therapeutic landscape in diabetes, particularly with the early use of SGLT2 inhibitors and GLP-1 receptor agonists, while noting the ongoing unmet need to address the underlying disease mechanisms and progression.

Juliet Tammenoms Bakker, Endogenex Board Chair and Managing Director at Longitude Capital, also remarked on the company's progress and the successful funding round. She noted that this milestone reflects the confidence of the investors in Endogenex’s vision and its potential impact on the global type 2 diabetes epidemic.

The ReCET Clinical Study is a pivotal, multicenter, prospective, randomized, double-blinded, sham-controlled study designed to evaluate the safety and effectiveness of the ReCET System. The study, which received IDE approval in November 2023, aims to enroll up to 350 patients across clinical sites in the United States and Australia.

The ReCET procedure represents a novel, endoscopic outpatient approach targeting cellular pathology in the duodenum, which may contribute to the onset and progression of type 2 diabetes. The system employs highly controlled, non-thermal pulsed electric fields to the mucosal and sub-mucosal duodenal tissue to trigger the body's natural regenerative processes. This method aims to restore proper cellular signaling from the duodenum, potentially improving metabolic functions and enhancing blood glucose control.

Feasibility clinical studies, such as REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands, have already evaluated the ReCET System. These studies focused on assessing the safety and efficacy of the treatment in adults with type 2 diabetes whose blood glucose levels were poorly controlled despite the use of insulin and non-insulin medications. Preliminary results from these studies have been shared at medical conferences worldwide.

The ReCET System has also been designated as a Breakthrough Device by the FDA, recognizing its potential to treat adults with type 2 diabetes inadequately managed by existing glucose-lowering medications.

Founded in collaboration with Mayo Clinic, Endogenex aims to revolutionize treatment options for individuals with type 2 diabetes by resetting the body's metabolic signaling system. By leveraging the body's natural regenerative capabilities through the development of the ReCET System and the innovative use of precise, controlled, non-thermal pulsed electric fields, Endogenex seeks to inaugurate a new era in type 2 diabetes therapy, helping patients achieve better blood glucose control and slow the progression of the disease.