Endogenex
Overview
Endogenex is a clinical-stage medical device company that focuses on developing innovative therapies to treat Type 2 diabetes. Founded in 2017 in partnership with the Mayo Clinic, Endogenex is headquartered in Minneapolis, Minnesota. The company specializes in endoscopic procedures, particularly its novel ReCET System, which utilizes pulsed electric fields to regenerate the duodenal mucosa to improve glycemic control in diabetes patients. The company has secured substantial investment, including a recent Series C funding round, which raised $88 million in June 2024. Endogenex was founded by Michael Brenzel.
Recent Developments
- June 2024: Endogenex announced the closing of an $88 million Series C funding round. This financing was led by new and existing investors, including Hatteras Venture Partners, Lumira Ventures, and Orlando Health Ventures, and was aimed at completing the pivotal clinical study of the ReCET System.
- January 2024: The company received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to commence a clinical study of its ReCET System. This milestone allows Endogenex to begin assessing the safety and efficacy of its innovative treatment in a prospective, randomized, double-blinded, sham-controlled study across multiple sites in the United States and Australia.
- Stacey Pugh Appointment: Former Medtronic executive Stacey Pugh was appointed as CEO of Endogenex in March 2023, bringing extensive experience in medical device innovation to the leadership team.
- IDE Approval: The FDA granted an IDE for the ReCET Clinical Study, enabling the evaluation of this endoscopic procedure designed to treat duodenal tissue pathology responsible for Type 2 diabetes progression.
Company Information
| Attribute | Information |
|---|---|
| Founding Date | 2017 |
| Headquarters | Minneapolis, Minnesota, USA |
| Founders | Michael Brenzel |
| Revenue | Not publicly disclosed |
| Profits | Not publicly disclosed |
| Key Investors | Hatteras Venture Partners, Lumira Ventures, Orlando Health Ventures, Mayo Clinic, Longitude Capital |
| Industry | Medical Devices, Diabetes Treatment |
| Number of Employees | 24 |
Early History
Endogenex was established in 2017 in collaboration with the Mayo Clinic to address unmet needs in Type 2 diabetes treatment. The company focused on developing a novel endoscopic procedure known as the ReCET System, designed to promote the regeneration of duodenal mucosa. Initial funding rounds began shortly after its founding, with early-stage investments facilitating extensive research and development. The founding team, led by Michael Brenzel, included members with substantial backgrounds in medical technology and diabetes care. This foundation enabled Endogenex to make significant strides in introducing advanced therapeutic options for patients inadequately served by existing diabetes treatments.
Company Profile and Achievements
Endogenex's business model is centered on harnessing its ReCET System to transform the landscape of Type 2 diabetes treatment. The company's ReCET System employs non-thermal pulsed electric fields to induce the regeneration of duodenal tissue, addressing the root causes of diabetes progression. This innovative approach has positioned Endogenex as a pioneering entity in metabolic therapy.
- Technology Milestones:
- Developed the ReCET System, which targets the duodenal pathology linked to Type 2 diabetes.
- Achieved FDA Breakthrough Device Designation, recognizing the treatment's potential for substantial improvement over existing diabetes management options.
- Funding and Financial Growth:
- Raised a total of $140 million across several funding rounds, including the noteworthy $88 million Series C in 2024.
- Attraction of distinguished investors like Mayo Clinic and Hatteras Venture Partners, underscoring confidence in the technology's market potential.
- Clinical Trials:
- Engaged in significant clinical studies, including REGENT-1 in the US and Australia, which were aimed at validating the system's efficacy and safety in real-world medical settings.
Current Operations and Market Position
Endogenex continues to focus on the development and eventual commercial deployment of its ReCET System. The company maintains a competitive edge through its unique approach to treating Type 2 diabetes by addressing cellular signaling disruptions at the root level. With its operations primarily in the U.S. and an expanding presence in Australia, Endogenex is poised to significantly impact diabetes treatment paradigms. The company’s strategic initiatives include expanding clinical trial sites and enhancing its research capabilities to streamline FDA approval processes.
Endogenex FDA
Endogenex's ReCET System has garnered significant attention following its FDA Investigational Device Exemption approval, indicating that it meets all necessary regulatory requirements to start clinical trials aimed at assessing safety and efficacy. This key regulatory milestone sets the stage for broader clinical adoption and eventual commercialization.
Endogenex Funding
The company’s financial journey encompasses several pivotal funding rounds accumulating to $140 million. These funds are integral to advancing the ReCET Clinical Study and positioning the company to bring its cutting-edge diabetes therapy closer to market. The support from high-profile investors highlights the potential impact of the ReCET technology in diabetes care.
Conclusion
Endogenex holds a promising position in the medical device industry, primarily through its innovative use of pulsed electric field technology to treat Type 2 diabetes. With significant funding secured and regulatory hurdles being systematically addressed, the company is well-positioned for future growth. If successful, the ReCET System could dramatically change the way diabetes is managed, addressing a pressing global health need. Given the ongoing advancements and strategic efforts, Endogenex is on track to make a profound impact on diabetes treatment and patient care.