Fractyl Health (formerly Fractyl Laboratories) has closed a US$100 million Series F financing to support multiple late-stage clinical studies of potential of Revita DMR to reduce insulin dependence in type 2 diabetes. Revita DMR is based on Fractyl’s groundbreaking insights surrounding the role of the gut in metabolic diseases. An outpatient endoscopic procedure, Revita DMR resurfaces the lining of the upper intestine (duodenal mucosa).
Revita DMR has been studied in clinical trials involving close to 300 patients. Revita DMR has received FDA Breakthrough Device Designation and a European Union CE mark. In the US, the device has not yet been authorized for marketing, but is the subject of an FDA-approved Investigational Device Exemption study. The Revita DMR System may be available for investigational use in other regions.
“We’re immensely proud of the leadership role Fractyl has established in creating innovative treatments to address the root cause of metabolic disease, with an initial focus on type 2 diabetes. The closing of this Series F financing, the significant experience of our new board members and our company’s renaming as Fractyl Health reflect the momentum we have built and the vast potential that lies ahead for our approach,” said Dr Harith Rajagopalan, co-founder and CEO of Fractyl. “By controlling the body’s central metabolic control organ, the duodenum, we believe we’ve discovered a novel way to treat metabolic disease at its source. This financing will enable the expansion and acceleration of our clinical development efforts with the goal of reducing insulin dependence for patients with type 2 diabetes on a global scale.”
Fractyl recently obtained FDA Breakthrough Device Designation for Revita DMR in patients with type 2 diabetes (T2D) who are currently treated with insulin. Proceeds from the financing will support initiation of multiple late-stage clinical studies to assess the potential for Revita DMR to treat and halt the progression of metabolic disease. These upcoming clinical studies, alongside the ongoing REVITA-T2Di clinical study, aim to establish Revita DMR as a cornerstone therapy in T2D, while eliminating burdensome, expensive, and outmoded therapies.
“Fractyl is developing technology that stands apart from the rest of the landscape in metabolic therapeutic innovation. Patients with diabetes - and our broader society - desperately need a therapy that offers disease modification as well as relief from the clinical, practical, and financial burden inherent in the current metabolic standard of care,” said Marc Elia, founder of M28 Capital. “Eliminating the need for insulin therapy from type 2 diabetes would be a landmark achievement for patients and society. I look forward to helping Fractyl as it works toward its mission.”
“Type 2 diabetes is one of the most urgent health problems of our time, but there has been a lack of investment in truly innovative approaches to take on the challenge of this population-level crisis,” said Dr Clive Meanwell, executive chairman and founder of Population Health Partners, vice chairman of BB Biotech, and previously founder and CEO of The Medicines Company. “Revita DMR is the first novel therapeutic approach in type 2 diabetes in many years to offer the promise of treating the root cause of the disease. We are enthusiastically committed to supporting Fractyl as it drives forward its development and commercial programmes to realise the full range of Revita’s potential in type 2 diabetes.”