Revita - Duodenal Mucosal Resurfacing System (DMR)
Our lead product candidate, the Revita DMR System, or Revita®, is a first-in-class procedural therapy designed to target the duodenum as a root cause of type 2 diabetes. For people with advanced type 2 diabetes, the main form of therapy to control HbA1c today is insulin dose escalation and lifestyle interventions. We have developed and are investigating Revita DMR with the goal of providing an important treatment alternative to people living with type 2 diabetes whose blood sugar levels remain uncontrolled despite being on insulin therapy.
Product Details
We’re developing a unique portfolio of approaches to address the organ level root causes of type 2 diabetes
Fractyl Health’s groundbreaking research and biological insights have led to a new understanding of the origins of type 2 diabetes. Based on these discoveries, we are advancing new approaches to the treatment of type 2 diabetes and other metabolic diseases that are designed to be disease-modifying and broadly accessible, to have the greatest possible impact on improving the lives of patients and society.
Revita DMR is being developed as a minimally invasive, outpatient, endoscopic procedural therapy. It is designed to be performed approximately one hour in an outpatient endoscopy setting, offering a potential non-surgical alternative for the treatment of type 2 diabetes.
Revita DMR has been developed on the basis of research conducted by Fractyl Health and others that has shown that an area of the intestine called the duodenum plays a key role in the development of insulin resistance. Diets high in fat and sugar cause thickening of the duodenal lining over time. The Revita DMR procedure uses SureLiftTM technology, which delivers fluid to expand the duodenal tissue, and targeted thermal energy to remove the excess layers of the duodenal lining. After treatment, the duodenum begins to regenerate a new lining within a matter of days.
THE REVITA DMR® SYSTEMThe Revita DMR system consists of a specially designed control console and a novel single-use balloon catheter. The console is used to monitor the procedure, while the physician uses the catheter to apply heat to the duodenum via the balloon.Revita’s purpose-built hardware and software automate key elements of the treatment, enhancing the procedure’s reproducibility.
To date, we have conducted clinical testing of Revita outside of the United States in close to 300 patients with a variety of metabolic disorders and varying degrees of insulin resistance, including type 2 diabetes, nonalcoholic steatohepatitis (NASH), and polycystic ovarian syndrome (PCOS).
Fractyl Health is currently developing Rejuva, a novel pancreatic gene therapy platform, to enable long-term remission of T2D.
Our novel Rejuva gene therapy platform is designed to restore insulin production capacity in the pancreas via endoscopic, locally delivered adeno-associated virus, or AAV, mediated gene therapy of key metabolic hormones necessary for proper insulin production in the beta cells of the pancreas.
We anticipate nominating our first gene therapy candidate under our Rejuva program in 2023.
Focus
Fractyl Health is developing treatments to regulate the body’s metabolic controller, the duodenum
Metabolic disease is a multi-organ pathology caused by insulin resistance which affects an estimated 1 billion people worldwide. Despite this high prevalence, the disease remains inadequately treated, with polypharmacy approaches managing the symptoms and co-morbidities of the disease — such as hypertension, atherosclerosis, and high blood sugar — rather than addressing its underlying cause.
Recently, a new scientific understanding of metabolic disease has emerged that points to the central role of the small intestine. Fractyl Health’s pioneering research has revealed a mechanism by which to control this metabolic controller. Our therapeutic focus is on developing treatments that act on the duodenum to control metabolism broadly.
The duodenum is the first section of the small intestine. It’s the first point in the intestine where nutrient absorption and hormonal signaling begins, immediately after food passes through the stomach. The lining of the intestine is the body’s largest endocrine organ, continuously sensing for the presence and type of ingested food in the gut and sending neurohormonal signals to the brain and the rest of the body.
In healthy diets, nutrients are absorbed throughout the length of the intestine. Unhealthy diets, such as those high in fats and sugars, are more easily digested, frontloading more of the nutrient absorption to the duodenum.
Role of the Duodenum in Type 2 Diabetes
The duodenum serves as a key regulator of metabolism by sending neurohormonal signals to the organs that regulate blood sugar and body weight.
Research conducted both by Fractyl Health and multiple independent scientific groups around the world has uncovered an important mechanism linking unhealthy diets to pathological changes in the duodenum and the development of metabolic diseases, including type 2 diabetes. When diets high in fats and sugars cause excessive nutrient absorption in the duodenum, the duodenum adapts by thickening its lining. A thickened lining causes the duodenum to absorb even more nutrients and inappropriately produce more signaling hormones, creating a cascade of events that lead to insulin resistance and weight gain.
Conversely, interventions on the duodenum may be able to reverse type 2 diabetes — an outcome which has already been clearly established thanks to research into the effects of bariatric surgeries. Certain bariatric surgeries that bypass the duodenum led to immediate improvements in insulin resistance and blood sugar levels even before patients lose any weight. However, if nutrition is delivered to the duodenum again, the insulin resistance and high blood sugar return.
Erase T2D
Led by world renowned experts in metabolic disease, the EraseT2D task force shares Fractyl Health’s mission to build evidence, understand, and ultimately eradicate metabolic disease.
The Erase T2D task force builds on over a decade of discovery uncovering the central role of the gut in metabolic disease and its capacity to signal other parts of the body. With so many questions still unanswered – the task force is charged to advance research by consolidating existing scholarship and catalyzing future discoveries.
This Fractyl Health funded initiative is designed to spur the kind of innovative thinking and fundamental breakthroughs that will point the way toward a future without type 2 diabetes.
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