Innovative Procedure for Type 2 Diabetes

At Fractyl, we are focused on improving the health of people with Type 2 diabetes. We’ve created an innovative clinical procedure based on new insights into the root cause of the disease. We are currently engaged in clinical trials designed to prove that our innovative procedure can dramatically improve glucose control and reduce the need for additional medications. Our mission is to set people free from the daily burdens of Type 2 diabetes management, empower physicians with a safe and reliable therapeutic treatment, and lower the tremendous human and financial costs of diabetic complications for patients, hospitals, and payers.

Type 2 Diabetes: Progressive and Not Easily Controlled

About Diabetes: Type 2 diabetes is a metabolic disorder involving the hormones that regulate blood sugar, leading to blood sugar levels that are higher than normal. It affects over 350 million people worldwide, and it is a progressive condition that worsens over time. The first stage of managing diabetes is through diet and exercise. Most people eventually require drugs, and potentially even insulin, to lower their blood sugar. While medications may lower blood glucose levels for a time, they do not fundamentally curb the progression of the disease. Because insulin therapy requires regular injections, and has side effects like hypoglycemia and weight gain, many people are overwhelmed by the prospect of insulin treatment.

Consequences of Poor Diabetic Control: Despite significant effort and numerous drug options, nearly half of the diabetic population in the U.S. and Europe will become poorly controlled. Poor control leads to chronically high blood sugar levels which can result in damage to the kidneys, eyes, nerves, and large blood vessels. In 2012, these complications associated with high blood sugar levels in patients with Type 2 diabetes cost the U.S. healthcare system $246 billion, a 41% increase over the prior five-year period.1 These costs are expected to rise dramatically as the population ages and more people develop the disease.

1American Diabetes Association. The Economic Costs of Diabetes in the U.S. in 2012. Diabetes Care. 2013.

Intestinal Hormone Changes Drive Type 2 Diabetes

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Hormonal Changes Precede Type 2 Diabetes: Insulin is normally produced by the pancreas to control blood sugar levels. In Type 2 diabetes, people become insulin resistant, meaning that the body can no longer properly use the insulin it produces. Insulin resistance often develops years before high blood sugar levels are detected. New scientific discoveries show that the intestine produces hormones that regulate insulin production and glucose control, and that a Western diet can cause significant changes in the intestine over time. These changes lead to hormonal imbalances that cause the body to become insulin resistant and intolerant to glucose. Insulin resistance and impaired glucose tolerance eventually lead to dysfunction of the insulin-producing pancreatic beta cells. Current medical therapies focus on lowering blood sugar but do not address the intestinal changes that trigger the development of Type 2 diabetes.

Endoscopic Procedure for Glycemic Control

New physiologic lessons highlight the role of intestine hormones in contributing to insulin resistance. We have developed a device-based procedure that directly addresses this intestinal hormonal impairment. Duodenal Mucosal Resurfacing™ (DMR) is a non-invasive therapeutic procedure intended to safely remodel the duodenal mucosa with thermal ablation. The Revita™ DMR System is designed to alter the body’s ability to process sugar and dramatically improve glycemic control for patients with Type 2 diabetes. The Revita™ DMR System is currently under clinical investigation and not yet commercially available.


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