Fractyl Labs Announces Approval to Initiate Multicenter Clinical Trial of Revita DMR Procedure
Emergent Medical Partners Joins Existing Fractyl Investor Syndicate
WALTHAM, Mass. – January 12, 2015 – Fractyl Laboratories Inc. (Fractyl) today announced the Company has received approval to begin enrollment in a multicenter clinical trial designed to evaluate the safety and performance of the Revita™ Duodenal Mucosal Resurfacing™ (DMR) procedure, the first procedural therapy designed to directly treat the underlying digestive causes of insulin resistance in patients with uncontrolled type 2 diabetes.
Revita DMR is a minimally-invasive procedure designed to safely alter the inner surface of the duodenum and change how the body absorbs and processes sugar. The REVITA-1 trial will be conducted at up to 10 sites in Europe and will begin enrollment in the coming weeks.
The Company also announced that Emergent Medical Partners (Emergent), a life sciences investment firm focused on high-potential early stage companies, joined existing investors, including General Catalyst, Bessemer Venture Partners, Domain Associates and Mithril Capital.
“Emergent has a long history of supporting healthcare companies with novel solutions to treat unmet clinical needs,” commented Thomas J. Fogarty, MD, Managing Director of Emergent Medical Partners. “Using unique clinical insights, Fractyl has developed a truly innovative procedure to treat type 2 diabetes as a digestive disease. I look forward to supporting the growth of this revolutionary therapy and am excited about its long-term potential.”
“We are grateful for the support of Emergent, and our existing investors, as we continue to make steady progress advancing the science and clinical proof of our technology,” commented Harith Rajagopalan, MD, Ph.D., Co-Founder and CEO of Fractyl. “With the help of the world’s leaders in endoscopy and diabetes, we are committed to improving the health of people with type 2 diabetes using our therapy and are anxious to begin enrollment in the REVITA-1 trial. I congratulate the entire team for meeting this important company milestone.”
New physiologic lessons highlight the role of intestine hormones in contributing to insulin resistance. Fractyl has developed a device-based minimally invasive, implant-free procedure that directly addresses this intestinal hormonal impairment with an outpatient therapy. Fractyl is currently engaged in clinical trials designed to demonstrate that the Revita DMR procedure can dramatically improve glucose control and potentially reduce the need for additional medications. The Company’s mission is to set people free from the daily burdens of type 2 diabetes management, empower physicians with a safe and reliable therapeutic treatment option, and lower the tremendous human and financial costs of diabetic complications for patients, hospitals, and payers.
Lisa Davidson, Chief Financial Officer,
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