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REVITA-1 trial

Fractyl to initiate clinical trial of Revita DMR procedure

After the mucosal layer is separated, the ablation balloon catheter is delivered into the duodenum
The REVITA-1 trial will be conducted at up to ten sites in Europe and will begin enrolment in the coming week

Fractyl Laboratories has received approval to begin enrolment in a multi-centre 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. The REVITA-1 trial will be conducted at up to ten sites in Europe and will begin enrolment in the coming weeks.

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 procedure is an endoscopic procedure that thermal ablates the duodenal mucosa.  The company claims procedure has the potential to delay the need for insulin therapy and free patients from the burdens associated with managing type 2 diabetes, particularly when oral medications have failed.

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.

“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,” said Dr Harith Rajagopalan, 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 enrolment in the REVITA-1 trial. I congratulate the entire team for meeting this important company milestone.”

“Emergent has a long history of supporting healthcare companies with novel solutions to treat unmet clinical needs,” said Dr Thomas J Fogarty, 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.”

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