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Lopez-Talavera is Fractyl’s chief physician. Rajagopalan is the co-founder and CEO of Fractyl.
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According to an industry press release, the FDA named the breakthrough devices a premier duodenal mucosal renewal intervention in adults with insulin-treated type 2 diabetes.
The Duodenal Mucosal Renewal Intervention (Revita DMR, Fractyl Laboratories) is an outpatient endoscopic therapy that uses heat to rebuild the lining of the upper intestine. Fractyl’s preliminary clinical results suggest that treatment with Revita DMR may decrease insulin resistance, improve glucose response, decrease body weight, and reduce liver fat.
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“We are excited to be working closely with the FDA to accelerate the adoption of a potentially significant therapy for patients with type 2 diabetes who continue to grapple with the stress and risk of their disease.” Harith Rajagopalan, MD, PhD, Co-founder and CEO of Fractyl said in the press release. “The pioneering designation offers FDA recognition of the potential value Revita DMR can bring to patients and an opportunity for accelerated access for patients in need of better treatment options.”
As Healio previously reported, data from the INSPIRE study presented at United European Gastroenterology (UEG) Week Virtual in October showed that more than half of patients who had duodenal resurfacing performed at 6 months and Remained insulin-free for 1 year and showed improved metabolic parameters. The INSPIRE study presented was a single-arm, single-center, open-label study in which surface resurfacing of the duodenal mucosa was performed in 16 patients. All participants had type 2 diabetes, which was treated with long-acting insulin, an HbA1c of 64 mmol / mol or less, and C-peptides of 0.5 nmol / l or less. Despite eliminating insulin, the researchers showed that glycemic parameters improved for the participants, with HbA1c falling from an average of 7.4% to 6.6% after 6 and 12 months.
Data from a feasibility study published in Gastrointestinal Endoscopy in February and reported by Healio similarly showed that the addition of liraglutide (Victoza, Novo Nordisk) and lifestyle advice for duodenal mucosal renewal reduced the need for insulin therapy in most patients Eliminated type 2 diabetes over a period of 18 months.
The FDA’s pioneering device program is designed to provide timely access to medical devices by accelerating their development, evaluation, and review while maintaining regulatory standards for regulatory approval, 510 (k) approval, and de novo marketing authorization . The Revita DMR currently has a CE mark from the European Union.
Fractyl is now enrolling patients in the REVITA-T2Di study, which will form the basis for pre-filing with the FDA in adults with insulin-treated type 2 diabetes. The study is a prospective, randomized, double-blind, sham-controlled study involving 300 participants in up to 35 locations worldwide.
Fractyl also announced that CMS has approved routine medical expenses coverage for Medicare patients in the REVITA-T2Di study. All eligible participants receive study-related health assessments free of charge. This CMS decision enables reimbursement of certain study costs to clinical research centers.
“We know that treatment alternatives to current drug therapy are urgently needed to combat the type 2 diabetes epidemic.” Juan Carlos Lopez-Talavera, MD, PhD, Fractyl’s chief medical officer said in the release. “Providing therapy that could improve glucose to the target range while reducing the need for injectable insulin would be a quantum leap forward for patients. Fractyl is committed to advancing Revita DMR through the clinical and regulatory process to make a potentially meaningful difference in the lives of patients affected by this serious chronic disease. “
Further information on the REVITA T2Di study and eligibility to participate can be found at www.revitastudy.com.
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