Tele: 561.316.3330
Breaking Medical Device News

Friday, October 15, 2021
HomeFUNDINGFractyl Raises $55 Million in Series E Financing

Fractyl Raises $55 Million in Series E Financing

To Advance Revita DMR for Type 2 Diabetes

Fractyl Laboratories Inc. (Fractyl), today announced a first close of $55 million in a Series E financing.

Fractyl reports financing was led by new investor Taiwania Capital Management Corporation and included returning investors Bessemer Venture Partners, General Catalyst, Domain Associates, Mithril Capital Management, Emergent Medical Partners, True Ventures, and GV. New investors, Catalio Capital Management, CDIB Venture Capital Corp., and YJ Capital, also participated in the round. Michael Huang, Managing Partner at Taiwania, will join Fractyl’s Board of Directors in conjunction with the financing.

The proceeds from the financing will be used to support the Revita T2Di pivotal clinical trial of Revita DMR (duodenal mucosal resurfacing) for the treatment of patients with type 2 diabetes (T2D). Revita T2Di aims to examine the effect of Fractyl’s Revita DMR treatment on glycemic control and insulin requirements. The primary endpoint of the study will be the percentage of patients who are able to achieve target glycemic control (HbA1c less than or equal to 7%) without the need for insulin at 24 weeks post-procedure, comparing Revita DMR to the sham arm. Secondary endpoints will assess the impact of Revita DMR on additional glycemic, hepatic, and cardiovascular endpoints.

“Type 2 diabetes and NAFLD/NASH are eroding our global health and are responsible for a large portion of global healthcare costs,” said Huang. “Fractyl has established through rigorous clinical studies that Revita, a breakthrough non-drug, non-surgical treatment, has the potential to significantly improve type 2 diabetes outcomes.”

“Fractyl’s founding mission was to find a better way to treat type 2 diabetes by addressing the root cause of disease that can reverse the disease process rather than manage its symptoms. We now have data from hundreds of patients with type 2 diabetes showing the durable benefits of a single Revita treatment,” said Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. “We welcome our new investors and the continued support of our returning investors, who recognize that we are at a pivotal moment in fundamentally redefining the treatment paradigm for metabolic diseases, including type 2 diabetes and NAFLD/NASH. We look forward to initiating our pivotal U.S. clinical trial later this year.”

The Revita DMR treatment harnesses breakthrough insights in intestinal biology and aims to reset key metabolic pathways, including insulin resistance, to reverse metabolic disease. This same-day, outpatient endoscopic procedure uses heat to resurface the lining of the upper intestine (duodenal mucosa) in a minimally invasive, outpatient procedure.

Data from clinical trials, involving close to 300 patients at more than 20 centers across three continents, has demonstrated that one Revita treatment can create long-lasting improvements in both T2D and fatty liver disease to help patients with type 2 diabetes avoid further medication escalation. Revita DMR has been shown to be safe and well-tolerated with no long-term adverse events in clinical studies to date.

In April 2016, the Revita DMR System received a CE mark in the European Union. In March 2020, the CE Mark label for Revita DMR was expanded from its original label for patients with poorly controlled type 2 diabetes on oral medications to include insulin withdrawal for patients with T2D, improvements in NAFLD/NASH in patients with T2D, and improvements in insulin sensitivity in patients with polycystic ovary syndrome (PCOS). In the United States, Revita is approved for investigational use only by the U.S. Food and Drug Administration. The Revita DMR System may be available for investigational use in other regions.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy