Welcome!

News Feed Item

Fractyl Labs Announces Positive Clinical Data for First Procedural Therapy to Treat Type 2 Diabetes

Mithril Capital Management Leads $40M Series C Financing to Join Early Investors General Catalyst, Bessemer and Domain Associates

WALTHAM, Mass., Sept. 4, 2014 /PRNewswire/ -- Fractyl Laboratories Inc. today announced positive clinical data for the first procedural therapy to directly treat the underlying digestive causes of insulin resistance in patients with uncontrolled type 2 diabetes. The non-invasive Revita™ Duodenal Mucosal Resurfacing™ (DMR) procedure is designed to alter the inner surface of the duodenum and change how the body absorbs and processes sugar. The Revita DMR 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.

According to the results of a single-site pilot study performed in Santiago, Chile, the Revita DMR procedure led to a greater than two percentage-point drop in hemoglobin A1C levels (HbA1c, the key measure of blood glucose control) by three months after the procedure with an excellent safety record. The patients in the study who were followed for up to six months maintained their improved HbA1c levels. These clinical data were presented in late August at the 19th World Congress of International Federation for the Surgery of Obesity & Metabolic Disorders (IFSO 2014) meeting in Montreal, Canada.

Mithril Capital Management Leads Series C Financing Round

The company also announced that Mithril, a growth-stage investment firm with a global portfolio, led a new $40 million Series C funding round. Existing investors General Catalyst (Fractyl was hatched in the General Catalyst Cambridge, Mass. office), Bessemer Venture Partners, and Domain Associates joined the round which will be used to help support clinical evaluation of the procedure in the U.S. and Europe. Ajay Royan, Mithril's co-founder and managing general partner, has been named to the company's Board of Directors.   

"Fractyl represents a new breed of health innovator, combining a singular mission with a sophisticated product," Royan said. "The company has created an easy-to-use device on the unique insight that diabetes is a treatable, digestive disease. We believe Fractyl's Revita DMR procedure will be the first solution that can scale to meet the challenges of an epidemic of this magnitude, significantly improving the lives of the 400 million people suffering from type 2 diabetes worldwide. I look forward to working with the Fractyl team to realize the potential of this revolutionary therapy."

Royan will fill a newly-created seat on the Fractyl Board, joining Chairman Allan Will; Stan Lapidus, President, CEO and Founder of SynapDX, who was designated by General Catalyst; Chris Gabrieli, Partner at Bessemer Venture Partners; Nimesh Shah, Partner at Domain Associates; Harith Rajagopalan M.D., PhD, Fractyl CEO and Co-Founder; and Jay Caplan, Fractyl Co-Founder and President.

Diabetes as a Digestive Disease

In recent years, a significant number of clinical studies have shown an almost immediate improvement in glycemic control following bariatric surgery where the duodenum is either blocked or bypassed. The duodenum, the first portion of the intestine, is where absorption of nutrients begins and hormones that control blood sugar levels are produced.

"The gastrointestinal tract plays a critical role in the regulation of glucose metabolism," said Francesco Rubino, M.D., Professor and Chair of Bariatric and Metabolic Surgery at King's College London. "Chronic exposure to food-borne and environmental toxins could cause disruption to gastrointestinal physiology, possibly explaining the link between modern diets and type 2 diabetes. On the other hand, operations used in bariatric surgery, especially those that involve a bypass of the duodenum, are the only type of treatment known to cause complete and long-term remission of diabetes. This knowledge provides a compelling reason to consider the gut as a physiologic and rational target for the development of more effective therapies of type 2 diabetes." 

The company believes that the Revita DMR procedure could be a compelling option for millions of patients, particularly those who are failing oral therapy and are transitioning to complicated drug regimens that may include insulin. Many patients fear insulin injections for their inconvenience and substantial side effects, including pain, weight gain, and risk of hypoglycemia.

The Impact of Revita DMR on Glucose Control

Manoel Galvao Neto, M.D., a bariatric surgeon in Sao Paulo, Brazil, announced the results of the company's proof-of-principal study, demonstrating the safety and effectiveness of the Revita procedure, during an oral presentation at IFSO 2014 on August 29.

Under endoscopic management, Dr. Neto and his team performed thermal ablation of the duodenal mucosa with the Revita System on 30 patients with uncontrolled diabetes and HbA1c levels averaging 9.2 prior to treatment. In the 19 patients who received DMR over several centimeters of their duodenum, HbA1c levels dropped to 7.1, on average, after three months and remained stable six months after the procedure. The treatment effect appears to be dose-dependent, as those patients who received DMR over a shorter segment of their duodenum did not experience as significant of a benefit.

"While early, we believe these results validate our approach and indicate the significant impact that the Revita DMR procedure could have for patients afflicted with type 2 diabetes," said Dr. Rajagopalan, Fractyl CEO. "We are preparing to launch our multinational study by the end of the year and working towards our clinical development efforts in the U.S., which we expect to commence during 2016. We are committed to bringing to market an innovative clinical procedure to improve the health of patients with type 2 diabetes." 

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. In 2012, these complications associated with high blood sugar levels in patients with type 2 diabetes cost the U.S. healthcare system $245 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.

About Fractyl

New physiologic lessons highlight the role of intestine hormones in contributing to insulin resistance. Fractyl has developed a device-based endoscopic procedure to directly address this intestinal hormonal impairment using an outpatient therapy. Fractyl is currently engaged in clinical trials designed to demonstrate that its endoscopic 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. More information is available at www.fractyl.com or www.twitter.com/FractylLabs.

About Mithril Capital Management

Mithril is a global investment firm founded by Ajay Royan and Peter Thiel that provides capital to leading growth companies by partnering with teams who use technology to build transformative and durable businesses, often in industries long overdue for change. Each of these businesses is unique, but all face common challenges to unlocking long-term growth. Mithril helps navigate these critical inflection points by investing in size and with conviction. For more information, please visit: www.mithril.com or www.twitter.com/Ajayatmithril.

About General Catalyst Partners

General Catalyst Partners is a venture capital firm that makes early-stage and growth equity investments. The firm backs exceptional entrepreneurs who are building innovative technology companies that transform industries, including KAYAK, Demandware, Stripe, Airbnb, The Honest Company, Warby Parker, Datalogix, BigCommerce, Snapchat, HubSpot, DataGravity and Datto. The General Catalyst partnership leverages its broad experience to help founders build market-leading businesses. General Catalyst has offices in Cambridge, MA, Palo Alto, CA and New York City. For more information, visit: www.generalcatalyst.com or www.twitter.com/gcvp.

About Bessemer Venture Partners

Bessemer Venture Partners (BVP) invests in early-stage, hyper-growth startups, partnering closely with entrepreneurs to build durable businesses. BVP is a global firm with offices in Menlo Park, Cambridge, New York, Mumbai, Bangalore, Herzliya and Sao Paolo. With $4 billion under management, BVP invests anywhere from $100,000 to $75 million in innovative companies like LinkedIn, Yelp, Skype, CornerstoneOnDemand, Pinterest, Box and Twilio. Over 100 BVP companies have gone public -- last year alone BVP had 5 IPOs, 7 M&A exits, and 20 new investments. Learn more at bvp.com and www.twitter.com/BessemerVP.

About Domain Associates

Founded in 1985, Domain Associates, L.L.C. is a venture capital firm with an exclusive focus on investing in life science companies that advance human health. Domain's focused network, deep experience, and dependable reputation have made it one of the top private-equity groups participating in healthcare investing. With more than $2.7 billion in capital raised, Domain invests in three major segments: pharmaceuticals, diagnostics, and medical devices. The partners of Domain have a total of more than 270 person-years of experience among them in the healthcare and venture capital industries and have been involved in the formation and growth of more than 250 life sciences companies. Representative past investments include Amgen, Amylin Pharmaceuticals, Cerexa, Biosite, Dura Pharmaceuticals, Pharmion and Volcano. Domain has offices in Princeton, N.J. and San Diego.  For more information, please visit http://www.domainvc.com.

Fractyl Media Contact
Erich Sandoval
Lazar Partners Ltd.
[email protected] 
Tel: 917-497-2867

Mithril Media Contact
Lindsay Andrews
Sard Verbinnen & Co.   
Tel: 415-618-8750

1 American Diabetes Association. The Economic Costs of Diabetes in the U.S. in 2012. Diabetes Care. 2013. http://www.diabetes.org/advocacy/news-events/cost-of-diabetes.html

SOURCE Fractyl Laboratories Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...
The question before companies today is not whether to become intelligent, it’s a question of how and how fast. The key is to adopt and deploy an intelligent application strategy while simultaneously preparing to scale that intelligence. In her session at 21st Cloud Expo, Sangeeta Chakraborty, Chief Customer Officer at Ayasdi, provided a tactical framework to become a truly intelligent enterprise, including how to identify the right applications for AI, how to build a Center of Excellence to oper...
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...
"Cloud Academy is an enterprise training platform for the cloud, specifically public clouds. We offer guided learning experiences on AWS, Azure, Google Cloud and all the surrounding methodologies and technologies that you need to know and your teams need to know in order to leverage the full benefits of the cloud," explained Alex Brower, VP of Marketing at Cloud Academy, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clar...
"We work around really protecting the confidentiality of information, and by doing so we've developed implementations of encryption through a patented process that is known as superencipherment," explained Richard Blech, CEO of Secure Channels Inc., in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
It is of utmost importance for the future success of WebRTC to ensure that interoperability is operational between web browsers and any WebRTC-compliant client. To be guaranteed as operational and effective, interoperability must be tested extensively by establishing WebRTC data and media connections between different web browsers running on different devices and operating systems. In his session at WebRTC Summit at @ThingsExpo, Dr. Alex Gouaillard, CEO and Founder of CoSMo Software, presented ...
High-velocity engineering teams are applying not only continuous delivery processes, but also lessons in experimentation from established leaders like Amazon, Netflix, and Facebook. These companies have made experimentation a foundation for their release processes, allowing them to try out major feature releases and redesigns within smaller groups before making them broadly available. In his session at 21st Cloud Expo, Brian Lucas, Senior Staff Engineer at Optimizely, discussed how by using ne...
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
Coca-Cola’s Google powered digital signage system lays the groundwork for a more valuable connection between Coke and its customers. Digital signs pair software with high-resolution displays so that a message can be changed instantly based on what the operator wants to communicate or sell. In their Day 3 Keynote at 21st Cloud Expo, Greg Chambers, Global Group Director, Digital Innovation, Coca-Cola, and Vidya Nagarajan, a Senior Product Manager at Google, discussed how from store operations and ...
In his session at 21st Cloud Expo, Carl J. Levine, Senior Technical Evangelist for NS1, will objectively discuss how DNS is used to solve Digital Transformation challenges in large SaaS applications, CDNs, AdTech platforms, and other demanding use cases. Carl J. Levine is the Senior Technical Evangelist for NS1. A veteran of the Internet Infrastructure space, he has over a decade of experience with startups, networking protocols and Internet infrastructure, combined with the unique ability to it...
"Infoblox does DNS, DHCP and IP address management for not only enterprise networks but cloud networks as well. Customers are looking for a single platform that can extend not only in their private enterprise environment but private cloud, public cloud, tracking all the IP space and everything that is going on in that environment," explained Steve Salo, Principal Systems Engineer at Infoblox, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventio...
Data scientists must access high-performance computing resources across a wide-area network. To achieve cloud-based HPC visualization, researchers must transfer datasets and visualization results efficiently. HPC clusters now compute GPU-accelerated visualization in the cloud cluster. To efficiently display results remotely, a high-performance, low-latency protocol transfers the display from the cluster to a remote desktop. Further, tools to easily mount remote datasets and efficiently transfer...
In his session at 21st Cloud Expo, James Henry, Co-CEO/CTO of Calgary Scientific Inc., introduced you to the challenges, solutions and benefits of training AI systems to solve visual problems with an emphasis on improving AIs with continuous training in the field. He explored applications in several industries and discussed technologies that allow the deployment of advanced visualization solutions to the cloud.
Gemini is Yahoo’s native and search advertising platform. To ensure the quality of a complex distributed system that spans multiple products and components and across various desktop websites and mobile app and web experiences – both Yahoo owned and operated and third-party syndication (supply), with complex interaction with more than a billion users and numerous advertisers globally (demand) – it becomes imperative to automate a set of end-to-end tests 24x7 to detect bugs and regression. In th...