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
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
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...
As popularity of the smart home is growing and continues to go mainstream, technological factors play a greater role. The IoT protocol houses the interoperability battery consumption, security, and configuration of a smart home device, and it can be difficult for companies to choose the right kind for their product. For both DIY and professionally installed smart homes, developers need to consider each of these elements for their product to be successful in the market and current smart homes.
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
Join IBM November 1 at 21st Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Cognitive analysis impacts today’s systems with unparalleled ability that were previously available only to manned, back-end operations. Thanks to cloud processing, IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Imagine a robot vacuum that becomes your personal assistant th...
Containers are rapidly finding their way into enterprise data centers, but change is difficult. How do enterprises transform their architecture with technologies like containers without losing the reliable components of their current solutions? In his session at @DevOpsSummit at 21st Cloud Expo, Tony Campbell, Director, Educational Services at CoreOS, will explore the challenges organizations are facing today as they move to containers and go over how Kubernetes applications can deploy with lega...
SYS-CON Events announced today that Avere Systems, a leading provider of hybrid cloud enablement solutions, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Avere Systems was created by file systems experts determined to reinvent storage by changing the way enterprises thought about and bought storage resources. With decades of experience behind the company’s founders, Avere got its ...
Though cloud is the future of enterprise computing, a smooth transition of legacy applications and systems is critical for seamless business operations. IT professionals are eager to start leveraging the cost, scale and other benefits of cloud, but with massive investments already in place in existing infrastructure and a number of compliance and resource hurdles, it can be challenging to move to a cloud-based infrastructure.
Microsoft Azure Container Services can be used for container deployment in a variety of ways including support for Orchestrators like Kubernetes, Docker Swarm and Mesos. However, the abstraction for app development that support application self-healing, scaling and so on may not be at the right level. Helm and Draft makes this a lot easier. In this primarily demo-driven session at @DevOpsSummit at 21st Cloud Expo, Raghavan "Rags" Srinivas, a Cloud Solutions Architect/Evangelist at Microsoft, wi...
SYS-CON Events announced today that Golden Gate University will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Since 1901, non-profit Golden Gate University (GGU) has been helping adults achieve their professional goals by providing high quality, practice-based undergraduate and graduate educational programs in law, taxation, business and related professions. Many of its courses are taug...
Today most companies are adopting or evaluating container technology - Docker in particular - to speed up application deployment, drive down cost, ease management and make application delivery more flexible overall. As with most new architectures, this dream takes significant work to become a reality. Even when you do get your application componentized enough and packaged properly, there are still challenges for DevOps teams to making the shift to continuous delivery and achieving that reducti...
SYS-CON Events announced today that SIGMA Corporation will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. uLaser flow inspection device from the Japanese top share to Global Standard! Then, make the best use of data to flip to next page. For more information, visit http://www.sigma-k.co.jp/en/.
As you move to the cloud, your network should be efficient, secure, and easy to manage. An enterprise adopting a hybrid or public cloud needs systems and tools that provide: Agility: ability to deliver applications and services faster, even in complex hybrid environments Easier manageability: enable reliable connectivity with complete oversight as the data center network evolves Greater efficiency: eliminate wasted effort while reducing errors and optimize asset utilization Security: imple...
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, will discuss how by using...
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lead...