|By PR Newswire||
|September 4, 2014 07:00 AM EDT||
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.
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
Lazar Partners Ltd.
Mithril Media Contact
Sard Verbinnen & Co.
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.
The Workspace-as-a-Service (WaaS) market will grow to $6.4B by 2018. In his session at 16th Cloud Expo, Seth Bostock, CEO of IndependenceIT, will begin by walking the audience through the evolution of Workspace as-a-Service, where it is now vs. where it going. To look beyond the desktop we must understand exactly what WaaS is, who the users are, and where it is going in the future. IT departments, ISVs and service providers must look to workflow and automation capabilities to adapt to growing ...
Mar. 4, 2015 04:00 AM EST Reads: 1,064
Docker is becoming very popular--we are seeing every major private and public cloud vendor racing to adopt it. It promises portability and interoperability, and is quickly becoming the currency of the Cloud. In his session at DevOps Summit, Bart Copeland, CEO of ActiveState, discussed why Docker is so important to the future of the cloud, but will also take a step back and show that Docker is actually only one piece of the puzzle. Copeland will outline the bigger picture of where Docker fits a...
Mar. 4, 2015 04:00 AM EST Reads: 3,098
Sensor-enabled things are becoming more commonplace, precursors to a larger and more complex framework that most consider the ultimate promise of the IoT: things connecting, interacting, sharing, storing, and over time perhaps learning and predicting based on habits, behaviors, location, preferences, purchases and more. In his session at @ThingsExpo, Tom Wesselman, Director of Communications Ecosystem Architecture at Plantronics, will examine the still nascent IoT as it is coalescing, includin...
Mar. 4, 2015 03:30 AM EST Reads: 2,706
The Internet of Things (IoT) promises to evolve the way the world does business; however, understanding how to apply it to your company can be a mystery. Most people struggle with understanding the potential business uses or tend to get caught up in the technology, resulting in solutions that fail to meet even minimum business goals. In his session at @ThingsExpo, Jesse Shiah, CEO / President / Co-Founder of AgilePoint Inc., showed what is needed to leverage the IoT to transform your business. ...
Mar. 4, 2015 02:45 AM EST Reads: 3,809
Hadoop as a Service (as offered by handful of niche vendors now) is a cloud computing solution that makes medium and large-scale data processing accessible, easy, fast and inexpensive. In his session at Big Data Expo, Kumar Ramamurthy, Vice President and Chief Technologist, EIM & Big Data, at Virtusa, will discuss how this is achieved by eliminating the operational challenges of running Hadoop, so one can focus on business growth. The fragmented Hadoop distribution world and various PaaS soluti...
Mar. 4, 2015 02:30 AM EST Reads: 1,154
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impac...
Mar. 4, 2015 02:00 AM EST Reads: 3,124
Advanced Persistent Threats (APTs) are increasing at an unprecedented rate. The threat landscape of today is drastically different than just a few years ago. Attacks are much more organized and sophisticated. They are harder to detect and even harder to anticipate. In the foreseeable future it's going to get a whole lot harder. Everything you know today will change. Keeping up with this changing landscape is already a daunting task. Your organization needs to use the latest tools, methods and ex...
Mar. 4, 2015 01:30 AM EST Reads: 3,512
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
Mar. 4, 2015 01:00 AM EST Reads: 4,384
Disruptive macro trends in technology are impacting and dramatically changing the "art of the possible" relative to supply chain management practices through the innovative use of IoT, cloud, machine learning and Big Data to enable connected ecosystems of engagement. Enterprise informatics can now move beyond point solutions that merely monitor the past and implement integrated enterprise fabrics that enable end-to-end supply chain visibility to improve customer service delivery and optimize sup...
Mar. 4, 2015 12:30 AM EST Reads: 3,533
Wearable devices have come of age. The primary applications of wearables so far have been "the Quantified Self" or the tracking of one's fitness and health status. We propose the evolution of wearables into social and emotional communication devices. Our BE(tm) sensor uses light to visualize the skin conductance response. Our sensors are very inexpensive and can be massively distributed to audiences or groups of any size, in order to gauge reactions to performances, video, or any kind of present...
Mar. 4, 2015 12:00 AM EST Reads: 3,086
Even as cloud and managed services grow increasingly central to business strategy and performance, challenges remain. The biggest sticking point for companies seeking to capitalize on the cloud is data security. Keeping data safe is an issue in any computing environment, and it has been a focus since the earliest days of the cloud revolution. Understandably so: a lot can go wrong when you allow valuable information to live outside the firewall. Recent revelations about government snooping, along...
Mar. 3, 2015 11:15 PM EST Reads: 742
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures...
Mar. 3, 2015 09:15 PM EST Reads: 861
Business and IT leaders today need better application delivery capabilities to support critical new innovation. But how often do you hear objections to improving application delivery like, “I can harden it against attack, but not on this timeline”; “I can make it better, but it will cost more”; “I can deliver faster, but not with these specs”; or “I can stay strong on cost control, but quality will suffer”? In the new application economy, these tradeoffs are no longer acceptable. Customers will ...
Mar. 3, 2015 07:30 PM EST Reads: 946
Red Hat has launched the Red Hat Cloud Innovation Practice, a new global team of experts that will assist companies with more quickly on-ramping to the cloud. They will do this by providing solutions and services such as validated designs with reference architectures and agile methodology consulting, training, and support. The Red Hat Cloud Innovation Practice is born out of the integration of technology and engineering expertise gained through the company’s 2014 acquisitions of leading Ceph s...
Mar. 3, 2015 06:30 PM EST Reads: 707
The free version of KEMP Technologies' LoadMaster™ application load balancer is now available for unlimited use, making it easy for IT developers and open source technology users to benefit from all the features of a full commercial-grade product at no cost. It can be downloaded at FreeLoadBalancer.com. Load balancing, security and traffic optimization are all key enablers for application performance and functionality. Without these, application services will not perform as expected or have the...
Mar. 3, 2015 05:30 PM EST Reads: 621