SAN CLEMENTE, Calif., Jan. 26, 2015 /PRNewswire/ -- USGI Medical®, Inc., a company pioneering incisionless procedures for weight loss, announced the closing of over $19.5 million in financing, bringing the total raised in the last year to $36 million in equity and debt.
This funding provides USGI with the capital resources to extend the commercial launch of POSE™ (Primary Obesity Surgery, Endolumenal) in Europe and the Middle East and begin pre-commercialization activities for the procedure in the U.S., as the company completes the follow-up phase of its U.S. pivotal study known as ESSENTIAL™, and prepares to submit an application to FDA for approval. This money will also fund the crossover study as part of the ESSENTIAL trial, health economics research and several important studies in Europe.
"This infusion of capital represents a very important milestone for USGI," said Scott Moonly, President and CEO, USGI Medical, Inc. "This positions us to expand further in Europe and the Middle East and launch our technology into new markets. In the U.S., we are actively working with the ESSENTIAL trial investigational sites to offer the POSE procedure to crossover patients who initially underwent a sham procedure as part of the protocol. We are collecting follow-up data from the study and preparing the documentation and information that will be needed for submission in a regulatory package to the Food and Drug Administration. We would like to thank our investors for their long-term support as we work to offer overweight patients struggling with diet and exercise and who don't want surgery, a non-invasive treatment option."
While the device remains investigational for weight loss in the U.S, POSE is now a widely used weight loss procedure outside of the U.S., where physicians have performed over 3,500 procedures. In clinical studies, patients lost up to 62% of their excess weight after a year, which equates to between 40 to 45 pounds lost, on average. For comparison, diet and exercise often yield five to 10 pounds of weight loss in a year, and weight loss drugs no more than 10 to 15 pounds.
"USGI Medical has developed a compelling solution that has the potential to address a significant unmet need in the growing, multibillion-dollar weight loss market. For every surgical patient in the U.S., there are 100 or more overweight or obese Americans on the sidelines today with no realistic option. The key to unlocking this market is an intervention that is a simple, outpatient procedure that offers a positive risk/cost/benefit proposition," said Guy Nohra, Chairman of the Board of USGI and Managing Director of Alta Partners. "We founded USGI in our offices and are excited to see the company entering this new phase of accelerated commercial penetration into the EMEA as they also prepare for a potential launch of this important and game-changing procedure in the U.S."
Existing investors contributed the equity portion of the financing, while GE Capital, Healthcare Financial Services agented the senior secured debt facility with East West Bank participating as a syndicate partner.
About USGI Medical, Inc.
USGI Medical is committed to the development of technologies to enable Incisionless Surgery – the treatment of diseases through the natural passageways of the body. USGI's Incisionless Operating Platform provides physicians the operating platform and specialized tools they need to perform procedures through a patient's mouth or other natural orifices, eliminating the need for painful and scarring incisions into the abdomen. USGI has demonstrated the capability to reliably and durably suture GI tract tissue without an incision, opening the way to a whole new generation of treatments for a wide variety of acute and chronic diseases. Operating through the body's natural orifices offers promise for less pain, shorter hospital stays, reduced risk of wound infection and no external scars – and is rapidly becoming an option demanded by patients and healthcare providers. USGI offers surgeons and gastroenterologists the tools they need to offer millions of potential patients a less invasive option to surgery. For more information, go to http://www.usgimedical.com/.
The Incisionless Operating Platform, including the g-Cath EZ Delivery Catheter with Snowshoe® Suture Anchors has both CE Mark and US 510(k) Clearance. As a treatment for obesity, however, the safety and effectiveness of the device has not been established in the United States. The device is considered an investigational device in the United States and is thereby limited by Federal Law to investigational use for this application.
About Alta Partners
Alta Partners is a San Francisco-based venture capital firm focused on life sciences investing. Founded in 1996, the firm currently manages $2 billion in committed capital through eight venture fund programs. Alta invests in biopharmaceutical and medical technology companies across the development continuum, from company formation to later-stage opportunities, and has funded more than 110 life sciences companies to date.
About GE Capital, Healthcare Financial Services
GE Capital's Healthcare Financial Services (HFS) business is one of the most active capital providers in the U.S. healthcare market, deploying approximately $9 billion in new commitments to customers via 200+ transactions in 2013. That adds up to more than $70 billion in financing over the past 10 years. For the fourth consecutive year, HFS was the top lead arranger by volume and number of transactions completed for all financings under $500 million in U.S. healthcare leveraged finance.
Customers across 45 healthcare sectors — including senior housing, hospitals, medical offices, outpatient services, pharmaceuticals and medical devices — rely on HFS to finance acquisitions, refinance existing debt, support working capital needs and fund growth initiatives. With in-depth industry knowledge and expertise, the HFS team of professionals creates financial solutions tailored to meet the individual needs of its customers. For more information, visit gecapital.com/healthcare or follow company news via Twitter (http://twitter.com/GELendLease).
GE Capital offers consumers and businesses around the globe an array of financial products and services. For more information, visit www.gecapital.com or follow company news via Twitter (http://twitter.com/GECapital).
GE works on things that matter. The best people and the best technologies taking on the toughest challenges. Finding solutions in energy, health and home, transportation and finance. Building, powering, moving and curing the world. Not just imagining. Doing. GE works. For more information, visit the company's website at www.ge.com.
About East West Bank
East West Bancorp through its wholly owned subsidiary, East West Bank, is one of the largest independent banks headquartered in California. East West is a premier bank focused exclusively on the United States and Greater China markets and operates over 130 locations worldwide, including in the United States markets of California, New York, Georgia, Nevada, Massachusetts, Texas and Washington. With assets over $27 billion, East West Bank provides a full array of products and services to companies in various industries. The Technology and Life Science group is a national practice, with teams based in the Silicon Valley, Boston and China that provides financing, treasury management and international banking services to its clients. For more information on East West Bancorp, visit the Company's website at www.eastwestbank.com.
USGI Medical Media Contact
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