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FDA Clears Apollo Endosurgery, Inc.'s SuMO(TM) Endoscopic Tissue Access and Resection System


1/9/2012 7:34:41 AM

AUSTIN, TX--(Marketwire - January 09, 2012) - Apollo Endosurgery Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its SuMO™ endoscopic tissue access and resection system. Apollo Endosurgery designed the scarless surgery system to help surgeons remove large, flat precancerous gastrointestinal lesions and polyps during endoscopy procedures.

"Early detection and removal of flat, precancerous lesions may help prevent development of invasive esophageal or colon cancer, however, until recently, most patients with these lesions had to undergo significant surgeries, often involving resection of large segments of non-diseased esophagus or the colon," said Lee Swanstrom, MD, director of the Oregon Clinic's Division of Gastrointestinal and Minimally Invasive Surgery (GMIS). "Endoscopic submucosal dissection, or ESD, is an established technique that allows for effective resection of the pre-cancerous tissue without the need for an esophagectomy or colectomy. However, even with newer advanced endoscopic tools, the procedure is very challenging, particularly for larger areas of tissue."

"With the SuMO technology, large submucosal dissections of pre-cancerous tissue can be done quickly and efficiently," Dr. Swanstrom continued. "The SuMO procedure represents a novel and significant advance in therapeutic endoscopy that may allow increasing numbers of patients to avoid or delay major surgery."

In 2010, Apollo Endosurgery received a $5 million award to support development and commercialization of the SuMO system from the Cancer Prevention and Research Institute of Texas ("CPRIT"). Apollo Endosurgery was the first company to receive this prestigious grant.

"We are extremely thankful to CPRIT for their generous support of the SuMO technology and the development of tools that enable scarless endoscopic alternatives to procedures that previously required major open surgery," said Dennis L. McWilliams, Apollo Endosurgery President and CEO. "Technologies that enable endoscopic alternatives to invasive surgery for mucosal lesions, such as Barrett's esophagus, have received significant attention from the medical and financial community in recent months. Together with our newest generation OverStitch™ device, Apollo Endosurgery now can offer surgeons access to the latest flexible endoscopic tissue access, resection and suturing technologies that make a new era of surgery a reality."

SuMO, which stands for Sub-Mucosal Operation, was developed through a partnership between Apollo Endosurgery and the Mayo Clinic, Johns Hopkins University, the Medical University of South Carolina, and the University of Texas Medical Branch. The SuMO system is comprised of flexible devices including injection needles, unique balloons and cutting tools that help the surgeon tunnel underneath the lesion and then resect, seal off and remove the unwanted tissue through a traditional endoscope. In preclinical proof-of-concept studies, gastrointestinal tissue up to 7 cm in diameter has been removed en bloc endoscopically.

About Apollo Endosurgery®, Inc.

Apollo Endosurgery®, Inc. is dedicated to revolutionizing patient care through the development of scarless surgery, which is emerging from the convergence of laparoscopic surgery and therapeutic gastroenterology. Scarless surgery minimizes the trauma of surgical access by taking advantage of natural orifices to deliver surgical tools to targeted areas. All of Apollo's products are compatible with existing flexible endoscope platforms. Apollo Endosurgery® was co-founded with the Apollo Group, a unique collaboration of physicians from the Mayo Clinic, Johns Hopkins University, Medical University of South Carolina, the University of Texas Medical Branch and the Chinese University of Hong Kong.




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