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FDA approval

Tissue access and resection device approved

Scarless surgery system for lesion and polyp removal approved by Food and Drug Administration
Device developed through partnership between Apollo Endosurgery and The Mayo Clinic, Johns Hopkins University
$5m grant awarded by the Cancer Prevention and Research Institute of Texas for development of device

Apollo Endosurgery has received FDA 510(k) clearance for its SuMO endoscopic tissue access and resection system, a scarless surgery system to help surgeons remove large, flat precancerous gastrointestinal lesions and polyps during endoscopy procedures.

“With the SuMO technology, large submucosal dissections of pre-cancerous tissue can be done quickly and efficiently,” said Dr Lee Swanstrom, Director of the Oregon Clinic's Division of Gastrointestinal and Minimally Invasive Surgery (GMIS). “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.”

SuMO (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 7cm in diameter has been removed en bloc endoscopically.

“Early detection and removal of flat, precancerous lesions may help prevent development of invasive oesophageal 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,” added Swanstrom. “Endoscopic submucosal dissection 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.

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

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