AUSTIN, Texas--(BUSINESS WIRE)--Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today an agreement with Istitudo Clinico Humanitas to establish a multicenter, retrospective, data repository for gastrointestinal applications performed using Apollo’s OverStitch™ Endoscopic Suturing System. Professor Alessandro Repici, Director of the Digestive Endoscopy Unit of Istituto Clinico Humanitas, will serve as the Principal Investigator.
Endoscopic suturing can be used to support a wide variety of therapeutic, gastrointestinal endoscopic procedures. Patients who have previously undergone an endoscopic suturing procedure at a participating center with the OverStitch device will be eligible for inclusion in the registry. The study will initially include six leading gastroenterology centers in five countries in Europe.
The objective of this registry is to collect European demographic, procedural and outcome data following the use of the OverStitch Endoscopic Suturing System. Data will be collected on a variety of applications including closure of full thickness and mucosal defects, post-operative leaks, perforations, fixation of endoprosthetics, treatment of gastrointestinal bleeding, and other procedures. The goal is to support the clinical use and benefits of endolumenal suturing as well as provide real-world data on safety and effectiveness which can support physicians, patients and payers in making informed decisions.
“The European GI Registry for endoscopic suturing is an amazing opportunity to create a repository of data on Advanced Gastrointestinal Applications coming from some of the most outstanding European centers and will allow an increased understanding of the efficacy, benefits and outcomes associated with endoscopic suturing procedures,” said Professor Alessandro Repici.
“The future for therapeutic endoscopy is very promising, especially with flexible endoscopic suturing utilizing OverStitch. By allowing physicians to suture with precision and assurance of depth, up to full thickness, OverStitch enables many improved therapy options for their patients. These leading centers participating in the registry will be instrumental in generating data for their peers and national health systems across Europe,” said Todd Newton, CEO of Apollo Endosurgery.
The Registry will start collecting data immediately.
About OverStitch
The OverStitch endoscopic suturing system enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures from a flexible endoscope. This new technology enables a secure approximation of tissue endoscopically and a wide range of less invasive solutions for physicians who treat defects in both the upper and lower GI tract of their patients. Additionally, physicians are leveraging endoscopic suturing to perform a variety of advanced bariatric procedures. For more information regarding OverStitch go to: www.apolloendo.com.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on less invasive therapies for the treatment of obesity, a condition facing over 650 million people globally, as well as other gastrointestinal conditions. Apollo’s device based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo's products are offered in over 70 countries today and include the OverStitch™ Endoscopic Suturing System, the ORBERA® Intragastric Balloon, and the LAP-BAND® Adjustable Gastric Banding System.
Apollo’s common stock is traded on Nasdaq Global Market under the symbol "APEN." For more information regarding Apollo, go to: www.apolloendo.com.
© 2018 Apollo Endosurgery, Inc. All rights reserved. Any third-party trademarks used herein are the property of their respective owners.
Cautionary Note on Forward-Looking Statements
Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: reports of adverse events related to our products, developments in medical technology, regulatory approvals and extensive regulatory oversight by the FDA or other regulatory bodies, unfavorable media coverage related to our products or related procedures, reimbursement decisions by private or government payors, physician adoption and recommendations of procedures utilizing our products and other factors detailed from time to time in the reports Apollo files with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2017, and its Form 10-Q for the three months ended June 30, 2018 and its FORM 424B5 Prospectus filed June 21, 2018. Copies of reports filed with the SEC are posted on Apollo’s website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
