SAM Client GI Logic Receives FDA 510K Clearance for AbStats™ System for Real-Time Digestive Telemetry

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SAM Client GI Logic, a privately held gastroenterology medical device company, announced today it has received FDA 510K clearance for the AbStats™ System to be used by physicians in hospitals and other healthcare settings for non-invasive, real time telemetry of the digestive system.

Recovery after surgery is frequently associated with diminished gastrointestinal function because anesthesia, pain medications and the surgery itself “shuts down” the digestive system. As a result, many post-operative patients suffer gastrointestinal dysfunction and cannot tolerate food until post-operative digestion is re-awakened.  Physicians and nurses often struggle with the timing of feeding, as either feeding too early or too late can result in negative consequences for the patient. The AbStats System, consisting of two AbStats Vibratory Sensors placed on the abdomen and the AbStats Telemetry Monitor. The monitor allows care providers to see digestive signals as they occur and evaluate the rate of digestive activity. This rate can help doctors determine when the GI tract re-engages The data offers healthcare professionals objective data on which to base post-operative feeding protocols.

“Prior to the AbStats System, doctors and nurses had to essentially guess when a patient’s GI tract reengaged by asking the patient questions about their symptoms, and recovery. Often patients do not know the answers to the questions and the doctor and nurses are left to following their gut or very general guidelines on when to feed a patient,” said Brennan Spiegel, MD, Director of Health Services Research at Cedars-Sinai Health System and UCLA Professor of Medicine and Public Health, “In the two published trials in The Journal of Gastrointestinal Surgery, Spiegel BM, Kaneshiro M, Russell MM, el al. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg 2014; 18: 1 795-803 and Kaneshiro M, Kaiser W, et al. Postoperative Gastrointestinal Telemetry with an Acoustic Biosensor Predicts Ileus vs. Uneventful GI Recovery. J Gastrointest Surg 2015; DOI 10.1007\s11605-015-2956-3 ,we demonstrated that AbStats is a valid measure of the intestinal engine – it can tell us whether the GI system is turned on or off, and when on, how fast it’s revving. Our data showed that AbStats could predict which of our patients would get into trouble with post-operative feeding.”

Phillip Fleshner MD, Director Colorectal Surgery Research at Cedars-Sinai, had several patients in the study and finds the results intriguing. “There’s been no way to tag these patients or markers to guide our feeding decisions,” Fleshner said. “This device may fill that void by forecasting who will do well on advanced feeding schedules.”

“Digestive diseases are extraordinarily prevalent and expensive in the United States and beyond,” said Spiegel “The cost of mismanaging post-operative feeding decisions, in particular, approaches $1 billion annually. As a health services researcher focused on maximizing the value of care, I view AbStats as a digital device with great potential to reduce costs while improving outcomes. That’s the ultimate goal of the emerging digital health movement, and a rare opportunity for any single biosensor to achieve.”

“We are very pleased to have received this initial FDA 510K clearance for the AbStats System, the first easy-to-use, reliable digestive telemetry system for surgeons and gastroenterologist,” said James Beeton, co-founder and CEO of GI Logic. “We will be introducing the AbStats System in the US in 2016 and plan to expand with additional indications and to additional markets following our successful introduction in the US market.”

About GI Logic, Inc.
GI Logic, Inc. (www.gi-logic.com) develops and markets innovative diagnostic devices that record discrete abdominal sounds and vibrations giving physicians a non-invasive method for diagnosing diseases and conditions of the GI tract and the abdomen. The company’s non invasive technology is designed to detect and recognize changes in digestive tract movements, providing physicians with vital information about the functional status of the digestive system. This information will provide the physician the ability to make informed decisions and will allow the patient to receive a new level of care.

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