Wednesday, February 22, 2012

NinePoint Medical starts imaging system clinical trial

By Lori Valigra

Medical device company NinePoint Medical Inc. of Cambridge said Wednesday that it has started a clinical trial of its optical imaging system after receiving 510(k) clearance from the U.S. Food and Drug Administration (FDA) for it last month.

The company also said it is on track to launch the product in 2013.

The trial will evaluate NinePoint’s Nvision VLE Imaging System to visualize subsurface tissue in patients undergoing esophagogastroduoenoscopy for suspected or confirmed Barrett’s esophagus, a common precursor condition to esophageal cancer. The trial is expected to enroll about 100 patients at five centers worldwide: the Mayo Clinic in Jacksonville, Fla. and Rochester, Minn.; Kansas University Medical Center in Kansas City, Mo.; Academic Medical Center in Amsterdam; University College London; and University Hospital in Nantes, France.

In January, NinePoint said it had received 510(k) clearance from the FDA to market Nvision as an imaging tool to evaluate human tissue microstructure using 2D, cross sectional, real-time depth visualization. The company said the system is the first volumetric optical coherence tomography device cleared by the FDA for endoscopic imaging that uses a circumferential scanning technique and an automatic pullback to generate cross sectional and longitudinal images simultaneously in real time.

“The Nvision VLE Imaging System has the potential to improve and accelerate the diagnosis and treatment of patients with potentially diseased tissues, including gastrointestinal conditions like Barrett’s esophagus, by providing physicians with high-resolution, volumetric images in real time,” Dr. Charles Carignan, president and CEO of NinePoint, said in a statement.

Separately, the company also said it had expanded its executive team by appointing Patrick MacCarthy to vice president of marketing.

In December 2010, NinePoint entered into an intellectual property licensing agreement with Massachusetts General Hospital (MGH) to support and advance the Nvision system’s development system.