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Devices Interventional FDA

 News Release - October 26, 2017

Nitiloop Announces FDA 510(k) Clearance for its Nova Cross Extreme and Nova Cross BTK Micro catheter for Support of Guidewire Access to Discrete Regions of the Coronary and Peripheral Vasculature

The Nova Cross™ Extreme and Nova Cross™ BTK demonstrated impressive performance in the clinical setting

NETANYA, Israel, October 26, 2017 -- (Healthcare Sales & Marketing Network) -- Nitiloop, a medical device company dedicated to the development of Cardiovascular and peripheral microcatheters for complex lesions, received FDA clearance for its new Nova Cross™ Extreme and Nova Cross™ BTK. These dedicated microcatheters are joining the Nova Cross™ product family combining innovative low profile microcatheter technology with uniquely designed Nitinol scaffold providing enhanced guidewire and microcatheter support for safer and more effective lesion crossing. The Nova Cross™ Extreme and Nova Cross™ BTK are intended to be used in conjunction with conventional guidewires to access discrete regions of the coronary and peripheral vasculature.

Recently, Nitiloop Ltd. successfully completed a pivotal study evaluating the safety and effectiveness of the NovaCross™ CTO Microcatheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The study was conducted on 145 Subjects diagnosed with a CTO in a coronary vessel that required revascularization after a previously failed attempt. The company submitted study results and is expecting FDA feedback within the next weeks.

Dr. William Nicholson, an expert in Interventional Cardiology at York hospital, PA: "with the continuing rise in CAD prevalence and increasing complexity of lesions requiring recanalization, the Nova Cross™ Extreme is a significant new addition to our tool box for tackling these lesions.

Chana Schneider, CEO of Nit loop Ltd. commented "We are very excited at receiving FDA clearance for the Nova Cross™ Extreme and Nova Cross™ BTK, which further establishes our Nova Cross™ product family. We are encouraged by the positive medical community response to our new products bringing solution to one of the last un-met clinical need in the Cath-lab."

About Nitiloop Ltd.

Nitiloop Ltd. is dedicated to the development of innovative cardiovascular and peripheral supporting microcatheters for complex lesions and Chronic Total Occlusions (CTO). Nitiloop's technology enables superior operator-controlled positioning and support in multiple vasculature applications. The company was founded by Prof. Ran Kornowski, MD, and is backed by Access Medical Ventures and Tal Capital.

Source: Nitiloop

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