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Corsens Medical Announces Clearance of a 510(K) Pre-Marketing Notification With The FDA for the Corsens Cardiac Monitor



11/28/2016 10:25:41 AM

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The Cardiac Monitor is intended to detect heart contractility parameters required for continuous heart function monitoring

TEL AVIV, Israel--(BUSINESS WIRE)--Corsens Medical Ltd., today announced that it has received clearance for a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Corsens Cardiac Monitor1,2.

“Corsens Device for Detection Of Myocardial Ischemia”

The company received the following indications statement for the Corsens Cardiac Monitor: "The Corsens Cardiac Monitor records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. Corsens Cardiac Monitor may be used as a tool to measure the timing of part of the events in the cardiac cycle for adult population.” The Corsens Cardiac Monitor is designed to detect cardiac contractility parameters via a series of acoustic, accelerometers and cardiac rhythm non-invasive sensors arrayed on the patient's chest.

Evgeny Fizgeer, CEO of Corsens Medical Ltd, commented, “We are thrilled to have reached this important milestone in the development of the Corsens Cardiac Monitor with the clearance of our Pre-Marketing Notification (510(k)) with FDA. We anticipate significant clinical interest for this innovative technology in the markets where the Corsens Cardiac Monitor will be cleared for commercial distribution. This is the first in a series of regulatory filings, while we continue the development of the Corsens Cardiac Monitor.”

Previous Announcements
On May 2, 2016, Corsens Medical Ltd., announced filing of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Corsens Cardiac Monitor.

About the Corsens Cardiac Monitor
The Corsens Cardiac Monitor is designed to detect cardiac contractility parameters via a series of acoustic, accelerometers and cardiac rhythm non-invasive sensors arrayed on the patient's chest. The Corsens Cardiac Monitor is intended to provide continuous monitoring of the heart activity with the assessment of patient's condition relative to their cardiac rhythm. Continuous monitoring is critical for detection of myocardial infarction. Rapid detection is critical for patient survival. In previous studies, conducted at the Ziv Medical Center, Safed, Israel3, the Corsens Cardiac Monitor demonstrated stable, reproducible, and consistent cardiac contractility changes in patients undergoing heart catheterization procedures4. The Corsens Cardiac Monitor has been developed in part with intellectual property licensed from the Sheba Medical Center at Tel Hashomer (Israel).

About Sheba Medical Center at Tel Hashomer
The Sheba Medical Center at Tel Hashomer is a university-affiliated tertiary referral hospital that serves as Israel's national medical center in many fields. Adjacent to Tel Aviv, it is the largest and most comprehensive medical center in Israel and the entire Middle East. With 120 departments and clinics, 1,700 beds, and 6,000 health professionals, the Sheba Medical Center at Tel Hashomer is renowned for its leading-edge medicine, scientific research, and medical education. It handles over a million and a half patient visits a year, including 200,000 emergency visits annually, and conducts more than two million medical tests a year.

About Corsens Medical, Ltd.
Corsens Medical, Ltd., founded in October, 2013, is a development stage medical device company based in Tel Aviv, Israel, developing the Corsens Cardiac Monitor. The Corsens Cardiac Monitor is intended to participate in the global cardiac monitoring and cardiac rhythm management devices market which is expected to reach $26B by the end of 2020 growing at a CAGR of around 4.7% from 2015 to 20205.

1 Patents pending
2 The Corsens Cardiac Monitor is not approved for sale in Europe.
3 Ziv Medical Center was established in 1910 in Safed, affiliated to Bar-Ilan University's Faculty of Medicine. Research cooperation takes place with the Faculty of Medicine and with Migal, the Galilee Research Institute.
4 Company data on file, "Corsens Device for Detection Of Myocardial Ischemia", Clinical Study Report, Protocol No. CS-ANG-1, January 9, 2015
5 Global Cardiac Monitoring Market Growth, Trends & Forecasts (2014 - 2020), July 2015

Contacts

Corsens Medical, Ltd.
Bill Edelman, (781) 436-0509
Chairman of the Board
bill.edelman@corsensmed.com


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