Corsens Medical – Corsens Medical Ltd

The CorSens Perfusion Monitor

heart-attack

Over 1.2 million Percutaneous Cardiac Intervention (PCI) procedures are performed each year in the US.^[1],^[2] During PCI, myocardial perfusion is a critical indicator of heart health and an indication of successful PCI.^[3] It has been estimated up to 20% of PCI fails to attain myocardial perfusion.^[4] Chest pain symptoms and non-invasive techniques, such as exercise electrocardiography (ECG) testing, have limited clinical significance for evaluating the efficacy of PCI and detecting restenosis which reduces myocardial perfusion.^[5] Chest pain following PCI is a poor indicator of restenosis since asymptomatic restenosis occurs in 18% to 59% of patients following PCI and in 30% to 58% of patients after stent placement, while up to 45% of patients developing chest pain after PCI do not have angiographic restenosis.^[6],^[7] Current techniques exist to measure myocardial perfusion require expensive imaging technologies and are not available during the PCI procedure.

Therefore, during PCI there exists a need for a continuous non-invasive myocardial perfusion monitor which provides real-time perfusion information to the cardiologist.

The CorSens Perfusion Monitor^{^[8]} has received FDA 510(k) Pre-Market Clearance for the continuous non-invasive detection of myocardial perfusion.

Device 02_2015 Device 2016 1

^[1] JAMA. 2011 May 4; 305(17): 1769–1776. doi:10.1001/jama.2011.551.

^{^[2]} Adams GL, Ambati SR, Adams JM, Borges-Neto S. Role of nuclear imaging after coronary revascularization. J Nucl Cardiol. 2006;13:163–9.

^{^[3]} Am J Cardiol. 2003 Sep 15;92(6):656-9.

^{^[4]} Circulation. 1996;93:223–228., Circulation. 2000;101:570–580., Am Heart J. 2000;140:S90–S102., Eur Heart J. 2002;23:1112–1117.

^{^[5]} Zhang X, Liu X, He ZX, et al. Long-term prognostic value of exercise 99mTc-MIBI SPET myocardial perfusion imaging in patients after percutaneous coronary intervention. Eur J Nucl Med Mol Imaging. 2004;31:655–62.

^{^[6]} Holmes DR, Jr, Vlietstra RE, Smith HC, et al. Restenosis after percutaneous transluminal coronary angioplasty (PTCA): a report from the PTCA Registry of the National Heart, Lung, and Blood Institute. Am J Cardiol. 1984;53:77–81.

^{^[7]} Ruygrok PN, Webster MW, de Valk V, et al. Clinical and angiographic factors associated with asymptomatic restenosis after percutaneous coronary intervention. Circulation. 2001;104:2289–94.

^{^[8]} https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160656.pdf

TIMELINE

2013

Seed investment initiates company operation.
Management assembled.
Initial IP filed.

2014

CPM prototype fabricated.

Phase 1 CPM clinical trials initiated.
The company began receipt of a multi-staged investment from the Office of the Chief Scientist of Israel’s Ministry of Economy.

2015

Phase 1 completed with 27 patients. Results show that CPM was able to provide stable, reproducible, and consistent detection of myocardial infarction and peak endocardial acceleration (PEA) signals in all patients.

2016

Successfully completed filing of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for the CPM on May 2nd, 2016.

Announces Clearance of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Corsens Cardiac Monitor. The Cardiac Monitor is intended to detect heart contractility parameters required for continuous heart function monitoring