MedHub Raises Funds, Completes Pivotal Validation Study of AutocathFFR

February 8, 2022—MedHub announced it has secured $1 million in a financing round, bringing the total amount raised to $4.2 million. The company also announced the completion of a pivotal multicenter validation study of its AutocathFFR.

MedHub is an Israel-based medical device company focused on simplifying cardiac care with artificial intelligence (AI) image–based tools.

According to the company, the two-dimensional, angiography-based AutocathFFR system is built on AI technology. It transforms routine x-ray coronary angiography into objective, comprehensive physiologic information, including automatic stenosis detection and anatomic structure identification, to help physicians optimize decision-making, including whether a stent is needed. It can be used in real time, during routine coronary angiography, and offline postprocedure to determine the necessity of a complete procedure.

Or Bruch-El, MedHub CEO, announced that this financing round, led by Mr. Ron Zuckerman and new investor Professor Rafael Beyar, will help expand the commercialization of the AutocathFFR system and support the transition to a hybrid model that allows on-premises and cloud-based service.

He further explained, “The company keeps working to develop its product portfolio, including AutocathMVD for wireless microvascular dysfunction assessment and AutocathiFR image-based [instantaneous wave-free ratio]-pullback assessment for vessels with multiple lesions.”

Data from the > 300-patient pivotal study, intended to support the company’s FDA application, showed that AutocathFFR’s accuracy exceeded 90% and demonstrated its clinical predictive value across a full range of coronary physiology, including complex lesion assessment in bifurcations and calcified lesions. The study also demonstrated the system’s ability to perform noninvasive, objective, multivessel, physiologic measurements to support percutaneous coronary intervention decision-making.

The company advised that AutocathFFR is commercially available and has been implemented in four large hospitals. A 510(k) premarket notification has been submitted to FDA for regulatory clearance.