MedHub, a privately held medical device company focused on improving and simplifying cardiac care by replacing risky and costly invasive procedures with AI image-based tools, announced that it has successfully secured $1 million bringing the total sum raised to $4.2 million. The round was led by Mr. Ron Zuckerman who was joined by new investor, Prof. Rafael Beyar.
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In addition, MedHub revealed today that it completed its pivotal validation study, intended to support the Company’s FDA application. The study yielded outstanding results, with data showing, amongst others, that AutocathFFR’s™ accuracy exceeds 90%, as compared to invasive FFR procedures. Carried out at multiple centers, the study evaluated more than 300 patients. It demonstrated the system’s clinical predictive value across a full range of coronary physiology, including complex lesion assessment in bifurcations and calcified lesions. The study also demonstrated that the AutocathFFR system could perform non-invasive, objective, multi-vessel, physiologic measurements to support PCI decision-making.
MedHub also announced today that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for regulatory clearance of its AutocathFFR™.
Or Bruch-El, MedHub CEO stated, “We are excited to have secured our latest investment, which included both new and existing investors. Proceeds from the financing round will be used to expand the commercialization of the company’s AutocathFFR™ system and to supports the company’s transition to a hybrid model allowing both on-premises and cloud-based service. Our initial market launch has demonstrated tremendous market enthusiasm around the clinical value of the MedHub AutocathFFR system. The company keeps working to develop its product portfolio including AutocathMVD for wireless microvascular dysfunction assessment, and AutocathiFR -image-based iFR-pullback assessment for vessels with multiple lesions. The investment will also enable continued commercialization and greater access to the technology by physicians, hospitals, and private clinics, and in other office-based settings.”
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MedHub’s AutocathFFR is the only 2D angio-based FFR capable of transforming routine x-ray coronary angiography into objective and comprehensive physiological information, including automatic stenosis detection and anatomical structure identification to help physicians optimize decision making, including whether a stent is needed.
The MedHub AutocathFFR System is a non-invasive diagnostic solution designed for use in real-time, during routine coronary angiography and offline post-procedure, to determine whether a complete procedure is deemed to be a necessity.
“The non-invasive AutocathFFR system has the potential to become standard of care,” Bruch-El, added, ” The pivotal validation trial proves the immense value of the system and serves as a key milestone in our endeavour to bring the best-in-class AutocathFFR technology to patients and physicians worldwide.”
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