MedHub has announced the completion of a funding round worth US$1 million in new financing, alongside the submission of a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its AutocathFFR system, following completion of a pivotal validation study, intended to support the FDA application.
AutocathFFR is a 2D angio-based fractional flow reserve (FFR) system, 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.
Detailing findings of the pivotal validation study of the system, MedHub said that the study yielded outstanding results, with data showing that AutocathFFR’s accuracy exceeds 90%, as compared to invasive FFR procedures. Carried out at multiple centres, 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, multivessel, physiologic measurements to support PCI decision-making, MedHub said.
Commenting on the developments, Or Bruch-El, MedHub CEO, said: “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 commercialisation of the company’s AutocathFFR system and to support 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 commercialisation and greater access to the technology by physicians, hospitals, and private clinics, and in other office-based settings.”