Jim Corbett, CathWorks CEO, stated, “We are delighted to have such a notable investor leading this round and for the continued full participation of our existing syndicate of investors. Our company was fortunate to have tremendous excitement around the CathWorks FFRangio System following release of the FAST-FFR clinical study results. This funding, coupled with our recent FDA 510(k) clearance, paves the way for acceleration of our clinical and commercial activities in the United States.”

Deerfield Management Principal, Andrew ElBardissi, MD, added, “The CathWorks FFRangio platform technology has the potential to become standard of care in PCI [percutaneous coronary intervention] and other interventions where physiologic assessment is critical to determining which patients would benefit from revascularization. We believe there is tremendous clinical and economic potential for all stakeholders, including clinicians, patients and payors.”

The CathWorks System received United States Food & Drug Administration 510(k) clearance on December 19, 2018. The predicate used for demonstrating substantial equivalence was conventional invasive FFR as demonstrated during the FAST-FFR clinical study.

The CathWorks FFRangio System quickly and precisely delivers the objective FFR guidance needed to optimize PCI therapy decisions for every patient across the full coronary tree. It is non-invasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per-procedure costs.

CathWorks co-founder Guy Lavi commented, “We are excited for the investment to support FFRangio market entry and continue with technical and clinical acceleration. As always, we want to thank our clinical development partners in Israel, the United States, and Europe for enabling us to reach this exciting milestone.”

Source: Company Press Release