Early-stage device company ConKay Medical Systems has raised $1.8m in a seed funding round, as it plans to head into its first-in-human clinical trial to treat valvular regurgitation in patients with progressive heart failure. 

The financing round, led by Unorthodox Ventures, SCP Ventures, WS Investment Company, and individual angel investors, will be used to propel ConKay’s catheter into first-in-human testing.

ConKay is anticipating its next round of financing in Q2 2024. 

The initial focus for the device is tricuspid regurgitation (TR), a heart valve disorder characterised by the leaking of blood backwards through the tricuspid valve during the heart’s contraction. This leads to inefficient blood flow and potential complications.  

Last month, Edward’s Lifesciences’ EVOQUE transcatheter tricuspid valve replacement (TTVR) system received approval from the US Food and Drug Administration (FDA), having already secured CE approval in October 2023. This device is currently the only transcatheter therapy available to treat severe TR.

According to GlobalData, the approval of the EVOQUE system will greatly contribute to the TTVR market’s expected aggressive growth to exceed $2bn by 2033. However, there is still a large, unmet clinical need for treating patients with severe TR, especially in developing countries, according to Globaldata analyst Joselia Carlos, MSc.  

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In the announcement accompanying the funding, section chief of interventional cardiology at the University of Washington Jamie McCabe said: “Despite recent advances in the treatment of tricuspid regurgitation, it’s clear that none of the current technologies are capable of addressing even a fraction of all patients with TR.” 

Medtronic is also jumping on the market, with a currently ongoing early feasibility study on its Intrepid system in patients with severe TR. The company received breakthrough device designation from the FDA for its Intrepid TTVR system in 2020.