MedAlliance recently announced that it has raised over US$50 million in equity funding. The new investor is Trustar Capital (formerly known as CITIC Capital Partners).
Proceeds from the financing will be used to fund commercialisation of Selution SLR—a novel sirolimus-eluting balloon that provides a controlled sustained release of a limus drug. They will also support global clinical programmes including enrolment of four additional US Food and Drug Administration (FDA) investigational device exemption (IDE) studies this year. The US coronary ISR study is underway and began enrolment in July 2020.
MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive FDA breakthrough device designation status for a sirolimus DEB, was recently awarded breakthrough status for Selution SLR in the treatment of atherosclerotic lesions in native coronary arteries. This was the fourth breakthrough designation awarded to MedAlliance for its sirolimus DEB, following coronary in-stent restenosis, peripheral below-the-knee and AV fistula indications.
In February 2021, MedAlliance enrolled the first patient in SUCCESS PTA, a 700-patient post-market study with Selution SLR for the treatment of peripheral arterial disease (PAD). This is the largest study undertaken to date with the device. Data from the SUCCESS PTA study will be part of the clinical evidence supporting CE mark renewal in 2023/2024 under the new European Medical Device Regulation (MDR).
Selution SLR was awarded CE mark approval for the treatment of PAD in February 2020 and for the treatment of coronary arterial disease in May 2020. It is now available in Europe and all other countries where the CE mark is recognised. The global market for DEB is estimated to be worth over US$1.5 billion.