MedAlliance Raises over USD 50 Million to Roll-Out SELUTION SLR™ and Begin Enrolment of Four US FDA Clinical Studies
17 March 2021 – MedAlliance SA, the company commercializing SELUTION SLR™, has raised over USD 50 Million in equity funding. SELUTION SLR™ is a novel sirolimus-eluting balloon that provides a controlled sustained release of a limus drug, with a similar elution time to that of a drug-eluting stent (DES), whilst leaving nothing behind. The new investor is Trustar Capital (formerly known as CITIC Capital Partners).
MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions
3 March 2021 – MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a sirolimus DEB, has now been awarded breakthrough status for SELUTION SLR™, its sustained limus release DEB catheter, in the treatment of atherosclerotic lesions in native coronary arteries. This is the fourth breakthrough designation awarded to MedAlliance for its sirolimus DEB, following coronary in-stent restenosis, peripheral below-the-knee and AV-Fistula indications
8 February 2021 – MedAlliance has announced enrolment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon SELUTION SLR™ for the treatment of patients with peripheral artery disease (PAD). SELUTION SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to that of a drug-eluting stent (DES).
12-Month Below-the-Knee Data with MedAlliance’s SELUTION SLR™ Presented as Late Breaking Trial at LINC
28 January 2021 – 12-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a Late Breaking Trial at LINC 2021. The objective of this clinical investigation has been to evaluate safety and performance outcomes of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions (TASC C & D) in patients with Critical Limb Ischemia (CLI).
MedAlliance announces successful completion of enrolment in ISABELLA clinical trial for the treatment of failing AV fistulas in hemodialysis patients
25 November 2020 – MedAlliance has announced completion of patient enrolment in the ISABELLA Clinical Trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of dysfunctional AV fistulas in end-stage renal failure patients undergoing hemodialysis. SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).