PR96391

LEIPZIG, Germany, June 8, 2022 /PRNewswire=KYODO JBN/ --

    The first patient has been enrolled in the FDA IDE BTK (Below-the-Knee)

SELUTION4BTK clinical trial involving SELUTION SLR(TM), MedAlliance's novel

sirolimus-eluting balloon, just one week after receiving IDE approval.

    "I am excited to begin an important trial which will establish the evidence

that this novel technology benefit patients suffering from CLTI," commented Dr.

Michael Lichtenberg, Chief of the Angiology Department at the Klinikum

Hochsauerland, Arnsberg, Germany. "So far nothing has worked consistently in

this patient population. The early clinical data from SELUTION SLR registries

are encouraging and I have seen the performance of this new technology in my

routine work. This study is designed to prove that SELUTION SLR is more

effective than the current standard of care in this difficult patient

population."

    The start of enrollment in the study follows IDE (Investigational Device

Exemption) approval in the US one week ago. The BTK indication for SELUTION SLR

was granted Breakthrough Device Designation by the FDA in 2019.

    The aim of the SELUTION4BTK clinical trial is to demonstrate the superior

efficacy and equivalent safety of SELUTION SLR compared to plain (uncoated)

balloon angioplasty (POBA) in the treatment of BTK arteries in CLTI (Chronic

Limb Threatening Ischemia) patients. The trial is a prospective, multi-center,

single blinded, randomized study.

    377 subjects are being randomized 1:1  to either SELUTION SLR or the

control. This is the first study of its kind where 'real world' patients with

CLI (Critical Limb Ischemia) can be included. Patients are being enrolled at

approximately 40 sites across the US, Europe and Asia.

    "I am very proud of the MedAlliance team which has been able to initiate

this study so quickly and have the first patient enrolled only a week after

receiving IDE approval," commented Jeffrey B. Jump, MedAlliance Chairman and

CEO. "This is a great achievement and a major milestone for MedAlliance."

    SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral

artery disease in February 2020 and for the treatment of coronary artery

disease in May 2020. The US FDA has awarded SELUTION SLR with four breakthrough

designations: for the treatment of atherosclerotic lesions in native coronary

arteries; coronary in-stent restenosis; peripheral below-the-knee and

AV-Fistula indications.

    In August 2021, the first of over 3,000 patients was enrolled in a

ground-breaking coronary randomized controlled study comparing SELUTION SLR

with a limus drug-eluting stent [DES]. This is the largest DEB study ever

initiated and has the potential to change medical practice.

    MedAlliance's DEB technology involves unique MicroReservoirs made from

biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These

MicroReservoirs provide controlled and sustained release of the drug for up to

90 days1. Extended release of sirolimus from stents has been proven highly

efficacious in both coronary and peripheral vasculatures. MedAlliance's

proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be

coated onto balloons and adhere to the vessel lumen when delivered via an

angioplasty balloon.

    SELUTION SLR is available in Europe and all other countries where the CE

Mark is recognized.

    Media Contact:

    Richard Kenyon

    rkenyon@medalliance.com

    +44 7831 569940

    About MedAlliance

     MedAlliance is a privately-owned medical technology company. It is

headquartered in Nyon, Switzerland, with offices in Germany, Singapore, UK and

USA. MedAlliance specializes in the development of ground-breaking technology

and commercialization of advanced drug device combination products for the

treatment of coronary and peripheral artery disease. For further information

visit: www.medalliance.com

    1.        Drug concentration evident in MicroReservoirs and tissue – Data on file

at M.A. Med Alliance SA

    Photo: https://mma.prnewswire.com/media/1834626/MedAlliance_Image.jpg

    Logo: https://mma.prnewswire.com/media/1196864/MedAlliance_Logo.jpg

    Source: MedAlliance