PR91848

GENEVA, Sept. 23, 2021 /PRNewswire=KYODO JBN/ --

    MedAlliance, with its Japanese partner MDK Medical, has completed

enrollment in the clinical study of its novel Sirolimus Drug Eluting Balloon

(DEB), SELUTION SLR(TM), for the treatment of peripheral arterial disease

(PAD). This follows the acceptance of a Clinical Trial Notification (CTN) by

Japan's Pharmaceutical and Medical Device Agency (PMDA) in June 2020.

    The study involves 133 patients across 13 centres in Japan. Its objective

is to assess the safety and efficacy of SELUTION SLR for the treatment of

lesions of superficial femoral arteries and/or popliteal arteries. The study is

a prospective, controlled, multi-centre, open, single-arm clinical

investigation. Its primary endpoint is the primary patency rate at twelve

months. Secondary endpoints include Major Adverse Events/TLR, Primary Patency,

and the change of Rutherford classification/ABI/WIQ.

    "We are extremely pleased with the regulatory and quality expertise

demonstrated by our partner MDK, and particularly proud that Japanese patients

can now benefit from our unique technology.  This is the first sirolimus drug

eluting balloon implanted in Japan, where the current paclitaxel coated balloon

market generates more than $100M in revenue per year," commented MedAlliance

Chairman and CEO Jeffrey B. Jump.  

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

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

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 CA(TM) (Cell Adherent Technology) enables the MicroReservoirs to be

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

angioplasty balloon.

    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

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

    Photo:

https://mma.prnewswire.com/media/1631888/MedAlliance_Selution_SLR.jpg

   Source: MedAlliance