PR91416

GENEVA, Sept. 1, 2021, /PRNewswire=KYODO JBN/ --

MedAlliance is pleased to announce the enrollment of the first patient in the

ground-breaking coronary randomized controlled study "SELUTION DeNovo". This

study utilizes SELUTION SLR(TM), a novel sirolimus drug-eluting balloon [DEB],

versus a limus drug-eluting stent [DES].

This is the largest DEB study ever initiated, with over 3,300 patients to be

enrolled at approximately 50 sites in 15 countries. Patients are randomized

before any vessel preparation to reflect current medical practice and to reduce

bias.  The objectives of the study are to demonstrate, at both one and five

years, non-inferiority and subsequently superiority for target vessel failure

(TVF).

This study is designed to change medical practice, as the majority of denovo

coronary vessels are currently treated with a permanent metallic stent. The

SELUTION SLR elutes sirolimus for over 90 days, similar to a DES, but without

leaving behind a metal scaffold, which has been associated with a complication

rate of 2% annually.

"We are pleased to participate in a robust prospective randomised study,

working with some of the leading institutions and operators in the world to

answer these important questions for patients and physicians alike", commented

Principal Investigator Dr Juan F. Iglesias, Geneva University Hospitals,

Switzerland. "We are excited to be the first enrolling center in this important

study. Initial use of this novel DEB has demonstrated a high level of

deliverability, especially in small vessels and side branches".

"This study is the largest, most ambitious study ever initiated to understand

the patient benefit of a DEB versus the latest generation DES. We hope to

demonstrate that limus DEB can replace DES in most coronary denovo lesions,

just as limus DES replaced paclitaxel DES", added Jeffrey B. Jump, Chairman and

CEO of MedAlliance.

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(TM) (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 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 the SELUTION SLR with four

breakthrough designations for coronaries, peripheral vascular and AV Fistula

indications.

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

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SOURCE: MedAlliance