PR97384

GENEVA, Aug. 10, 2022 /PRNewswire=KYODO JBN/ --

    SELUTION SLR™, MedAlliance's novel sirolimus-eluting balloon, has received

conditional FDA Investigational Device Exemption (IDE) approval to initiate its

pivotal clinical trial for the treatment of occlusive disease of the

superficial femoral artery (SFA).

    This comes only a few months after the company received IDE approval for

SELUTION SLR in the treatment of below-the-knee (BTK) indications (May 2022).

    Enrollment will begin in the SELUTION SLR IDE SFA study later this year. It

will be conducted at over 20 centers in the US and an additional 20 centers

around the world. This study will enroll 300 patients to demonstrate

superiority over balloon angioplasty (POBA). The Principal Investigator of this

study is Dr George Adams, Director, Cardiovascular and Peripheral Vascular

Research; Rex Hospital Inc., Raleigh, North Carolina, United States.

    "We are very excited that US patients suffering from PAD will have the

opportunity to receive this novel sirolimus drug coated balloon technology.  

This is yet another advancement in the field of treating vascular disease and

we are confident that this study will enroll quickly," Dr Adams commented.  

    "This is a significant milestone for MedAlliance: we are the first

non-paclitaxel drug coated balloon to receive IDE approval, and now the first

to have two applications approved. This is the culmination of a multi-year R&D

program to provide the comprehensive non-clinical data required to satisfy the

very high standards expected by the US FDA," added Jeffrey B. Jump, MedAlliance

Chairman and CEO. "We are very pleased with the rapid level of sales growth we

are experiencing in Europe, Asia and South America and very much look forward

to entering the US market."

    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 any 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

    Reference:

    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/1875120/MedAlliance_SELUTION.jpg

    Source: MedAlliance