PR97528

GENEVA, Switzerland, Aug. 24, 2022 /PRNewswire=KYODO JBN/ -

    The first US patient has been enrolled in the FDA SELUTION4BTK

(Below-the-Knee) clinical trial evaluating SELUTION SLR™, MedAlliance's novel

sirolimus-eluting balloon. This milestone follows Investigational Device

Exemption (IDE) approval in the US in May 2022, with enrollment of the first

patient occurring in Germany one week after approval.  

    "We are very excited to finally have drug-eluting technology in the US to

treat this difficult patient population," commented the trial's Principal

Investigator (PI) Dr. Ehrin Armstrong. "We are encouraged by the positive early

outcomes with this novel SELUTION SLR Sirolimus Drug Eluting Balloon (DEB) in

Europe and Asia. We hope this FDA IDE trial will demonstrate significant

benefit for patients who currently have limited treatment options."

    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 Chronic Limb

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

single blinded, randomized study (ClinicalTrials.gov Identifier: NCT05055297).

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

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

CLTI can be included. Patients are being enrolled at approximately 40 sites

across the US, Europe and Asia. This first US patient was enrolled at Vascular

Solutions in Cary, North Carolina by Dr. Siddhartha Rao.    

    "We are very pleased to be participating in this groundbreaking study,"

said Dr Rao, "We hope that this promising technology will fulfill a huge need

for our patients with chronic limb-threatening ischemia, saving life and limb.

We look forward to the rapid enrolment of this trial."

    "We were the first company to be granted 'Breakthrough Device Designation'

for a DEB by the FDA and are proud to enrol the very first US patient in a

sirolimus DEB study," added Jeffrey B. Jump, MedAlliance Chairman and CEO.

"Many companies have been trying for years to bring sirolimus to the US and we

are very pleased with our team for achieving this significant milestone. US

patients will now have an alternative to paclitaxel DEB, addressing the

concerns expressed by the FDA."

    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), powered to demonstrate superiority.

SELUTION DeNovo 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.

    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

    Media Contact:

    Richard Kenyon

    rkenyon@medalliance.com

    +44 7831 569940

    Photo: https://mma.prnewswire.com/media/1883511/MedAlliance.jpg

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

    Source: MedAlliance