PR88345

NYON, Switzerland, March 4, 2021 /PRNewswire=KYODO JBN/ --

MedAlliance, the first drug-eluting balloon (DEB) company in the world to

receive US Food and Drug Administration (FDA) Breakthrough Device Designation

Status for a sirolimus DEB, has now been awarded breakthrough status for

SELUTION SLR(TM), its sustained limus release DEB catheter, in the treatment of

atherosclerotic lesions in native coronary arteries. This is the fourth

breakthrough designation awarded to MedAlliance for its sirolimus DEB,

following coronary in-stent restenosis, peripheral below-the-knee and

AV-Fistula indications.

According to the FDA, the SELUTION SLR 014 DEB Breakthrough Designation is for

improving luminal diameter in patients with atherosclerotic lesions in native

coronaries.

"MedAlliance is honoured to have our sirolimus DEB selected for the FDA's

Breakthrough Device Program for a fourth time. This may provide US patients

faster access to our novel 90 day sustained sirolimus release technology, with

the potential to provide safer and more effective treatment," said Jeffrey B.

Jump, Chairman and CEO of MedAlliance. "This Designation, combined with the

previous coronary ISR Breakthrough Designation, will give US cardiologists

exciting new tools to fight coronary disease."

The FDA Breakthrough Device Program is intended to help patients receive more

timely access to breakthrough technologies that have the potential to provide

more effective treatment or diagnosis for life-threatening or irreversibly

debilitating diseases or conditions. Under the program, the FDA will provide

MedAlliance with priority review and interactive communication regarding device

development and clinical trial protocols, through to commercialization

decisions.

The goal of the Breakthrough Devices Program is to provide patients and

healthcare providers with timely access to these medical devices by speeding up

their development, assessment, and review, while preserving the statutory

standards for premarket approval, 510(k) clearance, and de novo marketing

authorization, consistent with the Agency's mission to protect and promote

public health.

SELUTION SLR's 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. 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.

About MedAlliance

Founded in 2008, MedAlliance is a privately-owned medical technology company.

It is headquartered in Switzerland, with facilities in Irvine, California;

Glasgow, UK; and Singapore. 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: medalliance.com.

Photo - https://mma.prnewswire.com/media/1449107/MedAlliance.jpg

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Media Contact:

Richard Kenyon

rkenyon@medalliance.com

+44 (0)7831 569940

Source: MedAlliance