PR98456

GENEVA, Oct. 25, 2022 /PRNewswire=KYODO JBN/ --

Following our communication last  week "MedAlliance to be acquired by Cordis",

MedAlliance is pleased to make the following announcement:

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

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

pivotal clinical trial.  This is the first sustained limus release coronary

drug eluting balloon (DEB) to receive FDA IDE approval for In-stent Restenosis

(ISR) indication. The study has already begun enrollment in Europe.

"We are pleased with the speed of European enrollment and look forward to

enrolling the first US patient before the year end; US site selections are

underway and will be finalized over the next several weeks. This study has the

potential to address the important unmet need of a non-stent treatment for the

ongoing problem of in-stent restenosis,"  commented Dr Don Cutlip, Principal

Investigator of the IDE SELUTION4ISR Study and the Chief Medical Officer at,

Baim Institute for Clinical Research.

"This is another significant milestone for MedAlliance: we were the first

sustained limus release balloon to receive FDA IDE approval, the first to begin

enrollment and now the first to have three applications approved.  This is the

culmination of a multi-year R&D program that delivered comprehensive

pre-clinical data meeting the very high standards of the US FDA," added Jeffrey

B. Jump, MedAlliance Chairman and CEO.  "We are very pleased with the high

level of market acceptance we are experiencing in Europe, Asia and South

America, and we look forward to entering the US market following the successful

culmination of this important clinical study and receipt of FDA approval.  We

are currently enrolling our US Below-the-knee (BTK) study, enrollment is ahead

of schedule.

"We have had significant success with enrollment of the larger randomized

sister study, the international  coronary SELUTION DeNovo study, and are

excited to offer this new treatment option to US patients, avoiding permanent

metal implants.   No drug coated balloon is currently approved in the US for

coronary indications."

MedAlliance was the first drug-eluting balloon company to receive FDA

Breakthrough Designation status.  In addition to the BTK and superficial

femoral artery (SFA) indications for which the company received FDA IDE

approval in May and August 2022, MedAlliance has now received coronary in-stent

restenosis (ISR) IDE approval. In the next few weeks, MedAlliance plans to

submit its 4th IDE application, for de novo coronary artery lesions, which will

complement the substantial experience that the company has gained with the

SELUTION DeNovo trial in Europe.  More than 540 patients of the 3,326 planned

have already been enrolled in this ground-breaking coronary randomized

controlled study comparing SELUTION SLR vs. any limus drug-eluting stent (DES).

The study is powered to demonstrate superiority of SELUTION SLR DEB over DES

for coronary de novo artery disease.  This is the largest DEB study ever

initiated and has the potential to change medical practice where implants

(metal stents) have been the standard of care for more than 30 years.

Enrollment of the IDE SELUTION4ISR FDA coronary study is already ongoing in

Europe, and will start in the US later this year.  The trial will be conducted

at up to 60 centers worldwide, and in up to 40 centers in the US.  This study

is powered to demonstrate non-inferiority vs. standard of care, (80% against

DES and 20% against POBA), and is currently 10% enrolled (ClinicalTrials.gov

Identifier: NCT04280029).

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.

MedAlliance's unique DEB technology involves MicroReservoirs which contain a

mixture of biodegradable polymer intermixed with the anti-restenotic drug

sirolimus applied as a coating on the surface of an angioplasty balloon. These

MicroReservoirs provide controlled and sustained release of the drug for up to

90 days(1).

SELUTION SLR is commercially available in Europe, Asia, the  Middle East and

the Americas (outside USA) and most other countries where the CE Mark is

recognized  and over 10,000 units have already been used for patient treatments

in routine clinical practice or as part of clinical trials.

Contact: Richard Kenyon, rkenyon@medalliance.com, +44 7831 569940

SOURCE MedAlliance