PR97750

GENEVA, Switzerland, Sept. 10, 2022 /PRNewswire=KYODO JBN/ --

    An 82-year-old Taiwanese man has become the first patient to be enrolled in

the initial Erectile Dysfunction (ED) randomized clinical trial (RCT) involving

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

    The PERFECT-SELUTION FIM (PElvic Revascularization For EreCTile

dysfuction-SELUTION First-In-Man) study involves a total of 54 patients

suffering from distal internal pudendal-penile artery stenotic disease and ED.

They are being randomized to treatment with either SELUTION SLR or plain old

balloon angioplasty (POBA), then followed-up for a period of 12 weeks. The

primary efficacy endpoint of the study is angiographic binary restenosis (>50%

lumen diameter stenosis) defined by computer tomography (CT) and the primary

safety endpoint is the rate of major adverse events.

    "We are excited to begin this study on such a long-suffering patient

population. We hope that this study will give these patients a better chance of

a normal life, and look forward to the results," said Tzung-Dau Wang, Professor

of Medicine and Director of Cardiac Cath Lab, National Taiwan University

Hospital, who has performed pudendal and penile artery angioplasty with

conventional devices ( POBA and/or stents) on more than 500 patients with

arteriogenic erectile dysfunction and acknowledged that restenosis occurred in

more than 30% of treated patients. "We do need a state-of-the-art technology to

break this barrier. We are pleased to initiate this study: the first patient

has responded well to this therapy."

    "We have been very pleased with the clinical results of this technology in

many applications: in-stent restenosis, coronary de novo, both below and above

the knee, AV fistula and now erectile dysfunction. This combination drug-device

technology seems to be very versatile, and we look forward to the results from

this physician-initiated study, as this is clearly an unmet need touching the

lives of hundreds of millions people," added Jeffrey B. Jump, Chairman and CEO

of MedAlliance.

    This study follows a successful feasibility study conducted in Europe in

August 2021, involving ten patients with ED.

    It is estimated that over 300 million men worldwide were affected by ED in

2020, a figure projected to increase to 322 million by 2025. Nearly 30% of

these were aged between 40 and 70. The most common cause of ED is vascular

disease. 70% of physical-related causes of ED are due to reduced blood

circulation to the penis. PDE5 inhibitors (e.g. Viagra, Cialis) are the most

commonly used form of drug treatment for ED, but up to 50% of those patients

treated, experience a suboptimal response. A potential alternative therapy for

these patients is to treat the pudendal and/or penile arteries via the

percutaneous approach, using a coronary metallic stent or a balloon.

Atherosclerotic occlusive disease of the ilio-pudendal-penile arteries

resulting in arterial insufficiency to the penis has been reported to affect up

to 75% of patients with ED.

    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 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]. 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.

    Reference:

    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

    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

    Photo: https://mma.prnewswire.com/media/1895522/MedAlliance_Image.jpg

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

    Source: MedAlliance