PR91204

NYON, Switzerland, Aug. 19 /PRNewswire=KYODO JBN/ --

    MedAlliance has announced enrollment of the first patient in an erectile

dysfunction (ED) feasibility study with its sirolimus drug-eluting balloon

[DEB]. This occurred at the University of Rome Tor Vergata, Italy, under the

direction of the study's Principal Investigator, Professor of Cardiovascular

Interventional Pathology Giuseppe Sangiorgi.

    The aim of the study is to assess the feasibility and safety of angioplasty

with a sirolimus-eluting balloon in patients with ED and distal internal

pudendal and/or penile artery stenotic disease, using Plain Old Balloon (POB)

angioplasty as a comparator. A total of 10 patients will be enrolled into the

feasibility study, whose successful outcome will lead to a larger ED study

involving around 50 patients.

    "We are very excited by the potential outcome of this study," said Prof

Sangiorgi. "There are a significant proportion of ED patients who don't respond

to conventional drug therapy, and initial studies have suggested that

drug-eluting balloons could provide the solution. The balloon used in this

study, providing a slow release of sirolimus, could be particularly suitable."  

    It is estimated that 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. PDE5i's (e.g. Viagra, Cialis) are the most commonly used form of drug

treatment for ED, but up to 50% of those 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

stent or PTCA 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.

    "This is a very exciting study for us, as we believe it will indicate the

potential of our sirolimus DEB to help significant numbers of ED sufferers who

are unresponsive to other therapies," said Jeffrey B. Jump, Chairman and CEO of

MedAlliance.  

    Med Alliance'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 days[1]. 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.

    Med Alliance's sirolimus DEB, known as 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.  It is now

available in Europe and all other countries where the CE Mark is recognized.  

SELUTION SLR is not currently licensed for the treatment of ED.

    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

    [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/1597150/Selution_MedAlliance.jpg

    Source: MedAlliance