Events 2019

MedAlliance Announces First Patient Enrolled in the 3,300 Patient Landmark Sirolimus DEB vs DES Study

Geneva – 31 August 2021 – MedAlliance is pleased to announce the enrollment of the first patient in the ground-breaking coronary randomized controlled study “SELUTION DeNovo”. This study utilizes SELUTION SLR™, a novel sirolimus drug-eluting balloon [DEB], versus a limus drug-eluting stent [DES].

This is the largest DEB study ever initiated, with over 3,300 patients to be enrolled at approximately 50 sites in 15 countries. Patients are randomized before any vessel preparation to reflect current medical practice and to reduce bias.  The objectives of the study are to demonstrate, at both one and five years, non-inferiority and subsequently superiority for target vessel failure (TVF).

This study is designed to change medical practice, as the majority of denovo coronary vessels are currently treated with a permanent metallic stent. The SELUTION SLR elutes sirolimus for over 90 days, similar to a DES, but without leaving behind a metal scaffold, which has been associated with a complication rate of 2% annually.

“We are pleased to participate in a robust prospective randomised study, working with some of the leading institutions and operators in the world to answer these important questions for patients and physicians alike”, commented Principal Investigator Dr Juan F. Iglesias, Geneva University Hospitals, Switzerland. “We are excited to be the first enrolling center in this important study. Initial use of this novel DEB has demonstrated a high level of deliverability, especially in small vessels and side branches”.

“This study is the largest, most ambitious study ever initiated to understand the patient benefit of a DEB versus the latest generation DES.   We hope to demonstrate that limus DEB can replace DES in most coronary denovo lesions, just as limus DES replaced paclitaxel DES”, added Jeffrey B. Jump, Chairman and CEO of MedAlliance.

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 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 the SELUTION SLR with four breakthrough designations for coronaries, peripheral vascular and AV Fistula indications.

1. Drug concentration evident in MicroReservoirs and tissue – Data on file at M.A. Med Alliance SA

MedAlliance Announces Enrollment of First Patient in Erectile Dysfunction Feasibility Study with Sirolimus Drug-Eluting Balloon

17 August 2021 – 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 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.

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.

Completion of Enrolment in PRISTINE Registry with SELUTION SLR™ Sirolimus Drug Eluting Balloon

12 August 2021 – MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of patients with Below-the-Knee (BTK) disease. SELUTION SLR is the first DEB to be awarded “Breakthrough Device Designation” by the FDA.

PRISTINE is a Prospective Registry to Investigate the Safety and efficacy of Treatment with SELUTION SLR Sirolimus Drug Coated Balloon in TASC C and D athero-occlusive Infra-iNguinal disease in patients with chronic limb threatening ischemia from SingaporE.

The objective of this trial is to evaluate the safety and efficacy of the SELUTION SLR DEB in the treatment of infra-inguinal occlusive lesions (TASC C and D) in patients with chronic limb threatening ischemia in 75 patients over 12 months at Singapore General Hospital.
PRISTINE is a follow up registry to the PRESTIGE Trial. The 12-month data from PRESTIGE was presented at LINC 2021 in January, showing sustained benefits up to one year. 18-month data is to be presented at VIVA in October this year, where it is anticipated that these benefits will be further sustained. A similar outcome benefit is expected from PRISTINE in a larger real-world population.

BTK represents the worse part of the spectrum of peripheral artery disease and patients are at an increased risk of limb loss and mortality. One of the cornerstones of BTK treatment is to re-establish blood flow to the foot to promote wound healing. Although percutaneous lower limb angioplasty has become the favored option of revascularization, its Achilles Heel is vessel recoil and restenosis from neointimal hyperplasia.
“One of the important things to note is that we had few exclusion criteria, unlike many of the RCTs using drug coated balloons in the peripheral vasculature, and the data represent real life lesions that we face every day as a vascular specialist in Singapore”, said Associate Professor Tjun Yip Tang, Lead Investigator & Senior Consultant, Department of Vascular Surgery, Singapore General Hospital.

“PRISTINE will offer further insight, leveraging on our initial experience with the PRESTIGE Trial, into whether this sirolimus eluting balloon will become an established device in our angioplasty armamentarium to fight the neointimal hyperplasia effect and restenosis phenomenon that lead to a significant number of clinically driven target lesion revascularizations in the below-the-knee arteries, in this frail and challenging cohort of patients, whose ischemic foot wounds are difficult to heal”.

“This is an important study for MedAlliance”, explained Chairman and CEO Jeffrey B. Jump. “Our breakthrough technology has demonstrated safety and efficacy in below-the-knee diseases in highly complex patients as seen in the PRESTIGE trial. We are expecting similar observations in the PRISTINE registry. This is particularly encouraging, as to date no other DEB has demonstrated effectiveness in this challenging patient population.”

In February 2020 MedAlliance received CE Mark approval for SELUTION SLR in the treatment of Peripheral Artery Disease (PAD) and in May 2020 received CE Mark approval for treatment in Coronary Artery Disease (CAD). MedAlliance has been awarded FDA Breakthrough designation for the SELUTION SLR for use in BTK and expect to begin the IDE study later this year. MedAlliance has a robust global clinical trial program to evaluate outcomes in Coronary, SFA, BTK, Dysfunctional AVF and Erectile Dysfunction, across different demographic population groups.

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.