Events 2019

See MedAlliance Technology presentations at the following congresses:

14 January 2020 – 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™, its sustained limus release DEB catheter, in the treatment of AV-Fistula indications. This is the third breakthrough designation awarded to MedAlliance for its sirolimus DEB, following coronary in-stent restenosis and peripheral below-the-knee indications.

SELUTION’s technology involves unique micro-reservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These micro-reservoirs provide controlled and sustained release of the drug. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the micro-reservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.

“MedAlliance is honored to have our sirolimus DEB selected for the FDA’s Breakthrough Device Program for a third time. This may provide US patients faster access to a new technology with the potential to provide safer and more effective treatment,” said Jeffrey B. Jump, Chairman and CEO of MedAlliance.

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.

Two-year clinical follow-up data on the company’s SFA (superficial femoral artery) sirolimus DEB and six-months follow up data on the coronary de-novo and in-stent restenosis DEB were presented at TCT and VIVA last year.

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10 January 2020 – MedAlliance has announced completion of patient enrolment in the PRESTIGE* Below-the-Knee (BTK) clinical trial. The objective of this clinical investigation is to evaluate the six-month safety and performance outcomes of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions (TASC C & D) in patients with Critical Limb Ischemia (CLI).

PRESTIGE is a prospective, single-center, physician-initiated clinical study, being run at Singapore General Hospital by Dr. Chong Tze Tec and Dr. Tang Tjun Yip. Twenty-two patients have now been enrolled. Clinical follow-up will be at one, three, six and 12 months.

“The initial performance of SELUTION SLR has been very encouraging”, commented Dr. Tec. “We have observed good blood flow in the amputation segment and some cases of fast wound healing. The device is also easy to track and deliver. We are eagerly awaiting the study’s follow-up data”.

CLI is a severe obstruction of the arteries which markedly reduces blood flow to the extremities. It can progress to the point of severe pain and skin ulcers or sores: CLI often leads to amputation.

Singapore has a high percentage of diabetics in its population and CLI therefore constitutes a major challenge among patients seen with Peripheral Artery Disease (PAD). Singapore General Hospital (SGH) performs over 1000 interventional procedures a year on patients suffering from CLI.

The PRESTIGE study, utilizing a sirolimus eluting balloon, is particularly significant in the wake of current controversy surrounding paclitaxel-coated balloons.

Historically, paclitaxel has been the drug of choice for use in drug-coated balloons (DCBs). SELUTION SLR is the first sirolimus drug-eluting balloon specifically designed to treat PAD. This device uniquely combines the proven safety and efficacy of sirolimus with advanced MicroReservoir and Cell Adherent Technology (CAT™) to offer a sustained therapeutic effect for over 60 days, achieving long-term clinical benefits.

The MicroReservoir combines sirolimus, the proven, safe and effective anti-inflammatory drug, with a biodegradable polymer. Millions of these MicroReservoirs act as miniature drug delivery systems, achieving sustained sirolimus release.

The Cell Adherent Technology (CAT™) achieves an unmatched drug bioavailability and minimal systemic loss allowing for a lower drug dose concentration on the balloon surface (1 μg/mm²). Proprietary amphipathic lipid technology binds micro-reservoirs to the balloon surface to protect during insertion and navigation of the balloon. Once the balloon is inflated, CAT ensures optimal transfer of micro-reservoirs to the tissue and enhanced cellular uptake of the sirolimus drug.

SELUTION SLR is using the latest generation of PTA Balloons, offering a broad portfolio for peripheral indications, best in class deliverability and trackability.

“We are excited at the prospect of demonstrating that our breakthrough technology is effective in below-the-knee lesions, so bringing much-needed relief to a substantial group of patients who might otherwise not be effectively treated”, added MedAlliance Chairman and CEO Jeffrey B. Jump.

MedAlliance was granted breakthrough designation by the FDA on September 20th 2019.

Positive, two-year data from the first-in-human study of SELUTION SLR was presented at VIVA 2019 by Principal Investigator Professor Thomas Zeller, M.D., Ph.D., Universitaets-Herzzentrum, Bad Krozingen, Germany. The study involved 50 patients treated with the investigational device in lesions of the superficial femoral artery (SFA) and popliteal artery.

* Physician initiated, prospective, non-Randomized single-center trial, investigating the safety and Efficacy of the Treatment with the Selution Sirolimus Coated Balloon in TASC C and D Tibial occlusive disease In patients with critical limb Ischemia from SinGaporE.

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6 January 2020 – Sirolimus-eluting balloon specialist MedAlliance has announced the appointment of Scott Addonizio as Chief Operating Officer. Scott has an excellent track record and reputation in the global medical device industry, with over 24 years’ experience. This includes expertise in balloon manufacturing, in-depth knowledge of the global coronary, peripheral and AV Fistula marketplace, as well as a solid understanding of the global regulatory environment.

Scott was most recently a Board Director of OrbusNeich Medical, where he was responsible for global operations. He held the titles of Senior Vice President & Chief Operating Officer. Having spent the last 15 years overseas, the majority in mainland China, he has considerable knowledge of key global markets and has familiarized himself with the local language, customs and business culture of those regions. Scott is the primary patent holder for the “Stent Having Dual Helical Design”, which provides the backbone for all OrbusNeich stent platforms. Scott holds a degree in Packaging Engineering from Michigan State University and an MBA in International Business from the University of Miami.

As COO Scott will lead MedAlliance operations including Manufacturing, Regulatory, Clinical and R&D, as well as MA’s logistical organization. He will be based in Irvine, California.

“We are delighted to welcome someone of Scott’s calibre to MedAlliance” commented Chairman and CEO Jeffrey B. Jump. “His inherent knowledge and experience in a rapid growth company will be an important contribution to our continued success”.

“I’m extremely excited to be joining the MedAlliance team at this critical stage in the company’s development” added Scott. “We are on the brink of receiving the first regulatory approvals to facilitate launch of our sirolimus-eluting balloon, as well as further expanding clinical trials and indications. I believe MedAlliance will have a significant impact on addressing several of the key deficiencies that exist in the drug-eluting balloon marketplace today”.

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