SELUTION SLR Enrollment of 4 Clinical Studies to Commence: MedAlliance Raises over USD 50 Million from New Investor

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Sirtex Medical and BlackSwan Vascular Report 1st Patient Enrolled in Pivotal LAVA Study

The LAVA Study, which stands for Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature, is a prospective, multicenter single-arm study of 113 subjects at 20 investigational sites in the U.S.

March 17, 2021

SELUTION SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of a limus drug, with a similar elution time to that of a drug-eluting stent (DES), whilst leaving nothing behind.

MedAlliance notes the new investor is Trustar Capital (formerly known as CITIC Capital Partners).

Proceeds from the financing will be used to fund the commercialization of SELUTION SLR™ and support global clinical programs including the enrolment of four additional FDA IDE studies this year. The US coronary ISR study is underway and began enrolment in July 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 recently been awarded breakthrough status for SELUTION SLR™ in the treatment of atherosclerotic lesions in native coronary arteries.  This is the fourth breakthrough designation awarded to MedAlliance for its sirolimus DEB, following coronary in-stent restenosis, peripheral below-the-knee, and AV-Fistula indications.

In February 2021 MedAlliance enrolled the first patient in SUCCESS PTA, a 700-patient post-market study with SELUTION SLR™ for the treatment of peripheral artery disease (PAD). This is the largest study undertaken to date with the device. Data from the SUCCESS PTA study will be part of the clinical evidence supporting CE Mark renewal in 2023/2024 under the new European Medical Device Regulation (MDR).

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.  The global market for DEB is estimated to be worth over USD 1.5 Billion.

“We are very pleased to have Trustar Capital as a valued partner and have established a strong relationship with their team over a substantial period of time.  Their in-depth knowledge and expertise in the global medical device market will be of tremendous benefit to us”, said Jeffrey B. Jump, Chairman, and CEO of MedAlliance.  “Validation from this highly successful and respected organization represents a significant endorsement of both our technology and our team and will help us to improve and extend the lives of patients around the world.”

Boon Chew, Senior Managing Director and Managing Partner of Trustar Capital, said: “The global market size for medical devices addressing coronary and peripheral diseases has increased in recent years. In particular, we have seen exciting breakthroughs in technological development and clinical adoption in the interventional device space. MedAlliance has a very solid team of seasoned veterans with strong R&D capability and has successfully developed innovative products that lead the market in terms of technology and registration progress. We have been closely following MedAlliance for a considerable amount of time and have established a strong relationship with its management team.  We are excited to be working together and will continue to bring good news to coronary and peripheral disease patients worldwide.”

SELUTION SLR™’s 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. 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.

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