Tele: 561.316.3330
Breaking Medical Device News

Monday, October 18, 2021
HomeFUNDINGSELUTION SLR Enrollment of 4 Clinical Studies to Commence: MedAlliance Raises over...

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

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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Adam S. Epstein New CEO of AliMed, Inc.

In his prior role as Chief Commercial Officer, Epstein directed all customer-facing, demand generation and product development activities. Under his new leadership, AliMed will continue to build a robust portfolio of contracted positions with major, national GPO’s, IDN’s, and Distribution partners to drive sales growth.

Tony Collins Appointed CFO of Xenter

“Xenter is building a platform for medical innovations that is transformational. The only way we can achieve our objectives is if we have great leaders like Tony Collins leading our company,” stated Richard J. Linder, Founder, Chairman & CEO of Xenter, Inc. “Tony brings incredible depth and experience to his new role as Chief Financial Officer.

HistoSonics Receives FDA “Breakthrough Device Designation” for Novel Sonic Beam Therapy

Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat.

Scott Sexton Appointed President at FIGUR8

"Scott brings to FIGUR8 30 years of workers' compensation, casualty, disability, and commercial health experience, most recently serving as a market leader for CorVel's national carrier practice sales team," said Nan-Wei Gong, CEO, and co-founder of FIGUR8.

Endolumik Inc. of Morgantown Secures $175,000 Angel Investment from Country Roads Angel Network

Endolumik, Inc. was founded in May 2020 by Mara McFadden, chief executive officer, and Dr. Nova Szoka, inventor of the surgical device.

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced...

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

By using this website you agree to accept Medical Device News Magazine Privacy Policy