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Anteris Technologies Global Corp. — Capital/Financing Update 2021
Oct 11, 2021
33869_rns_2021-10-11_5be3b26d-182f-498c-b3cf-f4295a4339b0.pdf
Capital/Financing Update
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ASX ANNOUNCEMENT
12 October 2021
ANTERIS ANNOUNCES PARTNERSHIP WITH LEADING RESERCH ORGANISATIONS FOR ITS DURAVR™ EARLY FEASIBILITY STUDY AND APPOINTMENT OF M&A ADVISER
Brisbane, Australia and Minneapolis, USA . Anteris Technologies Ltd (ASX: AVR) (“Anteris” or the “Company”) announces its partnership with IQVIA Inc (“IQVIA”) and the Cardiovascular Research Foundation (“CRF”) for its plan to conduct an FDA early feasibility study (“Study”).
CRF and IQVIA have led hundreds of cardiovascular clinical trials, including many landmark studies in the TAVR space. Their vast experience positions them as prime partners for the Company’s clinical program.
IQVIA will be responsible for clinical data monitoring, project and site management, data management and safety. CRF will provide core lab services for the Study (echo CT) and the independent Clinical Events Committee.
The Study is a single arm, multi-center clinical trial designed to test the safety and feasibility of the Company’s DurAVR™ THV System on patients with severe aortic stenosis. It will focus on durability and calcification at 30 days post implant procedure as a primary end point. It will also include a durability study over 10 years as part of the long term follow up. This Study represents an important milestone in the DurAVR™ clinical development program as it will provide valuable clinical data to support the Company’s pursuit of regulatory approvals in multiple geographies.
Further details on CRF and IQVIA are provided below.
CRF
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Renowned nonprofit research and education organization founded by Dr Martin Leon MD (Professor of Medicine at Columbia University) more than 25 years ago and led by visionary physicians, key opinion leaders the field of interventional cardiology.
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The CRF’s Clinical Trials Center (CTC) plans and executes clinical investigations from first-in-man studies to large, multicenter, international trials and provides expert, independent qualitative and quantitative analyses of clinical and imaging data.
IQVIA
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IQVIA is one of the world largest clinical research organizations, with global footprint and reputation.
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IQVIA has completed hundreds of studies in the cardiovascular medical device space in different phases of research from EFS with novel products under the FDA Breakthrough Program to large post-market studies/registries.
Anteris Technologies Ltd Registered Office: Toowong Tower, Suite 302, Level 3, 9 Sherwood Rd, Toowong, Queensland, 4066 Customer Service
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T +61 1300 550 310 | F +61 1300 972 437 | E [email protected] | W anteristech.com Brisbane ▪ Minneapolis ▪ Geneva ▪ Malaga
Appointment of Piper Sandler as M&A adviser
The Company has engaged US investment bank Piper Sandler & Co. as its M&A adviser. Piper Sandler ranks number one in Med-Tech M&A advisories by number of sell-side deals, cross border deals and buy-side deals[1] . The firm is the leading Med-Tech equity bookrunner and has an accomplished Med-Tech research team[2] .
“These appointments mark a significant milestone. Not only are the companies we have partnered with the best in their space but they also validate the Company’s viability by them agreeing to work with us. Having these important partnerships in place as we head towards our human TAVR study ensures Anteris is well prepared to optimize the future,” Anteris CEO Wayne Paterson said.
ENDS
About Anteris Technologies Ltd (ASX: AVR)
Anteris Technologies Ltd is a structural heart company delivering clinically superior and durable solutions through better science and better design. Its focus is on developing next generation technologies that help healthcare professionals create life-changing outcomes for patients.
The Anteris DurAVR™ aortic replacement valve addresses the acute need in terms of superior hemodynamic profile as well as chronic needs in its ability to sustain that profile longer over the lifetime of the patient.
The proven benefits of its ADAPT[®] tissue technology, paired with DurAVR™’s unique 3D singlepiece aortic valve design, has the potential to deliver a functional cure to aortic stenosis patients and provide a much-needed solution to the challenges facing heart surgeons today.
Authorisation and Additional information
This announcement was authorised by the Board of Directors.
For more information:
Hannah Howlett WE Communications E: [email protected] P: +61 4 5064 8064 www.anteristech.com Twitter: @AnterisTech Facebook: www.facebook.com/AnterisTech
1 Source: Piper Sandler, Healthcare The right partner to realize your vision , https://www.pipersandler.com/2col.aspx?id=111, viewed 11 October 2021. 2 Source: Piper Sandler, Healthcare The right partner to realize your vision , https://www.pipersandler.com/2col.aspx?id=111, viewed 11 October 2021.
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