Company Funded Through Results of U.S. Early Feasibility Study of DurAVR�

BRISBANE, Australia and EAGAN, Minn.--(BUSINESS WIRE)--Anteris Technologies Ltd (ASX: AVR), a structural heart company developing DurAVR�, the world�s only balloon-expandable, 3D single-piece biomimetic aortic valve, announced today the completion of a A$35M equity fundraising initiated on February 9^th 2023. In this transaction the Company has issued 1.458 million new ordinary shares to at an issue price of $24.00 per New Share, to raise the A$35 million amount. Newly issued shares will commence trading today.

The company�s two largest share-holders Perceptive Advisors and L1 Capital corner-stoned the Placement, each subscribing beyond their existing pro-rata shareholding. The transaction also saw returning investors Sio Capital, and CEO Wayne Paterson. Additionally, the Company welcomes New York based Affinity Asset Advisors, a healthcare dedicated fund, into this syndicate. This raise also marks the first US-Australian joint fundraise for the Company.

Proceeds from the Placement will be used primarily for the clinical development of DurAVR�, the Company�s 3D single-piece aortic valve (TAVR) for the treatment of aortic stenosis and for general working capital purposes.

Participants in the Placement will also receive one attaching unlisted option to acquire an ordinary share in Anteris for each New Share, expiring two years from the date of issue with an exercise price of $29.00. The face value of these options, if exercised, can bring in a maximum of A$56M funding into the company over the following two year period.

Anteris also takes this opportunity to announce the milestones in front of the Company in the next 6-12 months. The Company announces that its 15 aortic stenosis patient US Early Feasibility Study (EFS) will commence across 7 TAVR Centers of Excellence in early 2Q2023 and will report interim and final 30-day data in 3Q2023. This trial will also report 3-month data in 4Q2023 and then proceed to its 12-month safety and efficacy milestone for 2Q2024.

In parallel, in 1H2023 the company will report 12-month data from the second cohort of patients (n=8) from its 13 patient ex-US pilot study. This data will build upon the successful 12-month data that was already reported for the first cohort of patients (n=5 of 13) in Jan 2023. With 12-mo ex-US data and 30-day and 3-month data from the US EFS study, Anteris will approach the FDA to finalize the design of their premarket authorization (PMA) trial of US approval of DurAVR�. Additional clinical milestones will be announced through the course of 2023.

CEO Wayne Paterson commented �With the lineup of clinical work that Anteris has to accomplish in 2023 I am incredibly pleased the Company has strong support from new and existing investors through today�s $A35M raise. This kind of capital assurance enables us to march forward confidently with our novel, biomimetic, first-in-class TAVR technology DurAVR�. With our US EFS study initiating in early 2Q2023, the A$35M raise completed today funds the Company through the completion of that trial, release of data and conversations with the FDA towards a plan for the pivotal (PMA) trial for US commercialization.�

About Anteris Technologies Ltd (ASX: AVR)

Anteris Technologies Ltd is a structural heart company that delivers clinically superior and durable solutions through better science and better design.

Its focus is developing next-generation technologies that help healthcare professionals deliver consistent life-changing outcomes for patients.

Anteris� DurAVR� 3D single-piece aortic heart valve replacement addresses the needs of today�s younger and more active aortic stenosis patients by delivering superior performance and durability through innovations designed to last the remainder of a patient�s lifetime.

The proven benefits of its patented ADAPT^� tissue technology, paired with the unique design of our DurAVR� 3D single-piece aortic heart valve, have the potential to deliver a game-changing treatment to aortic stenosis patients worldwide and provide a much-needed solution to the challenges facing doctors today.

Authorisation and Additional information

This announcement was authorized by Mr Wayne Paterson, Chief Executive Officer.

www.anteristech.com
Twitter: @AnterisTech

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LinkedIn: https://www.linkedin.com/company/anteristech

Contacts

Investor contact

Deanne Curry

GRACosway

E: [email protected]
M: +61 414 388 997

Media contact

Nick Howe

GRACosway

[email protected]
M: +61 407 183 221