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Anteris Technologies Global Corp. — Capital/Financing Update 2017
Nov 13, 2017
33869_rns_2017-11-13_a4868d6f-8e4a-409e-9778-5fe16ca800d6.pdf
Capital/Financing Update
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NEWS RELEASE 14 November 2017
UPDATE ON THE ADMEDUS SHAPED PATCH PRODUCT FRANCHISE
Minneapolis USA – Admedus Limited (ASX:AHZ) today announced the successful conclusion of its CardioCel 3D expanded evaluation program and its intention to commence sales of this new flagship product in North America from 1 February 2018.
The successful evaluation phase of CardioCel 3D has also led to a potential line extension for the VascuCel product range, with Admedus submitting a Note to File for the development of a new three-dimensional scaffold product to be used in peripheral vascular repair.
These are exciting developments for Admedus which further demonstrate the versatility and reliability of its clinically superior ADAPT technology platform.
Earlier this year, Admedus received FDA 510(k) clearance to market CardioCel 3D in North America, this led to an expanded evaluation program to gather expert data before the product’s full commercial introduction.
The program has been very successful, with a significant number of highly complex congenital heart defect (CHD) arch repair cases completed across seven key reference centres across North America and Australia.
Throughout the evaluation program, world-leading physicians have expressed positive feedback and enthusiasm for the benefits of CardioCel 3D, including, its optimized arch shape, off-the-shelf availability, non-antigenic response and unique calcification resistance.
“We have taken a strategic and measured approach with CardioCel 3D to ensure the product is backed by the best possible science. The evaluation program has provided us with extensive clinical data and we’re extremely excited by the results,” said Admedus CEO Wayne Paterson.
We have worked closely with leading surgeons and Admedus staff have been in attendance for the majority of operations as advisers. Therefore, we can now bring CardioCel 3D to market with complete confidence and look forward to releasing it for sale in North America from 1 February 2018.”
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“The 3D evaluation program also provided valuable data and experience that presented an exciting opportunity to develop another three-dimensional product (half pipe) for potential use in peripheral vascular repair as an extension of our VascuCel range,” added Paterson.
“These are both important developments that further validate the enormous potential of Admedus ADAPT beyond the flat tissue space as we look towards a future in high-value 3D applications of our proprietary technology,” Paterson said.
Background
CardioCel 3D represents a disruptive technology in the $2.5 billion heart valve repair and replacement market. It is the first product of its kind and is for heart procedures that require more than a single dimension patch material to optimise cardiac and vascular repair. It is already coming off the line at the company’s state-of-the art manufacturing facility in Australia. Some 85% of surgeons polled by Admedus stated they would use CardioCel 3D immediately and the recent experience of the expanded evaluation program is consistent with that encouraging finding.
VascuCel features all the benefits and features of the proprietary Admedus ADAPT technology and is used in vascular repair and reconstruction procedures. The flat patch is currently available in North America where approximately 250,000 vascular repair procedures are performed each year in a commercial market worth an estimated $500M. It offers optimized healing, superior clinical performance, enhanced procedural efficiency and improved handling.
About Admedus Limited
Admedus (ASX:AHZ) is a medical technologies company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. Our focus is on investing in and developing next generation technologies with world class partners, acquiring strategic assets to grow product and service offerings and expanding revenues from our existing medical sales and distribution business. The company has assets from research & development through clinical development as well as sales, marketing and distribution.
Website: www.admedus.com Twitter: @Admedus Facebook: www.facebook.com/pages/Admedus
For more information, please contact:
Admedus Limited Barb Ferres +61 7 3152 3216 [email protected]
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