? HSV-2 therapeutic vaccine Phase II study closed and initial study results pending
? CardioCel® used in over 135 centres globally
? Aortic Heart Valve reconstruction study initiated at leading Heart Centres
? Growing revenue and strong cash position heading into 2016
Brisbane, Australia 24 December 2015
Admedus Limited (ASX: AHZ) today announced it has finished 2015 in a strong position following a number of key milestones achieved throughout the year.
“2015 has been a very positive year for Admedus and we approach 2016 in a very strong position. In the last 12 months, we have focused on the ongoing global launch of CardioCel and this has resulted in continued quarter on quarter revenue growth and an additional 80 new centres using CardioCel to treat cardiovascular diseases. We have also made significant progress in our immunotherapy programs with key clinical data expected in 2016,” said Admedus CEO, Mr Lee Rodne.
HSV-2 Study Update
The HSV-2 therapeutic vaccine Phase II study has closed recruitment, with over 40 study participants in the study. Admedus will continue to progress the existing study participants through the trial to ensure all study participants complete the vaccination period.
The study is progressing well with 25% of study participants having received their six month booster. The Company anticipates the release of additional study data early in the first quarter of 2016 when all study participants have received their initial doses.
The Phase II study is designed to examine the safety of the HSV-2 vaccine in people with the virus as well as look at its ability to stimulate an immune response against the virus.
HPV Therapeutic Vaccine
Admedus has been working with Professor Ian Frazer on his next HPV product as a treatment against HPV and associated cancers.
In 2015, the HPV therapeutic vaccine continued to show exceptional pre-clinical results targeting HPV and HPV related tumours and is scheduled to enter into a Phase Ib study in 2016 in HPV infected patients.
The Company has completed manufacture of the therapeutic vaccine, which is currently in formal preclinical studies in preparation for the initiation of the Phase 1b clinical study.
Aortic Valve Reconstruction Post-market Study
Admedus continues to progress its post market aortic heart valve study with two of the intended four centres now recruiting patients and over 10% of patients already enrolled. Admedus anticipates the additional study centres to initiate recruitment in the first quarter of 2016.
The purpose of the study is to highlight the improved patient benefits of using CardioCel to reconstruct aortic heart valves versus the need to replace it with a bio-prosthetic valve. Current data suggests CardioCel can address the disadvantages found with existing bio-prosthetic valves, which are known to have complications for patients and result in a need for replacements or re-do surgery.
Aortic stenosis is the most common valvular heart disease in developed countries, with the incidence rate of around 25% in people over the age of 65 and prevalence increasing with age. Last year, there were 165,000 aortic valve replacement surgeries undertaken in the US alone. While these were symptomatic patients, Admedus expects the market size for valve reconstruction will be larger once the benefits of treating patients earlier and more effectively is recognised.
CardioCel®
In the last 12 months, the Company achieved approval for CardioCel in Hong Kong, Singapore and Malaysia, opening up more of the Asian market. In addition, sales of CardioCel have continued to grow with quarter on quarter sales growth throughout 2015, with the December quarter continuing to be strong for sales, a clear indication of growing interest in the product and its benefits for patients.
During the year, an additional 80 centres came on board using CardioCel to treat cardiovascular defects. The Company has also expanded the CardioCel product range with the addition of 2cm X 2cm and 2cm x 8cm sized products. Admedus will continue to focus on growing revenue for CardioCel in 2016 in both the paediatric and adult markets treating congenital heart defects and repairing and reconstructing heart valves, increasing centre on centre growth and opening up new markets. Admedus anticipates its first sales in the MENA region in the first quarter of 2016.
Regenerative Tissue Portfolio
Admedus has been very successful this year in expanding our ADAPT® regenerative tissue portfolio for additional soft tissue repair applications.
In 2016, the Company is looking to launch a vascular repair tissue product to complement its existing CardioCel sales in the cardiovascular surgical repair and reconstruction market. The launch of a vascular product franchise will help build Company revenue over the coming years and is intended for procedures such as repairing the carotid arteries to reduce the incidence of stroke.
Our R&D team will continue to progress key regenerative ADAPT tissue projects in 2016 in dura mater repair (to treat head and brain injuries) as well as progressing our ADAPT tissue scaffolds for stem cell and cellular therapy delivery and ‘off-the shelf’ whole vessels for applications such as coronary artery bypass grafts (CABG).
Admedus will provide updates on these projects throughout 2016.
“2016 is shaping up to be a very exciting and important year for Admedus with growing sales, key product launches, progressing our regenerative tissue pipeline and important clinical milestones in our regenerative tissue and immunotherapy programs. The Company is looking forward to continuing to build our company with many successes in 2016” said Mr Rodne.
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For more information, please contact:
Dr Julian Chick | Chief Operating Officer | Admedus Limited
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About Admedus Limited
Admedus (ASX: AHZ) is a specialist healthcare company. 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, profitable medical sales and distribution business. The company has assets from research & development through clinical development as well as sales, marketing and distribution.
Admedus has commercialised its innovative tissue engineering technology for regenerative medicine in four continents. We also have a major interest in developing the next generation of vaccines with a Brisbane-based research group led by Professor Ian Frazer. The vaccine programmes target disease with significant global potential, such as Herpes and Human Papillomavirus.
Further information on the company can be found on www.admedus.com
