www.avitamedical.com Page 1 of 2 MEDIA RELEASE THURSDAY, 26 JUNE 2008 AVITA BEGINS TRADING UNDER AVH 26 June 2008: Avita Medical Limited (formerly named Clinical Cell Culture Ltd) today begun trading on the ASX under its new code AVH. On Tuesday the company completed a 10 for 1 share consolidation. Avita Medical now has 93,476,181 shares on issue. The company is also pleased to release an Investor Update (attached) for shareholders. Avita Medical Managing Director Bill Dolphin said the merged company was making significant progress and expected to announce a number of key developments in coming weeks. “As a merged entity we have hit the ground running, particularly in Australia where our respiratory products are gaining significant sales traction,” said Dr Dolphin. “We have established a number of key milestones for the coming few months and look forward to updating shareholders on our progress in due course,” he said. - ENDS - FOR FURTHER INFORMATION PLEASE CONTACT: William Dolphin Avita Medical Limited Tel: +1 617 209 2190 Email: [email protected]FOR GENERAL INFORMATION PLEASE CONTACT: John McGlue Porter Novelli Tel: +61 (0) 8 9386 1233 Mob: +61 (0) 417 926 915 For personal use only
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www.avitamedical.com Page 1 of 2
MEDIA RELEASE THURSDAY, 26 JUNE 2008
AVITA BEGINS TRADING UNDER AVH 26 June 2008: Avita Medical Limited (formerly named Clinical Cell Culture Ltd) today begun trading on the ASX under its new code AVH. On Tuesday the company completed a 10 for 1 share consolidation. Avita Medical now has 93,476,181 shares on issue. The company is also pleased to release an Investor Update (attached) for shareholders. Avita Medical Managing Director Bill Dolphin said the merged company was making significant progress and expected to announce a number of key developments in coming weeks. “As a merged entity we have hit the ground running, particularly in Australia where our respiratory products are gaining significant sales traction,” said Dr Dolphin. “We have established a number of key milestones for the coming few months and look forward to updating shareholders on our progress in due course,” he said.
- ENDS - FOR FURTHER INFORMATION PLEASE CONTACT: William Dolphin Avita Medical Limited Tel: +1 617 209 2190 Email: [email protected] FOR GENERAL INFORMATION PLEASE CONTACT:
ABOUT AVITA MEDICAL LIMITED Avita Medical Limited is a publicly listed biomedical company that is evolving to become a global medical device company. The merger with Visiomed Group Ltd was completed in February 2008 and following the merger the company is now active in the regenerative medicine and respiratory markets. Regenerative Medicine The company develops and distributes tissue-engineered products for the treatment of wounds and other skin defects. Using proprietary tissue-culture/collection technology, the company is able to provide innovative treatment solutions derived from the patients own skin, to enhance healing rates, reduce scar formation and reintroduce pigmentation into the skin. ReCell® (www.recell.info) is a stand-alone, rapid cell harvesting device that enables surgeons to treat skin defects using the patient’s own cells that are collected during surgery. The surgeon can prepare a small quantity of cells within 30 minutes on site rather than having to send a biopsy to the laboratory. ReCell® has been designed for use in a wide variety of plastic, reconstructive and cosmetic procedures. ReCell® is gaining acceptance in a number of indications including Vitiligo, a common skin pigmentation disease. ReCell® is approved for sale in Australia, Brazil, Canada, Chile, Croatia, European Union, Hong Kong, Israel, Japan, Malaysia, New Zealand, Norway, Singapore, South Africa, Switzerland and Turkey. The company is currently focused on securing FDA approval for sale of the product in the USA. Respiratory The company commercialises innovative medical technologies for improved medication delivery and adherence in patients suffering from chronic respiratory diseases. The company manufactures and sells a range of spacers for the paediatric, adolescent and adult market and is the leading provider of spacers in Australia. The Funhaler® incentive asthma spacer has been designed specifically for the paediatric market, incorporating auditory and visual incentives to encourage children to comply with their medication plan. Clinically demonstrated to improve compliance to prescribed medication by 38% and increase proper inhalation technique in children by 60%. The Funhaler® is patented, CE marked for the EU, FDA cleared for the US and TGA registered in Australia. Breath-A-Tech is the leading spacer for adolescents and adults in Australia. The product is effective, compact, easy to use and competitively priced. The Breath-A-Tech hospital-grade spacer can also be autoclaved in the hospital or clinical setting. www.avitamedical.com
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Dear Shareholder, 2008 has been a year of major changes for the Company: the merger of CCE and VSG was completed in late February; the name changed to Avita Medical to reflect the expanded range of applications in the medical technology sector; a restructuring of the Board and man-agement team; share consolidation; and regulatory clearance for the Company’s Funhaler Paediatric Spacer in the US. This is the beginning of a new and successful company.
My appointment as CEO of Avita Medical commenced 15 June 2008. I have taken on this role with a firm commitment and focus on execution: hitting operational targets, growing revenues, progressing corporate strategic initiatives and recovering shareholder value.
Avita Medical represents a unique approach for an Australian listed medical technology company – a multi-enterprise global medical device company.
The company is exceptionally well positioned for growth. We have a number of products in the market ranging from well established, market-leading products such as the Breath-a-Tech asthma spacer which has captured 75% share of the Australian market, to newly intro-duced, highly innovative technologies such as ReCell®, a unique and revolutionary device in the burgeoning field of regenerative medicine.
Our commercialised products address the respiratory and regenerative medicine markets and are generating revenues. Sales of the Company’s respiratory products in particular are exceeding expectations and we look forward to announcing our financial results for the 12-month period through 30 June 2008 in the coming weeks.
Our markets are large and growing; our products innovative and unique. We have every reason to be confident that we will hit our growth targets and achieve commercial success in the global markets.
The Company has put in place a strategic plan built on five key components:
♦ Increase sales in key markets with regulatory approvals in place ♦ Implement ‘continuous improvement’ models to operations and manufacturing ♦ Obtain regulatory approval for current products in key markets ♦ Enhance our product portfolio and expand applications of our intellectual property ♦ Tighten management of working capital Thank you for your continued support. Please feel free to con-tact me to answer any of your questions or provide additional information regarding our progress. A brief update on the Com-pany’s recent activities follows. Sincerely, William F. Dolphin, Ph.D. - Chief Executive Officer [email protected]
Investor Update HIGHLIGHTS
Change of name to Avita Medical Ltd
Share consolidation completed
New strategic plan in place
Senior management team strengthened
Sales of respiratory products exceeding expectations
Continued expansion into overseas
markets
MANAGEMENT CHANGES
On 15 June 2008, Dr William Dolphin was appointed as Chief Executive Officer of Avita Medical. With 25 years of experience in the international medical device markets, Dr Dolphin has had significant success in growing early stage medical companies, shepherding products through the US FDA approval process and extensive experience in mergers and acquisitions.
Ms Lorraine Glover was recently appointed as General Manager for the Asia Pacific region. Based in Avita Medical’s offices in Perth WA, Ms Glover was previously Executive Manager of Visiomed Group and previous to that was Manger Sales & Marketing Australia. Ms Glover has over 15 years experience in the biotech/medical devices market.
Commencing 1 July 2008 Mr William Marshall will be joining the Company as VP Operations. During 35 years of experience in the medical device industry Mr Marshall has been responsible for management of all aspects of operations including logistics, manufacturing, quality/regulatory programs, IT, telecommuni-cations and technical service working with companies and governments in North America, Europe, Middle East and Asia.
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COMPANY DETAILS
ASX code: AVH Market capitalisation: $9.06m Shares on issue: $93.47m Cash balance: $8.7m (as at 30 April 2008) BOARD & SENIOR MANAGEMENT
Mr Dalton Gooding Chairman, Non Exec. Director Mr Ian Macpherson Director, Deputy Chairman Dr William Dolphin Director, Managing Director Mr Andrew Cannon Director, CFO Dr Paul Watt Director Dr Fiona Wood Non Exec. Director
SALES & MARKETING UPDATE The generation of sales and development of international markets is of the highest priority for Avita Medical.
In April, the Company appointed Clear Sales, one of Australia’s leading pharmacy sales brokers, as distributor for the Australian spacer market. Sales of the Respiratory product line continue to show strong growth with revenues continuing to exceed budget. Sales of the Breath-a-Tech spacers, targeting the adolescent and adult asthma market, are already ahead of the previous quarter and sales of the Funhaler® Incentive Spacer, addressing the needs of the paediatric asthma market, will also be up on the previous quarter.
The Company has continued the expansion of its respiratory spacer products into the large international markets. The Company re-ceived FDA approval for the Funhaler Paediatric Spacer in the United States in December 2007 and has subsequently been work-ing with key thought leaders and distributors to accelerate clinical acceptance of the device. In Europe, the Company is focusing its sales and marketing efforts on a small number of key markets. This strategy appears to be paying off with a steady increase in reorders from European distributors.
The Company is continuing discussions with potential distributors in additional overseas markets, including Germany and Japan. However, we are planning our international efforts to ensure we also continue to remain focused on providing strong support for our current distributors.
Avita Medical has recently implemented a highly structured and targeted sales and marketing strategy for the ReCell® products. As with the respiratory product line, the Company is focussing resources on a small number of select distributors in key markets. Additionally, a direct sales representative has been hired for the UK market. As a novel product introducing a new paradigm to surgeons this remains a concept sale. The Company believes this focused approach will yield positive results in the near term.
Avita Medical is also participating in a French Government-funded medico-economic study for ReCell®. The study is designed to assess the benefits of ReCell® in comparison with the current standard of care. ReCell® will be supplied to a total of 13 centres in France with 200 patients being treated under the study.
In the US, the FDA trial for ReCell® has been hampered by excessively restrictive inclusion criteria and consequently the trial has experienced disappointing recruitment during the last year. The Company is working closely with investigators and the US FDA to implement an effective clinical protocol for the critical US market.
Over the coming months, Avita Medical will be making a considerable investment in its overseas marketing efforts as it continues to build presence globally. It must be kept in mind that regulatory clearance and appointment of a distributor are the first in a series of steps that must be taken in order to penetrate a market. Avita Medical has committed to supporting several clinical studies, attending trade shows and professional conferences, and supporting its distributors with advertising and marketing efforts.
OUTLOOK Avita Medical is determined to become a major player in the multi-billion dollar global medical technology market. The Company’s products offer superior qualities over competing products and Avita Medical is focused on capitalising on these advantages to capture greater market share and generate strong cash flow.
Avita Medical has achieved the projected major growth in sales during the recent Quarter with continued growth expected in Australia and overseas. We will continue our investment in marketing efforts, particularly overseas where we expect to see significant returns and high growth in the com-ing quarters.
While in a strong financial position, cash flow will be tempered somewhat by the expenditures re-lated to reinvigorated sales and marketing programs and build-up of a US office as the company pursues sales in international markets.
Management has set ambitious targets for the coming year – sales, operations and corporate. We are confident that the Company will deliver significant growth and sustained profitability.
