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1 November, 2006 - 17:34 By Staff Reporter

C3 eyeing the American dream

Clinical Cell Culture (C3) has announced plans to raise £4 million so it can take its flagship skin regeneration product, ReCell, through the necessary regulatory process that will allow it to break a potentially huge United States market.Clinical Cell Culture (C3) has announced plans to raise £4 million so it can take its flagship skin regeneration product, ReCell®, through the necessary regulatory process that will allow it to break a potentially huge United States market.

The Cambridge company has six centres lined up to conduct the clinical trials and hopes to gain approval in the US by quarter three of 2007, though this is dependent on subject recruitment for the trials.

ReCell is a stand-alone, ‘off-the-shelf’, rapid cell harvesting device that enables surgeons to treat skin defects using the patient’s own cells that are collected during surgery and has been designed for use in a wide variety of plastic, reconstructive and cosmetic procedures.

The surgeon can prepare a small quantity of cells within 30 minutes on site rather than having to send a biopsy to the laboratory, producing a large enough cell population to treat minor burns and wounds.

C3’s failure to achieve US approval for ReCell within its original timeframe has proved a costly miss for the Australian-founded firm, which has had to mothball a number of projects, reduce staff by a quarter and review both strategy and company targets to offset a monthly cash burn which reached £330,000.

As well as facing a 12 month delay in its efforts to achieve regulatory approval, ReCell has suffered in some of the other markets where the product is already selling.

C3’s chief financial officer, Andrew Cannon, said: “Commercialisation has taken longer than we wanted and entrance to the US markets is now a major focus. We are also focusing on key approved markets and are taking appropriate steps to change certain distributors.”

C3 intends to to raise A$10 million (£4.0m) in additional capital via a Share Purchase Plan (SPP) underwritten by Bell Potter Securities on the Australian Stock Exchange.

This gives existing shareholders the opportunity to subscribe for shares in C3 up to a maximum value of A$5,000 (£2,020) at a price of A6.8 cents (2.7 pence) per share. It represents a discount of 30 per cent to the weighted average market price of the company’s shares in the five trading days immediately preceding the date of fundraising announcement.

Chief executive officer at C3, Bob Atwill, said: “C3 had taken major steps forward in recent months in terms of product commercialisation and alignment of distributors to maximise penetration in key approved markets.

“The additional capital will provide the company with the financial strength and capacity to fully commercialise C3’s tissue engineering technology, and in particular provide C3 with the financial resources required to continue to roll out C3’s core product offering, ReCell.

“Approval for the sale of ReCell in the United States and the selection of the right partners for its successful launch remain the most important milestone for C3 and we remain on track to secure Food and Drug Administration (FDA) app-roval in the third quarter of 2007.

“This capital raising will ensure C3 has the financial capacity to implement our growth strategy in existing approved markets. It will also enable high potential markets to be funded through regulatory approval and most importantly support our trial, approval and entry into the lucrative US market.”

Though C3 took the decision to raise the funds on the Australian Stock Exchange, rather than make a dual listing by going on to London’s Alternative Investment Market, the company still looks favourably on the London markets.

Cannon, said: “At this stage we decided to go with the Australian option, though we have not ruled the London option out yet.”

ReCell has already been approved in Argentina, Aus-tralia, Canada, Chile, Croatia, the European Union, Hong Kong, Israel, Japan, Malaysia, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Switzerland and Turkey.

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