Avita Medical (ASX:AVH) said today that it hopes to raise $13.2 million to fund its efforts to bring its ReCell autologous cell harvesting device for treatment of burn injuries to the U.S.
The Australia-based company said it received commitments from investors for a $3.5 million private placement. Avita added that it plans to undertake a rights issue to existing shareholders, offering one new share for every 2.8 existing shares at 3¢ apiece.
“We sincerely appreciate the support received from investors under the private placement, indicating confidence in Avita’s pursuit of its future milestones, including PMA approval in 2018 followed by a successful commercial launch of ReCell in the U.S. burns market. In gratitude for the support from our shareholders, we have also secured for them the opportunity to invest at the same issue price,” CEO Mike Perry said in prepared remarks.
“This fund raising is expected to underpin Avita through key milestones including, initial BARDA product procurement, U.S. FDA approval, and the launch of ReCell in the U.S. burns market.
“What we consider compelling for investors is the strength of our clinical data from the two U.S. trials of 131 patients at 12 leading U.S. burn centres demonstrating that use of the ReCell device results in significantly less donor skin harvesting, relative to standard care, for treatment of burn injuries. The data has revealed a 97.5% reduction in donor skin harvested for treatment of second-degree burn injuries, while also showing a 4.4 times greater likelihood of donor site healing for those patients after just one week. In our U.S. FDA pivotal trial for third-degree burns we achieved the co-primary endpoints along with data exhibiting a 32% reduction in the use of donor skin, with no safety concerns.”
In September, Avita submitted a pre-market approval application for its ReCell device to the FDA.
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