Avita Medical (ASX:AVH), a regenerative medicine company specialising in the treatment of wounds and skin defects, is undertaking a capital raising in aggregate to raise $16.9 million.
The company said the funds will be used to support its preparedness for US ReCell commercialisation for burn injuries and to further evaluate new indications.
The company said it has received commitments from wholesale and institutional investors for a private placement of $4.5 million at an issue price of $0.045 per share (Private Placement).
"Avita also proposes to undertake a non-renounceable rights issue to existing shareholders (Rights Issue) offering one new share for each 2.8 existing shares (as at the record date) at the same issue price as under the Private Placement," said the company.
According to Avita CEO, Dr Mike Perry, "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 US 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.
“This fund raising is expected to underpin Avita through key milestones including, initial BARDA product procurement, US FDA approval, and the launch of ReCell in the US burns market.
“What we consider compelling for investors is the strength of our clinical data from the two US trials of 131 patients at 12 leading US 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 US 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.”
Last month Avita submitted a Pre-Market Approval application for its ReCell Autologous Cell Harvesting Device for treatment of burn injuries to the US FDA.