Avita Medical, a regenerative medicine company specializing in the treatment of wounds and skin defects, is gearing up for entry to the U.S. market pending regulatory approval of its ReCell therapy.
The Perth, Australia-based company, which has its main U.S. offices in Valencia, is raising $16.9 million Australian, equal to $13.2 million in U.S. currency.
Avita has received commitments from wholesale and institutional investors for a private placement of A$4.5 million at an issue price of A$0.045 per Avita share. It is also issuing one new share of stock to existing shareholders for each 2.8 existing shares.
“We sincerely appreciate the support received from investors under the private placement, indicating confidence in Avita’s pursuit of its future milestones, including [pre-market approval] in 2018 followed by a successful commercial launch of ReCell in the U.S. burns market,” said Avita CEO Dr. Mike Perry in a statement. “In gratitude for the support from our shareholders, we have also secured for them the opportunity to invest at the same issue price.”
Perry said the fundraising is expected to underpin Avita through key milestones including, initial BARDA product procurement, U.S Food and Drug Administration approval, and the launch of ReCell in the U.S. burns market.
BARDA is the Biomedical Advanced Research and Development Authority, a U.S. Department of Health and Human Services office responsible for developing countermeasures principally against bioterrorism, but also including chemical, nuclear and radiological threats as well as pandemic influenza and emerging diseases.
“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 centers demonstrating that use of the ReCell device results in significantly less donor skin harvesting, relative to standard care, for treatment of burn injuries,” Perry said. The data revealed a 97.5 percent 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 September, Avita submitted a Pre-Market Approval application for its ReCell Autologous Cell Harvesting Device for treatment of burn injuries to the FDA. This is a precursor to achieving U.S. product approval.
Avita’s patented and proprietary collection and application technology provides treatment solutions derived from the regenerative properties of a patient’s own skin combined with wound healing factors. The product is marketed in Europe, Australia, and China. In the United State, it continues to be limited by federal law to investigational use.
