NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM -- (Marketwired) -- Oct 28, 2015 -- Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, today announced its financial results and provided a corporate update for the first fiscal quarter of 2016 which concluded on 30 September 2015.
Q1 and Recent Business and Clinical Development
- ReCell® revenues for the quarter increased 52% year-over-year
- Total sales for the quarter increased 5.1% year-over-year and 1.6% on a sequential basis
- Awarded a contract with BARDA for up to USD$53.9M
- Received CE Mark for ReGenerCell and ReNovaCell
- Entered into a research partnership with University of Huddersfield
- Received patent validation in 11 European Countries
- Secured AUD$10 million in equity financing to support ongoing commercialization efforts and operational expenses
- Achieved significant clinical trial progress for FDA U.S. Pivotal Trial for acute burn, enrolling 24 of the 30 targeted subjects
- Remain on track for results of Venous Leg Ulcer randomized controlled pilot trial in Q4 CY2015
- Publication of results from a series of cases using ReCell® showing clinically significant improvements in aesthetic outcomes in the Journal of Cranio-Maxillo-Facial Surgery
- First patient treated in investigator-initiated trauma wound trial at Walter Reed National Military Medical Center
- FDA-approval of expanded Compassionate Use Investigational Device Exemption (IDE) program for ReCell® to continue clinical evaluation on twice as many patients as originally permitted
- Presentation of three academic papers at the 16th European Burns Association Congress that further demonstrate ReCell®'s effectiveness
During the first fiscal quarter of 2016, Avita continued to increase sales, enhance its financial strength, and position the company for growth across global markets. Total group sales in the quarter were 5.1% higher than the same quarter last year. In particular, Avita achieved revenue growth of 52% for its ReCell® segment during the first quarter compared to the previous year, with strong showings in Germany and China, and new market expansion into Taiwan.
Importantly, Avita was recently awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), a unit of the United States government responsible for federal disaster preparedness. This contract is worth up to USD$53.9 million and further validates the Company's point-of-care technology to regenerate healthy skin damaged from burns and the importance of preparedness for mass casualty scenarios involving burn injuries. This is a five-year contract that includes procurement of ReCell® devices while also providing capital to support Avita's ongoing clinical efforts in the U.S. as it works toward FDA approval for commercialization.
In October, Avita closed an AUD$10 million capital raise to support its ongoing growth efforts. This includes funds for operational expenses as well as providing support for the Company's execution of its large scale contract with BARDA. Funds from this financing will provide sufficient capital for the company for at least the next twelve months.
In addition, the Company announced publication of four academic papers in leading medical journals that further demonstrate ReCell®'s clinical effectiveness for triggering healing in burns, and helping with scar revision and repigmentation. Three of these papers were recently presented to peers in the wound-care space at the 16th European Burns Association Congress, of which the Congress proceedings appeared in a September supplement to the Annals of Burns and Fire Disasters. A report published in the Journal of Cranio-Maxillo-Facial Surgery represents one of the many real-world aesthetic applications of Avita's unique ReCell® technology. Results demonstrated that a secondary procedure including RES™ produced by ReCell® improved the pigment, volume, texture and elasticity of free flaps in the facial region in patients with repaired complex facial defects resulting from surgical removal of non-melanocytic skin cancers.
Regarding the FDA U.S. Pivotal Trial for acute burns, Avita has achieved significant clinical trial progress by enrolling 24 of the 30 targeted subjects and is on track to complete recruitment by the end of 2015.
Also on the clinical front, Avita recently announced commencement of enrolment at Walter Reed National Medical Center of an investigator-initiated trial to evaluate how ReCell® can be used to treat trauma wounds suffered by civilians and wounded military personnel. Avita will play an advisory supporting role in the study, which is funded through a US Department of Defense research program. Given that physicians are often limited in choice of donor sites for skin grafts when treating injuries associated with severe trauma, Avita believes there is a tangible need for an acceptable alternative to conventional skin autografting.
Adam Kelliher, Chief Executive Officer of Avita Medical, commented, "We entered the fiscal year with a renewed vigor led by a focused and dedicated management team with strong industry knowledge and a long-term vision for the Company. We are making tremendous strides to move the Company forward and bring our innovative, regenerative skin therapy to markets, and more importantly patients, that can truly benefit from our product. Through the increased sales over the last quarter, we believe that physician end-users are starting to recognize the true benefit that our technology can bring to patients in healing patients quickly with an aesthetic likeness to their natural skin. We look forward to continuing the momentum generated over this quarter and continuing to expand access to our ReCell® portfolio of products for the treatment of wounds, burns and skin defects."
ABOUT RECELL® AND RES™
ReCell® is Avita Medical's unique proprietary technology that enables a clinician to rapidly create, at point of care in approximately 30 minutes, Regenerative Epithelial Suspension (RES™) using a small sample of the patient's skin. RES™ is an autologous suspension comprising the cells and wound healing factors necessary to regenerate natural, healthy skin. RES™ has a broad range of applications and can be used to restart healing in unresponsive wounds, to repair burns using less donor skin yet with improved functional and aesthetic outcomes, and to restore pigmentation and improve cosmesis of damaged skin.
ABOUT AVITA MEDICAL LIMITED
Avita Medical develops and distributes regenerative products for the treatment of a broad range of wounds, scars and skin defects. Avita's patented and proprietary collection and application technology provides innovative treatment solutions derived from a patient's own skin. The Company's lead product, ReCell®, is used in the treatment of a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell® is patented, CE-marked for Europe, TGA-registered in Australia, and CFDA-cleared in China. In the United States, ReCell® is an investigational device limited by federal law to investigational use. A pivotal US trial is underway, with patient enrollment completion anticipated by the end of 2015. To learn more, visit www.avitamedical.com.
Release with 4C report, click here.
FOR FURTHER INFORMATION Avita Medical Ltd Adam Kelliher Chief Executive Officer Phone: +44 (0) 1763 269 772 [email protected] UK/EU Instinctif Partners Gemma Howe/Sue Charles T +44 (0)20 7866 7860 [email protected] Avita Medical Ltd Tim Rooney Chief Financial Officer Phone: + 1 (818) 356-9400 [email protected] USA The Ruth Group Lee Roth, Investor Relations Kirsten Thomas, Public Relations Phone: +1 (646) 536-7012 / +1 (508) 280-6592 [email protected] / [email protected] Avita Medical Ltd Gabriel Chiappini Company Secretary Phone +61(0) 8 9474 7738 [email protected] Australia Monsoon Communications Rudi Michelson Investor Relations / PR Phone: +61 3 9620 3333 [email protected]
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