Ruling Means Earlier Regulatory Approval in the US for ReCell(R)
NORTHRIDGE, CA, USA and CAMBRIDGE, UNITED KINGDOM -- (Marketwired) -- Dec 14, 2015 -- Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY)
- FDA rules Avita's ReCell® device is eligible for earlier regulatory approval under EAP guidelines
- FDA says device eligible because it may offer 'significant, clinically meaningful advantages' over other current alternatives in the US for burns treatment
- New approval date remains to be determined in follow-on discussions with the FDA
- Company now nearing completion of patient enrollment for US regulatory approval trial
Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, today announced that the US FDA has ruled that the ReCell® Autologous Cell Harvesting Device is eligible for earlier regulatory approval for burns treatment in the United States.
The ruling came under new FDA guidelines called the Expedited Access Pathway (EAP), which are aimed at helping patients get more timely access to life-saving medical devices, while preserving the statutory standards of safety and effectiveness for Premarket Approval (PMA). In a written response to the Company's formal request for an EAP designation, the FDA said ReCell® meets the EAP criterion in that "the device may offer significant, clinically meaningful advantages over existing legally marketed alternatives."
The FDA's Center for Biologics Evaluation and Research (CBER) issued the designation, and will now enter into further discussions with Avita to resolve a data development plan that will describe the extent of preclinical and clinical data required to support the PMA. A strategic data development plan, combined with priority review, is anticipated to underpin an earlier timeline. Avita is currently near to completing enrollment in its FDA approval trial being conducted at seven of the nation's leading burns centers, with 26 of the 30-patient target recruited. Prior to receiving the notice of EAP eligibility, the Company estimated that regulatory approval would come in Q3 2017, pending submission to the FDA of full safety and effectiveness data, under an application on the PMA regulatory route.
"The FDA's decision that we meet the criteria tallies with our view that ReCell® is a unique offering for helping burns victims, and as such, approval would be preferable sooner than later," said Andrew Quick, Avita's Vice President of Research & Technology. "So we are very excited that we can now advance discussions with the Agency to determine exactly how this changes our timeframes."
The FDA's program is titled "Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions." It was introduced in April, and Avita is one of the first to achieve a designation of meeting the criteria. In addition to interactive review of a data development plan, the EAP program features involvement of senior FDA management and the use of a case manager. The scheme does not relax any of the FDA's safety or effectiveness requirements, but allows early approval with commitments that all data will be submitted to the FDA under agreed timeframes.
The Company is also engaged with the FDA under a Compassionate Use program, under which US burns centers are able to use ReCell® when no other treatment is possible. The number of patients allowed to access this scheme was recently doubled to 24 based on demand from various burns surgeons, who have used the device with encouraging clinical outcomes. As such, the Company believes its credentials as a supplier of a life-saving device for burns are now achieving recognition in the US.
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 U.S. trial is underway, with patient enrollment completion anticipated by the end of 2015. To learn more, visit www.avitamedical.com.
FOR FURTHER INFORMATION Avita Medical Ltd Adam Kelliher Chief Executive Officer Phone: +44 (0) 1763 269 772 [email protected] Avita Medical Ltd Tim Rooney Chief Financial Officer Phone: + 1 (818) 356-9400 [email protected] Avita Medical Ltd Gabriel Chiappini Company Secretary Phone +61(0) 8 9474 7738 [email protected] UK/EU Instinctif Partners Gemma Howe/Sue Charles Phone +44 (0)20 7866 7860 [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] Australia Monsoon Communications Rudi Michelson Investor Relations / PR Phone: +61 3 9620 3333 [email protected]
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