Regenerative medicine company (ASX: AVH), (OTCQX: AVMXY) announced that it has been awarded a grant of an additional US$880K in support for its on-going pivotal US FDA trial for the use of ReCell® Spray-On-Skin® in the treatment of burn injuries.
The award, supplementing the $1.75 million provided in prior funding, underscores the commitment by the US Department of Defense, the US Army, and the US Armed Force Institute for Regenerative Medicine (AFIRM) to bringing the 'revolutionary' ReCell technology through the FDA approval process and cleared for sales in the US, thereby having it available for the military and civilian population.
The AFIRM program, established in March 2008, is dedicated to bringing 'transformational technologies' in regenerative medicine to wounded soldiers by developing clinical therapies and advanced treatment options. AFIRM has a special interest in using the most advanced regenerative medicine for its wounded soldiers and recognises Avita's innovative treatment for burns and other skin injuries has the benefits of using the patient's own skin, yields improved healing, reduced scar formation, and reintroduction of pigmentation into the skin.
As a first of its kind, the FDA-approved study is rigorous and highly conservative in its design. Each patient in the study receives both the standard-of-care graft treatment and the new ReCell treatment consisting of sprayed autologous cell suspension, with a host of separate assessments beyond standard care required for each enrolled patient. The study design requires similarity across patients, and, within patients, two comparable wounds for treatment, which although necessary for a randomized controlled clinical trial, imposes tight inclusion and exclusion criteria and therefore constrains the use to a particular (and small) subset of burn patients.
The approved FDA protocol permits the Company to treat 106 patients with partial-thickness thermal injuries; patients are assessed for healing and pain on a weekly basis during the initial four weeks post-treatment; at weeks 8, 12, 16, 24 and 52 the treatment site will be assessed for healing and aesthetic outcomes. Clinical data at the 16 week follow-up will be reported to the FDA in support of an application to market ReCell in the US. Approximately 75% of the required subjects have been enrolled in the study.
"We are pleased and grateful for the continued support of the US Department of Defense and AFIRM program," said Dr William Dolphin, Avita Medical's CEO. "As a first-of-its-kind study the patient selection criteria and protocol for the FDA study are stringent, requiring significant commitment from the participating surgeon and their team. AFIRM has recognized the difficulty of the protocol -- reflected in the slower than hoped for enrollment -- and, following close scrutiny and careful review, have provided additional funding in support of the study -- further indication of the importance of this innovative technology. ReCell has shown the potential to provide significant benefits over current options in the treatment of burns and other acute and chronic wounds and for a wide range of skin defects."
Dr James H. Holmes IV, Director of the Wake Forest Baptist Medical Burn Center and Program Leader for the Wake Forest-Pittsburgh Consortium of AFIRM, said, "AFIRM views the ReCell FDA study as a high priority project and recognizes ReCell as a potential game-changer in the treatment of burns and acute wounds. The AFIRM program managers have acknowledged that this is an extremely difficult study and are backing their assessment of the importance of the ReCell technology with additional funding at a time of tight budgetary constraints."
About Avita Medical Ltd.
Avita Medical (http://www.avitamedical.com/) develops and distributes regenerative and tissue-engineered products for the treatment of a broad range of wounds, scars and skin defects. Avita's patented and proprietary tissue-culture, collection and application technology provides innovative treatment solutions derived from a patient's own skin. The company's lead product, ReCell® Spray-On Skin?, is used in a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell is patented, CE-marked for Europe, TGA-registered in Australia, and SFDA-cleared in China. ReCell is on market and generating early revenues. ReCell is not available for sale in the United States; in the U.S. ReCell is an investigational device limited by federal law to investigational use. A Phase III FDA trial is in process.
The Armed Forces Institute of Regenerative Medicine (AFIRM, www.afirm.mil) is a six-way partnership among the U.S. Army, Navy, and Air Force, the Veterans Health Administration, the Defense Health Program, and the National Institutes of Health. The US Department of Defense established the AFIRM in 2008 with the mission of developing new products and therapies to treat severe injuries suffered by U.S. service members.
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