VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Medical (ASX – AVH, OTCQX: AVMXY) announced that Maricopa Integrated Health System (MIHS) Burn Center will hold a press conference today to highlight the recent treatment with RECELL® of a woman with necrotizing fasciitis, or flesh eating bacteria. The woman was treated with the RECELL Autologous Cell Harvesting Device under a U.S. Food and Drug Administration (FDA) approved Compassionate Use Investigational Device Exemption (IDE) program.
RECELL is a medical device designed to facilitate skin regeneration. In the United States, RECELL is an investigational device limited by federal law to investigational use. In September 2017, Avita submitted to the U.S. Food and Drug Administration (FDA) a PreMarket Approval (PMA) application for RECELL for the treatment of severe burn injuries, and that application is currently under review.
An announcement from MIHS about the press conference is included below.
MARICOPA INTEGRATED HEALTH SYSTEM (MIHS)
Maricopa County Special Health Care District
March 21, 2018
Flesh eating bacteria survivor to tell her story of survival; Burn surgeon to discuss groundbreaking use of “skin spray” to treat wounds from the disease
A Peoria woman who contracted flesh eating bacteria in January will appear at a news conference Thursday to discuss her fight for survival against the rare disease.
Christin Lipinski, still a patient at MIHS’s Arizona Burn Center, will appear with Burn Center Director Dr. Kevin Foster, who has pioneered use of the investigational RECELL® “skin spray” to treat burn victims.
Dr. Foster obtained FDA approval for “compassionate use” of Avita Medical’s RECELL treatment on Mrs. Lipinski. This is the first time in the United States that RECELL has been used to treat a victim of necrotizing fasciitis, or flesh eating bacteria.
When: 10 a.m., Thursday, March 22, 2018
Where: Maricopa Medical Center Administration Building, 2601 E. Roosevelt Street (just east of the hospital)
Who: Christin Lipinski, a mother and Peoria school teacher who contracted flesh eating bacteria in January. She will talk about her experience, her treatment, and outlook for recovery.
Contact: Michael Murphy (602) 568-0010
About Maricopa Integrated Health System (MIHS)
Located in Phoenix, Ariz., Maricopa Integrated Health System has a proud tradition of being both the community safety net health care system, with a mission and commitment to serving the underserved and Arizona’s only public teaching hospital. MIHS consists of Maricopa Medical, the only Level I Trauma Center in Arizona verified by the American College of Surgeons to care for both adults and children, Arizona’s only nationally verified Burn Center serving the entire Southwestern United States, MIHS’s McDowell Healthcare Center, which is the largest provider of HIV primary care in Arizona, the Refugee Women’s Health Clinic, the Arizona Children’s Center, two behavioral health centers, and 13 neighborhood Family Health Centers. To learn more about MIHS, please visit www.mihs.org.
ABOUT AVITA MEDICAL LIMITED
AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. Avita’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. Our medical devices work by preparing a Regenerative Epithelial Suspension (RES™), an autologous suspension comprised of the patient’s own skin cells and wound healing factors that are necessary to regenerate natural healthy skin. This autologous suspension is then sprayed onto the areas of the patient to be treated.
In all countries outside of Europe, our portfolio is marketed under the RECELL® brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. RECELL® is TGA-registered in Australia, and CFDA-cleared in China.
In Europe, our portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. RECELL® is designed for the treatment of burns and plastic reconstructive procedures; ReGenerCell™ has been formulated for chronic wounds including leg and foot ulcers; and ReNovaCell™ is tailored for aesthetic applications including the restoration of pigmentation.
To learn more, visit www.avitamedical.com.
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