AVITA Medical Completes Recruitment in Pivotal Trial Evaluating the RECELL® System for Soft Tissue Reconstruction
Key figures expected in the second half of 2022
VALENCIA, California and MELBOURNE, Australia, January 6, 2022 (GLOBE NEWSWIRE) – AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that develops and markets a technology platform that enables recovery autologous skin care provider for multiple unmet needs, today announced that it has completed enrollment in its pivotal trial for the use of RECELL® Soft tissue reconstruction system. Currently, the RECELL System is indicated in the United States for the treatment of acute thermal burns. Data from the topline will be shared later this year.
“Completion of the recruitment of the pivotal trial evaluating the use of RECELL® The Soft Tissue Reconstruction Treatment System is a milestone for AVITA Medical and furthermore synergizes with our current business focus on burns. Ultimately, with the approval of this indication by the FDA, we plan to expand the use of RECELL to include all acute wounds, ”said Dr. Mike Perry, CEO of AVITA Medical. “The early completion of recruitment into our soft tissue reconstruction trial underscores the physician’s need and desire for new treatment options. “
Skin grafting is the standard of care for soft tissue reconstruction, including post-traumatic and post-surgical skin reconstruction. Skin grafting requires the removal of the donor’s skin, resulting in additional injury to the patient. Significant pain, delayed healing, risk of infection, need for multiple procedures, discoloration and scarring are associated with donor site wounds. While skin grafting is commonly associated with the treatment of burns, in 2017 approximately 80% of acute wounds requiring skin grafting were non-burn injuries accounting for more than 200,000 procedures in the United States.I The total addressable market (“TAM”) for soft tissue repair is approximately $ 1 billion and more than twice as large as the TAM for burns. In addition, the existing reimbursement codes used for the treatment of burns with the RECELL system will apply to this indication.
“I am very happy to have participated in this clinical trial, which should confirm that less donor skin is needed for soft tissue damage without compromising the healing results compared to conventional autologous transplantation,” said Dr. Steven E. Mapula, Assistant Professor of TCU Surgery and Division Head of Plastic Surgery at John Peter Smith Hospital. “We believe the RECELL System has the potential to become an important new treatment option for those in need of soft tissue reconstruction. “
For more information on the RECELL system, please visit www.RECELLSystem.com.
ABOUT AVITA MEDICAL, INC.
AVITA Medical is a regenerative medicine company with a technology platform positioned to meet unmet medical needs for burns, chronic wounds and aesthetic indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s skin. Medical devices work by preparing an RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension composed of the patient’s skin cells necessary to regenerate the healthy natural epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
AVITA Medical’s first American product, RECELL® System, was approved by the United States Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for the treatment of acute thermal burns. The RECELL System is used to prepare Spray-On Skin ™ cells using a small amount of patient skin, providing a new way to treat severe burns, while dramatically reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn. Compelling data from randomized, controlled clinical trials conducted in major burn centers across the United States and actual use in over 10,000 patients worldwide supports the fact that the RECELL system is a significant advance over the current standard of care for burn patients and offers benefits in terms of clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE – RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of the indications for use and important safety information, including contraindications, warnings, and precautions.
In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL system is registered with the TGA in Australia and has received CE mark approval in Europe. To learn more, visit www.avitamedical.com.
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This press release has been authorized by the review board of AVITA Medical, Inc.
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