医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

RECELL® System Data Accepted to 52nd Annual American Burn Association Meeting Available Online

2020年04月02日 AM09:35
このエントリーをはてなブックマークに追加


 

VALENCIA, Calif. & MELBOURNE, Australia

AVITA Medical Limited (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, announced today the availability of RECELL® Autologous Cell Harvesting Device (RECELL® System) abstracts in a supplement of the Journal of Burn Care & Research highlighting data accepted for presentation at the 52nd annual American Burn Association (ABA) Meeting prior to its cancellation due to the COVID-19 pandemic.

“With the safety and health of all a top priority amid the current COVID-19 pandemic, we are pleased the ABA is finding ways for burn surgeons to digitally access scientific data that would have been presented at its annual meeting,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer. “We are committed to our role of advancing burn care, and the positive clinical outcomes and health economic benefits of the RECELL System are reflected in the breadth of data the ABA accepted. We look forward to continued collaboration with burn surgeons who are increasingly using the RECELL System across a range of burn sizes and look forward to continuing to explore the potential to expand the use of RECELL to benefit pediatric patients following the commencement of our pivotal trial for pediatric scald injuries earlier this month.”

RECELL® System Data Abstracts Available in Journal of Burn Care & Researchi:

Abstract Number

Abstract Title

Presenter

56

Reduced Length of Stay with Autologous Skin Cell Suspension Reduces Burn Injuriesii

Jeffrey E. Carter, MD

Louisiana State University

University Medical Center New Orleans

96

Treatment of Donor Sites in Large TBSA Burn Injuries with an Autologous Skin Cell Suspension Supports Early Reharvestingiii

Kevin Foster, MD, MBA, FACS

Arizona Burn Center Valleywise Medical Center

525

Autologous Skin Cell Suspension May Enhance Healing of Burn Wounds and Skin Graft Donor Sites in Elderly Burn Patientsiv

Arhana Chattopadhyay

Stanford School of Medicine

550

Real World Treatment Trends for Patients TBSA ≤20%: Evaluating Important Shifts in Care and Budget Impact of ASCS Adoptionv

James H. Holmes, IV, MD

Wake Forest Baptist Medical Center

558

Relationship Between Patient Characteristics and Number of Procedures as well as Length of Stay for Patients Surviving Severe Burn Injuries: Analysis of the American Burn Association National Burn Repositoryvi

Stacy Kowal, IQVIA Inc.

727

Use of a Biodegradable Dermal Matrix in Conjunction with Meshed and Sprayed Autologous Cell Suspension with a Vacuum Assisted Dressing Achieved Limb Salvage in a 73-Year Old with Deep Full Thickness Burns Despite Exposed Tendon and Bonevii

Joe Olivi, MD

Northwest Arkansas Medical Center

728

The Faces of Autologous Skin Cell Suspension as Epidermal Graftsviii

Justin Van Hoorebeke, MD, MS

UCSF Fresno Community Regional

Medical Center

736

Autologous Skin Cell Suspension in Combination with Meshed Autograft: A Case Report Demonstrating the Efficacy in NSTIix

Nicole Kopari, MD

UCSF Fresno Community Regional Medical Center

738

Post-Operative Wound Care Using Silver-Based Dressing with Autologous Skin Cell Suspensionx

 

Jeffrey E. Carter, MD

Louisiana State University

University Medical Center New Orleans

BARDA Funding Supports Development of RECELL System

Funding for the development of the RECELL System was provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under ongoing USG Contract No. HHSO100201500028C.

Authorized for release by the Chief Executive Officer of AVITA Medical Limited.

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 Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION™ (RES™), an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly 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 injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. Burn Centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in 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 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 TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

This press release was authorized by the review committee of AVITA Medical Limited.

i J Burn Care Res, Volume 41, Issue Supplement 1, March 2020, American Burn Association 52nd Annual Meeting. https://academic.oup.com/jbcr/issue/41/Supplement_1 Accessed 3/24/2020
ii J Burn Care Res, Volume 41, Issue Supplement_1, March 2020, Pages S37–S38, https://doi.org/10.1093/jbcr/iraa024.060
iii J Burn Care Res, Volume 41, Issue Supplement_1, March 2020, Pages S62-S63, https://doi.org/10.1093/jbcr/iraa024.099
iv J Burn Care Res, Volume 41, Issue Supplement_1, March 2020, Pages S100–S101, https://doi.org/10.1093/jbcr/iraa024.155
v J Burn Care Res, Volume 41, Issue Supplement_1, March 2020, Page S115, https://doi.org/10.1093/jbcr/iraa024.178
vi J Burn Care Res, Volume 41, Issue Supplement_1, March 2020, Page S115, https://doi.org/10.1093/jbcr/iraa024.178
vii J Burn Care Res, Volume 41, Issue Supplement_1, March 2020, Page S195, https://doi.org/10.1093/jbcr/iraa024.311
viii J Burn Care Res, Volume 41, Issue Supplement_1, March 2020, Pages S195–S196, https://doi.org/10.1093/jbcr/iraa024.312
ix J Burn Care Res, Volume 41, Issue Supplement_1, March 2020, Page S200, https://doi.org/10.1093/jbcr/iraa024.319
x J Burn Care Res, Volume 41, Issue Supplement_1, March 2020, Page S201, https://doi.org/10.1093/jbcr/iraa024.321

View source version on businesswire.com: https://www.businesswire.com/news/home/20200401005826/en/

CONTACT

U.S. Media

Sam Brown, Inc.

Christy Curran

Phone +1-615-414-8668

christycurran@sambrown.com

O.U.S. Media

Rudi Michelson

Phone +61 (0)3 9620 3333

Mobile +61 (0)411 402 737

rudim@monsoon.com.au

Investors

Westwicke Partners

Caroline Corner

Phone +1-415-202-5678

caroline.coner@westwicke.com

Related Posts Plugin for WordPress, Blogger...
TimeLine:

同じカテゴリーの記事 

  • AbbVie, Harbour BioMed, Utrecht University and Erasmus Medical Center Announce Collaboration to Develop Monoclonal Antibody Therapy to Prevent and Treat COVID-19
  • In COVID-19, Pudu Robotics Provides Non-contact Delivery Service in Hundreds of Hospitals Worldwide
  • AVITA Medical Limited Proposed Redomiciliation to the United States of America – Satisfaction of FIRB Condition
  • Assurance of Safety for Your Reopening: Hytera Unveils COVID-19 Pandemic Prevention Solution for Smaller Organizations
  • Noxopharm Reports Veyonda’s Potential in Late-Stage Cancer at ASCO 2020