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

AVITA Medical Announces Schedule for Six RECELL® Device Presentations at American Burn Association (ABA) 50th Annual Meeting

2018年04月03日 AM10:59
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 (ASX: AVH, OTCQX: AVMXY) announced today new data to be presented describing clinical and cost-savings advantages of RECELL® Device in the treatment of severe burns at the American Burn Association (ABA) 50th Annual Meeting to be held from April 10 through 13, 2018 at the Hyatt Regency Chicago in Chicago. This is the first time clinical investigators are presenting the full effectiveness and safety data from the two pivotal trials used to support AVITA Medical’s U.S. PreMarket Approval (PMA) application for the treatment of burn injuries.

RECELL Device is an investigational medical device developed by AVITA Medical and designed to facilitate skin regeneration for the treatment of burns and other wounds while reducing the amount of skin harvested at the time of surgery. Reduction in donor site skin requirements has important benefits from both clinical and health economic perspectives.

One of the RECELL Device pivotal studies has been selected as a top five abstract for presentation during a plenary session at the ABA conference. Researchers also will present the positive results from other clinical studies and the conclusions from a model showing the health economic benefits of RECELL Device.

Oral Presentations

Session Date, Time, Location (all

times CDT)

    Session Description     Presenter

Wednesday, April 11, 2018
4:15 – 4:30 p.m.
International Ballroom – L
Abstract T1A

 

   

*TOP FIVE ABSTRACT*

“A Comparative Study of Autologous Skin Cell Suspension to Split-Thickness Autografting in the Treatment of Acute Burns.” Full clinical results from U.S. controlled, randomized pivotal trial of RECELL Device in the treatment of deep partial-thickness (second-degree) burns.

 

    William Hickerson, MD, FACS, Firefighter Burn Center, Memphis, Tennessee, and University of Tennessee Health Science Center,

Memphis, Tennessee

Friday, April 13, 2018
11:15 – 11:30 a.m.
Salon A-1 – LL
Abstract 109

 

   

“Demonstration of the Safety and Effectiveness of Autologous Skin Cell Suspension Combined with Meshed Skin Grafts for the Reduction of Donor Area in the Treatment of Acute Burns.” Full clinical results from U.S. controlled, randomized pivotal trial of RECELL Device in the treatment of full-thickness (third-degree) burns.

 

   

James H. Holmes, IV, MD, FACS Wake Forest Baptist Medical Center, Winston-Salem, North Carolina

 

Thursday, April 12, 2018
11:15 – 11:30 a.m.
Salon A-5 – LL
Abstract 77

 

   

“Initial Experience with Autologous Cell Suspension for Treatment of Partial Thickness Facial Burns.” Review of clinical outcomes obtained in the treatment with RECELL Device of facial burns in adults and children under FDA-approved Compassionate Use Investigational Device program.

 

   

Nicholas Walker, MD
Wake Forest University School of Medicine, North Carolina

Thursday, April 12, 2018
11:00 – 11:15 a.m.
Salon A-5 – LL
Abstract 76

 

   

“Validation and Characterization of an Immediate, One-Stage Technique to Treat Full-Thickness Wounds in Swine.” Results of preclinical study of RECELL Device in combination with a dermal substitute in the treatment of full-thickness burns in an animal model.

 

   

Jongwon Genevieve Park, MD, PhD
Wake Forest Baptist

Medical Center, North Carolina

       

Poster Presentations

Session Date, Time, Location (all times CDT)     Session Title, Description     Presenter

Wednesday, April 11, 2018
12:30 – 1:30 p.m.
Stevens Salon C&D – LL
Abstract 288

 

   

“Cost-Effectiveness (CE) of an Autologous REGENERATIVE EPITHELIAL SUSPENSION™ (RES) Versus Standard of Care (SOC) for Treatment of Severe Burns in the United States.” Highlights a cost-effectiveness and budget impact model that demonstrates the economic value of RECELL Device versus standard of care for the treatment of severe burns.

 

   

Kevin Foster, MD
Arizona Burn Center

 

Wednesday, April 11, 2018
12:30 – 1:30 p.m.
Stevens Salon C&D – LL
Abstract 348

 

    “A Prospective Evaluation of RECELL Device in Compassionate Use: Experience with the Use of RECELL Device to Treat Large TBSA Injuries.” Review of clinical outcomes obtained in the treatment with RECELL Device of patients with extensive burn injuries under FDA-approved Compassionate Use Investigational Device program.    

Dr. Rajiv Sood
Indiana University Purdue University Indianapolis School of Medicine

       

“We look forward to the first presentation of the full results from our two pivotal clinical trials of RECELL Device, as well as cases from our Compassionate Use program and our health economic model,” said Dr. Michael Perry, AVITA Medical’s Chief Executive Officer. “We thank the medical professionals, researchers and patients who participated in the development of RECELL Device and in the clinical studies being presented at the ABA conference.”

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. Our medical devices work by preparing a REGENERATIVE EPITHELIAL SUSPENSION™, 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 the United States, RECELL Device is an investigational device limited by federal law to investigational use. In September 2017, AVITA Medical submitted to the U.S. Food and Drug Administration (FDA) a PreMarket Approval (PMA) application for RECELL for the treatment of burn injuries.

In all countries outside of Europe, our portfolio is marketed under the RECELL Device brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. RECELL Device 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 Device is designed for the treatment of burns and plastic reconstructive procedures; REGENERCELL™ Autologous Cell Harvesting Device has been formulated for chronic wounds including leg and foot ulcers; and RENOVACELL™ Autologous Cell Harvesting Device is tailored for aesthetic applications including the restoration of pigmentation.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180402005980/en/

CONTACT

OUS Media
Monsoon Communications

Sarah Kemter
Phone:
+61 (0)3 9620 3333
Mobile: +61 (0)407 162 530
sarahk@monsoon.com.au
or
US
Media
Syneos Health Public Relations

David Polk
Phone:
+1 (310) 309 1029
Mobile +1 (805) 428 5775
david.polk@syneoshealth.com
or
Investors:
Westwicke
Partners Caroline Corner

Phone: +1 (415) 202-5678
caroline.corner@westwicke.com
or
AVITA
Medical Ltd

Dale A. Sander
Chief Financial Officer
Phone:
+1 (858) 663-6993
dsander@avitamedical.com

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • Clover Biopharmaceuticals Doses First Patient in Australia in Phase I Study of SCB-313 for Malignant Ascites
  • 三叶草生物制药在澳大利亚开展的SCB-313恶性腹水临床试验入组首例患者
  • Brightreeがアテナヘルスと電子的患者紹介システムのインテグレーションを発表
  • PHCホールディングス株式会社: NPO法人 日本医療ネットワーク協会と、医療データ連携の実証実験に関する業務委託契約を締結
  • Dr. Reddy’s Laboratories defends its right to launch Buprenorphine and Naloxone Sublingual Film in the U.S. Market