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 Ten RECELL® System Presentations at the American Burn Association (ABA) Annual Meeting

2019年03月11日 AM09:24
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 the schedule for ten presentations describing clinical and cost-savings advantages of the RECELL® Autologous Cell Harvesting Device (RECELL® System) in the treatment of severe burns. The presentations at the American Burn Association (ABA) 51st Annual Meeting to be held from April 2 – 5, 2019 in Las Vegas will highlight positive results obtained with treatment using the RECELL System in a broad range of patient populations and burn types. One of the RECELL System presentations describing the treatment of pediatric patients was selected as a “Best of the Best Abstract” out of more than 500 submissions.

The RECELL System uses a small amount of a patient’s own skin to prepare Spray-On Skin™ Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns. Two randomized, controlled clinical trials demonstrated that treatment of acute burn wounds with the RECELL System required substantially less donor skin than required with conventional treatment to achieve closure of burn wounds. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment. The RECELL System was approved by the U.S. Food and Drug Administration (FDA) in September 2018 for the treatment of acute thermal burns in patients 18 years and older.

“With more than 10 years of clinical experience with the RECELL System, our long-term effectiveness and safety data underscore how we are changing the treatment paradigm for burn patients,” said Dr. Michael Perry, AVITA Medical Chief Executive Officer. “Following our recent FDA approval, our goal is to partner with burn specialists across the country to help facilitate optimal outcomes for burn patients using this novel therapy.”

Podium Presentations

Session Date, Time, Location
(all times PDT)

   

Session Description

   

Presenter

Friday, April 5, 2019

8:36 – 8:54 a.m.

Amazon G

    *BEST OF THE BEST ABSTRACTS*

“Evaluation of Pediatric Population Treated for Burn Injuries Using an Autologous Skin Cell Suspension.”

   

Jeffrey Carter, MD, FACS

University Medical Center New Orleans Burn Center and LSU Health New Orleans School of Medicine

Friday, April 5, 2019

10:30 – 10:45 a.m.

Amazon A

Abstract 107

    “Post-Operative Wound Management Following the Use of an Autologous Cell Harvesting Device in the Treatment of Patients with Life-Threatening Injuries: A Single Center’s Experience.”    

Christopher Craig, PA-C, MMS

Wake Forest Baptist Health

Friday, April 5, 2019

11:15 – 11:30 a.m.

Amazon A

Abstract 109

    “Evaluation of Autologous Skin Cell Suspension for Healing of Burn Injuries of the Hand.”     Joseph Molnar, MD, PhD, FACS

Wake Forest Baptist Health

Friday, April 5, 2019

11:30 – 11:45 a.m.

Amazon A

Abstract 111

    “10 Years of Clinical Experience Using Point of Care Non Cultured Autologous Skin Cell Suspension.”     Professor Fiona Wood, AM

Burns Service of Western Australia, Fiona Stanley Hospital, Princess Margaret Hospital for Children

Friday, April 5, 2019

11:45 a.m. – 12:00 p.m.

Amazon L

Abstract 104

    “This is How We Do It: Rehabilitation Following the Use of an Autologous Cell Harvesting Device.”     Dana Nakamura, OTR/L

Wake Forest Baptist Health

       

Poster Presentations

Session Date, Time, Location
(all times PDT)

   

Session Title, Description

   

Presenter

Wednesday, April 3, 2019

12:30 – 1:45 p.m.

Exhibit Hall – Rio Pavilion Abstract 339

    “The Use of an Autologous Cell Harvesting and Processing Device in Two Burn Patients at an Urban Pediatric Burn Center.”    

Paul Glat, MD, FACS

St. Christopher’s Hospital for Children

Wednesday, April 3, 2019

12:30 – 1:45 p.m.

Exhibit Hall – Rio Pavilion Abstract 340

    “Autologous Regenerative Epidermal Suspension (RES™): A Case Study.”    

Kristina Chang, BA

Massachusetts General Hospital

Thursday, April 4, 2019

12:30 – 1:45 p.m.

Exhibit Hall – Rio Pavilion Abstract 498

    “Healing of Donor Sites with an Autologous Skin Cell Suspension for Large TBSA Burn Injuries: A Prospective Evaluation.”     Kevin Foster, MD, MBA, FACS

Arizona Burn Center

Thursday, April 4, 2019

12:30 – 1:45 p.m.

Exhibit Hall – Rio Pavilion Abstract 381

    “Budget Impact of Autologous Cell Harvesting Device (ACHD) Use versus Standard of Care (SOC) for Treatment of Severe Burns: A Case Study”     Kevin Foster, MD, MBA, FACS

Arizona Burn Center

Thursday, April 4, 2019

12:30 – 1:45 p.m.

Exhibit Hall – Rio Pavilion Abstract 509

    “Evaluation of Autologous Skin Cell Suspension for Definitive Closure of Extensive Burn Injuries in Adult Population.”    

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

       

 

Funding and technical support for the development of the RECELL System is 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. Programs funded under the BARDA contract include two randomized, controlled pivotal clinical trials, the Compassionate Use and Continued Access programs, development of the health economic model demonstrating the cost savings associated with the RECELL System, and two randomized, controlled clinical trials in pediatric burn patients.

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 7,000 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, acute wounds, scars and vitiligo. The RECELL System is TGA-registered in Australia and CFDA-cleared in China.

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/20190310005056/en/

CONTACT

U.S. Media
Sam Brown, Inc.
Christy Curran
Phone
+1-615.414.8668
christycurran@sambrown.com

O.U.S Media
Monsoon Communications
Sarah Kemter
Phone
+61 (0)3 9620 3333
Mobile +61 (0)407 162 530
sarahk@monsoon.com.au

Investors:
Westwicke Partners
Caroline Corner
Phone
+1-415-202-5678
caroline.corner@westwicke.com

AVITA Medical Ltd
Dale A. Sander
Chief Financial Officer
Phone
+1-661-367-9178
dsander@avitamedical.com

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • P&G Sets New Goal to Deliver 25 Billion Liters of Clean Drinking Water to Families in Need Worldwide
  • Puma Biotechnology’s Licensing Partner Specialised Therapeutics Asia Receives Regulatory Approval to Commercialize NERLYNX® (neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
  • Takeda Receives U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia
  • オクタファルマ・グループが2018年の好業績を発表
  • 香港贸发局香港国际医疗及保健展尖端医疗科技及保健产品 迎合采购所需