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AVITA Medical, Inc. (AVHHL)

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Market Cap494.621M
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  • New RECELL® System Data to be Presented at 43rd Annual John A. Boswick Burn & Wound Care Symposium
    GlobeNewswire

    New RECELL® System Data to be Presented at 43rd Annual John A. Boswick Burn & Wound Care Symposium

    Presentations include data highlighting real-world use of RECELL in combination with complementary treatments, clinical versatility, and cost effectiveness of RECELL to advance patient careVALENCIA, Calif. and MELBOURNE, Australia., April 15, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced that nine abstracts highlighting the clinical and cost-savings benefits of the RECELL® Autologous Cell Harvesting Device (RECELL® System) have been accepted at the 43rd Annual John A. Boswick Burn & Wound Care Symposium. The international conference will be held in Maui, Hawaii, April 17-22, 2021, and covers the latest advancements in burn care, wound healing, and infection control. “The strong presence and broad range of physician-initiated data at this year’s Boswick Symposium reflects the rapidly expanding use of the RECELL System to treat burns of varying depth and size, as well as in combination with complementary surgical technologies, to advance patient care,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer. “We remain committed to partnering with physicians and progressing our pipeline to realize the full potential of this innovative technology platform to treat a wide array of skin defects and wounds.” RECELL System Accepted Abstracts A Real World Economic Evaluation of the Cost-Effectiveness of Autologous Cell Harvesting Device for the Treatment of Burns Requiring Hospitalization. Author: W Hickerson, Memphis, TNAutologous Skin Cell Suspension Early in the Acute Thermal Burn Injury Treatment Pathway: A Single Institution Experience. Author: N Kopari, Community Regional Medical Center, Fresno, CACase Review Using Autologous Skin Cell Suspension in Combination with Widely Meshed Split-Thickness Autografts in the Treatment of Complex Soft Tissue Injuries. Author: N Kopari, Community Regional Medical Center, Fresno, CACombining Two State-of-the-Art Surgical Techniques for the Treatment of Deep Second-Degree Burns. Author: S Blome-Eberwein, Lehigh Valley Hospital, Allentown, PAEvolving Concepts for RECELL Use. Author: R Sood, Burn and Reconstructive Centers of America, Augusta, GAEvolving Concepts in the Management of Coverage of Large Burns. Author: R Sood, Burn and Reconstructive Centers of America, Augusta, GAImplementing Autologous Skin Cell Suspension at an ABA Burn Center: A Comparison of Operative Efficiency using RECELL Versus Standard Split Thickness Autografting. Author: K Skibba, University of Rochester, NYOptimal Donor Sites for Autologous Cell Suspension Device (RECELL) in Pediatric Burn Reconstruction. Author: B Temple, St. Christopher's Hospital for Children, Philadelphia, PARITA: A Simulation Based Training Program to Replicate Real-Life Wound Care Experiences in Burns Treated with Autologous Skin Cell Suspension. Author: C Bell, AVITA Medical, Valencia, CA For more information about the RECELL System, please visit https://recellsystem.com/. ABOUT AVITA MEDICAL, INC.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 RES® REGENERATIVE EPIDERMAL SUSPENSION, 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 10,000 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 STATEMENTSThis 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, Inc. FOR FURTHER INFORMATION: U.S. MediaSam Brown, Inc.Christy CurranPhone +1-615-414-8668christycurran@sambrown.comO.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline CornerPhone +1-415-202-5678 caroline.corner@westwicke.com

  • All You Need to Know About AVITA Medical, Inc. (RCEL) Rating Upgrade to Buy
    Zacks

    All You Need to Know About AVITA Medical, Inc. (RCEL) Rating Upgrade to Buy

    AVITA Medical, Inc. (RCEL) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

  • 15 RECELL® System Abstracts Accepted for Presentation at 53ʳᵈ Annual American Burn Association Meeting
    GlobeNewswire

    15 RECELL® System Abstracts Accepted for Presentation at 53ʳᵈ Annual American Burn Association Meeting

    Record Number of Accepted Abstracts Highlight Benefits of RECELL System and Reinforce Rapid Adoption by Surgeons to Advance Burn CareVALENCIA, Calif. and MELBOURNE, Australia, March 30, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced that 15 abstracts highlighting the clinical and cost-savings benefits of the RECELL® Autologous Cell Harvesting Device (RECELL® System) have been accepted at the American Burn Association (ABA) 53rd Annual Meeting. The meeting, which will be held virtually April 7-9, 2021, annually brings together more than 2,000 multi-disciplinary burn care professionals from around the world. “This year’s ABA meeting features the highest number of presentations on the clinical and health economic benefits of the RECELL System since its U.S. Food and Drug Administration approval in 2018,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer. “The acceptance and adoption of RECELL is reflected in these physician-initiated presentations, representing the collective experience of 20 burn centers. With more than 80% of burn surgeons in the United States now certified in the use of the RECELL System, we are encouraged by their continuing exploration of RECELL in the treatment of various burn depths and sizes, and we remain committed to enabling the realization of the full potential of this innovative platform technology.” RECELL® System Accepted Abstracts Outcomes for Hand Burns Treated with Autologous Skin Cell Suspension in 20% TBSA and Smaller Injuries. Author: M Taylor, Tulane University School of Medicine, New Orleans, LAAutologous Skin Cell Suspension (ASCS) for the Treatment of Small (<10% TBSA) Mixed-Depth Burn. Author: J Carter, University Medical Center Burn Center, New Orleans, LA72 Facial Burns Treated with Autologous Skin Cell Suspension - A Real World Data Analysis Across 5 U.S. Burn Centers. Author: J Carter, University Medical Center Burn Center, New Orleans, LAEvaluating Real-World National and Regional Trends in Definitive Closure in US Burn Care: A Survey of US Burn Centers. Author: J Carter, University Medical Center Burn Center, New Orleans, LACost-effectiveness of Autologous Cell Harvesting Device for the Treatment of Burns Requiring Hospitalization: An Economic Evaluation using Real World Data. Author: J Carter, University Medical Center Burn Center, New Orleans, LAAutologous Skin Cell Suspension Achieves Closure of Donor Site Wounds Facilitating Early Reharvesting for Large TBSA Burn Injuries. Author: K Foster, Arizona Burn Center, Phoenix, AZUtilizing Simulation Based Training to Teach Wound Management Strategies When Caring for Burns Treated with ASCS. Author: J Johnson, Wake Forest, Winston-Salem, NCMinimally Invasive Skin Grafting with Enzymatic Debridement and Autologous Skin Cell Spray. Author: S Kahn, Medical University of South Carolina, Charleston, SCEarly Interventions with Autologous Skin Cell Suspension Leads to Positive Outcomes. Author: N Kopari, Community Regional Medical Center, Fresno, CAAutologous Skin Cell Suspension in Combination with Meshed Autograft: A Case Series Demonstrating the Efficacy in Complex Wounds of Non-Burn Etiologies. Author: Y Qumsiyeh, Community Regional Medical Center, Fresno, CAAutologous Skin Cell Suspension is Associated with Decreased Hospital Length of Stay. Author: Y Qumsiyeh, Community Regional Medical Center, Fresno, CAInconspicuous Donor Sites-: A Patient-Centered Approach to Donor Site Management with Autologous Skin Cell Suspension. Author: N Kopari, Community Regional Medical Center, Fresno, CAEvaluation of Healing Outcomes Combining Negative Pressure Wound Therapy with Autologous Skin Cell Suspension and Meshed Autografts: Pre-Clinical and Clinical Evidence. Author: B Carney, MedStar Health Research Institute, Washington, DCBiodegradable Temporizing Matrix in Combination with Wide Meshed Graft and Autologous Spray Cell Suspension (ASCS) Graft can be used for Reconstruction of Extensive Necrotizing Infections: A Case Report. Author: J Olivi, Mercy Hospital, Rogers, ARVacuum Assisted Dressing can be used as an Effective Dressing over Non-cultured, Autologous Skin Cell Suspension (ASCS) Combined with Wide Meshed Split Thickness Autografts (mSTSG). Author: J Olivi, Mercy Hospital, Rogers, AR For more information about the RECELL System, please visit https://recellsystem.com/. ABOUT AVITA MEDICAL, INC.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 RES® REGENERATIVE EPIDERMAL SUSPENSION, 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 10,000 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 STATEMENTSThis 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, Inc. FOR FURTHER INFORMATION: U.S. MediaSam Brown, Inc.Christy CurranPhone +1-615-414-8668christycurran@sambrown.comO.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline CornerPhone +1-415-202-5678 caroline.corner@westwicke.com