AVITA Medical, Inc. (AVH.AX)
| Previous close | 5.46 |
| Open | 5.41 |
| Bid | 5.30 x 734600 |
| Ask | 5.32 x 258500 |
| Day's range | 5.30 - 5.43 |
| 52-week range | 4.55 - 11.24 |
| Volume | 193,037 |
| Avg. volume | 676,168 |
| Market cap | 671.192M |
| Beta (5Y monthly) | 0.47 |
| PE ratio (TTM) | N/A |
| EPS (TTM) | -0.54 |
| Earnings date | 30 Apr 2020 |
| Forward dividend & yield | N/A (N/A) |
| Ex-dividend date | N/A |
| 1y target est | 0.21 |
- 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
- GlobeNewswire
AVITA Medical, Inc. Names Michael Holder as Chief Financial Officer
VALENCIA, Calif. and MELBOURNE, Australia, March 22, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (Nasdaq: RCEL; ASX: AVH) (“AVITA Medical”), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today the appointment of Michael Holder as Chief Financial Officer effective March 22, 2021. Mr. Holder will assume responsibility for overseeing the global finance, accounting, M&A, and investor relations functions and will be based in AVITA’s Valencia office in California. “Michael’s extensive background in finance, M&A, business development, strategy, and operations, along with his demonstrated track record of creating and realizing shareholder value for private and public companies in the cell and gene therapy and other industries, will certainly strengthen our leadership team,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer. Mr. Holder commented, “I am excited to join the AVITA Medical team. I believe the opportunity for growth at Avita Medical is tremendous given its initial FDA approved burn indication, promising clinical portfolio, development pipeline, M&A related opportunities, and its smart and dedicated team operating with Dr. Perry’s leadership.” A seasoned executive with more than 25 years of experience, Mr. Holder has served in senior financial, executive management, and board roles with leading private and public companies in the medtech, biotech, and pharma related industries. Most recently, he served as Chief Financial Officer with ImmuneCyte, Inc., a global clinical stage biopharmaceutical company with innovative cell and gene immune-oncology therapeutics. At ImmuneCyte, Inc., Mr. Holder led preparations for a major IPO or SPAC transaction and was responsible for the development of financial team and infrastructure capital raises, M&A, and external audits. Prior to ImmuneCyte, Inc., Mr. Holder was CEO and Portfolio Manager at Carolina Longevity Institute, LLC, a global investment company focused on investments in medtech, biotech and pharma companies that improve healthspan and longevity. At Carolina Longevity Institute, LLC, Mr. Holder managed all investment, financial, administrative, corporate development, and operational activities. Prior to Carolina Longevity Institute, LLC, Mr. Holder was initially CFO and later Chairman and CEO at Organ Transport Systems, Inc., a medical device company, where he built the company from early stage through multiple financing rounds as well as research, regulatory, and commercial launch activities. Prior to Organ Transport Systems, Inc., Mr. Holder was the CFO of three public or private medtech and pharma related companies. Mr. Holder holds a Master of Business Administration from the Wharton School of Business at the University of Pennsylvania, a Bachelor of Science in Business Administration from the Kenan-Flagler Business School at the University of North Carolina., and previously obtained his CPA. 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 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 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. 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 3333Mobile +61 (0)411 402 737rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline Corner Phone +1-415-202-5678caroline.corner@westwicke.com
- GlobeNewswire
Avita Medical, Inc. Announces Closing of Offering of 3,214,250 Shares of Common Stock
VALENCIA, Calif. and MELBOURNE, Australia, March 01, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (Nasdaq: RCEL; ASX: AVH) (“AVITA Medical”), 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 the successful closing of an underwritten registered public offering of its shares of common stock, the details of which were released to the market on February 24, 2021 (United States) / February 25, 2021 (Australia). AVITA Medical has issued 3,214,250 shares of common stock at the offering price of US$21.50 per share. This amount includes 419,250 shares of common stock issued upon the exercise in full by the underwriters of their option to purchase additional shares. The gross proceeds from the offering are approximately US$69.1 million, before deducting underwriting discounts and commissions and estimated offering expenses. AVITA Medical expects to use the net proceeds from the offering to fund its product development pipeline, to pursue approvals of its products for additional indications and for general corporate purposes, which may include licensing arrangements. Piper Sandler & Co. and Cowen and Company, LLC acted as joint book-running managers for the offering. BTIG, LLC acted as lead manager and Lake Street Capital Markets, LLC acted as co-manager for the offering. The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-249419) that was previously filed with the Securities and Exchange Commission (the “SEC”) on October 9, 2020 and declared effective on October 16, 2020 and that was also publicly released on the Australian Securities Exchange (“ASX”). The final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and released on the ASX on February 25, 2021 (in the United States) / March 1, 2021 (in Australia). A copy of these documents may be obtained by visiting EDGAR on the SEC's website at www.sec.gov or by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by e-mail at prospectus@psc.com, or by phone at (800) 747-3924, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com. This announcement shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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 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 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. Forward-Looking Statements: This announcement contains “forward-looking statements” within the meaning of Section 27A of the Private Securities Litigation Reform Act of 1995. Although the forward-looking statements in this announcement reflect the good faith judgment of management, forward-looking statements are inherently subject to known and unknown risks and uncertainties that may cause actual results to be materially different from those discussed in these forward-looking statements. Readers are urged to carefully review and consider the various disclosures made by AVITA Medical in the reports it has filed with the SEC, including the “Risk Factors” section of the Company’s Annual Report 10-K for the year ended June 30, 2020 for a description of the risks that may affect its business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, AVITA Medical’s actual results may vary materially from those expected or projected. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this announcement. AVITA Medical assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this announcement, except as required by law. For Further Information: U.S. MediaSam Brown, Inc. Christy CurranPhone +1-615-414-8668christycurran@sambrown.com O.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333Mobile +61 (0)411 402 737rudim@monsoon.com.au InvestorsWestwicke PartnersCaroline Corner Phone +1-415-202-5678caroline.corner@westwicke.com
