AVITA MEDICAL WKN: A0Q40S ISIN: AU000000AVH4 Kürzel: AVMXF Forum: Aktien Thema: Hauptdiskussion

https://hotcopper.com.au/threads/ann-form-8-k.7611749/ AVITA Medical, Inc. (the "Company") will lodge the following Form 8-K with the United states Securities and Exchange Commission (the "SEC") before the market opens on 2 October 2023, being 2 October 2023 AEDT and date of lodgement on the Australian Securities Exchange. The Form 8-K describes a recent U.S. Food and Drug Administration (the "FDA") letter to the Company that is requesting additional information on its premarket approval supplement application for its latest device, RECELL GO. This places the application file on hold for approximately 4 to 6 months while the Company addresses the FDA's questions.

https://beststocks.com/analysts-express-growing-positive-sentiment-t/

AVITA Medical Receives Best Product Award at the American Association for the Surgery of Trauma https://finance.yahoo.com/news/avita-medical-receives-best-product-120000477.html

AVITA Medical GAAP EPS of -$0.41 misses by $0.10, revenue of $11.75M beats by $0.18M https://seekingalpha.com/news/4001261-avita-medical-gaap-eps-of-0_41-misses-0_10-revenue-of-11_75m-beats-0_18m • AVITA Medical press release (NASDAQ:RCEL): Q2 GAAP EPS of -$0.41 misses by $0.10. • Revenue of $11.75M (+40.9% Y/Y) beats by $0.18M. • Financial Guidance • Commercial revenue for the third quarter 2023 is expected to be in the range of $13 to $14 million • Raising commercial revenue for the full year 2023 from $49 to $51 million to an expected range of $51 to $53 million • Gross margin for the full year 2023 expected to be in the range of 83% to 85%

AVITA Medical Reports Second Quarter Financial Results https://www.globenewswire.com/news-release/2023/08/10/2723105/0/en/AVITA-Medical-Reports-Second-Quarter-Financial-Results.html

https://beststocks.com/avita-medical-receives-positive-outlook-and-i/

AVITA's Balancing Act: RECELL System's Promise Amid Market Uncertainties https://seekingalpha.com/article/4618423-avitas-balancing-act-recell-systems-promise-amid-market-uncertainties

AVITA Medical Submits FDA PMA Supplement for RECELL GO https://finance.yahoo.com/news/avita-medical-submits-fda-pma-222100572.html

Skin Grafts Disruption: Avita Medical's Regenerative Medicine System Poised to Disrupt Traditional Skin Grafts, Says Analyst https://markets.businessinsider.com/news/stocks/skin-grafts-disruption-avita-medical-s-regenerative-medicine-system-poised-to-disrupt-traditional-skin-grafts-says-analyst-1032413234 Cantor Fitzgerald has initiated coverage on Avita Medical Inc (NASDAQ:RCEL) at an Overweight rating and a price target of $23.  The analyst notes that the company's RECELL system will disrupt traditional split-thickness skin grafts, requiring 97.5% less donor skin when used alone in second-degree burns and 32.0% less donor skin when used with autograft for third-degree burns. It requires 56% and 60% fewer autograft procedures for pediatric and adult patients with >60% TBSA (total body surface area), respectively, a shorter length of hospital stay, and reduced scarring and pain. ...

AVITA Medical Rejoins the Russell 3000 Index https://www.globenewswire.com/news-release/2023/06/26/2694404/0/en/AVITA-Medical-Rejoins-the-Russell-3000-Index.html

AVITA scores US FDA approval for vitiligo treatment https://www.businessnewsaustralia.com/articles/avita-scores-us-fda-approval-for-vitiligo-treatment.html

AVITA Medical Announces FDA Approval of RECELL for Skin Repigmentation in Vitiligo Patients https://www.globenewswire.com/news-release/2023/06/16/2689906/0/en/AVITA-Medical-Announces-FDA-Approval-of-RECELL-for-Skin-Repigmentation-in-Vitiligo-Patients.html

Da fehlt aber noch die Zulassung für vitiligo oder?

👍 hört sich schon mal gut an

AVITA Medical Announces FDA Approval of RECELL for Treatment of Full-Thickness Skin Defects https://www.businessupturn.com/brand-post/avita-medical-announces-fda-approval-of-recell-for-treatment-of-full-thickness-skin-defects/

AVITA Medical Reports First Quarter Financial Results and Affirms Full Year Guidance https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-reports-first-quarter-financial-results-and