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AVITA Medical Submits Response to FDA, Resuming Review Clock for RECELL GO PMA Supplement

Retrieved on:

Thursday, February 29, 2024

Avita Medical, AVH, PMA, FDA, Food, Growth, ASX, Health

The response addresses various questions and incorporates data from in-house testing to support the PMA supplement and fulfil the additional information request, which we received in October of 2023.

Key Points:

The response addresses various questions and incorporates data from in-house testing to support the PMA supplement and fulfil the additional information request, which we received in October of 2023.
Upon receipt by the FDA, the application of the PMA supplement resumes its 180-day real time review, with 90 days remaining in the review period.
“RECELL GO will enhance our capabilities and reach to continue our already impressive growth,” said Jim Corbett, Chief Executive Officer of AVITA Medical.
The supplement follows the original PMA of its RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.

AVITA Medical to Present at TD Cowen 44th Annual Health Care Conference

Retrieved on:

Thursday, February 29, 2024

Avita Medical, AVH, ASX, Event, Conference, Webcast

VALENCIA, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that David O’Toole, Chief Financial Officer, will present at TD Cowen’s 44th Annual Health Care Conference on Tuesday, March 5, 2024, at 9:50 a.m. Eastern Time.

Key Points:

VALENCIA, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that David O’Toole, Chief Financial Officer, will present at TD Cowen’s 44th Annual Health Care Conference on Tuesday, March 5, 2024, at 9:50 a.m. Eastern Time.
A live audio webcast of the presentation will be available under the Events & Presentations section of AVITA Medical's website at https://ir.avitamedical.com .
A replay of the webcast will be available at the same location for approximately 90 days following the conclusion of the event.

AVITA Medical to Host Investor Webinar Briefing

Retrieved on:

Friday, February 23, 2024

Avita Medical, PST, AVH, ASX, Q&A, Webcast, AEDT

VALENCIA, Calif., Feb. 23, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, invites shareholders and prospective investors to attend its investor webinar briefing and presentation by Jim Corbett, Chief Executive Officer, and David O’Toole, Chief Financial Officer, on February 27, 2024, at 2:00 p.m. (PST) / February 28, 2024, at 9:00 a.m. (AEDT).

Key Points:

VALENCIA, Calif., Feb. 23, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, invites shareholders and prospective investors to attend its investor webinar briefing and presentation by Jim Corbett, Chief Executive Officer, and David O’Toole, Chief Financial Officer, on February 27, 2024, at 2:00 p.m. (PST) / February 28, 2024, at 9:00 a.m. (AEDT).
The webinar presentation will cover financial highlights from our recent fourth quarter and full-year 2023 earnings webcast, business highlights, 2024 revenue guidance, and conclude with a Q&A session.
To register for the presentation, please follow this Zoom link:

AVITA Medical Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides 2024 Financial Guidance

Retrieved on:

Thursday, February 22, 2024

Human services, Avita Medical, AVH, PMA, Assistant, Telephone, FDA, Marketing, Food, Growth, Commercial, ASX, Patient, G&A, Development, Travel, Pharmaceutical industry

Total revenue, which includes BARDA revenue, increased by 50% to $14.2 million compared to $9.5 million in the same period in 2022.

Key Points:

Total revenue, which includes BARDA revenue, increased by 50% to $14.2 million compared to $9.5 million in the same period in 2022.
Gross profit margin was 87.3% compared to 85.8% for the fourth quarter of 2022.
Total operating expenses for the quarter were $24.7 million, compared to $15.0 million in the same period in 2022.
AVITA Medical will host a conference call to discuss its financial results, business highlights, and 2024 revenue guidance on Thursday, February 22, 2024, at 1:30 p.m. Pacific Time (being Friday, February 23, 2024, at 8:30 a.m. Australian Eastern Daylight Time).

Fisker to Release Ocean OS 2.0 Software Update, Improving Performance, SolarSky, Energy Management, and Other Features

Retrieved on:

Tuesday, February 6, 2024

View the full release here: https://www.businesswire.com/news/home/20240206806730/en/

Key Points:

View the full release here: https://www.businesswire.com/news/home/20240206806730/en/
Fisker to Release Fisker Ocean Software Update V2.0, Improving Performance, SolarSky, Energy Management, and Other Features.
(Photo: Business Wire)
The Ocean OS 2.0 OTA update includes performance and powertrain improvements, enhancements for SolarSky, improved energy management, and other user experience improvements.
“Our over-the-air software update strategy has shown the Fisker Ocean is a true connected car.
Ocean OS 2.0 is a progressive update that demonstrates we can adapt and improve performance, energy management, and other key features in the Ocean,“ Chairman and CEO Henrik Fisker said.

AVITA Medical to Announce Fourth Quarter and Full Year 2023 Financial Results

Retrieved on:

Thursday, February 1, 2024

AVH, Telephone, Webcast, GAAP, ASX, Avita Medical

VALENCIA, Calif., Feb. 01, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices and autologous cellular therapies for skin restoration, today announced that it will report its fourth quarter and full year 2023 financial results after the close of the U.S. financial markets on Thursday, February 22, 2024.

Key Points:

VALENCIA, Calif., Feb. 01, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices and autologous cellular therapies for skin restoration, today announced that it will report its fourth quarter and full year 2023 financial results after the close of the U.S. financial markets on Thursday, February 22, 2024.
AVITA Medical will host a conference call and webcast that day at 1:30 p.m. Pacific Time (Friday, February 23, 2024, at 8:30 a.m. Australian Eastern Daylight Time) to discuss its financial results, business highlights, 2024 revenue guidance, and achievement of cashflow breakeven and GAAP profitability in a specific quarter in 2025.
To access the live call via telephone, please register in advance using the link here .
The live webcast of the call may be accessed by visiting the Investor Relations section of the AVITA Medical website at https://ir.avitamedical.com/events-and-presentations .

AVITA Medical Announces Exclusive Distribution Agreement with Stedical Scientific

Retrieved on:

Wednesday, January 10, 2024

ASX, Patient, Permeability, Avita Medical, Burn, Hospital, Partnership, Sale, Food, AVH, Wound healing, Physician

Under the terms of the agreement, AVITA Medical will hold the exclusive rights to market, sell, and distribute PermeaDerm products, including any future enhancements or modifications, within the United States.

Key Points:

Under the terms of the agreement, AVITA Medical will hold the exclusive rights to market, sell, and distribute PermeaDerm products, including any future enhancements or modifications, within the United States.
“Our partnership with Stedical Scientific is an important step in expanding our portfolio and addressing the unmet needs of our patients,” said Jim Corbett, Chief Executive Officer of AVITA Medical.
“AVITA Medical and Stedical Scientific are ideal partners given the complementary nature of our products, the overlap of call points, and the strength of our footprint and sales force.
“AVITA Medical has an established presence in the U.S. wound care market, further validating the clinical and commercial value of PermeaDerm.

AVITA Medical Announces Preliminary 2023 Financial Highlights, Provides 2024 Financial Guidance and Business Update

Retrieved on:

Wednesday, January 10, 2024

ASX, Vitiligo, Patient, Avita Medical, Commercial, Mental health, Quality of life, Disease, AVH, Growth, Pharmaceutical industry

“We have made tremendous progress over the last four quarters, with consecutive commercial revenue growth rates of 40%, 42%, 51%, and 50%, respectively, over the same periods in 2022.

Key Points:

“We have made tremendous progress over the last four quarters, with consecutive commercial revenue growth rates of 40%, 42%, 51%, and 50%, respectively, over the same periods in 2022.
Key study endpoints include patient and clinician satisfaction of treatment, burden of disease, and patient mental health status.
The Company completed enrollment of TONE with 109 patients at investigational sites across the United States earlier than anticipated.
Patients will be followed for a 12-month period, with the primary follow-up period being 6-months after treatment.

AVITA Medical to Present at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on:

Thursday, January 4, 2024

AVH, Webcast, Event, Conference, Avita Medical, ASX

VALENCIA, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices and autologous cellular therapies for skin restoration, today announced that Jim Corbett, Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024, at 11:15 a.m. Pacific Time.

Key Points:

VALENCIA, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices and autologous cellular therapies for skin restoration, today announced that Jim Corbett, Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024, at 11:15 a.m. Pacific Time.
A live audio webcast of the presentation will be available under the Events & Presentations section of AVITA Medical's website at https://ir.avitamedical.com .
A replay of the webcast will be available at the same location for approximately 30 days following the conclusion of the event.

AVITA Medical to Host Investor Webinar Briefing

Retrieved on:

Monday, December 4, 2023

AVH, PST, AEDT, Avita Medical, ASX, Regenerative medicine

VALENCIA, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, invites shareholders and prospective investors to attend its investor webinar briefing and presentation by Jim Corbett, Chief Executive Officer, and David O’Toole, Chief Financial Officer, on December 5, 2023, at 2:00 p.m. (PST) / December 6, 2023, at 9:00 a.m. (AEDT).

Key Points:

VALENCIA, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, invites shareholders and prospective investors to attend its investor webinar briefing and presentation by Jim Corbett, Chief Executive Officer, and David O’Toole, Chief Financial Officer, on December 5, 2023, at 2:00 p.m. (PST) / December 6, 2023, at 9:00 a.m. (AEDT).
The webinar will cover highlights from AVITA Medical’s recent third quarter 2023 webcast with commercial revenue growth of 51% compared to the same period in 2022, business highlights, revenue guidance, and conclude with Q&A.
To register for the presentation, please follow this Zoom link: