Avita Medical – Page 5 – BioScience Managers

AVITA Medical Announces FDA Approval of the RECELL® System for the Treatment of Severe Burns in the U.S.

20th September 2018/in Avita Medical

Point-of-care regenerative medicine technology approved to treat secondand third-degree burns using Spray-On Skin™ Cells product U.S. market launch planned for 4th calendar quarter 2018. Target market for burns approximates USD $200 million Valencia, Calif., USA, and Melbourne, Australia, 21 September 2018 — AVITA Medical (ASX: AVH, OTCQX:AVMXY), a global regenerative medicine company, today announced that […]

AVITA Medical Announces Commencement of Manufacturing of RECELL® Device in Newly Acquired Facility in Preparation for Planned U.S. Launch

23rd August 2018/in Avita Medical

Valencia, Calif., USA, and Melbourne, Australia, 23 August 2018 — AVITA Medical (ASX: AVH, OTCQX: AVMXY) today announced the successful completion of multiple production runs for the RECELL Device® within its newly acquired manufacturing facility in Ventura, California. Effective July 1, 2018 AVITA Medical acquired the facility from a Fortune 500 manufacturer that had previously […]

AVITA Medical Announces Presentation of RECELL® Device Effectiveness and Safety in Treatment of Thermal Burns at Premier U.S. Military Conference

22nd August 2018/in Avita Medical

Results from two U.S. pivotal trials featured in plenary session at U.S. Defense Department Military Health System Research Symposium Valencia, Calif., USA, and Melbourne, Australia, 22 August 2018 AVITA Medical (ASX: AVH, OTCQX: AVMXY) today announced that results from two U.S. pivotal clinical trials demonstrating the effectiveness and clinical benefits of the RECELL® Autologous Cell Harvesting […]

AVITA Medical Announces Expanded Compassionate Use of RECELL® Device in Life-Threatening Burns

9th August 2018/in Avita Medical

FDA approves expansion of program to include up to 108 patients and 26 U.S. burn centers Valencia, Calif., USA, and Melbourne, Australia, 9 August 2018 — AVITA Medical (ASX: AVH, OTCQX: AVMXY) today announced that the U.S. Food and Drug Administration (FDA) has approved a significant increase in the number of patients who may be […]

AVITA Medical Announces Acquisition of Manufacturing Facility to Support Planned U.S. Launch of RECELL® Device

28th June 2018/in Avita Medical

Valencia, Calif., USA, and Melbourne, Australia, 28 June 2018 — AVITA Medical (ASX: AVH, OTCQX: AVMXY) today announced that it has entered into an agreement to acquire a manufacturing facility to support the planned U.S. launch of the RECELL® Autologous Cell Harvesting Device in the treatment of burns. The facility is currently operated by a […]

RECELL Successful Pivotal Trial Data Presented at ABA Day 3

16th April 2018/in Avita Medical

Valencia, Calif., USA, and Melbourne, Australia, 13 April 2018 — AVITA Medical (ASX: AVH, OTCQX: AVMXY) today announced that its pivotal, controlled clinical trial in the treatment of deep full-thickness (third-degree) burns with the RECELL® Autologous Cell Harvesting Device achieved its co-primary endpoints, demonstrating a statistically significant reduction in donor skin requirements versus standard of […]

AVITA Medical Announces Government Funded Clinical Trial of RECELL® in China

19th March 2018/in Avita Medical, Portfolio Companies

Also Announces that Major Hospital Will Host New Training Center for RECELL in Beijing Valencia, CA, USA, and Melbourne, Australia, 19 March 2018 — AVITA Medical (ASX: AVH, OTCQX: AVMXY) today announced the commencement of a randomized, controlled clinical trial of RECELL® in the treatment of deep partial-thickness (second-degree) burns in China. RECELL is a medical […]

AVITA Medical Announces FDA Approval of Expansion of RECELL Compassionate Use Program in Life Threatening Injuries

12th February 2018/in Avita Medical, Portfolio Companies

Expanded Protocol Allows Treatment of Up to 88 Patients Valencia, CA, USA, and Melbourne, Australia, 12 February 2018 — AVITA Medical (ASX: AVH, OTCQX: AVMXY) today announced that the U.S. Food and Drug Administration (FDA) has approved a significant increase in the number of patients who may be treated in the United States with the […]

Avita Announces Five RECELL® Abstracts Accepted for Presentation at American Burn Association (ABA) 50th Annual Meeting

30th January 2018/in Avita Medical, Portfolio Companies

Valencia, CA, USA, and Melbourne, Australia, 30 January 2018 — Avita Medical (ASX – AVH, OTCQX: AVMXY) announced that five abstracts highlighting the compelling clinical data and health economic benefits of RECELL® in the treatment of burns have been accepted for presentation at the American Burn Association 50th Annual Meeting to be held from April […]

AVITA Announces Office Transitions in Australia and the UK

29th November 2017/in Avita Medical

Avita Announces Office Transitions in Australia and the UK Decision Optimizes Access to Strategic Markets to Support Long-Term Growth Strategy Valencia, CA, USA, Perth, Australia and London, United Kingdom, 29 November 2017 — Avita Medical (ASX: AVH, OTCQX: AVMXY), a regenerative medicine company with a platform technology creating opportunities in burn and wound care, and […]