Follow the Money to Medical Devices & Diagnostics
Spotlight on Avita Medical Ltd.

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Follow the Money to Medical Device & Diagnostic Opportunities highlights a newly funded medical device or diagnostic company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities.

Avita Medical is a public company based in the United Kingdom that develops regenerative and tissue-engineered products to treat a broad range of wounds, scars and skin defects. It has raised $9 million in a completion of a secondary public offering as reported in the PharmSource Lead Sheet on July 14, 2016.

Corporate Highlights

  • Avita Medical was incorporated in Australia in 1993.
  • Corporate Headquarters: Wimbledon, London
  • Other locations: Northridge, CA, US; South Perth, Australia
  • As of June 30, 2015, they had 21 employees.
  • Stock Exchange: Australian Securities Exchange (ASX)
  • Stock Symbol: AVH

Sourcing Opportunities

  • Avita Medical plans to use the proceeds to support US commercialization of its pipeline, such as the ReCell. This point-of-care kit uses autologous cell harvesting technology for the treatment of burns and skin injuries:

Development Phase: Pivotal studies
Medical Specialty: Cell & Tissue Processing; Dermatology/Wound Care
Purpose: Device – Therapeutic/Interventional
Type: Assay/Test/Kit; Dressing/Material/Liner/Mesh

Approvals/Clearances:
US – PMA planned
EU – CE Mark approval
Australia – TGA approval
China – CFDA clearance/approval
US – Other (FDA Expedited Access Pathway status)
US – IDE approval

Classification: EU Class III

Previous Financings

  • June 2016: $7.96 million in a government grant from the US BARDA
  • October 2015: $7.3 million in a completed secondary public offering
  • September 2015: $16.9 million in a government grant from the US BARDA

Medical Device & Diagnostics Pipeline1

Product Candidate Indication Medical Specialty Purpose Type
ReCell Burn/Skin injuries Cell & Tissue Processing;
Dermatology/Wound Care
Device-Therapeutic/
Interventional
Assay/Test/Kit;
Dressing/Material/
Liner/Mesh
ReGenerCell Diabetic foot ulcers Cell & Tissue Processing;
Dermatology/Wound Care
Device-Therapeutic/
Interventional
Implant- Graft/Scaffold
ReNovaCell Skin pigmentation Cell & Tissue Processing;
Dermatology/Wound Care
Device-Therapeutic/
Interventional
Dressing/Material/
Liner/Mesh;
Implant- Graft/Scaffold

Regulatory Approvals and Clearances

Product Candidate Region Approval/Clearance Year of Approval or Clearance
ReCell USA FDA Expedited Access Pathway 2015
RegenerCell EU CE Mark 2015
ReNovaCell EU CE Mark 2015
ReCell EU CE Mark 2015
ReCell USA IDE approval 2011
ReCell China CFDA approval 2007
ReCell Australia TGA approval 2006

Finances

(In $ thousands) 2015 2014
Revenues
2,750
2,683
R&D Expenditures
2,330
2,151
General & Administrative Expenditures
4,429
4,272
Total Operating Expenses
9,970
9,056

1Source: PharmSource Lead Sheet

Contact Information

Avita Medical Ltd. Key Officers
85 Ridgeway, 1st Floor Adam Kelliher, President & CEO
Wimbledon, London, SW19 4ST, UK Tim Rooney, CFO & COO
Phone: + 44 2089 479 804 William Marshall, VP, Operations & Quality
Web: www.avitamedical.com Andrew Quick, VP, Research & Technology

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Follow the Money to Medical Device & Diagnostic Opportunities – Spotlight on EndoStim, Inc.
Follow the Money to Medical Device & Diagnostic Opportunities – Spotlight on Organogenesis, Inc.

Scotty is a Research Analyst at PharmSource. He holds a BS degree in Biology from George Mason University and an MPH degree from Eastern Virginia Medical School. He’s experienced in data collection, analysis and management, and has done laboratory analysis and safety program development.

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