• Contact us
  • Customer support
  • Login
  • Home
  • Technology
    • Introduction to Ex Vivo Lung Perfusion
    • The Ex Vivo Lung Perfusion Process
    • Clinical
    • Protocols
    • Starting your clinical EVLP program
    • Articles about EVLP
    • EVLP with Manual method
    • EVLP with XPS™
    • Training and workshops
    • Patents
  • Products
    • Our Products
    • XPS™
    • XPS Disposable Lung Kit™
    • STEEN Solution™
    • PERFADEX® Plus
    • XVIVO
      Organ Chamber™
    • XVIVO
      Lung Cannula Set™
    • Instruction for Use
  • Knowledge
    • NOVEL Lung Trial
    • Literature
    • Insights
  • Media
    • Videos
    • Webinars
    • Establishing a successful EVLP program
  • About us
    • About XVIVO
    • History
    • Our market
    • News
    • Career
    • Working at XVIVO
  • Corporate
    • Corporate
    • The share
      • Info
      • Ownership structure
      • Insiders (PDMRs)
    • Press releases
      • 2023
      • 2022
      • 2021
      • 2020
      • 2019
      • 2018
      • 2017
      • 2016
      • 2015
      • 2014
      • 2013
      • 2012
    • Financial calendar
    • Financial reports
    • Financial reports – ESEF
    • Prospectus and material offerings
      • Material offerings
      • Prospectus
    • Financial presentations
      • Capital Markets Day
      • Earnings calls
    • Corporate governance
      • Article of Association
      • General meetings
      • Board of Directors
      • Senior Management
      • Auditors
      • Board Committees
      • Board and Senior Management share holdings
      • Guidelines for remuneration
      • Nomination Committee
      • Corporate Governance Reports
    • Analyst Coverage
    • Code of Conduct
    • Environmental Policy
    • Code of Conduct for Suppliers
    • Privacy policy
    • Contact us
    • Subscribe
    • Thank you
    • Error
XVIVO
  • Contact us
  • Customer support
  • Home
  • Technology
    • Introduction to Ex Vivo Lung Perfusion
    • The Ex Vivo Lung Perfusion Process
    • Clinical
    • Protocols
    • Starting your clinical EVLP program
    • Articles about EVLP
    • EVLP with Manual method
    • EVLP with XPS™
    • Training and workshops
    • Patents
  • Products
    • Our Products
    • XPS™
    • XPS Disposable Lung Kit™
    • STEEN Solution™
    • PERFADEX® Plus
    • XVIVO
      Organ Chamber™
    • XVIVO
      Lung Cannula Set™
    • Instruction for Use
  • Knowledge
    • NOVEL Lung Trial
    • Literature
    • Insights
  • Media
    • Videos
    • Webinars
    • Establishing a successful EVLP program
  • About us
    • About XVIVO
    • History
    • Our market
    • News
    • Career
    • Working at XVIVO
  • Corporate
    • Corporate
    • The share
      • Info
      • Ownership structure
      • Insiders (PDMRs)
    • Press releases
      • 2023
      • 2022
      • 2021
      • 2020
      • 2019
      • 2018
      • 2017
      • 2016
      • 2015
      • 2014
      • 2013
      • 2012
    • Financial calendar
    • Financial reports
    • Financial reports – ESEF
    • Prospectus and material offerings
      • Material offerings
      • Prospectus
    • Financial presentations
      • Capital Markets Day
      • Earnings calls
    • Corporate governance
      • Article of Association
      • General meetings
      • Board of Directors
      • Senior Management
      • Auditors
      • Board Committees
      • Board and Senior Management share holdings
      • Guidelines for remuneration
      • Nomination Committee
      • Corporate Governance Reports
    • Analyst Coverage
    • Code of Conduct
    • Environmental Policy
    • Code of Conduct for Suppliers
    • Privacy policy
    • Contact us
    • Subscribe
    • Thank you
    • Error
  • Corporate
  • The share
    • Info
    • Ownership structure
    • Insiders (PDMRs)
  • Press releases
    • 2023
    • 2022
    • 2021
    • 2020
    • 2019
    • 2018
    • 2017
    • 2016
    • 2015
    • 2014
    • 2013
    • 2012
  • Financial calendar
  • Financial reports
  • Financial reports – ESEF
  • Prospectus and material offerings
    • Material offerings
    • Prospectus
  • Financial presentations
    • Capital Markets Day
    • Earnings calls
  • Corporate governance
    • Article of Association
    • General meetings
    • Board of Directors
    • Senior Management
    • Auditors
    • Board Committees
    • Board and Senior Management share holdings
    • Guidelines for remuneration
    • Nomination Committee
    • Corporate Governance Reports
  • Analyst Coverage
  • Code of Conduct
  • Environmental Policy
  • Code of Conduct for Suppliers
  • Privacy policy
  • Contact us
  • Subscribe
  • Thank you
  • Error

XVIVO granted Breakthrough Device Designation from the FDA for the Liver Assist device

XVIVO has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for their Liver Assist device, indicated for ex-vivo oxygenated machine perfusion for preservation of donor livers prior to transplantation. The FDA’s Breakthrough Device Program is intended to expedite the development and prioritize the regulatory review of certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions than previous therapies.

The US is the largest liver transplant market globally with more than 8,600 livers transplanted in 2021[1]. In that year, the US performed more transplants than the next three largest markets combined (China, Brazil and Italy)[2]. The total US liver transplant market is expected to grow at an annual rate of 6 percent until 2030[3]. Additionally, the donation after circulatory death (DCD) segment of the market is expected to grow faster at approximately 15 percent per year in the same time frame[4]. An article published last year in The New England Journal of Medicine, shows that oxygenated hypothermic perfusion of DCD donor livers before transplantation has a significant positive impact on post-transplant clinical outcomes[5].
 
The overall goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to life-saving technologies by expediting their development, assessment, and review, through the FDA. As part of this program, the FDA will provide XVIVO with priority review and interactive communication (“sprint discussions”) which provide a faster mechanism for communication with FDA compared to Pre-Sub meetings. This enables device development and review to move forward in an efficient manner and achieve a faster path to market access. The Breakthrough Devices Program not only expedites FDA review but also has the potential to facilitate Centers for Medicare and Medicaid Services (CMS) payment and positively affect future coverage benefits.

“In line with our strategy to become the market leader within abdominal transplantation we have taken a decision to commercialize our liver technology in the US. FDA’s decision to grant a breakthrough designation indicates that the technology is innovative with the potential to be an improvement upon what is available on the market today. With more than 10 years of clinical experience, the Liver Assist is the most used device globally for machine perfusion of livers. As we believe in the extended life of organs we are very much looking forward to expanding this technology in the US after an FDA approval” says Dag Anderson, CEO of XVIVO.
 
 
September 20, 2022
Gothenburg
Dag Andersson, CEO
XVIVO Perfusion AB (publ)


[1] OPTN (Organ procurement and transplantation network – USA)
[2] GODT (Global observatory on organ donation and transplantation)
[3] XVIVO Market Intelligence & Forecast
[4] XVIVO Market Intelligence & Forecast
[5] https://www.nejm.org/doi/full/10.1056/NEJMoa2031532

For further information, please contact:


Dag Andersson, CEO, +46 76 643 30 31, e-mail: dag.andersson@xvivogroup.com
Kristoffer Nordström, CFO, +46 73 519 21 64, e-mail: kristoffer.nordstrom@xvivogroup.com

About Us


Founded in 1998, XVIVO is the only medical technology company dedicated to extending the life of all major organs – so transplant teams around the world can save more lives. Our solutions allow leading clinicians and researchers to push the boundaries of transplantation medicine. XVIVO is headquartered in Gothenburg, Sweden, and has offices and research sites on two continents. The company is listed on Nasdaq and has the ticker symbol XVIVO. More information can be found on the website www.xvivogroup.com.

Attachments


XVIVO granted Breakthrough Device Designation from the FDA for the Liver Assist device

About us

Founded in 1998, XVIVO is the only medical technology company dedicated to extending the life of all major organs so transplant teams around the world can save more lives.
Our solutions allow leading clinicians and researchers to push the boundaries of transplantation medicine.
XVIVO is headquartered in Gothenburg, Sweden, and has offices and research sites on three continents. The company is listed on Nasdaq.

Contact

Visiting address:
Swedish Office
XVIVO Perfusion AB
Entreprenörsstråket 10
431 53
Sweden

Phone: +46 31 788 21 50
Fax: +46 31 788 21 69
info@xvivogroup.com

 

Report a violations or breach here: Whistleblower

  • Home
  • Technology
  • Products
  • Knowledge
  • Media
  • About us
  • Corporate

Copyright © 2023 XVIVO. All rights reserved.

Design mkmedia
To top

We use cookies to improve the user experience on XVIVO. Read more about Cookies

Approve