PMA application for XPS™ with STEEN Solution™ submitted to the FDA

XVIVO Perfusion has submitted the PMA (Premarket Approval) application for the XPS™ with STEEN Solution™ to the FDA. The NOVEL Extension Clinical trial, that completed enrollment in 2017 constitutes the basis of the company’s PMA application. 

Lung transplantation remains a last treatment option for patients with end stage lung disease. Unfortunately, the lung is one of the least transplanted organs, leaving many patients with end stage lung disease to die without ever receiving a lung transplant. In 2016, 2322 patients received lung transplants in the US, 136 patients were removed from the wait list because they became too sick to undergo transplant, and 201 people died waiting for a transplant. It is estimated that between 37 - 45 percent of initially rejected lungs could be used for transplant.

XPS™ is an integrated system, that provides clinicians the flexibility to evaluate lungs before transplantation by means of a standardized and simplified procedure. The XPS™ System with STEEN Solution™ allows marginal quality lungs, that initially failed to meet standard transplant criteria, to be perfused and ventilated at normothermic conditions for up to 4 hours, thus providing an opportunity for surgeons to reassess transplant suitability. XPS™ and STEEN Solution™ are used worldwide with good clinical results. The XPS™ and STEEN Solution™ have already been CE-marked and thus approved for sales on the European market, and are also approved for sales in Canada and Australia.

In March 2014, the FDA Advisory Panel voted unanimously 10-0 that the XPS™ System with STEEN Solution™ met the requirements for HDE (Humanitarian Device Exemption) approval by proving safety. In August 2014, XVIVO Perfusion received HDE approval from the FDA for the XPS™ with STEEN Solution™ for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reassessed for transplantation. HDE approval entails certain restrictions, amongst other things that no more than 8,000 patients may be treated per year under HDE approval and that separate institutional IRB approval may be required for treatment. A PMA will no longer entail any such restrictions.  

The NOVEL Extension study which completed enrollment in June 2017 involves follow-up of the patients for up to one year. XVIVO Perfusion’s PAS (Post Approval Study) required by the FDA for all approvals includes a total of 126+126 patients that will be followed for 3 years. The inclusion of all patients for the PAS was completed in late 2017.

“The submission of the PMA application was the goal of a six-year effort with the company’s largest multicenter study ever performed in the largest market in the world, and is therefore an important milestone for the company,” says Dr. Magnus Nilsson, CEO of XVIVO Perfusion.

May11, 2018
Gothenburg
Magnus Nilsson, CEO
XVIVO Perfusion AB (publ)

For further information please contact:

Christoffer Rosenblad, CFO, +46 735 192159, christoffer.rosenblad@xvivoperfusion.com
Magnus Nilsson, CEO, +46 31 788 2150, magnus.nilsson@xvivoperfusion.com
For further information on XVIVO Perfusion’s business, please refer to the company’s website, www.xvivoperfusion.com

This information is information that Xvivo Perfusion AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation.  The information was submitted for publication, through the agency of the contact person set out above, at 06:00 am CET on May 11, 2018.

This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.

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XVIVO Perfusion AB is a medical technology company which develops solutions and systems for assessing and preserving organs outside the body and for selecting usable organs and maintaining them in optimal condition pending transplantation.
The company is headquartered in Gothenburg, Sweden, and has one office in Lund, Sweden and one office in Denver, the USA. The XVIVO share is listed on Nasdaq Stockholm and has the ticker symbol XVIVO. More information can be found on the website www.xvivoperfusion.com.
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XVIVO Perfusion AB (publ), Box 53015, SE-400 14 Göteborg. Corporate identity number 556561-0424.
Tel: 46 31 788 21 50. Fax: 46 31 788 21 69.
E-mail: info@xvivoperfusion.com. Website: www.xvivoperfusion.com

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