NOVEL trial recruitment of patients complete, FDA has decided that an expert panel meeting will be held Q1 of 2014.
| Source:Xvivo Perfusion AB
All 42 planned patients in Xvivo Perfusion’s American clinical trial using STEEN
Solution™ have received transplants. In the ongoing follow-up good clinical
results have been obtained. The patients are being followed up over a period of
one year. During a meeting with the FDA it was decided that the expert panel
meeting preceding the decision on HDE registration (Humanitarian Device
Exemption) will be held within four to five months. During the meeting the FDA’s
remaining questions were also discussed. Following the advice of the FDA, the
clinics taking part in the trial are continuing to transplant lungs that have
been perfused outside the body using STEEN Solution™ and so far 52 patients have
received transplants at the centers taking part in the trial.
The NOVEL trial is being performed at 7 centers in the USA and was designed to
safely increase the number of usable lungs from the donor pool. In the study,
clinical outcomes associated with ex-vivo lung perfusion (EVLP) of organs
initially assessed to be unusable were compared with a control group consisting
of lungs that were transplanted after having been initially assessed to be
usable. A total of 42 patients received transplants using the STEEN Solution™
method and these were matched with 42 control patients. The results so far from
the study continue to indicate that lungs evaluated using STEEN Solution™
perform as well as lungs transplanted directly.
"It is a big step forward for XVIVO Perfusion that the FDA has now decided to
hold an expert panel meeting. Such meetings precede decisions on registration.
Unfortunately the FDA is not able to hold this meeting until after the turn of
the year. We continue to note that clinics in the USA continue to show great
interest in STEEN Solution™," says Dr Magnus Nilsson, CEO at XVIVO Perfusion.
September 20, 2013
XVIVO Perfusion AB (publ)
For further information please contact:
Christoffer Rosenblad, CFO, tel: 46 31 788 21 59, e-mail:
For further information on XVIVO Perfusion’s business, please refer to the
company’s website, www.xvivoperfusion.com
Xvivo Perfusion is required to publish the information in this press release in
accordance with the Swedish Securities Market Act and/or the Financial
Instruments Trading Act. The information was submitted for publication
on September 20, 2013 at 4:55 p.m.
This is a translation of the Swedish version of the press release. When in
doubt, the Swedish wording prevails.
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 the
USA. The Xvivo share is listed on NASDAQ OMX First North and has the ticker
symbol XVIVO. More information can be found on the website
www.xvivoperfusion.com. The Certified Adviser is Redeye, www.redeye.se.
XVIVO Perfusion AB (publ), Box 53015, SE-400 14 Göteborg. Corporate identity
Tel: 46 31 788 21 50. Fax: 46 31 788 21 69.
E-mail: firstname.lastname@example.org. Website: www.xvivoperfusion.com
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