It all started in 1998, when Dr Magnus Nilsson acquired the rights to Perfadex®, which is used for the preservation of lungs before transplantation. Magnus Nilsson's company merged with Vitrolife in 1999 and became Business Area Transplantation within Vitrolife. In 2009 this was formed into a company of its own, XVIVO Perfusion AB, still under Vitrolife. In October 2012 XVIVO Perfusion AB was distributed to the shareholders of Vitrolife and became thereby an independent listed company. XVIVO was listed on First North in October 2012. Follow our journey with milestones here below.
In February, the first machine of the new generation of LS™ was installed in Copenhagen.
In April, the first XPS™ was sold to Australia and the Netherlands. Both countries are new markets with an XPS™.
Recruitment completed for NOVEL study in the US on STEEN Solution ™ and XPS™. The clinical trial includes 220 patients which will form the bsis of the company’s PMA application.
Recruitment completed for PrimECC® study a Sahlgrenska University Hospital. The study intends to expand the clinical documentation for PrimECC® and included a total of 80 (40+40) patients.
The first clinical heart transplant using the heart preservation technology developed by XVIVO’s partner Professor Stig Steen was performed. The aim is so make it possible to transport and preserve the heart from a donor in a more optimized way.
CPT (Current Procedural Terminology) code approval. The code is a direct mechanism for a hospital and surgical team to bill for a specific procedure. The code is related to preparation of marginal donor lungs and any additional hour(s) needed for and EVLP.
In December, the first XPS™ was installed in China.
In December, the first LS™ was installed in Portugal.
Pre-launch of Perfadex® Plus, a ready-to-use product that is pre-buffered with THAM and pre-supplemented with Calcium.2017
In January PrimECC™ is granted CE mark.
End of January the first XPS™ to Switzerland is sold.
XVIVO Perfusion is admitted to trading at NASDAQ First North Premier.
Mid February PERFADEX® and STEEN Solution™ are approved for sales in Russia.
End of February the first XPS™ to a clinic in France is sold and delivered.
In April an XPS™ contract is signed with a leading hospital in Boston.
Mid April XVIVO Perfusion announces a recommended public offer to the holders of shares and warrants of series 2015/2016 in Vivoline Medical.
In June XVIVO Perfusion declares the public offer on Vivoline Medical unconditional, announces the outcome and extends the acceptance period.
Mid June the first patient PrimECC™ study in included.
XPS™ contract with leading hospital in Alabama is signed in June.
In June the acceptance period for the public offer on Vivoline Medical is extended.
A lung cancer patient is given chemotherapy through In Vivo Lung Perfusion with STEEN Solution™ .
In July the extension of the acceptance period of XVIVO Perfusion public offer on Vivoline ends.2016
In February the first XPS™ in Europe is delivered to a hospital in Germany. During the same period the first XPS™ is delivered to Texas, USA.
XPS™ receives approval in Australia by TGA.
Two clinics in Florida sign XPS™ agreements.
Method patent for STEEN Solution™ in USA is granted with increased patent protection.
First XPS™ to southern Europe is delivered and additional XPS™ contract in the USA is signed. In total 16 clinics in the USA have access to the XPS™ system to facilitate lung evaluation using STEEN Solution™.
In August additional two XPS installations are performed.
The first liver transplant with STEEN Solution™ performed.
In October, AKH University Hospital in Vienna, which is the world´s second largest lung transplant clinic decided to use the XPS™ in their clinical program.
In November STEEN Solution™ is approved in China.
XPS™ obtains approval by Health Canada in November.2015
In March the XPS™ and accompanying disposable products receive CE marking.
In August the XPS™, STEEN Solution™ and accompanying disposable products receive FDA approval.
In September XVIVO receives funding through the Research and Innovation Framework Program Horizon 2020. The project “Biomarkers for clinical assessment of lungs intended for transplantation” is selected among 2666 proposals.
The first installation of an XPS™ in Asia is performed in September.
Financing from Vinnova for cancer research is obtained in November.2014
In July all patients are included in the NOVEL trial in the USA.
In October Dr Joel Cooper becomes the Medical Advisor to XVIVO Perfusion.
In November the NOVEL study is expanded with more centers.2013
In April all patients in the US clinical study on STEEN Solution™ are included.
In July an application for market approval of STEEN Solution™ in the USA is submitted to the FDA.
In October XVIVO Perfusion was spun off from Vitrolife and introduced on the stock exchange First North.2012
Positive results from Toronto on 1-year survival data are published in the New England Journal of Medicine.
Important Study published on STEEN Solution.
From Q3 2011, XVIVO is operated as a more separate entity within the Vitrolife Group.
Magnus Nilsson, former CEO of Vitrolife, becomes CEO of XVIVO and an external board is appointed, headed by Fredrik Mattsson, investment director at Bure Equity AB and board member of Vitrolife.2011
The clinical study in Canada is finished.2010
A separate legal entity, XVIVO Perfusion AB was re-created to increase focus on Business Area Transplantation. The organization is fully dedicated to offering service, support and education to meet the specific needs of transplantation customers.
STEEN Solution™ is approved for sales in Australia.2009
The Canadian authorities approve start of clinical trial in Canada.2008
Notice of allowance for STEEN Solution Patent in USA is received.
International breakthrough for Ex vivo lung perfusion (EVLP). The first transplant outside of Sweden is performed in UK.
First transplantation in North America is performed in Toronto, Canada.2007
STEEN Solution™ obtained CE mark in January.2006
Perfadex® obtained FDA clearance.2001
The first human transplant with the warm perfusion method ex vivo was performed in Lund in 2000.2000
Collaboration was initiated with Shaf Keshavjee, MD and thoracic surgeon at Toronto General Hospital.
End of 1999 XVIVO Transplantation Systems AB was merged with Scandinavian IVF Science AB and formed Vitrolife AB.
A new concept for lung transplantation was developed in collaboration with Stig Steen with the aim of reaching a new group of donors (non-heart beating) using a warm lung perfusion solution, STEEN Solution™, ex vivo.1999
XVIVO Transplantation Systems AB was started by Dr Magnus Nilsson in 1998.
A research agreement was signed with Professor Stig Steen in 1998 on preclinical and clinical research for lung transplantation and vein-preservation during coronary by-pass operation.1998