History

The further developed and more user-friendly PERFADEX® Plus with Click Port has been launched worldwide.

Dag Andersson appointed new President and CEO. XVIVO’s founder and former CEO, Magnus
Nilsson, remains as Senior Advisor to primarily work with R&D.

In September, XVIVO announce the first patient included in the extended PrimECC® study.

In October, XVIVO acquires the Dutch medical technology company Organ Assist B.V.

In December, XVIVO announce the first patient included in the European Heart Preservation Study (NIHP2019).

In April, results from the heart preservation study performed by Prof. Johan Nilsson at Lunds University Hospital were presented on ISHLT.

In April, XVIVO received market approval (PMA) for STEEN Solution™ and XPS™ by the US FDA.

XVIVO’s patent for the heart preservation fluid approved in US and Europe.

First XPS™ sold to Canada.

In May, XVIVO received approval from the Swedish MPA to begin clinical studies on the new products for heart preservation.

XVIVO’s patent for PERFADEX® Plus approved in Europe.

Breakthrough Device Designation granted by the FDA for the XVIVO Heart Preservation System.

Subsidiary established in Australia.

PMA application for STEEN Solution™ and XPS™ were submitted to the US FDA.

PERFADEX® Plus, a new and improved version of PERFADEX® – ready-to-use were launched in Europe and the US.

XVIVO was awarded as Exporter of the Year by the news magazine Dagens Industri and The Swedish Export Credit Agency (EKN).

PrimECC® study shows that the product is safe and proves positive results.

The first clinical heart transplantation with XVIVO’s new technology was performed at Skåne University Hospital.

XVIVO’s new Heart preservation machine prototype has successfully passed pre-clinical tests with good results.

Unitied Therapeutics and XVIVO initied a collaboration with their  subsidiary Lung Bioengeneering and purchased 2 XPS™.

In February, the first machine of the new generation of XVIVO 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 basis 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 XVIVO 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.

In January PrimECC® is granted CE mark.

End of January the first XPS™ to Switzerland is sold.

XVIVO 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 announces a recommended public offer to the holders of shares and warrants of series 2015/2016 in Vivoline Medical.

In June XVIVO 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 public offer on Vivoline ends.

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.

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.

In July all patients are included in the NOVEL trial in the USA.

In October Dr Joel Cooper becomes the Medical Advisor to XVIVO.

In November the NOVEL study is expanded with more centers.

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 was spun off from Vitrolife and introduced on the stock exchange First North.

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.

The clinical study in Canada is finished.

A separate legal entity, XVIVO 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.

The Canadian authorities approve start of clinical trial in Canada.

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.

STEEN Solution™ obtained CE mark in January.

PERFADEX® obtained FDA clearance.

The first human transplant with the warm perfusion method ex vivo was performed in Lund in 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.

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.