Organ transplant medtech company XVIVO Perfusion AB has terminated a clinical study investigating its heart-lung machine priming solution, with the company saying it will now evaluate the commercial viability of the product.
The solution, called PrimECC, had demonstrated promising safety results in 2017. The Swedish company had hoped the current study, initiated in 2020, would expand the clinical dataset for PrimECC. But XVIVO pointed to Covid-19-induced patient enrolment issues, general challenges around identifying recruitment sites, and lack of criteria fulfilment as reasons for shortcomings in the trial.
If XVIVO decides to shelve the product, it is set to lose $1.45m (SEK 15m) which has been poured into the clinical project.
The solution, which received CE-marking in 2016, is a fluid added to heart-lung machines, used in cardiopulmonary bypass procedures, to prevent air bubbles from entering circulation. Currently, saline is used.
Christoffer Rosenblad, XVIVO’s CEO said: “Closing the study recruitment early is the right decision in the current situation. We will now analyse the data and evaluate the strategic and commercial opportunities for PrimECC.”
The cardiopulmonary bypass equipment market is set to be worth nearly $500m by 2033, according to a model forecast by GlobalData. LivaNova are current clear market leaders, with Medtronic and Terumo also possessing significant market share. LivaNova recently launched its latest US Food and Drug Administration (FDA)-cleared heart-lung machine, which itself has multiple features to prevent the formation of air bubbles.
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“With the decision to close the study for further patient inclusions, we will increase focus on our core business within organ transplantation, where the great opportunities deserve our full attention,” said Rosenblad.
The medtech company recently entered into a partnership with MTJ Aviation, a flight services company, to aid in transportation logistics for its organ procurement.