XVIVO Perfusion AB announced a significant regulatory setback for its innovative heart preservation technology, with CE approval for the heart perfusion solution and supplement delayed by approximately 6-12 months due to additional scientific consultation requirements at EU competent authorities. While the XVIVO Heart Assist Transport and XVIVO Heart Assist Transport Perfusion Set have already received CE approval, the perfusion solution component faces extended regulatory review.
Regulatory Hurdles Delay Market Access
The delay stems from the composition of the perfusion solution used in XVIVO's heart preservation technology, which requires the notified body to seek scientific opinions from both the European Medicines Agency (EMA) and another EU competent authority before issuing the CE certificate. Although the heart solution has passed consultation at one competent authority (EMA), the company estimates the additional scientific consultation procedure will take approximately 6-12 months due to additional requests for information.
"The exact time of delay will be pending submission slot times available for consultation," the company stated, highlighting the uncertainty surrounding the approval timeline.
Strong Clinical Trial Results Support Technology
Despite the regulatory delays, XVIVO's European multicenter heart trial has demonstrated compelling clinical outcomes. The first randomized controlled trial with superiority design showed a 76% risk reduction in severe primary graft dysfunction (PGD), which is the leading cause of early and late mortality in heart transplantation.
The 12-month follow-up results revealed improved one-year survival rates in the XVIVO group, with 92% survival compared to 86% in the control arm. This translates to six additional lives saved in the XVIVO group, demonstrating the technology's potential clinical impact.
Industry Response and Patient Impact
The outstanding clinical results have generated significant interest among surgeons worldwide who are eager to implement the technology for patient care. However, the regulatory delay means European patients will have to wait longer for access to this potentially life-saving technology.
"We are very disappointed by this delay, as it deprives many European patients the chance to a life-saving transplant until the technology is regulatory approved," said Christoffer Rosenblad, CEO of XVIVO. "We have spent a year on this regulatory process and made significant achievements. One final step remains and XVIVO will continue working closely with the relevant authorities."
Technology's Broader Significance
Rosenblad emphasized the transformative potential of the technology, stating that achieving CE approval "would be a significant step towards transforming the paradigm of heart preservation and that one day nobody should die waiting for a new organ." He described the XVIVO Heart Assist Transport system as "not just a technological breakthrough - it is a symbol of hope for the thousands of patients waiting for a new heart."
The company expressed gratitude to the patients, clinicians, transplant teams, and partners across Europe whose dedication has supported the development process. XVIVO continues to work closely with relevant authorities to complete the final regulatory step for full system approval.
