Synklino A/S has raised €29.8 million (US$31.8 million) in a series A round to take forward SYN-002, a treatment for cytomegalovirus (CMV) infections in both donated organs and patients undergoing hematopoietic stem cell and solid organ transplants.
Organ transplant diagnostic company Caredx Inc. has received CE marking for its Alloseq HCT chimerism testing kit and Alloseq HCT interpretation software for use in patients who have received hematopoietic cell transplantation (HCT). The NGS-based solution is used to monitor engraftment and evaluate the success of a hematopoietic stem cell transplant by measuring the relative ratio of the recipient and the donor cell population post-transplantation.
The U.S. FDA has granted premarket approval for Transmedics Group Inc.’s OCS heart system for use with organs from donors after circulatory death (DCD). The approval expands on a prior FDA approval of the device for use with organs from donors after brain death in September 2021. Andover, Mass.-based Transmedics said its system can now be used for ex vivo reanimation, functional monitoring, and beating-heart preservation of donation-after-circulatory-death hearts.
Researchers have discovered a blood signature of protein isoforms that could potentially predict which patients may reject a new organ transplant, helping inform therapeutic decisions. The findings of this study are reported online in the January 27th edition of Science.
Organ transplantation is often a life-saving intervention whose success is mediated by the host's immune system. Immune-mediated rejection of an organ transplant destroys the transplanted organ or tissue and can be fatal.
The FDA advisory hearing for the Transmedics Organ Care System (OCS) resulted in a unanimous vote in favor of the OCS’s safety and efficacy numbers, although there will be a considerable post-approval study requirement. The company was able to overcome a number of problems with the pivotal study that might otherwise have tanked the application, such as the lack of blinding of transplant surgeons, which the FDA said could have biased the determination of whether a liver was acceptable for transplant.
Takeda Pharmaceutical Co. Ltd. said findings from its phase III Solstice study testing oral antiviral TAK-620 (maribavir) in treating solid organ transplant recipients with cytomegalovirus infections resistant or refractory to prior therapy (R/R CMV), showed twice the rate of confirmed CMV viremia clearance compared to other conventional therapies.
The shortage of hearts for transplant is a matter of record for both cardiologists and patients, a problem that Transmedics Inc. proposed to solve with its Organ Care System (OCS). Despite several significant issues associated with the pivotal clinical study for the OCS, Transmedics snared a 12-5 vote that the benefits of the system outweigh the risks, an outcome that may bring at least some relief for heart transplant patients by mid-year if analyst expectations are on target.
TORONTO – What’s the difference between an organ transplant container tucked under a paramedic’s arm and an ordinary beer cooler packed with ice? Surprisingly, not much, according to researchers at London, Ontario’s Western University. They’ve come up with a portable, temperature-controlled container that prevents spoilage of donor organs during transport to the operating room – and of potential vaccines.
