A recent study led by researchers from the University of Minnesota, both from the College of Science and Engineering and the Medical School, demonstrated how heart valves that were developed in the lab and infixed in young lambs for a year could grow in the recipient. When tested in the same lamb model, the researchers found that the valves demonstrated decreased calcification and better flow of blood function in comparison with valves derived from animals.
If those results are confirmed in humans, these heart valves may help prevent multiple valve replacement surgeries for children born annually with heart defects. Additionally, these valves can be stored for roughly half a year, which means that they could offer surgeons an alternative treatment option.
The method used to make the valves has been licensed and patented to Vascudyne Inc., a startup firm formed by the University of Minnesota. The study, which was reported in the “Science Translational Medicine” journal, was financed by the National Institutes of Health.
Professor from the Departments of Materials Science and Chemical Engineering and Biomedical Engineering Robert Tranquillo stated that the study was a big step forward in pediatric heart research, adding that this was the first time that researchers had found a valve that could be implanted into an animal model and then grow with the animal. Tranquillo, who was the senior researcher during the study, noted that while there was still a long way to go, the researchers were optimistic and excited about the potential of this becoming a reality in the future.
At the moment, researchers haven’t been able to create a heart valve that can maintain its function and grow in pediatric patients, with the only approved option for kids with congenital heart defects being valves that have been developed from animal tissues that are chemically treated. These tissues often become defective, mainly because of calcification, and usually need to be replaced as they don’t grow as the child grows. Additionally, these young patients often undergo more than five open heart surgeries by the time they reach adulthood, after which, a mechanical valve will be implanted, and they will have to depend on blood thinners for the rest of their lives.
Tranquillo revealed that the next steps would be to implant the tri-tube valves that they developed directly into the right ventricle of the heart and begin the process of requesting approval from the U.S. Food and Drug Administration (“FDA”) for permission to commence human clinical trials in the near future.
As we await the next step in the process before lab-made valves become available to patients, other biomed firms are also coming up with innovations that are disruptive to the way various treatments are currently offered. For example, Brain Scientific Inc. (OTCQB: BRSF) has two FDA-approved devices that are transforming the neurology sector because these devices conduct EEG scans rapidly — and at a fraction of the current cost of performing such diagnostic tests.
NOTE TO INVESTORS: The latest news and updates relating to Brain Scientific Inc. (OTCQB: BRSF) are available in the company’s newsroom at https://ibn.fm/BRSF
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