BMI OrganBank's Innovative Device Receives FDA Breakthrough Device Status for Kidney Transplantation Improvements
BMI OrganBank, a frontrunner in organ preservation technologies, is making waves in the medical community with its groundbreaking kidney preservation device. This innovative technology recently earned the esteemed Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), signifying its potential to revolutionize kidney transplantation. The designation paves the way for expedited collaboration with the FDA as BMI OrganBank gears up for clinical studies slated for early next year.
Kidney transplantation remains a crucial yet challenging procedure, particularly due to the significant wait times experienced by patients. Current kidney preservation methods often rely on cold storage, leaving donated organs susceptible to damage and functional evaluation challenges before transplantation. As a result, many potential kidney donations go unused, exacerbating the organ shortage crisis. BMI OrganBank aims to tackle this issue head-on with its innovative room-temperature machine perfusion (RTMP) technology, which allows for better kidney quality assessment and extended preservation periods.
Developed in close collaboration with renowned transplant surgeons and leading academic medical institutions, this RTMP platform aims to not only improve the assessment of kidney viability but also increase the available transplantable kidneys and thereby reduce the waiting times faced by patients on the transplant list. Carrie DiMarzio, CEO and Co-Founder of BMI OrganBank, expressed her enthusiasm regarding the FDA's designation, highlighting the potential impact of this technology on the future of organ transplantation.
"This designation from the FDA is a significant milestone for us, and we are eager to partner with them as we prepare to initiate clinical studies," DiMarzio stated. Dr. David A. Gerber, BMI OrganBank's Chief Medical Officer and an abdominal transplant surgeon, echoed this sentiment, emphasizing the promising data gathered during preclinical trials and the excitement surrounding the upcoming World Transplant Congress.
BMI OrganBank's work doesn't stop here; the organization is also engaged in the broader development of advanced perfusion systems intended for evaluating and preserving other organs and tissues. Along with its facilities located in Winston-Salem and Research Triangle Park, North Carolina, the company continues to drive forward with multiple medical devices that leverage its proprietary technologies. The flagship product, the portable OrganBank kidney device, is anticipated to commence clinical investigations soon.
This major advancement signifies a step toward aligning technological innovation with urgent medical needs, aiming to enhance the lives of countless patients awaiting organ transplants. As BMI OrganBank forges ahead, its successes could pave the way for a new standard in organ preservation and transplantation, fundamentally altering the landscape of renal medicine for years to come. Those interested in learning more about BMI OrganBank and its innovative offerings can explore its website at www.bmiorganbank.com.
Kidney transplantation remains a crucial yet challenging procedure, particularly due to the significant wait times experienced by patients. Current kidney preservation methods often rely on cold storage, leaving donated organs susceptible to damage and functional evaluation challenges before transplantation. As a result, many potential kidney donations go unused, exacerbating the organ shortage crisis. BMI OrganBank aims to tackle this issue head-on with its innovative room-temperature machine perfusion (RTMP) technology, which allows for better kidney quality assessment and extended preservation periods.
Developed in close collaboration with renowned transplant surgeons and leading academic medical institutions, this RTMP platform aims to not only improve the assessment of kidney viability but also increase the available transplantable kidneys and thereby reduce the waiting times faced by patients on the transplant list. Carrie DiMarzio, CEO and Co-Founder of BMI OrganBank, expressed her enthusiasm regarding the FDA's designation, highlighting the potential impact of this technology on the future of organ transplantation.
"This designation from the FDA is a significant milestone for us, and we are eager to partner with them as we prepare to initiate clinical studies," DiMarzio stated. Dr. David A. Gerber, BMI OrganBank's Chief Medical Officer and an abdominal transplant surgeon, echoed this sentiment, emphasizing the promising data gathered during preclinical trials and the excitement surrounding the upcoming World Transplant Congress.
BMI OrganBank's work doesn't stop here; the organization is also engaged in the broader development of advanced perfusion systems intended for evaluating and preserving other organs and tissues. Along with its facilities located in Winston-Salem and Research Triangle Park, North Carolina, the company continues to drive forward with multiple medical devices that leverage its proprietary technologies. The flagship product, the portable OrganBank kidney device, is anticipated to commence clinical investigations soon.
This major advancement signifies a step toward aligning technological innovation with urgent medical needs, aiming to enhance the lives of countless patients awaiting organ transplants. As BMI OrganBank forges ahead, its successes could pave the way for a new standard in organ preservation and transplantation, fundamentally altering the landscape of renal medicine for years to come. Those interested in learning more about BMI OrganBank and its innovative offerings can explore its website at www.bmiorganbank.com.
Topics Health）
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