BMI OrganBank Obtains FDA Breakthrough Designation for Kidney Tech

BMI OrganBank Achieves Milestone with FDA Designation

BMI OrganBank is making waves in the medical field by developing innovative medical devices aimed at significantly reducing the waitlist for life-saving organ transplants, starting with kidneys. This initiative has recently gained momentum as the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for their pioneering organ preservation technology.

Revolutionizing Kidney Preservation

This designation proves BMI OrganBank's dedication to revolutionizing the organ transplant process through advanced technologies that enhance transplant outcomes. Traditional kidney perfusion methods typically rely on cold storage, which poses challenges such as evaluating the kidneys' functionality prior to transplantation and the potential risk of injury during storage. As a result, a considerable percentage of donated kidneys remain unused, further exacerbating the existing organ shortage dilemma.

Innovative Technology in Action

BMI OrganBank's room temperature machine perfusion (RTMP) platform, developed in collaboration with esteemed transplant surgeons and prestigious academic medical centers, is poised to change this narrative. By allowing for better kidney quality assessments and extending preservation times, this technology aims to increase the availability of kidneys for transplantation while addressing the frustratingly long wait times for patients in need.

What Does This Mean for the Future?

The implications of the FDA's Breakthrough Device Designation are vast. It paves the way for expedited engagement with the FDA as BMI OrganBank gears up for clinical studies slated for early next year. This significant step reflects the anticipation surrounding their revolutionary approach and the hope it brings to those awaiting transplants.

Statements from Leadership

"We are incredibly honored to receive this significant designation from the FDA and look forward to working with them as we prepare for clinical studies," stated Carrie DiMarzio, the Chief Executive Officer and Co-Founder of BMI OrganBank. Additionally, Dr. David A. Gerber, the Chief Medical Officer, expressed enthusiasm about the promising preclinical data, saying, "The timing of this news is outstanding as my colleagues and I participate in the World Transplant Congress this week." This enthusiasm is a testament to the confidence in the potential of their technology and its prospects for the transplant community.

About BMI OrganBank

BMI OrganBank is committed to developing groundbreaking perfusion systems that enhance organ and tissue evaluation and preservation. With state-of-the-art facilities in Winston-Salem and Research Triangle Park, the company is on the forefront of advancing multiple medical devices that utilize their patented and proprietary technologies. Their flagship product, the portable OrganBank kidney device, reflects collaborative efforts with leading transplant surgeons and is about to embark on clinical trials, potentially redefining patient care in the field of organ transplantation. They are driven by a mission to ensure that more organs can be successfully preserved and utilized for those in dire need.

Frequently Asked Questions

What is the significance of the FDA Breakthrough Device Designation?

The FDA Breakthrough Device Designation allows for expedited development and review of innovative medical technologies that have the potential to offer significant benefits to patients.

How does BMI OrganBank's technology improve kidney preservation?

The room temperature machine perfusion (RTMP) technology facilitates better quality assessment and extends preservation times, making more kidneys available for transplantation.

When are the clinical studies planned to begin?

Clinical studies are scheduled to commence early next year, allowing for further evaluation of the innovative kidney preservation device.

Who is leading BMI OrganBank?

Carrie DiMarzio serves as the Chief Executive Officer and Co-Founder, with Dr. David A. Gerber acting as Chief Medical Officer.

Where are BMI OrganBank's facilities located?

BMI OrganBank has established facilities in Winston-Salem and Research Triangle Park, focusing on the development of transformative medical devices.

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