The problem we solve: It is simply un-American that around 120,000 people are wait-listed to receive an organ transplant. This number increases every 10 minutes, yet sadly 20 families will experience the heartbreak of losing a loved one today and every day because of the inability to deliver a viable donor organ. The national underperformance is so acute that 50% of those waitlisted will die within 5 years and, in 2019, the best year ever, only 23,401 successful transplants were performed in the United States. Add to this over 500,000 people are enduring the relentless and awful cycle of dialysis, which costs our nation almost $40 billion, P.A. We need to extend the length of time organs remain viable for transplant, therefore extending the distance they can be transported to find the best recipient. We are determined to help bring the national waitlist to ZERO and to improve the quality of lives of millions of Americans.
About our solution: BMI's technology has been proving its capabilities in the laboratories of leading American research institutions and now it is time to create a truly mobile platform. We will demonstrate the advantages of BMI's mobile platform over today's industry standard (static cold storage). Currently, it can take days for urine production to begin, as an early sign of a successful procedure. Our aims are to provide data to better inform transplant surgeons and reduce cold ischemic injury to the organ that can dramatically decrease delayed graft function. We will use an animal model to replicate human transplant conditions, retrieving a kidney from fifteen pigs, perfuse the organ obtained at non-hypothermic temperature, and implant the kidney back into the donor and remove their remaining kidney. The animals will be monitored post operatively to ascertain kidney health. This study will validate BMI's new technology and methods to increase the number of lifesaving kidneys.Progress to date:
BMI’s cardiovascular emulation technology CaVESWave® has been developed over many years and has supported ex vivo organ perfusion by some of the world’s leading clinical research facilities, including Yale, Duke, UNC and Wake Forrest. BMI ‘s eminent Medical & Scientific Advisory Board of renowned surgeons and physicians has guided the progress of BMI’s system. The team is determined to scale (down) the proven laboratory system to create PROPEL™, a mobile and transportable device, to carry more lifesaving organs, for longer and further, from donor and recipient. To date progress has supported perfusion of ex vivo organs to enable research into drug therapies. Recently BMI has supported perfusion on a bench top prototype and seen success in auto-transplant of organs on rats. Now a study has been designed and surgeons are ready to begin a series of auto-transplants on pigs. This will be an important study on the road to achieving FDA clearance for the commercial deployment of PROPEL™.
Creator: Carrie DiMarzio
Location: North Carolina
Bio: Ms. Carrie DiMarzio was appointed CEO of BioMedInnovations, LLC (“BMI”) in July 2020, having being COO since 2015, in recognition of her significant leadership role, not least in guiding BMI’s Federal national award-winning COVID response partnership with the Lawrence Livermore National Laboratory (LLNL), that resulted in achieving FDA EUA status for an emergency use ventilator, SuppleVent™. Ms. DiMarzio has also leads BMI’s work for the Cystic Fibrosis Foundation (CFF), undertaken with Duke University ExVivo Organ Lab, and the company’s deployment and partnerships in Yale University, UNC and Porter Adventist. Ms. DiMarzio has been involved with and managed every aspect of BMI’s corporate development since first joining the company. Current and prior experience includes being CEO of Industrial Hard Carbon, LLC (“IHC”), a precision engineering business that serves biomedical (in-vivo and ex-vivo prostheses and medical instruments) and other sectors, by providing microscopically thin and diamond-like hard surface film modifications. Ms. DiMarzio introduced Quality Assurance processes to BMI, achieving ISO 9000 and ISO 13485 certifications, and she is known for her attention to detail, for personal commitment to company, team and stakeholders alike, and her remarkable ability to elicit individual ‘personal bests’ from the high performing teams under her charge.
CMO (Customer, Stakeholder and Governmental Relations), BSc, FRICS, MAPM
Biography: Mr. Finlay operates between Capitol Hill in Washington, D.C. and BMI’s facilities in North Carolina. Born in Belfast, Northern Ireland, he was actively involved in peace process and post-conflict transformation following the Good Friday Peace Agreement in 1998. Mr. Finlay has experience across a broad spectrum of the technology sector, including in business innovation center development, technology transfer partnerships, capital and structured finance raising, and the negotiation and management of significant grant awards. Mr. Finlay has advised elected representatives and national leaders as a Special Advisor in the United States, the UK, and EMEA and has been a counselor and C-Suite Advisor to major quoted and private corporations in the United States and worldwide. He is a Chartered Surveyor and Project Manager by profession, with over 25 years executive experience in the delivery of multi-jurisdictional projects and in the operation of public private partnerships and significant corporations.
Title: CMO (Customer, Stakeholder and Governmental Relations)
Advanced Degree(s): BSc, FRICS, MAPM
Laboratory Technician, BS in Animal Science
Biography: Ms. Kendall Hlewicki is a recent graduate from North Carolina State University with a Bachelor's of Science in Animal Science. She will be attending Veterinary school in the fall to pursue her Doctorate of Veterinary Medicine. She has been with BMI for two years now, originally working as an administrative intern and now as a laboratory technician and is the project head for MedStartr.
Title: Laboratory Technician
Advanced Degree(s): BS in Animal Science
PROPEL™by BMI device will allow more organs to made available for transplant as we propel the organ from donor to recipient, it will even more quickly communicate the hope and possibility to critically ill patients.
It is simply un-American that over 100,000 people are wait-listed to receive an organ transplant. This number increases every 10 minutes, yet sadly 20 families will experience the heartbreak of losing a loved one today and every day because of the inability to deliver a viable donor organ.
The national underperformance is so acute that 50% of those waitlisted will die within 5 years and, in 2019, the best year ever, only 23,401 successful transplants were performed in the United States. Add to this over 500,000 people are enduring the relentless and awful cycle of dialysis, which costs our nation almost $40 billion, P.A.
We need to extend the length of time organs remain viable for transplant, therefore extending the distance they can be transported to find the best recipient.
We are determined to help bring the national waitlist to ZERO and to improve the quality of lives of millions of Americans.
In reaching that goal, it is important to note that BMI's technology will communicate in real-time the availiability and key metrics of a donor organ. This communications capability, harnesed together with BMI's central cloud server hub, will become a much-accessed resrource for patients, families and clinicians alike. By way of illustrative example, a donor organ that becomes available in Seattle, Washington State could 'show-up' as a viable organ for a recipient in Washington, D.C. and could be transported on BMI's PROPEL device from coast-to-coast, while continuing to communicate the organ's metrcs to the prepping transplant team. This full functionality will bring many more opportunities for a successful transplant than has hitherto been possible. Not only will the device propel the organ from donor to recipient, it will even more quickly communicate the hope and possibility to critically ill patients.
Accordingly, BMI believes it will deliver hope and ultimately life-extending organs to millions.
BMI's organ transport device brings clinical teams, at both ends of the transplant spectrum - donor hospital and recipient surgical team - the data to make informed decisions and the ability to schedule and perform procedures during optimal hours.
BMI's underlying capabilities, to maintain the viability of organs for significantly longer, will open up many more opportunities for transplant surgeries to take place. The current eco-system in the USA has limited transport of organs to 300 nautical miles - ostensibly because distance is a function of time. This has more recently been extended out to 500 nautical miles through a relaxation of national policy. However, BMI believes its PROPEL device can extend range to enable coast-to-coast and even international delivery.
An important aspect to remember is that this extended time (and distance) means that procedures can be scheduled at optimal times to ensure that the best surgical and clinical teams are available, to increase the likihhood of a successful outcome and minimize the possibilities of a recipient rejecting a donor organ.
We already have world class clinical partners working with us and performing animal trials but we would love to work with more groups. Currently our focus is on Kidneys although our multirole device is being used to profuse all organs in many different clinical research studies. We encourage you to reach out to us and discuss options to collaborate.
Note: We don't expect clinical partners to contribute cash, we are hoping for a contribution of time/resources as well as brainpower and creativity.
BMI's ex vivo profusion technology solution is both data driven and will drive data, that is to say, the device will communicate vital end-to-end data, from donation to longterm survivors, enabling a streamlined process in turn saving hours and growing a centralised data hub that will become the go-to resource when analysising reimbursements, overall comparative costs, hospital performance, OPO performance, etc.
The resource that BMI will provide will enable hospitals to maximise the number of surgeries delivered and the efficient use of clinical facilities, while minimising downtime and waste.
One aspect that BMI's technology is already demonstrating is its value in research, increasgingly enabling BioPharma and other institutions to undertake better and more cost effecrtive research, into, for example, new therapies and vaccines. BMI's cardiovascular emulating technology, already deployed in leading research centers, is in essence allowing teams to fail early and succeed more quickly and cost effectively.
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