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PROPEL™ by BMI OrganTransplant: Significantly Advancing the World of Kidney Transplantation

by Carrie DiMarzio

Deploying BMI's mobile CardioVascular Emulation technology to demonstrate the quality and viability of donated organs can be significantly extended:An auto-transplantation study of 15 porcine kidneys.
Morrisville, NC United States Medical Device Biotech

All Team Company Patients Physicians Hospital Partners Innovation Details Supporters Comments Updates

About our project

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™.

About Our Team

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.

Title: CEO

About Team Members

Mark Finlay
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
Twitter: @MarkJFinlay
LinkedIn: https://www.linkedin.com/in/markfinlay?trk=people-guest_people_search-card

Kendall Hlewicki
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

About Our Company

BioMedInnovations LLC

Location: 2 Davis Drive
Morrisville, NC 27709

Founded: 2005

Website: http://bmi.llc/

Twitter: https://twitter.com/bmi_llc?lang=en

Facebook: https://www.facebook.com/biomedinnovations

Product Stage: Prototype/MVP

Employees: 3-5

How We Help Patients

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.     

How We Help Physicians

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.  

How We Help Hospitals

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. 

 

 

How We Help Partners

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. 

Innovation Details

Intellectual Property Summary

Over the years BMI developed a laboratory research platform, CaVESWave®, that imbeds BMI's 5 patents and multiple trade secrets held in 16 countries. Our team continues to evaluate new IP and we are expecting to learn more things that we will be holding as trade secrets or patent protecting as necessary.

Clinical Information

BMI has extensive FDA experience and has received FDA EUA approval for SuppleVent™ device in 2020. We are ready to submit a 510K application FDA for clearance for PROPEL™, BMI's fully transportable device, containing its patented cardiovascular emulation technology developed in the laboratories of leading American research institutions, such as Virginia Tech, Duke ExVivo Organ Lab., UNC, Wake Med, Yale Neuroscience Lab. 

Your help with completing the auto transplant study will be used as part of the FDA submission and application process.  A 510K approval is reviewed based off of similarities to a predicate device therefore does not require clinical trial.

Below are a selection of published studies in leading professional journals:

 

1). S1160 Obeticholic Acid Increases Hepatic Artery Flow Rate in Non-Cirrhotic Porcine Livers Perfused Using a Cardio-emulation Pump System: Possible Mechanism of Action in NASH

https://journals.lww.com/ajg/Fulltext/2020/10001/S1160_Obeticholic_Acid_Increases_Hepatic_Artery.1161.aspx

2). 1094 A Study of the Characteristics of Hepatic Blood Flow Ex Vivo Using a Cardio-Emulation Arterial Pump Perfusion System

https://journals.lww.com/ajg/Abstract/2019/10001/1094_A_Study_of_the_Characteristics_of_Hepatic.1094.aspx

https://www.gastrojournal.org/article/S0016-5085(20)34291-8/pdf?referrer=https%3A%2F%2Fwww.researchgate.net%2F

3). A study of Renal Extracellular Matrix scaffolds from discarded kidneys to maintain glomerular morphometry and vascular resilience and retains critical growth factors

https://journals.lww.com/transplantjournal/Fulltext/2015/09000/Renal_Extracellular_Matrix_Scaffolds_From.14.aspx

4). Study of restoration of brain circulation and cellular functions hours post-mortem

https://news.yale.edu/2019/12/17/nature-honors-yales-sestan-reviving-pigs-brain-function-after-death

https://www.nature.com/articles/s41586-019-1099-1

https://www.nature.com/articles/d41586-019-01216-4

5). Characterization of Irreversible Electroporation Ablation with a Validated Perfused Organ Model

https://pubmed.ncbi.nlm.nih.gov/27663353/ 

6). Assessment of ex vivo perfused liver health by Raman spectroscopy

https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/abs/10.1002/jrs.4688

Regulatory Status

BMI's plans to apply for a 510K preliminary-application to the FDA for PROPEL™.  The auto transplant kidney study will be used as part of the FDA submission and application process.  A 510K approval is reviewed based off of a predicate device therefore does not require clinical trial.  Our FDA consultant who has 19 years of experience as an FDA reviewer is confident we will get approval within 6-12mths.  We worked with this same consultant on our SuppleVent™ ventilator submission and achieved EUA approval in 9 weeks.  BMI is ISO 13485 certified and ISO 9001 compliant. 

How we will use the funds raised

The funds will specifically fund the purchase of 15 pigs, consumables, Operating Room time, Clinicians surgery time, perfusionist time, Post operative and Post transplant Vet animal care.

This study will show the eficacy of BMI's PROPEL™ portable device and provide research data needed for FDA as well as published in leading medical journals.

Thank You

WE NEED YOUR HELP TO SAVE LIVES  -  AND BRING HOPE TO MANY AMERICANS YOU COME IN CONTACT WITH EACH DAY!

  • We think it is simply un-American that over 100,000 people are languishing on waitlists awaiting a life-saving organ for transplant and that in our best year ever the USA only managed to transplant 23,401 organs total. 
  • Sadly, every day 20 American families suffer the heart break of losing a loved one from the waitlist because an organ transplant remains out of reach. 
  • Add to that human tragedy the fact that we spend almost $40 billion per annum to maintain people on the relentless cycle of dialysis. 

BMI’s organ perfusion and preservation platform, developed and proven in the labs of Yale, UNC, Duke and Porter Adventist, is set to positively disrupt the world of organ transplant. 

The goal is to reduce the national waitlist to ZERO and to offer many more organs for transplant than has hitherto been possible. 

Ahead of FDA clearance for its commercial mobile device, BMI’s multi-role platform is already being used to perfuse an array of organs in research settings, from Kidney to liver, lungs and small intestine – even a human brain in Yale’s Neuroscience lab.

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