Developing Next-Generation Organ and Tissue Transplant Solutions

Robert Neusner
908.581.5059

STAGE: Seed

INDUSTRY: MedTech / Regenerative Medicine / AI

NUMBER OF EMPLOYEES: 6

MARKET SIZE: $6.4 B WW sales

USE OF FUNDS: FDA verification and validation studies, clinical study design, manufacturing scale-up, patent work, pipeline expansion

MANAGEMENT

Chief Executive Officer

Carrie DiMarzio

Experienced CEO, visionary leader, respected perfusion expert

Carrie DiMarzio has dedicated her career to creating a better future by using her leadership skills in tandem with her expertise in science and engineering. DiMarzio is the CEO of BMI OrganBank and Industrial Hard Carbon LLC (IHC).

At BMI OrganBank, DiMarzio leads a team of experts in perfusion technology that will advance organ transplantation and novel ex vivo laboratory research - both projects have the potential to save thousands of lives. She guides partnerships of BMI OrganBank with organizations such as the Wake Forest Institute for Regenerative Medicine (WFIRM), Lawrence Livermore National Laboratory (LLNL), Duke Ex-Vivo Organ Laboratory (DEVOL), Cystic Fibrosis Foundation, and RegenMed Development Organization (ReMDO). Additionally, DiMarzio also serves on the Executive Leadership Council Board of ReMDO. During her time at BMI OrganBank, DiMarzio has led successful negotiations with the US FDA, gaining FDA EUA status for BMI OrganBank's SuppleVent™ device for use during the COVID-19 pandemic. DiMarzio's current endeavor is guiding OrganBankTM technology - a proprietary organ preservation system - through the FDA clearance project.

As noted, DiMarzio also serves as CEO for IHC, a precision engineering business that serves the bio-medical, aerospace, and automotive sectors, providing microscopically thin and diamond-like hard surface film modifications that vastly improve equipment performance and durability.

DiMarzio has relevant business experience in sales and marketing as well as quality control, can help to guide business owners on the difficult road toward increased efficiency and productivity, and has an in-depth familiarity with human capital development. DiMarzio is known for her attention to detail, her equal commitment to her company, team, and stakeholders, and her remarkable ability to elicit 'personal bests' from each member of the high-performing teams under her charge.

When DiMarzio is not making a difference by managing cutting-edge projects at these two innovative companies based in North Carolina, she engages deeply with her local church and community, coaches female sports for the local schools, and is significantly involved in global outreach programs to provide for those in need.

Robert Neusner Headshot
Chief Operating and Business Officer

Robert Neusner

Ex-J&J, 20+ years device and drug development and commercialization

25+ years of life science experience, including over 20 years with Johnson & Johnson, a leading pharmaceutical and medical device company.

Wide range of leadership positions in the commercialization and development of drugs and devices. Notable career experiences include planning launches for novel devices and drugs, establishing research, development and commercial partnerships, and overseeing payor strategy and patient support services for a multi-billion-dollar product franchise. Co-invented and led the development of a diagnostic device now under ongoing approval by regulators around the globe.

Bachelor of Science in Chemical Engineering from Rice University and MBA from Columbia Business School.

Chief Medical Officer

David Gerber

Chief of Surgery and transplant surgeon, University of Cincinnati, deep clinical trial experience

Distinguished Professor and Vice Chair Clinical Affairs and Chief of the Division of Abdominal Transplant at UNC.

2020, US Secretary of Defense awarded the Defense Meritorious Service Medal to Dr. Gerber for exceptionally meritorious service for the Armed Forces.

In 2010 David was appointed by the Secretary of the Department of Health and Human Services (HHS) to the Advisory Committee on Transplantation.

CHALLENGE

Over 100,000 Americans are waitlisted for organ transplants, and many will die before they receive one.  At the same time, many usable organs are being discarded.

SOLUTION

BMI has developed patented technologies that (1) extend the time and distance over which an organ can be kept viable, and (2) enable new types of organ testing and reconditioning.

MARKET

85% of the transplant waitlist is for kidneys, which will be BMI’s first FDA approved indication.  The closest publicly traded competitor (TMDX) has a market cap of $2.7 B.

RECENT MILESTONES

(1) Robust BMI prototypes successfully used in almost 100 pre-clinical procedures, (2) research revenues of ~ $1 MM / year, and (3) generated data showing advantage vs. older technologies (publication pending).

REVENUE MODEL

Procedure-based pricing will fit within existing insurance payment models on Day 1 of launch.  Razor / razor blade pricing approach whereby device is sold at cost and profit is derived from disposable organ cassettes and fluids.

COMPETITIVE ADVANTAGE

BMI has generated data showing that their patented technology allows much longer preservation times than competing devices.

EXIT

There are multiple exit points, including the interim readout of the pivotal clinical study in 2025.  Options include horizontal integration with an established provider of organ transplant technologies or a bolt-on acquisition for a large medical device manufacturer who already markets related products, such as Medtronic.