BMI OrganBank

Cover Block

PUBLIC

Field	Value
Name	BMI OrganBank
Tagline	Develops medical devices and perfusion technology to improve organ and tissue preservation for transplantation
Headquarters	Winston-Salem, NC, USA (additional facility at Research Triangle Park, NC)
Stage	Seed
Business Model	B2B (medical devices, clinical research services)
Industry	Healthtech / Medical Devices
Technology Type	Biotech / Life Sciences (ex vivo organ perfusion)
Geography	North America
Growth Profile	Venture Scale
Founding Team	Co-Founders (2): Carrie DiMarzio, George Barr
Funding Label	Seed
Total Disclosed	$600,000 seed plus $3,500,000 grant funding [Crunchbase] [BMI OrganBank]

Links

PUBLIC

• Website: https://bmiorganbank.com/
• LinkedIn: https://www.linkedin.com/company/bmiorganbank
• Crunchbase: https://www.crunchbase.com/organization/bmi-organbank

Executive Summary

PUBLIC

BMI OrganBank is a Winston-Salem, North Carolina medical device company building ex vivo perfusion and preservation technology aimed at extending the viable transport window for transplantable organs, with an initial focus on kidneys [BMI OrganBank] [Crunchbase]. The company traces its commercial roots to BioMedInnovations, LLC, founded by industry veteran George Barr, and is now led by co-founder and CEO Carrie DiMarzio, who previously guided BMI's SuppleVent ventilator through FDA Emergency Use Authorization during the COVID-19 pandemic [BMI OrganBank]. Its flagship portable kidney preservation device, co-developed with surgeons at Duke University's Ex-Vivo Organ Lab (DEVOL), has secured FDA Breakthrough Device Designation, an early but meaningful regulatory tailwind for a category whose clinical economics depend on closing the gap between donor and recipient [North Carolina Biotechnology Center] [BMI OrganBank]. Disclosed capitalization to date includes a $600,000 seed round and roughly $3.5 million in grant funding, with the National Institutes of Health among funders and the company actively raising additional seed capital [Crunchbase] [BMI OrganBank]. The business model combines device commercialization with a fee-for-service preclinical research arm, the Ex Vivo Institute, which performs perfusion-based studies for academic and industry clients [BMI OrganBank]. Over the next 12 to 18 months, the items most worth watching are the start of clinical studies for the portable kidney device, FDA clearance progress for the broader OrganBank system, and the operational impact of a recently announced partnership with Dedicated Staffing Solutions [BMI OrganBank] [PR Newswire].

Data Accuracy: GREEN -- Confirmed by BMI OrganBank primary materials, Crunchbase, NC Biotechnology Center, and PR Newswire.

Taxonomy Snapshot

Axis	Value
Stage	Seed
Business Model	B2B
Industry / Vertical	Healthtech / Transplantation Medical Devices
Technology Type	Biotech / Life Sciences (ex vivo perfusion)
Geography	North America
Growth Profile	Venture Scale
Founding Team	Co-Founders (2)
Funding	Seed plus federal grant funding

Company Overview

PUBLIC

BMI OrganBank is the current operating identity of BioMedInnovations, LLC, a North Carolina medical device developer founded by George Barr, who also founded Anatech Ltd. and Industrial Hard Carbon and has worked in advanced medical technologies for more than four decades [BMI OrganBank]. The company operates from facilities at the Wake Forest Institute for Regenerative Medicine (WFIRM) campus in Winston-Salem and at Research Triangle Park, two locations that situate it inside one of the densest regenerative medicine and clinical research clusters in the United States [BMI OrganBank].

The company's near-term identity was shaped by two distinct chapters. During the COVID-19 pandemic, BMI developed the SuppleVent ventilator and secured FDA Emergency Use Authorization, an effort led by Carrie DiMarzio that demonstrated the team could move a device from concept to authorized use under regulatory pressure [BMI OrganBank]. The transplantation chapter began in earnest with a perfusion technology license from Duke University's Ex-Vivo Organ Lab, led by Drs. Andrew S. Barbas and Matthew Hartwig of the Department of Surgery [BMI OrganBank]. That license underpins the OrganBank Transport device and the portable kidney preservation device that the company is now advancing.

Key milestones, in approximate chronological order, include the founding of BioMedInnovations by Barr, the SuppleVent EUA during the pandemic, the Duke perfusion technology license, the launch of the Ex Vivo Institute services arm, the award of FDA Breakthrough Device Designation for the kidney preservation device, selection by the North Carolina Biotechnology Center for funding to advance medical device development, and the 2024-era strategic partnership with Dedicated Staffing Solutions to align preservation technology with clinical staffing capacity [BMI OrganBank] [North Carolina Biotechnology Center] [PR Newswire].

Data Accuracy: GREEN -- Confirmed by BMI OrganBank primary site, NC Biotechnology Center, PR Newswire, and Crunchbase.

Product and Technology

MIXED

BMI OrganBank's product portfolio is organized around a proprietary ex vivo organ perfusion platform marketed under the OrganBank brand, which is currently going through the FDA clearance process [BMI OrganBank] [PUBLIC]. The flagship clinical product is a portable kidney preservation device, co-developed with leading transplant surgeons and described by the company as set to begin clinical studies in the near term [BMI OrganBank] [PUBLIC]. The kidney device received FDA Breakthrough Device Designation, a status reserved for technologies that may offer more effective treatment of life-threatening or irreversibly debilitating conditions and that grants the sponsor more frequent FDA interaction during development [North Carolina Biotechnology Center] [PUBLIC]. A second device line, the OrganBank Transport, was co-developed with Duke University's DEVOL lab and the company has stated it is set to launch [BMI OrganBank] [PUBLIC].

Beyond devices, BMI runs two adjacent platforms that are commercially relevant. The Ex Vivo Institute offers customized preclinical translational research services for ex vivo and in vivo studies spanning immunology, tissue engineering, regenerative medicine, vascularized composite allotransplantation, cardiovascular disease, and oncology, providing a fee-for-service revenue channel that also strengthens scientific relationships with potential acquirers and academic partners [BMI OrganBank] [PUBLIC]. The OrganBank Lab markets a patented cardio-vascular emulating system branded CaVESWave for ex vivo pharmacodynamic research, positioning the company as both a device maker and a tools provider [BMI OrganBank] [PUBLIC].

The underlying intellectual property combines licensed perfusion technology from the Duke Ex-Vivo Organ Lab with BMI's own patents, methods, and trade secrets in organ perfusion and preservation [BMI OrganBank] [PUBLIC]. The company has also signaled work on whole-eye transplantation in collaboration with academic partners, an early-stage application area rather than a near-term commercial product [BMI OrganBank] [PUBLIC]. Manufacturing scale, software stack, and specific device componentry are not publicly disclosed at this time.

Data Accuracy: GREEN -- Confirmed by BMI OrganBank product pages and NC Biotechnology Center coverage.

Market Research and Opportunity

PUBLIC

The organ preservation market matters now because the constraint on transplantation is increasingly logistical rather than surgical: organs that could save lives are discarded because the cold-storage clock runs out before a recipient can be matched and prepared. Improvements in perfusion technology directly translate into more transplants completed, fewer organs discarded, and better post-transplant outcomes, which is why FDA Breakthrough Device Designation in this category is a signal worth taking seriously [North Carolina Biotechnology Center].

What can be stated from cited primary and secondary materials is that the company is targeting kidney transplantation first, the highest-volume solid-organ transplant category in the United States, and is building a platform with claimed applicability across additional organs and into preclinical research services [BMI OrganBank] [Innovation Quarter]. The Ex Vivo Institute services line and the CaVESWave research platform extend the addressable demand into pharmaceutical R&D budgets, which historically tolerate higher per-study price points than provider-side device procurement [BMI OrganBank].

The demand drivers surfaced by cited research are concrete. Innovation Quarter's profile of the company frames the kidney preservation device as a response to the persistent gap between organs recovered and organs successfully transplanted [Innovation Quarter]. FDA Breakthrough Device Designation, granted by the agency itself, is in effect a regulatory acknowledgment that the unmet clinical need is material [North Carolina Biotechnology Center]. The company's recent partnership with Dedicated Staffing Solutions points to a parallel demand driver on the operational side: even when preservation technology works, transplant centers need clinical perfusion staff to operate it, and capacity constraints on that workforce can throttle adoption [PR Newswire].

Adjacent and substitute markets include hypothermic and normothermic machine perfusion systems already commercialized by larger players in the global transplant device market, as well as conventional cold static storage, which remains the default standard of care and the price-and-workflow benchmark any new device must beat. Regulatory and macro forces include the U.S. organ procurement reform agenda, ongoing scrutiny of organ procurement organizations, and federal research funding via NIH, which is already a confirmed BMI funder [BMI OrganBank].

Sizing claim	Value	Source
Disclosed seed funding	$600,000	[Crunchbase]
Disclosed grant funding	$3,500,000	[BMI OrganBank]
Kidney device regulatory status	FDA Breakthrough Device Designation	[North Carolina Biotechnology Center]

Analyst takeaway: the market opportunity is real and clinically validated by FDA designation, but the absence of a cited third-party TAM in available materials means investors should request a sized market model directly from the company before underwriting a category-leadership thesis.

Data Accuracy: YELLOW -- Regulatory and funding facts confirmed by two sources each; market sizing not independently cited.

Competitive Landscape

MIXED

BMI OrganBank competes in ex vivo organ perfusion and preservation, a category where the incumbents are established machine perfusion device makers and the default substitute is conventional cold static storage.

The segment-by-segment map breaks into three groups. Incumbent machine perfusion device makers, primarily larger global medical device companies with commercialized hypothermic and normothermic systems, hold the installed base inside major U.S. transplant centers and set the price-and-evidence bar for any new entrant [PUBLIC]. Challenger device makers, including BMI, compete on a combination of portability, cost per use, organ-specific optimization, and integration with clinical workflow [BMI OrganBank] [PUBLIC]. Adjacent substitutes include the entrenched cold static storage workflow, which is inexpensive, familiar, and deeply embedded in transplant logistics; any new device must justify its incremental cost with measurable improvements in organ utilization or post-transplant outcomes [PUBLIC].

Where BMI appears defensible today: the Duke Ex-Vivo Organ Lab license and the named clinical collaborators (Drs. Barbas and Hartwig) provide both IP and credibility with the academic transplant community, which is a meaningful distribution advantage in a market where surgeons drive purchasing [BMI OrganBank] [PRIVATE-flavored interpretation, but sourced]. FDA Breakthrough Device Designation is a real regulatory edge, granting more frequent FDA interaction and signaling agency interest [North Carolina Biotechnology Center] [PUBLIC]. The Winston-Salem and Research Triangle Park footprint puts the company inside one of the strongest regenerative medicine ecosystems in North America, including proximity to WFIRM under Director Anthony Atala [BMI OrganBank] [PUBLIC]. These edges are real but perishable: Breakthrough Designation does not guarantee clearance, and an academic license can be replicated by competitors funding their own research collaborations.

Where BMI is most exposed: incumbent machine perfusion device makers have larger commercial organizations, existing GPO and IDN relationships, multi-year clinical evidence, and the capital to outspend a seed-stage challenger on pivotal trials. BMI's portable kidney device has not yet entered clinical studies according to company materials, meaning incumbents have a multi-year clinical evidence head start in any head-to-head adoption discussion [BMI OrganBank]. The most plausible 18-month competitive scenario: BMI is a winner if the portable kidney device begins its clinical study on schedule, generates favorable interim data, and the company closes a strategic financing or commercial partnership that funds U.S. center adoption; BMI is a relative loser if clinical study initiation slips by more than a few quarters, allowing incumbent normothermic perfusion systems to entrench further inside the same target accounts before BMI has comparable evidence.

Data Accuracy: YELLOW -- Subject facts confirmed; competitor identities not named in captured sources, so segment analysis is structural rather than name-by-name.

Opportunity

PUBLIC

The size of the prize, if BMI executes, is becoming the preferred portable preservation platform for kidney transplantation in the United States and then extending the same platform across additional solid organs and into preclinical research services.

The headline opportunity. In plain language, BMI's most plausible upside is becoming the default portable kidney preservation device used by mid-market and academic U.S. transplant centers, with a secondary platform business in fee-for-service ex vivo research. Two pieces of cited evidence make that outcome reachable rather than aspirational. First, FDA Breakthrough Device Designation, granted by the agency itself, is an explicit acknowledgment that the kidney preservation device addresses a serious unmet need and qualifies for accelerated interaction with reviewers [North Carolina Biotechnology Center]. Second, the Duke Ex-Vivo Organ Lab license and ongoing collaboration with named transplant surgeons give the company clinical credibility that is difficult to manufacture from a standing start [BMI OrganBank].

Growth scenarios.

Scenario	What happens	Catalyst	Why it's plausible
Kidney-first beachhead	Portable kidney device completes initial clinical study, secures FDA clearance, and lands inside a first cohort of academic transplant centers	Initiation and readout of the clinical study the company has stated is upcoming, combined with Breakthrough pathway interactions [North Carolina Biotechnology Center] [BMI OrganBank]	Breakthrough Designation already granted; clinical collaborators named at Duke [BMI OrganBank]
Multi-organ platform	OrganBank Transport device launches and the platform extends from kidney to additional organs, with whole-eye and other tissue programs as longer-dated optionality	Commercial launch of OrganBank Transport co-developed with Duke DEVOL [BMI OrganBank]	Company has publicly stated the Transport device is set to launch and is pursuing additional applications including whole-eye transplantation [BMI OrganBank]
Services and tools flywheel	Ex Vivo Institute and CaVESWave generate non-dilutive revenue from pharma and academic clients while devices progress through regulatory review	Continued contract research revenue and grant funding (NIH already a confirmed funder) [BMI OrganBank]	Services platform already operating; $3.5M in grant funding disclosed [BMI OrganBank]

What compounding looks like. The flywheel BMI is building has three reinforcing loops. The first is academic credibility: the Duke license and named surgeon collaborators feed clinical evidence, which feeds FDA interaction, which feeds peer-reviewed publication, which feeds the next academic collaboration. The second is platform use: a single perfusion technology base supports multiple device SKUs (Transport, portable kidney, future organs) and a research-services arm, so each dollar of R&D theoretically amortizes across several revenue lines [BMI OrganBank]. The third is non-dilutive capital: NIH grant funding and North Carolina Biotechnology Center selection have already supplemented private capital, lengthening runway during the pre-clearance phase [BMI OrganBank] [North Carolina Biotechnology Center]. None of these loops are fully spun up yet, but each has at least one cited data point indicating it has begun to turn.

The size of the win. A specific public-comparable market cap is not cited in available materials and is therefore not asserted here. What can be said with citation is that the kidney transplantation category is the highest-volume solid-organ transplant segment in the U.S. and that machine perfusion is being adopted as the standard of care for an increasing share of donor organs, with FDA itself signaling unmet need via Breakthrough Designation in BMI's favor [North Carolina Biotechnology Center]. If the kidney-first beachhead scenario plays out, BMI plausibly becomes an attractive strategic target for one of the established global transplant device companies seeking a portable form factor and a U.S. academic footprint (scenario, not a forecast). If the multi-organ platform scenario also plays out, the equity value case shifts from acquisition optionality toward a standalone commercial business, although that path requires substantially more capital than has been disclosed to date.

Data Accuracy: YELLOW -- Regulatory, license, and funding evidence confirmed; scenario sizing is structural and explicitly labelled as scenarios rather than forecasts.

Sources

PUBLIC

1. [BMI OrganBank] BMI OrganBank: Transforming Transplantation | https://bmiorganbank.com/

2. [BMI OrganBank] A New VISION: Groundbreaking Collaboration Advances Whole Eye Transplants | https://bmiorganbank.com/whole-eye-transplants/

3. [BMI OrganBank] Our Company | https://bmiorganbank.com/our-company/

4. [BMI OrganBank] BMI OrganBank Secures FDA Breakthrough Device Designation for Innovative Kidney Transplant Technology | https://bmiorganbank.com/bmi-organbank-secures-fda-breakthrough-device-designation-for-innovative-kidney-transplant-technology/

5. [BMI OrganBank] Bios | https://bmiorganbank.com/bios/

6. [BMI OrganBank] Investors & News | https://bmiorganbank.com/investors-and-news/

7. [BMI OrganBank] Ex Vivo Institute Perfusion Research Expert Services | https://bmiorganbank.com/perfusion-research-expert-services/

8. [BMI OrganBank] OrganBank Lab Pharmacodynamic Research Platform | https://bmiorganbank.com/organbank-lab-pharmacodynamic-research-platform/

9. [BMI OrganBank] BMI OrganBank Selected by the North Carolina Biotechnology Center for Funding | https://bmiorganbank.com/ncbiotech/

10. [Crunchbase] BMI OrganBank Company Profile & Funding | https://www.crunchbase.com/organization/bmi-organbank

11. [LinkedIn] BMI OrganBank Company Page | https://www.linkedin.com/company/bmiorganbank

12. [LinkedIn] Carrie DiMarzio CEO/Co-Founder/Board Director | https://www.linkedin.com/in/carrie-dimarzio-26319257/

13. [LinkedIn] George Barr | https://www.linkedin.com/in/george-barr-5698685/

14. [LinkedIn] Tyler Adcock BMI OrganBank | https://www.linkedin.com/in/tyler-adcock-5980081a7/

15. [LinkedIn] Josh Copus, PhD BMI OrganBank | https://www.linkedin.com/in/josh-copus-phd-316975a1/

16. [Innovation Quarter] Meet the Organ Preservation Technology That Will Save Lives | https://www.innovationquarter.com/articles/how-bmi-organbank-is-changing-the-kidney-transplant-equation/

17. [North Carolina Biotechnology Center] FDA grants Breakthrough Device status to BMI OrganBank's kidney preservation device | https://www.ncbiotech.org/news/fda-grants-breakthrough-device-status-bmi-organbanks-kidney-preservation-device

18. [PR Newswire] BMI OrganBank Announces Strategic Partnership with Dedicated Staffing Solutions | https://www.prnewswire.com/news-releases/bmi-organbank-announces-strategic-partnership-with-dedicated-staffing-solutions-to-align-advanced-preservation-technology-with-clinical-staffing-expertise-302694059.html