ExVivo Organ and Tissue Preservation Studies
Our cardiovascular emulating CaVESWave® laboratory platform is allowing clinicians and researchers to advance organ preservation through novel oxygen delivery technologies, perfusates, cellular, drug, and gene therapies evaluated ex vivo and in vivo in pre-clinical animal and human models.
Specialty Lab Services and BioMarker Assays
BioMedInnovations (BMI) offers access to advanced laboratory services to support biomarker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis to accelerate drug, vaccine and therapeutic development.
Our full-service suite of services come with powerful translational informatics and computational biology approaches that maximize information from each sample and study subject. The goal is to allow predictive modeling and biomarker signature development in transplant immunology, organ preservation, and drug discovery.
Examples of services provided include:
Tissue analysis (histopathology, cellular and molecular imaging),
Cell profiling (flow cytometry and mass cytometry),
Biomarker analysis (multiplex cytokine assays),
Pharmacokinetic and pharmacodynamic testing (LC/MS-MS with advanced quadrupole instrumentation),
Genomic quantitation (nCounter Nanostring ® assay).
BMI services proactively address challenges of sample size and statistical methodology in translational sciences.
BMI offers expert biostatisticians and statistical programmers to craft detailed study plans, including precise definitions of endpoints and descriptions of analyses, to address regulatory risks and maximize success from the outset.
Our Team of Experts
At BMI, 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 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, DiMarzio has led successful negotiations with the US FDA, gaining FDA EUA status for BMI’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.
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.
14 years from research and development of perfusion tech
Co-author of many peer reviewed publications and papers
Leading the BMI lab at Duke Hospital
30+ years of engineering experience from US security clearance systems
US veteran who has held security clearance
Worked on multiple groundbreaking medical advancement systems