08 / About HemoDefend
Developed within CytoSorbents. Built for the next stage.
HemoDefend was developed within CytoSorbents through years of research, government-supported development and collaboration with blood-sector organizations.
Development history
- Technology formation: affinity-ligand platform developed to selectively remove anti-A and anti-B antibodies.
- Government validation: more than $16M secured through multiple U.S. government development awards.
- Plasma development: demonstrated high antibody removal, preservation of coagulation factors and gravity-driven processing.
- Whole-blood expansion: evaluated for expanding the low-titer Type O donor pool.
- Platelet focus: platelets prioritized based on shortage severity, operational need and commercial opportunity.
- External validation: testing and collaboration with NHSBT, Hoxworth, Teleflex and other blood-sector organizations.
- Regulatory progress: FDA Pre-Submission engagement and a defined testing and clinical pathway.
- Manufacturing: ISO 13485-certified facility in Princeton, NJ, with dedicated HemoDefend cleanroom and production space.
Management team
Chris Cramer
General Manager
25+ years of leadership in the medical-device industry spanning business development, corporate strategy, venture/M&A, commercialization, and general management. Held senior roles at Johnson & Johnson and CytoSorbents, with experience building businesses, executing strategic transactions, and advancing new technologies toward commercialization. MBA and MSc, Carnegie Mellon University; BSc, Miami University.
Maryann Gruda
Chief Development Officer
30+ years in biomedical R&D across pharmaceuticals, biologics and medical devices. Led HemoDefend from concept through more than $16M in DoD-funded development. PhD in Molecular Biology, University of Pennsylvania; BS in Microbiology, University of Pittsburgh.
Advisors
Phillip Chan, MD, PhD
Expertise: Medicine, Medical Devices, Business, Finance
Efthymios N. Deliargyris,
MD, FACC, FESC, FSCAI
Expertise: Clinical, Health Economics, Medicine
Vincent Capponi, MS
Expertise: Manufacturing, Regulatory, Operations
Peter J. Mariani
Expertise: Finance, Accounting, Fund Raising
07 / Development progress
A deliberate path from development to use.
None of these steps implies FDA acceptance, authorization or commercial readiness.
Investigational device. HemoDefend is under development and is not commercially available in the U.S. or anywhere else in the world.
- FDA De Novo pathway (Class II device) Strategy
- FDA Pre-Submission: ≤1:32 target accepted, no major concerns identified Completed
- Low-titer target ≤1:32 anti-A/anti-B IgM Target
- Bench, biocompatibility and usability testing Planned
- Platelet recovery & survival study (randomized, healthy volunteers, n=24) Planned
- Manufacturing readiness: ISO 13485-certified facility in place In progress
- De Novo submission Target Q4 2029
09 / Partner with us
Build the next stage with us.
We welcome discussions with blood centers, strategic partners, plasma processors, potential investors and biomedical collaborators on:
Blood-center collaboration
Strategic partnerships
Research & development
Plasma-processing applications
Investment
Business development