Data & validation
Measured progress. Defined limitations.
Technical data and external evaluation across plasma, platelets and whole blood. These research findings are not platelet clinical evidence, proof of clinical benefit, or FDA authorization.
$16M+
Non-dilutive U.S. government funding
6
External testing & collaboration organizations
35/35
Internally tested high-titer plasma units reached the ≤1:32 IgM target
≤1:32
Anti-A/anti-B IgM low-titer target
01 / Antibody reduction
Meaningful anti-A and anti-B removal.
In internal testing, 35 type O plasma units with high anti-A and/or anti-B titers were filtered through HemoDefend by gravity (about 15 minutes, ~17 mL/min). All 35 reached low titer, with a highest post-filtration IgM titer of 1:16. IgG anti-A/anti-B was reduced by an average of 7 titer steps, and antibody removal exceeded 99% across diverse donor types.
Source: HemoDefend internal testing (35 type O FFP units). Reproducibility: 10 high-titer units pooled and split, each filtered through a separate device; all 12 quantitative measurements differed minimally (CoV 0.1–5.3%).
02 / Product quality
Quality and volume preserved.
Plasma volume recovered was 102%, with minimal change in the activity of a broad panel of coagulation factors. In a Teleflex evaluation of 18 high-titer plasma units, filtered plasma met all current release specifications for freeze-dried plasma (FDP).
| Treatment | FVIII | Free PS | PT | INR | Total protein | Agglutination | NAPTT | APTT |
|---|---|---|---|---|---|---|---|---|
| Pre-HemoDefend | 105.8 | 91.3 | 12.4 | 1.2 | 5.9 | 1+ | 224.2 | 32.1 |
| Post-HemoDefend | 106.7 | 92.0 | 12.4 | 1.1 | 6.0 | 0 | 222.5 | 32.1 |
| Freeze-dried* | 98.3 | 91.4 | 13.2 | 1.2 | 5.7 | 0 | 286.5 | 35.1 |
03 / Results by blood product
One technology, evaluated across products.
Lead program
Platelets
Platelets are the lead program. HemoDefend has been validated by NHSBT in platelets, and a randomized platelet recovery and survival study in healthy volunteers (n=24) is planned. [Add platelet data.]
Extensively evaluated
Plasma
35 of 35 internally tested high-titer plasma units reached the ≤1:32 IgM low-titer target, with preservation of plasma quality reported. Highest post-filtration IgM titer 1:16; 102% volume recovery. Source: HemoDefend internal testing.
Evaluated
Whole blood
Evaluated in whole blood with Hoxworth Blood Center / University of Cincinnati, supporting expansion of the low-titer Type O donor pool. [Add data.]
04 / External evaluation
Technical evaluation with blood-sector organizations.
External technical evaluations and collaborations inform development. No independent clinical validation or partner endorsement is implied.
Validation · Plasma & platelets
NHS Blood and Transplant
Validated HemoDefend in plasma and platelets. Separate NHSBT market research surveying 200+ hospitals found universality (NHSBT’s term) ranked the #1 unmet need: 91% of hospitals expected lower plasma stockholding, 74% anticipated reduced wastage and 45% would pay at least 25% more for universal plasma.
Case study · [Product tested]
Vitalant
[Study summary: objective, design, key outcome.]
Case study · [Product tested]
American Red Cross
[Study summary: objective, design, key outcome.]
Evaluation · Whole blood
Hoxworth Blood Center / University of Cincinnati
Evaluated HemoDefend in whole blood, supporting expansion of the low-titer Type O donor pool.
Collaboration · Freeze-dried plasma
Teleflex
Filtered plasma met all current release specifications for freeze-dried plasma, with seamless integration into existing FDP workflows. “HemoDefend is super easy to use and has no measurable negative effects on the plasma.” — James Murto, Sr Director Global R&D, Teleflex
Case study · [Product tested]
Walter Reed National Military Medical Center
[Study summary: objective, design, key outcome.]
05 / Publications, posters & abstracts
Published and presented work.
- [Title] — [Conference, Year] Poster
- [Title] — [Journal / Conference, Year] Abstract
- [Title] — [Journal, Year] Publication
06 / Regulatory progress
Development timeline
Completed
FDA Pre-Submission
Feedback received; ≤1:32 target accepted
Planned
Bench & preclinical testing
Biocompatibility, V&V and usability
Planned
Platelet clinical development
Recovery & survival study, n=24
In progress
Manufacturing readiness
ISO 13485 facility in place
Upcoming
FDA De Novo submission
Target: Q4 2029
Investigational device. HemoDefend is under development and is not commercially available in the U.S. or anywhere else in the world.
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