PURIFYZE

Incumbent pathogen-reduction platforms add a photosensitizing compound to the blood unit, illuminate it, then work to remove or tolerate what was added. That means a reagent supply chain, extra bag transfers, and residual-compound questions in every unit.

MSD-405 removes that layer. Violet light at 405 nm excites naturally occurring porphyrins in microbial cells, generating reactive oxygen species that inactivate the pathogen from within. No exogenous compound is introduced, so there is no post-illumination adsorption or wash step and no consumable reagent per unit. The treated bag is the bag that ships.

Platelet hemostatic function was retained at the microbicidal dose across 22 donors, and in-vivo platelet recovery was confirmed in a SCID mouse model.

Reference dose: 270 J/cm² at 15 mW/cm² over 5 hours
Agitation: 84 rpm reciprocating
Patent envelope: 380–500 nm (preferred 380–420 nm), 3–80 mW/cm² at bag surface

Scope, stated plainly: the current field is ex-vivo platelets and plasma. Hemoglobin absorbs strongly at 405 nm, limiting penetration in whole blood to roughly tens of microns up to about 150 µm, so any whole-blood configuration requires a thin-film, dual-illuminated, recirculating architecture. That engineering question is open and is treated as such.

Peer-reviewed and FDA-authored. Bacterial results are reported as reduction, viral and parasitic results as inactivation, each in its own matrix. Sixteen FDA-authored publications underpin the platform; the studies below are representative.

Across the published body of work, pathogen reduction spans a 4–9 log₁₀ range depending on organism, matrix, and dose. Purifyze does not aggregate bacterial, viral, and parasitic results into a single headline figure.

MSD405-B

Benchtop

Single-bag unit for hospital blood banks and research settings; the configuration that carries the initial validation and regulatory work.

One bag per cycle · High-intensity 405 nm LED array · Closed-system design

MSD405-CW8

Clinical Workstation

Eight-bag floor console for blood-center throughput, sized to the footprint of existing pathogen-reduction consoles.

Eight bags per cycle · Floor-standing console · Blood-center workflow

MSD405-F

Portable Field Unit

Ruggedized, battery-operated unit designed to MIL-STD-810H for forward deployment with the Armed Services Blood Program and the Defense Health Agency, in keeping with Tactical Combat Casualty Care and Prolonged Field Care principles.

Battery operation · MIL-STD-810H design target · Austere-environment use

All three configurations are at early-stage prototype maturity, with benchtop work at TRL 3–4. Each runs a per-cycle disposable kit that contains no photosensitizer and no reagent; it exists for sterility and handling, not chemistry.

U.S. patent: US 11,951,217 B2, issued April 2024; continuation US 2024/0252697 A1 pending. Co-owned by HHS/FDA.

European patent: EP 16784311, granted 3 June 2026 (PCT/US2016/054508; priority 2 October 2015). Validation intended in France, Germany, and the United Kingdom.

Executed license: FDA Patent License Agreement 2026-0093-LIC, effective 12 August 2026. Worldwide; field of use is inactivation of pathogens in blood products such as plasma and platelets. U.S. products 100% manufactured in the United States.

Exclusive terms: FDA Ref. 2026-0010-LIC, E-2014-013.

Maturity: Early-stage prototype; benchtop configuration at TRL 5–6.

Regulatory strategy: Planned 510(k) pathway on the basis of an existing predicate device, with a FDA pre-submission (Q-Sub) as the next regulatory milestone. The licensing lane and the regulatory lane are run as separate workstreams.

Near-term engineering: Design and fabrication of a three variations utilizing our patented and updated closed benchtop unit with a high-intensity 405 nm LED array, validated by dose-ranging pathogen-reduction and platelet-quality studies.

Partners: A device engineering and fabrication partner and a clinical-research supporter are identified and on standby pursuant to funding. Purifyze retains biological testing, regulatory strategy, and program management.

The FDA license is a commercial agreement. It is not an FDA clearance, approval, or endorsement of any Purifyze product.

Purifyze is working alongside divisions of the U.S. Department of Health and Human Services, the Department of War, and Armed Forces special-operations commands. The commercial sequence follows the logistics: the Armed Services Blood Program and special-operations medicine first, U.S. civilian blood centers second, Europe through licensing third. A reagent-free process is what lets a device deploy.

Entity: Purifyze Corporation, a Texas C-Corporation founded in Austin, Texas, based in Bethesda, MD & West Palm Beach, FL
100% U.S.-owned small business; minority-owned; VOSB.

Leadership: Led by a team of tenured scientists and world-renowned subject-matter experts looking to enhance combat medicine for the US Warfighter.

Build-out on funding: Executive board of five, advisory board of seven, and named strategic partners on standby pursuant to funding.

Non-dilutive funding: Targeted federal vehicles include DARPA, NIH/NHLBI SBIR (Direct-to-Phase II), BARDA, USSOCOM, CDMRP PRMRP, and MTEC. This list is non-exhaustive.

Seed round: Five-year model and data room available to qualified parties.