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Gloved hands pipetting a sample in a laboratory biosafety cabinet — illustrative of analytical bench work, not a specific FabUTech assay.

Evidence and development

DuraRad rests on three measured results.

It is in active development, and this page draws the same line a diligence team would: what is established, and what is underway.

A pre-commercial platform is worth what it has de-risked. DuraRad rests on three independent measured results: a peroxide-clearance rate, durability across repeated challenges without wearing out, and retained activity after dry storage. Behind them sit filed provisional applications, demonstrated proof of concept, and a radioactive validation study designed and scheduled. The proof-of-concept data is shown here in full; what stays private is the coating's composition and how it is made.

Measured result

The coating clears peroxide. We measured how fast.

k = 0.107 per minute

Pseudo-first-order hydrogen peroxide clearance rate constant

Batch 2 fit · 6R vial · 3.0 mL fill

t½ 6.5 min

Clearance half-life, t½ = ln2 / k

In plain terms: the coating clears about half of the added peroxide every 6 to 7 minutes, and roughly 90 percent of it within about 20 minutes.

Measured pseudo-first-order hydrogen peroxide clearance in DuraRad-coated vials, fitted on the Batch 2 challenge (6R / 3.0 mL). Curve shown: a Batch 4 vial, which clears faster; the model uses the Batch 2 fit. A cold-chemistry bench result. Clearance under continuous irradiation is the subject of the scheduled validation study.

Measured hydrogen peroxide clearance in a DuraRad-coated vial versus an uncoated control. Curve shown: a Batch 4 vial; the model uses the Batch 2 fit, k = 0.107 min⁻¹. Measured bench data. DuraRad-coated: 5.06 mM at 0 min, 3.66 mM at 3 min, 2.66 mM at 5 min, 1.31 mM at 10 min, 0.66 mM at 15 min, 0.32 mM at 20 min, 0.14 mM at 30 min, 0.1 mM at 40 min. Uncoated control: 5.13 mM at 0 min, 5.11 mM at 40 min. 0 1 2 3 4 5 010203040 [H₂O₂] mM time (min)

DuraRad's coating immobilizes two enzymes on the vial wall. Radiolysis generates short-lived reactive oxygen species, including hydroxyl and superoxide radicals; what persists and accumulates over a dose's shelf life is hydrogen peroxide, the stable oxidant they leave behind. Manganese superoxide dismutase converts radiolytic superoxide to hydrogen peroxide and oxygen, and immobilized catalase decomposes that hydrogen peroxide to water and oxygen, so the coating lowers the steady-state concentration across the coupled superoxide-and-peroxide cascade rather than acting on peroxide in isolation. On the bench, we spiked coated vials with hydrogen peroxide and tracked how quickly the immobilized catalase cleared it. Because the enzyme loading in the coating is fixed, the clearance follows pseudo-first-order kinetics, with a rate constant of k = 0.107 per minute.

This is the measured input the interactive model runs on. It is a cold-chemistry result: the coating clearing peroxide added by pipette, not peroxide generated by live radioactive decay. Whether that clearance holds while an isotope irradiates the enzymes is exactly what the validation study is built to test.

See it drive the model

This is the rate the interactive radiolysis model runs on.

 See how it gets tested

The hot study tests whether the clearance holds under live irradiation.

 See the mechanism

The disclosed sol-gel enzyme coating this measured rate comes from.

The bench proof

Three ways the coating earns the number.

The same enzyme coating, tested three ways on the bench. You can watch it work, it clears repeated challenges without wearing out, and it still works after storage.

You can watch it happen

A bench functional test: a vial of blue methylene-blue dye at left beside a hand-labeled clear control vial at right — a qualitative demonstration of the coating's oxidative activity, not the DuraRad product or its color.

A methylene-blue redox test: the coated vial drives a visible color change the uncoated control does not. A qualitative bench demonstration of catalytic activity — not the product, its coating, or its color.

It doesn't wear out

Peroxide clearance across two challenges in the same DuraRad-coated vial, refilled with fresh 5 mM peroxide at the dashed line. Measured bench data. DuraRad vial (same vial, refilled): 4.67 mM at 0 min, 3.18 mM at 7 min, 0.76 mM at 17 min, 0.25 mM at 32 min, 0 mM at 37 min, 4.67 mM at 40 min, 2.27 mM at 45 min, 1.12 mM at 49 min, 0.37 mM at 62 min, 0 mM at 70 min. Uncoated control: 4.67 mM at 0 min, 4.67 mM at 70 min. 0 1 2 3 4 5 0204060 refill [H₂O₂] mM time (min)

Clear the vial, refill it with fresh peroxide, and it clears the second dose just like the first. The immobilized catalase is a catalyst — it is not consumed as it works.

It survives storage

Peroxide clearance in a fresh coated vial versus a sibling stored five days empty and dry, each given a fresh 5 mM challenge. Measured bench data. Fresh (Day 0): 4.67 mM at 0 min, 3.18 mM at 7 min, 0.76 mM at 17 min, 0.25 mM at 32 min, 0 mM at 37 min. After 5 days dry: 4.85 mM at 0 min, 1.4 mM at 10 min, 0.25 mM at 31 min, 0.11 mM at 45 min. Uncoated control: 4.85 mM at 0 min, 4.83 mM at 45 min. 0 1 2 3 4 5 010203040 [H₂O₂] mM time (min)

A vial stored five days empty and dry still clears a fresh challenge on the same curve as a fresh one. The activity is built into the wall, and it stays there.

Measured cold-bench data (Batch 2, 6R / 3.0 mL). A cold-chemistry result, not a performance claim under live irradiation — that is what the validation study tests.

Where DuraRad stands

A platform being de-risked, step by step.

Each step converts an assumption into a result. Two are behind us, the third is being prepared, and the study that bridges modeled to proven is designed and scheduled.

  1. Provisional applications completed Filed
  2. Bench proof of concept completed Demonstrated
  3. FDA classification feedback in progress Submitted August 2026
  4. Radioactive validation upcoming Scheduled Q4 2026
  5. International (PCT) filing upcoming Planned
Bench results to date are cold-chemistry results. Radioactive validation at Washington University's Mallinckrodt Institute of Radiology is designed and scheduled for Q4 2026.

Development status

01 Filed

Intellectual property

Filed provisional applications cover the coating chemistry, the enzyme immobilization, and their application to pharmaceutical containers. An international (PCT) filing is planned.

02 Demonstrated

Proof of concept

Bench proof of concept has demonstrated the coating's core function: the immobilized enzymes stay active on the wall and clear hydrogen peroxide from solution. The measured clearance rate is the headline; the same coating also clears repeated peroxide challenges without wearing out, and still works after storage, all shown above.

03 In progress

Regulatory strategy

DuraRad's regulatory strategy runs through container closure, not reformulation: it is being developed and positioned as a container closure system component under 21 CFR 211.94, assessed as primary packaging against established expectations rather than as a new device review pathway. Because the scavenger enzymes are immobilized in the bonded silica matrix by design, rather than dissolved in the fill, an extractables and leachables assessment is part of the container-closure qualification. We have submitted a pre-RFD to FDA's Office of Combination Products for the agency's early read on how the product should be classified.

04 Scheduled

Radioactive validation

The hot-validation protocol is finalized. DuraRad-coated vials will be irradiated with Pb-212 and Lu-177 to measure enzyme activity retention under live decay, in Dr. Daniel Thorek's laboratory at Washington University's Mallinckrodt Institute of Radiology. Radioactive testing is scheduled for Q4 2026; results will be reported once available and confirmed.

The proof-of-concept data is on this page, in full. What is held back is the coating's composition and production process, which are not disclosed to anyone, and unfiled next-generation work, which is described under appropriate terms in the data package. Validation data will be reported once the radioactive study reads out.

Ready to look under the hood?

The data package includes the technical detail appropriate to a diligence conversation.

Request the data package Meet the team behind it