HOCl Wound Irrigation System, per-patient bag and single-use head (Aquaceso variant) — viability

The chair: the investor, and the operator who has to run this as a business.

How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-023.md. The number is the claim's position in its ## Claims list. The tag is copied from that claim as it stands at build time and is never adjusted here. A [no claim] marker means nothing in the file speaks to the condition. No number appears here that isn't in a claim, and there is no ask slide. Where another lens holds a condition, this deck points at that deck rather than restating it. See docs/deck-spec.md.

What the file looks like from this chair. This deck is built on P1 per-patient HOCl bag. P1 per-patient HOCl bag sells two things: a single-use, hand-squeezed, three-nozzle head with an integral shield, one per irrigation session, made to fit only this maker's bag; and a per-patient bag of HOCl-preserved saline, labelled for multiple use within one patient. Four facts frame every slide.

• Nobody pays for it separately. Every verified reimbursement claim describes an obstacle or a bare code. None of them describes a payment.
• No price exists. Setting one is a Tier 3 act, and no claim carries one.
• No size exists to multiply a price against. The file verifies a count of people, not irrigations.
• The money is meant to come from the head. The head is the half nobody has built, and its pull-through rests on a keyed connector nobody has shown can be made.

Slide 1 — Who pays, from which budget

Would have to be true: A US facility or agency would have to pay for every head and every bag out of its own supply budget. That budget sits inside a bundled payment that does not change when it buys this product. A physician-office clinic would pay out of the practice-expense allowance of the service it bills. No other payer would be needed.

Where it stands:

• Hospital outpatient, including a hospital wound clinic: OPPS packages medical and surgical supplies into the payment for the related service claim 65verified.
• Skilled nursing facility: the per diem is payment in full for routine and ancillary costs, and consolidated billing excludes outside suppliers during a Part A stay claim 66verified.
• Home health: the episode payment is payment in full, and payment for medical supplies goes to the agency claim 67verified.
• Physician office: office and home services carry non-facility practice-expense RVUs claim 164verified. Whether irrigation supplies are itemised inputs to that allowance is open claim 165unconfirmed.
• Hospital inpatient: the regulation text verifies, but the step to "paid inside the MS-DRG" is not in it claim 136unconfirmed. The original four-setting claim is held for the same reason claim 30unconfirmed.
• A bag sent home outside a home health plan of care: wound cleansers (A6260 (a HCPCS code for a supply)) are non-covered under the Part B surgical dressing benefit claim 29verified. Whether any other Part B benefit pays is not established claim 166unconfirmed. Whether a bag ever goes home is the owner's shape decision (REQ-0235 For the P1 per-patient HOCl bag).
• How money reaches the maker: through a distributor or a GPO contract, so the maker's net per unit is the facility's price less the channel's share. This is the business case's assumption claim 196unverified. The HOCl incumbent already holds a Premier GPO agreement claim 103verified and a Federal Supply Schedule contract claim 104verified.
• Denmark: regions and municipalities buy wound products by public tender claim 25unconfirmed. The business case assumes the buying authority pays from its own operating budget, with no separate reimbursement or co-payment claim 198unverified.

The verified lines on this slide back the condition, and every one of them is a constraint. They say who writes the cheque. None says that anyone will.

What would settle it: For the US, the payer map is mostly settled, and settled as an obstacle. Three pieces stay open:

• claims 136 and 166 are CMS (Centers for Medicare & Medicaid Services) application questions, and only CMS answers them;
• claim 196unverified needs distributor and GPO term quotes, which a human has to obtain;
• claim 165unconfirmed needs the CMS PFS (physician fee schedule) direct practice-expense input files, which no connector reads.

If it's false: Nobody else is available to pay. If facilities will not fund a premium supply from inside the bundle (Slide 3), there is no second payer to turn to. Reimbursement sits at 1/5 in the file on verified evidence, and nothing on this slide could move it.

Slide 2 — The three reimbursement questions

Would have to be true: The system would have to sell with no code, no payment rate and no coverage policy behind it. All three would have to be irrelevant because every intended-use setting buys supplies from a bundle. And the business would have to need no separate-payment mechanism at all.

Where it stands:

• Code exists:
  • A6260, "Wound cleansers, any type, any size", exists claim 28verified, and so does A4322 for an irrigation syringe claim 69verified.
  • Whether any code describes a single-use pressurised irrigation head is not addressed by any claim [no claim].
  • Irrigation in the same session as a debridement is believed not separately reportable claim 32unconfirmed, and the debridement descriptor is AMA-licensed and out of reach claim 31unconfirmed.
• Payment amount: none. A6260 is non-covered under the surgical dressing benefit claim 29verified. OPPS device pass-through excludes "a material or supply furnished incident to a service". Whether CMS would read this system that way is a CMS determination nobody has asked for claim 137unconfirmed.
• Coverage policy: non-covered claim 29verified. That the product therefore has to win on cost-in-use is reasoning claim 33unconfirmed.

What would settle it: Nothing cheap. The one separate-payment mechanism named in the file is a CMS pass-through application, and the Verifier's note on claim 137unconfirmed says CMS decides it.

If it's false: If the product cannot sell without separate payment, there is no route. The file's Gate Check reads Reimbursement as "every separately payable channel checked is closed". The question then is entirely Slide 3.

Slide 3 — What one session pays, and to whom

Would have to be true: For each irrigation session, the facility's price for one head plus that session's share of a bag would have to be above its per-session cost with saline and a syringe, or with an HOCl bottle alone. The maker's net, after the distributor's and GPO's share, would also have to be above the fully loaded cost of the head plus the bag's cost divided by the sessions that bag actually serves. Both would have to hold at the business case's volume and at one tenth of it, including the setting where a bag serves only one session.

Where it stands:

• The premium. Whether purchasers pay more per session for P1 per-patient HOCl bag than for saline and a syringe is a buyer-behaviour question no connector reaches claim 161unconfirmed. Its P0 the original shape twins are claim 62unconfirmed and claim 117unconfirmed. A standard-spike head for anyone's bag carries its own version claim 201unverified.
• The cost test claim 188unconfirmed. No bill of materials exists.
• The price. No claim carries one claim 37unconfirmed. The per-session price is X, where X is unknown, and this deck states no X.
• Comparators, none of them this product's price:
  • the Medicare DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) allowed amounts for 500 mL saline ($3.80-4.47) and an irrigation syringe ($3.78-4.35), which are allowed amounts and not market prices claim 69verified;
  • one retailer's list price on one day of about $141.66 per 1 L Vashe bottle, listed as unavailable to buy claim 105verified;
  • a $38.28 pulsed-lavage protocol cost at one institution, in arthroplasty claim 109verified;
  • the VA FSS per-unit price for Vashe, which has not been retrieved claim 131unconfirmed.
• Sessions per bag. This depends on whether the bag's in-use period covers the gap between one patient's sessions claim 163unconfirmed claim 189unconfirmed. Neither cleared HOCl bag's summary states an in-use period claim 169verified. The feasibility deck carries this as its load-bearing condition.
• Channel share claim 196unverified.
• Displaced spend. No face or eye protection is displaced, on the business case's assumption claim 197unverified, read against the OSHA duty claim 48verified. What is displaced is saline, a syringe and staff time. Staff time is unmeasured (desirability Slide 4, claim 204unverified).

What would settle it:

• The VA FSS catalogue price for claim 131unconfirmed, a human lookup with no connector.
• A costed bill of materials and a filler quote for claim 188unconfirmed.
• The buyer calls designed under REQ-0225 Design for claims 161 and 162, which are fieldwork the owner must authorise.
• Regulatory's answer to REQ-0216 Does 29 CFR 1910.1030 for claim 197unverified.

If it's false: Every session loses money, or no buyer pays above saline. Volume does not rescue a negative margin. In an outpatient clinic where the bag serves one visit, that one session carries the whole bag.

Slide 4 — TAM, decomposed

Would have to be true: Four factors would each have to be large enough:

• US chronic-wound patients treated in the four settings;
• irrigation sessions per wound per year;
• a per-session price;
• the share of encounters that irrigate at pressure and would buy this.

The file has a verified figure for only the first, and only for Medicare.

Where it stands:

• Population: 10.5 million Medicare fee-for-service beneficiaries had a wound in 2019, across all wound types claim 34verified, and 8.2 million in 2014 claim 35verified. These are people, not irrigations. A UK count of nurse visits exists as an analog only claim 111unconfirmed.
• Rate: irrigations per wound per year has no figure claim 36unconfirmed. A floor exists. Medicare fee-for-service Part B practitioner services in 2024 were 684,939 under 97597, 2,042,234 under 11042, 506,331 under 11043 and 650,800 under 11045 claim 68verified. These are debridement services, not irrigation events, and a floor is never a market size. Volume per session is the feasibility deck's blank claim 210unverified.
• Price: blank (Slide 3) claim 37unconfirmed.
• Reachable share: no figure claim 38unconfirmed. Head volume follows sessions, and bag volume follows patients and in-use periods claim 189unconfirmed.
• A sanity check that cuts down: one HOCl incumbent's total US revenue, across all its products, was $2.611 million in FY2025, down 15% claim 106verified. That is one company, not a category.

What would settle it: A licensed wound-care market report or GPO price data, attached by a human. Share needs primary research. The per-session volume needs a literature pull (claim 210unverified).

If it's false: TAM (total addressable market) sits at the 2/5 floor in the file and is not computable as a dollar figure. Suppose the price lands near saline-and-syringe and the share is small. Then the best-evidenced factor, population, multiplies to something that cannot carry a sterile bag-fill programme and two clearances (Slide 5).

Slide 5 — Capital to first dollar

Would have to be true: Before the first US sale, four things would have to be done:

• a sterile HOCl bag fill transferred to a filler, with real-time stability and worst-case in-use data;
• a head designed, verified and sterilization-validated;
• each half cleared by 510(k) (premarket notification) or exemption without clinical data;
• the head, which fits only the bag and cannot sell before it, reaching market on a schedule that someone has actually built from quotes.

Where it stands:

• Starting point: no kit exists and no data exist for it claim 63unconfirmed.
• Largest cost: the business case assumes the bag's sterile fill is the largest cost item before first sale claim 199unverified.
• Regulatory leg, on precedent:
  • HOCl FRO cleansers have cleared on bench data alone claim 7verified.
  • Vashe Plus states that no clinical data were required. Its testing included USP <51> with a 7-day simulated multi-use period and a GLP porcine study claim 178verified.
  • Granudacyn went from receipt to decision in about nine months claim 8verified.
  • How FDA (US Food and Drug Administration) would classify the head is unconfirmed claim 180unconfirmed.
• Schedule: a critical-path schedule that puts first sale of the head before 2032-03-14 is unconfirmed claim 194unconfirmed. That date matches the term end recorded for US 12,208,226 claim 152verified.
• Sourcing: that two independent fillers who do not sell HOCl cleansers in the US can supply the bag is unconfirmed claim 128unconfirmed. A listing search found no contract manufacturer listing a sterile HOCl solution in a flexible bag claim 190unconfirmed.
• The cost figure: no claim carries a dollar cost or a calendar for any step [no claim]. This deck states none.

What would settle it: Filler requests for information and quotes, which the owner must authorise. A costed development plan, which is Stage 7 work for a human.

If it's false: If the bag fill costs more than the Slide 4 market can repay, the programme pays to put a parity bag into a crowded category (Slide 7) in order to carry a head.

Slide 6 — What stops a fast-follower

Would have to be true: The head would have to be keyed to this maker's bag by a connector that FDA accepts and buyers put on formulary. The head's design would also have to be patentable over the art. Both are needed because the irrigant is not protectable, and an incumbent HOCl bag maker is one product-line extension away from a head for its own bag.

Where it stands:

• The irrigant is not a moat. HOCl in irrigation bags is already cleared and sold claim 6verified. That defensibility would rest on hardware design IP (intellectual property) is reasoning claim 59unconfirmed.
• The keyed connector. One connector that accepts only this maker's head, reseals, and is acceptable to FDA is unchecked claim 195unverified. The build half is held in the feasibility deck, Slide 3.
• Buyers accept a keyed head on formulary without requiring it to fit bags they already stock claim 162unconfirmed.
• Patentability of the head. That the head's combination of squeeze chamber, check valve, three nozzles, integral shield and keyed connector is novel and non-obvious is on record from this deck claim 208unverified. The art it would have to clear:
  • a published PCT (Patent Cooperation Treaty) application on an HOCl delivery apparatus for wounds claim 157verified, whose US members are abandoned claim 83verified;
  • expired shield patents going back to 1987 claim 54verified claim 57verified claim 79verified;
  • IRRISEPT's cleared multi-port splashguard claim 13verified.
• Hardware rights. Who makes Aquaceso is unknown claim 2unconfirmed, and so is whether the referrer can bring its rights claim 3unconfirmed.

What would settle it:

• A patentability search by counsel, which the owner must engage.
• The records search under REQ-0255 P1's mechanism makes the single-use head… for any cleared fluid container whose port accepts only its own maker's device.
• Technology's answer to REQ-0234 In the P1 reference design.
• The buyer calls for claim 162unconfirmed.
• The referrer's answer on Aquaceso (REQ-0224 Ask the referrer and REQ-0208 Obtain from the referrer).

If it's false: Moat stays at 1/5 in the file. The head becomes an accessory for anyone's bag. That has no pull-through, and it competes with a syringe and a cleared shield on price (claim 201unverified).

Slide 7 — Who is already there

Would have to be true: No incumbent HOCl bag maker would already sell, or be close to selling, a hand-operated pressurised head for its own bag. And the bag would have to win a place in a category where entry is still continuing.

Where it stands:

• The solution field is crowded:
  • HOCl FRO clearances from four makers between 2013 and 2025 claim 4verified claim 6verified claim 7verified claim 8verified;
  • Vashe Plus, cleared 2026-08-11 claim 76verified;
  • Spectricept and MiraChlor, cleared in 2025-2026 claim 77verified;
  • a scan count of 35 FRO clearances in two years, not tag-bearing claim 158unconfirmed.
• Bags already exist. Puracyn Plus is sold in 1-3 L bags labelled for multiple use within a single patient claim 6verified claim 122verified. Its 2026 clearance records compatibility testing with the InterPulse, Pulsavac and MicroAire powered lavage systems claim 169verified. So the incumbent already pairs its bag with powered hardware.
• Hand-operated kits exist:
  • IRRISEPT, a squeeze bottle with a multi-port splashguard claim 13verified;
  • BD Surgiphor, a bottle in a tray with a screw cap for manual squeeze claim 144verified;
  • IRRIGO, a hand-squeezed jet claim 16verified;
  • the Zerowet shield claim 18verified.
• Incumbents are consolidating and contracting. Mölnlycke acquired Granudacyn's maker claim 110verified. Urgo holds GPO and FSS contracts claim 103verified claim 104verified.
• No incumbent head for its own bag. That no clearance or listing shows one is on record from this deck claim 209unverified. The opposite route, an incumbent buying or licensing a head, is the business case's assumption claim 202unverified. The wider landscape claim is unconfirmed claim 60unconfirmed.

What would settle it: An openFDA 510(k) search under FQH and KYZ for claim 209unverified. A registration-and-listing pull, which has no connector and is a human fetch (the note on claim 190unconfirmed says so). Any conversation with an incumbent is Tier 3.

If it's false: Competitive intensity stays at 1/5 in the file. An incumbent with a GPO contract and a bag already on the shelf adds a head and reaches the buyer first.

Slide 8 — The cheapest way to find out

Would have to be true: The incumbent HOCl solution's federal contract price per unit would have to be retrievable. Set beside the saline-and-syringe amounts already on file, it would have to leave a per-session price band above the comparator. The buyer calls could then test that band against claims 161 and 162.

Where it stands: The FSS contract number is on record claim 104verified, but the price is not claim 131unconfirmed. The comparator amounts are on file claim 69verified. The questions the calls would test are open claim 161unconfirmed claim 162unconfirmed.

What would settle it: A VA National Acquisition Center FSS catalogue lookup. No connector reaches it; a human can do it in minutes. The calls under REQ-0225 Design come after, and fielding them is the owner's decision.

If it's false: If the contract price, per session's worth of solution, sits close to saline, the bag has no room above its comparator, and the whole premium has to come from the head.

Slide 9 — Where this deck outruns the file

Every condition above with nothing verified behind it that supports it. Most verified claims on this deck are constraints or obstacles: the bundles, the non-coverage listing, the crowded solution field, and the art a head patent would have to clear. Those are not backing.

• Facilities fund a premium supply from inside the bundle (Slides 1 and 3) — claim 161unconfirmed claim 62unconfirmed claim 117unconfirmed claim 201unverified. Settled by the buyer calls (REQ-0225 Design), owner-authorised.
• The inpatient and home-use payer lines (Slide 1) — claim 136unconfirmed claim 30unconfirmed claim 166unconfirmed. Only CMS answers these.
• The channel takes a share, and the maker's net is below the facility price (Slides 1 and 3) — claim 196unverified. Settled by distributor and GPO term quotes.
• The office-clinic practice-expense inputs (Slide 1) — claim 165unconfirmed. Settled by the CMS direct PE input file, a human download.
• No code, rate or coverage is needed (Slide 2) — claim 33unconfirmed claim 137unconfirmed claim 31unconfirmed claim 32unconfirmed. Whether a code describes the head is [no claim], left unappended because no intended-use setting pays a supply separately.
• Price clears the fully loaded session cost (Slide 3) — claim 188unconfirmed claim 37unconfirmed. Settled by a bill of materials and a filler quote.
• Sessions per bag, and the bag's in-use period (Slides 3 and 4) — claim 163unconfirmed claim 189unconfirmed. Held in the feasibility deck.
• No PPE displaced (Slide 3) — claim 197unverified. Settled by Regulatory's answer to REQ-0216 Does 29 CFR 1910.1030.
• Irrigations per wound, price and share (Slide 4) — claim 36unconfirmed claim 37unconfirmed claim 38unconfirmed claim 210unverified. Share needs primary research.
• The development cost, the calendar, and sourcing (Slide 5) — [no claim] for any dollar figure; claim 199unverified claim 194unconfirmed claim 128unconfirmed claim 180unconfirmed. Settled by a costed Stage 7 plan and filler quotes.
• A keyed connector FDA accepts and buyers put on formulary (Slide 6) — claim 195unverified claim 162unconfirmed. Settled by REQ-0255 P1's mechanism makes the single-use head…, REQ-0234 In the P1 reference design and the buyer calls.
• A patentable head (Slide 6) — claim 208unverified. Newly on record from this deck. Settled by a counsel patentability search.
• Aquaceso rights (Slide 6) — claim 2unconfirmed claim 3unconfirmed. Settled by the referrer's answer.
• No incumbent head for its own bag (Slide 7) — claim 209unverified claim 202unverified claim 60unconfirmed. Newly on record from this deck. Settled by openFDA and a listing pull.
• The incumbent's contract price (Slide 8) — claim 131unconfirmed. Settled by an FSS catalogue lookup.

Slides 1, 4 and 5 carry verified claims that support part of their condition. Slide 1 has the bundle regulations, which confirm who pays. Slide 4 has the Medicare wound population. Slide 5 has the bench-only clearance precedents. Nothing verified supports Slides 2, 3, 6, 7 or 8. Of eight conditions, five have nothing verified behind them.

Slide 10 — The load-bearing condition

If only one thing from this chair could be checked: whether US hospital, outpatient wound-clinic, skilled nursing facility and home health buyers, paying from a supply budget inside a bundled payment, would pay more per irrigation session for one P1 per-patient HOCl bag head plus its share of a bag than their saline-and-syringe cost, at a price that clears the fully loaded cost of a session at the business case's volume and at one tenth of it claim 161unconfirmed claim 188unconfirmed.

Why this one:

• Every other money question sits downstream of it. The keyed moat (Slide 6) protects a premium. TAM (Slide 4) multiplies a price. Capital (Slide 5) is repaid out of margin. None of those exists if no buyer pays above saline.
• Every verified reimbursement fact on file says there is no other payer to fall back on (Slides 1 and 2).
• The first half, whether a premium is paid at all, can be tested before anything is built: an FSS price lookup, then twenty structured calls. The second half waits on a bill of materials.

Naming it is not a recommendation, a gate, or a kill.