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

Intended use: For prescription use by or under the direction of a healthcare professional in hospital, outpatient wound clinic, skilled nursing facility and home health settings, to cleanse, irrigate and mechanically remove debris, exudate and foreign material from acute and chronic dermal wounds in adults (Stage 2-4 pressure injuries, venous and arterial leg ulcers, diabetic foot ulcers, post-surgical and traumatic wounds, and first- and second-degree burns), at each dressing change. A sterile, hypochlorous acid-preserved saline irrigation solution, supplied in a bag for multiple use within a single patient over its labelled in-use period, is delivered at each irrigation session through a single-use, three-nozzle spray head with an integral splash shield that is connected to the bag at the point of use, at an irrigation pressure within 4-15 psi. The hypochlorous acid acts as a preservative of the solution. No claim is made that it kills microorganisms in the wound or treats or prevents wound infection.

Read this first. This case is built on P1 per-patient HOCl bag, the shape recorded in the loop record as a redesign: a per-patient bag of HOCl-preserved saline, labelled the way the one cleared HOCl irrigation bag is labelled claim 122verified, and a single-use, hand-squeezed three-nozzle head with a shield, sold once per irrigation session. Four things govern everything below.

1. Nobody pays for this product separately, in any setting the intended use names. The three reimbursement pillars that rest on verified claims all verify an obstacle or a bare code. None verifies a payment.
2. No price is set here. REQ-0244 For P1 and REQ-0200 What per-kit price does the money model… ask what per-head and per-bag price the money model assumes. Setting a price is a Tier 3 act, so this case does not assume one. It states the two tests a price chosen by a human would have to pass. Both are already claims, and both are unconfirmed.
3. No size exists to multiply a price against. The market model bounds one leg of ten, a count of Medicare beneficiaries with any wound, and calls its band "not computable".
4. The money is meant to come from the head, and the head is the half nobody has built. The bag is a parity product on its label. The head's pull-through rests on a keyed connector nobody has shown can be made claim 195unverified, and on buyers accepting it claim 162unconfirmed.

Who pays

The chain is the same in every US setting. A facility or agency writes the cheque out of a supply budget, and that budget is funded by a bundled payment that does not move when it buys this product. One exception sits outside the chain: a bag sent home with the patient, where the patient pays.

• Writes the cheque, by setting:
  • Hospital outpatient, including a hospital-based wound clinic: the hospital. OPPS packages "medical and surgical supplies" into the payment for the related service claim 65verified. Whether the clinic's own debridement visit is separately paid under OPPS could not be read, because apc has no Addendum B cache. That is a tooling gap, and it does not change who buys.
  • Physician-office wound clinic: the practice. Its supplies sit inside the non-facility practice-expense allowance of the service it bills claim 164verified. Whether irrigation supplies are itemised inputs to that allowance is open claim 165unconfirmed.
  • Skilled nursing facility: the SNF. Its per diem is payment in full for routine and ancillary costs, and consolidated billing shuts out outside suppliers during a Part A stay claim 66verified.
  • Home health: the agency. Its episode payment is payment in full, and payment for medical supplies goes to the agency claim 67verified.
  • Hospital inpatient: the hospital, on the file's reading. The regulation text verifies, but the step to "a wound supply is paid inside the MS-DRG and not separately" is not in it claim 136unconfirmed. The original four-setting claim is held for the same reason claim 30unconfirmed.
  • An opened bag dispensed to an outpatient for use at home, outside a home health plan of care: the patient. The Part B policy article lists wound cleansers (A6260 (a HCPCS code for a supply)) and irrigating solutions as non-covered claim 29verified. Whether any other Part B benefit pays for one is not established claim 166unconfirmed. Whether the bag ever goes home is the owner's shape decision (REQ-0235 For the P1 per-patient HOCl bag), and nothing here makes it.
• How the money reaches the manufacturer: through a distributor or a GPO contract, so the manufacturer's net per unit is the facility's price less the channel's share [assumption A1 Assumption]. The HOCl incumbent already holds both channels: a Premier GPO agreement claim 103verified and a Federal Supply Schedule contract claim 104verified. Neither discloses a price.
• Out of which budget line: med-surg supplies in hospitals, SNFs and agencies, and practice expense in an office clinic. No separate-payment mechanism reaches the product. OPPS device pass-through excludes "a material or supply furnished incident to a service". Whether CMS (Centers for Medicare & Medicaid Services) would read this system that way is a CMS determination nobody has asked for claim 137unconfirmed.
• Against which comparator: there are two, one for each half of P1 per-patient HOCl bag.
  • The head, per session, is set against saline and a syringe, two Medicare allowed amounts in single digits claim 69verified. It is also set against a syringe with a cleared shield accessory claim 18verified, and against a hand-squeezed single-patient jet claim 16verified.
  • The bag, per patient, is set against an incumbent HOCl bag or bottle claim 105verified. One is already cleared in bags labelled for multiple use within a single patient claim 6verified, claim 122verified.
• Stops buying instead: saline and syringes per session, and an incumbent HOCl bag or bottle per patient where the facility already stocks one. Not face and eye protection, on this case's reading. OSHA requires masks with eye protection or face shields wherever splash is anticipated claim 48verified. This case assumes an integral shield does not lift that duty [assumption A2 FDA 510]. REQ-0216 Does 29 CFR 1910.1030 asks Regulatory whether it does. If it does, a PPE line joins the displaced spend. The staff-time and clean-up savings that the premium rests on are unmeasured for this design claim 49unconfirmed, claim 173unconfirmed. The one measured analog is a syringe shield claim 101verified.
• Whether anyone pays the premium at all: this is the revenue premise, and it is a buyer-behaviour question no connector reaches claim 161unconfirmed. Its P0 the original shape twins are claim 62unconfirmed and claim 117unconfirmed.
• Denmark, the referrer's home market:
  • Who buys: regions and municipalities buy wound products on public tenders claim 25unconfirmed. Region Nordjylland's joint tender, run with ten municipalities, buys HOCl wound irrigation fluid as a lot of its own, lot 50 claim 113unconfirmed.
  • Who pays: this case assumes the buying authority pays from its own operating budget, with no separate reimbursement and no patient co-payment [assumption A3 FDA 510].
  • Where the head fits: the bag would be the fluid the lot buys. The head has a priced place only if the lot or another lot admits it claim 171unconfirmed.
  • Every DK line is unconfirmed. No connector reaches a Danish source. Nothing in the US chain above stands in for Denmark.

Reimbursement path

These are the six questions the rubric's Factor 2 collapses into one number. Each has its own evidence position and one basis. No score, no tier and no composite. Read the coverage line first. Then note what the three verified pillars verify: a code that exists, a bundle that packages supplies, and a policy that lists the product as non-covered.

Pillars on verified claims: 3/6 · on assumptions: 1 · queued as research: 0

The other two pillars, 2b and 2c, rest on unconfirmed claims. The three verified pillars verify a code's existence (2a), a bundle (2d) and a non-coverage listing (2e). Not one of them verifies that money flows to the product. A reader who counts 3/6 as half a pathway has read the line backwards. What is verified is that the product is a supply bought inside a fixed payment, which is the premise of the whole case.

Three distinctions this section keeps apart:

• A code existing is not payment, and payment is not coverage. A6260 exists (2a). It has no rate (2b). The policy article lists it as non-covered (2e). Those are three facts, and the first does not soften the other two.
• Packaging is the governing fact here, not a corner case. OPPS, the SNF per diem and the home health episode all pay the facility the same with or without this system claim 65verified, claim 66verified, claim 67verified. The inpatient DRG is believed to do the same claim 136unconfirmed.
• 2f is permanently unconfirmed. For Denmark, the tender documents would settle more than any connector could claim 170unconfirmed, and they need a human download (REQ-0201 For Region Nordjylland's joint wound tender).

Verdicts from cold runs during this build, recorded whatever came back:

• python3 -m connectors hcpcs A6260 --jurisdiction US → verified, "Wound cleansers, any type, any size". It travels as claim 28verified.
• python3 -m connectors payment A6260 --jurisdiction US → refuted, "No payment row for A6260 in the cached CMS file(s)". This is consistent with claim 29verified. It is a statement about a cache and is not used as a basis.
• python3 -m connectors coverage A6260 --jurisdiction US → refuted, "No NCD (national coverage determination) or LCD (local coverage determination) in the cached coverage file names A6260". This is a cache linkage gap, as the Verifier recorded at claim 29verified and claim 166unconfirmed.
• python3 -m connectors procedures A6260 --jurisdiction US → refuted: no national row in either cached release. The product is bought by facilities, not billed, so the absence says nothing about irrigation volume.
• python3 -m connectors payment A4217 --jurisdiction US and payment A4322 → verified, July 2026 DMEPOS allowed amounts, as recorded at claim 69verified.
• python3 -m connectors rvu 97597 --jurisdiction US → verified, the 2026 PFS (physician fee schedule) decomposition. That split is recorded in the note at claim 165unconfirmed.
• python3 -m connectors apc 97597 --jurisdiction US and apc A6260 → unconfirmed: "No local cache at data/opps_addendum_b.csv". This is a tooling gap, not a finding.
• python3 -m connectors cpt 97597 → unverifiable: descriptors are AMA-licensed. The code number is used only as a key for rvu. No descriptor is reproduced here.
• python3 -m connectors payment A6260 --jurisdiction DK and coverage A6260 --jurisdiction EU → unconfirmed: no primary-source connector for either jurisdiction. That is the correct refusal.

The money model

The size comes from the market model and is not rebuilt here. Its coverage line reads one leg of ten on a verified claim, eight queued as research and one on an unconfirmed claim. It computes no band. It splits the chain into two quantities: a head pool, one head per session, and a bag pool, sessions divided by sessions served per bag. This case quotes the legs it needs and sets out the unit economics the file can support. No price, volume, share or margin is supplied where the file has none.

Read the bolded rows together. The head's comparator costs single-digit dollars per session in Medicare's allowed amounts claim 69verified. The bag's comparator costs tens to low hundreds of dollars per container at one retailer's list price claim 105verified. P1 per-patient HOCl bag puts the per-session revenue on the head, so the head is priced against the cheap comparator. P1 per-patient HOCl bag's design added a squeeze chamber and check valve to the head to reach the pressure window claim 143verified, which adds cost to the very unit that faces the cheapest comparator. Whether that inequality can close is the joint question of claim 161unconfirmed and claim 188unconfirmed. Neither has a number on either side.

The cadence differs by setting, and the case does not average it away. Where the patient stays (SNF, inpatient, home health), one bag spreads over many sessions claim 189unconfirmed. In a visit-based outpatient clinic, it may serve one session and be discarded, unless someone holds it between visits claim 163unconfirmed. Then every clinic session costs a head plus a whole bag. That is P0 the original shape's economics with the waste shown. The choice of custody (REQ-0235 For the P1 per-patient HOCl bag) and fill volume belongs to the owner.

What REQ-0244 For P1 asks, answered in this department's field only:

• Per-session head price and per-bag price: none is assumed. Setting either is a Tier 3 act. The two tests are above.
• Volumes in years one and three: not established.
• Sessions per bag by setting: this is claim 189unconfirmed, and nothing narrower exists.
• Is "made to fit only this bag" a requirement of the money model? It is a requirement of Route A below and of no other route. Routes B and C sell a head that fits someone else's bag, and Route D sells into a tender lot.

The answer leaves Operations' cost test (claim 188unconfirmed) with nothing to compare against. That is a visible blank, not a number.

State the market and adoption verdicts explicitly, from cold runs during this build:

• python3 -m connectors market "The annual US revenue available to a single-use three-nozzle hand-squeezed wound irrigation head sold once per irrigation session, plus a per-patient hypochlorous acid-preserved saline bag, bought from facility and agency supply budgets inside bundled payments in hospitals, outpatient wound clinics, skilled nursing facilities and home health" → unverifiable: "no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report". The market model's own run returned the same verdict. So did the P0 the original shape market claims claim 36unconfirmed, claim 37unconfirmed.
• python3 -m connectors market "The annual Danish public-tender spend on hypochlorous acid wound irrigation fluid across regions and municipalities" → unverifiable, the same verdict. The connector takes no jurisdiction flag. It would refuse a Danish source in any case.
• python3 -m connectors adoption "US facility and agency purchasers would replace saline-and-syringe irrigation sessions with a per-session single-use HOCl bag-and-head system at a price above their current per-session cost" → unverifiable: "needs primary research (interviews, survey, published preference study) ... Do NOT substitute a model's own estimate of stakeholder behaviour". This is the verdict already recorded at claim 161unconfirmed.
• python3 -m connectors adoption "Danish regional and municipal tender buyers would admit a single-use wound irrigation head into a wound-care tender as its own priced product alongside HOCl irrigation fluid" → unverifiable, the same verdict. The checkable twin is the lot specification claim 171unconfirmed.

The revealed-behaviour twins of the class-3 questions are already filed. The market model filed the share row and the realized-price row. The assessment filed the analog row on premium single-use accessories inside bundled budgets. This case files no further rows.

Path to first revenue

• The first US dollar comes from: a hospital, SNF, home health agency or wound practice buying heads and bags out of its supply budget, most plausibly through a distributor or GPO contract [assumption A1 Assumption], in settings where the payment it receives does not change claim 65verified, claim 66verified, claim 67verified.
• Nothing exists yet: no kit or system has been built, and no stability, pressure, splash or biocompatibility data exist for it claim 63unconfirmed. Whether the hand-squeezed head holds 4-15 psi is open claim 145unconfirmed.
• Who owns the hardware is unknown: the referrer's ability to bring the Aquaceso rights is the first dependency claim 3unconfirmed, and no regulatory record for Aquaceso has been found claim 2unconfirmed.
• What must exist before a US dollar, the bag:
  • A 510(k) as an FRO wound wash. The 2023 proposed rule is not codified claim 12verified, and it lists HOCl in its low-concern Class II (FDA device class II) tier claim 120verified.
  • In-use data that support the labelled period claim 177unconfirmed.
  • A filler that does not itself sell HOCl cleansers in the US claim 128unconfirmed. The supply record points at incumbents claim 190unconfirmed.
• What must exist before a US dollar, the head:
  • An FDA (US Food and Drug Administration) classification within an existing regulation rather than a De Novo (De Novo classification request) claim 180unconfirmed.
  • Clinical-use evidence that it delivers 4-15 psi in every operator's hands claim 172unconfirmed.
  • For Route A only, a keyed, resealing port acceptable to FDA claim 195unverified.
• The IP (intellectual property) the head must clear:
  • Counsel's read of the live hardware families, which nobody has done. The Schultz utility terms end about 2032 claim 152verified, and its design patents run to about 2037 and 2040 claim 183verified.
  • The landscape for the squeeze chamber and keyed connector is unsearched claim 193unconfirmed.
  • A refuted claim bears here. claim 153refuted described two Schultz independent claims that do not exist claim 153refuted. The real independent claims recite a generic "fluid source connector", not a squeeze bottle or syringe claim 181verified. So the hardware claims reach wider than the refuted line suggested. That cuts against the head, not for it.
  • The earlier refuted inventor attribution claim 55refuted concerns a lapsed patent and changes nothing here claim 79verified.
• Calendar to the first US dollar: not established. No claim carries a duration for filler transfer, stability, head verification or either FDA review. The one dated proposition on record is a schedule nobody has built. It says the first US head sale lands before 2032-03-14 claim 194unconfirmed, which is about when the last Schultz utility term ends claim 152verified.
• Capital to the first US dollar: not established. The largest item is taken to be the bag's sterile fill and its stability and in-use data [assumption A4 Generator's belief]. No figure exists for any item.
• The first Danish dollar comes from: a region or municipality buying the bag under a tender lot, paid from its own budget [assumption A3 FDA 510]. The lot on record is Region Nordjylland's lot 50 claim 113unconfirmed. The award notice is dated 2025-10-24 claim 115unconfirmed. If the lot runs 48 months claim 134unconfirmed, the next chance to bid opens about late 2029 by this case's arithmetic, and no newcomer supplies it before then [assumption A5 FDA 510]. A CE mark must exist first claim 21unconfirmed, and its class decides whether the solution needs a Class III conformity route claim 135unconfirmed.

Routes

Four routes to a first dollar, in no order. Each sells a different unit to a different buyer. None is ranked here, and choosing between them is a human decision. Each route's kill condition is the finding that would end that route specifically. A finding that ends all four, such as no rights to any hardware, sits under every one of them and is not repeated as a kill.

Route A — US system: keyed head plus per-patient bag, to facility supply budgets

• Requires: the P1 per-patient HOCl bag shape as framed.
  • The keyed connector: a head that fits only this bag, through a port that reseals and that FDA accepts claim 195unverified, on a formulary that accepts it claim 162unconfirmed.
  • Buyers paying more per session than saline and a syringe claim 161unconfirmed, at a price that clears cost claim 188unconfirmed.
  • A bag that serves more than one session in each setting sold to claim 189unconfirmed, made by a non-competing filler claim 128unconfirmed.
  • Two clearances, one for the bag and one for the head claim 120verified, claim 180unconfirmed.
  • The Aquaceso rights claim 3unconfirmed and counsel's read of the hardware families claim 193unconfirmed.
  • A channel into GPO-held formularies [assumption A1 Assumption], claim 103verified.
• Costs: the largest outlay is taken to be the bag's sterile fill and its in-use data [assumption A4 Generator's belief]. Head design, tooling and two submissions come on top. The schedule proposition is claim 194unconfirmed. No time or capital figure exists.
• Killed by: a finding that a single port cannot both accept only this maker's head and reseal between sessions within a 510(k) or exempt route claim 195unverified. Without the keyed fit, the bag is not pulled through. The route then becomes Route B with a bag nobody needs to buy.

Route B — US head only: a standard-spike head for any maker's bag

• Requires:
  • A single-use, hand-squeezed three-nozzle head with a shield that spikes into irrigation bags facilities already stock, including an incumbent HOCl bag claim 6verified or plain saline.
  • A classification within the irrigating-syringe or jet-lavage regulations claim 180unconfirmed. The irrigating-syringe route is Class I and exempt claim 17verified.
  • A head that holds 4-15 psi claim 145unconfirmed.
  • Buyers paying more per session for it than for a syringe with a shield accessory [assumption A6 21 CFR 880.6960 classifies an irrigating…].
  • Counsel's read of the hardware families against the head's geometry claim 193unconfirmed, claim 181verified.
  • It does not require a bag, a filler, an in-use study, an HOCl label or the keyed connector. One incumbent has already tested its bag for compatibility with third-party lavage systems claim 169verified.
• Costs: head design, verification, sterilization validation and tooling, and a 510(k) only if the classification takes it out of the exemption claim 180unconfirmed. No time or capital figure exists in the file.
• Killed by: a priced buyer finding that US facilities will not pay more per session for the head than for a syringe with a separate shield accessory [assumption A6 21 CFR 880.6960 classifies an irrigating…].

Route C — Head supplied or licensed to an incumbent HOCl bag maker

• Requires:
  • An incumbent that already sells HOCl in bags or spikeable containers claim 6verified, claim 122verified agreeing to buy, license or co-market a head built to fit its container [assumption A7 FDA 510].
  • That incumbent's channel, which already reaches GPO and FSS buyers claim 103verified, claim 104verified.
  • The head working claim 145unconfirmed and clearing its classification claim 180unconfirmed.
  • Rights the partner will accept claim 3unconfirmed.
  • The bag, its filler and the solution patents become the partner's problem. The solution families point at the same incumbents claim 149verified, claim 190unconfirmed.
  • Revenue is a supply price or a royalty, and no claim prices either.
• Costs: head development to a partner's specification, plus the partner's own clearance work. No time or capital figure exists in the file. Approaching an incumbent discloses the opportunity, which makes it the owner's decision.
• Killed by: no incumbent engaging on a supply, licence or co-marketing term sheet for the head [assumption A7 FDA 510].

Route D — Denmark first: the bag into a Danish tender lot

• Requires:
  • A CE mark for the HOCl solution, Class IIb or Class III depending on how a notified body reads HOCl's role claim 21unconfirmed, claim 135unconfirmed. The one company statement of a IIb HOCl wound product is a press release claim 22unconfirmed.
  • The bag offered on its own conforming to Region Nordjylland's lot 50 claim 170unconfirmed. Award criteria that weigh more than price claim 132unconfirmed.
  • A place for the head, which needs a lot that admits it claim 171unconfirmed.
  • The next tender round, because the current award runs its term claim 134unconfirmed, [assumption A5 FDA 510].
  • Payment from the buying authority's own budget [assumption A3 FDA 510].
  • The referrer's rights claim 3unconfirmed.
  • It does not require a US clearance or a US buyer study.
• Costs: a notified-body conformity assessment and a tender bid. No time or capital figure exists in the file. Mölnlycke, which owns an HOCl solution maker, is among the tenderers on record claim 115unconfirmed, claim 110verified.
• Killed by: the lot-50 product specification admitting neither a per-patient HOCl bag offered alone nor a head offered alone claim 170unconfirmed, claim 171unconfirmed. That leaves no priced place in the one Danish tender on record. Reading it needs a human download of the tender documents (REQ-0201 For Region Nordjylland's joint wound tender).

Assumption register

Every assumption cited above is listed here, with what would settle it and who could run it. All seven were appended to the candidate as unverified claims 196-202 via append_commercial_claims.py.

Where this case outruns the file

Every figure the case needed and the file does not carry, gathered in one place. These are the work items.

• Price per head and price per bag. Not set, by design. Setting them is Tier 3. Claims 161 and 188 test any price once a human states one.
• Annual head and bag volumes in years one and three, and the share won. Nothing in the file carries a share. The market model's leg 10 is queued as research.
• Sessions per patient-year and the irrigation share of sessions. No US figure exists (market model legs 5 and 6, one research row). The only analog is the NHS (National Health Service), which is held unconfirmed on jurisdiction.
• Sessions per bag in each setting. This waits on an in-use study on a bag that does not exist (claim 189unconfirmed). For outpatient clinics it also waits on REQ-0228 Retrieve the labelled storage condition (the incumbent bag's labelled in-use period) and the owner's custody choice (REQ-0235 For the P1 per-patient HOCl bag).
• Gross margin and cost per session. No bill of materials, quote or supplier exists (claim 188unconfirmed, REQ-0233 For the P1 shape answered with a structure and no figure).
• The channel's take (A1 Assumption). The structure is assumed. Its size is nowhere.
• A contract price for any HOCl cleanser. The FSS entry is believed to carry one (claim 131unconfirmed, REQ-0230 Retrieve the VA Federal Supply Schedule…). Only retail list prices are in hand.
• Calendar and capital to first dollar, US and Denmark. No duration and no figure exists for any step. claim 194unconfirmed is a dated proposition about a plan nobody has built.
• The value, winner and criteria of Danish lot 50. The dossier records an unconfirmed estimated-value field from flattened API data whose alignment to the lot was never established. It is not a claim and is not used here. The winner and criteria are claims 132 and 134, both unconfirmed.
• Non-Medicare coverage of A6260. State Medicaid and commercial treatment was never searched (REQ-0202 Outside Medicare is open with research). It would affect only home-dispensed bags.
• An incumbent's revenue beyond Sonoma's. The dossier carries Urgo Medical North America's announced turnover at its 2018 formation. The market model names it as a draftable line, and it is not a claim, so it is not used here.