Single-use office radiofrequency applicator with integrated dosimetry and disposable anoscope for grade II-III internal hemorrhoids, sized to the CPT 46930 non-facility payment — business case

Intended use: For use by a physician in an office setting to coagulate and devascularise symptomatic grade II and grade III internal hemorrhoids in adults, delivered transanally through an anoscope without sedation, in patients who have failed conservative medical management.

Who pays

• Writes the cheque: the office practice — a colorectal surgeon, gastroenterologist, or proctology practice already billing CPT (Current Procedural Terminology) 46930 — buys the disposable applicator-plus-anoscope kit and, on the razor-and-blade structure the candidate's own moat claim implies, the RF (radiofrequency) console that reads it claim 10unconfirmed. No claim in the file names a distributor or GPO as the actual purchaser; that is unestablished either way.
• Out of which budget line: the practice's disposable-supply budget, sized against the professional fee the physician collects for the procedure — the candidate's own load-bearing claim is that the kit must "cost the practice materially less than the non-facility payment for 46930, net of the physician's own work, or the office will not adopt it" claim 6unconfirmed.
• Against which comparator: the office's already-owned, already-amortised instruments — rubber-band ligation forceps, an infrared-coagulation unit, or (for a subset of practices) an existing bipolar RF console from the HET Bipolar family, a four-clearance, Covidien-held product line active as recently as 2020 claim 40verified. All three sit inside a 510(k) (premarket notification)-exempt or long-cleared, cheap incumbent category claim 56verified.
• Stops buying instead: for grade I-II patients, this is straight substitution against RBL, IRC, or the existing bipolar RF line — a fleet-slot swap, not new spend. For grade III patients, the candidate's own scope note frames the device as displacing escalation to surgery rather than substituting for an office instrument claim 24unconfirmed — but no bipolar/RF applicator predicate's cleared indication reaches grade III at all claim 42verified, claim 52verified, so which of these two budget lines actually applies is unresolved by any verified claim.

The chain's weakest link is the same one the candidate's own scope note names as the whole premise. The budget line for a grade I-II sale is well understood and crowded. The budget line for a grade III sale — the one that would make this device more than a fourth entrant in an already-occupied category — depends on a clinical and regulatory claim claim 33unconfirmed, claim 51unconfirmed that is, on the file's own reading, its central unproven premise.

The money model

Decomposed, not asserted. Every line resolves to a copied claim or a declared assumption.

The size decomposition lives in the market model, which carries the chain, its six legs, and what each one rests on. Read one thing from it before the table below: the chain is a per-episode consumable one, so the non-facility payment for the destruction code claim 1unconfirmed enters as a ceiling on the kit price and never as a multiplier. Multiplying office episodes by the fee-schedule amount would size a professional-fee pool this company never invoices. Three of the six legs are filed as research rows rather than left as holes.

Read the largest number first, and note it still does not exist — but one of its three legs now does. No claim in the file, and no connector run for this case, produces a national revenue figure. What changed on 2026-09-11 is that the one genuinely checkable component is checked: procedure volume claim 7verified is 8,090 Medicare fee-for-service services a year across the three codes, and the floor caveat travels with it verbatim — Medicare FFS excludes Medicare Advantage (Medicare Advantage), commercial, Medicaid, VA and cash-pay, and hemorrhoid disease skews younger than the Medicare population, so this understates US volume by an unknown factor. It is a floor, never a market size. The two legs that would turn a volume into a dollar figure — price claim 8unconfirmed and share claim 9unconfirmed — remain Generator assumptions the file records as such, and market refuses any composite of them permanently. So the chain is now one verified floor multiplied by two assumptions, which is a better-founded way of having no number than three assumptions was.

The two payment readings in the table above disagreed about which site of service pays more, and the disagreement is now resolved against the one this candidate was sized from. The candidate's $40-60 disposable-price ceiling was derived from the aggregator reading, ~$158 non-facility. CMS's own PFS (physician fee schedule) file says the opposite: non-facility total RVU 7.42 against facility 4.72, i.e. $249.07 in the office against $158.44 in the facility claim 58verified. Both dollar amounts in the aggregator reading were real CMS numbers attached to the wrong settings, which is why claim 5refuted is refuted rather than unconfirmed — a contradiction of the primary source, not a gap in the check.

What that does to this case is not small, and it points the favourable way. The price ceiling every dollar here is measured against was set from the lower of the two figures, and the office setting this device is built for turns out to be the one paying $249.07 — because the practice-expense component alone is $188.99 of the office rate, the burden sitting with the practice that buys the disposable. A $40-60 kit fits inside a $249 office payment very differently from how it fits inside $158. This case does not restate the price line on that basis, and the reason is a boundary rather than caution: the ceiling lives in claim 8unconfirmed, a Generator assumption no Verifier has reached, and re-deriving it here would be this artifact issuing a number the candidate file does not carry. What is recorded is that the input it was derived from was wrong in the direction that makes the model easier, and that re-deriving it is now cheap and owed.

The two connectors that would ordinarily carry a business case both refuse, and the verdicts go on the page rather than being routed around:

• python3 -m connectors market "US addressable market for a single-use office RF hemorrhoid applicator, sized as Medicare-code volume for 46930/46945/46946 x a $40-60 per-kit price x a 15-25% addressable share within five years" → unverifiable — "Market-size claim (...) has no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report and edits the claim by hand."
• python3 -m connectors adoption "Proceduralists who currently own a reusable RBL/IRC instrument will switch to a per-case disposable RF applicator and single-use anoscope combination, priced to fit inside the CPT 46930 non-facility payment" → unverifiable — "Adoption/preference claim (...) asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study). ... Do NOT substitute a model's own estimate of stakeholder behaviour: a synthetic stakeholder opinion is a fabricated claim. Consider rescoping to a checkable proxy instead — coverage (does a payer policy exist for the comparator?) or procedures (how often is this actually performed?)."

The connector's own suggested proxies were both attempted by the candidate's own Verifier passes, and they have now split. procedures 46930 resolved when data/medicare_procedure_volumes.csv was attached — that is claim 7verified and the 8,090 figure above, and it is the clearest demonstration in this file that a unconfirmed resting on a missing cache is a job rather than a finding. coverage 46930 remains blocked: no local cache at data/medicare_coverage_policies.csv, so no Medicare NCD (national coverage determination) or LCD (local coverage determination) has been located and the existence of a coverage policy is still open. A payment rate is not a coverage decision, and this case has the first without the second.

Path to first revenue

• First dollar comes from: the first practice that buys a starter kit inventory, and on the razor-and-blade structure a console claim 10unconfirmed, after clearance — a device sale, not a reimbursement event. The physician's own procedural reimbursement arrives on a separate track and only sets the ceiling this case's price line is measured against.
• What must exist first, each attributed:
  • 510(k) clearance. Every candidate regulation is verified Class II (FDA device class II) claim 16verified, claim 17verified, claim 18verified, and a predicate pool now exists where the frontmatter said none had been identified claim 20verified, claim 46refuted — refuting the "no predicate ⇒ possible De Novo (De Novo classification request)" premise. But the nearest-modality predicates stop at grade II claim 42verified, claim 52verified, and whether FDA (US Food and Drug Administration) accepts a grade II-III indication on that mixed predicate story without a De Novo or a clinical study is unresolved claim 51unconfirmed.
  • Bench dosimetry and animal thermal-spread data supporting the impedance-control claim claim 12unconfirmed, claim 31unconfirmed — no connector answers this; it is Stage 7 work.
  • A billable code with a confirmed payment level. The payment level is now confirmed — 46930 pays $249.07 non-facility against $158.44 facility claim 58verified, and the contrary aggregator reading is claim 5refuted. Two things are still missing behind it: the descriptor is permanently unverifiable, being AMA-licensed claim 1unconfirmed, and no Medicare coverage policy has been located, because data/medicare_coverage_policies.csv is not cached. A rate is not a coverage decision, and this line is half met.
  • A contract-manufacturing quote establishing the disposable's landed cost against the price ceiling [assumption A1].
  • An FTO (freedom to operate) position. Zero patents have ever been searched on this design claim 11unconfirmed, claim 34unconfirmed — the rubric's one automatic-kill factor, in a field whose parties are now named by K-number: Covidien/Medtronic claim 40verified, Haemoband Surgical claim 44verified, and F Care Systems, ruled out as an anorectal competitor on the record claim 37verified.
• Calendar to first dollar: the file's own estimate is eighteen to thirty months to clearance claim 14unconfirmed, plus a go-to-market lag for sales cycle, distributor onboarding, and any GPO contracting, which is not established in the file [assumption A5].
• Capital to first dollar: the file's own estimate is low-single-digit millions to clearance claim 14unconfirmed, which explicitly excludes the comparative-durability spend needed to prove the grade III premise, plus a channel-build cost not established in the file [assumption A6].

Routes

Four, laid out and not ranked. Choosing a commercial strategy is a Tier 3 act — the same class of decision as choosing what to shortlist — so this section presents options and stops.

Route A — Narrow to grade I-II and compete head-on with the entrenched bipolar RF incumbent

Match the intended use to the nearest predicate exactly — the HET Bipolar family's cleared scope claim 52verified — trading away the candidate's own stated premise (durability at grade III) for the fastest, least contested clearance path.

• Requires: 510(k) clearance against the grade I-II bipolar RF predicates claim 40verified; a contract-manufacturing quote showing the kit can be priced below a Covidien-owned, already-amortised console's per-case cost to the practice [assumption A1]; and distribution relationships with practices already billing 46930.
• Costs: the file's own regulatory estimate of eighteen to thirty months and low-single-digit millions to clearance claim 14unconfirmed, plus channel-build cost and calendar [assumption A6].
• Killed by: the incumbent HET Bipolar line — active, Covidien-held, most recently cleared in 2020 claim 40verified — being confirmed as still actively marketed and sold claim 49unconfirmed at a price this candidate's kit cannot beat once its own landed cost is known [assumption A1]. If the practice's existing amortised console is cheaper per case than a new disposable-per-case model, there is no reason to switch.

Route B — Hold the grade II-III indication and argue the cross-code predicate story

Keep the candidate's own stated premise — durability at grade III — and pursue clearance on a mixed predicate argument: grade I-II bipolar RF applicators for modality and delivery route, plus the Ultroid grade I-IV predicate claim 53verified for indication scope, even though it sits in a different product code and panel.

• Requires: FDA accepting that cross-code substantial-equivalence argument without a De Novo or a clinical study claim 51unconfirmed; bench thermal-spread and animal sphincter-injury data supporting the dosimetry claim claim 12unconfirmed, claim 31unconfirmed; and, separately from clearance, comparative-durability evidence strong enough to change referral behaviour at grade III, on the split the file's own capital estimate already draws claim 14unconfirmed.
• Costs: the same clearance baseline as Route A claim 14unconfirmed, plus the separate comparative-evidence spend the file says clearance does not require, scoped as [assumption A8].
• Killed by: FDA declining the cross-code argument and requiring a De Novo or a clinical study for the grade III half of the indication — claim 51unconfirmed resolving false. That would erase the eighteen-to-thirty-month, low-single-digit-million estimate this entire route's calendar and capital lines rest on claim 14unconfirmed.

Route C — License the dosimetry-and-cutoff module into an already-cleared applicator

Ship the differentiator, not the whole device: an OEM impedance-dosimetry module into an existing bipolar RF or anorectal RFA platform — the HET Bipolar family claim 40verified or the Barrx Anorectal RFA Wand claim 43unconfirmed — neither of which claims dosimetry today.

• Requires: the dosimetry module validated as a standalone subsystem claim 31unconfirmed; an FTO position on impedance-controlled coagulation claim 34unconfirmed; and a partner who believes a dose record is worth carrying — the same switching/adoption premise the file records as unverifiable claim 63unconfirmed.
• Costs: no console-placement capital [assumption A2] and no channel build [assumption A6]; in their place, a regulatory-qualification spend to determine whether adding the module to a cleared host device is a letter-to-file, a special 510(k), or a new submission [assumption A7]. Revenue in this route is a royalty or transfer price, not the device price this case's money model otherwise assumes claim 8unconfirmed, [assumption A1].
• Killed by: bench data showing the module cannot hold a defensible depth-of-injury read across the range of tissue and delivery conditions a host device's cleared population spans — claim 31unconfirmed resolving false. There is nothing to license if the dosimetry record does not mean the same thing device to device.

Route D — Position against the surgical budget line, not the office one

Sell the grade III half of the indication as a substitute for escalation to hemorrhoidectomy rather than as a substitute for RBL or IRC, moving the comparator, and the budget, from the office consumable line to the facility/surgical-avoidance line the candidate's own scope note gestures at claim 24unconfirmed.

• Requires: a US comparative study showing a single office RF session at grade III measurably reduces escalation to surgery, against a published base that currently shows hemorrhoidectomy has the lowest recurrence but the highest rates of bleeding, urinary retention, and incontinence of fourteen compared treatments claim 61unconfirmed; and discharging or referring clinicians willing to act on that evidence rather than defaulting to the existing referral pattern claim 48unconfirmed.
• Costs: the clearance baseline claim 14unconfirmed plus a comparative-study spend, scoped against the one relevant published trial design claim 59unconfirmed, [assumption A8].
• Killed by: a US comparative study finding no meaningful reduction in escalation to surgery — plausible on the existing, non-US evidence, where a modified rubber-band technique alone cut three-month recurrence from 13.6% to 5.4% without any new hardware claim 62unconfirmed. If the incumbent, cheaper modality is closing the gap on its own, the surgical-avoidance argument this route is built on may not hold long enough to matter.

Assumption register

Every assumption cited above, with what would settle it and who could run it. These are written back to the candidate as unverified claims 65-72 — an assumption that lives only in a business case is invisible to the Verifier.

Where this case outruns the file

Every figure with no claim behind it, gathered as work items.

• The national revenue pool — never computed here, and no claim in the file asserts one. Its one genuinely checkable input is now resolved: procedure volume claim 7verified at 8,090 Medicare FFS services, carrying the floor caveat. Price and share remain Generator assumptions the file already labels as such, not market data, and market returns unverifiable on any composite of them permanently. A verified floor times two assumptions is still not a market size, and this case declines to multiply them.
• The disposable kit's landed manufacturing cost (A1) — the file's own Wrap section names a contract-manufacturing quote against the applicator specification as "the most neglected item in the file" across three successive deck builds, and no claim in the file supplies one.
• Console-placement economics (A2) and console utilisation (A3) — nothing in the candidate file speaks to either half of the razor-and-blade structure the moat claim claim 10unconfirmed implies; together they are the entire device-side P&L this case cannot compute.
• Practice-adoption pace against the 15-25% share figure (A4) — the file records the share itself as a Generator assumption claim 9unconfirmed but never a calendar for reaching it.
• The lag to first paid order (A5) and channel-build cost (A6) — the file's capital and calendar estimate claim 14unconfirmed covers only the regulatory leg and explicitly excludes the go-to-market leg, which is where both of these sit.
• Which of the two payment readings was correct — settled, and this case is no longer the thing reporting it. The CMS-primary reading won claim 58verified and the aggregator pairing is claim 5refuted. What outruns the file now is the consequence: the $40-60 disposable ceiling in the money model was derived from the refuted reading, and nobody has re-derived it against $249.07. That is claim 8unconfirmed, it is a Generator assumption rather than a checked one, and re-deriving it is a Commercial deliverable this case names and does not perform.
• Whether a Medicare coverage policy exists for 46930 at all. coverage 46930 is still blocked on a missing data/medicare_coverage_policies.csv. Every payment figure above is a rate, and a rate says what Medicare pays if it pays. Attaching that cache is a job, not a question.
• Module-licensing terms (A7) and comparative-study cost (A8) — Route C's royalty/transfer price and Route D's study spend are named as the load-bearing figures for those two routes specifically, and neither has a claim behind it in the candidate file.