Who pays, from which budget, how much, and 2-4 commercial routes to
first revenue — every figure below traces to a copied claim or a declared assumption, and the
routes are laid out unranked. Choosing a commercial strategy is a Tier 3 act, so this page
presents options and stops.
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 46930 — buys the disposable applicator-plus-anoscope kit and, on the razor-and-blade structure the candidate's own moat claim implies, the RF console that reads it [claim 10: unconfirmed]. 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 6: unconfirmed].
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 40: verified]. All three sit inside a 510(k)-exempt or long-cleared, cheap incumbent category [claim 56: verified].
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 24: unconfirmed] — but no bipolar/RF applicator predicate's cleared indication reaches grade III at all [claim 42: verified], [claim 52: verified], 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 33: unconfirmed], [claim 51: unconfirmed] 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.
not established — Generator states no number, and the check is blocked only by a missing data/ cache
[claim 7: unconfirmed]
Non-facility payment for 46930, aggregator-sourced reading
~$158 non-facility / ~$248 facility
[claim 5: unconfirmed]
Non-facility payment for 46930, CMS-primary-file-sourced reading — the reverse pairing
non-facility total RVU 7.42 is higher than facility total RVU 4.72, i.e. non-facility is the higher-paying setting (~$248), not the lower one (~$158)
[claim 58: unconfirmed]
90-day global surgical period on 46930/46945/46946
confirmed to exist as a CMS administrative field, independent of the AMA-licensed descriptor
[claim 57: unconfirmed]
Realistic net selling price per disposable kit to the practice, constrained by the payment figure above
roughly $40-60
[claim 8: unconfirmed]
Landed manufacturing cost of the kit at that price
not established
[assumption A1]
Console placement cost to the manufacturer, recovered through the consumable margin
not established
[assumption A2]
Procedures per practice per year, which decides whether a placed console pays back
not established
[assumption A3]
Addressable share of qualifying procedures within five years
15-25%
[claim 9: unconfirmed]
Pace of practice adoption needed to reach that share inside the stated window
not established
[assumption A4]
Gross margin on the disposable kit
not established — depends on [assumption A1] against [claim 8: unconfirmed]
[assumption A1]
Read the largest number first, and note it does not exist. No claim in the file, and no connector run for this case, produces a national revenue figure — the one genuinely checkable component (procedure volume, [claim 7: unconfirmed]) is unresolved for lack of a cached CMS file, and the two components that would turn a volume into a dollar figure — price [claim 8: unconfirmed] and share [claim 9: unconfirmed] — are Generator assumptions the file itself already records as such, not market data.
The two payment readings in the table above disagree about which site of service pays more, and that disagreement runs through every dollar figure downstream of it. The candidate's own $40-60 disposable-price ceiling was derived from the aggregator reading, ~$158 non-facility [claim 5: unconfirmed], not the CMS-primary-file reading, which puts non-facility at ~$248 and facility at ~$158 instead [claim 58: unconfirmed]. This case reports the discrepancy; the file itself records it as unresolved rather than as evidence either way.
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 both remain blocked: coverage 46930 → unconfirmed, no local cache, the companion check behind [claim 5: unconfirmed]; procedures 46930 → unconfirmed, same missing-cache reason [claim 7: unconfirmed].
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 10: unconfirmed], 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 [claim 16: verified], [claim 17: verified], [claim 18: verified], and a predicate pool now exists where the frontmatter said none had been identified [claim 20: verified], [claim 46: refuted] — refuting the "no predicate ⇒ possible De Novo" premise. But the nearest-modality predicates stop at grade II [claim 42: verified], [claim 52: verified], and whether FDA accepts a grade II-III indication on that mixed predicate story without a De Novo or a clinical study is unresolved [claim 51: unconfirmed].
Bench dosimetry and animal thermal-spread data supporting the impedance-control claim [claim 12: unconfirmed], [claim 31: unconfirmed] — no connector answers this; it is Stage 7 work.
A billable code with a confirmed payment level. The descriptor is permanently unverifiable, being AMA-licensed [claim 1: unconfirmed]; the payment figure itself is contested between two unconfirmed readings [claim 5: unconfirmed], [claim 58: unconfirmed]; no Medicare coverage policy has been located, the companion check behind [claim 5: unconfirmed].
A contract-manufacturing quote establishing the disposable's landed cost against the price ceiling [assumption A1].
An FTO position. Zero patents have ever been searched on this design [claim 11: unconfirmed], [claim 34: unconfirmed] — the rubric's one automatic-kill factor, in a field whose parties are now named by K-number: Covidien/Medtronic [claim 40: verified], Haemoband Surgical [claim 44: verified], and F Care Systems, ruled out as an anorectal competitor on the record [claim 37: verified].
Calendar to first dollar: the file's own estimate is eighteen to thirty months to clearance [claim 14: unconfirmed], 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 14: unconfirmed], 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 52: verified] — 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 40: verified]; 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 14: unconfirmed], plus channel-build cost and calendar [assumption A6].
Killed by: the incumbent HET Bipolar line — active, Covidien-held, most recently cleared in 2020 [claim 40: verified] — being confirmed as still actively marketed and sold [claim 49: unconfirmed] 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 53: verified] 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 51: unconfirmed]; bench thermal-spread and animal sphincter-injury data supporting the dosimetry claim [claim 12: unconfirmed], [claim 31: unconfirmed]; 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 14: unconfirmed].
Costs: the same clearance baseline as Route A [claim 14: unconfirmed], 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 51: unconfirmed] 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 14: unconfirmed].
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 40: verified] or the Barrx Anorectal RFA Wand [claim 43: unconfirmed] — neither of which claims dosimetry today.
Requires: the dosimetry module validated as a standalone subsystem [claim 31: unconfirmed]; an FTO position on impedance-controlled coagulation [claim 34: unconfirmed]; and a partner who believes a dose record is worth carrying — the same switching/adoption premise the file records as unverifiable [claim 63: unconfirmed].
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 8: unconfirmed], [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 31: unconfirmed] 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 24: unconfirmed].
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 61: unconfirmed]; and discharging or referring clinicians willing to act on that evidence rather than defaulting to the existing referral pattern [claim 48: unconfirmed].
Costs: the clearance baseline [claim 14: unconfirmed] plus a comparative-study spend, scoped against the one relevant published trial design [claim 59: unconfirmed], [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 62: unconfirmed]. 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.
#
Assumption
Falsifier
Owner
A1
A contract-manufacturing quote for the single-use bipolar RF applicator with integrated impedance-dosimetry electronics, at commercial launch volumes, yields a landed cost that leaves margin under the price ceiling the candidate's own economic claim implies [claim 65: unverified]
A bill-of-materials cost roll-up / contract-manufacturing quote from an electrosurgical-device CM at stated launch volumes (e.g. 1,000 / 10,000 / 50,000 units/yr)
Engineering + operations
A2
The RF console can be placed into a purchasing practice at little or no upfront capital cost, recovered through the disposable-applicator margin on a razor-and-blade model [claim 66: unverified]
Comparable console-placement terms for the incumbent HET Bipolar or Barrx Anorectal RFA lines — list price, lease terms, or placement agreements — from a distributor price list or a competitor quote
Commercial / business development
A3
A colorectal surgery, gastroenterology, or proctology practice performs enough qualifying grade II-III procedures per year that one placed console reaches consumable-margin payback within a normal capital-equipment payback window [claim 67: unverified]
Office procedure-volume-per-practice data — the same CMS Part B utilisation file that would resolve claim 7, cut by billing NPI or practice — benchmarked against the disposable margin from A1
Commercial / business development
A4
The number of practices adopting the device by year three to five is large enough, at the pace of a comparable single-specialty office-device launch, to reach the 15-25% addressable-share figure [claim 9: unconfirmed] inside the candidate's own five-year window [claim 68: unverified]
Revealed-behaviour twin: practice/console adoption curves in the twelve to twenty-four months following the last two comparable clearances in this exact modality — K200146 (2020) and K250645 (2025) — from distributor sell-through data or the device makers directly
Commercial / business development
A5
The lag between 510(k) clearance and the first paid consumable order — sales cycle, distributor onboarding, any GPO or health-system contracting — is short enough to finance inside a normal launch runway [claim 69: unverified]
Time-to-first-order data from a comparable single-specialty office capital-equipment launch (e.g. the HET Bipolar or SleeveLUX launch), from a distributor or the device maker directly
Commercial / business development
A6
The cost and calendar to build a sales and distribution channel into colorectal surgery, gastroenterology, and proctology practices, separate from the clearance spend, is affordable within a launch budget [claim 70: unverified]
A signed or quoted distribution agreement in a comparable single-specialty office-device category, or headcount/cost data from a comparable launch
Commercial / business development
A7
The impedance-dosimetry control module can be qualified for integration into an already-cleared bipolar RF or anorectal applicator, as a licensing or OEM route, without triggering a new full 510(k) for the host device [claim 71: unverified]
A regulatory consultant's written scoping opinion on whether adding the module to a cleared host device is a letter-to-file, a special 510(k), or a new submission, plus a bench-validation quote for the standalone module
Regulatory consultant + engineering
A8
A US comparative study large enough to demonstrate that a single office RF session at grade III reduces escalation to surgical hemorrhoidectomy, relative to rubber band ligation, is affordable and can be run in a useful calendar [claim 72: unverified]
A CRO protocol scoping and quote against that endpoint, benchmarked to the design of the one relevant registered trial in this space, NCT04621695, the RBL-vs-hemorrhoidectomy noninferiority trial underlying [claim 59: unconfirmed]
Clinical
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. The one genuinely checkable input, procedure volume [claim 7: unconfirmed], is unresolved for lack of a cached CMS file; price and share are Generator assumptions the file already labels as such, not market data. market returns unverifiable on any composite of them permanently.
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 10: unconfirmed] 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 9: unconfirmed] 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 14: unconfirmed] 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 is correct — the aggregator pairing this candidate's own $40-60 disposable ceiling was derived from [claim 5: unconfirmed] versus the CMS-primary reading that reverses which site of service pays more [claim 58: unconfirmed]. This case reports the disagreement; it does not resolve it, and the disposable price ceiling in the money model rests on whichever reading turns out to be correct.
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.