idea-008 · human · US

Office Hemorrhoid RF Treatment

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.

Finished enough to read, and waiting for you. No department has been asked. 21 of 84 claims verified, 4 refuted. Nobody has yet written down what it rests on.

Open the decide panel →wrappedunassessed status: wrapped updated 2026-09-29 Ask or request work ↗

The bet

In plain words

A single-use device for treating internal haemorrhoids in a doctor's office rather than an operating theatre. Haemorrhoids that keep bleeding after diet and ointments are usually treated in the office by strangling them with a rubber band or burning them with heat; the larger ones often come back, and the alternative is surgery with a slow, painful recovery. This is a disposable applicator that delivers radiofrequency energy to shut off the blood supply, with a sensor that measures the tissue as it heats and stops automatically at the right depth — the point being to treat the larger grade III haemorrhoids consistently enough that they do not come back, without cutting anything. It ships with its own single-use scope, and the whole kit is meant to be paid for out of what Medicare already pays a doctor's office for the procedure.

In the Wrap's one-paragraph version, written for someone who has not opened the file. Domain: internal-hemorrhoids-office-based-treatment

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 business case →

What would kill it

What this idea rests on that is not yet known, in the order this idea's own decision queue puts it: worst if false first, cheapest to settle first inside that. The first row is open; open any other for what would settle it.

This idea is unassessed, so nobody has yet named the few things it rests on. Until then, the gaps below are the rubric factors that are unscored or carry an open question. /assess idea-008 replaces this list with the real one.

Regulatory pathway score 2

Why it scored what it did: intended_use: is present, so this factor is scoreable. But frontmatter carries two candidate regulations in different FDA (US Food and Drug Administration) panels (878.4400, general/plastic surgery vs. an unidentified Part 876 GI (gastroenterologist)-urology regulation), no product…

the rest of this reasoning code, and the predicate_or_analog field explicitly names no K-number. Rests only on the Generator's belief plus the descriptor claim (CPT 46930 names RF as an existing office modality), which is reimbursement evidence, not clearance evidence. Scored as "a 510(k) route is plausible and entirely unresolved", not as a known pathway.

What would settle it: openFDA regulation, classification, 510k, and clearance-summary lookups — confirm the 878.4400 text, recover the real product code, find a predicate K-number, and check its IFU (instructions for use). All free via the connectors; a few minutes of analyst…

the rest of this gap analysis time each.

Reimbursement pathway score 3

Why it scored what it did: Strongest factor on paper and the least connector-checkable. Rests on: 46930 descriptor claim (thermal destruction, RF named by example — i.e. the mechanism is already inside an existing code, no new code needed); 46945/46946 existence…

the rest of this reasoning claim; the 2026 fee-schedule claim (~$158 non-facility) sourced from two commercial aggregator sites; and two explicitly negative claims — CCI bundling of 46930 into 46945, and one-unit-per-session with a 90-day global. Not scored higher because the load-bearing number is the payment level, not code existence, and it currently comes from exactly the secondary sources this pipeline distrusts. Code existence alone would not be a pathway.

What would settle it: A licensed AMA CPT source (codebook or vendor feed — AMA CPT API, Optum EncoderPro, Find-A-Code; low hundreds of dollars) for the descriptor and unit rules; free public CMS (Centers for Medicare & Medicaid Services) payment, RVU (relative value unit) (GLOB DAYS), NCCI edit-pair, and coverage/LCD files…

the rest of this gap analysis once loaded into data/.

TAM score 2

Why it scored what it did: No market number is claimed anywhere. All three TAM (total addressable market) components are open: volume (Generator states no figure), per-kit price of $40-60 (derived from the unverified payment claim, not from market data), and a 15-25% five-year addressable…

the rest of this reasoning share (Generator's assumption). Scored at the floor because the only component that is genuinely checkable — procedure volume — is unchecked, and the other two are assumptions stacked on a third assumption.

What would settle it: Free CMS procedures lookups (46930/46945/46946) for volume, read as a Medicare-only floor; a licensed anorectal-devices market report (iData/Grand View-type, several thousand dollars) plus a practice-count denominator for price and…

the rest of this gap analysis addressable share.

FTO / IP score 1

Why it scored what it did: Rests on a single claim that states outright that no patent search was performed and names no patent, live or expired. The file itself records this as an unexamined gap. Scored as unexamined, not as open: an absence of found…

the rest of this reasoning patents is not freedom to operate, and the likely estates (existing office-device and ligation-system manufacturers, impedance-controlled RF generator IP (intellectual property)) are precisely where a blocking claim would sit. This score reflects zero search, not a clean result.

What would settle it: A CPC A61B18/12 / A61B17/12 search plus assignee sweeps on incumbent manufacturers in Patents Public Search or Espacenet (free, analyst time only), then each named hit through the patent connector once a PatentsView API key is obtained.

Moat / defensibility score 1

Why it scored what it did: Rests on the moat claim, which the Generator itself labels weak and marks not connector-checkable: the RF generator is a commodity, office electrosurgical devices are widely copied, and the CPT code is open to any thermal modality, so…

the rest of this reasoning a fast-follower can bill the same code. The only asserted defensible assets are the impedance-dosimetry control algorithm, applicator geometry, and the consumable stream — and the first two are unprotected as long as FTO (freedom to operate)/IP is unexamined, so this score is capped by the row above.

What would settle it: Resolves as a by-product of the FTO/IP patent search above; a free clearances lookup by product code adds a read on how fast followers copy comparable devices.

Mechanism & clinical risk score 3

Why it scored what it did: Rests on the mechanism/clinical-risk claim plus the indication-scope rationale. Favourable: RF thermal destruction of hemorrhoidal tissue is an established modality already named in the 46930 descriptor, so the mechanism is not…

the rest of this reasoning novel-risky, and the failure modes are named honestly — recurrence at grade III, post-procedure pain and bleeding, and rare thermal injury to the sphincter complex or rectal wall — with impedance dosimetry and auto-cutoff proposed as the mitigation. Held at 3 because the premise is durability at grade III, which is unevidenced, and the mitigation itself is the thing that must be proven.

What would settle it: Free literature, trials, and recalls connector scans give leads only (no confidence tag); the differentiating claims are settled by a funded bench thermal-spread and animal sphincter-injury study at Stage 7.

Capital intensity & time-to-revenue score 3

Why it scored what it did: Rests on the capital/time claim: low-single-digit millions and 18-30 months for a 510(k) with bench dosimetry and animal thermal-spread data and no pivotal trial. Credited for correctly splitting the clearance spend from the separate,…

the rest of this reasoning later comparative-durability study needed to change referral behaviour — conflating them is how this class of candidate gets scored as cheaper than it is. Held at 3 rather than higher precisely because that second spend is real and unbudgeted, and because the 18-30 month figure assumes a predicate that has not been identified (see Factor 1) — no predicate means a De Novo (De Novo classification request), and a different calendar.

What would settle it: Depends on Factor 1's predicate/De Novo answer and the special controls it implies; the cost and calendar figures themselves need a Tier 3 human budget estimate, not a connector.

Competitive intensity score 1

Why it scored what it did: Rests on the competitive-intensity claim, which is a direct read of the descriptor claim: CPT 46930's own descriptor names three competing thermal modalities (infrared coagulation, cautery, radiofrequency) already in office use, plus…

the rest of this reasoning rubber-band ligation as the entrenched standard. So the candidate enters a mature category with cheap, amortised, already-owned incumbent instruments and must win on durability alone — against which the adoption assumption (switching from an owned instrument to a per-case disposable for an unproven benefit) is explicitly flagged as unresearched. Low score = high intensity = unfavourable.

What would settle it: Free clearances/recalls lookups once a product code is identified cover the competitor count; the switching half needs commissioned primary research (a proctology/colorectal practice survey), since adoption is unverifiable by design.

Strategic fit & portfolio balance score 2

Why it scored what it did: No claim in this file addresses portfolio fit, so this score is a shape judgement only, not evidence-backed. The candidate's shape is a cash-generative spoke rather than a hero bet: disposable consumable stream, no pivotal trial…

the rest of this reasoning required for clearance, modest capital. Weighing against it — weak moat, unexamined FTO, and a hard $40-60 COGS (cost of goods sold) ceiling imposed by the payment claim, which makes it a thin-margin spoke if the aggregator payment figure is even slightly high. Scored conservatively because the portfolio it is supposed to fit is not defined anywhere in the repo.

What would settle it: A Tier 3 human portfolio statement at Stage 6 (## Human Review Notes); knowledge-base/calibration-log.md would supply the evidence base once populated. No connector cost — this is a human input.

What the departments said

Seven chairs, each answering from its own field. The verdict, and the first condition it set.

Not convened. No department has stated a position on this idea yet — a normal state, not a defect. /round-table idea-008 asks all seven.

What has been checked

The count

21/84
claims verified
4
refuted
9/9
factors scored
4/4
core factors
verifiedunconfirmedrefutednot yet checked

Only verified counts toward a score. A low count is usually a statement about the tooling — an absent data file, an unset key — rather than about the idea.

The claim ledger → · the nine factors ↓

What was found to be false

4 claim(s) the Verifier found to be false — a refuted claim is a finding, and the loop owes each one an answer.

  • claim 52026 Medicare physician fee schedule values, as reported by secondary sources: 46930 at 1.57 work RVUs and roughly $248 facility / $158 non-facility; 46945 at 3.60 work RVUs and roughly $350; 46946 at 4.39 work RVUs and…the check →
  • claim 19~~The panel question is now evidenced, and it points at Part 876, not Part 878. The only cleared office hemorrhoid coagulation device the connectors surface — Ultroid Hemorrhoid Management System, Ultroid LLC — was…the check →
  • claim 23No product code for the candidate device itself was established, and none is assumed. classification --device-name "hemorrhoid coagulation" and --device-name "electrosurgical cutting and coagulation" both returned…the check →
  • claim 46The frontmatter predicate_or_analog position is wrong and must be rewritten by the Generator/Scorer. It reads: "The Generator did not identify a specific cleared device by K-number and is not naming one; 'no specific…the check →

What to do next

The next move

A CPC A61B18/12 and A61B17/12 search plus assignee sweeps on the incumbent office-device and banding-system manufacturers in Patents Public Search or Espacenet — free, analyst time only — producing named patent numbers, each then run through the patent connector.

Selected from the FTO/IP row of the Scores table's "What would settle it" column; this is a selection from that gap analysis, not a new judgement and not a view about the idea. The previous selection is spent: the CMS cache files the Reimbursement and TAM rows were waiting on are now in data/, and this candidate was run against them on 2026-09-11 and again on 2026-09-29. Of what the column still names, this is the only free item that can produce a verified claim on a factor the kill conditions read — FTO is the one gate factor that has never been examined at all claim 11unconfirmed, claim 34unconfirmed — and the assignee sweeps now have named parties (Covidien/Medtronic, Haemoband Surgical, F Care Systems, per the Verified Composite's FTO/IP row). Nothing blocks it but the work: the connector's EPO (European Patent Office) OPS keys are set, and python3 -m connectors patent-scan --cpc A61B18/12 gives the field sweep. The Reimbursement row's remaining items are either licensed (an AMA CPT source, low hundreds of dollars, for the descriptor and unit rules) or have no connector (the NCCI edit-pair file; the GLOB DAYS column, see below), so neither would produce a verified tag. The other half of the viability deck's load-bearing condition — a contract-manufacturing quote against the applicator specification claim 65unconfirmed — is not in the Scores table and would move no factor, but it is the unsourced term in the subtraction the candidate says decides it claim 6unconfirmed.

Decisions on the table

Shortlist review — yours, at Stage 6
The packet is wrapped, which means it is finished enough to read — not that anything has judged it. Approve, reject or defer is a human act and is recorded only by a person.

Open the decide panel →

Go deeper

All 84 claimsevery claim with its confidence tag and sourceStorythe whole thing as one narrativeDesirability deckwhat would have to be true — for the userViability deckwhat would have to be true — for the investorFeasibility deckwhat would have to be true — for engineeringBusiness casewho pays, how much, routes to revenueDomain dossierinternal hemorrhoids office based treatmentSearch inside this ideaevery section of every file about it
Where it stands in the machine stage verified · not in the loop · unassessed — every stage this idea has been through, and what each holds
Running alongside every stage

A human decision, and only a human's

No human review is recorded. Shortlisting, legal and clinical sign-off and capital allocation are Tier 3: no agent in this repo makes or simulates one. The packet is wrapped, so it can be read now.

Click any step to see what it holds for this idea. donecurrentloopinghuman only

The full packet the whole ## Wrap section, as written

The packet a human reads. See docs/wrap-spec.md. This section says nothing about whether the idea is good — it says the file is finished enough to be read, and names what to do next. Filling it in advances no candidate and approves nothing.

The one-paragraph version. A single-use device for treating internal haemorrhoids in a doctor's office rather than an operating theatre. Haemorrhoids that keep bleeding after diet and ointments are usually treated in the office by strangling them with a rubber band or burning them with heat; the larger ones often come back, and the alternative is surgery with a slow, painful recovery. This is a disposable applicator that delivers radiofrequency energy to shut off the blood supply, with a sensor that measures the tissue as it heats and stops automatically at the right depth — the point being to treat the larger grade III haemorrhoids consistently enough that they do not come back, without cutting anything. It ships with its own single-use scope, and the whole kit is meant to be paid for out of what Medicare already pays a doctor's office for the procedure.

What would have to be true, quoted verbatim from each deck's load-bearing condition (all three decks rebuilt 2026-09-29 against this file):

No assessment exists for this candidate (wrap_status.py: "none — unassessed, not a zero"), so there is no decision queue, no posture and no top-two pillars to set beside these, and only one cheapest next test below. Writing the bet down with /assess idea-008 is the thing most worth adding before a human reads this packet.

Cheapest next test: A CPC A61B18/12 and A61B17/12 search plus assignee sweeps on the incumbent office-device and banding-system manufacturers in Patents Public Search or Espacenet — free, analyst time only — producing named patent numbers, each then run through the patent connector.

Selected from the FTO/IP row of the Scores table's "What would settle it" column; this is a selection from that gap analysis, not a new judgement and not a view about the idea. The previous selection is spent: the CMS cache files the Reimbursement and TAM rows were waiting on are now in data/, and this candidate was run against them on 2026-09-11 and again on 2026-09-29. Of what the column still names, this is the only free item that can produce a verified claim on a factor the kill conditions read — FTO is the one gate factor that has never been examined at all claim 11unconfirmed, claim 34unconfirmed — and the assignee sweeps now have named parties (Covidien/Medtronic, Haemoband Surgical, F Care Systems, per the Verified Composite's FTO/IP row). Nothing blocks it but the work: the connector's EPO OPS keys are set, and python3 -m connectors patent-scan --cpc A61B18/12 gives the field sweep. The Reimbursement row's remaining items are either licensed (an AMA CPT source, low hundreds of dollars, for the descriptor and unit rules) or have no connector (the NCCI edit-pair file; the GLOB DAYS column, see below), so neither would produce a verified tag. The other half of the viability deck's load-bearing condition — a contract-manufacturing quote against the applicator specification claim 65unconfirmed — is not in the Scores table and would move no factor, but it is the unsourced term in the subtraction the candidate says decides it claim 6unconfirmed.

Where the evidence actually stands. From wrap_status.py --candidate idea-008: 21 of 84 claims verified — 50 unconfirmed, 9 unverified, 4 refuted. Verified by evidence class: 1 registry fact, 20 unstamped. All 9 factors carry a score in the Stage 2 triage table and all 4 core factors do; that is the triage table, not verified coverage. The Verified Composite and Gate Check sections above were last recomputed 2026-08-29 and 2026-08-25 respectively, before any of the payment and volume claims below were verified, and they still read Reimbursement and TAM as blank. Claims 5, 58 and 74 each record that the Scorer must recompute against the verified numbers; until /rescore runs, the 3/9 and 1/4 counts in those sections describe the file as it stood a month ago.

What changed since the previous wrap, and it is mostly money. The previous version of this section said no payment level and no procedure volume had ever been verified here. That is no longer true:

  • The office payment is checked, and it is higher than the file assumed. Non-facility total 7.42 RVUs against facility 4.72 claim 58verified, which the Verifier's note on that line records as $249.07 non-facility against $158.44 facility — national unadjusted, no GPCI, PFS (physician fee schedule) only. The aggregator figure the file's economics were built on had the two settings swapped claim 5refuted — a correction in the candidate's favour — and every figure derived from the old ~$158 input, including the $40-60 kit ceiling claim 6unconfirmed, is computed off a wrong number.
  • The practice-expense share of that payment is $188.99, clearing a $60 per-use test value with $128.99 left claim 74verified. The $60 is the Verifier's test value taken from the candidate's own ceiling, not a sourced cost, and whether the $188.99 is free headroom or already spoken for by staff, supplies and room is open claim 80unverified.
  • Medicare fee-for-service volume across 46930, 46945 and 46946 is 8,090 services per the Verifier's note on claim 7verified, and 66% of Medicare FFS 46930 services are billed in the office claim 29verified. That is a floor on US volume, never a market size: it excludes Medicare Advantage, commercial, Medicaid, VA and cash-pay, and this disease skews younger than the Medicare population.
  • No published Medicare NCD (national coverage determination) or LCD (local coverage determination) names 46930 — the 2026-09-29 coverage re-run recorded on claim 74verified. The Verifier's reading is that this is a code-keyed index and **not a denial**.

The regulatory picture from earlier passes stands: every candidate regulation is verified Class II, a bipolar RF applicator for internal hemorrhoids has a four-clearance US history on the frontmatter's lead route claim 40verified, and every located bipolar/RF indication stops at grade II claim 42verified, claim 52verified, with the only grade-III-spanning predicate a 2003 device in another panel claim 53verified. The "no predicate, therefore possibly De Novo" premise is claim 46refuted. The clinical context is sourced but not verified: at grade III, rubber band ligation carried 47.5% 12-month recurrence against 6.1% for hemorrhoidectomy claim 59unconfirmed. Both stakeholder questions — whether proceduralists switch claim 63unconfirmed and whether patients accept an unsedated RF procedure claim 64unconfirmed — are adoption claims that no connector can settle.

Blocked on tooling, not on a finding. None of the following is evidence that something does not exist:

  • The 90-day global period claim 57unconfirmed, claim 2unconfirmed. The rvu connector reads the CMS PFS file but does not surface its global field, so this is a connector gap on a public, code-keyed source.
  • payment returning "refuted" for 46930, 46945 and 46946. The cached payment files are the CLFS (clinical laboratory fee schedule) and DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) schedules, and these codes are paid under the PFS. The Verifier records this as the wrong instrument, saying nothing either way; the payment figures above come from rvu.
  • CPT descriptors and unit rules claim 1unconfirmed, claim 3unconfirmed are AMA-licensed and permanently outside any connector. The NCCI bundling claim claim 4unconfirmed has no connector either; the CMS edit-pair file is public and would need a human download.
  • A specific recall claim 54unconfirmed cannot be confirmed because the recalls connector filters by product code and date range, not by recall ID.

Open for other reasons — not tooling, and not a finding either:

  • FTO / IP claim 11unconfirmed, claim 34unconfirmed. **Zero patents have been searched — no search has been run yet.** The patent connector runs on EPO OPS, and its keys are configured; a field sweep exists (python3 -m connectors patent-scan --cpc A61B18/12). The earlier record of an unset PatentsView key on these lines is history, not the current blocker. What is missing is the search itself: no patent number is named, so there is nothing yet to look up one by one. The field is unexamined, not clear, and "FTO blocked?" cannot be evaluated in either direction until the search above is run.
  • The De Novo route claim 14unconfirmed. An earlier defect in the denovo connector — substring matching, so any query containing "hemorrhoid" returned a spurious "Rho" row (DEN230023 (an FDA De Novo decision number)), recorded as history on claims 14 and 46 — was found and fixed on 2026-09-29; it now matches whole words, and denovo "hemorrhoid radiofrequency" returns a genuine no-match against the cached De Novo listing. That is a null about a device-name string, and the De Novo route itself is still not established either way. claim 14unconfirmed remains a cost and timeline estimate that no connector answers; the predicate evidence above bears on the pathway question more directly than the De Novo list can.

The asymmetry this packet should leave a Stage 6 reader with: the payment and regulatory terms are now checked against CMS and FDA records, and both read more favourably than the file first assumed; the cost of the kit, the behaviour of the people who would buy and receive it, and the patent field are unsourced, and the last of those is the gate's automatic-kill factor.

The nine factors why each scored what it did, and what would settle it
FactorScoreWhyWhat would settle it
Regulatory pathway2intended_use: is present, so this factor is scoreable. But frontmatter carries two candidate regulations in different FDA panels (878.4400, general/plastic surgery vs. an unidentified Part 876 GI-urology regulation), no product…
the rest of this reasoning code, and the predicate_or_analog field explicitly names no K-number. Rests only on the Generator's belief plus the descriptor claim (CPT 46930 names RF as an existing office modality), which is reimbursement evidence, not clearance evidence. Scored as "a 510(k) route is plausible and entirely unresolved", not as a known pathway.
openFDA regulation, classification, 510k, and clearance-summary lookups — confirm the 878.4400 text, recover the real product code, find a predicate K-number, and check its IFU. All free via the connectors; a few minutes of analyst…
the rest of this gap analysis time each.
Reimbursement pathway3Strongest factor on paper and the least connector-checkable. Rests on: 46930 descriptor claim (thermal destruction, RF named by example — i.e. the mechanism is already inside an existing code, no new code needed); 46945/46946 existence…
the rest of this reasoning claim; the 2026 fee-schedule claim (~$158 non-facility) sourced from two commercial aggregator sites; and two explicitly negative claims — CCI bundling of 46930 into 46945, and one-unit-per-session with a 90-day global. Not scored higher because the load-bearing number is the payment level, not code existence, and it currently comes from exactly the secondary sources this pipeline distrusts. Code existence alone would not be a pathway.
A licensed AMA CPT source (codebook or vendor feed — AMA CPT API, Optum EncoderPro, Find-A-Code; low hundreds of dollars) for the descriptor and unit rules; free public CMS payment, RVU (GLOB DAYS), NCCI edit-pair, and coverage/LCD files…
the rest of this gap analysis once loaded into data/.
TAM2No market number is claimed anywhere. All three TAM components are open: volume (Generator states no figure), per-kit price of $40-60 (derived from the unverified payment claim, not from market data), and a 15-25% five-year addressable…
the rest of this reasoning share (Generator's assumption). Scored at the floor because the only component that is genuinely checkable — procedure volume — is unchecked, and the other two are assumptions stacked on a third assumption.
Free CMS procedures lookups (46930/46945/46946) for volume, read as a Medicare-only floor; a licensed anorectal-devices market report (iData/Grand View-type, several thousand dollars) plus a practice-count denominator for price and…
the rest of this gap analysis addressable share.
FTO / IP1Rests on a single claim that states outright that no patent search was performed and names no patent, live or expired. The file itself records this as an unexamined gap. Scored as unexamined, not as open: an absence of found…
the rest of this reasoning patents is not freedom to operate, and the likely estates (existing office-device and ligation-system manufacturers, impedance-controlled RF generator IP) are precisely where a blocking claim would sit. This score reflects zero search, not a clean result.
A CPC A61B18/12 / A61B17/12 search plus assignee sweeps on incumbent manufacturers in Patents Public Search or Espacenet (free, analyst time only), then each named hit through the patent connector once a PatentsView API key is obtained.
Moat / defensibility1Rests on the moat claim, which the Generator itself labels weak and marks not connector-checkable: the RF generator is a commodity, office electrosurgical devices are widely copied, and the CPT code is open to any thermal modality, so…
the rest of this reasoning a fast-follower can bill the same code. The only asserted defensible assets are the impedance-dosimetry control algorithm, applicator geometry, and the consumable stream — and the first two are unprotected as long as FTO/IP is unexamined, so this score is capped by the row above.
Resolves as a by-product of the FTO/IP patent search above; a free clearances lookup by product code adds a read on how fast followers copy comparable devices.
Mechanism & clinical risk3Rests on the mechanism/clinical-risk claim plus the indication-scope rationale. Favourable: RF thermal destruction of hemorrhoidal tissue is an established modality already named in the 46930 descriptor, so the mechanism is not…
the rest of this reasoning novel-risky, and the failure modes are named honestly — recurrence at grade III, post-procedure pain and bleeding, and rare thermal injury to the sphincter complex or rectal wall — with impedance dosimetry and auto-cutoff proposed as the mitigation. Held at 3 because the premise is durability at grade III, which is unevidenced, and the mitigation itself is the thing that must be proven.
Free literature, trials, and recalls connector scans give leads only (no confidence tag); the differentiating claims are settled by a funded bench thermal-spread and animal sphincter-injury study at Stage 7.
Capital intensity & time-to-revenue3Rests on the capital/time claim: low-single-digit millions and 18-30 months for a 510(k) with bench dosimetry and animal thermal-spread data and no pivotal trial. Credited for correctly splitting the clearance spend from the separate,…
the rest of this reasoning later comparative-durability study needed to change referral behaviour — conflating them is how this class of candidate gets scored as cheaper than it is. Held at 3 rather than higher precisely because that second spend is real and unbudgeted, and because the 18-30 month figure assumes a predicate that has not been identified (see Factor 1) — no predicate means a De Novo, and a different calendar.
Depends on Factor 1's predicate/De Novo answer and the special controls it implies; the cost and calendar figures themselves need a Tier 3 human budget estimate, not a connector.
Competitive intensity1Rests on the competitive-intensity claim, which is a direct read of the descriptor claim: CPT 46930's own descriptor names three competing thermal modalities (infrared coagulation, cautery, radiofrequency) already in office use, plus…
the rest of this reasoning rubber-band ligation as the entrenched standard. So the candidate enters a mature category with cheap, amortised, already-owned incumbent instruments and must win on durability alone — against which the adoption assumption (switching from an owned instrument to a per-case disposable for an unproven benefit) is explicitly flagged as unresearched. Low score = high intensity = unfavourable.
Free clearances/recalls lookups once a product code is identified cover the competitor count; the switching half needs commissioned primary research (a proctology/colorectal practice survey), since adoption is unverifiable by design.
Strategic fit & portfolio balance2No claim in this file addresses portfolio fit, so this score is a shape judgement only, not evidence-backed. The candidate's shape is a cash-generative spoke rather than a hero bet: disposable consumable stream, no pivotal trial…
the rest of this reasoning required for clearance, modest capital. Weighing against it — weak moat, unexamined FTO, and a hard $40-60 COGS ceiling imposed by the payment claim, which makes it a thin-margin spoke if the aggregator payment figure is even slightly high. Scored conservatively because the portfolio it is supposed to fit is not defined anywhere in the repo.
A Tier 3 human portfolio statement at Stage 6 (## Human Review Notes); knowledge-base/calibration-log.md would supply the evidence base once populated. No connector cost — this is a human input.
Packet status all eight wrap criteria met

All eight wrap criteria are met.

Source file: knowledge-base/candidates/idea-008.md

Nothing on this page is a recommendation. Shortlist review, legal and clinical sign-off and capital allocation are human-only decisions, and no agent in this repo may make or simulate one. This is a compilation of what the candidate file says.

Words on this page25 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md
21 CFR
Title 21 of the Code of Federal Regulations — the US food-and-drug rulebook; a number after it is one regulation, often the one that classifies a device type
510(k)
premarket notification — the FDA route for a device shown to be as safe and effective as one already on the market; months, no clinical trial as a rule
Class II
FDA device class II — moderate-risk devices, usually cleared by 510(k)
CLFS
clinical laboratory fee schedule — the Medicare price list for laboratory tests
CMS
Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
COGS
cost of goods sold — what it costs to make one unit
CPT
Current Procedural Terminology — the US billing codes for what a clinician does; owned by the American Medical Association
De Novo
De Novo classification request — the FDA route for a new, lower-risk device with no comparable product to point at; longer than a 510(k), usually needs clinical data
DEN######
an FDA De Novo decision number — the public record of one device granted a De Novo
DMEPOS
durable medical equipment, prosthetics, orthotics and supplies — the Medicare benefit and fee schedule that home equipment is paid under
EPO
European Patent Office — the European patent office
FDA
US Food and Drug Administration — the US regulator that clears or approves a device before it can be sold
FFS
fee-for-service — the traditional form of Medicare that pays per item or service
FTO
freedom to operate — whether a product can be sold without infringing someone else's live patent
GI
gastroenterologist — a doctor specialising in the gut
IFU
instructions for use — the labelling that says what a device is for and how to use it
IP
intellectual property — patents and the other rights that let a company stop others copying it
K######
an FDA 510(k) clearance number — the public record of one cleared device; the letter K and six digits
LCD
local coverage determination — a Medicare contractor's rule, valid in its region, saying when something is covered
Medicare Advantage
Medicare Advantage — Medicare delivered through a private insurer; must cover at least what Medicare covers
NCD
national coverage determination — a Medicare rule, valid everywhere in the US, saying whether and when something is covered
PFS
physician fee schedule — the Medicare price list for what clinicians do
RF
radiofrequency — heating tissue with a radio-frequency electrical current
RVU
relative value unit — the unit Medicare uses to price a clinician's work
TAM
total addressable market — how much money the whole market would be worth if every possible buyer bought