idea-008 · viability deck
Every slide states a condition that would have to be true, then reports where it stands using the candidate file's own claim and its own confidence tag. A deck never upgrades a tag, invents a number, or recommends anything, and there is no ask slide.
The chair: the investor, and the operator who has to sell a console-plus-disposable into office practices whose price ceiling is set by somebody else's fee schedule.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-008.md. The number is the claim's position in its ## Claims list, and the tag is copied from that line and never adjusted here. A [no claim] marker means nothing in the file speaks to the condition at all. Where this deck needed a condition the file did not carry, it appended the condition to the file as an unverified claim before this deck was written. No number appears here that is not in a claim, and there is no ask slide. See docs/deck-spec.md.
What the 2026-09-29 Verifier pass changed for this chair: coverage was looked at for the first time. The cached coverage index has no NCD (national coverage determination) or LCD (local coverage determination) naming 46930. The file reads that as a code-keyed index result, not a denial. It is recorded inside the Verifier notes on claim 30unconfirmed and claim 74verified, and this deck has now put it on record as its own proposition claim 78unverified. The ligation comparators 46945 and 46946 do sit under a Medicare billing-and-coding article, A53006 "Hemorrhoid Artery Ligation" claim 79unverified. The payment connector reads the wrong schedules for these codes, so its "no row" result says nothing either way. The rate still rests on rvu claim 58verified. The 90-day global period is still a connector gap claim 57unconfirmed. And the hemorrhoid clearance scan is now claim 47unconfirmed, not unverified. Rebuilt from the file, not patched.
Would have to be true: Medicare Part B (Medicare Part B), and commercial payers at a comparable rate, would have to pay the physician a fixed non-facility amount for 46930. The practice buys the kit out of its own operating budget inside that amount. So the company's customer is the practice, and its price ceiling is whatever the practice-expense share can give up.
Where it stands: The Medicare rate is checked. Non-facility total RVU (relative value unit) is 7.42 against 4.72 facility, so the office is the higher-paying setting claim 58verified. The payment is $249.07 non-facility and $158.44 facility, which reverses the file's original secondary-source figures, so that line is refuted claim 5refuted. Of the $249.07, $188.99 is practice expense claim 74verified. The sceptic's question on this slide is whether that $188.99 is headroom at all, or whether CMS (Centers for Medicare & Medicaid Services) has already allocated it to the staff time, supplies and equipment an office session uses. That is this deck's write-back claim 80unverified. The file's own claim 74verified treats the remainder after a $60 test cost as left over "for staff time, room and margin", which is the same question from the other side. Commercial rates are structurally unreachable by any connector here claim 30unconfirmed, and they matter because this disease skews younger than Medicare.
What would settle it: The CMS direct practice-expense input file for 46930 in the non-facility setting. It is public and code-keyed, but no connector reads it, so this is a Scout download and a human read claim 80unverified. After that, licensed commercial-rate data for the half no connector will reach.
If it's false: If the practice-expense share is already consumed by the session itself, the kit comes out of the physician's margin rather than out of headroom. The ceiling the design was sized to then shrinks again, whatever the gross rate says, and Factor 2's verified rate stops being evidence of room for a device.
Would have to be true: Three things would all have to land. 46930 has to exist with a descriptor that covers RF (radiofrequency) destruction. It has to pay at the checked rate. And no coverage policy can restrict it by modality or grade. Beside those, the billing rules would have to make recurrence the physician's cost rather than a second payment.
Where it stands:
unconfirmed for the pipeline, because the descriptor is
AMA-licensed, and the "RF is already inside the code" premise rests on it
claim 1unconfirmed. The ligation code descriptors are in the same position
claim 3unconfirmed.
What would settle it: A Verifier pass on claim 78unverified and claim 79unverified, since both are cached lookups. A global field added to the rvu connector, or a human read of the cached file, for claim 57unconfirmed. The NCCI PTP edit-pair file for bundling. A licensed AMA source for the descriptor and unit rules.
If it's false: If re-treatment inside 90 days were separately billable, recurrence would cost the physician nothing, and the durability argument this business is built on would lose its payer-side mechanism. If a contractor wrote a policy limiting 46930 by modality or grade, the grade III premise would meet a payment wall as well as a regulatory one.
Would have to be true: Enough office 46930 sessions, each consuming exactly one kit, at a kit price the practice economics allow, in a reachable share of practices, each large enough to pay back a placed console.
Where it stands:
What would settle it: A connector field for services per rendering provider from the already-cached utilisation file, which is the cheapest route to claim 67unconfirmed. Then a licensed market report plus a proctology and colorectal practice-count denominator for share.
If it's false: TAM (total addressable market) below floor is a hard kill under the rubric. It still cannot be evaluated in either direction, because two of the three legs carry nothing verified.
Would have to be true: A 510(k) (premarket notification) with bench dosimetry and animal thermal-spread data and no pivotal trial would have to be the whole regulatory bill, grade III included. After clearance, the channel build and the lag to the first paid consumable order would have to fit inside a normal launch runway.
Where it stands: The predicate position is verified and good up to its edge. The modality has a four-clearance history under GEI claim 40verified, a predicate with checked Indications for Use exists claim 20verified, and the no-predicate-so-De-Novo premise is claim 46refuted. The edge is grade III claim 42verified, claim 51unconfirmed. The newly cached De Novo (De Novo classification request) list cannot answer the fork, because its hemorrhoid queries collide with an unrelated row claim 14unconfirmed. Every money and calendar figure is unbenchmarked: clearance cost and 18-30 months claim 14unconfirmed, channel build claim 70unconfirmed, sales-cycle lag claim 69unconfirmed, and a durability study the file deliberately keeps outside the clearance budget claim 72unconfirmed.
What would settle it: An FDA (US Food and Drug Administration) pre-submission on the grade III indication, a human act and the only thing that answers claim 51unconfirmed. The cost and calendar lines need a Tier 3 human budget estimate. No connector reaches them.
If it's false: If grade III forces a clinical study before clearance, the durability study moves onto the critical path. It then gets paid for before first revenue rather than after, and Factor 7 changes category.
Would have to be true: The dosimetry algorithm and the applicator geometry would have to be protectable. The consumable stream would have to survive a strategic that already owns a cleared bipolar hemorrhoid line and can bill the same open code.
Where it stands: FTO (freedom to operate) has never been examined claim 11unconfirmed, claim 34unconfirmed. Zero patents searched, on the rubric's one automatic-kill factor. The moat assets are asserted only, and the Generator itself calls the moat weak claim 10unconfirmed. The field they would have to be defended against is mostly verified: a bipolar RF hemorrhoid line with a four-clearance history claim 40verified, whose most recent clearance is Covidien's claim 41unconfirmed, a single-use anoscope cleared through grade III claim 55verified, and rubber band ligation as a separate, 510(k)-exempt class claim 56verified. An alternative supply route, licensing the dosimetry module into an already-cleared applicator, turns on a verified test claim 75verified that nobody has applied claim 71unconfirmed.
What would settle it: A CPC A61B18/12 and A61B17/12 search plus assignee sweeps on the named parties, run by a human, with each hit through the patent connector. Even then a verified record is a fact about dates, and FTO is a Tier 3 legal opinion at Stage 7.
If it's false: FTO blocked is an automatic kill. If FTO is clear but the moat is not, the first grade III clearance in this category is a template a strategic can follow on the same code claim 13unconfirmed.
Would have to be true: No incumbent would be one indication extension away from grade III. The incumbent modality would also have to stay short of surgical durability without new hardware.
Where it stands: Grade III is the only ground no verified RF record occupies claim 42verified, claim 52verified. Whether that line is still actively sold claim 49unconfirmed, and whether anyone is extending it to grade III claim 50unconfirmed, are both unchecked. The incumbent technique is improving: modified ligation reported 5.4% against 13.6% 3-month recurrence claim 62unconfirmed. The ligator code now visibly includes a Doppler-guided hemorrhoidal artery ligation system, surfaced by a scan claim 47unconfirmed. The ligation codes carry their own Medicare billing guidance claim 79unverified.
What would settle it: Trade sources and distributor catalogues for claim 49unconfirmed, and company disclosures plus scheduled clearances re-runs for claim 50unconfirmed. Query by indication, never by device name. The file paid for that rule with a false negative.
If it's false: Factor 8 is scored so that low means high intensity. A busier field moves it down. If an incumbent reaches grade III first, or ligation technique closes the gap, the one unoccupied band closes and Slide 5 has nothing left to protect.
Would have to be true: Three cached-file reads, one contract-manufacturing quote and one assignee patent sweep would have to be enough to turn the money question from an assumption inventory into a subtraction with both terms measured.
Where it stands: The payment, coverage, HCPCS (Healthcare Common Procedure Coding System), De Novo, RVU and utilisation caches the earlier passes were blocked on are now present, and the file records 2026-09-29 lookups against them. The NCCI edit-pair file never was cached claim 4unconfirmed. What remains is connector gaps on files already on disk. The global field claim 57unconfirmed and services per provider claim 67unconfirmed are both in cached files that no connector surfaces. The direct practice-expense inputs are the one new download claim 80unverified. The quote is the most neglected item across every build of this candidate's decks, and it involves no outside party claim 65unconfirmed. The patent sweep is still undone claim 11unconfirmed.
What would settle it: In order of cost: Verifier passes on claim 78unverified and claim 79unverified (cached, free); two small connector fields (free, engineering time); the direct-PE input file (free, a download); a manufacturing quote (internal); assignee sweeps (a day plus a key); licensed AMA and commercial-rate sources (paid).
If it's false: This slide is a work order. If those reads leave the subtraction open, the remaining gap is the physician's decision, which the desirability deck carries.
Every condition above with nothing verified behind it. After write-back almost every line has a claim number. The measure is how much rests on unconfirmed and unverified.
Four verified claims in the file are about money: the RVU split claim 58verified, the practice-expense share claim 74verified, Medicare volume claim 7verified and the site-of-service split claim 29verified. The other seventeen are regulatory-database facts. No kit cost, kit price, share, coverage policy or patent has ever been verified here.
If only one thing from this chair could be checked: what a dosimetry-bearing disposable actually costs to land claim 32unconfirmed, claim 65unconfirmed. This build puts a second question beside it: how much of the $188.99 practice-expense share is actually free to pay for it claim 74verified, claim 80unverified.
The previous build named the cost alone. The 2026-09-29 pass does not change that the cost has no source. What this rebuild adds is that the other term is less settled than "$249.07, checked" makes it look. The verified number is a gross payment and its practice-expense split. It is not a measure of what is left once the session's own staff, supplies and room are paid for, and the file's only statement of the remainder uses a $60 test value, not a cost. So the subtraction the candidate says decides it claim 6unconfirmed has one unsourced term and one term whose usable size is open.
Everything else on this deck is downstream of that subtraction. Kit price claim 8unconfirmed cannot be restated until it is done. Whether the physician switches claim 15unconfirmed, claim 63unconfirmed depends on it. The favourable facts around it are real and sourced: the office pays more claim 58verified, the global period puts recurrence on the physician claim 57unconfirmed, and the grade III gap is measured claim 59unconfirmed. They make the subtraction worth doing. They do not do it.
Naming it is not a recommendation, a gate, or a kill.
_shared/plain-language.md