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, the tag is copied from it and never adjusted here. A [no claim] marker means nothing in the file speaks to the condition at all. No number appears here that is not in a claim, and there is no ask slide. See docs/deck-spec.md.
What changed since the 2026-08-25 build: two of the billing rules this deck called decisive now have sources — the 90-day global period [claim 57: unconfirmed] and the non-facility versus facility RVU split [claim 58: unconfirmed] — and both point the candidate's way. The clinical gap the business case rests on is measured [claim 59: unconfirmed], [claim 60: unconfirmed]. Rebuilt from the file, not patched.
Would have to be true: The payer pays the physician a fixed amount for the procedure, and the practice buys the kit out of that amount. The company's customer is the practice; its price ceiling is set by somebody else's fee schedule.
Where it stands: The structure is unchanged and the ceiling is now better located. Under the CY2026 PFS the non-facility total RVU for 46930 is 7.42 against a facility total of 4.72 [claim 58: unconfirmed] — the office setting pays more, which is the direction this candidate needs and the opposite of what a reader might assume. The payment amount itself is still known only through secondary reporting [claim 5: unconfirmed] and the decisive subtraction remains untested [claim 6: unconfirmed]. Commercial rates stay structurally unreachable here [claim 30: unconfirmed], and they matter because this disease skews younger than Medicare.
What would settle it: A human attaching data/hcpcs_payment_rates.csv and data/medicare_procedure_volumes.csv for the rate and the place-of-service split — noting that those caches existed on 2026-08-30 and this candidate was never re-run against them; then licensed commercial-rate data for the half no connector will ever reach.
If it's false: The price ceiling moves, and with it the entire product specification. This is the rare candidate where a reimbursement number is a design input rather than a consequence, so Factor 2 being unmeasured is not a scoring inconvenience — it means the spec has never been anchored.
Would have to be true: Code existence, payment amount and coverage policy would all three have to land — and on this candidate the billing rules matter as much as the money.
Where it stands: The most load-bearing rule now has a source. Under the CY2026 PFS, 46930, 46945 and 46946 each carry a 90-day global surgical period [claim 57: unconfirmed] — so re-treatment inside three months is not separately payable, and recurrence lands on the physician's own P&L. The last build named that as the rule whose inversion would "dissolve the durability pitch this business is built on"; the sourced reading is the favourable one. Still open: the descriptor and unit-of-service rules [claim 1: unconfirmed], [claim 2: unconfirmed], the CCI bundling relationship [claim 4: unconfirmed], and the payment amount against primary files [claim 5: unconfirmed].
What would settle it: The CMS PFS Relative Value File (including the GLOB DAYS column, to confirm [claim 57: unconfirmed] against primary rather than dossier-sourced data) and the NCCI PTP quarterly edit-pair file, both public; a licensed AMA source for the descriptors. One Scout task and one licence purchase.
If it's false: Factor 2 stays blank, and a single wrong rule inverts the physician's incentive. That risk is materially smaller than it was a week ago.
Would have to be true: Enough office procedures, at a kit price the payment allows, among a reachable share of practices.
Where it stands: All three components remain unmeasured [claim 7: unconfirmed], [claim 8: unconfirmed], [claim 9: unconfirmed], and the site-of-service assumption underneath them [claim 29: unconfirmed] is now better supported by the RVU split [claim 58: unconfirmed]. The volume leg is a free CMS cache re-run away.
What would settle it: The CMS procedure-volume cache for the one leg that is free; a contract-manufacturing quote against the applicator spec for the cost side that the economic claim never tests [claim 32: unconfirmed]; a licensed industry report and a proctology/colorectal practice-count denominator for the rest.
If it's false: TAM below floor is a hard kill condition under the rubric — but it cannot currently be evaluated in either direction, and the file says so. The risk on this slide is not a small market; it is a gate that has nothing to read.
Would have to be true: A 510(k) against an existing office thermal device, with bench dosimetry and animal thermal-spread data and no pivotal trial, would have to be the whole regulatory bill — and the grade III half of the indication would have to come with it.
Where it stands: The predicate position is the best-evidenced in the knowledge base and it improved again: the modality has a four-clearance US history under GEI [claim 40: verified], the codes and panels are re-established independently [claim 45: verified], a predicate with a checked Indications for Use exists where the file once said none had been identified [claim 20: verified], and the "no predicate, therefore possibly De Novo" premise is [claim 46: refuted]. What that leaves is the grade III question [claim 51: unconfirmed], and the verified boundary around it is sharp: every located bipolar/RF IFU stops at grade II [claim 42: verified], [claim 52: verified], with the only grade-III-spanning predicate being a 2003 device in another panel [claim 53: verified]. Capital and calendar remain unbenchmarked [claim 14: unconfirmed].
What would settle it: An FDA pre-submission putting the grade III indication and the predicate strategy in front of the review division — the only thing that answers [claim 51: unconfirmed], and a human act rather than a lookup.
If it's false: If grade III forces a De Novo or a clinical study, Factor 7 changes category — the durability trial the file deliberately holds outside the clearance budget [claim 14: unconfirmed] moves onto the critical path and gets paid for before first revenue.
Would have to be true: The dosimetry algorithm, the applicator geometry and the consumable stream would have to hold, in a category whose incumbents are cheap, established and — verified — include a strategic.
Where it stands: FTO has never been examined [claim 11: unconfirmed], [claim 34: unconfirmed] — zero patents searched, unexamined rather than clear, on the rubric's one automatic-kill factor. The moat assets are asserted only [claim 10: unconfirmed], and the field around them is now well characterised: a strategic-owned bipolar RF hemorrhoid line with three clearances [claim 40: verified], [claim 52: verified], an already-cleared single-use anoscope spanning grade III [claim 44: verified], [claim 55: verified], and rubber band ligation as a separately regulated established class [claim 56: verified].
What would settle it: A CPC A61B18/12 and A61B17/12 search plus assignee sweeps on those named parties, run by a human, producing numbers that then go through the patent connector — and even a verified result there is a database fact about filing and grant dates, not an FTO opinion, which is a Tier 3 legal question at Stage 7.
If it's false: FTO blocked is an automatic kill under the rubric. It currently cannot be evaluated in either direction, which is the single most consequential blank on this deck: the defensible asset is a control algorithm inside a disposable, sold into a category with cheap established modalities [claim 13: unconfirmed].
Would have to be true: The office thermal category would have to be beatable on durability at grade III — because it cannot be beaten on price, on novelty, or on being first.
Where it stands: Grade III remains the only verifiably unoccupied ground [claim 42: verified], and the clinical case for attacking it is now documented: ligation recurs at 47.5% at 12 months against 6.1% for hemorrhoidectomy [claim 59: unconfirmed], and within office ligation the grade III rate more than doubles the grade I-II rate [claim 60: unconfirmed]. The complication that belongs beside it is that the incumbent modality is improving without new hardware: a modified ligation technique reported 3-month recurrence of 5.4% against 13.6%, and eliminated delayed massive bleeding, 0 of 149 cases against 5 of 125 [claim 62: unconfirmed]. Whether the incumbent device line is actively marketed [claim 49: unconfirmed] and whether anyone is extending it to grade III [claim 50: unconfirmed] both remain unchecked.
What would settle it: Trade sources and distributor catalogues for whether the HET Bipolar line is marketed; clearances --product-code GEI re-run on a schedule, plus company disclosures, for the extension question. Note the reading rule the file paid for: query by indication, never by device name.
If it's false: Factor 8 measures competitive intensity where low means high intensity and is unfavourable — a busier field moves the row down, not up. If the incumbent extends to grade III first, or if modified ligation closes the recurrence gap [claim 62: unconfirmed], the only unoccupied ground on this slide closes and the moat question on Slide 5 has nothing left to protect.
Would have to be true: Two CMS cache re-runs, one contract-manufacturing quote and one assignee patent sweep would have to move this from an assumption inventory to a business case.
Where it stands: The list is unchanged and one item is now cheaper than described: the CMS caches were populated on 2026-08-30 and used to resolve nine claims on idea-001 that day, and this candidate was never re-run against them — so the ten unconfirmed results here that name a missing local cache are waiting on a scheduled pass, not on a download. The quote remains the most neglected item across three builds of this deck, and it is the half of the decisive subtraction that involves no external party at all.
What would settle it: In order of cost: restore the CMS caches and re-run (free), the NCCI edit file (free), a manufacturing quote (cheap, entirely internal), assignee patent sweeps (a day plus credentials), then the licensed AMA and commercial-rate sources (paid).
If it's false: Nothing on this slide is false — it is a work order, and its most neglected item is still a quote rather than a lookup.
Every condition above with nothing verified behind it.
Sixteen verified claims, and every one is a regulatory-database fact — class, code, panel, regulation, or somebody else's cleared indication. Not one of them is about money. No payment level, no coverage policy, no procedure volume, no price, no share, no patent has ever been verified on this candidate. What the week added was sourced but unverifiable: dataset and literature scans that cannot acquire a tag.
If only one thing from this chair could be checked: the actual non-facility payment for the procedure and the actual cost of a dosimetry-bearing disposable — the two halves of the subtraction the candidate itself says decides it [claim 6: unconfirmed], [claim 32: unconfirmed].
Everything else on this deck is downstream of that subtraction. It sets the kit price [claim 8: unconfirmed], which with volume [claim 7: unconfirmed] sets the market, and it decides whether the physician's switch [claim 15: unconfirmed], [claim 63: unconfirmed] is even arguable. The candidate's own title concedes the product was specified around that number — which means if the number is wrong, this is the wrong device, not merely a mispriced one. One half is a CMS cache re-run against files that already existed; the other is a quote from a contract manufacturer that three builds of this deck have now asked for.
What the week changed is the surrounding case, and it improved on both sides of the subtraction. The office is the higher-paying setting [claim 58: unconfirmed]. The 90-day global period means recurrence is the physician's cost rather than a second payment [claim 57: unconfirmed], which is the mechanism that makes durability worth paying for. And the durability gap is measured at grade III [claim 59: unconfirmed], [claim 60: unconfirmed] — on the one band no verified record shows already occupied [claim 42: verified].
So the framing for this chair has sharpened rather than moved: the economics are worth measuring because the grade III gap is now documented and the incentive structure now favours a durable device — and a favourable subtraction on grade I-II ground would still be a subtraction about a market someone else was cleared into in 2012 [claim 40: verified].
Naming it is not a recommendation, a gate, or a kill.