idea-001 · 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 would have to run this as a business. Under P2 the discriminating trigger the product is an intravaginal stimulator whose trigger adds an abdominal reference electrode the woman places herself each session, sold into the same E0740 (a HCPCS code for durable medical equipment) rental channel as the incumbents. P1 commercially-insured first's payer route (commercially insured first, Medicare later) is unchanged.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-001.md. The number is the claim's position in that file's ## Claims list. The tag beside it is copied from that line exactly as it stands today, never softened and never upgraded. A bracketed "no claim" marker means nothing in the file speaks to the condition. No number appears here that is not in a claim, and there is no ask slide. See docs/deck-spec.md.
Rebuilt 2026-10-01 from the candidate file after pivot P2 the discriminating trigger. The earlier 2026-10-01 build is retired, not amended. Its load-bearing condition was whether any prescription device is sold in the US with an EMG (electromyography)-triggered stimulation mode for incontinence. That question is answered: one is listed and offered for sale claim 167refuted. The candidate's mechanism: now names a trigger that fires on a voluntary pelvic floor contraction "and is withheld when the detector sees a Valsalva manoeuvre or abdominal brace before the burst". This deck describes the trigger at that level and no further. It put two new conditions on record today as claims 213 and 214.
Would have to be true: Under P1 commercially-insured first the launch payer would have to be a commercial health plan, paying from its durable medical equipment benefit for a home-dispensed stimulator billed as E0740 or its commercial equivalent. Later, Medicare Part B (Medicare Part B)'s DME (durable medical equipment) benefit would have to pay, for fee-for-service and Medicare Advantage (Medicare Advantage) enrollees alike. In every case the money would come out of a DME benefit, not out of a practice's budget or the woman's wallet.
Where it stands: The Medicare budget line is established for the device class. The commercial one, which P1 commercially-insured first launches on, is not.
What would settle it: A human pull of named commercial medical policies and DME benefit terms from the largest plans. No connector reaches commercial policy.
If it's false: If commercial plans do not pay through a DME benefit, P1 commercially-insured first's launch route has no payer, and the opportunity falls back to Medicare alone. That is the option to unwind P1 commercially-insured first, which is a human's call. Factor 2.
Would have to be true: A code, a payment amount and a coverage policy would each have to exist. On top of those, this system, with its abdominal reference electrode, would have to code to that code as one complete system. Finally, the electrodes it consumes every session would have to be paid for somewhere.
Where it stands:
What would settle it: A PDAC coding-verification submission for the P2 the discriminating trigger system, which is the only thing that produces a determination. Then a human read of the DME MAC (durable medical equipment Medicare administrative contractor) policy article on whether A4595 (a HCPCS code for a supply) or A4556 may be billed with an E0740 rental. No connector reaches the PDAC or MAC (Medicare administrative contractor) articles.
If it's false: If the reference channel is coded E0746, part of the system has no fee schedule amount. If the system goes to E1399, it is individually priced and the verified rate stops applying. If the electrodes ride inside the rental, every session's consumables come out of a fixed monthly amount (Slide 3). All three land on Factor 2.
Would have to be true: Four factors, each its own condition. A population of women at the label's moment. A rate at which they are dispensed a device. A price per woman that survives the supplier's margin and the per-session electrodes. And a reachable share.
Where it stands:
What would settle it: Population and rate: a human-attached insurance-mix and care-pathway source. Price: the PDAC outcome (Slide 2), the MyOnyx price from a primary source, and a supplier wholesale quote. Share: no source settles a modelling choice.
If it's false: The verified quantities on this slide are a floor and a fixed monthly price. Everything that would turn them into a market size rests on unconfirmed lines. Factor 3.
Would have to be true: Before anyone can bill, the following would have to fit a budget and a calendar a backer accepts: a 510(k) (premarket notification) under KPI cleared without clinical data, bench and electrical verification of the withhold logic, usability work on the self-placed electrode, software and cybersecurity documentation, and PDAC coding verification. No claim in the file carries a dollar figure for that sequence that anyone has checked.
Where it stands:
What would settle it: FDA (US Food and Drug Administration)'s MDUFA performance reports for KPI decision times, a quoted bill of materials, and an FDA pre-submission on the reference channel. Each is a human-attached input or a company act.
If it's false: Factor 7. If clinical data are required after all, the calendar on this slide is a different calendar.
Would have to be true: The withhold logic would have to be new, protectable, and not copyable by a firmware change. Concretely: no patent or prior publication discloses it, and an incumbent whose cleared triggered device already has two EMG channels could not add the same withhold without a new 510(k).
Where it stands: Nothing behind the moat is established, and the one verified fact on this slide cuts against it.
What would settle it: Counsel's landscape and full-text read on the withhold logic, including the two Chinese leads. An FDA pre-submission or a regulatory read of the change guidance for claim 213unverified. Both are human work, and the novelty question is Stage 7 counsel's.
If it's false: The moat is first-mover only, and any incumbent can follow at firmware cost. Factor 5, and Factor 4 if a prior disclosure turns up.
Would have to be true: The cleared, sold EMG-triggered devices would have to trigger on pelvic floor EMG alone, with no abdominal or pressure reference that withholds stimulation. Otherwise P2 the discriminating trigger is a me-too of a product already on sale. Separately, a DME supplier would have to add this device alongside or in place of them.
Where it stands:
What would settle it: A human read of the MyOnyx and NeuroTrac MyoPlus Pro user manuals for how the trigger decides to fire. No connector reaches manufacturer labelling. For suppliers, calls to some of the 28 that billed E0740 in 2024 claim 70verified.
If it's false: If an incumbent already withholds on a reference channel, P2 the discriminating trigger has no product difference. Slide 5 becomes moot, and the supplier has no reason to switch. Factor 8.
Would have to be true: Two cheap reads would have to come back in P2 the discriminating trigger's favour. First, the incumbents' labelling would have to show a single-channel trigger. Second, a supplier would have to say it pays a wholesale price that covers the per-session reference electrodes, although Medicare allows nothing more for them.
Where it stands: Neither has been done. The labelling read is claim 173unconfirmed. The supplier's willingness is claim 214unverified, put on record by this deck today, beside the assumption that wholesale sits below the allowed amount claim 122unconfirmed. The fixed allowable it would have to fit under is verified claim 193verified.
What would settle it: The two manuals, which are a human read of documents that already exist. Then a handful of supplier conversations. Neither needs a prototype.
If it's false: A two-channel incumbent ends the differentiation story (Slide 6). A supplier unwilling to absorb the electrodes puts the consumable cost on the manufacturer's margin, which no claim in the file sizes (Slide 3).
Every condition above has nothing verified behind it. Verified claims appear on Slides 1, 2, 3, 5 and 6, and each establishes the class's setting: the code, the fixed monthly allowable, the coverage duty, the Medicare floor, and the fact that the field is occupied. None of them says this system codes, gets paid, or is different. Two of them, the fixed allowable and the existing second EMG channel, cut against the conditions they sit beside.
If only one thing from this chair could be checked: whether any of the cleared, sold EMG-triggered stimulators for incontinence already uses an abdominal or other reference channel in deciding when to fire. The MyOnyx in particular matters, because its app can run two EMG channels claim 173unconfirmed.
Why this one: this deck's previous load-bearing question was whether a triggered device is sold. It was answered against the old shape claim 167refuted, and P2 the discriminating trigger is the response. Every other money question on this deck (coding, the electrode cost, the moat, the supplier's reason to switch) assumes there is a product difference to price. If the incumbent already has it, those questions describe a me-too, and the fixed allowable claim 193verified leaves nothing to differentiate on. The check is also the cheapest on the deck: two manuals that already exist. The demand half of the same question, whether a prescriber wants the difference, is the desirability deck's load-bearing condition claim 174unconfirmed.
Naming it is not a recommendation, a gate, or a kill.
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