idea-001 · human · wrapped
Read this before anything else on the page. A low count here is usually a
statement about this repo's tooling rather than about the idea — a
unconfirmed reimbursement claim most often means the CMS cache file
is absent and nothing was searched, which is not evidence that a code
does not exist.
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 prescription home device for women with stress urinary incontinence who have already tried pelvic floor exercises and not got better. It is a small probe used internally, at home, that stimulates the pelvic floor muscles electrically while simultaneously reading their electrical activity, so it can time the stimulation to what the muscle is doing rather than running on a fixed programme. A paired phone app shows the woman whether her muscles are responding and sends her usage and progress to the clinician who prescribed it. It is aimed at Medicare's existing code for this device class, E0740, with a second intended revenue line from the clinician billing for reviewing the data remotely.
What would have to be true, quoted from each deck's load-bearing condition:
Cheapest next test: A human resolves the NCD 230.8 cache-linkage ambiguity — either a codes-linked coverage cache or a manually-pulled NCD 230.8 PDF — which the file's own Highest-yield unblock section names as "the one item that could move Reimbursement well above 1/5 without any new connector", and which this repo cannot do itself because CMS returns HTTP 403 on the fetch path. Selected from the Reimbursement row of the Scores table and the Gate Check's unblock ordering; this is a selection from that gap analysis, not a new judgement, and not a view about the idea.
Where the evidence actually stands. 7 of 45 claims verified, 3 refuted, 35 unconfirmed. Two coverage numbers are reported here and they are not the same number: all 9 factors carry a score in the Stage 2 triage table and all 4 core factors do, but only 2 of 9 factors carry a verified-context score in the Verified Composite, which is the figure to read first.
This candidate is unusual in the portfolio in that its cheapest next test was actually spent. The CMS caches were loaded on 2026-08-30 and closed 5 of the 7 claims they were expected to close — 2 verified, 3 refuted. That is why the composite fell while factor coverage widened, and it is the honest shape of the result: the code exists and its descriptor matches the device [claim 7: verified], a DMEPOS rate is published [claim 10: verified], and against that, no coverage policy in the cached file names the code [claim 9: refuted] and both Medicare volume thresholds the TAM asserted came in well under what was claimed [claim 16: refuted], [claim 17: refuted].
Three things a reader should not misread. First, [claim 9: refuted] is a risk signal, not a denial: the Verifier found the NCD 230.8 row present in the same cache with a blank codes column, one of 356 of 646 rows with that field empty, so the refutation may be a cache-linkage gap rather than a finding about CMS policy — that ambiguity is exactly what the cheapest next test resolves. Second, the two refuted TAM claims refute the asserted thresholds, not the existence of the market; 28,093 allowed services and 4,130 allowed units are real, sourced, Medicare fee-for-service floors that exclude Medicare Advantage, commercial, Medicaid and cash-pay. Third, FTO is unexamined rather than clear: no patent search has ever run, the patent connector cannot perform discovery, and EPO_OPS_KEY/EPO_OPS_SECRET are unset — on the rubric's one automatic-kill factor. The five CPT-dependent claims are a separate class again: they are unverifiable by design, because AMA licensing prevents this repo from reproducing the descriptors, and no amount of connector work will ever move them.
| Intended use | The device is indicated for the treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic muscle exercise training. |
|---|---|
| Mechanism | Intravaginal probe delivering neuromuscular electrical stimulation (NMES) to the pelvic floor with concurrent surface-EMG sensing for closed-loop biofeedback; adherence and EMG-trend data transmitted from a paired app to the prescribing clinician |
| Device class | # One route, plus the one it is carved away from — the second; Class II — 21 CFR 876.5320 (product code KPI, "Stimulator, Electrical, Non-Implantable,; For Incontinence") — 510(k). Verified against the eCFR text, not only the openFDA; classification record.; Class III / PMA — 21 CFR 884.5940 ("powered vaginal muscle stimulator for therapeutic; use") — NOT live under the current intended_use. 876.5320 excludes 884.5940 devices, and; 884.5940 is scoped to sexual dysfunction and states it "does not include devices used to; treat urinary incontinence". The PMA route is carved away BY INDICATION; broadening the; indication beyond continence reopens it. |
| Predicate or analog | KPI / 21 CFR 876.5320 pool (intravaginal, non-implanted): InControl Medical; InToneMV (K133826) and InTone (K150180); Zynex InWave (K121820). ELITONE; (K183585) and ELITONE URGE (K223884) are NOT in this pool — both are product; code QAJ, regulation 876.5330 ("Cutaneous Electrode Stimulator For Urinary; Incontinence"), i.e. transcutaneous skin-electrode devices under a different; regulation from this candidate's claimed code. They are cited as adjacent; market analogs only, never as predicates. Corrected 2026-08-23 from a; web-search grouping that placed all four under KPI (backlog 3.1) |
| Launch jurisdiction | US |
| Target | human |
| Factor | Score | What would settle it |
|---|---|---|
| Regulatory pathway | 4 | classification --product-code KPI (class + regulation number); 510k "InTone" --applicant "InControl Medical", 510k "ELITONE" to confirm K133826 / K183585 / K223884 exist and their cleared indications; eCFR 21 CFR 876.5320 text for…the rest of this gap analysisthe regulation number. Residual after all four: whether the closed-loop EMG-gating element stays inside KPI or triggers a second product code — an FDA pre-submission question, not a database lookup |
| Reimbursement pathway | 4 | Leg A: hcpcs E0740 --expect "pelvic floor"; coverage E0740 --expect-stance covered (NCD 230.8 stance); payment E0740 — required before this is a pathway rather than a code, since a code paying below COGS is not reimbursement;…the rest of this gap analysiscurrent PDAC coding verification decision list, ideally a PDAC coding verification request on this device. Leg B: no connector, ever. Needs a human-attached licensed AMA CPT 2026 descriptor for 98977 and the CMS RTM billing FAQ / PFS final rule commentary on whether pelvic floor qualifies as musculoskeletal for RTM device supply |
| TAM | 3 | C1: procedures 90912 --expect-volume 200000 against a human-loaded CMS Part B National/Physician-Supplier Procedure Summary file (volume-by-code is checkable even though the CPT descriptor is not). C2: `procedures E0740 --expect-volume…the rest of this gap analysis10000 against CMS DMEPOS utilization (Medicare Provider Utilization & Payment Data: DMEPOS PUF) loaded into data/medicare_procedure_volumes.csv. C3: no connector — payment E0740 plus a human-attached competitor price benchmark (InControl / Elitone published cash or contracted pricing). C4: no source can settle it; carry it as an assumption, with a human-attached count of US pelvic floor PT practices/visits as the closest defensible substitute. Prevalence: a pulled NHANES/NHIS citation via literature` search plus human read |
| FTO / IP | 1 | No connector call is possible yet — patent <number> needs a number and there is none. The prerequisite is a search, not a verification: USPTO Patent Public Search / Google Patents over CPC A61N1/36007 and A61N1/372 (electrical…the rest of this gap analysisstimulation, incontinence) and A61B5/389 (EMG); assignees InControl Medical, Zynex, Laborie/Uroplasty, Atlantic Therapeutics; restricted to claims live past ~2030. That search yields candidate numbers, each then run throughpatent <number> for status and expiry. Full settlement is a counsel-drafted FTO memo at Stage 7 |
| Moat / defensibility | 2 | No connector settles a moat. Concretely: (a) the FTO search above run offensively — whether this closed-loop EMG-gating is patentable is the difference between a 2 and a 4; (b) clearances --product-code KPI over a trailing 3-5 year…the rest of this gap analysiswindow to measure the real fast-follower rate; (c) human-attached evidence that payers require the longitudinal documentation this dataset produces (a named MAC LCD or commercial policy with documentation requirements), which is what turns the dataset into a switching cost |
| Mechanism & clinical risk | 4 | literature "pelvic floor electrical stimulation stress urinary incontinence" and trials --condition "stress urinary incontinence" --intervention "electrical stimulation" for the base-rate evidence, then a human read of the Cochrane…the rest of this gap analysisreview on electrical stimulation for SUI. For the closed-loop-vs-open-loop increment there is likely no published head-to-head — that is a bench/pilot study scoped at Stage 7, and its absence should be stated rather than papered over. Alsorecalls --product-code KPI for realized safety signal in the class |
| Capital intensity & time-to-revenue | 4 | Not a connector question. Needs human-attached inputs: FDA quarterly MDUFA performance reports for decision times in product code KPI; a quoted contract-manufacturing BOM for probe plus controller; a PDAC coding verification timeline. The…the rest of this gap analysisthree510k predicate lookups give decision dates that bound the review-clock estimate. The Generator should also state an explicit cost/timeline claim so this factor rests on something at all |
| Competitive intensity | 2 | clearances --product-code KPI over a trailing 5-year window for the real count of cleared competitors and the follower rate; 510k "ELITONE" and 510k --applicant "Zynex" to confirm the named incumbents hold what the claim says;…the rest of this gap analysisrecalls --product-code KPI for incumbent stumbles. FDA Establishment Registration & Device Listing for KPI gives the full US-marketed roster — a better denominator than any of the above. Funding/launch activity needs a human-attached licensed source (PitchBook/Crunchbase); no connector covers it |
| Strategic fit & portfolio balance | 3 | No connector and no external database. Requires a human-authored portfolio thesis document in the repo (current holdings, capital constraints, target mix of hero bets vs. cash-generative spokes, therapeutic-area focus) before any Scorer…the rest of this gap analysiscan score this row non-arbitrarily. Until that exists this factor is unscoreable in the same way Factor 1 is unscoreable withoutintended_use: — and it will stay a placeholder through Stage 4, since no Verifier pass can produce a verified claim about a portfolio strategy nobody has written down |
All six wrap criteria are met.
Domain dossier: stress-urinary-incontinence
Source file: knowledge-base/candidates/idea-001.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.