idea-019 · human · active
For prescription use in the home by adults with symptomatic neurogenic; orthostatic hypotension due to primary autonomic failure (Parkinson disease, multiple; system atrophy, or pure autonomic failure) who remain symptomatic despite non-pharmacologic; measures, to apply servo-controlled abdominal compression automatically on assumption of; an upright posture and to release it on return to a seated or recumbent posture, to reduce; orthostatic symptom burden and increase upright standing time.
| Mechanism | A soft inflatable abdominal bladder worn over the splanchnic region under; clothing, driven by a small battery-powered pump and a posture sensor (accelerometer /; inclinometer). On detected transition to upright, the bladder inflates under closed-loop; servo control to a prescribed set pressure (the published investigational analog used; 40 mmHg) and holds it; on detected transition to seated or supine, it vents to zero. The; therapeutic target is splanchnic venous pooling — the abdominal vascular bed, not the; limbs — so the device is mechanically distinct from intermittent pneumatic limb; compression, which cycles inflation/deflation around an extremity to aid venous return.; Because compression is applied only while upright, supine exposure to the applied pressure; is zero by construction, which is the design property the Generator is trading against the; supine-hypertension liability of pressor drug therapy (claim 31 — reasoning, not a finding). |
|---|---|
| Device class | Class II — De Novo pathway, regulation not yet created — the route that applies if FDA; finds no substantially equivalent predicate for a powered, posture-triggered abdominal; (non-limb) compression device carrying an orthostatic-hypotension treatment claim.; Carried first because the Generator's search found no such cleared device (claim 3).; This is also the only route in this list that plausibly supports an IDE-stage pivotal; study, which matters for the design rationale below.; Class II — 21 CFR 870.5800 (Compressible limb sleeve), product code JOW — 510(k); repositioning route. Regulation and product code confirmed to exist by web search; (claim 1), NOT confirmed to read on a device that compresses the abdomen rather than a; limb, and NOT confirmed to admit an orthostatic-hypotension treatment claim (claim 2).; Class I (asserted, regulation NOT identified by the Generator) — a narrowed-indication; fallback in which the same hardware ships as a non-powered or manually-set abdominal; support garment with no blood-pressure or orthostatic-symptom claim. Carried because; indication scope is a real lever here, but stated plainly: the Generator did not locate; the governing regulation or product code and is not naming one. This route abandons the; therapeutic claim and, with it, most of the candidate's value — it is a floor, not a; plan. |
| Predicate or analog | No FDA-cleared 510(k) or De Novo-granted device indicated to treat; neurogenic orthostatic hypotension by automated abdominal/splanchnic compression was; identified by the Generator's web search (claim 3) — stated plainly rather than naming one; that may not exist. Closest classification analog located: 21 CFR 870.5800 / product code; JOW (compressible limb sleeve), which is a limb device by its own text (claims 1-2).; Mechanism precedent, not a regulatory predicate: an investigational servo-controlled; automated inflatable abdominal binder studied at Vanderbilt (PMID 27271310; trial; NCT03482297). The practical comparators in this indication are drugs, not devices —; midodrine and droxidopa (claim 11). |
| Launch jurisdiction | US |
| Target | human |
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 coverage above says how much is known. This says what any of it is for: the propositions this opportunity rests on, ordered by what a failure would cost and, inside that, by what settling it would take. Derived from the pillars and the claims' current tags, not written.
This packet is unassessed. Its claims carry tags, so the file says how sure anybody is about each one — and nothing says which of them the idea actually rests on, or what it would cost to be wrong about one. Run /assess idea-019 to add that. Unassessed is a state, not a failing score.
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. <not yet written — later-stage artifact>
What would have to be true.
Cheapest next test: <one sentence, selected from the Scores table's "What would settle it" column>
Where the evidence actually stands. <run python3 engine/scripts/wrap_status.py --candidate idea-019>
| Factor | Score | Why | What would settle it |
|---|---|---|---|
| Regulatory pathway | 2 | Claims 1-3. 870.5800 / JOW is confirmed only to exist, and is a limb regulation by its own text (1-2) — not confirmed to read on an abdominal device or an OH treatment claim. No cleared predicate or De Novo grant for this indication was…the rest of this reasoningfound (3). Scored as a De Novo launch with no regulation yet created, not as a 510(k). A defined but evidence-heavy route, not a blocked one. Claim 19 excluded — the Generator did not read it. | FDA classification, 510(k) and De Novo databases searched for any abdominal-compression device carrying an OH treatment claim; free, under a day. The substantial-equivalence question itself only settles at a Q-Sub pre-submission meeting,…the rest of this gap analysiswhich is human-run and multi-month. |
| Reimbursement pathway | 2 | Claims 9, 10 — base case only. The adjacent E0650/E0651/E0652 pneumatic-compressor family exists and already pays for other indications (10), but no device-specific HCPCS code was found (10) and NCD 280.6 reaches lymphedema and venous…the rest of this reasoningstasis ulcers, not OH (9) — recorded as an obstacle, and scored as one. A new-code application plus a coverage argument are inside the base case. Claim 32 (DME benefit category) is an explicit assumption and carries nothing. Claims 12-19 describe a notice not in force and contribute zero. | CMS HCPCS Level II alpha-numeric file for E0650-E0652 and the trunk/chest appliance codes, plus the NCD 280.6 text and any DME MAC LCD reaching compression devices — public, low cost. Benefit-category and separate-payability status is a…the rest of this gap analysisCMS determination, not a lookup. |
| TAM | 3 | Claims 21, 22 would give a population base if they held (~1M US PD prevalent, ~90k/yr incident; pooled OH 33%, North America 28%, neurogenic subtype 26%, symptomatic ~20%) — a six-figure prevalent US population before MSA and PAF. But…the rest of this reasoningclaims 23, 24 and 25 each assert no figure: price per unit, addressable share and the Medicare volume anchor are all empty. So there is a plausible population here and no dollar TAM at all. Scored as partially-evidenced on population only. | CMS CCW Parkinson-disease prevalence among Medicare FFS beneficiaries, plus DMEPOS utilization and published fee-schedule allowables for E0650-E0652 — public, hours of connector work. Addressable share needs human-attached primary research…the rest of this gap analysisand will not resolve from any source in this repo. |
| FTO / IP | 1 | Claim 26 names US20150313608A1, a Vanderbilt pre-grant publication sitting squarely on this candidate's mechanism, with grant status, claim scope, assignee/licensee and expiry all undetermined — a pre-grant publication is not a granted…the rest of this reasoningpatent and is not read as one in either direction. Claim 27 is the honest residual: no other patent search was performed, so the field is otherwise unexamined. Scored low for unexamined risk on a named on-mechanism family, not as a known block. | Patent-office file history for US20150313608A1 — grant status, issued claims, current assignee, term — free and a few hours. A real FTO opinion across posture-sensing compression and servo pneumatic-control art is outside counsel work at…the rest of this gap analysisfive figures. |
| Moat / defensibility | 2 | Claims 5-7 put this exact mechanism in the public literature since 2016 and under active academic trial, so the idea is already public. Claim 26's IP may sit with a third party and is listed as available for license — a route in or a…the rest of this reasoningblock, undetermined. The implied bill of materials (bladder, pump, accelerometer) is not a technical barrier. Defensibility would have to rest on licensed IP or on De Novo-plus-clinical-data first-mover status; neither is established by any claim here. | The same file-history check as FTO, plus Vanderbilt CTTC licensing/exclusivity status — a docket pull and a phone call. Little else moves this row before a build exists. |
| Mechanism & clinical risk | 4 | Strongest row. Claim 5, if it holds, is a randomized single-blind crossover in 19 autonomic-failure patients of this precise mechanism — servo-controlled 40 mmHg splanchnic compression, applied on standing only — reducing symptom burden…the rest of this reasoningversus placebo and comparably to midodrine; claims 6-7 add two registered trials, and claim 4 places abdominal binders in consensus nOH guidance. Held back by claim 8 (no prototype, no bench/animal/human data for this device) and claim 31's uncharacterized failure modes: posture-detection error, vent/pressure-sensor failure, skin and abdominal-wall injury, stoma and respiratory interference, BMI sensitivity. Mechanism plausibility is high; device-level risk is entirely unretired. | Retrieve the PMID 27271310 abstract and the NCT03482297 registry record including any posted results — free, minutes. Device-level risk closes only with a bench programme, which is a Stage 7 cost. |
| Capital intensity & time-to-revenue | 1 | Three gates in series, none started: a De Novo with no regulation created and a likely IDE-stage pivotal study (claims 1-3), a new HCPCS code application, and a coverage argument against an NCD that reaches other indications (claims 9-10).…the rest of this reasoningClaim 8 records that no prototype exists, so the calendar starts before bench. Hardware complexity is low and claim 5 supplies a prior cohort to write a protocol against, which caps cost but not calendar. Claims 12-19 supply no acceleration — that pathway is not in force and is not scored as if it were. | FDA De Novo decision summaries for comparable Class II devices (review clock, evidence demanded) and the published CMS HCPCS code-application cycle — public, low cost. A costed development plan is Stage 7 work. |
| Competitive intensity | 2 | Claim 34's null result is a web-search absence and is explicitly not scoreable as market absence; claim 3's missing predicate is likewise not white space. The occupied comparators are drugs — claim 11's midodrine and droxidopa, the latter…the rest of this reasoninglabelled for this exact indication and dispensed on the low-friction pharmacy benefit — plus claim 4's commodity elastic binders, which set the effort and price comparator. Claim 27 leaves IPC incumbents unsearched. Scored as a moderately contested indication, not an empty one. | Company and financing databases plus FDA registration-and-listing for abdominal-compression entrants, and assignee searches against IPC incumbents — a licensed-database pull a human would have to attach. |
| Strategic fit & portfolio balance | 2 | Thinnest row in the table. The only claim touching portfolio fit is claim 35, which lists an existing lower-extremity lymphedema compression dossier — a genuine compression-hardware adjacency — while disclaiming itself as evidence for any…the rest of this reasoningrubric factor and recording that no dossier exists for this clinical area. Scored as adjacency-plausible, domain-knowledge absent. | A research-lane dossier for orthostatic hypotension / autonomic failure, which does not exist yet — one Scout pass. Portfolio balance itself is a human judgement, not a source lookup. |
To finish this packet:
domains: — run /research**Cheapest next test:** is still the unfilled _template.md placeholder — name the test, or the criterion checks nothingDomain dossier: none linked
Source file: knowledge-base/candidates/idea-019.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.