idea-002 · vet · 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 wound-therapy device built for animals rather than adapted from one built for people. After a dog is degloved by a car or a horse tears open a lower leg, the wound is slow, dirty and hard to bandage; one treatment is to seal it under an airtight dressing and apply gentle suction, which draws out fluid and encourages healing. Human versions of this exist and vets already buy them off-label, but they are designed for flat, hairless skin, and the published veterinary experience is that the seal keeps failing on a furred, tapering, moving limb. This is a small single-use pump with no fluid canister, plus a dressing and adhesive drape designed specifically to hold suction on fur. There is no FDA premarket review for animal-only devices and no insurance code — the owner pays cash at the practice.
What would have to be true, quoted from each deck's load-bearing condition:
Cheapest next test: Restate claim 1 as the two CFR-cited sub-claims the Verifier already drafted — that 21 CFR 807.81(a) conditions premarket notification on a device intended for human use, and that 21 CFR 814.1(a) scopes PMA to devices intended for human use — and re-verify them against source_refs already recorded in the file. The Scores table calls this "the cheapest available score-mover in the file", a Generator edit plus a Verifier pass rather than new research, and notes Factor 1 plausibly moves from 3 to 4-5 if they verify. Selected from the Regulatory pathway row's gap analysis; this is a selection from it, not a new judgement, and not a view about the idea.
Where the evidence actually stands. 4 of 39 claims verified, 35 unconfirmed, none refuted. All 9 factors carry a score in the Stage 2 triage table and all 4 core factors do; read the Verified Composite for the narrower verified-context count.
The shape of this candidate's evidence problem is the opposite of the human candidates in this repo, and worth stating plainly for a Stage 6 reader. No commercial claim in this file has ever been verified, and on current tooling none can be — the connectors that produce real numbers elsewhere in this pipeline are CMS and openFDA, and neither sees a veterinary market at all. So caseload, price, obtainable share, margin and distribution are not weakly evidenced; they are outside the instrument. The two verified claims that do the work are both regulatory: 21 CFR 807.65(b) exempts veterinary-only manufacturers from registration [claim 2: verified], and the human counterfactual would be Class II [claim 4: verified] — which the Verifier explicitly scoped to the human-use comparison and which therefore contributes nothing to this candidate's own regulatory score.
Three things a reader should not misread. First, an empty FDA scan on this candidate is coverage absence, not competitive absence: openFDA holds no records for animal-only devices, so a clean clearances or recalls result says nothing about who is in the field. Second, FTO is the only barrier of any kind here — there is no premarket review to slow a fast-follower — and it is unexamined rather than clear: two foundational patents returned unconfirmed on a missing credential [claim 5: unconfirmed], [claim 6: unconfirmed], and the live canister-free family that actually matters is "not checkable as written" because the connector takes a patent number and cannot run a landscape search [claim 7: unconfirmed]. Third, the eight studies the research lane added since 2026-08-24 changed the clinical picture substantially — from thin-and-negative to genuinely mixed, including a 50-dog comparative result favouring NPWT [claim 34: unconfirmed] against an unfavourable controlled equine study at this candidate's exact anatomical site [claim 20: unconfirmed] — and moved no tag at all, because a literature scan can locate a paper but can never appraise one. Those are "attempted and structurally unverifiable, not unattempted". Reconciling them is a reading task for a human, not a connector gap.
| Intended use | For use by licensed veterinarians and veterinary technicians in clinical and post-discharge settings to apply controlled sub-atmospheric pressure to open, contaminated, or free-skin-grafted distal-extremity wounds in dogs and horses, as an adjunct to standard wound management. |
|---|---|
| Mechanism | Battery-powered disposable pump holding approximately -80 mmHg through a superabsorbent dressing, with a fur-compatible adhesive drape and a limb-conforming interface layer, applied over open or grafted distal-limb wounds to reduce edema, promote granulation, and stabilize skin grafts |
| Device class | # Two designations: one that genuinely has no referent, and one; n/a — veterinary-only device. FDA device classification (I/II/III) has no referent here.; Verified: 21 CFR 807.65(b) exempts "a manufacturer of devices to be used solely for; veterinary purposes" from registration, and 807.20(a)/807.81(a)/814.1(a) all attach their; duties to devices "intended for human use". (CPG Sec. 655.100 is the usual citation for; this, but a Compliance Policy Guide is not codified in the CFR and cannot be checked here; — see claim 1 and backlog 2.9.); Class II — 21 CFR 878.4780 — the HUMAN-USE ANALOG ONLY (product code OMP, powered suction; pump). Verified as a counterfactual for comparison; it is not this product's class and; scoring Factor 1 from it would score a different product. |
| Predicate or analog | Smith & Nephew PICO 1.6 (single-use canister-free NPWT, human product used off-label in published canine and equine studies); 3M/KCI V.A.C. as the conventional canistered analog. No veterinary-specific cleared or approved predicate exists because veterinary devices have no premarket pathway |
| Launch jurisdiction | US |
| Target | vet |
| Factor | Score | What would settle it |
|---|---|---|
| Regulatory pathway | 4 | FDA CPG Sec. 655.100 (CPG 7125.35, "Devices Used in Animals") read in full from the FDA Compliance Policy Guides manual, plus FD&C Act §§ 501/502 for the retained post-market authority in claim 3, and an FDA CVM primary page for the…the rest of this gap analysisregistration/listing exemption in claim 2. Note the connectors cannot settle this by themselves:python3 -m connectors 510k "negative pressure wound therapy" --jurisdiction US and classification --device-name ... --jurisdiction US will correctly return nothing for an animal device, and a null return is silence, not confirmation — it only supports the claim when paired with the CPG text. For the counterfactual only: python3 -m connectors classification --product-code OMP --jurisdiction US. |
| Reimbursement pathway | **n/a — not scored** | Nothing in the reimbursement connector track settles this — hcpcs, payment, coverage, and cpt will all correctly return nothing for veterinary NPWT, and that null is the expected correct result rather than a gap to be closed. What…the rest of this gap analysiswould actually inform the demand-side economics, both human-attached: the NAPHIA State of the Industry Report (licensed) for the pet-insurance penetration figure in claim 12, and a veterinary fee benchmark (AAHA/AVMA practice economics survey, purchased) for what a practice can pass through to an owner on a several-hundred-dollar adjunct. Neither is connector-reachable. |
| TAM | 2 | python3 -m connectors market "<claim text>" returns unverifiable by design and will not settle this — it is a typed refusal, not a lookup. The real artifacts are all human-attached: (a) volume — VetCompass US or the Veterinary…the rest of this gap analysisMedical Database, or Banfield/Mars State of Pet Health caseload extracts, for distal-limb degloving/shearing injury incidence; (b) price — Smith & Nephew PICO published US list/contract pricing plus a veterinary distributor price file (Covetrus, Patterson Veterinary); (c) share — ACVS diplomate/hospital directory counts and AAEP member practice counts to bound the referral segment. A human-NPWT market report is not a substitute for any of the three. |
| FTO / IP | 2 | python3 -m connectors patent US5636643 --jurisdiction US and patent US5645081 --jurisdiction US for status/expiry and to establish whether 5,645,081 is even the right family member. That connector takes a single patent_id and cannot…the rest of this gap analysisrun a landscape search, so the live risk in claim 7 needs a different artifact: a human-commissioned FTO landscape search by patent counsel or a professional searcher (assignees Smith & Nephew / T.J. Smith & Nephew / BlueSky Medical / Solventum; CPC A61M1/90-A61M1/98, formerly A61M1/0088), with each live number it returns then checked back through thepatent connector. Until at least one specific live patent number exists, this factor cannot rise above "unassessed." |
| Moat / defensibility | 2 | A USPTO / Google Patents prior-art search on animal-skin and fur-compatible adhesive drape chemistry and on limb-conforming NPWT interfaces, to establish whether patentable claim scope is even available in the two named areas — that is the…the rest of this gap analysisquestion, and it is answerable now, before any filing. Once applications exist, their serial/publication numbers throughpython3 -m connectors patent <id> --jurisdiction US. No connector can settle a moat claim before something is filed. |
| Mechanism & clinical risk | 1 | Read the AJVR 2022;83(10) full text — design, n, randomization, primary endpoint, the specific device, and whether distal-limb or grafted wounds were in scope. `python3 -m connectors literature "negative pressure wound therapy dogs"…the rest of this gap analysis--since 2022-01-01 --until 2022-12-31` confirms the record exists and returns its title only — not the abstract, and the connector stamps every literature record "not appraised, not evidence for any claim" for exactly this reason. Existence is not the claim here: the claim is about the direction and strength of the finding, which needs the full article (AVMA Journals; human-attached if paywalled). Same treatment for PMID 27569833 and PMC6404353 / PMC10458497. If the AJVR result is confirmed as a properly powered comparative inferiority finding in this form factor, the correct response is to reopen the idea's premise, not to reweight this factor. |
| Capital intensity & time-to-revenue | 4 | Three quotes, none connector-reachable, all human-attached: a converted/thermoformed dressing tooling quote from a contract manufacturer; an ISO 11607 sterile-barrier validation quote from a packaging test lab; and a written…the rest of this gap analysisprotocol-and-budget from an ACVS-affiliated veterinary teaching hospital for the prospective series — scoped to whatever comparative design the AJVR result forces, not to the case series claim 18 assumes. |
| Competitive intensity | 2 | No connector settles this: adoption returns unverifiable by design, and clearances / recalls are 510(k)-scoped and structurally blind to a veterinary market. Human-attached artifacts: veterinary distributor catalogs and price files…the rest of this gap analysis(Covetrus, Patterson Veterinary, Midwest Veterinary Supply) to establish whether a vet-labeled NPWT SKU already exists and at what price; Smith & Nephew and Solventum product catalogs / investor materials for any stated animal-health line; and primary practitioner research — a structured survey of ACVS and AAEP surgeons on current NPWT purchasing and willingness to switch — which is the only thing that retires claim 19. |
| Strategic fit & portfolio balance | 3 | A written portfolio thesis / capital-allocation mandate from Tier 3 humans: hero-bet vs. spoke targets, minimum revenue threshold, and whether veterinary is in scope at all. No such document exists in this repo, and…the rest of this gap analysisknowledge-base/calibration-log.md is still empty, so there is no logged outcome history to infer a house preference from either. This factor is a stated preference, not a fact, and no connector can ever evidence it. |
All six wrap criteria are met.
Domain dossier: canine-equine-distal-limb-wounds
Source file: knowledge-base/candidates/idea-002.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.