Domain dossier

Shared background for a clinical problem, keyed by domain rather than by candidate, so the second idea in an area starts from the first one's research. A dossier carries no confidence tags. A line here has to be copied into a candidate's claims as unverified before anything can check or score it.

Used by: idea-002

Research reports behind it: care-pathway · clinical-evidence · clinical-evidence · epidemiology · market-players · market-players · market-players · reference-products · reimbursement · technology · user-groups

Negative pressure wound therapy for open, contaminated, or grafted distal-limb wounds in dogs and horses

This domain spans two species with meaningfully different wound biology and practice settings and a reader should not expect one blended figure to answer for both: canine distal-limb wounds are managed in general practice and small-animal referral surgery on a haired, mobile, chewable limb, largely as an inpatient-to-outpatient transition; equine distal-limb wounds are managed in equine hospitals and ambulatory field practice on a weight-bearing limb with a well-documented predisposition toward exuberant granulation tissue and prolonged, complicated second-intention healing, and NPWT (negative-pressure wound therapy) use there is described mostly as an inpatient adjunct rather than a send-home device. Epidemiology (§1) and market players (§8) are written with species-split rows or subsections wherever a source supports one; where a source blends species or reports on humans only, that is stated rather than silently generalized. Read the thinness up front: no US federal dataset covers veterinary device epidemiology, pricing, or utilization at all (docs/research-lane-spec.md's stated veterinary-data limitation, confirmed again here), so §1 (epidemiology) and most of §6 (reimbursement) are genuinely thin and are reported as such rather than papered over. The human NPWT literature and FDA (US Food and Drug Administration) recall record for the human-labeled predicate devices (V.A.C., RENASYS, PICO (population, intervention, comparator, outcome)) are the deepest, most reusable part of this file, because the candidate is explicitly positioned against exactly that canister-based incumbent design.

This file carries no confidence tags. Every line below is context with a source attached. To affect a score, a line must be copied into a candidate's ## Claims as unverified via engine/scripts/append_research_claims.py and pass the Verifier or Corroborator. See README.md in this directory.

Citation format: sources are numbered [N] at first use, reused for repeats, and listed in full in ## Sources at the end of this file.


1. Condition & epidemiology

as_of: 2026-09-20 · previous stamp: 2026-08-27 (content below kept, not deleted; the 2026-09-20 refresh is appended at the end of this section) · sources searched: connectors literature (queries: "canine distal limb degloving wound incidence," "dog traumatic wound emergency presentation incidence veterinary," "equine limb wound incidence trauma prevalence," "equine wound trauma UK veterinary practice prevalence VetCompass") · not searched: Banfield/Mars State of Pet Health, VetCompass US, the Veterinary Medical Database, AAEP/ACVS caseload reports — none reachable by any connector in this repo and none located by web search either, per the candidate's own claim 13 finding

This section is genuinely thin, and the thinness is itself the finding. No connector and no web search located a US (or any-country) incidence or prevalence figure specifically for "distal-limb wounds severe enough to warrant NPWT or free skin grafting" in dogs or horses. What PubMed returns instead for "dog traumatic wound incidence" is a run of single-institution retrospective case counts on unrelated trauma categories (stair falls, vehicular rollover, head trauma, zinc toxicosis) from the Journal of Veterinary Emergency and Critical Care's "retrospective evaluation: N cases" series and the ACVECC Veterinary Committee on Trauma registry reports — none of which reports wound-specific or distal-limb-specific counts. Equine queries return horseback-riding and racing injury epidemiology (falls, musculoskeletal injury), not wound incidence.

FactQuantity (n, population, date)Source
Canine distal-limb wound incidence (US)Not foundnot found — see note above
Equine distal-limb wound incidence (US)Not foundnot found — see note above
Demographics / risk concentrationNot found for either speciesnot found
Trend directionNot found for either speciesnot found

Gaps: this is the same gap candidate idea-002's own claim 13 already names — no US connector covers veterinary procedure volume (procedures is Medicare fee-for-service and structurally blind to animal procedures) — and this pass's literature and web searches did not surface a substitute. Not searched rather than not found for one thing only: UK VetCompass-style primary-care EHR (electronic health record) studies specifically scoped to wound presentations (the diabetes-monitoring dossier [see veterinary-diabetes-glucose-monitoring.md] found VetCompass epidemiology for a different condition; a wound-specific VetCompass query was run here and returned nothing, which is recorded as found-and-negative, not unsearched).

Refresh 2026-09-20 — wound cause and location distributions found; caseload still not found

The 2026-08-27 verdict above stands on the question it asked: no source states how many US dogs or horses per year have a distal-limb wound severe enough to warrant NPWT or free skin grafting. Three of the three named registries were re-worked and returned nothing usable — Banfield's own State of Pet Health landing page lists only osteoarthritis (2019), skin allergies (2018) and obesity (2017) installments, with no wound-trauma edition [22]; a US-specific VetCompass instance was searched for and only the UK Royal Veterinary College program pages surfaced, which did not retrieve (HTTP 403); and vmdb.org failed at the network level (DNS resolution error), which is a retrieval failure, not a negative result.

What was found is one level down from a caseload: the distribution of wound cause, wound location and trauma category within cohorts whose denominators are not US-national.

FactQuantity (n, population, date)Source
Equine mortality attributable to injury/wounds/trauma27.8% of deaths in US resident equids under 1 year, and 16.3% of deaths in equids 1 to <20 years; nationally representative USDA survey covering 28 states and 71.8% of all US equids, 2015[30]
Canine trauma category mixPenetrating bite wounds 35%, vehicular strikes 17%, lacerations 12%, across 22 North American/UK Veterinary Trauma Centers, n=8,130 dogs, 2022–2023[31], PMID (PubMed identifier) 40898826
Canine road-traffic-accident prevalence, primary care0.41% of dogs attending 115 UK primary-care practices, n=199,464 dogs, 2009–2014; 22.9% of RTA cases died of an RTA-associated cause[32], PMID 29509322
Equine wound cause and siteWire/fence injury the most common cause at 38% (84/219 horses); distal hindlimb the most common location at 31% (79/251 wounds), owner-reported cohort[33], PMID 42193764

Why the fourth row matters and the others do not, by themselves. Only [33] reports location, and it puts the distal limb at the top of the distribution — which is a fact about where equine wounds occur, not a count of how many warrant NPWT. None of the four rows carries a US-national denominator for the specific population this domain is about. The jurisdiction mismatch on [32] (UK primary care) is stated rather than smoothed over.

Gaps unchanged: no US caseload figure for either species. Not searched (still): Banfield/Mars record-level data, the Veterinary Medical Database (attempted, DNS failure — that is not retrieved, distinct from not found), AAEP/ACVS caseload reports.

2. Care pathway & clinical setting

as_of: 2026-09-20 · previous stamp: 2026-08-27 (content below kept; refresh appended at the end of this section)

Step in the pathwaySetting / site of serviceWho performs itWhat equipment is already thereSource
Initial wound assessment/debridement, dogsGeneral practice or small-animal referral surgery, in-clinicVeterinarian (general practice or ACVS (American College of Veterinary Surgeons)-boarded surgeon)Standard surgical suite; canistered NPWT (V.A.C./RENASYS) or off-label human PICO if available[1][5]
NPWT application, skin-graft bolstering, dogsIn-hospital, then increasingly sent home with the owner for the balance of therapyVeterinarian/veterinary technician applies; owner manages at homePortable canister-free device (PICO-class); technician follow-up by phone/recheck[6][7]
NPWT application, limb wounds, horsesEquine hospital (inpatient) predominantly; ambulatory/field practice for less complex casesEquine surgeon or ambulatory practitionerStanding sedation/stocks for application; system left in place days at a time, not typically sent home with the owner in the reviewed case series[9][10]
Wound closure or transition to conventional bandagingSame setting as above, once granulation/graft take achieved or NPWT discontinuedSame as aboveConventional bandaging materials as the fallback/default[5][9]

The one directional finding this section can state with sources: in the largest equine case series located, NPWT was used as a days-to-weeks inpatient-adjunct therapy (mean application 11.5 days, system reset every ~4.5 days) rather than a send-home device, and over a quarter of the horses that were discharged were discharged before the treating team considered NPWT complete [9] — a site-of-service constraint this candidate's post-discharge, owner-managed design would need to engineer around specifically for the equine population, distinct from the canine population where send-home use is already described in the literature without that caveat [6].

Gaps: no source establishes what fraction of US general veterinary practices (versus referral/specialty practices) currently stock or offer any form of NPWT at all, typical visit or recheck frequency once a patient is discharged with a device, or staffing/throughput effects on either species' care pathway. Not searched beyond the case-series abstracts cited.

Refresh 2026-09-20 — the send-home step now has measured numbers behind it, in dogs

FactQuantity (n, population, date)Source
Canine NPWT application duration and discharge timing, this candidate's exact indicationPortable single-use NPWT applied 4–7 days; 5 of 7 dogs were discharged from hospital during the treatment period, retrospective series of 7 dogs with full-thickness meshed distal-extremity skin grafts, 2016[6], PMID 27569833
Equine wound-type mix inside the largest NPWT case series36% bony (15/42), 33% articular (14/42), 21% tenosynovial (9/42), 5% muscular (2/42), 5% cutaneous (2/42); second-intention healing the indication in 74% (31/42), n=42 horses, 2021[9], PMID 34670699
Human analog for the send-home NPWT pathwayAverage inpatient length-of-stay reduction of 20.2 days and a projected £12,350 hospital-cost saving per patient, versus patients kept in hospital until community NPWT was available; UK NHS (National Health Service) case series, n=5 human patients with open lower-limb wounds[34], PMID 40931370
Regulatory design constraint on NPWT usability, human-use counterfactual21 CFR (Title 21 of the Code of Federal Regulations) 878.4783's Class II (FDA device class II) special controls for a negative-pressure wound therapy device for reduction of wound complications require that usability testing demonstrate intended users can correctly use the device based solely on reading the instructions for use; the 2021 final rule creating the classification states such devices are prescription-use only[35], 21 CFR 878.4783; FR Doc 2021-26741 (86 FR 70373)

Read row 1 against row 2 the way §2's original directional finding already reads them: the canine literature describes discharge during NPWT as routine at n=7, while the equine literature describes an inpatient adjunct from which a quarter of horses were discharged early [9]. Row 3 is human, n=5, and non-US — it is the mechanism of the send-home argument measured somewhere, not evidence about dogs or horses. Row 4 describes a standard FDA applies to a human-use device and reaches this domain only as the counterfactual the candidate file already scopes at its claim 4; an animal-only device is not classified by FDA at all.

Gaps still open: the fraction of US practices stocking NPWT of any kind; recheck frequency after discharge with a device; staffing/throughput effect. Unchanged since 2026-08-27.

3. User groups & incentives

as_of: 2026-09-20 · previous stamp: 2026-08-27 (content below kept; refresh appended at the end of this section)

RoleWho they areWhat they gainWhat they lose / what it costs themWhose budgetSource
Prescriber / deciderGeneral practitioner, ACVS-boarded small-animal surgeon, or equine surgeonFaster healing/shorter time to closure reported for canine NPWT vs. bandage/foam [5]; reduced complication rate in the same series [5]No FDA-reviewed indication to rely on for an animal-only device — see §6; off-label use of a human device carries no veterinary-specific labeling to point toN/A[5]; §6
Operator / daily userVeterinary technician (application, dressing changes) and, post-discharge, the ownerTechnically straightforward application reported in a 7-dog canine series [6]Application support specifically for "seals, leaks, and dressing construction" is marketed as a distinct paid service by at least one US veterinary NPWT vendor — implying this is a recurring enough operational problem to build a support line around, not merely a hypothetical one—[6][16]
PurchaserPractice (equipment/rental) and/or owner (cash-pay per treatment)—Rental-or-purchase, quote-only pricing (no published rate found) from at least one named US veterinary NPWT rental/support vendorOwner's own funds via the practice's bill, per candidate idea-002's own claim 11 finding that no third-party payer exists[16]; §6
PayerNone federal; pet insurance inconsistent, per the diabetes-monitoring dossier's own §6 finding for a different device category in the same no-payer structure———see veterinary-diabetes-glucose-monitoring.md §6 for the same structural point, independently applicable here
Patient / owner (animal)Dog or horse with a distal-limb woundShorter healing time and fewer complications reported in the one canine comparative series located [5]In horses, discomfort/pain requiring euthanasia after surgery was recorded in 2 of 42 cases in the largest equine case series (see §5 for the full figure and the important caveat that this is not necessarily NPWT-attributable)—[5][9]

Gaps: no source separates veterinary-technician incentives from veterinarian incentives specifically for NPWT (as opposed to wound care generally); no source addresses clinic-side markup or margin on a rented or purchased NPWT system.

Refresh 2026-09-20 — the owner-as-payer row now has revealed-behaviour evidence, none of it NPWT-specific

The 2026-08-27 pass recorded the owner/payer row as essentially empty, because the question it was being asked ("would an owner pay several hundred dollars for an adjunct device?") is a class-3 stakeholder-future question that nothing answers. Four published cohort and survey findings answer its revealed-behaviour twins instead — what owners have actually spent, and what happens to an animal's treatment when they cannot.

FactQuantity (n, population, date)Source
Owner stated spend, uninsured dog owners44% willing to spend up to $1,000 and 46% willing to spend $3,000 or more to prolong their pet's life by a year; US survey, n=306 uninsured dog owners, 2021[36], PMID 33870521
Treatment abandonment at the point of decision, by insurance statusPre-surgical euthanasia in 10% of insured dogs versus 37% of uninsured dogs (p<0.001), retrospective study of 260 dogs with gastric dilatation-volvulus across 24 US emergency clinics[37], PMID 33364255
Clinician-reported budget constraint frequency57% (620/1,088) of respondents reported client economic limitations affected their ability to provide desired patient care on a daily basis; 2017 JAVMA survey of 1,122 US/Canadian small-animal veterinarians[38], PMID 28306486
Insurance as a spend driverPet health insurance had a significant and positive impact on the amount dog owners spent at the veterinarian; 2020 US logit-model study[39], PMID 32659934

What these are and are not. Row 1 is stated willingness to spend, which is a survey answer rather than a purchase, and is recorded as such. Row 2 is the closest thing in this domain to a revealed-behaviour figure for owner cash constraint — an outcome (euthanasia before surgery) measured against insurance status in a real clinical decision, for a different and far more acute condition (GDV) than a distal-limb wound. Row 3 is a clinician's report of a client's constraint, not the client's own. None of the four measures anything about NPWT, an adjunct wound device, or a distal-limb wound, and none of them makes the class-3 question in §9 answerable. They bound the payer's behaviour; they do not predict this product's.

4. Standard of care & clinical evidence

as_of: 2026-09-20 · previous stamp: 2026-08-27 (content below kept; refresh appended at the end of this section) · sources searched: connectors literature/literature-detail (canine and equine NPWT case-series and comparative-study queries listed in §10), one non-PubMed veterinary review page fetched directly · not searched: AAHA/ACVS wound management guidelines (no full-text guideline document located or fetched; not attempted this pass, distinct from the diabetes dossier's own 403-blocked AAHA attempt)

ItemWhat it establishesEvidence quality (design, n, endpoint)Source
Guideline positionNot retrieved — no ACVS or AAHA wound-management guideline document was fetched this pass—not retrieved
Comparative result, canine, general wound careNPWT halved time to wound closure versus a foam dressing, and both beat conventional bandaging, in a retrospective matched comparisonRetrospective multicentre matched-pairs, n=50 dogs total (bandage n=7, NPWT n=18, foam n=25); significantly fewer complications with NPWT than foam (p=0.008), significantly less sepsis (p=0.016)[5]
Feasibility result, canine, this candidate's exact indication (free skin grafts, distal extremity)Portable single-use canister-free NPWT achieved 100% graft survival in a small retrospective series; "minor complications consisted of fluid accumulation in the evacuation tubing"Retrospective case series, n=7 dogs, no comparator arm[6]
Comparative result, canine, general cutaneous wounds, this candidate's exact form factor (PICO 1.6)A pilot comparative study found the device feasible but reported control wounds better on every reported macroscopic/histologic measure; already independently verified at abstract depth in candidate idea-002 claim 9Pilot experiment, n=5 Beagles, hemithorax wounds (not distal limb), 14 days[11]
Comparative result, equine, this candidate's exact anatomical site (distal limb)NPWT gave significantly less early wound retraction than calcium alginate in noncontaminated wounds and no difference in contaminated wounds; already independently verified at abstract depth in candidate idea-002 claim 20Controlled experiment, n=10 horses (contralateral-limb design), short exposure windows (9 and 6 days)[10]
Case series, equine, mixed wound types including distal limbNPWT used successfully for various limb wound types over a mean 11.5-day application; healing "satisfactory at discharge" in 69% (29/42); 26% (11/42) discharged before NPWT was considered ideally complete; 2/42 euthanized post-surgery for unrelenting pain (not stated as NPWT-attributable)Retrospective case series, n=42 horses, no comparator arm[9]
Commentary/negative finding, equine, isolated NPWTA 2026 commentary describes a 3-horse case series (Schnierer et al., cited secondhand — not independently retrieved) in which isolated PICO-system NPWT "was not sufficient to stimulate the healing process," with no reduction in wound size observed; the same commentary states "recent reviews of the literature concluded that, to date, there is no solid evidence on best practices and many results are controversial" for equine distal-limb wound healing generallyCommentary/review citing a small case series not independently verified here[14]

Read the fourth and fifth rows the same way candidate idea-002's own Verifier already reads them: both are this candidate's exact anatomical site and both report a negative or equivocal direction, not merely a caveat. Nothing here licenses reading the canine skin-graft feasibility result [6] as neutralizing that, since it is a different indication (grafted wounds, not general cutaneous or non-grafted distal-limb wounds) and has no comparator arm at all.

Verbatim, for anything load-bearing:

"Wounds treated with NPWT suffered significantly less complications (p = 0.008) and were significantly less septic during treatment (p = 0.016) than wounds treated with a foam dressing." — [5], PMID 25449799

"Application and maintenance of the portable device was technically easy and no major complications were encountered. Minor complications consisted of fluid accumulation in the evacuation tubing." — [6], PMID 27569833

"In 69% (n = 29) of the cases, healing was considered satisfactory at discharge. 26 % (n =

  1. of horses were discharged whilst ideally NPWT should have been continued. 2 animals (n

= 2; 5%) were euthanized after surgery due to unrelenting pain." — [9], PMID 34670699

"the isolated use of NPWT (PICO® system) was not sufficient to stimulate the healing process, as the authors did not observe a reduction in wound size, indicating impaired healing" ... "recent reviews of the literature concluded that, to date, there is no solid evidence on best practices and many results are controversial." — [14], quoted as retrieved from the commentary's own text, describing a case series this dossier did not independently retrieve

Gaps: no canine or equine randomized controlled trial of NPWT versus conventional bandaging was located — every comparative canine/equine source above is retrospective, matched-pair, or a small controlled experiment, not an RCT (randomised controlled trial). No source with a head-to-head canister-based-versus-canister-free comparison in either species was found. The Schnierer case series [14] was not independently retrieved or verified — recorded here as a secondhand description from a commentary, not as an appraised primary source.

Refresh 2026-09-20 (a) — which NPWT system the equine distal-limb study used

This is the single question the 2026-08-27 pass left most exposed, because §4's fifth row and §5's equine inferiority signal both hang on it: if the unfavourable equine distal-limb result [10] came from a conventional canistered unit, it is a different form factor from the one this domain's candidate proposes. The answer is thinner than the question deserves, and the thinness is the finding.

What was askedWhat the retrieved sources saySource
Does the study's own published record name a device?No. The PubMed structured abstract for PMID 34115409 carries the Methods paragraph in full — "Circular wounds were created on the left and right dorsomedial metacarpus of 10 horses… In all horses, one limb was treated with NPWT, the other with calcium alginate dressings" — and names no device, manufacturer, model, pressure setting or dressing interface anywhere. The Ghent University Academic Bibliography record for the same article (Equine Veterinary Journal 2022; 54(3): 592–600) reproduces the identical abstract and likewise names none[10], PMID 34115409; [23], handle 1854/LU-8719353
Does any source name one?One, and only one. Table 2 of the 2023 equine NPWT scoping review — "List of the NPWT devices which were used in the studies considered in the review and their manufacturers" — carries a row for this study reading verbatim: "KCL Medical \VAC ATS \
How reliable is that row?Three transcription errors sit on it as printed: the author name is spelled "Haspelaslagh", the year is given as 2020 (and as 2021 in the same review's narrative) against a 2022 journal issue, and the manufacturer string "KCL Medical" matches no other row in a table that spells the firm "KCI" four times. The review does not state where it took the device name from, and it cannot have been the abstract, which has none[13], PMID 37624295
Is there a second tabulation to corroborate it?No — searched and not found. A 2025 review of NPWT in equine wound treatment tabulates the same study and leaves the device field empty ("Data not presented")[24], DOI 10.22363/2312-797X-2025-20-1-61-78
What is "VAC ATS," in the federal registry?FDA cleared to Kci USA, Inc. "V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423" (decision 2007-01-25), and separately "ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT" (decision 2012-05-31). The V.A.C. ATS is a named therapy unit with its own separately cleared, model-numbered canisters — a conventional canistered configuration, not a canister-free single-use one[25], K063590 (an FDA 510(k) clearance number); [26], K120033
Was the study's own Methods text read?No — not retrieved. DOI 10.1111/evj.13487 is subscription-only; both Wiley hosts returned HTTP 403, the Ghent deposit returned a sign-in page, Semantic Scholar reports the record closed-access with no OA PDF, and scholar.archive.org returned a rate-limit page. A ResearchGate figure caption said to describe the dressing was also HTTP 403. Nothing in this dossier rests on the paper's Methods section, and the dressing and interface used remain unestablishednot retrieved

What this section deliberately does not conclude. "Therefore the unfavourable equine distal-limb result does not apply to a canister-free single-use device" is a generalisation that no retrieved source states. It would rest on a single-source attribution carrying three visible transcription errors, against a primary Methods text nobody has read. It is recorded here as the shape of an argument someone might later make, explicitly not as a finding, and it is not drafted onto any candidate as a claim. The honest position is that the device used in [10] is named by one secondary table and confirmed by nothing.

Refresh 2026-09-20 (b) — two comparative findings not in the 2026-08-27 pass

ItemWhat it establishesEvidence quality (design, n, endpoint)Source
Canine comparative, prospective randomizedNPWT-treated wounds closed significantly faster (mean 14.2 days) than silver-coated foam dressing-treated wounds (mean 28.6 days), p=0.018Prospective randomized trial, n=26 dogs; comparator is a silver foam dressing, not conventional bandaging and not a canister-free device[27], PMID 29890536
Equine second-intention healing, evidence base as a wholeA 2024 scoping review of 81 manuscripts found only 36% of experimental studies (n=59) showed statistically significant healing improvement versus controlScoping review, 81 manuscripts, 2024; covers equine second-intention wound healing generally, not NPWT specifically[28], PMID 38791717

Row 1 is the first prospective randomized canine NPWT comparison this dossier has located and it runs in NPWT's favour, which the 2026-08-27 gap line ("no canine or equine randomized controlled trial was located") did not have. That gap line is superseded for dogs and stands for horses. Row 2 is the base rate a reader should hold the whole equine literature against: most experimental interventions at this site do not beat control.

Verbatim, for the load-bearing lines in this refresh:

"KCL Medical | VAC ATS | Haspelaslagh, M., et al., 2020" — [13], PMID 37624295, Table 2 row, quoted exactly as printed including its errors

"Circular wounds were created on the left and right dorsomedial metacarpus of 10 horses… In all horses, one limb was treated with NPWT, the other with calcium alginate dressings" — [10], PMID 34115409, abstract Methods, which names no device

"V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423" — [25], FDA 510(k) (premarket notification) K063590, device name field

5. Reference products — and why people stop using them

as_of: 2026-09-20 · previous stamp: 2026-08-27 (content below kept; refresh appended at the end of this section) · sources searched 2026-08-27: connectors literature/ literature-detail (queries in §10), connectors recalls --product-code OMP, connectors clearances --product-code OMP, connectors clearance-summary K211318, web search followed to vendor pages · not searched: MAUDE (Manufacturer and User Facility Device Experience) narratives (no connector in this repo, docs/backlog.md 1.9); veterinary-specific complaint/recall channel (none exists — no US federal dataset covers veterinary devices at all, stated plainly per this repo's known constraint)

The load-bearing section, worked hardest per the task brief. Three incumbents are relevant here: the practice being displaced (conventional bandaging), the canister-based human NPWT systems already on the market and occasionally used off-label or by rental in veterinary practice (3M/KCI V.A.C., Smith & Nephew RENASYS), and the canister-free single-use human NPWT system this candidate is explicitly positioned against and that is already being used off-label in dogs and horses (Smith & Nephew PICO).

Conventional bandaging (both species)

SignalQuantity (n, population, date)Source
Slower healing relative to NPWTTotal time to wound closure significantly shorter with NPWT than with conventional bandage (bandage n=7 dogs, NPWT n=18 dogs, matched pairs, 2015)[5]
Equine distal-limb-specific complication predispositionSecond-intention healing on the equine distal limb is described as prone to "exuberant granulation tissue, and consequent delay in epithelialisation" independent of which dressing is used[14]

"Total time to wound closure was significantly shorter in Group C [foam] compared to Group A [bandage] (p = 0.02) and in Group B [NPWT] compared to Group C (p = 0.003)." — [5], PMID 25449799

Canister-based human NPWT (3M/KCI V.A.C., Smith & Nephew RENASYS) — the conventional analog this candidate's design explicitly rejects

SignalQuantity (n, population, date)Source
Canister/dressing-connector/tubing-related device recalls, as a share of all recalls for this product code19 of 37 (51%) FDA device recalls for product code OMP (2011-08-31 to 2026-08-27) name a canister, dressing-connector, or tubing defect in their own stated reason — leaking, particulate contamination, sterile-barrier breach, O-ring/connector mating failure, fluid/blood not evacuated with the pump blockage alarm failing to alert[4], openFDA device/recall, queried 2026-08-27
A single recurring canister failure mode named across multiple recall eventsBlack particulate matter from a canister's carbon filter entering the pump, risking pump damage (2 recall records, Smith & Nephew RENASYS EDGE canisters, 2024)[4], Z-1596-2024, Z-1597-2024
A dressing/blockage-alarm failure mode named across 6 recall events for one company/product familyWound fluid and/or blood not evacuated from beneath the dressing, with the pump's own blockage alarm failing to indicate the problem (Smith & Nephew RENASYS Soft Port family, 6 recall records, initiated 2014-01-09)[4], Z-1157-2014 through Z-1162-2014
Leak-alarm complaint volume as a stated recall trigger"Due to increase in complaints related to leak alarms," FDA root cause "Device Design" (3M V.A.C. VIA, 2025)[4], Z-1176-2025
Human patient-level nonadherence rate20% of patients ceased NPWT prematurely at their own request, citing experienced limitations in daily activities, in a retrospective clinical-setting study[2], PMID 33581961
Human patient preference findingPatients interviewed preferred professionals make treatment decisions and did not want responsibility for wound self-management; NPWT was reported to influence patients' daily lives as one of four emergent themes[3], PMID 40358217, n=10 patients, qualitative interview study

"Due to increase in complaints related to leak alarms" — [4], FDA recall reason, Z-1176-2025 (3M V.A.C. VIA Negative Pressure Wound Therapy System)

"Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump" — [4], Z-1596-2024/Z-1597-2024

"Reports of wound fluid and/or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did [not alert]" — [4], Z-1157-2014 (text as returned by the connector; truncated in the source record itself)

"20% ceased NPWT prematurely because of experienced limitations in daily activities." — [2], PMID 33581961

Read this the way this repo's other dossiers read an abandonment record: the recall record is evidence that the canister component specifically is a repeat, named point of device failure across at least three different manufacturers' product lines (3M/KCI, Smith & Nephew, Cardinal Health, Medela all appear in the full 37-record set — see §10) over a 15-year window — not evidence that a canister-free replacement would avoid every failure mode a canister introduces, since dressing-connector and tubing-blockage failures (the mechanism this candidate's own dressing/drape is built around) recur too [4]. It is also not evidence that veterinary clinicians would switch to a canister-free product — that is a class-3 question and its twin is addressed below.

Canister-free single-use human NPWT (Smith & Nephew PICO) used off-label — this candidate's nearest direct predicate/analog

SignalQuantity (n, population, date)Source
Minor operational failure mode, canine, this exact device"Minor complications consisted of fluid accumulation in the evacuation tubing"[6], n=7 dogs, 2016
Discharge before treatment goal met, equine26% (11/42) of horses discharged while NPWT was still considered ideally indicated[9], n=42 horses, 2021
Adhesive-attachment limitation, equine, secondhand from a commentary"difficulties were reported with the dressing design, mainly related to the adhesive component, which would not be suitable for use on open wounds" in horses (as summarized by a secondary review, not independently verified here)search-result summary of [14]'s cited literature, not independently retrieved — recorded as such
Comparative inferiority signal, canine, this exact device (PICO 1.6)Control wounds outperformed NPWT on every reported macroscopic/histologic measure in a pilot study; already independently verified at abstract depth in candidate idea-002 claim 9[11], n=5 Beagles, hemithorax, 2022
Comparative inferiority signal, equine, this candidate's exact siteSignificantly less wound retraction (unfavorable direction) with NPWT than calcium alginate in noncontaminated wounds; already independently verified in candidate idea-002 claim 20[10], n=10 horses, 2022
Isolated-use insufficiency, equine, secondhand"the isolated use of NPWT (PICO® system) was not sufficient to stimulate the healing process"[14], describing a 3-horse case series not independently retrieved
Recalls of the identical or closely related physical product familyNo FDA recall record naming "PICO" was found among the 37 product-code-OMP recalls retrieved (2011-2026); the recalls in this window that name a specific product all name RENASYS, V.A.C., Cardinal Health, or Medela product lines, not PICO — recorded as an absence, not as evidence of superior reliability[4], full 37-record set, queried 2026-08-27

"Application and maintenance of the portable device was technically easy and no major complications were encountered. Minor complications consisted of fluid accumulation in the evacuation tubing." — [6], PMID 27569833 (repeated from §4 because it is the load-bearing abandonment-adjacent line for this specific incumbent)

Read this in both directions, per this repo's own standard for this kind of evidence. The complication and equivocal-outcome record above is real, measured evidence that the off-label incumbent this candidate is positioned against has documented failure modes at this candidate's exact site in both species — not evidence that a purpose-built veterinary canister-free device engineered around fur adhesion and a limb-conforming interface would fix them, and not evidence that clinicians would switch. A device engineered around exactly the adhesive/dressing-interface failures named here might address them or might not; nothing here tests that, the same caveat the diabetes-monitoring dossier states for its own analogous comparison.

Class-3 question this section deliberately does not answer, and its twin: "Would veterinarians adopt a purpose-built veterinary canister-free device over continuing to use off-label human PICO or canistered systems?" is unanswerable and is not answered here (see §9). Its revealed-behaviour twin — the documented complication, discontinuation, and equivocal-outcome record of the off-label incumbent already in use — is answered, above.

Gaps: no veterinary-labeled competing product (Aluco Guardian, GluCurve-style purpose- built devices — see §8) has any published complication or accuracy/outcome literature located in this pass; MAUDE narratives are unreachable (no connector); no data on what fraction of US veterinary practices offer any form of NPWT versus bandage-only.

Refresh 2026-09-20 (a) — the strongest abandonment line in this file: a canister-free trial in horses that could not be completed

The 2026-08-27 pass recorded the canister-free equine feasibility work [12] as bibliographic existence only. Read at the level of what the study reported, it is not a feasibility success with a caveat — it is a study that failed to complete, on the exact failure mode this domain's engineering problem is named after.

SignalQuantity (n, population, date)Source
Experimental study terminated on seal/adhesion, canister-free single-use device, horses"All horses readily tolerated the PICO® but difficulties with adhesion and seal prevented the completion of the experimental wound study despite the use of many adjunctive adhesives" — open wounds in horses, 2019[12], PMID 30841889
Device attribution for that studyTable 2 of the 2023 equine scoping review attributes PICO® (Smith & Nephew, Lachine, Canada) to this study and to no other in its set[13], PMID 37624295

Verbatim:

"All horses readily tolerated the PICO® but difficulties with adhesion and seal prevented the completion of the experimental wound study despite the use of many adjunctive adhesives." — [12], PMID 30841889

Read both directions, as this section's own standard requires. Against the product: the one published equine trial of the canister-free form factor this candidate proposes did not reach its endpoint, and the reason was seal on a furred, mobile limb — so the moat is real and the problem defeated a commercial device even with adjunctive adhesives. For the product: the failure is located in the adhesive/drape interface rather than in the therapy, and tolerance was not the limiting factor ("All horses readily tolerated the PICO®"). Nothing here establishes that a purpose-built fur-compatible drape would fix it. This is measured evidence about the incumbent's failure mode, which is the only kind of demand-adjacent evidence §3.1 of docs/research-lane-spec.md says a dossier can hold.

Refresh 2026-09-20 (b) — price and cost anchors for the incumbents, all human-market

The 2026-08-27 pass recorded "not established" for every price row. Four figures now exist, none of them a veterinary net price to a US practice.

ItemQuantity (n, population, date)Source
PICO 7 single-use dressing kit, US retail cash-payListed at $378.69 and at $388.13 (10% off a $431.26 list) for the 10×30 cm one-dressing kit across two independent, non-affiliated US medical-supply retailers, accessed 2026-09-13; approximately a $367–$431 per-unit range across sizes on both listings[41], mfr. catalog no. 66022013
PICO 14, per day of therapy$25.00 per day of therapy, the lowest among disposable NPWT systems compared, versus more than $180/day for two named 3M/KCI systems (V.A.C. Via, Prevena Plus); 2023 list-price-based cost comparison[40], PMID 37053369
PICO, UK NHS bulk procurement"The unit cost of the PICO™ NPWT system (£147.06) was obtained from NHS Supply Chain, with averaging of the unit cost across the various sizes available" — UK, 2021[42], PMID 33839751
Payer-side episode cost, human US MedicareMean Medicare payment $1,532 (±$1,767) per disposable NPWT episode (n=3,522 episodes, mean age 67.6 years, 2012–2014 national claims) versus $4,650 (±$2,782) per traditional durable-canister NPWT episode (n=2,938), P<.0001; restated at 2016 rates as $1,564 and $3,501[43], PMID 29406300
What NPWT cost literature stops short ofA decision-tree cost-minimization model of two durable canister-based technologies reports total expected per-patient costs of $41,206 (SD $8,194) for Cardinal Health PRO and $44,439 (SD $8,963) for V.A.C. ULTA — a full hospital episode, not a bill of materials or a distributor margin[44], PMID 33034531

The stated absence that matters more than any of the five rows: no public, citable source prices a bill of materials, a contract-manufacturer cost of goods, or a US veterinary distributor's margin schedule for a canister-free NPWT SKU. Searched and not found. Covetrus and Patterson Veterinary item-level pricing sits behind an account login and was not attempted (access-gated, not merely unfound) — those are different facts and both are recorded. A US veterinary net price for any NPWT unit remains not established.

Refresh 2026-09-20 (c) — six further device recalls and clearances on the canistered incumbents

RecordWhat it statesSource
K100823FDA 510(k) cleared to Accuro Medical Products, LLC for the Wound Pro Apex, decision 2011-01-24[45], K100823
Z-0009-2013Recall of the Accuro Medical Wound Pro Apex: the pump could fail or malfunction without notifying the user via the unit's display screen[46], Z-0009-2013
K161128FDA 510(k) cleared to Medela AG for the Invia Motion NPWT system family, decision 2016-12-01[47], K161128
Z-2528-2018Recall of the Medela Invia Motion: the device may display a battery-missing error[48], Z-2528-2018
Z-2543-2020 / Z-2544-2020Recall of Cardinal Health 200, LLC NPWT canisters: the canisters potentially contain an oversized O-ring that cannot be installed into the device's mating connector[49], Z-2543-2020

These extend rather than replace the 2026-08-27 recall analysis. Two of the five are canister/connector failures (Z-2543-2020's O-ring, and the canister family already counted at [4]); two are pump-electronics/alarm failures (Z-0009-2013's silent malfunction, Z-2528-2018's battery error) and those land on the pump subassembly a single-use canister-free design still has to build, not on the canister it removes.

Refresh 2026-09-20 (d) — FDA does act on veterinary-labelled devices, three times, all firm-initiated

This is a regulatory fact that belongs in a reference-product record because it is the only post-market evidence trail that exists for animal-labelled devices at all.

RecordWhat it statesSource
Z-1474-2024FDA classified as Class II on 2024-04-03; 147 units; Karl Storz Endoscopy; FDA recall-record product description "Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only"; reason "Inadequate reprocessing validation evidence"; recall initiated 2024-02-27; "Voluntary: Firm initiated"[29], Z-1474-2024; UDI (unique device identifier)-DI 04048551193587
Z-1640-2022FDA classified as Class II; bioMerieux, Inc.; "VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03…"; reason "There are 7 reported software anomalies that may affect use of the device"; report date 2022-09-07; "Voluntary: Firm initiated"[51], Z-1640-2022
Z-1911-2020FDA classified as Class II; ICU Medical, Inc.; "REF: AH7117 111\" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only"; reason a potential 15 drops/mL cannula substituted for a 10 drops/mL cannula; report date 2020-05-13; "Voluntary: Firm initiated"[52], Z-1911-2020
The definitional frame21 CFR 7.3(f) defines "Product" for Part 7 recall purposes to include any device "intended for human or animal use"; 21 CFR 7.3(g) ties "recall" to a product FDA "considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure"[50], 21 CFR 7.3(f)–(g)
The voluntariness frame21 CFR 7.40(a) states recall is a voluntary action carried out by manufacturers and distributors; 7.40(b) reserves an FDA request that a firm recall for urgent situations; 7.45 sets out the separate FDA-requested-recall mechanism[53], 21 CFR 7.40; 21 CFR 7.45
The stated-posture half, which is a documented negativeCPG Sec. 655.100's own text was not retrieved from any host reachable this pass, and nothing in this dossier quotes or characterises it. What was found is that the CPG number usually paired with it belongs elsewhere: a 2006 Federal Register notice records that FDA withdrew "CPG 7125.35," entitled "Human-Labeled Drugs Distributed and Used in Animal Medicine," as obsolete, and that the 7125.xx-to-6xx.xxx mapping it evidences is 7125.06 → 615.100. Whether 655.100 carries a 7125.xx number is not established[78], FR Doc E6-10672, 71 FR 38650

The absence, stated plainly so it is not read as a finding. All three records are "Voluntary: Firm initiated." A query of openFDA device/enforcement combining voluntary_mandated:"FDA Mandated" with a veterinary product description returned no matching record, while the same query shape with "Voluntary" returned 19 — so the syntax resolves and the null is a real null. That no FDA-mandated action against an animal-only device was found is silence, not evidence that FDA's posture is hands-off, and nothing in this dossier says otherwise. FDA's warning-letter database lives on fda.gov, which is bot-gated (HTTP 401 measured again this pass) and no connector in this repo reaches it — not searched, distinct from not found.

Gaps after this refresh: MAUDE narratives still unreachable; still no published complication or outcome literature for any purpose-built veterinary-labeled NPWT product; no veterinary net price; no bill of materials for any single-use NPWT device, human or veterinary; the Methods text of [10] still unread; the Schnierer case series still retrieved only secondhand.

6. Reimbursement landscape

as_of: 2026-09-20 · previous stamp: 2026-08-27 (content below kept; refresh appended at the end of this section)

No third-party payer exists for veterinary devices in the US, the same structural fact the diabetes-monitoring dossier records for a different device category — see veterinary-diabetes-glucose-monitoring.md §6 for the fuller treatment of why hcpcs, payment, coverage, and procedures are all structurally blind to animal care, not merely silent on this specific device. What a veterinary "reimbursement" section can actually contain, and what was found here:

ItemDetailSource
Codes in use (HCPCS (Healthcare Common Procedure Coding System); CPT (Current Procedural Terminology) only if licensed)None apply — no federal payer reaches veterinary devicesinference from independently re-verified 21 CFR 807.65(b) [21], the same regulatory structure candidate idea-002's own claim 2 rests on
Payment rate / fee scheduleNot applicable—
Coverage policy (NCD (national coverage determination)/LCD, commercial)Not applicable (federal); commercial pet-insurance policy documents not reviewed this passnot reviewed
Site-of-service differentialNot applicable—
Whose budget it comes out ofOwner's own funds, cash-pay through the practice; at least one US NPWT vendor's veterinary channel operates on rental-or-purchase with card/PayPal/Venmo/ACH payment, consistent with a direct-pay model[16]
Owner out-of-pocket cost contextNo published per-treatment or per-unit price found for veterinary NPWT (rental or purchase); the one vendor page located is quote-only[16]

Gaps: commercial pet-insurance coverage-policy documents for wound-care devices specifically — not reviewed this pass (would need the same human-attached Trupanion/Nationwide/ASPCA policy review the diabetes-monitoring dossier names as its own open item). No veterinary fee-benchmark survey (AAHA/AVMA practice economics) was reviewed for what a practice can pass through to an owner for an adjunct wound device — the same gap candidate idea-002's own Scores table already names for its TAM (total addressable market) component 2.

Refresh 2026-09-20 (a) — how US pet insurers say they compute a payment: off the invoice, not off a code set

The 2026-08-27 row "commercial pet-insurance policy documents not reviewed this pass" is now partly filled. Four insurers were worked; two state their adjudication basis publicly, one is silent on the reachable page, and one could not be reached at all.

InsurerWhat its own published page statesSource
ASPCA Pet Health Insurance (underwritten by Independence American Insurance Company, NAIC #26581, or United States Fire Insurance Company, NAIC #21113)"Complete Coverage℠ reimbursements are based on the invoice," against "Preventive care coverage reimbursements are based on a schedule." Its veterinary-facing FAQ describes submission as records-and-invoice: "Typically the pet owner pays the veterinarian at the time of service, and then the pet owner submits a claim for reimbursement," with "Please include 12 months of medical records with your submission." No procedure code is named anywhere on either page[54], ASPCA "What Does Pet Insurance Cover?"; [55], ASPCA Vet Services FAQs, both accessed 2026-09-20
Healthy Paws"Reimbursements are based on your actual veterinary bills"[56], Healthy Paws "Coverage & Exclusions Details", accessed 2026-09-20
NationwideSILENT on the reachable page, which states only "We'll reimburse you for eligible expenses once you've met your annual deductible." petinsurance.com, where the plan documents live, returned HTTP 403 for every URL tried, HTML and PDF alike[57], Nationwide "Pet Health Insurance", accessed 2026-09-20
TrupanionNot retrieved. www.trupanion.com returned HTTP 403 on every path tried; intrs-www3.trupanion.com likewise; prodrs.trupanion.com does not resolvenot retrieved

The statutory frame, which is the only non-directional line available here:

ItemWhat it statesSource
California Insurance Code § 12880.2Requires, before sale, that a pet insurer "clearly disclose a summary description of the basis or formula on which the insurer determines claim payments"; where a benefit schedule is used, that the insurer "clearly disclose the applicable benefit schedule in the policy"; and where usual-and-customary fees are used, that the policy "clearly describe the insurer's basis for determining usual and customary fees and how that basis is applied in calculating claim payments." It recognises exactly three bases and names no procedure-coding system at all[58], Cal. Ins. Code § 12880.2
California Insurance Code § 12880Its definitional list runs thirteen defined terms, (a) through (m) — including "chronic condition," "pet insurance," "preexisting condition," "veterinary expenses" and "wellness program" — and contains no definition of a benefit schedule, a usual-and-customary basis, or any procedure-coding system[59], Cal. Ins. Code § 12880

What follows from this, and what does not. Every source above is directional — two of them are companies describing their own products, and two are sections of one state's code, so nothing here rests on two independent non-affiliated witnesses. Note also the jurisdiction shape: §§ 12880/12880.2 are California state law, not a US federal registry, so a US federal typed connector cannot reach them; a reader should not expect the eCFR route that serves the rest of this dossier's regulatory lines to serve these.

Refresh 2026-09-20 (b) — what the published exclusion lists say, and where they are silent

InsurerExclusions stated verbatim on the retrieved pageNPWT / wound-care / device / experimental categories
ASPCA"Pre-existing conditions occur before coverage begins or during a waiting period. These conditions are not covered"; "Our plans do not cover elective procedures, such as tail docking, ear cropping, and claw removal"; "Our plans do not cover costs associated with breeding or pregnancy." The vet FAQ adds an exclusion for treatment by the owner or an immediate family memberSILENT. The elective exclusion is exemplified only by cosmetic procedures; the page names no exclusion for experimental or investigational treatment, for devices, or for wound care [54][55]
Healthy Paws"Pre-existing conditions are not covered under our insurance policy"; "Preventive healthcare is not covered. This includes vaccinations or titer test, parasite/flea control, heartworm medication, de-worming, nail trim, grooming, anal gland expression, spaying and neutering and dental healthcare"; "The plan does not reimburse the costs, fees or expenses associated for elective procedures, boarding, behavioral modification, training, therapy or medications for behavioral modification"; "Examination fees are not covered under our insurance policy"SILENT on devices, prosthetics, experimental or investigational treatment, bandaging and wound care, on a verbatim-targeted second retrieval of the same page [56]
NationwideOnly "Some exclusions may apply. Certain coverages may be excluded due to pre-existing conditions. See policy documents for a complete list of exclusions." The referenced documents were not reachableSILENT, on the only page reachable [57]
TrupanionNot retrieved — no position recordednot retrieved

SILENT is not permission. These rows record an absence of retrieved wording, not a grant of coverage. No filed policy form was read this pass: every PDF route attempted failed (a 4.2 MB Maine PFR filed exhibit and the NAIC "A Regulator's Guide to Pet Insurance" both fetched successfully and could not be converted to text in this environment; a third-party-hosted Nationwide plan summary and Healthy Paws form WFIC LD-51186 (08-18) yielded nothing, the latter a 404). Read the absence of filed-form wording here as an environment limit, not as evidence that filed forms say nothing. One further caution recorded by the retrieving pass: a first, summary-level read of the Healthy Paws page reported that "devices/prosthetics" were excluded, and a second retrieval of the same URL asking for literal strings found no such wording. The exclusion is therefore not recorded as a finding in either direction, and a later pass should re-read that page rather than trust either summary.

Refresh 2026-09-20 (c) — how many dogs are insured at all

FactQuantity (n, population, date)Source
US dog pet-insurance penetration5.99% at year-end 2025, against 2.29% for cats and 4.27% for all US pets, per NAPHIA's own free public State of the Industry Report Highlights. Denominator stated by NAPHIA as "approximately 87.3 million dogs and 76.3 million cats owned in the U.S.," which NAPHIA's own document attributes to the AVMA (American Veterinary Medical Association) Pet Owner Survey 2025 (not independently retrieved)[60], NAPHIA SOI 2026 Highlights, published 2026-06-21
Prior year5.46% for dogs and 2.04% for cats at year-end 2024[61], NAPHIA news release, published 2025-04-22

Both of NAPHIA's two most recent dated dog-specific figures are above 5%. Read the sourcing before the number: NAPHIA is a trade association whose stated purpose is to "advance and grow the pet health insurance industry," its data is compiled by Willis Towers Watson from member-contributed data, and its own methodology disclosure says "actuarial inferences … [are] applied to the aggregate publicly available data to determine approximate allocations" for at least some breakdowns. Two trade-press pieces from June 2026 repeat the same 4.27% / 5.99% / 2.29% set and attribute it to the same NAPHIA report; neither is an independent measurement, so this rests on one primary publisher. A reader should also note that 4.27% (all pets) and 5.99% (dogs) both appear on the same NAPHIA summary page, which is an easy conflation to make in either direction.

Gaps after this refresh: no filed policy form read for any insurer; Trupanion's and Nationwide's exclusion lists not retrieved at all; SERFF-adjacent public filing libraries outside Maine not searched; no AAHA/AVMA practice-economics fee benchmark reviewed; the AVMA Pet Owner Survey 2025 denominator not independently retrieved.

7. Technology trajectory

as_of: 2026-09-20 · previous stamp: 2026-08-27 (content below kept; refresh appended at the end of this section)

ChangeWhenWhat it enabledSource
Canister-free single-use NPWT (PICO) reaches the market and iteratesPICO 7/14 cleared under K211318, 2022-01-05The canister-free, absorbent-dressing form factor this candidate's own design is built on, as an off-label veterinary analog already in published use[17], K211318; [18]
Continued new entry into canister-based and canister-free NPWT under product code OMP103 total 510(k) clearances found under product code OMP in the 10-year window queried (2016-2026); 50 most recent inspected directlyA steady stream of new competitors and product iterations (ConvaVAC, CURASYS 2, Nisus, Wound Geni, Genadyne ASTRA, Prospera Spectruum, extriCARE, and continuing RENASYS/V.A.C. iterations) — this is a counted series and, per this repo's own rule, cannot carry a confidence tag or be scored from; it lives here as context only[17], openFDA device/510k, product_code=OMP, queried 2026-08-27
Purpose-built veterinary NPWT vendors appearAluco Guardian (UK), launch date not stated on its own site; The Wound Vac Company veterinary channel states operating "since 2009"A dedicated veterinary NPWT commercial channel (rental, purchase, and application support) exists independent of any single candidate, in at least one non-US and one US vendor[15][16]

Note per this repo's own template instruction: the 510(k) clearance count above is a counted series and cannot be scored from (docs/backlog.md 1.10).

Gaps: no patent-landscape check was run here (candidate idea-002's own claims 5-7 already carry this gap — PATENTSVIEW_API_KEY unset, and the live canister-free/dressing-interface FTO (freedom to operate) risk is unsearched by construction of the patent connector). No membrane/dressing chemistry literature specific to fur-compatible or limb-conforming adhesives was located — consistent with candidate idea-002's own moat claim (claim 16) being unchecked.

Refresh 2026-09-20 — the patent landscape gap above is partly closed: four live patents now have numbers

The 2026-08-27 gap line is superseded on its first half. A public keyword-and-assignee search of Google Patents surfaced named, live US patents covering the structural elements of canister-free/absorbent NPWT. These are patent-document facts — what each document's own claims and legal-status field say — not a freedom-to-operate opinion.

PatentAssignee, filing, statusWhat claim 1 recitesSource
US 9,061,095 B2 — "Wound dressing and method of use"Smith and Nephew PLC; filed 2015-06-23 grant, filed 2011-04-21 (priority 2010-04-27); listed active, expiring 2033-10-27A wound treatment apparatus with a wound-contact layer, a transmission layer, an absorbent layer, a gas-impermeable moisture-vapor-permeable cover layer, and a suction port with a filter element. The specification underlies the PICO dressing family[62], US9061095B2
US 11,395,870 B2 — "Negative pressure wound therapy apparatuses and methods for using the same"T.J Smith and Nephew Ltd; filed 2018-02-15 (priority 2017-02-15), granted 2022-07-26; listed active, expiring 2039-01-22A controller that detects, via a switch at the connector port, whether a canister or a canisterless wound dressing is attached, and adjusts operation accordingly — the pump's mode-switching logic, not drape or adhesive chemistry[63], US11395870B2
US 12,453,658 B2 — "Absorbent Negative Pressure Wound Therapy Dressing"Smith and Nephew PLC; filed 2021-08-16 (priority 2015-12-30), granted 2025-10-28; listed active, expiring 2040-01-11A backing layer with an opening, adhesive or glue on the backing layer's upper surface, and an absorbent layer between the backing layer and the wound site. The specification names PICO as a canister-less system with "a superabsorbent layer beneath a backing layer." Neither claim 1 nor the retrieved summary recites a human or species limitation[64], US12453658B2
US 12,447,258 B2 — "Negative pressure wound therapy (NPWT) dressing"Mölnlycke Health Care AB; filed 2021-05-24 (priority 2020-05-25), granted 2025-10-21; listed active, expiring 2042-09-26A backing layer, an adhesive skin-contact layer, and an absorbent structure with superabsorbent polymer particles at 10–20 mg/cm². Unlike the Smith & Nephew family, this dressing is explicitly designed to connect to a remote fluid collection means (a canister)[65], US12447258B2
US 7,004,922 B1 — "Animal wound wrap for holding a primary wound dressing on an animal wound"Davis and Shesol; granted 2006-02-28; listed expired (fee-related) as of 2024-04-09A hook-and-loop stretchable wrap. It names fur explicitly ("a portion of the animal's fur is shown shaved") and states its purpose as eliminating adhesive entirely[66], US7004922B1
US 11,260,164 B2 — "Negative pressure wound therapy dressing and related apparatus"Genesis Medical Devices LLC; listed active, expiring 2038-12-04A compressible, diameter-adjustable NPWT connector/adaptor — a dressing-interface patent, for human use, not fur- or limb-shape-specific[67], US11260164B2

The prior-art absence, and how to read it. Searched and not found: any US patent claiming an adhesive chemistry formulated for fur- or hair-bearing animal skin, and any US patent claiming a limb-conforming NPWT interface specific to veterinary use. The nearest hit in the animal space [66] avoids adhesive altogether and is expired. Not searched: a formal CPC-classification-restricted browse of A61M1/90–A61M1/98 (USPTO (United States Patent and Trademark Office) Patent Public Search is an interactive, session-based surface that was not reachable as a query surface); continuation, divisional and foreign family members of [62]–[65] beyond what Google Patents' own family links surfaced incidentally; Solventum/3M- and KCI-assigned NPWT patents specifically, where assignee searches returned only product and litigation-history material — a gap in the search, not a finding that no such patent exists. Every line above rests on one reading of one patent document; a typed connector lookup would read the same underlying USPTO record and would not supply an independent second witness, so this ceiling is structural to patent facts rather than a shortfall of this pass.

One further registry item belongs here: 21 CFR 878.4783 now exists as a distinct Class II classification — "negative pressure wound therapy device for reduction of wound complications" — created by a 2021 final rule, with special controls requiring usability testing that demonstrates intended users can correctly use the device based solely on reading the instructions for use, and prescription-use-only labelling [35]. That is a human-use classification and does not apply to an animal-labelled device; it is recorded here because it is the direction the human-use design standard for this device class has moved in ten years.

8. Market players & dynamics

as_of: 2026-09-20 · previous stamp: 2026-08-27 · sources searched 2026-08-27: openFDA recalls/clearances on product code OMP, web search followed to vendor primary pages

PlayerPositionEntered / exitedRecent activity (funding, launch, recall)Source
Smith & Nephew (PICO)Dominant off-label canister-free incumbent by literature volume in both speciesHuman product; never entered the US veterinary market as a labeled productK211318 clearance 2022-01-05 (human indication only); no PICO-named recall found in the 37-record OMP recall set 2011-2026[17][18][4]
3M/KCI (V.A.C. family)Canister-based conventional human incumbent, also used off-label/by rental in veterinary practiceLong-established human product lineMultiple recalls in the OMP set 2011-2026, including a 2025 leak-alarm-complaint-driven recall (Z-1176-2025) and a 2020 unannounced-power-off recall (Z-2542-2020)[4]
Smith & Nephew (RENASYS family, canister-based)Canister-based conventional human incumbent, distinct product line from PICOLong-established human product lineMost canister/dressing-connector recall events in the OMP set trace to this product family (see §5)[4]
Aluco Health (Aluco Guardian NPWT System)The only identified purpose-built veterinary-labeled NPWT product found in this passUK-based; site markets to "Vet clinics, hospitals and pet owners" in the UK and EU — non-US, jurisdiction mismatch noted explicitlyCase studies posted (dog bite injuries, oncology resections, orthopedic procedures, necrotizing fasciitis) but no peer-reviewed accuracy or complication data found; no price disclosed; no FDA regulatory status stated on the page[15]
The Wound Vac CompanyUS veterinary NPWT rental/sales and "application support" vendor, operating since 2009 per its own site, serving multiple species including equine and canineUS-based, ongoingOffers dedicated technical support for "seals, leaks, and dressing construction" — a vendor-disclosed signal, not a peer-reviewed one, that these are recurring operational problems worth a paid support line[16]

What this section explicitly does not record as fact: a web search for a "pet diabetes care devices market" figure was named as deliberately excluded in the diabetes-monitoring dossier for the same reason a "veterinary wound care market" figure would be excluded here — no comparable market-sizing report was pulled into this dossier because none was independently sourced and appraised this pass; if one surfaces later it should be named and explicitly not used, the same way the diabetes dossier's §8 records it.

Gaps: no funding data for Aluco Health or any purpose-built veterinary NPWT vendor was retrieved. No recall or complaint channel exists for a veterinary-only device (structural, per §6), so no complaint record for Aluco Guardian or GluCurve-style products can ever be established through a US federal source. (The second half of that sentence is narrowed by §5's refresh (d): FDA does hold and classify enforcement records for products labelled "veterinary use only" where the recalling firm reports them. What remains true is that no veterinary-specific complaint channel exists.)

Refresh 2026-09-20 (a) — the three named US veterinary distributors list no NPWT product in their public catalogs

The 2026-08-27 pass could say nothing about the distribution channel. Six direct catalog searches across three distributors were run on 2026-09-13:

ChannelWhat the public catalog returnedSource
CovetrusThe "Woundcare Other" category page lists three SKUs — a bitter-taste deterrent spray (SKU 2801490) and two sizes of Manuka honey wound gel (SKUs 2800417, 2800418) — and no NPWT device of any kind. A direct query against the "Treatment and Recovery" category returned "Your search returned 0 results. Please try a different search term"[68], [69]
Patterson VeterinaryPublic catalog search returned "No Search Results Found" for "wound vac" and again for "PICO"[70], [71]
Midwest Veterinary SupplyPublic catalog search for both "wound vac" and "PICO" returned no product results at all — only seven unrelated instructional videos[72], [73]
The Wound Vac Company (direct-to-clinic, not a distributor)Describes a "WoundPro" NPWT system (a Control Unit, a "WoundPro+" variant, and a portable "MicroDoc" unit) available "for rental or purchase, with equipment and supplies stocked in our Florida and Atlanta warehouses," alongside a separate "WoundPro® Canisters" consumable line, with direct application support by phone, text and email[16], accessed 2026-09-13
A canister-free NPWT component in a federal device registryFDA's GUDID (Global Unique Device Identification Database) carries a live record for "Snap Therapy System Snap 125mmHg Therapy Cartridge 60ml," company KCI USA, Inc., primary DI 00849554006058 — a single-use, portable, non-electric-canister NPWT format[74], GUDID DI 00849554006058

How to read six empty searches. They are consistent with none of the three currently stocking an NPWT product of any kind in their public catalog. They cannot rule out an account-gated or special-order SKU invisible to an unauthenticated fetch — all three sites limit catalog depth and contract pricing to logged-in accounts, and no account was used. The honest reading is "not found in the public catalog," not "not carried." Search terms beyond "wound vac," "PICO" and "negative pressure" (e.g. "V.A.C.," "3M," "Solventum," "SNAP," "Talley," "Venturi") were not searched. Covetrus's public "Supplier Network" page was fetched and read and states no admission criteria, minimum-volume commitment or private-label terms for a new SKU — that is a not found on a page that exists [75]. Patterson's and Midwest's supplier-onboarding pages, if public, were not located.

Refresh 2026-09-20 (b) — the size of the specialty/referral practice base

FactQuantity (n, population, date)Source
ACVS board-certified Diplomates2,686 following the February 2026 certification exam, self-reported by the College on its own site; 44.54% report small-animal general/orthopedic emphasis and 42.37% equine general/orthopedic emphasis (Diplomates may select more than one emphasis, so these do not convert to a headcount split)[76], accessed 2026-09-13
AAEP membership"more than 9,000" veterinarians and veterinary students, undated, on its own about page[77], accessed 2026-09-13

These are the practice base, not caseload and not adoption. No source located this pass states what fraction of either base stocks, purchases, or has adopted any NPWT product, and no comparable-device penetration figure was found for either segment.

9. Open questions — and what would settle them

QuestionClass (1 registry / 2 published / 3 stakeholder-future)What would settle itReachable by?
What is the current US population of dogs and horses with distal-limb wounds severe enough to warrant NPWT or free skin grafting?2A US veterinary EHR/claims study (VetCompass US, Veterinary Medical Database, Banfield/Mars State of Pet Health) scoped to distal-limb trauma or degloving injuriesNot reachable by any connector in this repo; not located by web search in this pass either — see §1
Does a species-specific (fur-compatible, limb-conforming) adhesive/dressing design reduce the adhesive-attachment failure and premature-discontinuation rates documented for off-label PICO use in horses and dogs (§5)?2, in principle, once such a product exists with published dataA comparative or single-arm complication study of a purpose-built veterinary canister-free NPWT device (Aluco Guardian or a successor)Not yet — no such literature was found; Aluco Guardian has no published accuracy/complication literature as of this pass
Would veterinary surgeons switch from off-label human PICO (or canistered V.A.C./RENASYS) to a purpose-built veterinary canister-free unit?3Nothing. Not answerableNobody — its twin is §5's off-label PICO and canister-based abandonment/complication record, which is answered above
Would owners pay several hundred dollars out of pocket for an adjunct veterinary NPWT device on top of a surgical bill?3Nothing. Not answerableNobody — no revealed-behaviour twin was located for veterinary owner cash-pay willingness specifically (unlike the diabetes-monitoring dossier, which has an owner-survey twin for a different device category); this is recorded as an open class-3 question with no available twin, not merely as unanswerable in principle
Is the equine-specific finding that isolated NPWT does not reduce wound size (secondhand, [14]) reproducible, and does it generalize beyond the small case series it is drawn from?2Independent retrieval and appraisal of the Schnierer et al. case series (not retrieved in this pass) and any follow-up equine RCTPartially — the commentary citing it was retrieved directly; the underlying case series itself was not
What patents, if any, block a new entrant on canister-free/superabsorbent NPWT or fur-compatible adhesive/dressing-interface chemistry?1patent connector, once PATENTSVIEW_API_KEY is set, against specific patent numbers from a human-commissioned FTO landscape searchBlocked today — a credential gap, mirroring candidate idea-002's own claims 5-7

Class-3 questions are recorded here and never answered here, per this repo's own rule.

Update 2026-09-20 — what moved, what did not, and three class-3 questions with their twins

The six questions above are kept as written. Their status after this refresh, plus what the refresh newly opened:

QuestionClassStatus after 2026-09-20What would still settle it
US caseload of dogs/horses with NPWT-warranting distal-limb wounds2Still not found. Banfield SOPH lists no wound-trauma edition; no US VetCompass instance retrieved; vmdb.org failed at DNS — not retrieved, not not found. Wound cause and location distributions were found instead (§1)A US veterinary EHR/claims study scoped to distal-limb trauma or degloving, with a national denominator
Would a species-specific drape reduce the documented adhesion/seal failure?2 once such a product publishesStill no such literature. But the failure it would have to beat is now measured: the one published equine canister-free trial did not complete, on seal and adhesion, despite many adjunctive adhesives [12]A complication study of a purpose-built veterinary canister-free NPWT device
Would veterinary surgeons switch from off-label PICO/canistered systems to a purpose-built veterinary unit?3Unanswered, deliberately. Its twin is now materially better evidenced: the off-label incumbent's failure record (§5), plus the finding that none of the three named US veterinary distributors lists any NPWT product in its public catalog while a direct-to-clinic vendor channel does exist (§8)Nothing settles the class-3 form. Its twin is settled further by distributor account-level catalog data and by any published veterinary NPWT purchase or utilisation series
Would owners pay several hundred dollars out of pocket for an adjunct veterinary NPWT device?3Unanswered, deliberately. The 2026-08-27 entry recorded no available twin; that is now wrong and is corrected rather than deleted. Twins found (§3): stated willingness to spend in 306 uninsured US dog owners [36], and pre-surgical euthanasia at 10% insured vs 37% uninsured in 260 GDV dogs [37]Nothing settles the class-3 form. The twins would be sharpened by a spend or abandonment cohort scoped to wound care specifically
Is the secondhand equine finding that isolated NPWT does not reduce wound size reproducible?2Unchanged — the Schnierer case series still retrieved only via a commentaryIndependent retrieval of the case series
What patents block a new entrant on canister-free/superabsorbent NPWT or fur-compatible interface chemistry?1Partly answered (§7). Four live patents now carry numbers and claim-1 summaries; no patent claiming adhesive chemistry for hair-bearing skin or a limb-conforming veterinary interface was foundA CPC-restricted browse of A61M1/90–A61M1/98, family-member enumeration, and a claim-chart comparison by counsel. A public keyword search is not an FTO opinion
New: Which NPWT system did the unfavourable equine distal-limb study use?2One secondary table names "VAC ATS"; nothing corroborates it; three transcription errors sit on that row; the primary Methods text was never read (§4)The Methods section of DOI 10.1111/evj.13487, or a correspondence/erratum from either author group
New: Do US pet insurers exclude NPWT or wound-care devices?2Two insurers are SILENT on the category in their published wording, one is silent on the only reachable page, and one was not retrieved at all (§6). Silence is not permissionA filed policy form read in full — every PDF route attempted this pass was unreadable in the retrieving environment
New: Would a US pet insurer in practice reimburse an owner for a veterinary NPWT course?3Not researched and not answered. Its twin is the published adjudication basis and exclusion wording recorded at §6Nothing settles the class-3 form
New: Would FDA exercise its §§ 351/352 authority against an animal-only NPWT device's labelling claims?3Not answered. "FDA's posture" invites a class-3 answer about agency intent and was deliberately read as two answerable questions instead — what a retrievable document states (CPG 655.100: not retrieved from any host) and what a retrievable record shows FDA did (three Class II classifications of veterinary-labelled devices, all firm-initiated, §5)Nothing settles the class-3 form. The stated half would be settled by the CPG text itself; the exercised half by an FDA-mandated action naming an animal-only device, of which none was found
New: What is a US veterinary net acquisition price for a single-use NPWT unit, and what margin remains at a $180–$320 practice price?2Not found. No public citable source prices a BOM (bill of materials), a contract-manufacturer COGS (cost of goods sold), or a veterinary distributor margin schedule for this SKU class. Human-market price anchors were found instead (§5)A distributor account catalog, a contract-manufacturer quote, or a distributor margin schedule — all human-attached

10. Provenance & staleness

Sectionas_ofHow it was gatheredNever checked
1 Epidemiology2026-08-27connectors literature (4 queries, listed above); no hits generalizable to this candidate's populationBanfield/Mars, VetCompass US, Veterinary Medical Database, AAEP/ACVS caseload reports
2 Care pathway2026-08-27Reused abstracts from §4/§5 sweeps (PMIDs 25449799, 27569833, 34670699, 34115409)US practice-level site-of-service mix, visit frequency, staffing
3 User groups2026-08-27Reused from §4/§5/§8 sources; one vendor page fetched directly for the operator-support findingclinic-side economics, technician-specific incentives, veterinary-specific owner cost-burden survey
4 Clinical evidence2026-08-27connectors literature/literature-detail on the PMIDs listed below, abstract depth; one review page (BEVA/Wiley) fetched directlyACVS/AAHA wound-management guideline full text (not attempted); the Schnierer et al. case series itself (only its secondhand description was retrieved)
5 Reference products2026-08-27Same PMIDs as §4, plus connectors recalls --product-code OMP (37 records, full set inspected), connectors clearance-summary K211318, two vendor pages fetched directlyMAUDE narratives (no connector); a systematic multi-vendor veterinary price survey; any veterinary-specific recall/complaint channel (none exists)
6 Reimbursement2026-08-27Inference from independently re-run regulation 807.65 [21]; one vendor page for the cash-pay/payment-method findingcommercial pet-insurance policy documents (Trupanion/Nationwide/ASPCA) for wound-care devices specifically
7 Technology2026-08-27connectors clearances --product-code OMP (103 total matches, 10-year window, 50 most recent records inspected); connectors clearance-summary K211318membrane/dressing-adhesive chemistry literature specific to fur-compatible or limb-conforming interfaces; patent landscape (credential-blocked, same gap as candidate idea-002)
8 Market players2026-08-27Web search followed to primary vendor pages (alucohealth.com, thewoundvaccompany.com/veterinary); openFDA recalls/clearances reused from §5/§7funding data for Aluco Health or any purpose-built veterinary NPWT vendor; any veterinary-specific recall channel (none exists)

Refresh pass 2026-09-20 — per-section stamps and how each was gathered

Sectionas_ofHow the 2026-09-20 material was gatheredNever checked, as of this pass
1 Epidemiology2026-09-20Sources of the fleet reports canine-equine-distal-limb-wounds.epidemiology.epidemiology-overview and …market-players.vet-npwt-tam-caseload-price-share, each cited here by its own primary identifiera US-national caseload denominator for either species; Banfield/Mars record-level data; VMDB (DNS failure — not retrieved)
2 Care pathway2026-09-20Sources of …care-pathway.care-pathway-overviewfraction of US practices stocking NPWT; recheck frequency post-discharge; staffing/throughput effect
3 User groups2026-09-20Sources of …user-groups.user-groups-overviewany owner spend or abandonment cohort scoped to wound care specifically; technician-specific incentives; clinic-side markup
4 Clinical evidence2026-09-20Sources of …clinical-evidence.npwt-device-form-factor-equine-distal-limb-rct (2026-09-20) and …clinical-evidence.clinical-evidence-overviewthe Methods text of DOI 10.1111/evj.13487 (paywall + HTTP 403 on both Wiley hosts, sign-in on the Ghent deposit, closed-access on Semantic Scholar, rate-limit on scholar.archive.org); the ResearchGate figure caption (HTTP 403); ACVS/AAHA/AAEP guideline full text; the Schnierer case series itself
5 Reference products2026-09-20Sources of …clinical-evidence.npwt-device-form-factor-equine-distal-limb-rct, …reference-products.reference-products-overview, cross-cutting.unit-economics.vet-npwt-cogs-distributor-margin, cross-cutting.fda-regulatory-posture.animal-device-postmarket-enforcement-practice, …market-players.vet-npwt-tam-caseload-price-shareMAUDE narratives (no connector); a BOM/COGS for any single-use NPWT device; a US veterinary net price; FDA's warning-letter database (fda.gov, bot-gated, not searched); the 510(k) summary PDF for K063590 (connector's PDF reader dependency not installed)
6 Reimbursement2026-09-20Sources of …reimbursement.pet-insurer-policy-wording-npwt-adjudication and …market-players.us-pet-insurance-penetration-dogsany filed policy form (every PDF route unreadable in the retrieving environment); Trupanion and Nationwide exclusion lists (HTTP 403, host-wide); SERFF-adjacent filing libraries outside Maine (not searched); the AVMA Pet Owner Survey 2025 denominator; the licensed NAPHIA State of the Industry Report itself
7 Technology2026-09-20Sources of cross-cutting.ip-patent-landscape.canister-free-npwt-patent-landscape and …care-pathway.care-pathway-overviewa CPC-restricted browse of A61M1/90–A61M1/98 (USPTO Patent Public Search not reachable as a query surface); continuation/divisional/foreign family members; Solventum/3M- and KCI-assigned NPWT patents (searched, nothing structural returned — a search gap, not a finding); fur-compatible adhesive chemistry literature
8 Market players2026-09-20Sources of …market-players.vet-distributor-npwt-listing and …market-players.vet-npwt-tam-caseload-price-shareaccount-gated distributor pricing and SKU views (never attempted); distributor searches on terms other than "wound vac"/"PICO"/"negative pressure"; Patterson's and Midwest's supplier-onboarding pages; mykci.com Animal Health page (two HTTP 505s and one blocked archive fetch — not retrieved)

Never folded into this dossier, and named so the hole is visible: the fleet report canine-equine-distal-limb-wounds.technology.technology-overview carries seven claim candidates on competing equine and canine wound-healing adjuncts (platelet-rich plasma, cord-blood MSCs, liquid amnion allograft, amorphous silicate dressing, ozone bagging, photobiomodulation, hyperbaric oxygen). They bear on the competitive landscape at this exact anatomical site and none of them is folded into §7 or §8 above — a deliberate scope call on this pass, not an absence of evidence, and the next refresh should work them.

Two sources named by their retrieving reports and deliberately not cited anywhere in this dossier: Trupanion's Form 10-K for FY2025 (SEC accession 0001371285-26-000018, CIK 0001371285), which describes veterinary hospitals receiving payment "directly for approved invoices"; and the Covetrus FY2020 (18.4% consolidated gross margin), Patterson FY2023 (21.2% consolidated gross margin) and Insulet 2007 IPO disclosures. Each was retrieved in full from SEC EDGAR by the retrieving pass and excluded on the identifier rule — an SEC accession number is not a resolvable identifier in this tree's vocabulary. They are named here so a later reader knows the material exists and why no line rests on it, not as findings.

Queries run against connectors literature in this pass (for anyone re-running this): "negative pressure wound therapy canister leak dressing failure," "single use negative pressure wound therapy discontinuation dressing," "PICO negative pressure wound therapy systematic review," "negative pressure wound therapy adverse events complications review," "vacuum assisted closure device complications dressing failure," "negative pressure wound therapy safety FDA bleeding death adverse event" (zero hits), "negative pressure wound therapy dog case series," "negative pressure wound therapy canine retrospective outcomes complications," "PICO single use negative pressure wound therapy randomized controlled trial device removed" (zero hits), "canister negative pressure wound therapy patient burden quality of life bulky noise" (zero hits), "negative pressure wound therapy quality of life patient experience," "PICO negative pressure wound therapy diabetic foot ulcer randomized" (request failed, HTTP 429, not retried), "negative pressure wound therapy horse retrospective case series," "equine distal limb wound healing second intention bandaging," "canine distal limb degloving wound incidence" (zero hits), "equine limb wound incidence trauma prevalence," "dog traumatic wound emergency presentation incidence veterinary," "equine wound trauma UK veterinary practice prevalence VetCompass" (zero hits), "cost negative pressure wound therapy veterinary practice economics" (zero hits), "Schnierer negative pressure wound therapy punch grafting horses" (zero hits), "equine wound healing distal limb review best practice evidence" (zero hits).

What this dossier has never looked at: MAUDE narratives (no connector exists in this repo, docs/backlog.md 1.9); any US veterinary epidemiology source outside PubMed's index (Banfield/Mars, VetCompass US, the Veterinary Medical Database — none reachable by connector, none located by web search this pass); the ACVS or AAHA wound-management guideline full text (not attempted, distinct from a 403-blocked attempt); the Schnierer et al. equine case series itself, only its secondhand description via a commentary; commercial pet-insurance policy text for any named insurer; a patent landscape search (credential-blocked); funding or company-financial data for any purpose-built veterinary NPWT vendor; a direct attempt at theveterinarynurse.com, which returned HTTP 403 and is recorded as not retrieved, the same class of failure this repo already names for fda.gov and aaha.org. Absence of scanning is not absence of change, and a later reader should treat §1 (epidemiology) and most of §6 (reimbursement) as a starting point, not as coverage.

What this dossier has still never looked at, restated 2026-09-20. Some of the 2026-08-27 list above is now closed and some of it is not, and a later reader needs the difference.

Closed or partly closed since 2026-08-27: the patent landscape (now six named US patents, §7 — but a keyword search, not a CPC browse and not an FTO opinion); commercial pet-insurance policy text for named insurers (§6 — public coverage pages only, no filed form); the distribution channel (§8 — public catalogs only, no account-gated view); veterinary epidemiology at the level of wound cause and location (§1 — still no caseload).

Still never looked at, or looked at and not reached: MAUDE narratives (no connector exists); Banfield/Mars, VetCompass US, and the Veterinary Medical Database (the last attempted 2026-09-13 and failed at DNS — not retrieved); the ACVS, AAHA or AAEP wound-management guideline full text; the Schnierer et al. equine case series itself; the Methods text of DOI 10.1111/evj.13487, which is the single highest-value unread document for this domain and is behind a paywall plus bot mitigation on every route tried; CPG Sec. 655.100's own text, not retrieved from any host, with fda.gov bot-gated (HTTP 401 measured again 2026-09-20); FDA's warning-letter database; any filed pet-insurance policy form (every PDF route attempted was unreadable in the retrieving environment); Trupanion's and Nationwide's exclusion lists (HTTP 403, host-wide); a US veterinary net acquisition price or any bill of materials for a single-use NPWT device; funding or company financials for any purpose-built veterinary NPWT vendor; case law applying FD&C Act §§ 501/502 to an animal-only device (no case-law connector exists in this repo's tool surface); and the seven competing-adjunct-therapy findings named at the end of §10's refresh table, which are sourced and sitting unfolded.

Sources

  1. PMID 33609382 — "Single-use negative-pressure wound therapy versus conventional dressings for closed surgical incisions: systematic literature review and meta-analysis," BJS Open, 2021 Jan 8. https://pubmed.ncbi.nlm.nih.gov/33609382/ (human population)
  2. PMID 33581961 — "Which determinants are considered to be important for adherence to Negative Pressure Wound Therapy: A multimethods study," Journal of Tissue Viability, 2021 May. https://pubmed.ncbi.nlm.nih.gov/33581961/ (human population)
  3. PMID 40358217 — "Patient preference with regard to negative pressure wound therapy and participation in wound care: a qualitative study," Journal of Wound Care, 2025 May 2. https://pubmed.ncbi.nlm.nih.gov/40358217/ (human population, n=10)
  4. openFDA device/recall, product_code=OMP, window 2011-08-31 to 2026-08-27, queried via python3 -m connectors recalls --product-code OMP --since 15y on 2026-08-27; 37 records retrieved and inspected in full. Individual record IDs cited inline: Z-1176-2025, Z-0507-2025, Z-0516-2025, Z-1596-2024, Z-1597-2024, Z-2542-2020, Z-1157-2014 through Z-1162-2014, Z-1067-2014, Z-1068-2014, among others in the full set. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm
  5. PMID 25449799 — "Negative pressure wound therapy, silver coated foam dressing and conventional bandages in open wound treatment in dogs. A retrospective comparison of 50 paired cases," Veterinary and Comparative Orthopaedics and Traumatology, 2015. https://pubmed.ncbi.nlm.nih.gov/25449799/
  6. PMID 27569833 — "Negative pressure wound therapy using a portable single-use device for free skin grafts on the distal extremity in seven dogs," Australian Veterinary Journal, 2016 Sep. https://pubmed.ncbi.nlm.nih.gov/27569833/
  7. PMID 28151546 — "Negative pressure wound therapy using polyvinyl alcohol foam to bolster full-thickness mesh skin grafts in dogs," Veterinary Surgery, 2017 Apr. https://pubmed.ncbi.nlm.nih.gov/28151546/
  8. PMID 33724500 — "Early and aggressive surgical debridement and negative pressure wound therapy to treat necrotizing fasciitis in three dogs," Veterinary Surgery, 2021 Nov. https://pubmed.ncbi.nlm.nih.gov/33724500/
  9. PMID 34670699 — "Use of Negative Pressure Wound Therapy in the Treatment of Limb Wounds: A Case Series of 42 Horses," Journal of Equine Veterinary Science, 2021 Nov. https://pubmed.ncbi.nlm.nih.gov/34670699/
  10. PMID 34115409 — "Limited added value of negative pressure wound therapy compared with calcium alginate dressings for second intention healing in a noncontaminated and contaminated equine distal limb wound model," Equine Veterinary Journal, 2022 May. https://pubmed.ncbi.nlm.nih.gov/34115409/ (also candidate idea-002 claim 20)
  11. PMID 35973001 — American Journal of Veterinary Research, 2022;83(10) — canister-free NPWT (PICO 1.6) pilot study in Beagles. https://pubmed.ncbi.nlm.nih.gov/35973001/ (also candidate idea-002 claim 9)
  12. PMID 30841889 — "Feasibility of a disposable canister-free negative-pressure wound therapy (NPWT) device for treating open wounds in horses," BMC Veterinary Research, 2019 Mar 6. https://pubmed.ncbi.nlm.nih.gov/30841889/ (also candidate idea-002 claim 10)
  13. PMID 37624295 — "Negative-Pressure Wound Therapy (NPWT) in Horses: A Scoping Review," Veterinary Sciences, 2023 Aug 6. https://pubmed.ncbi.nlm.nih.gov/37624295/ (also candidate idea-002 claim 10)
  14. Ribeiro et al., "Wound healing in horses: What went wrong?," *Equine Veterinary Education*, 2026, DOI 10.1111/eve.70089, retrieved directly 2026-08-27. https://beva.onlinelibrary.wiley.com/doi/10.1111/eve.70089 — commentary citing an equine case series (Schnierer et al.) not independently retrieved by this dossier.
  15. Aluco Health, "Aluco Guardian NPWT System," https://alucohealth.com/, retrieved directly 2026-08-27. UK-based vendor; non-US jurisdiction.
  16. The Wound Vac Company, veterinary services page, https://thewoundvaccompany.com/veterinary, retrieved directly 2026-08-27. US-based vendor.
  17. openFDA device/510(k), product_code=OMP, queried via `python3 -m connectors clearances --product-code OMP --since 10y` on 2026-08-27; 103 total matches, 50 most recent records inspected, including K211318 (Smith & Nephew PICO 7/14, cleared 2022-01-05).
  18. FDA 510(k) summary K211318, retrieved via `python3 -m connectors clearance-summary K211318` on 2026-08-27. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211318.pdf
  19. https://www.theveterinarynurse.com/content/clinical/the-use-of-negative-pressure-wound-therapy-in-veterinary-wound-care/ — attempted 2026-08-27, returned HTTP 403, not retrieved.
  20. knowledge-base/domains/veterinary-diabetes-glucose-monitoring.md — this repo's other veterinary domain dossier, cited for its parallel treatment of the no-federal-payer structure (§6) and its owner-survey abandonment-record method (§5), not as a source of fact about this domain's own population.
  21. `python3 -m connectors regulation 807.65 --title 21 --expect "veterinary" --jurisdiction US, run 2026-08-27 → status verified`, source_ref eCFR versioner title-21, issue 2026-08-19, section=807.65. Independently re-run for this dossier; the same section is already independently verified in candidate idea-002 claim 2.

Sources 22-78 added in the 2026-09-20 refresh.

  1. Banfield Pet Hospital, "State of Pet Health," https://www.banfield.com/State-of-pet-health — undated publisher page listing report years 2017/2018/2019; accessed 2026-09-13. Cited only for a negative finding (no wound-trauma installment named). No registry identifier.
  2. Ghent University Academic Bibliography record for "Limited added value of negative pressure wound therapy… equine distal limb wound model," handle 1854/LU-8719353, record for DOI 10.1111/evj.13487, https://biblio.ugent.be/publication/8719353 — accessed 2026-09-20. Its one deposited file returns a sign-in page rather than a PDF.
  3. "Advantages and disadvantages of negative pressure wound therapy in equine wound treatment," RUDN Journal of Agronomy and Animal Industries, Vol. 20 No. 1, pp. 61-78,
    1. DOI 10.22363/2312-797X-2025-20-1-61-78 — accessed 2026-09-20.
  4. FDA 510(k) K063590 — "V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423," Kci USA, Inc., decision date 2007-01-25. openFDA device/510k, accessed 2026-09-20. The 510(k) summary PDF itself was not retrieved (connector's PDF reader dependency not installed); only the openFDA record fields were read.
  5. FDA 510(k) K120033 — "ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT," Kci USA, Inc., decision date 2012-05-31. openFDA device/510k, accessed 2026-09-20.
  6. PMID 29890536 — prospective randomized trial of NPWT versus silver-coated foam dressing in 26 dogs. https://pubmed.ncbi.nlm.nih.gov/29890536/
  7. PMID 38791717 — 2024 scoping review of 81 manuscripts on equine second-intention wound healing. https://pubmed.ncbi.nlm.nih.gov/38791717/
  8. Device recall Z-1474-2024, Karl Storz Endoscopy — openFDA device/enforcement (FDA Recall Enterprise System), report date 2024-04-10, accessed 2026-09-20. Recall number Z-1474-2024; UDI-DI 04048551193587; catalogue REF 723014.
  9. USDA APHIS-VS-CEAH-NAHMS, "Equine Mortality in the United States, 2015" — nationally representative survey covering 28 states and 71.8% of all US equids; underlying data collection authorized under FR Doc. 2014-15749, 79 FR 38277.
  10. PMID 40898826 — canine trauma causes across 22 North American/UK Veterinary Trauma Centers, n=8,130 dogs, 2022-2023. https://pubmed.ncbi.nlm.nih.gov/40898826/
  11. PMID 29509322 — road-traffic-accident prevalence among dogs attending 115 UK primary-care practices, n=199,464. https://pubmed.ncbi.nlm.nih.gov/29509322/
  12. PMID 42193764 — owner-reported cohort of 219 horses with traumatic wounds. https://pubmed.ncbi.nlm.nih.gov/42193764/
  13. PMID 40931370 — UK NHS single-use NPWT discharge pathway case series, n=5 human patients with open lower-limb wounds. https://pubmed.ncbi.nlm.nih.gov/40931370/
  14. 21 CFR 878.4783 — negative pressure wound therapy device for reduction of wound complications, Class II with special controls; classification created by the final rule at Federal Register document 2021-26741 (86 FR 70373).
  15. PMID 33870521 — 2021 US survey of 306 uninsured dog owners on willingness to spend. https://pubmed.ncbi.nlm.nih.gov/33870521/
  16. PMID 33364255 — retrospective study of 260 dogs with gastric dilatation-volvulus across 24 US emergency clinics, pre-surgical euthanasia by insurance status. https://pubmed.ncbi.nlm.nih.gov/33364255/
  17. PMID 28306486 — 2017 JAVMA survey of 1,122 US/Canadian small-animal veterinarians on client economic limitations. https://pubmed.ncbi.nlm.nih.gov/28306486/
  18. PMID 32659934 — 2020 US logit-model study of pet health insurance and veterinary spend. https://pubmed.ncbi.nlm.nih.gov/32659934/
  19. PMID 37053369 — "A Cost and Metric Comparison of Disposable Negative-Pressure Wound Therapy Systems," Surgical Technology International, 2023. https://pubmed.ncbi.nlm.nih.gov/37053369/
  20. Retail listings for the human-labeled Smith & Nephew PICO 7 single-use NPWT dressing kit (10x30 cm, one dressing), manufacturer catalog no. 66022013 — Vitality Medical ($378.69) and WoundCareShop ($388.13, 10% off a $431.26 list), two independent non-affiliated US medical-supply retailers, both accessed 2026-09-13. Undated product listings; the catalog number is the only identifier either carries.
  21. PMID 33839751 — cost-effectiveness of single-use NPWT in prepectoral breast reconstruction, BJS Open, 2021, carrying the NHS Supply Chain PICO unit cost. https://pubmed.ncbi.nlm.nih.gov/33839751/
  22. PMID 29406300 — retrospective cost-minimization analysis of disposable and traditional NPWT Medicare paid claims, 2012-2014. https://pubmed.ncbi.nlm.nih.gov/29406300/
  23. PMID 33034531 — cost-minimization analysis of NPWT technologies for moderate-to-severe foot infections. https://pubmed.ncbi.nlm.nih.gov/33034531/
  24. FDA 510(k) K100823 — Accuro Medical Products, LLC, Wound Pro Apex, cleared 2011-01-24.
  25. FDA device recall Z-0009-2013 — Accuro Medical Wound Pro Apex.
  26. FDA 510(k) K161128 — Medela AG, Invia Motion NPWT system family, cleared 2016-12-01.
  27. FDA device recall Z-2528-2018 — Medela Invia Motion.
  28. FDA device recall Z-2543-2020 (with Z-2544-2020) — Cardinal Health 200, LLC NPWT canisters.
  29. 21 CFR 7.3 — Definitions (Part 7), subsections (f) and (g). eCFR, retrieved via this repo's regulation connector, issue 2026-09-16, accessed 2026-09-20. https://www.ecfr.gov/current/title-21/section-7.3
  30. Device recall Z-1640-2022, bioMerieux, Inc. — openFDA device/enforcement, report date 2022-09-07, accessed 2026-09-20.
  31. Device recall Z-1911-2020, ICU Medical, Inc. — openFDA device/enforcement, report date 2020-05-13, accessed 2026-09-20. Catalogue REF AH7117.
  32. 21 CFR 7.40 — Recall policy, and 21 CFR 7.45 — Food and Drug Administration-requested recall. eCFR, retrieved via this repo's regulation connector, issue 2026-09-16, accessed 2026-09-20. https://www.ecfr.gov/current/title-21/section-7.40 · https://www.ecfr.gov/current/title-21/section-7.45
  33. ASPCA Pet Health Insurance, "What Does Pet Insurance Cover?", https://www.aspcapetinsurance.com/research-and-compare/pet-insurance-basics/whats-covered/ — undated insurer-hosted coverage page, no policy form number, accessed 2026-09-20.
  34. ASPCA Pet Health Insurance, "Vet Services FAQs", https://vet.aspcapetinsurance.com/faqs/ — undated insurer-hosted FAQ page, accessed 2026-09-20.
  35. Healthy Paws Pet Insurance, "Coverage & Exclusions Details", https://www.healthypawspetinsurance.com/pet-insurance-coverage-and-exclusions.html — undated insurer-hosted coverage page, no policy form number, accessed 2026-09-20.
  36. Nationwide Mutual Insurance Company, "Pet Health Insurance", https://www.nationwide.com/personal/insurance/pet/ — undated insurer-hosted product page, accessed 2026-09-20. www.petinsurance.com, where the plan documents live, returned HTTP 403 on every path tried and is recorded as not retrieved.
  37. California Insurance Code § 12880.2 (pet insurance; required disclosures), California Legislative Information, accessed 2026-09-20. https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=INS&sectionNum=12880.2 — a codified state statute, not a US federal registry record.
  38. California Insurance Code § 12880 (pet insurance; definitions), California Legislative Information, accessed 2026-09-20. https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=INS&sectionNum=12880.
  39. North American Pet Health Insurance Association, "NAPHIA State of the Industry Report," 2026 edition, Highlights release, published 2026-06-21, accessed 2026-09-13. https://naphia.org/wp-content/uploads/2026/06/NAPHIA_SOI2026_Report_HIGHLIGHTS_26-06-24.pdf — the free public Highlights deck, distinct from the full licensed report, which was not purchased or accessed.
  40. NAPHIA News, "North American Pet Health Insurance Industry Market Reaches $5.2B in Written Premium," published 2025-04-22, accessed 2026-09-13, reporting year-end 2024 SOI data. https://naphia.org/news/naphia-news/soi-report-2025/
  41. US9061095B2 — "Wound dressing and method of use," Smith and Nephew PLC, granted 2015-06-23. https://patents.google.com/patent/US9061095B2/en — accessed 2026-09-13.
  42. US11395870B2 — "Negative pressure wound therapy apparatuses and methods for using the same," T.J Smith and Nephew Ltd, granted 2022-07-26. https://patents.google.com/patent/US11395870B2/en — accessed 2026-09-13.
  43. US12453658B2 — "Absorbent Negative Pressure Wound Therapy Dressing," Smith and Nephew PLC, granted 2025-10-28. https://patents.google.com/patent/US12453658 — accessed 2026-09-13.
  44. US12447258B2 — "Negative pressure wound therapy (NPWT) dressing," Mölnlycke Health Care AB, granted 2025-10-21. https://patents.google.com/patent/US12447258B2/en — accessed 2026-09-13.
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  46. US11260164B2 — "Negative pressure wound therapy dressing and related apparatus," Genesis Medical Devices LLC, granted 2022-03-01. https://patents.google.com/patent/US11260164B2/en — accessed 2026-09-13.
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  48. Covetrus North America, "Treatment And Recovery" category page, https://northamerica.covetrus.com/product-categories/treatment-and-recovery, accessed 2026-09-13 — returned "Your search returned 0 results."
  49. Patterson Veterinary catalog search for "wound vac", https://www.pattersonvet.com/Search?SearchTerm=wound+vac, accessed 2026-09-13 — cited for an absence.
  50. Patterson Veterinary catalog search for "PICO", https://www.pattersonvet.com/Search?SearchTerm=PICO, accessed 2026-09-13 — cited for an absence.
  51. Midwest Veterinary Supply catalog search for "wound vac", https://www.midwestvetsupply.com/search?q=wound+vac, accessed 2026-09-13 — cited for an absence.
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Words on this page24 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md
21 CFR
Title 21 of the Code of Federal Regulations — the US food-and-drug rulebook; a number after it is one regulation, often the one that classifies a device type
510(k)
premarket notification — the FDA route for a device shown to be as safe and effective as one already on the market; months, no clinical trial as a rule
ACVS
American College of Veterinary Surgeons — the US specialist board for veterinary surgeons
AVMA
American Veterinary Medical Association — the main US association of veterinarians
BOM
bill of materials — the list of parts in a product and what each costs
Class II
FDA device class II — moderate-risk devices, usually cleared by 510(k)
COGS
cost of goods sold — what it costs to make one unit
CPT
Current Procedural Terminology — the US billing codes for what a clinician does; owned by the American Medical Association
EHR
electronic health record — the hospital's or practice's patient-record software
FDA
US Food and Drug Administration — the US regulator that clears or approves a device before it can be sold
FTO
freedom to operate — whether a product can be sold without infringing someone else's live patent
GUDID
Global Unique Device Identification Database — the FDA's public list of marketed devices by their identifier
HCPCS
Healthcare Common Procedure Coding System — the US billing codes for equipment, supplies and some services; a code is how a payer recognises what to pay for
K######
an FDA 510(k) clearance number — the public record of one cleared device; the letter K and six digits
MAUDE
Manufacturer and User Facility Device Experience — the FDA's public database of reported device problems
NCD
national coverage determination — a Medicare rule, valid everywhere in the US, saying whether and when something is covered
NHS
National Health Service — the UK's public health service
NPWT
negative-pressure wound therapy — sealing a wound under an airtight dressing and applying gentle suction to help it heal
PICO
population, intervention, comparator, outcome — the four parts of a well-posed clinical question
PMID
PubMed identifier — the public id of one published medical paper
RCT
randomised controlled trial — the kind of clinical study that compares a treatment against an alternative by chance assignment
TAM
total addressable market — how much money the whole market would be worth if every possible buyer bought
UDI
unique device identifier — the barcode-style id every marketed device carries
USPTO
United States Patent and Trademark Office — the US patent office