Transparency register · site-wide
Sources, assumptions and the values we do not know yet.
Medical Cooling separates sourced facts from calculations and planning choices. A source link means that the linked source supports the cited external fact; it does not validate AIRCHILL. Derived values show arithmetic from sourced/local inputs. Transferred values are explicit cross-market comparison proxies and are kept separate from national epidemiology. Assumptions are editable planning inputs. Missing values are deliberately left open rather than filled with false precision.
Linked to the underlying publication, registry, authority or public dataset wherever an online source is available.
The formula or derivation must remain visible and is not presented as an independently measured value.
A local denominator multiplied by a foreign, European or other non-local rate. It may support sensitivity analysis but is not national epidemiology and is not auto-loaded into the impact calculator.
Used to test a scenario. It is not a clinical effect, authority decision, quotation or forecast.
The model leaves the epidemiologic default open rather than manufacturing a local number. A visitor may enter a scenario value, which is then labelled USER INPUT.
Current assumption and data-gap register
This table is the site-wide control layer for the values most likely to be misunderstood as facts. It should be updated whenever a new registry count, authority decision, quotation, product design freeze or clinical result replaces an assumption.
| Area | Value / question | Status | Current handling | What would replace it |
|---|---|---|---|---|
| Cardiac arrest · Germany | 7,500 potentially narrower early-cooling patients/year | ASSUMPTION | Operational modelling cohort; not registry-derived eligibility. | Prospective inclusion/exclusion study using final intended use and EMS workflow. |
| Stroke · Germany | 21,609 thrombectomies in 2024 | SOURCED SYSTEM FRAME | Updated nationwide hospital/procedure frame. AIRCHILL eligibility remains unknown and must be applied as a separate addressability parameter. | Final airway/timing eligibility study in EVT population plus state-level procedure extracts. |
| Neonatal HIE · generic fallback | 1.5 per 1,000 live births | TRANSFERRED PLANNING RATE | Used only where a comparable local HIE source has not yet replaced it; not device eligibility. | Market-specific clinically validated HIE incidence plus current therapeutic-hypothermia eligibility. |
| HIE · USA | ~1.7 per 1,000 live births; ~6,131/year when applied to 2025 births | LOCAL RATE + DERIVED COUNT | Population-based clinically reviewed US incidence is used instead of the generic 1.5/1,000 fallback. | Current national clinically confirmed moderate/severe HIE and therapeutic-hypothermia eligibility counts. |
| HIE · China | Literature range ~3–6 per 1,000; model midpoint 4.5/1,000 | RANGE / ASSUMPTION | The atlas exposes the range; 4.5/1,000 is only the midpoint used for an editable model conversion, not a measured national incidence. | Current nationally representative clinically validated HIE incidence and treatment eligibility. |
| Heat stroke | National severe device-eligible denominator | DATA GAP | Use standardized per-100 severe-case scenarios; no national AIRCHILL cohort asserted. | Prospective national or multicentre severe-heat-stroke case registry with ventilation status. |
| Severe TBI · Germany | 7,500 operational cohort | ASSUMPTION | Narrower than the ~11,400 moderate-to-severe system frame to reflect practical exclusions. | Final severe/intubated phenotype and eligibility analysis. |
| Concussion · Germany | ~44,000 sports-related concussions/year | ORDER-OF-MAGNITUDE FRAME | Used only for adjacent non-invasive research; not a current AIRCHILL indication. | Current national surveillance matched to the target sports population. |
| International severe TBI / concussion | No automatic local default where a comparable severity/community denominator is missing | DATA GAP | Deep Research removed the previous automatic German-rate population scaling from country defaults. Broad TBI hospitalization and hospital-only concussion counts are not treated as equivalent local epidemiology. | Local severity-specific trauma registry / surveillance data using comparable definitions. |
| USA OHCA | 263,711 EMS-treated non-traumatic OHCA (CARES 2024) | SOURCED | Hospital admission / ROSC are no longer used as automatic eligibility filters because they are downstream outcomes. AIRCHILL addressability and reach are separate editable parameters. | Final trial-eligible phenotype, timing window and actual adoption. |
| China OHCA | Population × BASIC-OHCA incidence; attempted-resuscitation filter | DERIVED | Population-scaled planning estimate, not audited annual national volume. | Current nationwide annual EMS-resuscitation count. |
| China thrombectomy | 81,865 procedures in reporting stroke centres (2023) | SOURCED NETWORK COUNT | Replaces the older 104,704 arithmetic estimate as the default national stroke-centre procedure frame. It is still not the same as an audited all-China population procedure census. | Current nationwide audited procedure count with province-level coverage. |
| China · 31 province-level regions | 2024 population + crude birth rates; provincial OHCA/MT direct overrides where available | MIXED SOURCE HIERARCHY | NBS supplies local denominators. Provinces without clinical direct data use visible national-rate derivations. Zhejiang OHCA and Guangdong MT override the national scaling with local evidence. | Province-specific EMS, stroke-centre, HIE, heatstroke, severe-TBI and concussion registries. |
| Germany · 16 Bundesländer | Exact 31 Dec 2025 populations; OHCA uses a transferred European proxy and MT a derived population-share allocation until local clinical sources are loaded | TRANSFERRED OHCA DERIVED MT | OHCA uses the 55/100,000 European comparison proxy; MT allocates the sourced 21,609 German total by population share. The atlas explicitly says neither is a measured state volume. | State-/network-level Reanimationsregister and thrombectomy procedure extracts. |
| Taiwan OHCA | Historical incidence scaled to 2025 population | HISTORICAL / DERIVED | Not presented as a current national annual count. | Current national OHCA registry volume. |
| Taiwan thrombectomy | ~2,000/year | HISTORICAL DIRECT | NHIA figure from before reimbursement-window expansion; current activity may be higher. | Current NHIA annual procedure count. |
| Qatar thrombectomy | ~38/year | HISTORICAL AVERAGE | Derived from registry period and reported MT rate. | Current annual national stroke-registry procedure count. |
| Qatar HIE | Birth denominator | STALE INPUT | Uses available 2021 official births, explicitly not a 2025/26 count. | Current official annual births. |
| EU OHCA comparison proxy | 55 OHCA/100,000 × national population where no compatible local value is loaded | TRANSFERRED PROXY | The proxy is retained for comparison only. The previously used 89/100,000 value is not treated as interchangeable because EuReCa/Utstein denominator definitions and registry coverage can differ. Transferred values are not auto-loaded into the calculator. | Denominator-compatible national EMS/OHCA registry extraction for each member state. |
| EU thrombectomy comparison proxy | ~66.4k/year across the current 2025 population snapshot | TRANSFERRED PROXY | Population × 249 strokes/100k × 80% ischaemic share × 7.4% MT sensitivity. Germany’s sourced 21,609 MT in 2024 overrides this proxy. | Country-level audited EVT/MT procedure counts from national claims, hospital or stroke-registry systems. |
| EU economic calculator · currency | Country-specific ISO 4217 currency | CORRECTED SYSTEM FIELD | EU membership no longer implies EUR. Czechia = CZK, Denmark = DKK, Hungary = HUF, Poland = PLN, Romania = RON and Sweden = SEK; Bulgaria is treated as EUR in the 2026 research frame. | Automated currency metadata plus dated FX source for cross-currency comparisons. |
| Primary value vs proxy | National/direct denominator and transferred sensitivity are separate concepts | GOVERNANCE RULE | SOURCED/DERIVED local values may load as defaults. TRANSFERRED values require explicit user activation. DATA GAP is never converted to zero, and USER INPUT does not overwrite the source record. | Versioned machine-readable register with primary_value, proxy_value, evidence_status and vintage_status. |
| United Arab Emirates / Dubai | UAE population ~11.29m (2024); 18,685 inpatient beds (~1.66/1,000). Dubai resident population ~4.471m (Q3 2025). | CLINICAL DATA GAP / SOURCED SYSTEM FRAME | Dubai is retained as a distinct emirate/subregional research target. UAE/Dubai system capacity and population are sourced, but they do not substitute for OHCA, EVT, HIE, severe heatstroke, severe TBI or concussion denominators. | DHA / Dubai Corporation for Ambulance Services / MOHAP: EMS-resuscitation OHCA, EVT procedures, T67.0 + hospital/ICU status and severe S06.x + ventilation/GCS filters. |
| Saudi Arabia | Population ~35.3m (2024); SOHAR recorded 3,671 OHCA cases in selected regions during 2019–2022 | NATIONAL DATA GAP / REGIONAL SOURCE | SOHAR is retained as regional evidence and is not scaled into a national Saudi OHCA count. No generic international rate is substituted. | SRCA/MOH national EMS denominator and catchment coverage; claims-based EVT; national T67.0 heatstroke and severity-specific trauma extracts. |
| Brazil | Population 213,421,037 (1 Jul 2025); OHCA ~100k derived frame; SUS MT ~759 in 2024; TBI hospitalisations ~131,015/year historical mean | MIXED: DERIVED / SOURCED | OHCA is a literature-derived planning magnitude, MT is a public-system procedure signal, and TBI hospitalisations are broader than severe/intubated TBI. | National OHCA registry-quality denominator; all-payer MT count; DATASUS severity/ICU filters; T67.0 and S06.0 extracts. |
| New Zealand | Population ~5.325m (Jun 2025); 2,466 treated OHCA in Jul 2024–Jun 2025; mild-TBI population evidence available | SOURCED / HISTORICAL CONTEXT | OHCA can be used as a national treated denominator. Mild-TBI evidence is not relabelled as total concussion or severe TBI. | National EVT count, HIE denominator, severe heatstroke and severity-specific TBI extracts. |
| Australia | Population ~27.5m research frame; ~26,000 OHCA/year; ~710 extreme-heat hospitalisations/year; 10,700 concussion hospitalisations in 2021–22 | SOURCED SYSTEM FRAMES | Heat hospitalisations are broader than clinically defined severe heatstroke, and concussion hospitalisations understate community burden. | National EVT procedure count, clinically defined severe heatstroke subset and severe/intubated TBI denominator. |
| Japan | Population ~123.05m (2025); nationwide EMS context with ~7.64m ambulance dispatches in 2023 and 5,415 ambulance teams by Apr 2024 | CLINICAL DATA GAP / STRONG SYSTEM DATA | Dispatch volume and ambulance capacity are system indicators, not OHCA counts. No unsupported clinical denominator is inserted. | FDMA Utstein-compatible national OHCA extraction; MHLW NDB Open Data for EVT; national heat/trauma/claims datasets for remaining indications. |
| South Korea | 33,586 OHCA cases transported by 119 EMS in 2023; population frame ~51.685m in 2025 | SOURCED NATIONAL OHCA | The national 119-EMS surveillance value replaces the previous OHCA data gap. It is a system denominator, not AIRCHILL eligibility. EVT, HIE, severe heatstroke, severe TBI and community concussion remain separate gaps. | HIRA/NHIS procedure-code extraction for EVT; national heat/trauma/claims datasets for the remaining models. |
| Future post-operative cooling model | No universal postoperative denominator is defined | DATA GAP / DEFINITION REQUIRED | No country is assigned a postoperative cooling population. A future model must first define target procedures, then apply ICU/ventilation and clinical-eligibility filters. | Frozen target-procedure list plus country-specific procedure counts and prospective eligibility definition. |
| International economics | Value per favourable outcome | DATA GAP | Global Impact calculator defaults to zero; user must enter a local value. | Country-specific societal-cost / QALY / payer analysis for the exact endpoint. |
| All impact models | +1 / +3 / +5 percentage-point effects | ASSUMPTION | Common sensitivity grid only; not AIRCHILL efficacy estimates. | Prospective randomized AIRCHILL clinical evidence. |
| Study planner | Control rates, effect, sites, recruitment, attrition and costs | ASSUMPTION | Editable planning defaults; binary power approximation only. | Protocol-specific current event rates, CRO/site quotes and regulator/statistician agreement. |
| EU regulation | MDR class IIb | REGULATORY HYPOTHESIS | Conservative planning case for current MVP. | Final intended purpose/design plus Notified-Body/competent-authority determination. |
| USA regulation | 510(k), De Novo fallback | REGULATORY HYPOTHESIS | Pre-Sub is the first formal gate. | FDA feedback on intended use, product code, predicate and evidence package. |
| China regulation | Imported Class III | REGULATORY HYPOTHESIS | Formal NMPA classification comes first. | NMPA classification / attribute determination. |
| Oxygen / LOX boundary | Device administration vs integral drug-device / medicinal-product route | UNRESOLVED ARCHITECTURE-DEPENDENT | External separately supplied medical oxygen is the lowest-complexity base case; integrated LOX is treated as a separate decision. | Frozen gas architecture plus NB/medicine-authority, FDA OCP and NMPA determination as applicable. |
| Standards | Exact applicable editions / national adoptions | TO BE FROZEN | Current matrix is an applicability map, not a declaration that every standard applies. | Final intended use, architecture and submission-date harmonized/recognized standards list. |
| Regulatory timeline / cost | EU, FDA, NMPA programme ranges | MANAGEMENT ENVELOPE | Planning sensitivity, not authority quotation or approval promise. | Notified-Body/FDA/NMPA feedback, lab/CRO quotes and final evidence plan. |
| Funding | €7.5m current round; €10–15m follow-on; €12/17/24m low/base/high | MANAGEMENT MODEL | Not committed financing and not quotations. | Signed financing, supplier/CRO quotes and updated development plan. |
| Founder capacity | Weekly hours, compensation, transition date, employment/IP terms | DATA GAP | Not modelled as full-time availability until documented. | Executed employment/secondary-employment and IP arrangements. |
| Patent control | Assignment / exclusive licence to operating company | OPEN CORPORATE ACTION | Public registers name the inventor/applicant; company ownership is not claimed. | Executed assignment or exclusive worldwide sublicensable licence plus register updates. |
| Germany EMS fleet | Absolute ambulance fleet count | DATA GAP | No official national count used; any fleet size must be derived from published deployment density. | Audited national vehicle inventory or validated district-level aggregation. |
| Commercial model | Final device price, consumable price, gross margin, adoption | UNVALIDATED COMMERCIAL ASSUMPTION | Peer and dealer prices are anchors only. | Frozen BOM, manufacturing quotes, tenders, customer interviews and signed procurement data. |
Register architecture. Evidence status and data vintage are separate concepts: a directly measured older registry value can be SOURCED + HISTORICAL. USER INPUT belongs to the active scenario and never overwrites the source record. The production target is a versioned machine-readable register with explicit primary values, proxies, source URLs, denominator definitions and review dates.
Linked primary and public sources used across the site
This directory prioritizes original publications, official registries, authorities and public datasets. Some project-internal documents, including the BMBF final report and investor model, are not public online and are therefore identified as internal/project sources rather than given a fabricated link.
AIRCHILL mechanism: Sedlacik et al. · high-flow cold-air MRI thermometry. The BMBF Go-Bio 031A530 final report and ISMRM 2016 poster are project sources and are available on request rather than linked to a non-existent public file.
Cardiac arrest: TTM2 · PRINCESS · PRINCESS2 design paper · PRINCESS2 100-patient pilot · HYPERION · German Resuscitation Register annual reports.
Stroke: COTTIS matched-pair analysis · COTTIS-2 / NCT06301412.
Neonatal HIE: Shankaran et al. whole-body hypothermia trial.
Heat stroke: RKI heat-attributable mortality · Destatis heat/sunlight hospital treatment statistics.
Severe TBI: LTH-1 · POLAR · Eurotherm3235.
Concussion: selective head–neck cooling cohort.
Therapeutic gases: HYBRID II hydrogen trial · TAME mild-hypercapnia trial.
Preclinical timing: Lyden et al. depth–delay–duration study.
EU regulation: Regulation (EU) 2017/745 (MDR).
Clinical investigations & human factors: ISO 14155:2026 · IEC 62366-1:2015 + Amd 1:2020 · FDA Applying Human Factors and Usability Engineering to Medical Devices.
FDA: 21 CFR 868.5895 · continuous ventilator · Q-Submission Program · IDE process · MDUFA fees · OCP RFD / Pre-RFD process.
International impact inputs: The Global Impact Atlas & Models covers USA, China, Taiwan, Qatar, all EU member states, Germany by Bundesland, China by province, Switzerland, United Kingdom, UAE with Dubai-specific context, Saudi Arabia, India, Brazil, New Zealand, Australia, Japan, South Korea, Canada, Mexico and Argentina. The evidence vocabulary now distinguishes SOURCED, DERIVED, TRANSFERRED, ASSUMPTION and DATA GAP; transferred proxies require explicit activation in the calculator. Key system sources include Eurostat, UAE MOHAP, Dubai DHA, Saudi GASTAT, Japan FDMA, Japan NDB Open Data, South Korea OHCA surveillance, HIRA, Hato Hone St John, AIHW and CIHI.
EMS reimbursement research: The Global EMS Reimbursement Atlas separates who funds the ambulance service, who procures equipment, the likely first access route and whether a separate device-payment mechanism is actually documented. Germany is treated as a local remuneration geography under §133 SGB V; England is linked to the NHS Payment Scheme; the United States to the Medicare Ambulance Fee Schedule; Australia to state/territory ambulance financing rather than Medicare. Markets without comparable payment-path research remain DATA GAP.
Patents: EP3509683B1 · US11395900B2 · WO2018046128A1.
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