What the thesis is built on
Every external source hmm has relied on across its research, memoranda, modelling and comparables. Primary sources come first: regulators and legislation registers, government datasets, statistics agencies, exchange filings, peer-reviewed literature and standards bodies. Named commercial datasets fill the gaps where no primary source exists, and sales-gated sources are named but not linked.
Sources marked IM are the ones the Information Memorandum relies on: cited in its text, or counted in its instrument count.
01Regulatory & legal instruments
Japan · enforceable
| Source | Issuer | In force | Juris. | Supports |
|---|---|---|---|---|
| PMD Act (Pharmaceuticals & Medical Devices, 145/1960) IM | PMDA / MHLW | 1961 | JP | Base drug / device statute |
| PMD Act 2019 amendment · IDATEN / conditional early approval IM | PMDA | 2020 | JP | Post-approval model-change protocol |
| JAS Act (Japanese Agricultural Standards, 175/1950) IM | MAFF | 1950 | JP | Agricultural standards |
| Cartagena Act (GMO / biodiversity, 97/2003) IM | MAFF/METI/MEXT | 2004 | JP | GMO biosafety |
| Food Labelling Act (70/2013) IM | Consumer Affairs Agency | 2015 | JP | Food labelling |
| Food Sanitation Act · HACCP mandate (233/1947) IM | MHLW | 2020 | JP | Mandatory HACCP hygiene |
| Economic Security Promotion Act (43/2022) IM | Cabinet Office / METI | 2022 | JP | Critical-minerals designation |
| APPI (Personal Information Protection, 57/2003, 2020 amdt) IM | PPC | 2022 | JP | Data privacy |
| FIT / FIP Renewable Electricity Act (108/2011) IM | METI | 2012 | JP | Feed-in tariff / premium |
| GX Promotion Act (32/2023) IM | METI | 2023 | JP | Decarbonised-growth transition |
| AI Promotion Act (53/2025) IM | Cabinet Office (AI Strategy HQ) | 2025 | JP | AI strategy framework |
| Basic Act on Food, Agriculture & Rural Areas (revised) | MAFF | 2024 | JP | Food security made statutory |
| Food Supply Emergency Measures Act | MAFF | 2024 | JP | Food-security emergency powers |
| Smart Agriculture Technology Promotion Act | MAFF | 2024 | JP | Certified smart-ag plans register |
| QMS Inspections to Foreign Manufacturing Facilities IM | PMDA | 2024 | JP | A partial-change approval and a quality-system inspection before a main assembly site is added or changed; periodic inspection every five years |
Australia · enforceable
| Source | Issuer | In force | Juris. | Supports |
|---|---|---|---|---|
| Therapeutic Goods Act 1989 (Cth) IM | TGA | 1991 | AU | Principal medical-device / medicines regime |
| TG Amendment · priority / provisional approval IM | TGA | 2018 | AU | Expedited approval pathways |
| Medical Devices Amendment (2021) · SaMD IM | TGA | 2021 | AU | Software-as-medical-device classification |
| Medical-device adverse-event reporting (ASDER) IM | TGA | 2026 | AU | Post-market device surveillance |
| AusUDID unique device identification IM | TGA | 2025 | AU | Device identification database |
| Food Standards Australia New Zealand Act 1991 IM | FSANZ | 1991 | AU/NZ | Food-standards statute |
| Food Standards Code 3.2.2A IM | FSANZ | 2023 | AU | Food-safety management tools mandate |
| Agricultural & Veterinary Chemicals Code Act 1994 IM | APVMA | 1995 | AU | Agvet chemical registration |
| Gene Technology Act 2000 IM | OGTR | 2001 | AU | GMO regime |
| Foreign Acquisitions & Takeovers Act 1975 (FIRB) IM | Treasury / FIRB | 2021 | AU | National-security investment screening |
| Privacy Act 1988 (amended 2024) IM | OAIC | 1989 / 2024 | AU | Data-privacy regime |
| Safeguard Mechanism (Crediting) Amendment Act 2023 | Clean Energy Regulator | 2023 | AU | Emissions baselines / credits |
| National Electricity Rules IM | AEMC / AEMO | standing | AU | NEM market rules |
| Future Made in Australia (CMPTI) Act 2025 IM | Treasury / ATO | 2025 | AU | Critical-minerals production tax incentive |
| AEMC draft rule · data-centre grid connection | AEMC | draft, 2026 | AU | Energy system re-regulated for AI demand. A draft rule determination, so it sits outside the counted stack |
| Access Standard Assessment Guide IM | AEMO | Jan 2019 | AU | Generator performance standards agreed at the connection point (NER 5.3.4A); alterations assessed again (NER 5.3.9) |
New Zealand · enforceable
| Source | Issuer | In force | Juris. | Supports |
|---|---|---|---|---|
| Medicines Act 1981 IM | Medsafe | 1981 | NZ | Medicines / devices interim regime |
| Medicines (Database of Medical Devices) Regs 2003 · WAND IM | Medsafe | 2003 | NZ | Post-market device notification |
| Hazardous Substances & New Organisms Act 1996 IM | EPA | 1996 | NZ | GMO / new-organism gate |
| Agricultural Compounds & Vet Medicines Act 1997 IM | MPI | 2001 | NZ | Agri-compound approval |
| Animal Products Act 1999 IM | MPI | 1999 | NZ | Animal-product risk management |
| Food Act 2014 IM | MPI | 2016 | NZ | Risk-based food control |
| Privacy Act 2020 IM | OPC | 2020 | NZ | Data privacy |
| Climate Change Response Act 2002, Pt 4 · NZ ETS | EPA | 2008 | NZ | Emissions trading |
| Electricity Industry Act 2010 | Electricity Authority | 2010 | NZ | Electricity market |
| Therapeutic Products Act Repeal Act 2024 IM | NZ Parliament | 2024 | NZ | Repeal of TPA 2023 |
Global / cross-border · why-now context
| Source | Issuer | In force | Juris. | Supports |
|---|---|---|---|---|
| How AI is used in FDA-authorized medical devices | Singh, Bapna, Diab, Ruiz & Lotter · npj Digital Medicine | 1 Jul 2025 | US | 33 authorisations 1995 to 2015 at a maximum of 6 a year; 1,016 authorisations across 736 unique devices on the FDA list of 20 December 2024, authorised to 27 September 2024 |
| Three Decades of FDA Authorizations of AI/ML-Enabled Medical Devices | Golshani & Joseph · Cureus 18(7) e112583 | 13 Jul 2026 | US | 1,430 authorisations September 1995 to December 2025, and 331 in 2025 alone |
| FDA PCCP final guidance | FDA | 2024 | US | Post-approval model-change route |
| CMS hospital-at-home reimbursement waiver | CMS | 2020 | US | The route by which hospital-level care at home is paid for |
| IRA Section 45X (domestic-content credit) | US Treasury / IRS | 2022 | US | Energy manufacturing incentive |
| BIOSECURE Act | US Congress | 2025 | US | Biotech supply-chain shift |
| EU AI Act (high-risk class) | European Commission | 2024 | EU | AI regulation direction |
| EU Critical Raw Materials Act | European Commission | 2024 | EU | Critical-minerals policy |
| ICH Q13 continuous manufacturing | ICH | 2023 | Global | Pharma manufacturing standard |
| WHO Listed Authority tiers / GBT maturity (ML3/ML4) | WHO | 2022 / 2026 | Global | Regulatory-maturity screening |
| PIC/S GMP mutual reliance IM | PIC/S | standing | Global | GMP recognition |
| Access Consortium reliance IM | Access Consortium | 2020 | CA / UK | Regulatory reliance pathways |
| Medical Device Single Audit Program (MDSAP) IM | US FDA | current 19 Dec 2025 | Global | One quality-system audit accepted by the TGA, ANVISA, Health Canada, the MHLW with the PMDA, and the FDA |
| Circular 2022-004 and its December 2023 amendment, reference authorities IM | FDA Philippines | Dec 2023 | PH | Sixteen reference authorities, the TGA listed first |
| International Recognition Procedure | MHRA | Jan 2024; updated 9 Oct 2026 | UK | The TGA one of seven reference regulators for UK medicine approvals; a 60-day Recognition A timetable against 210 days for a national assessment |
Frameworks & voluntary guidance
| Source | Issuer | In force | Juris. | Supports |
|---|---|---|---|---|
| METI AI Governance Guidelines v1.1 | METI | 2022 | JP | AI governance guidance |
| PMDA AI/ML Medical Device Evaluation Guidance | PMDA | 2023 | JP | AI-SaMD evaluation |
| DASH for SaMD / SaMD 2 | MHLW / PMDA | 2020 / 2023 | JP | SaMD acceleration strategy |
| METI Critical Minerals Strategy | METI | 2023 | JP | Supply-assurance policy |
| Critical Minerals Strategy 2023-2030 | DISR | 2023 | AU | Direction of travel, minerals |
| Australia's AI Ethics Principles | DISR | 2019 | AU | Voluntary AI principles |
| Voluntary AI Safety Standard | DISR / NAIC | 2024 | AU | Voluntary AI standard |
| TGA AI Review outcomes report | TGA | 2026 | AU | AI-SaMD regulatory review |
| FSANZ 2030 Roadmap / novel foods | FSANZ | 2025 | AU/NZ | Novel-food approval pathway |
| Algorithm Charter for Aotearoa NZ | Stats NZ | 2020 | NZ | Voluntary algorithm charter |
| Critical Minerals List & Strategy | MBIE / NZP&M | 2024 | NZ | Minerals policy + list |
02Academic & scientific literature
Peer-reviewed anchors.
| Source | Author(s) | In force | Venue | Supports |
|---|---|---|---|---|
| Effects of exclusivity on commercialisation | Gaessler & Wagner | 2022 | Rev. Econ. & Stat. | Reinforces patent-clock causality |
| Demographics and Automation | Acemoglu & Restrepo | 2022 | Rev. Econ. Studies | Acemoglu and Restrepo find that an ageing workforce raises automation innovation, measured on Japan among other economies. |
| Induced Innovation / factor scarcity | Hayami & Ruttan | 1970 | J. Political Economy | Labour scarcity pulls labour-saving agtech |
| Artificial Intelligence and Economic Growth | Aghion, Jones & Jones | 2017 | NBER | AI value concentrates in essential Baumol sectors |
| Macroeconomics of unbalanced growth (cost disease) | Baumol | 1967 | AER | Cost-disease diagnosis |
| Baumol's cost disease revisited | Nordhaus | 2008 | · | Cost-disease confirmation in US data |
| What drives health-care expenditure? Baumol's model | Hartwig | 2008 | J. Health Economics | Cost disease in OECD health spend |
| Innovation & regulation pioneer time-penalty | Stern | 2017 | J. Public Economics | Stern measures a 34% time penalty on the pioneer of a regulated technology, and the same regulatory path then excludes followers. |
| Regulatory arbitrage & institutional quality | Houston, Lin & Ma | 2012 | J. Finance | Arbitrage pays only in strong institutions |
| Learning curves / Wright's law | Farmer & Lafond | 2016 | Research Policy | Energy-hardware cost forecastability |
| Empirically grounded technology forecasts (energy) | Way et al. | 2022 | Joule | Energy cost-trajectory anchor |
| A Model of Growth Through Creative Destruction | Aghion & Howitt | 1992 | Econometrica | Entrants capture disruption rents |
| Income and health spending (elasticity ~0.7) | Acemoglu, Finkelstein & Notowidigdo | 2013 | Rev. Econ. & Stat. | Necessity-demand persistence (health) |
| The Value of Life and the Rise in Health Spending | Hall & Jones | 2007 | QJE | Health share rises with income |
| Money chasing deals? | Gompers & Lerner | 2000 | J. Financial Economics | Capital inflows inflate entry valuations |
| What drives private equity fund returns? | Diller & Kaserer | 2009 | Eur. Financial Mgmt | "Money chasing deals" drags returns |
| Private Equity Performance | Kaplan & Schoar | 2005 | J. Finance | Boom-vintage funds underperform |
| Borrow Cheap, Buy High? | Axelson, Jenkinson, Strömberg & Weisbach | 2013 | J. Finance | Axelson, Jenkinson, Strömberg and Weisbach find that higher purchase prices lead to lower returns on the same deals. |
| Investment cycles and startup innovation | Nanda & Rhodes-Kropf | 2013 | J. Financial Economics | Hot-market entrants fail more, win bigger |
| The Regulation of Entry | Djankov, La Porta, Lopez-de-Silanes & Shleifer | 2002 | QJE | Entry regulation as incumbent protection |
| Does regulation reduce innovation? | Aghion, Bergeaud & Van Reenen | 2023 | AER | Regulation cuts innovation 5.7%, hits small firms |
| Health-IT adoption and hospital costs | Agha | 2014 | J. Health Economics | Prior "tech fixes healthcare" wave failed |
| The Simple Macroeconomics of AI | Acemoglu | 2025 | · | Acemoglu estimates the addition of AI to total factor productivity at 0.66% or less over a decade. |
| The Productivity J-Curve | Brynjolfsson, Rock & Syverson | 2021 | AEJ: Macroeconomics | GPT gains lag a fund's 10-year clock |
| The Nobel Prize in Chemistry 2019, press release IM | Royal Swedish Academy of Sciences | 2019 | JP / Global | The carbon anode behind Japan's lead in Power: Akira Yoshino's petroleum-coke anode and the first commercially viable lithium-ion battery, 1985 |
| Gallagher, Alfred William IM | Te Ara, Dictionary of New Zealand Biography | rolling | NZ | The battery-powered electric-fence energiser developed in New Zealand in the late 1930s, behind New Zealand's lead in Eat |
03Government & institutional datasets
| Source | Issuer | In force | Juris. | Supports |
|---|---|---|---|---|
| FDA AI-Enabled Medical Devices list | FDA | 2026 | US | The authorisation table by decision date. It publishes no annual count, which is why the series above is cited to the two peer-reviewed counts |
| Energy and AI (WEO special report) IM | IEA | 2025 | Global | Data-centre electricity demand ~945 TWh by 2030 |
| Precision Agriculture in the Digital Era (EIB-248) | USDA ERS | 2023 | US | Precision-ag / autosteer adoption |
| 2020 Census of Agriculture & Forestry | MAFF / Statistics Japan | 2020 | JP | JP farmer counts & ageing structure |
| Labour Force Australia, Detailed (6291.0.55.001) | Australian Bureau of Statistics | 2026 | AU | AU agricultural-labour contraction |
| World Bank indicators (health/agri %GDP, energy) | World Bank | 2026 | Global | Market-sizing baselines JP/AU/NZ/US |
| WHO NRAs at ML3/ML4 & Transitional WLA lists | WHO | 2026 | Global | Regulatory-maturity screening |
| Care workers needed: about 570,000 more by FY2040 | MHLW | 12 Jul 2024 | JP | Care-sector demographic forcing |
| EDINET (securities-registration filings) | FSA Japan | 2024 | JP | Pre-IPO share-issuance / step-up series |
| Primary legislation registers (portal infrastructure) | e-Gov Japan; legislation.gov.au; legislation.govt.nz; regulators | rolling | JP/AU/NZ | Enacted-instrument register infrastructure |
| TGA ARTG datasets / register IM | TGA | rolling | AU | AU device / AI-device register |
| Global Innovation Index 2025, Australia profile IM | WIPO | 2025 | AU | Australia 22nd overall, 16th on innovation inputs, 27th on outputs; production and export complexity and labour productivity growth its listed weaknesses |
| Medicines Matter IM | Medicines Australia | 2016-21 series | AU | Registration to a Pharmaceutical Benefits Scheme listing at 466 days on new molecular entities registered 2016 to 2021, against a 384-day average across twenty OECD countries |
| ANZCTR clinical-trials registry | ANZCTR | rolling | AU/NZ | AU/NZ trial-registration activity |
| Cochlear implants IM | National Institute on Deafness and Other Communication Disorders | Dec 2019 count | GL | Approximately 736,900 registered devices implanted worldwide by December 2019, across all manufacturers |
| Mineral Commodity Summaries 2026, nitrogen IM | United States Geological Survey | 2026 edition | GL | 156 million tonnes of contained nitrogen synthesised in 2024, the revised figure in the 2026 edition |
| Australian IP Report 2025 IM | IP Australia | 2025 | AU | The United States is the most common overseas filing destination for Australian applicants, 36.3% of 2023 filings (p. 29) |
| About KiwiNet IM | KiwiNet | rolling | NZ | 14 universities and research organisations, 80% of New Zealand's publicly funded researchers |
04Market, financial & valuation data
Named commercial providers are the primary data pull; some are sales-gated, so only official pages are linked.
| Source | Provider | In force | Juris. | Supports |
|---|---|---|---|---|
| Damodaran datasets (NYU Stern) | Aswath Damodaran | annual | US/global | Valuation cross-check / discount-rate anchor |
| State of Private Markets | Carta | 2025-26 | US | US seed post-money median (USD 24M, Q4 2025) |
| Valuations / vertical / Digital-Health / Climate reports | PitchBook | 2025-26 | Global | Round-by-round valuation benchmarks |
| Reference dataset (company universe, funding, acquirers) | Crunchbase | 2026 | Global | Company universe, funding, acquirer data |
| Seed data (markup relationship) | AngelList | rolling | US | Seed quintile markup relationship |
| Startup survey, six-country listing comparison IM | METI / PwC / JVCA | 2026 | JP | JP exit structure (IPO-led, TSE Growth); cross-country M&A / IPO |
| Japan Startup Finance | INITIAL / Speeda (Uzabase) | 2025 | JP | JP seed valuations, M&A, step-up |
| Research on Speeda data | Japan Investment Corp | 2025 | JP | JP seed medians under USD 7M, flat 2021 to 2025 |
| State of Australian Startup Funding IM | Cut Through Venture / Folklore Ventures | 2025-26 | AU | AU seed median (around AUD 16.0M); exit-route mix and exit crunch; sector funding; biotech and medtech A$829M of A$5.4bn in 2025 (p. 11) |
| Australia Outliers Report 2026 | Side Stage Ventures / Dealroom | 2026 | AU | June 2026 edition: 1.09 companies above USD 1B and 0.16 above USD 10B, per USD 1B of venture invested since 2000. First of the hubs compared on the second, third on the first |
| NZ Tech Ecosystem Report 2026 IM | Dealroom.co / NZ Growth Capital Partners | 2026 | NZ | Capital efficiency, 10.89x enterprise value per venture dollar (p. 7); decacorns per USD 1bn invested (p. 12); sector funding (p. 20); seed-to-Series A and B rates (p. 24) |
| Digital-health funding | Rock Health | quarterly | US | Digital-health round benchmarks |
| Healthcare Investments & Exits | Silicon Valley Bank | annual | US | Health-sector exit benchmarks |
| Lithium-ion battery pack prices see largest drop since 2017 IM | BloombergNEF | 10 Dec 2024 | GL | Global average lithium-ion pack price USD 115/kWh in 2024, down 20% from 2023 |
| Global Secondary Market Review | Jefferies | 2025 | Global | 2025 secondary volume (around USD 240B) |
| Secondary Market Report | Lazard | 2024-25 | Global | Secondary volume (USD 233B, 2025) |
| Secondary Market Overview | Campbell Lutyens | 2025 | Global | Secondary volume (USD 225B, 2025) |
| Open Source VC databases | Airtree | rolling | AU | AU Series A/B downstream-capital bench |
| AgriFoodTech / deep-tech venture reports | AgFunder; S2G; DCVC | series | Global | Agri/food & deep-tech venture context |
| Asia-Pacific Private Equity Report | Bain & Company | 2025 | APAC | Regional PE / exit-market context |
| SE-Asia Tech Investment | Cento Ventures | 2024 | SE Asia | Regional venture context (comparison set) |
| Global VC Terms Report | Morrison Foerster | 2025 | Global | Venture terms benchmarks |
| VC Fund Performance (quarterly); Founder Ownership; State of Pre-Seed | Carta | 2024-25 | US | Fund-performance, dilution and pre-seed benchmarks |
| Southeast Asia Startup Funding Report: Full Year 2025 IM | DealStreetAsia | Jan 2026 | SEA | USD 5.4bn across 461 deals in 2025; healthtech USD 393M across 35 deals; fintech USD 1.3bn across 111. The report is gated; the same figures, on DealStreetAsia and Kickstart Ventures data, are public in CFOtech Asia, 3 Feb 2026 |
| LATAM Startup Market 2024 in Review, via LADP IM | Sling Hub and Itaú | Sep 2025 | LATAM | Deep tech USD 536M of USD 8.8bn tech funding in 2024 including debt (6%), fintech 55%; 11% of equity funding |
05Company, exit & comparables data
| Source | Provider | In force | Juris. | Supports |
|---|---|---|---|---|
| Reference dataset (classified) | Crunchbase base + hmm classifier | 2026 | APAC | The base of liquidity events, bucketed from USD 100M upward. |
| JPX / TSE Growth listings | Japan Exchange Group | rolling | JP | JP IPO tail |
| JP startup M&A / IPO databases IM | firstcvc.jp; ipokabu.net; minkabu.jp; STARTUP DB | rolling | JP | JP small-M&A exits (under-covered) |
| M&A data | RECOF / MARR | rolling | JP | JP startup M&A deal records |
| Company universe export (enriched) IM | Crunchbase / LinkedIn / G2 / SimilarWeb, enriched on a commercial B2B data platform | 2026 | JP/AU/NZ | In-mandate company universe |
| Exit cohort · named liquidity events (with source URLs) IM | hmm (primary-sourced) | 2026 | JP/AU/NZ | Realised M&A + listing exit base |
| ASX / NZX filings & listings | ASX; NZX | rolling | AU/NZ | IPO listings, market cap at listing |
| NZ Takeovers Panel records | Takeovers Panel (NZ) | rolling | NZ | NZ M&A / takeover confirmations |
| M&A / IPO announcements (press wires) | BusinessWire; PR Newswire; Cision | rolling | Global | Primary deal announcements |
| Company investor-relations releases | portfolio / acquirer IR pages | rolling | · | Deal terms cross-checked to primary |
| Regulated-software M&A comps | SEC filings / LSE RNS / proxies / IR | 2023-25 | US/UK | Indicative multiples for IM Appendix B (median EV/Rev 7.22x; small US/UK sample read across to JP/AU/NZ) |
| Takuo Aoyagi and the pulse oximeter IM | Nihon Kohden | 1972 | JP | The pulse-oximetry principle conceived at Nihon Kohden in 1972, with a Japanese patent application in 1974. The company's pages name no month |
| Amchepry approval IM | Sumitomo Pharma · MHLW | 6 Mar 2026 | JP | The first induced pluripotent stem cell medicine, approved conditionally and for seven years. Two iPS-derived products were approved that day on the same limit |
| Wireless LAN patent licensing IM | CSIRO | 2013 | AU | Around AUD 430M in licensing revenue across more than 20 international licence agreements |
| P5 collar, state approvals IM | Halter | Feb and Jul 2026 | AU | Approved in Victoria in February 2026 and in South Australia in July 2026, each a state approval under amended animal welfare regulations |
06Books, essays & named frameworks
| Source | Author | In force | Field | Supports |
|---|---|---|---|---|
| Engel's law (food-demand share falls with income) | Ernst Engel | 1857 | Economics | Necessity-demand inescapability (Eat) |
| Wright's law (learning curve) | T. P. Wright | 1936 | Aeronautics / econ | Forecastable hardware cost decline (Power) |