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AnGes Inc. · Confidential · 2026
Sizing the CollateGene Population
How many patients have chronic limb-threatening ischemia with tissue loss each year? On the same annual basis IQVIA used, far more than four thousand. Here is the number we can defend — and the funnel behind it.
The defensible number — treatable patients per year, US
200,000–300,000 / year
incident CLTI with neuroischemic tissue loss — the CollateGene / LEGenD-1 indication, on the same annual basis IQVIA modeled
~1.6M US diabetic foot ulcers / yr × ~50% with PAD → ~800K / yr; the non-healing CLTI subset ≈ 200–300K · NEJM 2017, Deng 2025
Conservative floor
~150,000 / yr
amputation-candidate · 30× IQVIA
vs the IQVIA basis
45–65×
their 4,700 / yr estimate
Prevalent market (TAM)
~1 million
CLTI with tissue loss
Peripheral artery disease
10–12M
AHA Scientific Statement · Circulation 2023
CLTI — prevalent, US
2–3.4M
1.3% of US adults · Circulation 2023
CLTI with tissue lossCollateGene indication
~1M
Rutherford 5–6 / neuroischemic ulcer · GVG 2019 · LEGenD-1, Circ Cardiovasc Interv 2026
Diabetic foot ulcers / yr
~1.6M
Armstrong, Boulton & Bus · NEJM 2017
Treatable / yearthe defensible number
200–300K
incident neuroischemic, non-healing · derived from NEJM 2017 & Deng 2025
Major amputations / yr
~150,000
AHA PAD Collaborative · CMS Medicare · the conservative floor
What IQVIA modeled
4,700 / yr
IQVIA market model · 2026 · a ~2px sliver: about 1/32 of the amputation floor
On its own annual basis, IQVIA's 4,700 is about 3% of a single year's amputations and under 2% of the patients treatable each year. That is not a conservative estimate — it is an error of roughly 45 to 65 fold.
Three estimates, reconciled
Rosenblatt · 2018
41,000
An annual no-option sliver, not the treatable indication.
L.E.K. · 2024
1.6 million
Matches the peer-reviewed DFU denominator. Defensible.
IQVIA · 2026
4,700
The signature of one mis-specified filter, not prevalence.
Five-year survival after major amputation is 32.1% — squarely in the cancer conversation.
Del Rio-Sola et al. · Advances in Wound Care 2026 · 5,698-patient cohort
References
1 · Allison MA, Armstrong DG, Goodney PP, et al. Health disparities in peripheral artery disease: a scientific statement from the American Heart Association. Circulation. 2023;148(3):286–296.
2 · Deng L, Du C, Armstrong DG, Mills JL, et al. Forecasting the global burden of peripheral artery disease from 2021 to 2050. Research. 2025;8:0702.
3 · Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, et al. Global vascular guidelines on the management of chronic limb-threatening ischaemia. Eur J Vasc Endovasc Surg. 2019;58(1S):1–109 / J Vasc Surg. 2019;69(6S):3S–125S.
4 · Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med. 2017;376(24):2367–2375.
5 · Armstrong DG, Swerdlow MA, Armstrong AA, et al. Five year mortality and direct costs for diabetic foot complications are comparable to cancer. J Foot Ankle Res. 2020;13(1):16.
6 · Del Rio-Sola ML, et al. Diabetic foot ulcers as a marker of systemic disease. Adv Wound Care (New Rochelle). 2026.
7 · AHA PAD Collaborative Heat Map · CMS Medicare geographic-variation files.