Global prevalence
589M
Adults living with diabetes worldwide
A global health crisis affecting every region and population.
IDF Diabetes Atlas, 2024
Kihealth Series A investor presentation
Real-Time Disease Biology for Precision Medicine
Kihealth is developing a molecular-intelligence platform designed to measure active cellular injury, support earlier biological understanding and enable disease interception.
Originated at Yale University
ADA Innovation of the Year — 2025
CLIA/COLA-certified laboratory infrastructure
01/37
02 / 37
The investment thesis
The Measurement Layer Preventive Medicine Has Been Missing
Kihealth translates tissue-specific signals of active cellular injury into real-time biological intelligence, beginning with beta-cell injury in diabetes and expanding into a multi-indication platform for clinical care and therapeutic development.
From a standard blood draw to biological intelligence
01 · Detect
Tissue-specific injury
02 · Quantify
Molecular signal
03 · Act
Clinical intelligence
01 — Differentiated biological signal
Measure What Current Tests Cannot
Beta Intercept is designed to measure active, tissue-specific cellular injury, not simply disease risk, remaining function or downstream metabolic consequences.
02 — Focused clinical entry point
A High-Value Beachhead in Diabetes
Beta Intercept provides a focused initial application for earlier T1D & T2D detection, therapeutic monitoring, patient stratification and pharmaceutical development.
03 — Multiple commercial pathways
One Platform. Multiple Revenue Channels.
Revenue pathways include clinical testing, pharmaceutical study services, therapeutic-response monitoring and companion-diagnostic partnerships.
04 — Scalable platform architecture
Built Beyond a Single Test
The molecular-intelligence approach can extend into additional metabolic, oncologic, autoimmune and neurodegenerative indications.
Foundation in place
De-risked where it matters most.
One platform combines validated biology, operational infrastructure, reimbursement progress, defensible IP, clinical evidence and early commercial traction.
CLIA/COLA-certified lab
Operational infrastructure
Fully validated LDT
Launch-ready lead assay
5+ studies
Clinical evidence engine
Existing revenue
Early commercial proof
Active PLA code
Reimbursement pathway
Issued + pending IP
Defensible platform position
The round
$15M Series A
- Diagnostics generate the revenue.
- Longitudinal data compounds the platform.
- Therapeutic integration expands the value.
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The problem
We Find Disease After the Damage Has Already Occurred
Current diagnostic tools frequently measure downstream consequences of disease rather than the active biological injury driving it.
01
Autoantibodies
May identify risk, but do not directly quantify active beta-cell death.
02
HbA1c and glucose
Reflect metabolic consequences after biological injury has progressed.
03
C-peptide
Measures remaining function rather than the real-time rate of cellular loss.
04
At clinical diagnosis
Meaningful beta-cell function may already have been lost.
The diagnostic gap
The biological signal exists before the symptoms.
Type 1 diabetes
50–70%
of beta-cell function is already lost at clinical diagnosis. In children presenting with DKA, over 80%.
All diabetes
$327B
Annual U.S. diabetes spend — most of it treating complications earlier detection could have prevented.
As diabetes care moves toward earlier intervention and increasingly sophisticated metabolic therapies, the value of measuring active disease biology increases.
The problem is not a lack of data.
It is a lack of direct biological visibility.
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Global impact
The Scale of Metabolic Disease Makes Earlier Insight Essential
Projection
853M
Projected to have diabetes by 2050
Without more effective prevention and earlier detection, prevalence will continue to rise.
IDF Diabetes Atlas, 2024
Economic burden
$1T+
Global annual diabetes-related health expenditure
The economic weight of late-stage disease continues to climb.
IDF / WHO
United States
98M
American adults with prediabetes
More than one in three adults is at increased risk for Type 2 diabetes.
CDC
Awareness gap
81%
Of adults with prediabetes are unaware
Silent progression can continue for years without clinical recognition.
CDC
Population at risk
1 in 3
U.S. adults have prediabetes
A third of the adult population sits inside the window where earlier detection matters most.
CDC
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THE MEASUREMENT GAP
The Window We’ve Been Missing
Kihealth detects active beta-cell destruction long before clinical symptoms emerge.
A tissue-specific signal creates a window to identify active disease biology while beta-cell mass may still be salvageable.
Biological visibility
The signal exists before standard diagnosis can see it.
625
days earlier, up to
Stage of disease
Stage 1
Autoimmune attack begins (T1D)
01Stage 2
Beta-cell death starts
02Stage 3
Compensation failing
03Stage 4
Blood glucose rising
04Stage 5
Symptoms appear
05
Window of opportunity
Standard diagnosis
For patients
Earlier detection enables earlier enrollment in disease-modifying therapy, when beta-cell mass is still salvageable and treatment has maximum impact.
For pharma
Kihealth’s signal can serve as a pharmacodynamic endpoint, showing drug effect weeks before C-peptide or HbA1c changes are detectable.
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THE MISSING GAP
A Clearer View of Beta-Cell Injury Could Change When and How We Intervene
Established tests reveal different dimensions of diabetes. Beta Intercept is designed to add a molecular view of active beta-cell injury and death.
- 01
HbA1c
Average glucose exposure over recent months
- 02
Glucose / CGM
Current glucose levels and daily patterns
- 03
Autoantibodies
Evidence of autoimmunity and associated disease risk
- 04
C-peptide
How much insulin the body is producing
Beta Intercept™
Designed to detect beta-cell active injury and cell death. The earliest sign of disease onset.
The missing dimension
Each established test answers a different question. None measures active beta-cell injury itself, the signal closest to the disease process.
The opportunity
Understand disease activity over time
Through repeated testing, Beta Intercept aims to help clinicians:
- 01
Detect active injury
Identify a molecular signal of ongoing beta-cell damage.
- 02
Track its course
Measure whether the injury signal is increasing, stable, or declining.
- 03
Understand progression
Help distinguish progressors from non-progressors and assess how quickly disease is advancing.
- 04
Inform intervention
Add biological context to disease staging, treatment timing, and therapeutic selection.
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The Kihealth solution
Intercept IQ™ turns molecular signals into biological intelligence
A tissue-specific, multi-omic platform that combines molecular measurements with clinical context to reveal disease biology and support earlier intervention.
01
Measure the molecular signal
Analyze tissue-specific cell-free DNA and complementary biomarkers in blood.
02
Identify the biological source
Determine which tissue the signal comes from, providing insight into cellular injury and disease activity.
03
Add predictive intelligence
Ki Intelligence™, our molecular AI engine, is designed to integrate these signals with clinical and longitudinal data to generate predictive models and disease-risk scores.
One platform connecting molecular detection with the opportunity for disease prevention.
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OUR FIRST PRODUCT
Beta Intercept™
An earlier window into diabetes. A greater opportunity to intervene.
A breakthrough blood-test approach designed to reveal active beta-cell injury and death, bringing the underlying disease process into view before clinical symptoms emerge.
Earlier detection creates an opportunity for prevention
Molecular evidence of injury could identify patients who need attention sooner, while insulin-producing function remains to be preserved.
Clinicians gain insight into active disease biology
Adds a critical dimension to established diabetes testing: evidence of ongoing cellular injury and how that signal changes over time. The opportunity is more informed monitoring and better-timed intervention.
Drug developers gain an early signal to investigate therapeutic response
Repeated measurements can help identify biologically active patient populations and evaluate whether treatments change beta-cell injury, supporting trials of therapies intended to preserve function.
IMPACT
Make the window for earlier intervention visible, and help evaluate the therapies that could change what happens next.
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TWO PRODUCTS. ONE PLATFORM.
One platform serving two major diabetes markets
Shared molecular and genetic measurements, connected to Ki Intelligence™ molecular AI.
BETA INTERCEPT T1D™ - FOR TYPE 1 DIABETES
Autoimmune beta-cell injury and loss
9.5M+
people worldwide live with Type 1 diabetes, across all ages.IDF
Designed for
- Pediatric screening
- T1D risk assessment
- Longitudinal monitoring
- Earlier detection opportunity
- Presymptomatic disease assessment and research into progression between disease stages, bringing the autoimmune process into view before clinical symptoms emerge.
- Intended clinical utility
- Add evidence of active beta-cell injury to patient assessment and longitudinal monitoring, so ongoing injury can be tracked rather than inferred from glucose levels alone.
- Therapeutic development
- Patient stratification and response research for therapies aimed at preserving beta cells, supporting trials designed to delay or prevent progression.
BETA INTERCEPT T2D™ - FOR TYPE 2 DIABETES
Metabolic beta-cell injury and dysfunction
634M+
more than 634 million adults worldwide are estimated to have impaired glucose tolerance (prediabetes).*
Designed for
- Prediabetes evaluation
- Metabolic risk
- Therapy monitoring
- Earlier detection opportunity
- Prediabetes and early Type 2 diabetes assessment, within a global population of 635 million adults with impaired glucose tolerance already identified as high risk.IDF
- Intended clinical utility
- Add molecular insight to metabolic risk assessment and longitudinal monitoring, complementing glucose-based measures with evidence of ongoing cellular injury.
- Therapeutic development
- Patient stratification and response research for GLP-1 and other metabolic therapies, helping identify who is biologically positioned to benefit.
Commercial opportunityInitial testing, repeat monitoring, and biopharma partnerships across two distinct disease markets.
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Why now
Diabetes Is Entering the Era of Therapeutic Interception.
Earlier identification and disease-modifying therapies are creating a new imperative: identify who needs intervention, and measure whether it is working.
Earlier identification
A massive opportunity before diabetes develops. ADA 2026 supports presymptomatic screening in elevated-risk populations, identifying disease activity before clinical diagnosis.
Type 1 diabetes
30–40%
of U.S. children newly diagnosed with T1D already have diabetic ketoacidosis.
Type 2 diabetes
115.2M
U.S. adults living with prediabetes
8 in 10
Do not know they have it
The Kihealth opportunity
Identify who is actively progressing and who could benefit from intervention before further loss of insulin-producing capacity.
Disease-Modifying Therapies
Therapies are demonstrating the ability to delay diabetes progression. The opportunity is to identify patients who could benefit before further loss of insulin-producing capacity.
2×
Longer to clinical T1D
Tzield extended median time to Stage 3 diagnosis to 50 months versus 25 months.
93%
Lower risk of progression to T2D
Tirzepatide reduced progression risk over 176 weeks in participants with obesity and prediabetes.
The Kihealth opportunity
Reveal beta-cell injury earlier, helping identify potential treatment candidates, inform intervention timing and assess biological response.
A Massive Metabolic Therapeutic Market
Billions in therapies. A growing opportunity for biological insight, every new therapy depends on knowing who to treat, and whether it is working.
Goldman Sachs Research
$114B
Projected global obesity-drug sales by 2030
J.P. Morgan
$200B
Projected global incretin market by 2030
The Kihealth opportunity
Identify candidates earlier. Inform treatment selection. Track biological response.
Therapeutic competition creates a measurement imperative
More competing therapies raise the bar for evidence. Developers need answers to five critical questions:
- 01
Efficacy — How much benefit does the therapy deliver?
- 02
Patient selection — Which patients are most likely to benefit?
- 03
Durability — How long does the benefit last?
- 04
Biological response — What changes beneath the clinical outcome?
- 05
Differentiation — What evidence distinguishes this therapy from alternatives?
The Kihealth opportunity
Help developers connect treatment to biological response, and build stronger evidence across the therapeutic lifecycle.
The imperative
The therapeutic revolution now requires a corresponding measurement revolution.
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One platform. Many applications.
Molecular Intelligence Across the Care Continuum
Intercept IQ™ generates biological intelligence across prevention, clinical care, therapeutic innovation, and population health.
Population Screening
Identify metabolic risk earlier across communities and systems.
Clinical Trials
Stratify and monitor patient populations for therapeutic development.
GLP-1 Monitoring
Quantify biological response to GLP-1 and metabolic therapies.
Functional & Longevity
Evaluate metabolic health through a root-cause clinical lens.
Pediatric Diabetes
Support pediatric Type 1 diabetes screening and monitoring.
Employer Programs
Power workforce health and preventative initiatives at scale.
Four high-value decisions
01
Earlier disease detection
Identify active beta-cell injury before conventional metabolic diagnosis.
02
Patient stratification
Identify patients with distinct levels or patterns of active biological injury.
03
Therapeutic monitoring
Measure whether an intervention is meaningfully altering disease biology.
04
Clinical development
Provide developers with faster pharmacodynamic endpoints and improved trial selection.
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The science
The Beta-Cell Progression
From healthy islet to clinical diabetes. Kihealth's diagnostics detect the earliest of these stages, inside the window where intervention still preserves function.
01Healthy Beta Cell
Islet β-cells maintain glucose homeostasis through tightly regulated, biphasic insulin secretion. Cellular architecture and mitochondrial function are intact.
02Metabolic Stress
Chronic hyperglycemia, hyperlipidemia, and increased secretory demand drive endoplasmic reticulum stress and mitochondrial dysfunction within the β-cell.
03Inflammation
Islet-resident macrophages release IL-1β and TNF-α; in T1D, autoreactive T cells infiltrate the islet. Local cytokine signaling amplifies β-cell injury.
04Apoptosis
Injured β-cells undergo caspase-mediated programmed cell death, releasing fragmented, tissue-specific DNA into the peripheral circulation.
05Loss of Function
β-cell mass falls and remaining cells de-differentiate. First-phase insulin release is blunted before fasting glucose becomes abnormal.
06Prediabetes
Impaired fasting glucose and impaired glucose tolerance emerge. HbA1c drifts into the 5.7–6.4% range; ~50% of β-cell function may already be lost.
07Diabetes
Clinical diagnosis by HbA1c ≥ 6.5%, fasting glucose ≥ 126 mg/dL, or symptomatic hyperglycemia. Microvascular complications have often begun.
Intercepting disease at stage 02
Kihealth measures differentially unmethylated INS cfDNA, a blood-based molecular signal associated with pancreatic beta-cell injury and death, years before conventional markers move.
Why it matters
Conventional laboratory markers describe the endpoint of the process, not its onset. By the time diabetes is diagnosable, up to 50% of functional β-cell mass may already be lost.
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How it works
One Blood Draw. A Molecular View of Beta-Cell Biology.
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Analytical validation
Performance Established Across Core Analytical Characteristics
Kihealth’s Beta Intercept assay was evaluated across eight core analytical characteristics using predefined study designs, controls and acceptance criteria. The validation program assessed whether the method could reliably, reproducibly and specifically measure differentially unmethylated INS cfDNA.
Analytical acceptance criteria met
01Accuracy
Within 20%
Results within the predefined 20% acceptance range
Measurements remained within the predefined 20% acceptance range during the five-day accuracy assessment.
Acceptance criterion met
02Precision
CV <20%
Repeatability and reproducibility
Replicate measurements met the report’s predefined precision criteria.
Acceptance criterion met
03Linearity
R² >0.9999
Across the evaluated range
Observed copy-number measurements showed a highly linear relationship across the evaluated concentration range.
Acceptance criterion met
04Limit of Detection
4.5 copies/µL
Analytical detection capability
Analytical detection capability is distinct from clinical sensitivity.
Acceptance criterion met
05Analytical Specificity
Target-Specific
Intended INS methylation targets
In-silico and experimental studies supported specific measurement of the intended INS methylation targets.
Acceptance criterion met
06Extraction Recovery
65.73%
Mean recovery of input DNA · 4.52% CV
The cfDNA isolation workflow demonstrated consistent recovery across the evaluated specimens.
Acceptance criterion met
07Carryover
<1%
Positive droplets in no-template control wells
Representative testing demonstrated minimal detectable carryover between high-concentration samples and no-template controls.
Acceptance criterion met
08Specimen Stability
5 Days
Room temperature and 2–8°C
Plasma cfDNA measurements were supported through five days under the evaluated room-temperature and refrigerated conditions.
Acceptance criterion met
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Proprietary Targets
Assay Design
Kihealth’s Beta Intercept assay combines target-specific primer-and-probe design with methylation-sensitive restriction digestion to measure three differentially methylated regions of the INS gene.
- 01
Targeted Genomic Regions
The assay measures three beta-cell-associated regions of the INS gene and uses LMO1 as an intra-chromosomal reference target.
Chromosome 11
INS gene — three evaluated regions
- 02
Distinguishing Methylated and Unmethylated DNA
The methylation state of each evaluated INS restriction site determines whether the DNA fragment is preserved or cleaved during enzyme treatment.
MethylatedHpaII blocked → fragment preserved
UnmethylatedHpaII cleaves → fragment lost
- 03
Intra-Chromosomal Reference Normalization
LMO1 provides a chromosome 11 reference target used to support normalization across the multiplex measurement.
Quadruplex assay panel
INS −233
Measurement target
INS −135
Measurement target
INS +399
Measurement target
LMO1
Intra-chromosomal reference
LMO1 contains no evaluated HpaII site and supports normalization and quality assessment; it is not interpreted as a biological marker of beta-cell death.
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Clinical and analytical evidence
The Signal Is Detectable, Quantifiable and Biologically Dynamic
The insulin gene locus is uniquely demethylated in pancreatic beta cells. When those cells die, locus-specific cell-free DNA is released into circulation and can be quantified in plasma.
Cell-type specificity
Unmethylated INS cfDNA by sample type
Signal is concentrated in beta-cell-derived material and remains below the assay cutoff in leukocyte and no-template controls. Values shown as % unmethylated INS cfDNA (relative signal).
- Pancreatic islets92%
- Beta-cell line78%
- Type 1 diabetes plasma34%
- Healthy donor plasma — control6%
- Leukocyte DNA (control) — control3%
- No-template control — control0%
Empirical proof
Islet-infusion kinetics
Plasma unmethylated INS cfDNA measured before and after clinical islet infusion.
8.7%
45%
5%
5.5%
Pre-infusion baseline
30 minutes
6 hours
24 hours
View key findings
Acute peak captured
Approximately fivefold increase detected within 30 minutes.
Rapid plasma clearance
Signal returns toward baseline by six hours.
Real-time rather than cumulative signal
Mechanistically distinct from C-peptide.
Analytical specificity
Cell-type specific % unmethylated INS
Across all three differentially methylated INS CpG sites, the unmethylated signal is concentrated in beta-cell-derived material and is effectively absent from methylated control DNA.
- EndoC-βH5 gDNA
- Unmethylated gDNA
- Islet Cell DNA
- Buffy Coat gDNA
- Methylated gDNA
95.0
74.5
56.3
8.6
0.0
INS +399
97.6
78.5
70.6
13.2
0.0
INS −135
99.3
86.3
79.3
15.6
0.0
INS −234
% unmethylated INS by sample type at each evaluated CpG site. Controls: methylated / unmethylated human gDNA, mixed methylation standards, EndoC-βH5 beta-cell DNA, synthetic gBlocks, donor-derived cfDNA. Specificity confirmed by BLAST + HpaII digestion studies.
View chart data table
| CpG site | EndoC-βH5 gDNA | Unmethylated gDNA | Islet Cell DNA | Buffy Coat gDNA | Methylated gDNA |
|---|---|---|---|---|---|
| INS +399 | 95.0% | 74.5% | 56.3% | 8.6% | 0.0% |
| INS −135 | 97.6% | 78.5% | 70.6% | 13.2% | 0.0% |
| INS −234 | 99.3% | 86.3% | 79.3% | 15.6% | 0.0% |
Preliminary findings are not presented as final clinical performance. Source available in data room.
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Scientific evidence
Pilot T1D Interventional Treatment Cases
Exploratory analysis of 11 evaluable subjects from an interventional teplizumab T1D dataset — 9 treated and 2 placebo — together with 5 healthy controls for contextual comparison.
Treatment assignment
Treated subjects show a lower mean β-cell injury signal and higher mean C-peptide
Takeaway — Treatment exposure is associated with a lower β-cell injury signal and greater functional reserve.
Diabetes outcome
Greater functional reserve is associated with delayed or absent clinical progression
Takeaway — C-peptide reflects remaining secretory capacity, while %U provides a distinct measure of active β-cell injury.
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The window of opportunity
Beta-Cell Death Is Measurable Before HbA1c Ever Changes
Traditional biomarkers move only after substantial, irreversible β-cell loss. Kihealth detects the molecular signature of active β-cell death years earlier, inside the window where intervention still preserves function.
01 · Conventional markers stay silent
Normal
HbA1c while injury is underway
Glycemic measures reflect downstream consequence, not active beta-cell loss.
02 · WE REVEAL ACTIVE BETA-CELL DEATH
Earlier
Molecular signal of apoptosis
Demethylated INS cfDNA rises as beta cells die — a direct measurement, not an inference.
03 · Intervene while function remains
Preserve
Functional beta-cell mass
Detection inside the window creates the opportunity to act before irreversible loss.
- % Demethylated INS cfDNA
- Functional Beta-Cell Mass
- Insulin
- C-peptide
- HbA1c
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Market opportunity
A Focused Diabetes Beachhead Opens a Much Larger Molecular-Intelligence Market
01
Beachhead opportunity
$400M+
- Pharmaceutical trials and research-use applications
- Targeted Type 1 diabetes testing and monitoring
- Initial commercial laboratory services
02
Expansion opportunity
$12B+
- Broader T1D screening and therapeutic monitoring
- Type 2 diabetes and prediabetes monitoring
- GLP-1 response and disease-mitigation applications
- Companion diagnostics
03
Long-term platform opportunity
$86B+
- Additional metabolic diseases
- Oncology
- Autoimmune disease
- Neurodegenerative disease
Already in place
A trusted network of leading institutions
Multi-center collaborations with the academic and clinical organizations defining the future of metabolic health.
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Commercialization
Evidence Generates Revenue. Revenue Generates Evidence.
Kihealth begins with paid research and therapeutic programs, then compounds evidence into clinical utility, reimbursement and recurring testing.
Phase 1
2026-2027Pharma + research
- Banked-sample studies
- Prospective therapeutic trials
- Pharmacodynamic monitoring
- Biomarker analysis
Phase 2
2027Clinical validation
- Value beyond conventional measures
- Prospective, independent validation
- Longitudinal response relationships
Phase 3
2027-2028Clinical utility
- Define who gets tested
- Define when testing occurs
- Show which clinical decision changes
Phase 4
2028Scale
- Specialty endocrinology
- Reimbursement
- Regulatory expansion
- Recurring longitudinal testing
- Phase 1 economics
- Revenue before broad reimbursement
- Customer
- Pharma, biotech and research sponsors
- Revenue
- Contracted testing + sponsored research
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COMMERCIAL ENTRY POINT
Pharma Is the Initial Revenue + Evidence Engine
Help drug developers understand who is progressing, how quickly, and whether treatment is changing the underlying biology.
Contracted studies generate revenue while building the evidence for broader adoption.
01
Retrospective Validation
Reveal patterns in existing trial data
Analyze banked samples against known outcomes to evaluate whether Beta Intercept distinguishes progressors from non-progressors and responders from non-responders.
Value to pharmaEvidence to sharpen patient selection and future trial design.
02
Prospective Trial Integration
Track disease progression over time
Embed baseline and longitudinal testing alongside C-peptide and glycemia to evaluate how beta-cell injury patterns relate to disease-stage progression and its pace.
Value to pharmaBetter patient stratification and insight into when intervention may matter most.
03
Pharmacodynamic Development
Investigate early evidence of treatment response
Test whether early changes in beta-cell injury distinguish biological response from non-response and predict later preservation of beta-cell function.
Value to pharmaEarlier evidence to inform decisions about which therapeutic programs to advance.
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First clinical market
T1D Is the First Market. Pharma Is the Entry Point.
Paid therapeutic programs can build the evidence needed for broader clinical adoption.
Pharma / Research · Initial revenue opportunity
Help drug developers understand progression and biological response.
- New-onset T1D and beta-cell-preservation trials
- Retrospective analysis of banked samples
- Prospective longitudinal testing and pharmacodynamic assessment
Customers: Pharma, biotech and research sponsors
Commercial model: Contracted testing, program support and analytics
Clinical Care · Expansion through validation
Translate validated biological insight into defined care decisions.
- Stage 1/2 progression assessment
- Treatment-response monitoring
- Longitudinal surveillance
Adoption requirements: Prospective validation, demonstrated clinical utility, defined decision pathways and reimbursement
VALUE ACROSS THERAPEUTIC DEVELOPMENT
- Patient identification
- Trial enrollment
- Baseline
- Therapeutic intervention
- Early biological signal
- Longitudinal response
- Outcome
- Patient identification
- Trial enrollment
- Baseline
- Therapeutic intervention
- Early biological signal
- Longitudinal response
- Outcome
Beta Intercept role: Trial enrichment · Patient stratification · Baseline biological activity · Pharmacodynamic research · Response characterization · Longitudinal biomarker analysis
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Initial Market Opportunity
Type 1 Diabetes Surveillance, Beta Intercept™ T1D
Management market model
$42M
~$3.69B
~$9.5B
SOM · U.S. near-term
Illustrative annual revenue target by year three of clinical commercialization
- 2.1M Americans with diagnosed T1D
- 2% penetration → 42,000 monitored patients
- 84,000 tests annually
- ~64,000 new U.S. diagnoses annually
Potential SAM · U.S. + EU27
Future annual opportunity under broad clinical adoption
- ~3.69M people: 2.1M U.S. + 1.59M EU27
- ~120,000 annual new cases/diagnoses: ~64,000 U.S. + ~55,800 EU27
Potential TAM · global category
Worldwide annual category opportunity under broad clinical adoption
- ~9.5M people estimated to be living with clinical T1D globally
- ~513,000 new cases annually
Commercial expansion line
- Pharma-funded research
- Validated clinical applications
- Broader surveillance adoption
Expand through clinical evidence, specialty-channel adoption and geographic access.
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Commercial strategy
T1D: A 12-Month Path to Paid Adoption
Pharma-funded studies generate initial revenue and evidence for focused adoption in specialty endocrinology.
Initial commercial focus
Pharma programs studying beta-cell preservation, supported by pediatric and adult endocrinology centers evaluating early T1D and therapeutic response.
01
Months 1–3
Commercial readiness
A test ready for operational deployment
- Finalize intended use, assay validation and laboratory readiness.
- Establish sample collection, reporting and ordering workflows.
- Convert priority pharma discussions into scoped proposals with pricing and study endpoints.
02
Months 4–6
Initial paid programs
Pharma-sponsored testing and evidence generation
- Initiate the first contracted pharma study.
- Begin prospective clinical-utility enrollment.
- Activate one protocol evaluating Beta Intercept within the teplizumab treatment pathway.
03
Months 7–12
Specialty adoption
Integration into clinical workflows and recurring use
- Reach 12 active specialty ordering sites, with 20 as the stretch goal.
- Measure repeat testing among patients eligible for six-month follow-up.
- Use paid volume, realized pricing and cost per test to guide expansion.
Month-12 success targets
12+
Active specialty ordering sites
1+
Contracted, funded pharma program
1
Prospective utility study enrolling
≥35%
Six-month repeat-test completion among eligible patients
Commercial economics
$500 modeled net revenue per test70% gross-margin target, subject to cost validation
Expansion gateBroader distribution follows evidence of clinical utility, repeat demand and sustainable unit economics.
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Market opportunity
A Staged Market Expansion
Revenue today, a recurring clinical market next, and platform expansion beyond.
Pharma Entry
Paid programs that build clinical evidence
Evaluate active beta-cell injury in studies of disease progression, beta-cell preservation and therapeutic response.
- Customers
- Pharma, biotech and research sponsors
- Revenue model
- Contracted studies, serial testing and analytics
Strategic value
Generate revenue and clinical datasets before broad clinical reimbursement.
T1D Clinical Adoption
Repeat testing across the patient journey
Extend Beta Intercept into specialty care for longitudinal assessment of beta-cell injury as disease and treatment response evolve.
- Customers
- Endocrinology practices and specialty centers
- Revenue model
- Repeat testing in defined patient populations
Expansion gate
Prospective validation, demonstrated clinical utility and a viable payment pathway.
T2D Platform Expansion
Additional indications built on shared infrastructure
Develop applications in T2D and metabolic disease, followed by additional tissue-specific injury assays.
- Applications
- Prediabetes progression, metabolic treatment-response research and future tissue-specific monitoring
- Revenue model
- Additional assays and development partnerships
Expansion gate
Indication-specific validation and demonstrated customer demand.
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Second platform application
T2D: Extending the Platform into the World's Largest Metabolic Disease Population
GLP-1 / incretin therapy monitoring
The Scale
589M
Global
Adults worldwide living with diabetes in 2024. Type 2 accounts for more than 90% of diabetes cases. (IDF Diabetes Atlas, 2025)
115.2M
United States
U.S. adults with prediabetes, representing a substantial population at elevated risk of T2D. (CDC, 2026)
The Therapeutic Market
$114B
Projected global obesity-drug sales by 2030
Goldman Sachs Research
$200B
Projected global incretin market by 2030
J.P. Morgan Global Research
Beta Intercept does not need to capture the therapeutic dollar. It can become part of the measurement infrastructure surrounding it.
The Measurement
Opportunity
Molecular visibility into beta-cell injury is designed to complement established metabolic & functional assessments with a tissue-specific signal of cellular injury.
The Pathway
Initial Entry — Pharma Research
Characterize biological response to intervention
Evaluate whether baseline injury and changes over time improve patient stratification and reveal differences in therapeutic response.
Priority studies include GLP-1 / incretin therapies, metformin, bariatric procedures and lifestyle interventions.
Commercial model
Sponsored studies, serial testing and analytics
Clinical Expansion — Progression & Monitoring
Identify patients whose disease biology is changing
Evaluate whether serial injury measurements distinguish progressors from non-progressors and improve assessment of disease trajectory.
Potential use spans defined prediabetes-risk populations, early T2D and longitudinal treatment monitoring.
Commercial model
Repeat testing in validated clinical populations
The Evidence Gate
Detect presymptomatic T2D
Beta-cell death predates hyperglycemia and a rise in A1c, so active injury can be measured before glucose-based detection.
Monitor GLP-1 and incretin therapies
Assess whether serial measurements reflect treatment effect on beta-cell injury as therapeutic response evolves.
Establish clinical risk factors
Evaluate added predictive value beyond A1c, glucose / CGM, weight, insulin / C-peptide and established clinical risk factors.
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Second market opportunity
Prediabetes Type 2 Market Opportunity
Management market model
~$315M
annually
~$30.9B
annually
~$317.4B
annually
SOM scenario · U.S.
~630,000 monitored patients
Illustrative 2% adoption across 31.48M U.S. adults with impaired glucose tolerance.
31.48M × 2% × 1 test annually × $500
Potential SAM · U.S. + EU27
61.85M adults with impaired glucose tolerance
31.48M U.S. + 30.37M EU27
61.85M × 1 test annually × $500
Potential TAM · global
634.77M adults with impaired glucose tolerance
634.77M × 1 test annually × $500
The Opportunity
Add biological insight to established metabolic testing — supporting the development of more informed prevention and intervention strategies.
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Commercial strategy
Prediabetes: Build Adoption Through Specialists. Expand With Evidence.
A focused 12-month program to establish clinical relevance, paid demand and repeat use.
01Months 1–3
Establish the entry point
Adult endocrinology + academic centers
- Prioritize adults with confirmed prediabetes, including those with a family history of T2D.
- Finalize intended use, evidence-supported reporting and clinical launch requirements.
- Design a prospective study assessing added value beyond A1c, glucose and established risk factors.
02Months 4–8
Prove value in practice
Up to four specialty pilot programs
- Initiate testing and enroll the utility study.
- Measure clinician interpretation, ordering demand and willingness to pay.
- Track appropriate repeat testing and longitudinal changes in beta-cell injury.
03Months 9–12
EXPAND WHEN DATA SUPPORTS IT
Selective distribution, measurable economics
- Target 8–12 ordering specialty sites, subject to pilot results.
- Evaluate a Genova clinician-led, cash-pay channel.
- Make a scale decision based on evidence, repeat ordering, realized pricing and delivery costs.
Year-one targets
Up to 4
pilot programs
8–12
ordering specialty sites
1
prospective utility study enrolling
≥25%
six-month retesting among patients eligible and due for follow-up
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Platform expansion
One Platform. Many Products.
The same platform architecture applies across multi-billion dollar indications.
2026–2027
Type 1 diabetes
Beta Intercept™ T1D
Early autoimmune beta-cell injury detection for earlier identification, monitoring, and intervention in Type 1 diabetes.
2027
Type 2 diabetes · GLP-1
Beta Intercept™ T2D
Beta-cell dysfunction detection and GLP-1 therapy monitoring across metabolic disease and Type 2 diabetes.
Kihealth
Intercept IQ™
2028
Pancreatic & oncology
Onco Intercept™
Early cancer detection beginning with pancreatic cancer, with a growing future oncology pipeline.
2029
Neurodegeneration
Neuro Intercept™
Alzheimer's disease and broader CNS biomarker detection — future neurodegenerative applications.
The Intercept IQ™ platform
A multi-omic disease interception platform.
A unified molecular intelligence platform that integrates complementary biomarkers to detect disease earlier, improve diagnostic accuracy, and enable precision medicine.
Epigenomics
Proteomics
Clinical & phenotypic data
Cell-free DNA
Transcriptomics
Gene sequencing
AI & predictive analytics
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The AI intelligence backbone
Ki Intelligence™
Molecular Signals. An Evolving View of the Individual.
Kihealth’s molecular AI engine, developed to interpret tissue-specific measurements, analyze biological change and support predictive modeling.
From measurement to intelligence
- 01
Intercept IQ™
Tissue-specific molecular and genetic measurements
- 02
Ki Intelligence™
The AI layer of Intercept IQ™ · Longitudinal modeling · Molecular Digital Twin
- 03
Biological Insight
Disease activity · Progression patterns · Therapeutic response
The Molecular Digital Twin
Designed to create an evolving molecular representation of each individual.
Serial measurements update the model over time, connecting a patient’s baseline biology with changes observed during disease progression and intervention.
Understand activity
Interpret molecular signals associated with tissue injury.
Track change
Compare new measurements with the individual’s biological history.
Model trajectories
Investigate progression risk and patterns of therapeutic response.
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Traction
Traction & Momentum
Kihealth is not a concept — execution is already underway.
ADA Innovation Challenge Winner 2025
Automated low-abundance extraction workflow.
5+ ongoing academic studies
Yale · Nemours · CHOC · Mayo Clinic · Children's Diabetes Foundation.
Defensible IP portfolio
Issued patents on core cfDNA methylation methodology.
Already generating revenue
DTC and physician channels — no debt on the cap table.
Reimbursement infrastructure
PLA pathway active with cfDNA ADLT pricing anchors.
Science
- Beta Intercept Version 3 completed01
- Analytical validation established02
- Multiple ongoing clinical-validation programs03
- Longitudinal studies & biobank studies ongoing04
- Publications progressing05
- AI engine built06
Regulatory + Infrastructure
- CLIA-certified high-complexity molecular laboratory01
- COLA-accredited02
- FDA Pre-Submission completed03
- PLA strategy established04
- LIS / digital infrastructure05
- Quality systems06
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Business model
A Multi-Channel Model Designed for Early Revenue and Scalable Adoption
Clinical testing
- Per-test laboratory revenue
- Initial targeted clinical populations
- Expansion through physician adoption and reimbursement
Pharmaceutical services
- Clinical-study testing
- Biomarker and endpoint services
- Patient-stratification programs
- Potential milestone, licensing or companion-diagnostic economics
Population and payer programs
Begins 2030- Targeted screening programs from 2030
- Therapy-optimization programs
- Annual program service fees and population-health analytics
Projected annual revenue
Revenue ($M)
Clinical testingPharmaceutical testingPopulation and payer
2027
$2.38M
2028
$9.64M
2029
$19.28M
2030
$41.86M
2031
$89.68M
The growth thesis
Annual testing targets grow from 5,000 tests in 2027 to 182,000 in 2031. Population and payer programs begin in 2030, adding $3.3M in 2030 and $17.08M in 2031. Total 2031 revenue is $89.68M: $22.5M T1D, $46.5M T2D/IGT, $3.6M pharma and $17.08M population and payer programs.
Clinical testing: $500 per test. Pharma testing: provisional $300 per test, pending confirmation. T1D uses two annual tests per patient; T2D/IGT uses one. All figures are in US dollars.
Underlying assumptions
| Operating driver | 2027 | 2028 | 2029 | 2030 | 2031 |
|---|---|---|---|---|---|
| T1D monitored patients | 700 | 3,000 | 6,000 | 12,000 | 22,500 |
| T1D annual tests · 2 per patient | 1,400 | 6,000 | 12,000 | 24,000 | 45,000 |
| T2D IGT monitored patients | 3,000 | 12,200 | 24,400 | 48,800 | 93,000 |
| T2D annual tests · 1 per patient | 3,000 | 12,200 | 24,400 | 48,800 | 93,000 |
| Annual pharma tests delivered | 600 | 1,800 | 3,600 | 7,200 | 12,000 |
| Population and payer-program tests | 0 | 0 | 0 | 6,000 | 32,000 |
| Total annual tests | 5,000 | 20,000 | 40,000 | 86,000 | 182,000 |
| Revenue stream | 2027 | 2028 | 2029 | 2030 | 2031 |
|---|---|---|---|---|---|
| T1D testing | 0.7 | 3 | 6 | 12 | 22.5 |
| T2D/IGT testing | 1.5 | 6.1 | 12.2 | 24.4 | 46.5 |
| Pharma testing | 0.18 | 0.54 | 1.08 | 2.16 | 3.6 |
| Population and payer programs | 0 | 0 | 0 | 3.3 | 17.08 |
| Total modeled revenue | 2.38 | 9.64 | 19.28 | 41.86 | 89.68 |
| Operating driver | 2030 | 2031 |
|---|---|---|
| Targeted screening programs | 4 | 8 |
| Patients screened per program | 1,000 | 2,500 |
| Screening tests · 1 per patient | 4,000 | 20,000 |
| Therapy optimization programs | 2 | 4 |
| Monitored patients per program | 500 | 1,500 |
| Therapy optimization tests · 2 per patient | 2,000 | 12,000 |
| Total payer-program tests | 6,000 | 32,000 |
| Annual service fee per screening/therapy program | $50,000 | $50,000 |
| Population-health analytics contracts | 0 | 2 |
| Total covered members across analytics contracts | 0 | 40,000 |
| Billable months | 0 | 6 |
| Fee per member per month | — | $2 |
| Revenue component | 2030 | 2031 |
|---|---|---|
| Targeted screening · $500/test | $2,000,000 | $10,000,000 |
| Therapy optimization · $500/test | $1,000,000 | $6,000,000 |
| Program service fees | $300,000 | $600,000 |
| Population-health analytics fees | $0 | $480,000 |
| Shared savings or performance bonuses | $0 | $0 |
| Total channel revenue | $3,300,000 | $17,080,000 |
Alternative pricing. If every test, including pharma, is priced at $500, annual revenue including unchanged payer program and analytics fees is $2.5M, $10.0M, $20.0M, $43.3M, $92.08M, respectively.
Model basis. Volume-driven management targets, not validated demand. Assumes all modeled tests are completed within the stated year and full prices are realized. Net revenue must reflect any discounts, payer allowances and uncollected amounts. Costs and profitability are not modeled.
Population and payer revenue includes screening and therapy tests, annual service fees per program and analytics fees based on total covered members across contracts. Payer volumes are additional to clinical testing; shared savings and performance bonuses are zero. Licensing, milestone payments and other analytics fees are excluded. SOM, SAM and TAM are market-size scenarios, not additions to this volume-driven forecast.
This forecast doesn't account for any pipeline development products in oncology or neurodegenerative diseases.
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Regulatory and development roadmap
The Series A Advances Kihealth from Validated Platform to Scaled Clinical Product
01
Current foundation
- Fully operational CLIA-certified, COLA-accredited laboratory
- Existing analytical validation
- PLA code assigned
- FDA pre-submission completed
- Active clinical and research programs
02
Near-term milestones
2027
- Full FDA submission
- Additional clinical validation
- Clinical utility
- Payer engagement
- Expanded pharmaceutical partnerships
- Payer or health-system pilot
03
Longer-term milestones
2028
- FDA authorization target
- Expanded reimbursement
- Broader T1D commercialization
- Type 2 diabetes and GLP-1 applications
- Additional tissue-specific assays
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Leadership
Built to Translate Breakthrough Science into Clinical and Commercial Impact
Jenna Anderson
Chief Executive Officer
Translates Kihealth’s scientific advantage into an executable growth strategy.
Robert E. Mons III
Chief Operating Officer
Builds the operating and partnership infrastructure required to scale Kihealth.
Matthew Benson, MD
Chief Medical Officer
Board-certified pediatric endocrinologist and diabetes specialist leading clinical strategy.
Clifford Morris, PhD
Chief Scientific Officer
Molecular biologist and diagnostics innovator leading biomarker discovery.
Pat Nashorn
SVP, Business Development
Leads commercial partnerships and business development across clinical.
Scientific & clinical advisors
Dr. Kevan Herold
Professor of Immunobiology & Medicine, Yale School of Medicine
World-leading authority in Type 1 diabetes prevention and immunotherapy, central to the development of teplizumab and to the foundational science underpinning Kihealth's platform.
ImmunobiologyT1D prevention
Dr. Camillo Ricordi
Director Emeritus, Diabetes Research Institute, University of Miami
Internationally renowned physician-scientist and pioneer in diabetes research, regenerative medicine and cellular transplantation.
Diabetes researchCell transplantation
Eitan Akirav, PhD
Director of Business Development, Harvard University
Dual focus on scientific innovation and biotechnology business strategy, advising on translational programs and partnership development.
Translational scienceBiotech strategy
Dr. Larry Fox
Chief of Pediatric Endocrinology, Nemours Children's Health
More than 34 years in pediatric endocrinology and clinical research, with a focus on integrating novel diagnostics into routine care pathways.
Pediatric endocrinologyClinical research
Dr. Shadi Abdelnour
Endocrinologist, Cedars-Sinai Medical Center
Board-certified endocrinologist combining evidence-based care with advances in precision metabolic medicine.
EndocrinologyPrecision metabolic medicine
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The Investment
Investment Opportunity
$15 million Series A
24 months to inflection
Use of funds
- Clinical validation$5.25M · 35%
- Regulatory execution$3.75M · 25%
- Platform scale$3.75M · 25%
- New-indication R&D$2.25M · 15%
Milestones for the next 24 months
- 01
Expand paid pharma programs
Retrospective trial analysis, prospective therapeutic studies, and longitudinal biomarker services.
- 02
Establish incremental value
Does Beta Intercept predict progression or response beyond C-peptide, HbA1c and conventional measures?
- 03
Validate clinical utility
Define the patient, the testing cadence, and the clinical decision — demonstrate that the result changes management.
- 04
Advance regulatory + reimbursement
Generate evidence supporting the intended use and payment pathway.
- 05
Expand the platform
T2D / metabolic intervention studies and a second tissue-specific indication.
Allocation and milestone timing are operating targets, not guaranteed outcomes, and are subject to execution, regulatory processes and market conditions.
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Closing
Earlier Detection.A Greater Opportunity to Prevent Disease.
Kihealth is developing molecular tests and AI to reveal active tissue injury and track biological change, with the goal of informing intervention earlier in the disease process.
Who we serve
Earlier Insight. More Informed Decisions. Greater Potential Impact.
- Clinicians
Identify patients who may benefit from earlier intervention—and track biological response to guide more personalized care.
- Therapeutic developers
Improve trial selection, distinguish progressors from non-progressors, and evaluate early signals of therapeutic response.
- Payers
Generate evidence to target effective care, assess treatment value, and evaluate the potential to reduce costly disease progression.
- Patients
Gain earlier insight into disease activity—and a clearer path to timely, personalized intervention.
Our ambition: make earlier molecular insight a foundation for disease prevention.
The Series A is designed to advance a validated lead application, expand commercial and pharmaceutical adoption and establish the foundation for a multi-indication disease-interception platform.
01
Continue diligence
Work through the full thesis from the top.
02
Access investor resources
Approved presentations, financials and scientific materials.
03
Review the confidential data room
Confidential materials are available following execution of an NDA.
04
Schedule a management discussion
Arrange time with the Kihealth management team.
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Let's discuss the opportunity.
Important investor information
Purpose and investment risk
This presentation provides an overview of Kihealth and does not contain all information necessary to evaluate an investment. Any investment should be evaluated together with definitive offering documents and applicable risk disclosures. An investment involves substantial risk, including illiquidity, dilution and possible loss of the entire investment.
Forward-looking statements and projections
Statements regarding future revenue, market penetration, clinical development, regulatory milestones, reimbursement, partnerships and commercialization reflect management’s current expectations and assumptions as of the presentation date. Actual results may differ materially due to clinical outcomes, regulatory requirements, adoption, competition, financing needs and other risks. Financial projections and illustrative program economics are estimates, not guaranteed results or contracted revenue unless expressly identified.
Market opportunity
Market estimates combine third-party information and management assumptions concerning patient populations, eligibility, testing frequency, pricing and adoption. Population prevalence does not establish clinical eligibility or achievable demand. Market size estimates do not represent expected company revenue.
Clinical and regulatory development
Potential applications described for Beta Intercept™, Intercept IQ™ and Ki Intelligence are subject to the validation and regulatory requirements applicable to each intended use. Exploratory findings do not establish clinical utility or guarantee future performance. Laboratory certification, accreditation, coding and FDA pre-submission activities do not themselves establish FDA marketing authorization or reimbursement coverage.