01 / READER
Reusable electronics.
Electrochemical AFE, BLE, battery, charger, optical path, thermal sensing, haptics, firmware scheduler, and sealed cartridge contacts.
Clinical biochemical monitoring platform
CBM is the hardware base for validated biochemical cartridges.
CBM fills specific biochemical monitoring gaps where current care still relies on sparse blood draws. It provides the reusable reader, skin interface, cartridge contact system, and confidence-gated software needed to validate one cartridge at a time. The first fundable cartridge is CKM-HF 30: post-discharge potassium trend monitoring for high-risk heart-failure patients.
Medical thesis
Build the reusable device once. Validate each biochemical cartridge separately.
CBM is the shared infrastructure for clinical biochemical monitoring: reusable electronics, disposable chemistry, controlled skin contact, data quality gates, and an app layer that can suppress outputs when confidence fails.
02 / CARTRIDGE
Disposable chemistry.
Replaceable electrochemical flex with working electrodes, reference/counter system, microneedle access, gasket, contact field, and analyte-specific membranes or enzymes.
03 / SOFTWARE
Confidence-gated output.
The app displays channel status, calibration age, sensor confidence, and confirmation rules before it displays biomarker interpretation.
Program selection criteria
Each program must name the clinical decision it changes.
AcceptPrograms where a trend triggers a specific action: confirmatory lab, medication review, protocol escalation, or treatment de-escalation.
RejectPrograms where the biomarker is interesting but not actionable, has weak ISF-to-blood interpretation, or cannot meet drift and fouling limits over wear time.
First wedgeCKM-HF 30, because post-discharge HFrEF medication management has a measured monitoring gap, high event density, clear workflow, and strong economics.
Current care gap
Remote monitoring sees physiology. It usually does not see chemistry.
Heart-failure remote patient monitoring is clinically useful: meta-analyses show lower mortality and fewer HF hospitalizations. But most noninvasive RPM programs transmit weight, symptoms, blood pressure, heart rate, and ECG. They do not continuously measure potassium, glucose/ketone dynamics, lactate, or other biochemical variables that drive medication safety and escalation decisions.
0.81 ORHF RPM meta-analysis: lower mortality risk vs. usual care.
0.78 ORHF RPM meta-analysis: lower first HF hospitalization risk vs. usual care.
46.5%Eligible HFrEF patients with no serum K+ check within 7 days after MRA initiation in a multicenter cohort.
2026Microneedle ISF monitoring remains an emerging clinical technology with unresolved validation, reliability, regulatory, and reimbursement barriers.
Where care failsThe patient leaves the hospital after medication changes. Potassium, renal function, and metabolic status are checked only when the schedule, patient access, and clinician orders align. High-risk drift can occur between those points.
What CBM addsA chemistry channel between visits. It does not replace confirmatory labs; it determines when the next lab should happen sooner.
First usePotassium trend monitoring after HF discharge, paired with a protocol for confirmatory potassium/creatinine/magnesium testing and medication review.
Medical applications
Prioritize the applications where a trend changes clinical timing.
Below is the practical roadmap. Only potassium is ready to be treated as the first clinical cartridge program. Other analytes are future programs with clear medical rationale but material validation gaps.
01 / HF POTASSIUM
Post-discharge HFrEF.
Patients on loop/thiazide diuretics, MRA/RAASi titration, CKD, diabetes, ischemic cardiomyopathy, or ICD history. Action: earlier K+/creatinine/magnesium confirmation and medication review.
02 / CKD + RAASi
Hyperkalemia prevention.
CKD/HF patients benefit from RAASi but hyperkalemia leads to dose reduction or discontinuation. Action: earlier detection of rising K+ so clinicians can preserve therapy with binders, dose changes, or closer labs.
03 / DIALYSIS
Interdialytic K+ risk.
Hemodialysis patients experience rapid K+ shifts and long interdialytic intervals associated with arrhythmia concern. Action: identify high-risk pre-dialysis drift and support dialysate / binder / diet review.
04 / DKA
Insulin infusion safety.
DKA treatment rapidly shifts potassium intracellularly. 2025 real-world DKA data reported hypokalemia during treatment in 67.9% of patients. Action: continuous K+ trend between scheduled BMPs.
05 / SEPSIS
Lactate dynamics.
Sepsis guidelines require lactate measurement and remeasurement when elevated. Continuous lactate remains developmental, but a hospital cartridge could reduce blind time between serial draws.
06 / VANCOMYCIN
Antibiotic TDM.
Vancomycin has a narrow therapeutic window and nephrotoxicity risk. ISF/microneedle TDM is promising but preclinical. Action: future dose adjustment support if ISF-to-blood correlation is validated.
07 / TRANSPLANT
Tacrolimus monitoring.
Tacrolimus requires frequent therapeutic drug monitoring with narrow toxicity/rejection margins. Future CBM cartridges could support home or clinic trend monitoring after strong comparator validation.
08 / GLUCOSE + KETONE
Diabetes safety.
CGM proves glucose monitoring. Continuous ketone monitoring is emerging for DKA prevention but shows drift challenges. Action: future glucose/BHB/K+ safety cartridge if multi-day enzyme accuracy is proven.
09 / CORTISOL
Research only.
Wearable cortisol is advancing, but medical actionability is less direct. It remains lower priority until time-resolved cortisol can change a specific endocrine decision.
Prioritization rule
The first funded use case should maximize lives saved per dollar.
Rank 1CKM-HF 30: large risk pool, defined monitoring failure, mortality/readmission relevance, low cartridge cost, and clear confirmatory-lab action.
Rank 2Hospital electrolyte and DKA potassium surveillance: shorter wear, easier calibration, direct workflow integration, and clear scheduled-lab gaps.
Rank 3CKD/RAASi, dialysis, sepsis lactate, and therapeutic drug monitoring are credible medical programs but require separate comparator studies and operational integration.
Evidence matrix
Condition-specific cost / benefit anchors.
HF potassiumBurden: ~1.09M U.S. HF hospitalizations/year; vulnerable-phase mortality can approach 10%; MRA monitoring gap: 46.5% untested by day 7. Cost: ~$18k per HF hospitalization. CBM benefit hypothesis: earlier confirmatory K+/Cr/Mg testing and medication review during the first 30 days after discharge. Validation endpoint: fewer days below/above protocol K+ range, faster lab confirmation, fewer urgent electrolyte events, readmissions, ICD therapies, and mortality signal.
CKD / RAASiBurden: hyperkalemia causes RAASi dose reduction or discontinuation; RAASi interruption is associated with higher hospitalization and mortality in large observational analyses. Cost: hyperkalemia in CKD/HF is associated with roughly $24k higher 1-year cost vs. controls in U.S. claims analyses. CBM benefit hypothesis: detect rising K+ early enough to preserve RAASi with binder, dose, diet, or lab strategy. Validation endpoint: RAASi continuation, fewer severe hyperkalemia events, fewer hyperkalemia admissions.
DialysisBurden: arrhythmia/cardiac arrest is the leading known cause of death in hemodialysis; long interdialytic intervals and K+ shifts are recognized risk periods. Cost: ESRD inpatient Medicare spending is >$24k per patient-year in historical USRDS data. CBM benefit hypothesis: identify high-risk interdialytic K+ drift before dialysis sessions or weekend gaps. Validation endpoint: pre-dialysis K+ prediction, urgent hyperkalemia detection, dialysate/binder/diet changes, arrhythmia-event tracking.
DKABurden: DKA admissions cost ~$26.6k per admission in inflation-adjusted 2014 U.S. data; aggregate costs reached ~$5.1B. During treatment, 2025 data show hypokalemia developed in 67.9% of DKA patients. CBM benefit hypothesis: continuous K+ trend between q2-4h BMPs during insulin infusion. Validation endpoint: fewer severe hypokalemia episodes, fewer insulin holds, faster K+ replacement, fewer arrhythmias/ICU escalations.
Sepsis lactateBurden: sepsis accounts for millions of U.S. hospital stays and >$50B aggregate hospital costs; mortality in sepsis stays remains high. Guidelines recommend lactate measurement and repeat measurement when elevated. CBM benefit hypothesis: hospital lactate cartridge reduces blind time between serial draws and detects unfavorable lactate clearance. Validation endpoint: agreement with blood lactate, time-to-detection of rising lactate, resuscitation changes, ICU transfer and mortality endpoints.
VancomycinBurden: vancomycin has a narrow therapeutic window; nephrotoxicity/AKI is reported in ~5-43% depending on population and exposure. Cost: nephrotoxicity prolongs stay, can require additional antibiotics or dialysis, and increases medical cost. CBM benefit hypothesis: future TDM cartridge improves AUC-guided dose timing and toxicity avoidance. Validation endpoint: ISF-to-blood correlation, AUC prediction, AKI reduction, dose adjustment accuracy.
Transplant TDMBurden: tacrolimus has a narrow therapeutic index; variability is associated with rejection, renal insufficiency, and graft failure. Cost: antibody-mediated rejection adds tens of thousands of dollars per patient-year; graft failure incremental costs can exceed $150k/year. CBM benefit hypothesis: home or clinic trend monitoring to reduce trough variability and missed toxic/subtherapeutic windows. Validation endpoint: trough prediction, time in therapeutic range, rejection, nephrotoxicity, graft survival.
Glucose / ketoneBurden: CGM lowers severe hypoglycemia hospitalization risk in insulin-treated T2D; DKA remains costly and dangerous. Continuous ketone monitors can capture BHB dynamics but 2026 trial data show drift across 14 days. CBM benefit hypothesis: future combined glucose/BHB/K+ cartridge for pump failure, illness, and DKA prevention. Validation endpoint: BHB accuracy over wear time, DKA alerts, severe hypoglycemia/DKA admissions.
Product viewer
Explore the wearable hardware in 3D.
Inspect the reusable puck, disposable cartridge, contact field, microneedle array, optical path, and electronics in a dedicated interactive viewer.
Investment thesis
Fund the first cartridge that validates the platform and the clinical workflow.
The investment case is a specific post-discharge heart-failure monitoring product that uses CBM hardware and CKM potassium chemistry to close a documented medication-safety gap.
~4 / moTarget cartridges per monitored patient at 7-day wear, not daily replacement.
$20-$124Modeled monthly disposable cost after reader placement, using current prototype BOM assumptions.
$18kMean U.S. heart-failure hospitalization cost used on the CKM evidence page.
12-75 yrsOne avoided HF hospitalization offsets roughly 12-75 patient-years of cartridge cost at prototype ranges.
Use of fundsBench fixtures, sterile K+ cartridge fabrication, reference stability, biofouling controls, 7-day wear testing, paired laboratory potassium study, and clinician dashboard workflow.
Why CBM mattersIf CKM-HF 30 succeeds, the reusable reader, app, manufacturing envelope, and fail-closed architecture become reusable infrastructure for future cartridges.
Prototype limitations
The current CBM package is an engineering envelope, not a validated monitor.
The viewer and page define physical architecture. They do not prove any analyte. The investment case depends on retiring the specific risks below.
LIMIT 01
Biofluid correlation.
ISF and blood are related but not identical. Each analyte needs paired comparator data, lag characterization, and thresholds that map to clinical action.
LIMIT 02
Electrode stability.
Reference drift, membrane leaching, enzymatic decay, fouling, sweat ingress, and motion artifact can dominate the signal unless the cartridge is designed to fail closed.
LIMIT 03
Wear and manufacturing.
Microneedle insertion, adhesive wear, biocompatibility, sterile packaging, lot control, and 7- to 14-day repeatability must be validated before clinical or consumer deployment.
Future model roadmap
What future CBM versions could do after validation.
V1Potassium-only CKM-HF 30 cartridge with post-discharge clinician dashboard and confirmatory lab workflow.
V2Hospital tethered electrolyte cartridge with larger references, bay-driven recalibration, shorter wear, and EHR-integrated trend alerts.
V3Diabetes safety cartridge combining glucose, beta-hydroxybutyrate, and potassium if enzyme stability and DKA intervention endpoints are validated.
V4Multiplex research cartridge only after individual channels prove drift, cross-talk, and clinical decision value.
Does not claim
Validated multi-analyte diagnosis, treatment guidance, stress scoring, hydration diagnosis, lactate threshold prescription, or medical-device readiness.
Does claim
A reusable reader and disposable cartridge architecture designed to support analyte-specific validation programs, starting with CKM potassium monitoring.