UTI and Sexual Health.
Decentralized.
One Platform. Multiple Diagnostic Panels. Regional Population Health.
Smart URx transforms fragmented clinical signals into predictive treatment intelligence — helping providers reduce diagnostic uncertainty by converting real-time urine biomarker data into evidence-based clinical recommendations, without routine clinic visits.
Message from the CEO
A platform built to earn trust, improve outcomes, and generate durable value
Smart URx was formed around a straightforward conviction: diagnosing and treating urinary tract infections and sexually transmitted infections should not require a clinic visit. The infrastructure to do this well — with accuracy, security, and clinical accountability — simply did not exist in an integrated form.
We build with clinical rigor by design. Every component of the Smart URx platform — device, software, data pipeline, and care delivery — is structured from the outset to meet the standards of a regulated medical device.
Selected for the HBS Foundry Deep Tech Cohort
As Smart URx advances its point-of-care evidence engine and long-term infection intelligence platform, participation in the July 2026 HBS Foundry Deep Tech cohort is helping us pressure-test our commercialization strategy and prepare for the next stage of company growth.
One Platform. Multiple Diagnostic Panels.
Both products share the same disposable pod platform, the same workflow, and the same care delivery ecosystem.
Panel 1
Smart URx UTI
Optical reagent detection for screening uncomplicated urinary tract infections.
Detects
- Leukocyte esterase
- Nitrite
Panel 2
UpcomingSmart URx Sexual Health Panel
Molecular amplification for rapid screening of common sexually transmitted infections.
Detects
- Chlamydia trachomatis
- Neisseria gonorrhoeae
- Trichomonas vaginalis
Common Infections. Inefficient Workflow.
Two of the most frequent diagnostic categories in outpatient medicine — urinary tract infections and sexually transmitted infections — still require clinic visits for testing.
System Burden
- ~11 million UTI outpatient visits annually in the United States
- ~50 million STI diagnostic tests annually
- Urgent care and emergency department congestion
- High antibiotic utilization and delayed diagnosis
Current Friction Points
- Patients must travel to clinic for routine testing
- Delayed lab processing and result delivery
- Overburdened urgent care and ED systems
- Workflow inefficiency for providers
Smart URx Disposable Diagnostic Platform
One connected pod architecture. Multiple diagnostic panels. No external strips, no manual interpretation, no in-person visit required.
Device Integrates
- UTI panel — nitrite & leukocyte esterase detection
- Sexual health panel — molecular detection (CT, NG, Trich)
- Optical interpretation system
- Encrypted transmission
- Direct telehealth connection
Workflow
- 1Patient collects urine sample in Smart URx diagnostic pod
- 2Lid closure initiates timed reagent saturation
- 3Embedded CMOS optical sensor reads reagent pads
- 4URxOS™ transmits structured results securely via BLE
- 5URx Nexus™ routes data to licensed clinician for review
- 6Prescription sent to pharmacy — URx Atlas™ logs the encounter
From Pod to Clinician in Minutes
The Smart URx device pairs with a user-friendly mobile app that guides patients through every step — from scanning the pod to picking up their prescription.
Scan Smart URx Pod
Processing
View Results
Indicators Detected
Talk with a Clinician
Pickup Prescription
Intuitive Mobile Interface
Designed for first-time users — no medical knowledge required to complete a test.
Live Telehealth Connection
If indicators are detected, the app connects patients directly to a licensed clinician for real-time consultation.
End-to-End Care Delivery
From test initiation to prescription pickup, every step is managed within a single app workflow.
One Platform. Four Capabilities.
Smart URx addresses the full chain of failure in UTI care — from diagnostic ambiguity to treatment delay.
Connected Diagnostics
Integrated at-home diagnostic testing
The Smart URx pod integrates optical reading directly into the collection vessel. No external strips, no subjective color matching — the device reads, interprets, and transmits.
- Nitrite & leukocyte esterase detection
- Optical interpretation eliminates user error
- Encrypted data transmission
- Patent-pending reagent-pod geometry
Three Layers. One Intelligent Platform.
Smart URx is not a device with an app. It is a connected diagnostics infrastructure anchored by three proprietary platform layers — each with a distinct role, all sharing a common data and security foundation.
Layer 1
URxOS™
Workflow Operating System
The core operating layer that controls the diagnostic episode — from test initiation to result capture, clinical routing, and pharmacy handoff. Every encounter runs through URxOS.
- Diagnostic session engine
- Optical signal processing
- Rules-based clinical routing
- Audit trail & event logging
- BLE device communication
Layer 2
URx Nexus™
Interface & Care Coordination
The experience layer for patients, clinicians, telehealth partners, and pharmacies. URx Nexus surfaces the right information to the right stakeholder at every step of care.
- Patient mobile experience
- Clinician review dashboard
- Telehealth workflow integration
- Pharmacy prescription routing
- Partner & enterprise portal
Layer 3
URx Atlas™
Longitudinal Diagnostic Intelligence
The structured data layer that turns every diagnostic episode into longitudinal, de-identified clinical intelligence — powering AMR surveillance, predictive models, and research partnerships.
- Longitudinal encounter dataset
- AMR resistance trend tracking
- Outbreak & cluster detection
- Population health analytics
- Pharma & CDC data licensing
Strategic Moat
The longitudinal, structured, multi-facility clinical dataset accumulating in URx Atlas™ cannot be replicated retroactively by any competitor. Every encounter logged today is a future training example for predictive resistance models.
Why Smart URx Stands Apart
A set of structural advantages that are difficult to replicate and represent defensible moats.
Patent-Pending Pod Architecture
Reagent or molecular cartridges integrated directly into the urine collection device — no strip handling, no separate components.
Automated Digital Interpretation
Optical and molecular signals interpreted digitally. No user judgment required — eliminating subjective color comparison entirely.
Encrypted Transmission
Secure GATT-based wireless data transmission from device to clinician platform.
510(k) Aligned Documentation
Quality management and design documentation structured for FDA clearance from inception.
Diagnosis Linked to Treatment
From sample collection to prescription — a single integrated system linking diagnosis directly to care delivery.
Physician-Led Company
Founded by an emergency physician with direct clinical insight into infection diagnosis and care delivery gaps.
Large, Recurring, Expanding
Home diagnostics market projected 8–10% CAGR through the decade. High frequency. Repeat use. Expanding consumer acceptance.
Primary Markets
- UTI diagnostics — ~11M annual US visits
- Sexual health testing — ~50M annual STI tests
Both represent high-frequency, repeat testing with no current integrated at-home solution.
Adjacent Markets
- Kidney disease screening (albumin/creatinine)
- Drug testing panels
- Multi-pathogen respiratory panels
Bridging Diagnostic Validation with Clinical Action
Current Alternatives
- Clinic-based urinalysis
- OTC dipsticks with subjective interpretation
- Direct-to-lab mail-in kits
Smart URx Differentiation
- Integrated optical reading
- Eliminates subjective color comparison
- Direct physician integration
- Single workflow ecosystem
Current Stage
Active Work
- Engineering refinement of reagent matrix
- OEM engagement in Taiwan
- Biochemistry validation planning
- Pre-seed raise underway
Clear Milestones
- 1Reagent validation
- 2Functional prototype
- 3Regulatory consultation
- 4Pilot testing
Scalable. Recurring. Multi-Channel.
Disposable pod sales
Telehealth consultation fee
Institutional licensing
Employer screening applications
Future diagnostic panel expansion
Clinical data analytics and research partnerships
Built on Trust
Sensitive health data demands the highest standards. Smart URx is built with security, privacy, and regulatory compliance as foundational requirements — not afterthoughts.
HIPAA-Aligned Backend
Patient data handled under HIPAA-compliant data architecture from day one.
Encrypted Transmission
BLE GATT with end-to-end encryption ensures test data stays secure in transit.
ISO 13485 Framework
Quality management system aligned to ISO 13485 for medical device documentation.
510(k) Rigor
Design and testing documentation built to support FDA 510(k) clearance pathway.
Secure Data Pipeline
Encrypted cloud infrastructure with access controls protecting all diagnostic data.
Physician Oversight
Every result reviewed by a licensed clinician before any treatment is initiated.
Beyond Diagnostics. Predictive Treatment Intelligence.
Smart URx is not building a strip with an app. It is building a clinical intelligence engine — converting real-time urine biomarker data and patient context into evidence-based treatment recommendations that reduce diagnostic uncertainty at the point of care.
Phase 1 — Now
Rule-Based Interpretation
Urine biomarker signals are optically read, digitally interpreted, and linked directly to clinical decision support — removing subjective color comparison and enabling immediate treatment routing.
- NIT & LEU optical detection
- Automated result interpretation
- Evidence-based treatment recommendation
- Direct telehealth escalation
Phase 2 — Roadmap
Multi-Signal Prediction Engine
Combining biomarker data with clinical context to predict diagnosis probability, resistance likelihood, and optimal empiric treatment — a multi-signal recommendation engine for infection care.
Outputs
Population-Level Intelligence
At scale, every Smart URx test contributes structured clinical data — biomarker results, geographic region, treatment outcomes — forming a continuously expanding infection dataset that powers regional surveillance and clinical research.
Regional infection surveillance
Antibiotic stewardship insights
Recurrence pattern detection
Public health monitoring
Clinical research datasets
The Team
Peter Spence MD
Chief Executive Officer
Emergency physician, healthcare entrepreneur, and operator with over a decade of frontline clinical experience. Founded Smart URx to transform infectious disease diagnosis through real-world clinical intelligence and scalable point-of-care diagnostics.
Adolfo Alvino MD
Chief Medical Officer
Clinical oversight and regulatory alignment. Provides medical leadership across device validation, clinical protocol development, and physician integration strategy.
Joseph Cineas
Chief Technology Officer
Leading the architecture and development of the Smart URx device firmware, software platform, and secure data pipeline.
Johnson Yun
Manufacturing Advisor
President of Broad Solutions. Hardware development strategy and pilot manufacturing preparation.
Scientific validation support in development.
Path to Market
Hover over each phase to explore milestones, timelines, and current status.
Validation
Q1–Q2 2026
- Reagent matrix validation
- Optical read accuracy testing
- Biochemistry protocol finalized
- Initial prototype assembly
Prototype
Q3 2026
- Functional device prototype
- BLE transmission testing
- App integration testing
- Design iteration complete
Regulatory
Q4 2026
- Q Sub FDA consultation
- 510(k) submission prep
- ISO 13485 audit readiness
- Clinical validation study
Launch
2027
- FDA clearance target
- OEM manufacturing ramp
- Telehealth partner launch
- Commercial sales begin
Pre-Seed Raise: $1,500,000
Structured to de-risk the core validation phase.
The Convergence Moment
Healthcare is shifting toward validated, decentralized diagnostics. Smart URx is positioned at the intersection of device engineering, telehealth, and consumable diagnostics.
Request Investor Materials
Confidential investor materials available upon request. Contact management directly to begin the conversation.