CerebroPulse Analytics - Quantifying Cerebral Perfusion to Advance Safer Neurotherapeutics
CerebroPulse Analytics provides AI-assisted cerebral perfusion data for pharmaceutical research and Alzheimer's drug safety trials (RUO). Our Quadplex Ultrasound™ platform delivers continuous, non-invasive monitoring of cerebral blood flow—transforming how the industry detects and manages ARIA-related safety events in next-generation Alzheimer's therapeutics.
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Business Case for CerebroPulse Analytics
Our Mission
CerebroPulse Analytics leverages NASA-derived ultrasound technology and proprietary AI algorithms to quantify cerebral perfusion in real time. We're addressing the most critical safety challenge in Alzheimer's drug development: ARIA monitoring.
Strategic Positioning
As the flagship platform from Pulse Logic's innovation ecosystem, CerebroPulse represents the cutting edge of neuroimaging for drug safety. Our Quadplex Ultrasound™ technology provides pharmaceutical partners with unprecedented insight into cerebral hemodynamics during clinical trials.
Research Use Only (RUO)
Designed specifically for pharmaceutical research applications and clinical trial safety monitoring
AI-Powered Analysis
Advanced algorithms transform raw perfusion data into actionable clinical intelligence
Continuous Monitoring
Real-time cerebral flow assessment beyond episodic MRI snapshots
The ARIA Challenge in Alzheimer's Drug Development
Amyloid-Related Imaging Abnormalities (ARIA) represent the primary safety hurdle for anti-amyloid monoclonal antibodies like lecanemab and donanemab. ARIA-E (vasogenic edema) and ARIA-H (microhemorrhages) complicate trial design, delay regulatory approvals, and create significant barriers to widespread therapeutic adoption.
Current Monitoring Limitations
Standard practice relies on episodic MRI surveillance—expensive, logistically complex, and incapable of capturing dynamic perfusion changes between imaging intervals. This creates blind spots in patient safety monitoring.
Clinical Trial Impact
ARIA events require dose modifications or treatment discontinuation in 12-17% of patients in pivotal trials. The inability to predict or detect early ARIA increases patient risk and trial costs significantly.
Regulatory Scrutiny
FDA briefings on lecanemab highlighted ARIA as a critical safety consideration. Enhanced monitoring capabilities could accelerate approval pathways and support risk mitigation strategies for novel therapeutics.

Key Reference: FDA and NEJM publications document ARIA incidence rates of 12.6% (ARIA-E) and 17.3% (ARIA-H) in recent Alzheimer's therapeutic trials, underscoring the urgent need for improved monitoring technologies.
Quadplex Ultrasound™: Four Channels, One Complete Picture
Quadplex Ultrasound™ integrates four synchronized imaging modalities to deliver comprehensive cerebral perfusion assessment. Unlike conventional duplex or triplex systems, our platform captures anatomical, hemodynamic, and biomechanical data simultaneously—providing the most complete non-invasive picture of cerebrovascular health available for research applications.
01
B-Mode Imaging
High-resolution anatomical baseline visualization of cerebral vasculature and surrounding tissue structures
02
Color Doppler Flow
Real-time spatial distribution mapping of blood flow direction and velocity throughout the cerebral circulation
03
Spectral Doppler Analysis
Quantitative velocity waveform characterization with precise measurement of systolic peaks, diastolic flow, and pulsatility indices
04
Compliance & Micromotion Detection
Sub-micron tissue displacement sensing derived from Pulse Phase-Locked Loop (PPLL) technology—uniquely sensitive to early edema formation
"MRI provides snapshots of structural change. Quadplex Ultrasound™ shows the hemodynamic movie—capturing the dynamic perfusion patterns that precede visible ARIA manifestations."
Stakeholder Value Proposition
Healthcare Systems
Healthcare innovation institutions gain first-mover advantage as the pioneering U.S. health system validating real-time ARIA monitoring—establishing reputation as a leader in neurotherapeutic safety innovation and attracting top-tier pharmaceutical partnerships.
Pharmaceutical Partners
Biogen, Eli Lilly, and emerging biopharma gain risk mitigation tools that reduce trial failures, accelerate regulatory pathways, and strengthen payer confidence in anti-amyloid therapeutic safety profiles—directly impacting market adoption curves.
Investment Community
Platform technology with horizontal scalability across neurology, trauma, orthopedics, and critical care—billion-dollar addressable market potential with capital-light SaaS business model and defensible IP position.
Patient Safety
Earlier detection of adverse cerebrovascular events enables proactive intervention, reducing severe ARIA outcomes and building patient trust in breakthrough Alzheimer's therapeutics—ultimately improving treatment adherence and outcomes.
Platform Technology: Beyond Alzheimer's
Quadplex Ultrasound™ represents a versatile platform architecture applicable across multiple high-value clinical domains. The same core technology that monitors cerebral perfusion in Alzheimer's trials adapts seamlessly to trauma care, critical care monitoring, and surgical applications—maximizing return on R&D investment.
Neurocritical Care
Non-invasive intracranial pressure monitoring, cerebral edema tracking, and stroke perfusion assessment in ICU settings
Trauma Medicine
Acute Compartment Syndrome detection via TraumaPulse Analytics—validated technology preventing limb loss in emergency departments
Cardiology
Tissue perfusion assessment in sepsis, transplant viability monitoring, and peripheral vascular disease management
Orthopedics
Post-surgical healing monitoring, vascular flow assessment in reconstructive procedures, and tissue viability tracking
Obstetrics
Fetal cerebral perfusion monitoring, placental function assessment, and maternal vascular health evaluation

Clinical References: NIH guidelines on ICP monitoring and AAOS protocols for compartment syndrome detection validate the clinical need for continuous, non-invasive perfusion monitoring across these specialties.
Market Opportunity Analysis
Alzheimer's Therapeutics Surge
The global Alzheimer's drug market is projected to exceed $13 billion by 2030, driven by the approval of disease-modifying therapies from Biogen, Eli Lilly, and emerging pipeline candidates. ARIA monitoring represents a critical unmet need in this rapidly expanding segment.
With lecanemab generating $2 billion in projected peak sales and donanemab pursuing similar trajectories, pharmaceutical sponsors face immense pressure to demonstrate safety. CerebroPulse Analytics addresses this need directly, positioning as essential infrastructure for next-generation trial design.
$13B
Alzheimer's Drug Market
Projected value by 2030
$8.3B
Trauma Care Market
Annual addressable opportunity
200+
Target Hospitals
Adoption scale for unicorn valuation
Beyond Alzheimer's research, the broader trauma and critical care monitoring market represents an $8.3 billion annual opportunity. Adoption by approximately 200 hospital systems can support a billion-dollar platform valuation—achievable within 5-7 years through our capital-efficient SaaS model.
Sources: EvaluatePharma Alzheimer's market forecasts, Grand View Research trauma care reports, and TraumaPulse Analytics' internal market analysis.
Technology Foundation & Intellectual Property
NASA Heritage
Core ultrasound technology derived from NASA space medicine research—validated in extreme environments and adapted for clinical precision
Proprietary AI Algorithms
Machine learning models trained on extensive perfusion datasets enable automated ARIA risk scoring and predictive analytics
Patent Protection
U.S. non-provisional patent filed (also a supplemented provisional with explicit Quadplex definition); PCT international filing pending for global IP coverage
Hardware-Agnostic Architecture
Our Software as a Medical Device (SaMD) approach runs on existing ultrasound platforms, eliminating capital equipment barriers and accelerating hospital adoption. This capital-light strategy maximizes margin potential while minimizing deployment friction.
Defensible Innovation
The simultaneous acquisition of B-mode, Color Doppler, Spectral Doppler, and Compliance data represents a novel technical achievement explicitly defined in our patent claims—creating substantial barriers to competitive entry in cerebral perfusion monitoring.

Technology Validation: NASA's extensive publication record (270+ peer-reviewed articles) on ultrasound technology in microgravity environments provides third-party validation of our core sensing methodologies.
Regulatory Strategy & Pathway
CerebroPulse Analytics is currently positioned as Research Use Only (RUO) for pharmaceutical clinical trials and institutional research applications. Our regulatory roadmap targets FDA 510(k) clearance by 2026 and EU CE Mark under the Medical Device Regulation (MDR) framework.
1
2024-2025: RUO Validation
Healthcare innovation institution collaboration establishes clinical evidence base with ARIA monitoring data in controlled research settings
2
2025-2026: FDA Submission
510(k) clearance pathway as Software as a Medical Device (SaMD) with predicate device strategy leveraging established ultrasound platforms
3
2026: International Expansion
CE Mark under MDR (anticipated Class IIa/IIb classification) enables European pharmaceutical partnership opportunities
4
2027+: Clinical Adoption
Commercial launch in neuroimaging centers and expansion into trauma, critical care, and surgical monitoring applications
SaMD Advantages
The FDA's Software as a Medical Device guidance provides an established regulatory pathway that accommodates AI-enabled algorithms and continuous software improvements—critical for maintaining competitive advantage in rapidly evolving neuroimaging applications.
Global Compliance
EU MDR Rule 11 classification methodology positions CerebroPulse for streamlined international approvals, supporting partnerships with European pharmaceutical sponsors and academic medical centers conducting multinational trials.
High-Margin Business Model
CerebroPulse Analytics operates a capital-light, dual-revenue model that maximizes margins while enabling rapid scalability. Our approach eliminates traditional medical device challenges—no manufacturing facilities, no probe inventory, no hardware distribution logistics.
SaaS Hospital Subscriptions
Annual licensing from $45,000 (community hospitals) to $250,000 (academic medical centers) based on imaging volume and research intensity—predictable recurring revenue with 85%+ gross margins
OEM Licensing Partnerships
Upfront technology access fees plus per-unit royalties with major ultrasound manufacturers—creates embedded revenue streams in existing capital equipment sales cycles
Pharmaceutical Research Contracts
Custom analytics packages for clinical trial sponsors—premium pricing for ARIA monitoring protocols, data integration services, and specialized algorithm development
Platform scalability across trauma, neurology, orthopedics, and obstetrics creates multiple expansion vectors without additional core R&D investment—each specialty representing incremental margin contribution on the same foundational technology.
World-Class Leadership Team
CerebroPulse Analytics is led by proven medical technology entrepreneurs with multiple successful exits, deep regulatory expertise, and established relationships across pharmaceutical, clinical, and investor communities. Our team combines commercial execution capability with scientific credibility.
John Nguyen, Chief Executive Officer
Founded Pulse Logic and architected both TraumaPulse and CerebroPulse platforms. Extensive trauma care background with proven track record building SaMD companies from concept to revenue. Strategic vision combines clinical insight with commercial discipline.
Chief Medical Officer
Emergency Medicine and Trauma Surgery specialist with 15+ years academic medical center experience. Published researcher in cerebrovascular monitoring and neurocritical care. Maintains active clinical practice providing real-world validation of product-market fit.
Chief Technology Officer
Biophysics doctorate with specialization in ultrasound signal processing and AI algorithm development. Led development of Quadplex simultaneous acquisition methodology. Named inventor on core patent applications with deep expertise in FDA SaMD regulatory requirements.
Chief Regulatory Officer
Former FDA reviewer with 20+ years medical device regulatory experience spanning neurology, imaging, and SaMD classifications. Successfully navigated 510(k) and PMA pathways for eight prior medical technologies. VA healthcare system collaboration expertise.
Distinguished Advisory Board
NASA Ultrasound Pioneer
270+ peer-reviewed publications in space medicine and remote diagnostics. Developed foundational ultrasound protocols for International Space Station medical operations—direct technology heritage to CerebroPulse platform.
Ultrasound Technology Innovator
40+ issued patents in Doppler imaging, tissue characterization, and AI-assisted diagnostics. Former R&D executive at leading ultrasound OEM—provides strategic guidance on commercial partnerships and competitive positioning.
Healthcare Innovation Institution Leadership
Strategic collaboration with South Florida's premier health system innovation arm. Clinical validation partner with access to neurology centers of excellence and Alzheimer's research infrastructure.

Team Distinction: Our leadership combines rare expertise in NASA-derived medical technology, FDA regulatory pathways, clinical neuroimaging, and pharmaceutical partnership development—creating unique capability to execute the CerebroPulse vision.
Strategic Partnership Roadmap
CerebroPulse Analytics seeks strategic partnerships that validate technology, accelerate market access, and establish category leadership in cerebral perfusion monitoring for drug safety applications. Our phased approach builds momentum from clinical validation through pharmaceutical adoption.
Phase 1: Clinical Validation Partnership
Collaborate with healthcare innovation institutions to establish Quadplex Ultrasound™ protocols for ARIA monitoring in controlled research settings. Generate peer-reviewed publications demonstrating sensitivity, specificity, and predictive value versus MRI gold standard.
Phase 2: Pharmaceutical Data Presentation
Present validated clinical evidence to Biogen, Eli Lilly, and emerging anti-amyloid therapeutic sponsors. Demonstrate value proposition for clinical trial risk mitigation, regulatory pathway support, and post-market surveillance capabilities.
Phase 3: Co-Development & Investment
Secure pharmaceutical industry partnerships structured as co-development agreements, clinical trial integration contracts, or strategic equity investment. Position CerebroPulse as essential infrastructure for next-generation Alzheimer's therapeutic development.
Near-Term Objectives
  • Complete healthcare innovation pilot with 50+ ARIA monitoring datasets
  • Submit findings to Alzheimer's & Dementia and Journal of Neuroimaging
  • Initiate discussions with Biogen Medical Affairs and Eli Lilly Clinical Development teams
  • Demonstrate 6-12 month advance warning capability for ARIA-E events
Value Creation Milestones
  • First pharmaceutical partnership validates $50M+ platform valuation
  • Multi-site trial integration creates defensible competitive moat
  • RUO revenue generation funds FDA clearance pathway investment
  • OEM licensing discussions leverage pharmaceutical validation
Making the Invisible Visible
"We turn suspicion into certainty—quantifying the hemodynamic signals that precede visible brain injury."
Quadplex Ultrasound™ represents the evolutionary leap beyond triplex imaging—adding the fourth dimension of biomechanical compliance that unlocks early ARIA detection. Where conventional monitoring sees structural damage after it occurs, CerebroPulse reveals the dynamic perfusion changes that predict adverse events.
Safer Alzheimer's Therapies
Earlier ARIA detection enables proactive dose management, reducing severe adverse event rates and accelerating patient access to breakthrough treatments
Stronger Clinical Confidence
Continuous perfusion data transforms trial safety monitoring from reactive to predictive—giving investigators unprecedented insight into cerebrovascular response patterns
Scalable Platform Technology
From Alzheimer's research to trauma care, neurocritical monitoring to surgical applications—one core technology platform addressing billion-dollar market opportunities
The pharmaceutical industry faces mounting pressure to demonstrate safety in disease-modifying neurotherapeutics. Regulatory agencies demand better monitoring. Payers require risk mitigation evidence. Patients deserve protection from preventable adverse events. CerebroPulse Analytics delivers the technology infrastructure that makes safer drug development possible.
Join Us in Advancing Safer Neurotherapeutics
CerebroPulse Analytics stands at the intersection of breakthrough Alzheimer's science, proven ultrasound technology, and urgent clinical need. We invite pharmaceutical partners, academic medical centers, and strategic investors to join us in establishing the new standard for cerebral perfusion monitoring in drug safety applications.
Pharmaceutical Sponsors
Integrate Quadplex monitoring into your Alzheimer's clinical trials. Gain competitive advantage through enhanced safety profiles and regulatory confidence. Contact our Clinical Partnerships team to discuss custom research protocols.
Healthcare Systems
Join healthcare innovation institution as an early validation partner. Establish your institution as a leader in neurotherapeutic safety innovation. Explore RUO collaboration opportunities with our Clinical Research team.
Strategic Investors
Participate in building platform technology with billion-dollar market potential. Capital-light SaaS model, defensible IP, proven leadership team. Review investment materials through our secure data room.
Contact CerebroPulse Analytics
Ready to discuss how Quadplex Ultrasound™ can transform your Alzheimer's drug development program? Our team is available to present clinical validation data, discuss custom research protocols, and explore partnership structures.
CerebroPulse Analytics
A division of Pulse Logic Biosystems
CerebroPulse Analytics Quadplex Ultrasound™ platform is currently available for Research Use Only (RUO). Not approved for clinical diagnostic use. FDA 510(k) clearance targeted for 2026.