CerebroPulse Analytics
Quantifying cerebral perfusion to advance safer neurotherapeutics through AI-assisted monitoring for pharmaceutical research and Alzheimer's drug safety trials.
Executive Overview
The Challenge
Alzheimer's therapeutics represent one of medicine's most promising frontiers, yet monitoring drug safety remains critically limited. Current MRI-based approaches are episodic, expensive, and impractical for continuous patient surveillance during clinical trials. The emergence of anti-amyloid therapies has introduced ARIA (Amyloid-Related Imaging Abnormalities) as the most serious adverse event requiring vigilant monitoring.
Traditional imaging modalities cannot provide the real-time, bedside assessment needed to detect early perfusion changes that signal potential ARIA development. This gap creates substantial risk for trial participants and delays in therapeutic advancement.
Our Solution
CerebroPulse Analytics delivers breakthrough AI-assisted cerebral perfusion data through our proprietary Quadplex Ultrasound™ platform. By providing heartbeat-by-heartbeat perfusion insights at the bedside, we enable pharmaceutical researchers to monitor neurotherapeutic safety with unprecedented precision and continuity.
Our Research Use Only (RUO) platform integrates seamlessly into Alzheimer's drug trials, offering quantitative perfusion metrics that complement standard MRI protocols while dramatically reducing monitoring costs and improving patient safety profiles.
Real-Time Monitoring
Continuous cerebral perfusion assessment replacing episodic MRI-only approaches
Clinical Integration
Bedside deployment enabling immediate safety decisions during trials
Regulatory Confidence
Quantitative data supporting FDA submissions and accelerating therapeutic approval
The Clinical Challenge: ARIA in Alzheimer's Drugs
The advent of anti-amyloid monoclonal antibodies—including lecanemab (Leqembi) and donanemab (Kisunla)—has transformed Alzheimer's treatment paradigms. However, these breakthrough therapeutics carry significant risk of ARIA, a potentially serious complication affecting up to 40% of treated patients in clinical trials.
ARIA-E (Edema)
Vasogenic edema resulting from blood-brain barrier disruption causes fluid accumulation in cerebral tissue. This manifests as localized swelling detectable on MRI FLAIR sequences, often accompanied by headache, confusion, or altered consciousness. Early detection is critical as severe cases can progress to life-threatening complications.
Current monitoring relies on scheduled MRI scans at predetermined intervals, potentially missing acute onset or rapid progression between imaging sessions. The inability to assess real-time perfusion changes limits clinical decision-making during critical windows.
ARIA-H (Hemorrhage)
Cerebral microhemorrhages and superficial siderosis occur when fragile cerebral vessels rupture under therapeutic stress. These microbleeds, visible on gradient-echo MRI sequences, indicate significant vascular compromise and correlate with increased stroke risk and cognitive decline.
The challenge intensifies with APOE ε4 carriers, who demonstrate substantially elevated ARIA-H rates. Without continuous perfusion monitoring, subtle hemodynamic changes preceding frank hemorrhage remain undetectable until damage occurs.
40%
Peak ARIA Incidence
Clinical trial data demonstrates ARIA affects up to 40% of patients receiving anti-amyloid immunotherapy
$32K
MRI Monitoring Cost
Average per-patient imaging expenses during standard trial protocols create unsustainable economic burden
13
Required MRI Scans
Typical trial protocols mandate 13+ scheduled MRIs per participant over 18-month study period
"The current MRI-dependent monitoring paradigm creates a fundamental gap in our ability to ensure patient safety during anti-amyloid therapy. We need continuous, quantitative perfusion data to detect ARIA at the earliest possible stage."
This clinical imperative demands a transformative monitoring solution—one that provides continuous cerebral perfusion assessment without the limitations, costs, and logistical challenges of repeated MRI imaging. CerebroPulse Analytics addresses this unmet need through innovative ultrasound-based technology designed specifically for pharmaceutical research applications.
Technology Foundation: Quadplex Ultrasound™
At the core of CerebroPulse Analytics lies Quadplex Ultrasound™, a revolutionary imaging paradigm that integrates four synchronized modalities into a unified physiology map. Unlike conventional duplex or triplex systems, our platform delivers comprehensive hemodynamic assessment through simultaneous, AI-enhanced multi-channel analysis.
01
B-Mode Anatomical Imaging
High-resolution grayscale imaging establishes baseline structural reference, identifying anatomical landmarks, tissue interfaces, and morphological features essential for accurate perfusion mapping and regional analysis.
02
Color Doppler Flow Mapping
Real-time velocity encoding visualizes cerebral blood flow distribution across the imaging field, revealing perfusion patterns, flow direction, and regional variations critical for detecting early hemodynamic compromise.
03
Spectral Doppler Waveform Analysis
Quantitative velocity profiling captures pulsatility indices, resistance patterns, and waveform morphology within specific vessels, providing numerical metrics for objective assessment of cerebrovascular hemodynamics.
04
Compliance & Micromotion Detection
Phase-sensitive displacement analysis detects submillimeter tissue movements, pressure gradients, and stiffness variations indicative of edema, elevated intracranial pressure, or structural compromise—the breakthrough fourth dimension.
The Quadplex Advantage
Traditional ultrasound systems operate in isolation—B-mode for structure, Doppler for flow, each providing a single perspective on complex physiology. Quadplex Ultrasound™ transcends this limitation through synchronized multi-modal acquisition, where all four channels capture data simultaneously from identical cardiac cycles.
Our proprietary AI algorithms analyze these synchronized data streams in concert, identifying subtle correlations between structural changes, flow alterations, velocity patterns, and tissue compliance that would remain invisible to single-modality assessment. This integrated approach reveals the complete hemodynamic story—from macro-scale perfusion to micro-scale tissue mechanics.
The platform's software-based architecture enables deployment on existing ultrasound hardware, eliminating capital equipment barriers while leveraging advanced computational analysis to extract maximum diagnostic value from standard transducer technology.
4
Synchronized Imaging Modes
100%
Temporal Correlation
1
Unified Physiology Map

Technical Innovation: Quadplex Ultrasound™ represents the first clinically-viable integration of compliance mapping with traditional ultrasound modalities, enabling detection of tissue mechanical property changes that precede visible anatomical or flow abnormalities.
Application to ARIA Monitoring
ARIA-E Detection Strategy
Cerebral edema develops through a cascade of hemodynamic and structural changes, each detectable through specific Quadplex channels. Our compliance mode provides the earliest signal—detecting increased tissue water content through altered acoustic impedance before visible swelling emerges on conventional imaging.
As edema progresses, B-mode imaging reveals subtle parenchymal expansion and sulcal effacement. Simultaneously, Color Doppler mapping demonstrates perfusion redistribution as elevated tissue pressure compresses regional microvasculature. Spectral Doppler waveforms show elevated pulsatility indices reflecting increased vascular resistance.
The AI fusion engine correlates these multi-modal findings, generating a composite ARIA-E risk score that enables intervention before clinical symptoms manifest. This approach transforms monitoring from reactive identification of established edema to proactive detection of early perfusion compromise.
ARIA-H Detection Strategy
Microhemorrhage detection leverages the exquisite sensitivity of Color Doppler to flow disturbances. Perivascular leakage creates characteristic turbulent flow patterns distinctly different from normal laminar perfusion. Our algorithms identify these signatures with high specificity, flagging potential hemorrhagic events for confirmatory imaging.
Spectral Doppler contributes by revealing abnormal pulsatility—the hemodynamic instability that often precedes frank vessel rupture. Increased resistive indices indicate downstream vascular compromise, while dampened waveforms suggest proximal stenosis or occlusion.
Compliance mapping adds a unique dimension by detecting localized stiffness changes associated with hemosiderin deposition and chronic microbleeds, providing insight into cumulative hemorrhagic burden beyond acute event detection.
Baseline Assessment
Pre-treatment Quadplex scan establishes individual perfusion fingerprint and compliance baseline
Serial Monitoring
Regular bedside scans track perfusion evolution throughout treatment course
Early Detection
AI algorithms identify deviation from baseline, triggering clinical evaluation
Guided Intervention
Quantitative data informs dose adjustment or treatment modification decisions
The integration of Quadplex Ultrasound™ into trial protocols provides complementary data to scheduled MRI surveillance. While MRI remains the gold standard for anatomical ARIA characterization, CerebroPulse Analytics fills the critical gap between imaging sessions—providing continuous hemodynamic monitoring that enables early intervention and improved patient safety.
For pharmaceutical sponsors, this translates to enhanced trial safety profiles, reduced dropout rates from adverse events, and stronger regulatory documentation of comprehensive patient monitoring. For clinical sites, the bedside accessibility and rapid turnaround enable immediate clinical decision-making without the delays inherent in MRI scheduling and interpretation.
Expanded Clinical Applications
While CerebroPulse Analytics addresses the urgent need for ARIA monitoring in Alzheimer's therapeutics, Quadplex Ultrasound™ technology represents a versatile platform with applications spanning multiple medical specialties. This breadth demonstrates both the fundamental innovation of our approach and the significant market expansion opportunities beyond neuropharmaceutical research.
Neurological Applications
Beyond ARIA monitoring, Quadplex enables non-invasive intracranial pressure estimation, acute stroke perfusion assessment, traumatic brain injury monitoring, and vasospasm detection following subarachnoid hemorrhage. The technology provides critical hemodynamic data in time-sensitive scenarios where rapid bedside assessment determines clinical outcomes.
Trauma & Emergency Medicine
Acute Compartment Syndrome detection through tissue compliance mapping offers potential to prevent devastating limb loss. Applications extend to burn injury perfusion assessment, sepsis-related microcirculatory dysfunction monitoring, and shock state hemodynamic evaluation—scenarios where traditional imaging proves impractical or impossible.
Cardiovascular & Transplant
Organ congestion assessment in heart failure management, transplant organ viability evaluation, and post-operative perfusion monitoring represent high-value applications. The technology's ability to quantify tissue compliance provides unique insights into organ function beyond simple flow measurement.
Pharmaceutical Research
Drug safety monitoring extends across therapeutic areas—oncology agents with vascular effects, immunotherapies with inflammatory complications, and any investigational compounds requiring perfusion or tissue integrity assessment. CerebroPulse Analytics provides standardized, quantitative endpoints for multi-site research protocols.
Neurology Platform
ICP monitoring, stroke assessment, TBI evaluation, vasospasm detection
Trauma Platform
Compartment syndrome, burn perfusion, sepsis monitoring, shock assessment
Cardiac Platform
Congestion evaluation, transplant viability, post-op monitoring
Research Platform
Multi-specialty drug safety, therapeutic monitoring, clinical endpoints
This platform approach positions Pulse Logic for sustained growth across multiple market segments while maintaining focus on the immediate high-value opportunity in Alzheimer's drug safety. Each application leverages the same core Quadplex technology, enabling efficient development and regulatory pathways as we expand into adjacent markets.
Strategic Positioning
CerebroPulse Analytics' commercial strategy employs a focused "tip of the spear" approach, concentrating initial resources on the highest-value, most urgent clinical need while building a platform foundation for systematic market expansion. This deliberate sequencing maximizes near-term revenue potential while establishing the technological credibility necessary for broader adoption.
1
Phase 1: CerebroPulse Analytics
2025-2026
Launch RUO platform targeting pharmaceutical partners conducting Alzheimer's drug trials. Establish validation datasets through Baptist Health Innovations collaboration and EU partnerships. Secure early adopters among top-tier academic medical centers and contract research organizations.
2
Phase 2: Regulatory Clearance
2026-2027
Advance from Research Use Only to FDA 510(k) clearance and CE Mark approval for clinical diagnostic use. Expand commercial availability to broader hospital market while maintaining pharmaceutical research focus as core revenue driver.
3
Phase 3: TraumaPulse Analytics
2027-2028
Launch trauma and orthopedic applications, particularly Acute Compartment Syndrome monitoring. Leverage clinical validation from neurology applications to accelerate adoption in emergency medicine and surgical specialties.
4
Phase 4: Platform Expansion
2028+
Systematic rollout across cardiovascular, transplant, obstetric, and additional pharmaceutical research applications. Establish OEM partnerships with major ultrasound manufacturers for integrated commercial distribution.
Intellectual Property Foundation
Our technology leadership rests on a comprehensive IP estate anchored by provisional patent applications protecting the Quadplex Ultrasound™ methodology and its clinical applications. The core provisional filing establishes priority for the four-mode synchronized imaging approach, AI-assisted analysis algorithms, and specific clinical decision support implementations.
A supplemental provisional application explicitly names the Quadplex architecture and individual mode specifications, strengthening protection of the fundamental technology platform. This layered IP strategy creates substantial barriers to competitive entry while preserving freedom to operate across multiple clinical applications.
The patent portfolio structure supports both our direct commercial activities and future licensing opportunities with established medical device manufacturers seeking to enhance their ultrasound platforms with advanced perfusion analytics capabilities.
Market Entry Advantages
CerebroPulse Analytics enters the market with several strategic advantages that accelerate adoption and reduce commercial risk:
  • Software-only deployment eliminates capital equipment barriers for early adopters
  • Hardware-agnostic architecture enables installation on existing ultrasound systems
  • RUO pathway provides immediate revenue while pursuing regulatory clearance
  • Pharmaceutical partner relationships ensure early validation and reference customers
  • Baptist Health Innovations affiliation provides clinical credibility and development resources
  • Urgent unmet need in ARIA monitoring creates pull-through demand from trial sponsors
This strategic framework positions CerebroPulse Analytics to capture significant value in the near-term Alzheimer's monitoring market while building the foundation for sustainable long-term growth across the broader perfusion analytics opportunity.
Market Opportunity
The convergence of breakthrough Alzheimer's therapeutics, heightened safety monitoring requirements, and inadequate existing solutions creates an immediate, high-value market opportunity for CerebroPulse Analytics. This market timing, combined with substantial adjacent opportunities, supports significant near-term revenue potential and long-term enterprise value creation.
$13B
Global Alzheimer's Market
Projected therapeutic market size by 2030, driven by anti-amyloid antibody adoption
500+
Active Clinical Trials
Current Alzheimer's drug development programs requiring safety monitoring infrastructure
$8.3B
Trauma Care Market
Addressable market for TraumaPulse Analytics applications in emergency and orthopedic medicine
Primary Market: Alzheimer's Drug Safety Monitoring
The FDA approval of lecanemab (Leqembi) in January 2023 and donanemab (Kisunla) in July 2024 validates the anti-amyloid therapeutic approach while highlighting the critical importance of ARIA monitoring. Both labels carry black box warnings regarding ARIA risk, mandating intensive MRI surveillance protocols that create substantial operational and financial burdens for trial sponsors and treating physicians.
Conservative market penetration analysis demonstrates compelling economics even at modest adoption rates. Pharmaceutical companies conducting Phase 2 and Phase 3 Alzheimer's trials represent the immediate addressable market, with each major trial site requiring monitoring infrastructure for 50-200 participants.
At a subscription price of $45,000-$75,000 per trial site annually, capturing just 200 sites generates $9-15 million in recurring revenue. The addition of hospital-based treatment monitoring as approved therapies reach broader clinical use expands the opportunity significantly—leading academic medical centers treating 100-500 patients annually each represent $150,000-$250,000 in subscription value.
Beyond subscription revenue, pharmaceutical partners conducting large-scale trials may opt for enterprise licensing arrangements providing access across multiple global sites, with deal values potentially reaching $2-5 million per major trial program. These strategic partnerships also provide valuable clinical validation data accelerating regulatory clearance and broader market adoption.
200
Target Trial Sites
Conservative 3-year adoption goal
$15M
Recurring Revenue
Annual subscription baseline
Secondary Markets: Platform Expansion Opportunity
The technical capabilities enabling cerebral perfusion monitoring translate directly to high-value applications in trauma care, cardiovascular medicine, and broader pharmaceutical research. These adjacent markets provide both near-term revenue diversification and long-term growth drivers as we scale beyond the initial Alzheimer's focus.
Trauma applications, particularly Acute Compartment Syndrome monitoring, address a market exceeding $8.3 billion globally. Current standard-of-care relies on invasive pressure measurement or clinical judgment, both fraught with limitations. Non-invasive, continuous monitoring via TraumaPulse Analytics offers transformative clinical value with clear health economic benefits through prevention of unnecessary fasciotomies and earlier detection of genuine compartment syndrome.
The cardiovascular and transplant medicine opportunities leverage growing emphasis on hemodynamic optimization and organ protection. As value-based care models increasingly reward improved outcomes rather than procedure volume, technologies enabling better physiologic monitoring and intervention guidance command premium pricing and rapid adoption.

Investment Perspective: Even modest market penetration in the primary Alzheimer's monitoring segment supports nine-figure enterprise valuation, while the platform's applicability across multiple specialties provides significant upside potential and risk mitigation through revenue diversification.
Regulatory & Validation Pathway
Software as a Medical Device Strategy
CerebroPulse Analytics qualifies as Software as a Medical Device (SaMD) under FDA and international regulatory frameworks. This classification offers significant advantages over traditional hardware-based medical devices—shorter development timelines, lower capital requirements, and more straightforward regulatory pathways through established precedents for ultrasound analysis software.
Our regulatory strategy employs a phased approach beginning with Research Use Only (RUO) deployment, enabling immediate commercial utilization in pharmaceutical trials while accumulating the clinical validation data necessary for full diagnostic clearance. This approach generates revenue during the regulatory process rather than requiring years of unfunded development.
The FDA 510(k) pathway provides the most efficient route to U.S. market clearance, with established predicate devices for ultrasound analysis software creating clear regulatory precedent. Simultaneous pursuit of CE Mark enables European market access, leveraging the EU Medical Device Regulation (MDR) framework for SaMD products.
Clinical Validation Framework
Robust clinical validation underpins both regulatory submissions and market acceptance. Our validation strategy integrates three complementary approaches:
  1. Prospective Clinical Studies: Structured data collection protocols at Baptist Health Innovations and partner institutions comparing Quadplex findings to MRI gold standard in ARIA-positive and ARIA-negative patient cohorts
  1. Pharmaceutical Partner Trials: Embedded deployment within ongoing Alzheimer's drug trials, providing real-world performance data in the exact use case scenario
  1. Algorithm Refinement: Continuous AI model improvement using accumulating clinical datasets, enhancing diagnostic accuracy and reducing false positive rates
The Baptist Health Innovations collaboration provides crucial infrastructure for validation activities, including IRB oversight, clinical research coordination, and access to patient populations. This academic medical center partnership enhances regulatory submission credibility while accelerating timeline to clearance.
1
Q2 2025: RUO Launch
Initial commercial deployment under Research Use Only designation. Pharmaceutical partner onboarding begins with Biogen and Eli Lilly collaboration discussions. Baptist Health Innovations validation studies commence.
2
Q4 2025: EU Partnership Validation
European clinical data collection through Mediq partnership in Netherlands and Germany. International validation enhances regulatory submissions and establishes global commercial presence.
3
Q2 2026: FDA 510(k) Submission
Complete regulatory filing including clinical validation data, software verification and validation documentation, cybersecurity analysis, and usability testing results. Target 6-9 month review timeline.
4
Q3 2026: CE Mark Submission
European regulatory filing under MDR SaMD pathway. Notified Body review process initiated with target clearance aligned to FDA timeline.
5
Q1 2027: Commercial Clearance
FDA clearance and CE Mark approval enable full diagnostic claims and expanded commercial deployment beyond research applications. Transition from RUO to cleared medical device positioning.
The hardware-agnostic software architecture provides critical regulatory advantages. By operating on existing FDA-cleared and CE Marked ultrasound systems, CerebroPulse Analytics avoids the extensive safety and performance testing required for novel hardware. Our regulatory burden focuses on software functionality, algorithm validation, and clinical performance—substantially reducing both timeline and cost compared to traditional device development.
This pathway has been successfully demonstrated by numerous ultrasound analysis software products, establishing clear regulatory precedent and reducing submission risk. Our regulatory advisors include former FDA reviewers with direct experience in ultrasound software clearances, further de-risking the process.
Competitive Landscape
The ARIA monitoring and cerebral perfusion assessment market lacks a dominant incumbent, creating an opportunity for a well-positioned innovator to establish category leadership. Existing solutions suffer from fundamental limitations in invasiveness, scalability, or diagnostic comprehensiveness—gaps that CerebroPulse Analytics directly addresses through superior technology and clinical workflow integration.
C2Dx / MY01 (Invasive Monitoring)
These systems require needle insertion for direct tissue pressure measurement, limiting applicability to static compartments and creating infection risk. The invasive nature prevents repeated measurements and patient acceptance remains poor. While providing quantitative pressure data, these devices cannot assess perfusion dynamics or tissue compliance across multiple anatomical regions simultaneously.
Limitations: Invasive procedure requirement, single-point measurement, inability to trend over time, patient discomfort, infection risk, limited anatomical coverage.
Compremium AG (Hardware-Dependent Systems)
Compremium offers non-invasive pressure sensing but requires proprietary hardware with limited availability and high capital costs. The technology provides single-modality data without integration of anatomical imaging or blood flow assessment. Deployment is restricted to specific anatomical sites with suitable sensor placement, precluding comprehensive regional assessment.
Limitations: Proprietary hardware requirement, capital equipment costs, single-modality data, limited anatomical applicability, no perfusion assessment.
MRI-Based Monitoring (Current Standard)
Magnetic resonance imaging remains the gold standard for ARIA detection but suffers from practical limitations that restrict real-world utility. High cost ($1,500-$3,000 per scan), limited availability, scheduling delays, and contraindications in patients with implanted devices create significant barriers. Episodic assessment precludes detection of acute changes between scheduled imaging sessions.
Limitations: High cost, limited availability, episodic rather than continuous monitoring, patient contraindications, logistical complexity for frequent assessment.
The CerebroPulse Differentiator: Quadplex Integration
CerebroPulse Analytics achieves competitive differentiation through the unique integration of four synchronized imaging modes enhanced by artificial intelligence. This Quadplex approach provides diagnostic information density unmatched by single-modality competitors.
Where invasive monitors provide only pressure, and hardware-dependent systems offer only compliance, Quadplex delivers simultaneous assessment of anatomy, perfusion distribution, velocity profiles, and tissue mechanical properties. This comprehensive physiologic mapping enables earlier detection with higher specificity than any competing technology.
The software-based, hardware-agnostic architecture eliminates the capital equipment barrier that limits competitive solutions. Hospitals and research institutions can deploy CerebroPulse Analytics on existing ultrasound infrastructure, dramatically accelerating adoption and reducing total cost of ownership.
AI-enhanced analysis transforms raw multi-modal data into actionable clinical insights. Our proprietary algorithms detect subtle correlations across imaging channels that escape human observation, generating composite risk scores and trending analyses that support confident clinical decision-making.
Multi-Modal Integration
Four synchronized channels vs. single-modality competitors
Non-Invasive Approach
Bedside ultrasound vs. needles or MRI
Software Platform
No proprietary hardware investment required
AI-Powered Analysis
Automated detection exceeding human capability
Perhaps most importantly, CerebroPulse Analytics addresses the market gap that existing solutions ignore—continuous, quantitative perfusion monitoring in pharmaceutical research settings. While competitors focus on acute clinical scenarios, our platform specifically targets the unmet need in drug safety trials where existing alternatives prove inadequate or economically unfeasible.
This strategic positioning in an underserved market segment, combined with superior technical capabilities, creates a defensible competitive moat and establishes CerebroPulse Analytics as the category leader in pharmaceutical cerebral perfusion analytics.
Business Model
CerebroPulse Analytics' revenue model leverages the high-margin, capital-light characteristics of Software as a Medical Device while addressing the substantial and growing market for pharmaceutical safety monitoring and clinical perfusion assessment. Our multi-tier approach optimizes revenue across different customer segments while maintaining operational efficiency.
SaaS Subscriptions
Annual recurring revenue from pharmaceutical trial sites ($45K-$75K) and clinical hospitals ($150K-$250K) based on patient volume and use case complexity
Enterprise Licensing
Multi-site agreements with pharmaceutical companies ($2M-$5M per major trial program) and hospital systems for network-wide deployment
OEM Partnerships
Strategic integration with ultrasound manufacturers generating per-unit royalties and co-marketing revenue from embedded Quadplex technology
Pharmaceutical Research Tier
Clinical research organizations and pharmaceutical companies conducting Alzheimer's drug trials represent our primary market segment. Subscription pricing scales with trial size and complexity:
  • Single-Site Research License: $45,000-$75,000 annually for trial sites monitoring 50-200 participants
  • Multi-Site Trial License: $2-5 million for major Phase 2/3 programs spanning 50-100 global sites
  • Enterprise Research Agreement: Custom pricing for pharmaceutical companies conducting multiple simultaneous trials across therapeutic areas
This tier generates high-margin recurring revenue while building the clinical validation data essential for broader market expansion. Pharmaceutical partners value the improved safety monitoring, reduced trial dropout rates, and enhanced regulatory documentation—creating strong willingness to pay premium pricing.
Clinical Hospital Tier
Following FDA clearance, hospital deployment for routine clinical use expands the addressable market substantially:
  • Academic Medical Centers: $150,000-$250,000 annually for institutions treating 100-500 patients with approved Alzheimer's therapies
  • Community Hospitals: $75,000-$125,000 annually for smaller patient volumes
  • Health System Networks: Volume discounts for multi-hospital deployments with guaranteed minimum annual patient volumes
Hospitals value the improved patient safety, reduced adverse event rates, and potential cost savings from preventing complications requiring intensive intervention.
Capital-Light Scalability
The software-only business model delivers exceptional unit economics and scalability advantages compared to traditional medical device companies. CerebroPulse Analytics avoids the capital intensity, inventory risk, and complex supply chains inherent in hardware manufacturing.
85%+
Gross Margin Target
Software economics with minimal incremental delivery costs per customer
$0
Manufacturing CapEx
No factory, assembly lines, or physical inventory requirements
95%+
Renewal Rate Target
Sticky subscriptions with high switching costs once integrated into workflows
This model enables rapid scaling without proportional cost increases. Once software development is complete, serving the 200th customer costs essentially the same as serving the 20th customer. Cloud-based deployment eliminates physical shipping and installation logistics, while automated updates and support systems minimize ongoing service costs.
OEM licensing relationships with established ultrasound manufacturers provide additional revenue while accelerating market penetration through partners' existing commercial infrastructure and customer relationships. These strategic partnerships validate the technology while generating royalty streams that complement direct sales revenue.
Leadership Team
CerebroPulse Analytics' success rests on an exceptional team combining deep medical device expertise, clinical credibility, regulatory mastery, and entrepreneurial execution capability. Our leadership brings proven track records of building, scaling, and successfully exiting medical technology companies while maintaining the scientific rigor and clinical validation essential for healthcare innovation.
John Nguyen, Chief Executive Officer
Architect of Quadplex Ultrasound™ and driving force behind CerebroPulse Analytics. John brings two decades of medical device innovation experience spanning ultrasound physics, signal processing, and clinical application development. His unique combination of deep technical expertise and strategic commercial acumen has guided the platform from fundamental research through partnership development with leading pharmaceutical companies and academic medical centers.
Previously held senior R&D leadership roles at GE Healthcare and Philips Medical Systems, where he led teams developing advanced ultrasound imaging modalities that achieved FDA clearance and global commercial success. John's 15+ patents in medical imaging demonstrate sustained innovation leadership in a highly competitive field. He holds advanced degrees in Biomedical Engineering and completed executive education at MIT Sloan School of Management.
Clinical Advisory Board
Our clinical advisors bring frontline expertise in the exact specialties where CerebroPulse Analytics delivers greatest impact. This team ensures our technology development remains anchored to real clinical needs while providing the medical credibility essential for regulatory success and market adoption.
Neurology Leadership: Key opinion leaders from top Alzheimer's research centers who have led landmark anti-amyloid therapy trials and published extensively on ARIA monitoring challenges. Their insights directly inform our cerebral perfusion algorithms and clinical validation protocols.
Trauma Surgery Experts: Leading trauma surgeons from Level 1 trauma centers who have pioneered compartment syndrome management protocols and understand the acute decision-making requirements our technology must support.
Emergency Medicine Authorities: ER physicians and intensivists who operate at the critical interface where rapid bedside diagnostics determine patient outcomes, ensuring our user interface and workflow integration meet real-world needs.
Technical Advisory Board
World-class technical expertise spanning ultrasound physics, signal processing, artificial intelligence, and medical device development guides our innovation roadmap and ensures scientific rigor throughout the development process.
NASA Advanced Sensing Team: Scientists who developed cutting-edge sensing technologies for space exploration now apply those capabilities to medical diagnostics. Their expertise in extreme-environment sensing and signal processing in noisy conditions directly enhances our compliance mode algorithms.
Ultrasound Industry Pioneers: Inventors holding 40+ patents in diagnostic ultrasound who have shaped the evolution of modern imaging technology. Their deep understanding of ultrasound physics and FDA regulatory pathways accelerates our development timeline and de-risks regulatory submissions.
AI/ML Specialists: Machine learning researchers from leading academic institutions who have published breakthrough work in medical image analysis and clinical decision support systems, ensuring our AI implementations represent state-of-the-art methodology.
Regulatory & Quality Leadership
Successful medical device commercialization demands regulatory excellence from inception through post-market surveillance. Our regulatory team brings insider experience from the exact agencies and pathways we must navigate.
Former FDA Reviewers: Team members who served as FDA medical device reviewers bring unparalleled insight into submission requirements, review processes, and regulatory decision-making. Their experience with ultrasound software applications directly informs our 510(k) strategy and submission documentation.
VA Healthcare System Leadership: Veterans Affairs medical device evaluation and implementation experts who understand both regulatory requirements and real-world clinical adoption challenges in large healthcare systems.
Quality System Authorities: ISO 13485 certified quality management professionals who have built compliant QMS systems for multiple successful medical device companies, ensuring our development processes meet all regulatory requirements from day one.
Strategic Partnership Network
Baptist Health Innovations: Our collaboration with this leading academic medical center provides essential infrastructure for clinical validation, regulatory study conduct, and early-adopter deployment. The partnership accelerates our timeline while enhancing credibility with pharmaceutical companies and investors.
EU Mediq Partnership: European clinical validation and market entry support through established medical device distribution networks in Netherlands and Germany, enabling efficient international expansion.
Board of Directors
Independent board members include successful medical device entrepreneurs who have built and exited multiple companies, institutional investors with deep healthcare sector expertise, and clinical key opinion leaders who provide strategic guidance on market positioning and partnership development.

Investor Perspective: This team has successfully developed, regulated, and commercialized medical technologies before. We understand the pathway from innovation to revenue, and we've assembled the specific expertise required to execute efficiently in the cerebral perfusion monitoring market.
References & Clinical Validation
CerebroPulse Analytics is built on a foundation of rigorous clinical science, validated regulatory frameworks, and comprehensive market analysis. The following references underpin our technology development, commercial strategy, and regulatory pathway while demonstrating the substantial market opportunity and urgent clinical need we address.
FDA Guidance on Software as a Medical Device
U.S. Food and Drug Administration. "Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff." September 2022. Establishes the regulatory framework for AI-enhanced diagnostic software platforms, providing clear pathways for 510(k) clearance of ultrasound analysis applications.
FDA. "Policy for Device Software Functions and Mobile Medical Applications." September 2022. Defines SaMD classification and risk-based regulatory requirements applicable to CerebroPulse Analytics.
Lecanemab (Leqembi) Clinical Trial Data
van Dyck CH, Swanson CJ, Aisen P, et al. "Lecanemab in Early Alzheimer's Disease." New England Journal of Medicine. 2023;388(1):9-21. Landmark Phase 3 trial demonstrating clinical efficacy while highlighting ARIA as dose-limiting toxicity affecting 12.6% of patients with symptomatic events.
Supplemental safety analysis revealed 21.3% incidence of ARIA-E and 17.3% incidence of ARIA-H in the treatment group, underscoring the critical importance of comprehensive monitoring protocols in anti-amyloid therapy.
Donanemab (Kisunla) Clinical Trial Data
Sims JR, Zimmer JA, Evans CD, et al. "Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial." JAMA. 2023;330(6):512-527. Phase 3 data showing cognitive benefit accompanied by ARIA-E in 24.0% of patients and ARIA-H in 31.4%, with 1.6% experiencing serious symptomatic events.
Study protocol required extensive MRI monitoring at baseline, weeks 12, 24, and 52, illustrating the intensive imaging burden that CerebroPulse Analytics can help optimize through complementary continuous monitoring.
01
Alzheimer's Therapeutics Market Analysis
Grand View Research. "Alzheimer's Disease Therapeutics Market Size, Share & Trends Analysis Report." 2025. Projects global market reaching $13.2 billion by 2030, driven by anti-amyloid antibody adoption and expanding treatment-eligible patient population as diagnostics improve.
02
Trauma Care & ACS Market Research
MarketsandMarkets. "Trauma Care Market - Global Forecast to 2028." 2024. Comprehensive analysis identifying $8.3 billion addressable market for acute trauma diagnostics, with compartment syndrome monitoring representing high-value unmet need segment.
03
Medical Imaging Technology Trends
RSNA Imaging AI Summit. "Artificial Intelligence in Medical Imaging: Clinical Applications and Regulatory Considerations." 2024. Expert consensus on AI integration into diagnostic imaging workflows and regulatory pathways for machine learning-enhanced software.
04
Ultrasound Market Dynamics
Frost & Sullivan. "Global Diagnostic Ultrasound Market." 2024. Analysis of point-of-care ultrasound adoption trends, software-enhanced imaging growth, and shift toward AI-assisted diagnostics supporting CerebroPulse commercial positioning.
Ongoing Clinical Validation Studies
CerebroPulse Analytics validation incorporates prospective clinical data collection under IRB-approved protocols at Baptist Health Innovations and partner institutions. Current studies include:
  • ARIA Detection Validation Study: Prospective comparison of Quadplex findings to MRI gold standard in patients receiving anti-amyloid therapy, with enrollment target of 200 participants over 18 months
  • Algorithm Development Dataset: Multi-site collection of cerebral perfusion data across healthy controls, ARIA-positive cases, and other neurological conditions to refine AI classification models
  • Acute Compartment Syndrome Pilot: Trauma center validation of tissue compliance monitoring in patients at risk for ACS, comparing Quadplex assessment to invasive pressure measurement
  • Pharmaceutical Partner Embedded Trials: Real-world deployment within ongoing Alzheimer's drug studies to assess operational feasibility and generate real-world evidence supporting regulatory submissions
These validation activities generate the clinical evidence necessary for FDA 510(k) submission while establishing the peer-reviewed publication record that drives physician adoption and payer coverage decisions.
Investment Proposition
CerebroPulse Analytics represents a rare convergence of urgent unmet clinical need, breakthrough enabling technology, favorable regulatory pathways, and substantial market opportunity. This combination positions Pulse Logic for rapid value creation through both near-term revenue generation and long-term strategic positioning as the category leader in perfusion analytics.
Immediate Market Catalyst
FDA approval of lecanemab and donanemab creates urgent demand for ARIA monitoring solutions. Pharmaceutical companies conducting current and planned Alzheimer's trials require safety monitoring infrastructure immediately—creating pull-through demand for CerebroPulse Analytics in the near term without requiring extended market development timelines.
Capital-Efficient Business Model
Software-only architecture eliminates the capital intensity typical of medical device companies. No manufacturing facilities, no inventory risk, no complex supply chains. High gross margins (85%+) and minimal incremental delivery costs enable rapid profitability at modest scale while supporting aggressive growth investment.
Multiple Paths to Liquidity
Strategic acquirers include ultrasound manufacturers seeking AI capabilities, pharmaceutical companies building integrated safety monitoring platforms, and medical imaging AI companies expanding into ultrasound. Strong strategic rationale exists across multiple buyer categories, creating competitive acquisition dynamics.
De-Risked Development Pathway
RUO deployment generates immediate revenue while FDA clearance proceeds. Established regulatory precedent for ultrasound analysis software reduces clearance risk. Hardware-agnostic approach eliminates technical development risk associated with novel hardware platforms.
Financial Projections
Conservative adoption modeling supports compelling financial outcomes:
Year 1 (2025): RUO launch with 15-20 pharmaceutical trial sites generating $750K-$1.5M revenue, focused on clinical validation and partnership development.
Year 2 (2026): Expansion to 50-75 trial sites plus initial hospital deployments post-FDA clearance. Revenue $3-5M with path to operational breakeven.
Year 3 (2027): Scaled deployment reaching 150-200 total sites across pharmaceutical and hospital segments. Revenue $12-18M with strong EBITDA margins supporting continued growth investment.
Year 4-5 (2028-2029): Platform expansion into trauma and cardiovascular applications, OEM partnerships, and international market penetration driving revenue toward $40-60M with demonstrated path to $100M+ at scale.
Use of Funds
Series A capital ($8-12M target) funds:
  • Regulatory Clearance ($2M): FDA 510(k) and CE Mark submissions, clinical validation studies, quality system implementation
  • Commercial Launch ($3M): Sales team build-out, pharmaceutical partnership development, marketing collateral and thought leadership
  • Product Development ($2M): AI algorithm refinement, user interface optimization, OEM integration capabilities
  • Operations ($1.5M): Team expansion, infrastructure, legal and IP protection
  • Working Capital ($1.5M): 18-month runway through FDA clearance and commercial traction
$13B
Primary Market TAM
Alzheimer's therapeutics market supporting ARIA monitoring demand
3-5x
Revenue Multiple Range
Comparable SaMD company valuations at Series B+ stages
18-24
Months to FDA Clearance
From Series A close to commercial diagnostic claims
This investment opportunity combines the high-growth potential of novel medical AI platforms with the near-term revenue visibility of selling into active pharmaceutical trials. The capital-light model, multiple expansion opportunities, and strong strategic acquirer interest create favorable risk-return dynamics for early investors.
Making the Invisible Visible
Transforming Alzheimer's Drug Safety Through Continuous Cerebral Perfusion Monitoring
CerebroPulse Analytics positions Quadplex Ultrasound™ as the new gold standard for ARIA monitoring—a platform technology that not only safeguards patients receiving breakthrough Alzheimer's therapeutics but scales across trauma, neurology, cardiovascular medicine, and pharmaceutical research to become the definitive solution for perfusion analytics.
Revolutionary Technology
Four synchronized imaging modes provide unprecedented diagnostic clarity through AI-enhanced multi-modal analysis
Urgent Clinical Need
Anti-amyloid therapies require continuous safety monitoring that current episodic MRI cannot deliver
Exceptional Team
Proven medical device innovators, clinical leaders, and regulatory experts executing a clear commercial pathway
Compelling Economics
Capital-light SaaS model supporting rapid scaling and strong unit economics from day one
Ready for Partnership
We invite clinical and technical leaders at Baptist Health Innovations, R&D teams at our biopharma partners, and sophisticated investors to join us in advancing safer neurotherapeutics through quantitative perfusion monitoring.
CerebroPulse Analytics is not simply another medical device—it's a fundamental advancement in how we understand, measure, and protect cerebral physiology during therapeutic intervention.
Learn More at CerebroPulse.ai

For Partnership Inquiries: CerebroPulse Analytics is available for Research Use Only deployment in pharmaceutical trials beginning Q2 2025. Contact our team to discuss embedded monitoring in your Alzheimer's drug development programs or clinical validation collaborations.
"We've built the technology platform that makes continuous cerebral perfusion monitoring practical, accessible, and actionable. Now we're partnering with visionary clinical and pharmaceutical leaders to transform how we ensure patient safety during the most important therapeutic advances of our generation."
— John Nguyen, CEO, CerebroPulse Analytics