MD824598

Represents a strong investment opportunity due to its innovative approach to brain healthcare. Its portable, AI-powered brain imaging device addresses a significant unmet need in diagnosing strokes and brain injuries rapidly and affordably, offering a solution where bulky, expensive equipment falls short.

The rapidly growing market for portable medical devices, combined with the company’s early traction and upcoming regulatory milestones, positions it for high growth. With the potential to save lives and reduce healthcare costs globally, this technology is poised to disrupt the brain imaging sector.

Overview

Industry: Medical Imaging and Stroke Detection
Founded: 2019, Canada
Mission: To revolutionize brain healthcare by making advanced imaging accessible through portable, affordable solutions for early diagnosis and real-time monitoring of neurological conditions like stroke and traumatic brain injury.
Vision: To lead a global transformation in brain healthcare with cutting-edge, cost-effective imaging technologies that improve patient outcomes.
Unique Value Proposition: Offers a portable, AI-enhanced electromagnetic tomography device for rapid, on-site diagnostics in diverse settings, providing a cost-effective alternative to traditional, bulky imaging technologies, while delivering rapid, on-the-spot diagnostics, enabling quicker intervention and better patient management.

Problem & Solution

Problem: Traditional imaging methods (CT/MRI) are large, expensive, and confined to hospital settings, delaying diagnoses for conditions like strokes and TBIs, especially in prehospital and remote environments.

This problem is urgent, as stroke remains a leading cause of death and disability worldwide. Quick, accurate diagnosis is crucial, as every minute untreated results in significant brain cell death, dramatically affecting patient outcomes. The lack of portable, accessible imaging solutions hinders timely treatment decisions, especially in underserved and remote locations, leading to higher mortality and disability rates. Addressing this gap is vital for improving emergency care and patient outcomes globally.
Solution: The startup provides a portable brain imaging device using AI-enhanced electromagnetic tomography, suitable for both hospital and prehospital settings. This solution is portable, cost-effective, and offers real-time imaging, enabling faster and more accurate diagnosis and treatment decisions. Utilizing electromagnetic tomography paired with advanced AI algorithms, the devices deliver real-time imaging, supporting faster and more precise clinical decisions in urgent situations.

Market Potential

Target Market:

Hospitals (EDs, ICUs, Neurology Wards): Approximately 103,000 hospitals globally.
EMS and Ambulance Services: Around 183,000 ambulances worldwide.
Market Size:

Total Addressable Market (TAM): $30.8B (Trolley Devices: $14.0B, Compact Devices: $16.8B).
Serviceable Available Market (SAM): $7.8Bin Canada and the USA.
Serviceable Obtainable Market (SOM): $780M, assuming a 10% capture rate in the initial markets.
Growth Rate: The medical imaging market growing at 7-8% CAGR.
Trends:

Increased demand for portable, point-of-care imaging devices.
Growing use of AI and advanced analytics in medical imaging.
Expansion of EMS and remote healthcare services.
Customer Segments:
‍
Hospitals and Healthcare Institutions
EMS and Ambulance Services

Product / Service

Core Features: Ultra-compact, lightweight, cost-effective, point-of-care solution, easy to operate, diagnostic and monitoring capabilities, high-contrast imaging, safe non-ionizing radiation, rapid triage capability, and real-time data processing.
Technology: Electromagnetic Imaging, AI Algorithms, Advanced Image Processing, Wearable and Portable Design
Development Stage: MVP is fully developed and undergoing iterative refinements based on preclinical and clinical testing feedback.
Intellectual Property:

Pending:
2 utility patents (covering advanced imaging methods and device configurations)
1 design patent (focused on device ergonomics and usability)
6 trademarks (protecting branding and product names)

Published: 1 utility patent
Product Roadmap:

Upcoming Features

→ Brain Image Reconstruction: Developing enhanced capabilities for dielectric property mapping to improve brain imaging detail.

→ AI Algorithm Enhancements: Further refinement of AI algorithms to boost imaging resolution, diagnostic speed, and accuracy.

→ Hardware Upgrades: Continuous improvements to hardware components to ensure optimal performance and adaptability across various clinical settings.

Development Timeline

2024/Q4 to 2025/H1: Focus on integrating advanced brain imaging and AI algorithms, conducting comprehensive safety tests (EMI, EMC), and initiating human factors and usability testing. Completion of Design Verification Testing (DVT).

2025/H2: Conduct design validation, perform first-in-human clinical tests, and submit a second Q-submission to the FDA.

2026: Undertake a pilot study, finalize the product design for clinical trials, and complete the manufacturing process validation. Prepare for regulatory submission for FDA clearance.

2027: Execute full-scale clinical trials to gather extensive data on device safety and efficacy, achieve regulatory approval, and lock preproduction.

2028: Obtain regulatory clearance and proceed with a soft launch, implementing a post-market surveillance plan to monitor real-world performance and safety.

Business Model

Revenue Model: Sales of devices ($50,000 each) with recurring revenue from software subscriptions, maintenance, per-scan fees ($50 /scan), and consumables (disposable caps $10/scan).
Sales Channels: Direct sales team, strategic distributors, and online platforms targeting hospitals and EMS providers.
Partnerships: The company collaborates with leading hospitals and stroke centers for clinical validation, helping establish credibility in the medical community. Additionally, it partners with Original Equipment Manufacturers (OEMs) and specialized technology firms to integrate advanced components, enhancing the capabilities of its brain imaging devices.
Future Partnerships: Aims to expand its market reach by partnering with global and regional medical device distributors. It also seeks to collaborate with large healthcare networks to standardize the use of its devices across multiple facilities, driving adoption. Additionally, partnerships with academic and research institutions will support further validation and innovation of its product offerings.
Marketing Plan: Focuses on direct engagement with hospitals and EMS services through product demonstrations, workshops, and educational sessions. They also leverage digital channels, such as social media, webinars, and content marketing, to raise brand awareness and educate the market. Active participation and sponsorship at major healthcare conferences and industry events help showcase their technology and build relationships with key stakeholders, positioning the company for broader market adoption.
Customer Retention: Plans to provide comprehensive training programs to ensure seamless integration of its technology into customers' workflows. It will offer ongoing customer support along with regular software and hardware updates to maintain optimal device performance. Additionally, the company aims to develop customer loyalty programs, offering incentives such as discounts on consumables and service contracts to encourage long-term commitment and regular usage, ensuring sustained customer engagement and satisfaction.

Financials

Current Status: Pre-revenue with a $20k burn rate and 12-month runway.
Funding to Date: $1 million from founders, grants, and non-dilutive funds.
Use of Funds: Allocated towards de-risking the technology through comprehensive research and development, including preclinical testing, prototype development, and initial regulatory submissions.
Projections: Expected revenue of $3M in 1 year, $22M in 3 years, and $76M in 5 years.
Key Metrics: Customer acquisition cost (CAC) of $20,000, lifetime value (LTV) of $725,000, gross margin of 75%, and net profit margin of 30%.

Team

Core Team: Founders with extensive experience in neuroscience, imaging technology, and microwave/radiofrequency technology. Supported by a technical lead, regulatory affairs specialist, and engineers with deep expertise in medical device development.

CEO & Co-Founder
The CEO holds a PhD specializing in instrumentation and imaging techniques, with over a decade of experience in neuroscience and medical imaging. She has led numerous collaborations between academia and industry, focusing on advancing portable brain imaging technologies. As CEO, she oversees the company’s strategic direction, leads fundraising efforts, manages partnerships, and drives product development to ensure alignment with market needs.

CTO & Co-Founder
With 25 years of experience in microwave and radiofrequency technology, the CTO has a proven track record in commercializing advanced tech products. His expertise drives the technological innovations behind the company's brain imaging devices. In his role, he leads the technical strategy, manages the engineering team, and oversees the development and protection of intellectual property.
Key Team Members: The hardware development is led by a specialist with over 30 years of experience in microwave and RF engineering, ensuring optimized hardware for the brain imaging devices. Regulatory compliance and clinical trials are managed by a regulatory expert with extensive project management experience. An electromagnetic systems specialist focuses on system design and optimization, contributing to technology refinement. Additionally, a senior mechanical engineer specializes in mechanical design, enhancing the devices' durability and usability. Together, the team drives innovation and ensures regulatory standards are met.
Advisors: Industry veterans in medical devices and neurology, providing strategic guidance on commercialization and clinical development.

Competitive Analysis

Direct Competitors: Companies utilizing electromagnetic tomography or signal-based technologies for brain imaging.

Competing companies using electromagnetic tomography face challenges with lower resolution, limiting diagnostic accuracy, and have high production costs that affect scalability. Others using radar-based technologies offer more affordable, scalable solutions but lack comprehensive imaging, focusing primarily on rapid monitoring rather than detailed diagnostics. In contrast, this company's solution addresses these gaps by offering a balance of portability, cost-effectiveness, and enhanced imaging capabilities, making it more suited for both rapid and comprehensive diagnostic needs.
Indirect Competitors: Traditional imaging devices (CT/MRI) and telemedicine solutions.

Indirect competitors include traditional imaging devices like CT and MRI machines, which, while offering high-resolution images, are expensive, bulky, and limited to hospital use. These characteristics make them impractical for point-of-care or remote settings. Additionally, telemedicine solutions rely on existing imaging infrastructure and do not provide portable options. This company bridges the gap by offering a versatile, portable imaging solution that can be deployed immediately in various environments, making advanced diagnostics accessible in prehospital and remote settings.
Competitive Advantage: Superior portability, cost-effectiveness, and enhanced imaging capabilities, bridging gaps left by traditional and existing technologies. Barriers to entry for competitors include the complexity of developing high-resolution, portable imaging technology, high R&D costs, stringent regulatory approvals, and the need for clinical validation and trusted healthcare partnerships.

Traction

Key Metrics: The company is currently in the technology development phase with strong interest from potential partners and early adopters. Significant growth is anticipated post-market entry, driven by strategic clinical partnerships, successful pilot studies, and regulatory approvals. High adoption rates are expected among hospitals and emergency medical services, particularly in key North American markets. Early feedback from clinical collaborators and industry experts has been positive, indicating strong demand and interest in the company’s innovative brain imaging technology.
Milestones: Development of MVP and advanced through iterative refinements based on preclinical feedback. Significant partnerships with hospitals, pre-submission meetings with regulatory bodies, and multiple awards recognizing innovation in medical imaging.
Customer Feedback: Positive early feedback from clinical partners and key opinion leaders.

Risks & Mitigation

Risks: Market adoption, competition, regulatory approvals, financial constraints, and operational challenges.
Mitigation Strategies: Building strong clinical partnerships, robust project management, diversified funding, early regulatory engagement, and maintaining flexibility in production.

Funding Requirements

Amount Raised: $5 million
Use of Funds:

Team Expansion and Salaries: $1,800,000 (36%) – Hiring additional technical, regulatory, and clinical professionals to accelerate product development and market readiness.

Software and Equipment Investment: $600,000 (12%) – Investment in essential software licenses and specialized testing equipment to support development and regulatory compliance.

Prototyping and R&D Materials: $500,000 (10%) – Funds allocated for materials needed for prototyping, device testing, and preparation for clinical trials.

Intellectual Property and Legal: $500,000 (10%) – Covering costs for patent filings, legal services, and IP protection to safeguard innovations and maintain competitive advantage.

Clinical Trials and Validation: $500,000 (10%) – Funding first-in-human and pilot studies to validate the safety and efficacy of the product.

Regulatory Compliance and Advisory Services: $400,000 (8%) – Costs related to regulatory testing, compliance efforts, and advisory services across multiple markets.

Operational and Infrastructure Costs: $400,000 (8%) – Leasing office space, utilities, logistics, and other operational expenses to support an expanding team.

Overhead and Contingency: $300,000 (6%) – General overhead and a contingency buffer for unforeseen expenses.

Market Development and Outreach: $200,000 (4%) – Participation in healthcare conferences, exhibitions, and marketing activities to build brand visibility and establish market presence.

Customer Support and Training: $100,000 (2%) – Developing training materials, user manuals, and establishing a customer support system.

Quality Management Systems (QMS): $100,000 (2%) – Establishing and maintaining QMS for compliance with regulatory standards and risk management to ensure compliance and product safety.
Runway: 24 months with new funding.

Exit Strategy

Potential Scenarios:

Targeting an IPO within the next 5-7 years, contingent upon achieving significant market penetration, strong revenue growth, and a robust product pipeline. An IPO would provide the company with access to a larger capital base, increased visibility, and enhanced valuation potential, supporting further expansion and innovation.

Likely exit via acquisition by a major medical device or healthcare technology company seeking to expand its brain imaging portfolio or enter the portable imaging market. Potential acquirers could be firms looking to leverage the innovative technology to gain a competitive edge or diversify their product offerings.

Exploring strategic partnerships or mergers with companies that have complementary technologies or market reach. This could accelerate market penetration, enhance product offerings, and strengthen competitive positioning.
Timeline: The company aims to be strategically positioned for an exit within 5 to 7 years, depending on market dynamics, growth achievements, and strategic opportunities. The company will continuously evaluate market conditions and potential exit opportunities to optimize shareholder value.