Summary of Modular Medical, Inc.

Business Overview

• Core Focus: Design, development, and commercialization of innovative insulin pump devices.
• Market Aim: Expand insulin pump adoption beyond highly motivated "super users" to the mass market, including Type 1 and Type 2 diabetes patients requiring multiple daily insulin doses.
• Product Development:
  • Initial Product: MODD1 insulin pump.
  • Upcoming Product: Pivot, a tubeless, integrated set version designed for improved usability and cost-efficiency.
• FDA Status:
  • MODD1: Submitted 510(k) in January 2024, received FDA clearance to market in September 2024.
  • Pivot: Planning to submit for FDA clearance by October 31, 2025, with potential market launch in Q1 2026 pending approval.
• European Market: Working toward CE mark clearance in first quarter 2026 to enable international sales.
• Manufacturing: Partnered with Phillips Medisize for scale manufacturing, aiming for lower production costs and high-quality assembly.

Target Market

• Global Diabetes Population (2021): Approximately 537 million people with diabetes worldwide; projected to rise to 783 million by 2045.
• US Market: About 34 million Americans with diabetes.
  • Type 1 Diabetes (T1D): ~1.8 million people, all require daily insulin.
  • Type 2 Diabetes (T2D): Over 32 million, with 1.6 million treated with intensive insulin therapy.
• Current Pump Users: Approximately 670,000 people (33% of those indicated for pump therapy).
• Market Opportunity:
  • Primary Target: "Almost Pumpers" — approximately 28-33% of Americans with T1D and T2D who are interested in switching to easier, more affordable pump technology but haven't adopted due to issues like cost and complexity.
  • Market Size: Estimated at about $3 billion in total addressable market, with potential cartridge revenue per patient at around $4,100 annually.

Company Size & Financials

• Employees: 54 (all located in the United States; 49 in research and development/manufacturing, 5 in general/admin as of March 31, 2025).
• Revenue & Income:
  • Currently: Pre-revenue; no product sales or revenues reported.
  • Losses:
    • Year ended March 31, 2025: Net loss of approximately $18.9 million.
    • Year ended March 31, 2024: Net loss of approximately $17.5 million.
• Cash & Capital:
  • Cash and cash equivalents (March 31, 2025): $13.1 million.
  • Outstanding Shares (June 16, 2025): 54,247,388 common shares.
• Funding:
  • Recent Financing:
    • March 2025 private placement of 6,247,656 units at $1.92 per unit (~$12 million gross proceeds).
    • Concurrent direct placement of 260,417 units (~$0.5 million).
    • November 2024 public offering (~$7.3 million).
    • Additional proceeds from warrant exercises and ATM sales.

Development & Strategy

• Product Goals:
  • Commercialize MODD1 and commence initial shipments by September 2025.
  • Obtain regulatory approval for Pivot and market in 2026.
  • Expand internationally, particularly into Europe.
• Technology & Design:
  • Focus on a simplified, low-cost pump using consumer electronics manufacturing lines.
  • Push-button operation, no external controller, lightweight, and smaller in size.
  • Reusable system with a 90-day lifecycle, with disposable cartridges lasting 3 days.
• Market Differentiation:
  • Address shortcomings of existing pumps related to complexity, size, cost, and outdated design.
  • Leverage new proprietary mechanical and electronic technologies.
  • Expand usability for the "Almost Pumpers" market segment.
• Manufacturing & IP:
  • Partnership with Phillips Medisize for scale manufacturing.
  • Hold five U.S. patents and two foreign patents, with additional pending applications.
• Regulatory Focus:
  • Maintaining FDA clearance, seeking CE mark, and future clinical studies for safety and efficacy.
  • Preparing for potential future features such as closed-loop AI control and integration with CGMs.

Key Challenges

• No current revenue; reliance on future product approval and market acceptance.
• Extensive regulatory pathway with ongoing need to secure FDA and international approvals.
• Competition from established companies like Medtronic, Tandem, and Insulet.
• Dependence on third-party manufacturing and supply chain stability.
• Need to raise additional capital to fund development and commercialization efforts.

Note: The company has not yet made any product sales, has significant R&D expenditures, and is in the process of regulatory approval and commercial launching.