Modular Medical, Inc.

Modular Medical, Inc.

Overview

Modular Medical is a medical device company focused on the design, development, and commercialization of modern insulin pumps. The company aims to expand pump adoption beyond advanced users by simplifying usability, reducing costs, streamlining prescriptions and insurance reimbursement, and providing clinical support. Primary targets are people with Type 1 diabetes and Type 2 patients who require multiple daily insulin doses.

Products

• MODD1: First-generation insulin pump cleared by the FDA (510(k)) in September 2024. The company does not intend to commercialize MODD1.
• Pivot: Next-generation, tubeless patch insulin delivery system. FDA 510(k) clearance obtained in April 2026; commercial availability began June 2026 in the United States. CE marking for Europe is planned with a targeted clearance by Q2 2027.

Pivot — product details

• Form factor: Three-part system — one reusable component plus two disposables (cartridge and set) that snap together.
• Infusion set integrated into an adhesive patch; the pump is removable during the wear period; no external controller required.
• Operation: Simple one-button interface for bolus delivery; basal insulin delivered continuously; boluses delivered using the on-pump button.
• Reservoir and wear: 3 mL cartridge (300 units); 90-day reusable component life and a 3-day disposable cartridge. Cartridge life is also described as approximately 80 hours.
• Power: Battery included in the cartridge (coin cell); no charging or external battery required.
• Size and weight: Empty weight 20 g versus 26 g for a comparable competitor; filled weight 23 g versus 28 g for that competitor, while carrying roughly 50% more insulin than the comparator.
• Connectivity: Low-power Bluetooth and NFC options for smartphone or device communication.
• Positioning: Marketed as a simpler, more affordable, and easier-to-train tubeless pump intended to broaden pump adoption.

Regulatory status

• United States: MODD1 cleared September 2024 (not planned for commercialization). Pivot cleared via 510(k) in April 2026.
• Europe: Company plans to pursue CE marking and targets CE clearance by Q2 2027 for EU/EEA sales.
• International: Strategy includes partnering with distributors for international rollouts.

Manufacturing and operations

• Primary manufacturing partner: Phillips Medisize (a Molex company), a tier-one medical device manufacturer responsible for production and compliance.
• Production capacity and readiness:
  • In-house automated cartridge assembly capability of about 60,000 cartridges per month (capacity equivalent to ~6,000 patients).
  • Production molding ordered at scale; initial manual packaging with automation planned in a second phase.
  • Pivot-focused production line conversion began in August 2025; lines are being scaled to support commercial volumes.
• Cost and scale: Components are designed for high-volume production and are expected to yield lower cost of goods versus competitors at scale.
• Logistics and support: PivotPump.com launched June 2026 to educate and support patients. An international operations lead based in Switzerland was hired in 2026.

Market and customers

• Market context: The company cites a large addressable market for insulin pumps and identifies an “Almost Pumpers” segment—people who require insulin but are deterred by cost or complexity—as a key growth target.
• TAM assumptions: The company references approximately 4.2 million potential insulin pump users (U.S. and global context) and applies estimated cartridge revenue per patient per year in its addressable market calculations.
• Competitive landscape (U.S., 2026): Insulet (patch pumps ~43% market), Tandem (~34%), Minimed (~21%). Pivot targets a simpler, tubeless design distinct from patch pumps that typically require a separate controller and longer tubing.

Financial highlights (selected)

• Employees: 51 total employees as of March 31, 2026 (50 full-time). Functional breakdown: 42 in research & development and manufacturing, 6 in general and administrative, 3 in sales and marketing.
• Headquarters and facilities: Principal operations in San Diego, California; approximately 24,000 square feet; lease through January 2027.
• Revenue and commercialization: No reported product revenue prior to Pivot commercialization. Pivot began U.S. commercialization with initial shipments in June 2026.
• Net income (loss): Year ended March 31, 2026: net loss of approximately $28.2 million. Year ended March 31, 2025: net loss of approximately $18.8 million.
• Liquidity: Cash and cash equivalents of $6.9 million as of March 31, 2026. Net proceeds of approximately $3.0 million from a public offering in April 2026.
• Outlook: The company expects ongoing need for additional funding to support commercialization, regulatory approvals, and expansion, and does not guarantee future profitability or timely access to capital.

Intellectual property

• As of June 29, 2026: eight U.S. utility patents and six foreign patents, with additional applications pending.
• Patent focus: Proprietary fluid movement technology and insulin delivery methodologies.

Key risks and regulatory considerations

• Dependence on FDA clearance/approval for future products and compliance with post-market obligations (QSR compliance, labeling, adverse event reporting, recalls).
• Competition from established insulin pump manufacturers and changing reimbursement environments.
• Reliance on third-party manufacturing partners and suppliers; scale-up and supply chain risks.
• Revenue dependence on payer reimbursement; Pivot lacked U.S. reimbursement at the time of the filing.
• Ongoing requirement to obtain CE marking and other international regulatory approvals.
• Cybersecurity, data privacy, and product security liabilities.

Notable disclosures

• The company describes itself as an early commercial-stage entity with ongoing losses and a need for significant capital to continue operations and commercialization.
• Pivot is the company’s primary commercial product; MODD1 is not planned for commercialization.

Website and filings

• Public disclosures include the annual report on Form 10-K and related SEC filings.
• Primary website: www.modular-medical.com