By Warren.AI in June 2025 — Jun 20, 2025

Modular Medical, Inc. (MODD)

Modular Medical, Inc. is a pre-revenue medical device company focused on revolutionizing insulin delivery through its two-part patch pump system. In September 2024, the company received FDA 510(k) clearance for its initial MODD1 product, a slim, reusable pump body paired with 3-day disposable car...

Modular Medical, Inc.: 2025 10-K Deep Dive

The 2025 Annual Report on Form 10-K from Modular Medical, Inc. (Nasdaq: MODD) marks a pivotal year in the evolution of this pre-revenue medical device innovator. With FDA clearance in hand for its first product, the MODD1 insulin pump, strategic fundraising complete, and manufacturing partnerships in place, Modular Medical stands at the threshold of commercial launch. In this in-depth review, we examine the companys business model, technological differentiation, market opportunity, financial position, risk factors, and near-term milestones.

1. Business Overview

Modular Medical is a medical device company focused on modernizing insulin delivery with a two-part patch pump system. Its flagship product, MODD1, received FDA 510(k) clearance in September 2024. Key features include:

Reusable Pump Body: A 90-day reusable motor housing
Disposable Cartridge & Set: 3-day insulin reservoir and infusion set
One-Button Control: Simple basal/bolus dosing interface
Optional Bluetooth & NFC: For integration with mobile apps
No External Controller: Eliminates bulky handsets and frequent charging

The upcoming Pivot successor product will integrate the set into a true tubeless patch, further enhancing wearability and manufacturability. European CE Mark clearance is targeted by Q1 2026.

Leadership & IP

CEO & Chairman: Paul DiPerna (inventor of Tandems t:slim pump)
CFO: James E. Besser (veteran investor, MMC)
Multiple issued and pending patents on fluid movement and pumping mechanisms

2. Technology & Differentiation

The MODD1 Innovation

Traditional insulin pumps fall into two categories: durable pumps with tubing and disposable patch pumps requiring full electronics disposal every few days. MODD1 bridges cost and complexity by separating the electronics from the disposable set:

Pumping Modality: Proprietary cam-driven motor for microdose precision
Form Factor: 3 mL reservoir (50% more insulin vs. most patch pumps) in a slim 23 g package
User Experience: One-button interface, minimal training (9 steps vs. 42), reusable body
Manufacturability: Consumer electronics lines with Philips Medisize partnership for scalable, low-cost assembly
Integration Roadmap: Future Automated Insulin Delivery (AID) via ACE designation, multi-chamber artificial pancreas potential

Insurance & Reimbursement

A 2019 ISA payor study (50M covered lives) indicated payors would provide equivalent coverage in exchange for ~20% discounts. MODD1 is engineered to fit both DME and Pharmacy Benefit pathways, streamlining the insurance journey.

3. Market Landscape

Diabetes Prevalence: ~34M in U.S.; 537M globally (IDF 2021)
Insulin-Requiring: 3.6M potential pump users (Type 1 & intensive Type 2)
Current Pump Penetration: 33% T1D, ~4% T2D
Almost Pumpers: ~32% of T1D MDI users open to pump if complexity/cost barriers removed
TAM: ~$3B (cartridge revenues of $4,100/patient/year) potential via mass-market conversion

Competitive Landscape

Company	Technology	Market Share (U.S.)	Key Drawbacks
Medtronic	Durable 770G	51%	Bulky, complex, high cost
Tandem	Durable t:slim X2	28%	Pump+handset, training load
Insulet	Omnipod patch	19%	Expensive disposables, waste
MannKind	V-Go patch (mechanical)	<1%	No basal adjust, daily change

MODD1s cost & training advantage aims to unlock the 2.5M MDI users staying almost marginalized.

4. Commercialization Strategy

Staged Launch

Q3 2025: Regional soft launch with select providers for MODD1
Q1 2026: National Pivot rollout post-FDA clearance
2026: CE Mark launch in Europe via distributor partnerships

Go-to-Market

Primary Care / Diabetologists via DME distributors
Diabetes Educator practices with sample kits
Prescriber training incentive: 30 min vs. 2-4 hr for existing pumps
PBM engagement for frictionless pharmacy benefit model

Customer Support

24/7 call center
Virtual training & onboarding
Reimbursement assistance teams

5. Financial Performance & Cash Position

Fiscal Year Ended March 31	2025	2024
R&D Expense	$14.7M	$12.9M
G&A Expense	$4.4M	$4.6M
Net Loss	$(18.8M)	$(17.5M)
Cash & Equivalents	$13.1M	$9.2M
Conversion Raises	$18.7M	$21.1M

Operating Cash Burn: ~$15.7M in FY25 vs. $14.0M in FY24 Runway: ~9–12 months post-March 2025 (depending on Pivot build-out) Key Financings:

Nov 2024 public offering: net $7.3M
Mar 2025 private placement: net $11.4M

Liquidity & Capital Needs

With zero product revenue, managements plan to profitability depends on: 1) successful soft & national launch of MODD1/Pivot; 2) sustained ADU/ACE pipeline development; 3) additional capital or strategic partnership by Q3 2025.

6. Risk Factors

Modular Medicals 10-K outlines key headwinds:

Going Concern: Substantial doubt within 12 months; need timely financing
No Revenue: Pre-revenue company with history of operating losses
FDA Clearance Risks: Pivot requires new 510(k); delays or adverse FDA guidance
Manufacturing: Reliance on third-party contract manufacturer; quality system risk
Intellectual Property: 5 issued U.S. patents, 20 pending; no guaranteed freedom to operate
Reimbursement: Must secure payer coverage or face limited uptake
Competition: Entrenched incumbents and emerging patch pump ventures

Investors should weigh each against the potential mass-market disruption Modular proposes.

7. Looking Ahead: Catalysts & Milestones

Milestone	Timeline	Potential Impact
MODD1 regional launch	Q3 2025	First revenue; real-world data
Pivot 510(k) submission	Oct 31, 2025	Lower cost, tubeless patch
Pivot FDA clearance	Q1 2026	National commercial rollout
CE Mark for Pivot & MODD1	Q1 2026	Europe revenue & validation
AID/ACE integration trials	2026–2027	Higher ASP, better outcomes
Strategic partnership / licensing	2026	Non-U.S. expansion

8. Valuation & Investment Thesis

Comparable Benchmarks: Patch pumps trade at 3–5x revenue; durable pumps 5–8x
TAM Serviceable: $3B annual consumables; 670k current users; up to 2M new almost pumpers
Value Drivers: first-mover reusable/tubeless economics, DME+PBM reimbursement, lower training
Risks to upside: execution on manufacturing, slow initial adoption, follow-on capital needs

Bull Case

MODD1 soft launch meets adoption & TIR improvements; Pivot brings $2,500/device economics
Strategic alliance with CGM leader or payer drives rapid scale
1% U.S. market share by 2028 = $100M+ revenue; 5% share $500M

Bear Case

FDA or manufacturing delays stall Pivot
Reimbursement push-back or provider inertia
Cash runway forces dilutive equity raise

9. Conclusion

Modular Medicals 2025 10-K reveals a company at terabytes of critical inflection points: FDA clearance for MODD1, robust IP portfolio, and a capital structure refreshed with $18.7M of net proceeds in H2 FY25. A small but growing team and manufacturing partnership with Philips Medisize position the company to launch a pump engineered to bridge the gap between super-pumper incumbents and MDI- dependent "almost pumpers." That said, near-term execution across launch, payer engagement, manufacturing scale, and "Pivot" clearance is critical. Investors with conviction in patch-pump mass adoption could view the current $13M runway and 5.5 rating as an asymmetric opportunity, albeit one requiring careful watch on non-dilutive partnerships.

Net Loss (FY25): $(18.8) million

Investment Score: 5.5/10

Key Catalyst: Regional launch of MODD1 in Q3 2025 & Pivot 510(k) by October 2025

Disclaimer: This report is for informational purposes only. It does not constitute an offer or recommendation to buy or sell securities. Please consult your investment adviser before making any investment decisions.