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New Alert: Modular Medical, Inc. (Nasdaq: MODD)

MODD is our brand new NASDAQ high-growth alert.

This is a hidden gem opportunity that not many have seen and we are amongst the first to bring it to your attention.

Plus, the company just crossed the single most important milestone a medical device company can reach, it received FDA clearance and has now transitioned from development stage to a commercial company delivering its product to real patients.

The chart setup is pointing to a potential breakout opportunity.

This means that momentum can build very quickly.

MODD is a NASDAQ listed “commercial-stage medical device company that is commercializing the next generation of insulin delivery technology”.

Using its “patented technologies, the Company seeks to eliminate the tradeoff between complexity and efficacy, thereby making top quality insulin delivery both affordable and simple to learn”.

Its mission is “to improve access to the highest standard of glycemic control for people with diabetes taking it beyond "superusers" and providing "diabetes care for the rest of us."”

The company’s flagship product is the Pivot, “designed for people living with diabetes who rely on daily insulin injections, as well as those who have encountered technological, usability, or cost-related barriers with traditional pump systems”.

“Pivot is purpose-built for adults with diabetes on daily injections who have faced cost, complexity, and usability barriers with traditional pump systems.”

This group, “which the Company calls the "almost-pumpers," represents an estimated 70% of insulin-dependent adults who remain on multiple daily injections, a multi-billion-dollar opportunity within the diabetes technology market.”

“The system emphasizes simplicity and ease of use for the patient and full access to clinical information for the clinician to reduce adoption friction.”

As “only the second fully electronic, tubeless insulin pump available in the United States, Pivot is designed to make pump therapy simpler to learn and easier to live with.”

“Its removable two-part design and 3 mL reservoir, intuitive interface, and flexible, wearable form factor support everyday activities, such as showering and sports, with no battery recharging required - all while maintaining clinical accuracy and connectivity.”

The pedigree here stands out. MODD was “founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer. Prior to founding Modular Medical, Mr. DiPerna was the founder (in 2005) of Tandem Diabetes and invented and designed its t:slim insulin pump.”

The market opportunity is substantial. According to the company's investor presentation, its flagship Pivot pump targets a “$3 Billion unmet market need”

The company describes this underserved market clearly:

  • 1 in 4 Healthcare dollars in the US are spent on diabetes and diabetes related complications

  • 27 million people with diabetes. 4.88 million require daily insulin

  • Only 1 in 3 Americans with type 1 diabetes use a pump. This number has been materially unchanged for 15 years.

  • Only 20% of insulin dependent people with diabetes use a pump for insulin delivery. 80% rely on multiple daily injections (MDI).

  • Only 8% of insulin dependent Americans with type 2 diabetes use a pump. This number is just starting to rise.

  • Only 21% of T1D’s reach ADA guidelines for glycemic control.

The reason so many remain on injections comes down to what the company describes as “feature-heavy and complex systems have hampered adoption. These products are for “superusers.” Prohibitive for many to learn and manage.”

The company also points to a powerful precedent: “Abbott Freestyle Libre made continuous glucose monitoring easier and more affordable. This expanded the product category and doubled its size.”

They “believe the insulin pump market is ready for a similar transition.”

The company has announced multiple major milestones recently.

On April 9, the company announced big news:

“Modular Medical Receives FDA 510(k) Clearance for Pivot Tubeless Insulin Patch Pump”

  • “First Removable 2-Part Design Targets $3 Billion "Almost-Pumper" Market with Expected Q2 2026 initial deployment.”

Key Milestones & Investment Highlights:

  • “FDA 510(k) Clearance Achieved: Pivot™ pump now cleared for commercial sale in the U.S. - major de-risking event unlocking revenue path.

  • First-in-Class Removable Tubeless Patch Pump: 3 mL detachable reservoir; no battery recharging required; removable for showering, sports or discretion; quick bolus button without a separate controller.

  • Targets Massive Underserved Market: ~70% of insulin-dependent adults remain on multiple daily injections (MDI) due to complexity, cumbersomeness and cost - Pivot addresses the "3 Cs" for "almost-pumpers" with its 2-part reusable pump.

  • Manufacturing Readiness: Production validation lots well underway; initial capacity supports ~6,000 users with scalable low-cost platform enabling a rapid production ramp-up.

  • Commercial Timeline: Initial customers expected by end of Q2 2026; software enhancements (e.g., variable bolus, improved alarms, ACE/AID compatibility) in development; CE Mark targeted Q4 2026/Q1 2027.”

Jeb Besser, CEO of Modular Medical, said:

"FDA clearance for Pivot represents years of focused innovation to deliver a truly differentiated tubeless patch pump. By addressing the key barriers - complexity, bulkiness, and high cost - we believe we are positioned to convert millions still on injections to pump therapy. With manufacturing on track and our software roadmap advancing toward automated insulin delivery ("AID") features, we believe this clearance significantly de-risks our commercial launch and opens a clear path to capturing share in the growing diabetes technology market.

"We thank our team, stakeholders, and shareholders for their support. We now shift focus to our rapid commercialization strategy, additional software enhancements, and European CE Mark progress in the second half of 2026. We look forward to providing operational and adoption updates in the coming months."

In April, the company also announced:

  • “Modular Medical Announces Pricing of $3.4 Million Registered Direct Offering of Common Stock”

In June, the company announced:

“Modular Medical Announces Commercial Availability of Pivot Tubeless Insulin Patch Pump Ahead of Commercial Expansion”

  • “Full commercial launch is expected to roll out in phases, initially targeting select high-volume endocrinology practices and expanding across multiple metropolitan markets by late 2026.”

Here are some of the company’s comments from this press release:

"Reaching commercial availability is a transformational milestone that marks Modular Medical's transition from a development-stage company to a revenue-generating commercial business," said Jeb Besser, Chief Executive Officer of Modular Medical. "As only the second fully electronic tubeless pump on the U.S. market, Pivot is positioned to serve a large, underserved 'almost-pumper' population. With first shipments beginning this week, we are focused on disciplined execution, as we scale adoption and seek to build long-term value for patients and shareholders."

On June 26, 2026, the company announced:

“Modular Medical Announces Shipment of Pivot Tubeless Patch Pumps”

  • “Pivot starter kits are now shipping to multiple endocrinology practices”

This is another “significant milestone in the deployment of Pivot. Modular Medical looks forward to updating the market when these first patients are using the pump to deliver insulin.”

Most recently, on June 30, the company announced:

“Modular Medical Delivers Insulin to First Patients on Pivot Tubeless Insulin Patch Pump”

Here are some of the company’s comments from this press release:

"Today represents a defining moment for Modular Medical," said Jeb Besser, Chief Executive Officer of Modular Medical. "For the first time, patients are using Pivot to manage their insulin therapy, validating our vision of creating a simpler, more accessible pump solution for people who have historically remained on multiple daily injections. This is only the beginning of our efforts to address this substantial market opportunity, and we look forward to gathering real-world data and feedback, as we seek to scale adoption and achieve long-term growth."

On July 1, the company announced:

“Modular Medical Announces FDA Submission of Pivot Tubeless Insulin Patch Pump Enhancements”

"This submission is the first of a series of further improvements and upgrades planned for the Pivot platform, now that our core form factor has been cleared by the FDA and is in the market. I want to congratulate our whole team for getting this submission in so quickly after the initial Pivot clearance," said Jeb Besser, Chief Executive Officer of Modular Medical. "We look forward to getting feedback from the FDA in the coming weeks."

But that’s not all…

Yesterday the company announced breaking news:

“Modular Medical Announces Completion of Research Initiative Indicating Strong Interest in Simpler Insulin Delivery”

  • “97% of Surveyed Injection Users Would Consider Pump Therapy - if Easier to Learn and Improved Outcomes

  • Conducting Additional Research Initiative in Conjunction with Commercialization of the Pivot Tubeless Insulin Patch Pump

  • Company to Showcase Pivot at Association of Diabetes Care & Education Specialists (ADCES) Annual Conference, August 7-10, 2026”

In addition, just this morning, the company announced:

“Modular Medical Receives Research Demonstrating Positive Payor Reception of Pivot Tubeless Patch Pump”

  • “Completed Independent Study Strongly Supports Favorable Payor Receptivity to Pivot's Differentiated Design and Simplified User Experience, and provides further validation of significant progress towards goal of achieving broad market access for Pivot”

We believe MODD could be positioned for big upside potential.

Make sure to do your own due diligence.

Happy Trading!

SmallCapStocks Team

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