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October 15, 2026 | Unsubscribe
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New Alert: Modular Medical, Inc. (NASDAQ: MODD)
MODD is our new NASDAQ high-growth alert.
This is a hidden gem opportunity that not many have seen.
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 and momentum can build very quickly.
MODD is a NASDAQ listed “commercial-stage medical device company”.
MODD is “focused on the development of innovative insulin delivery technologies designed to simplify diabetes management and increase access to insulin pump therapy. “
The company's “Pivot™ tubeless patch pump has been developed to provide a user-friendly, flexible, and accessible approach to insulin delivery for people requiring intensive insulin therapy.”
Now, the company is “preparing for the full commercial launch of its next-generation Pivot™ tubeless patch pump”.
“The Pivot™ tubeless patch pump is a simple, wearable insulin delivery platform designed to provide continuous subcutaneous insulin infusion with both basal and bolus insulin delivery over a three-day wear period.”
“The system is intended to offer a practical and accessible pathway from multiple daily injections to insulin pump therapy for a broader population of people living with diabetes.”
“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 market opportunity is substantial.
According to the company, 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.
Earlier this year, the company announced:
“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."
Here are some other notable accomplishments since June:
“Modular Medical Delivers Insulin to First Patients on Pivot Tubeless Insulin Patch Pump”
“Modular Medical Announces FDA Submission of Pivot Tubeless Insulin Patch Pump Enhancements”
“Modular Medical Receives Research Demonstrating Positive Payor Reception of Pivot Tubeless Patch Pump”
“Modular Medical Announces Formation of Pivot Innovation Council and Appointment of Robert Gabbay, MD, PhD, FACP as Chairman”
In July, the company announced:
“Modular Medical and IMO Health Launch Strategic Pilot to Enable Real Time Insulin Pump Patient Identification Into Electronic Health Records”
“The pilot aims to help clinicians successfully surface multiple‑daily‑injection (MDI) patients, who exhibit clinical characteristics associated with insulin pump hesitancy or prior pump failure, enabling more timely and targeted conversations about modern pump therapy options, such as the Company's Pivot pump.”
Here are some of the company’s comments from this press release:
"Clinicians often know which patients could benefit from pump therapy but identifying them within the EHR can be time consuming and inconsistent," said Matt McKinley, Executive Vice President and General Manager of Life Sciences at IMO Health. "By combining our terminology expertise with Modular Medical's clinician guided phenotypes, we expect to create a practical, scalable tool that reduces burden on clinicians and helps ensure patients who stand to benefit from pump therapy are not overlooked."
"Commercial success isn't only about building a better insulin pump, it's about helping clinicians identify the patients who will benefit from it," said Jeb Besser, Chief Executive Officer of Modular Medical. "This collaboration with IMO Health should allow us to find those patients more effectively and bring modern pump therapy to individuals who may have been underserved by existing technologies, while minimizing clinician effort in identification. We believe this capability can become an important component of our commercial strategy as Pivot launches and scales."
In addition, the company also announced:
“Modular Medical Announces Launch of Pivot Insulin Delivery System Across Five Key U.S. Markets Beginning October 2026”
MODD “announced plans to initiate the first phase of commercialization of its Pivot tubeless patch pump across five strategically selected U.S. markets beginning in October 2026. The initial rollout will include Atlanta, Cincinnati/Lexington, Dallas, Houston, and Philadelphia, representing a foundational step in the Company's capital efficient commercialization strategy with its mission to expand access to simplified insulin delivery solutions for all people living with diabetes.”
“This full-commercial launch follows an extensive analysis of national insurance claim, prescription, and market adoption data spanning more than 100 U.S. markets. The Company selected the initial five launch regions based on their concentration of high-value diabetes prescribers, robust new insulin pump adoption activity, and significant populations of patients currently managing diabetes with multiple daily injections (MDI), the primary population for whom the Pivot is be focused on.
Collectively, these five markets account for:
14% of the nation's highest volume insulin pump prescribers‡
15% of all new insulin pump starts‡
21% of prescribers who have a historically high affinity for new brand adoption for patients using MDI[JS1]”
Here are some of the company’s comments from this press release:
"Launching Pivot in these five markets represents a critical first step in our commercialization strategy," said Jeb Besser, CEO of Modular Medical. "Despite meaningful advances in insulin pump technology, millions of people who rely on multiple daily injections have yet to adopt pump therapy because existing options can be perceived as too complex, burdensome, expensive, or difficult to integrate into everyday life. Pivot was developed to address these barriers by delivering a simpler insulin delivery experience designed around the needs of both the patients and providers."
The Company “believes the selected initial markets will provide an optimal environment to establish a commercial foundation, while generating meaningful insights to support rapid, cost effective future geographic expansion.”
“To support this launch, Modular Medical has partnered with Inizio, a global commercialization partner that brings deep expertise, global reach, and integrated support to the commercial rollout. With strong therapeutic capabilities in metabolic health and diabetes care, Inizio will provide Modular Medical with specialized commercial execution, provider engagement, and launch support resources designed to accelerate awareness and adoption of the Pivot tubeless patch pump across its initial and future launch markets.”
Furthermore:
"Partnering with Inizio strengthens our ability to execute a focused and efficient launch strategy," continued Besser. "Their proven track record, diabetes expertise, and ability to deliver integrated commercialization support make them an ideal partner as we continue to introduce Pivot to patients, providers, and health systems."
In September, the company announced:
“Modular Medical Announces FDA Clearance of Pivot Tubeless Insulin Patch Pump Enhancements”
MODD “announced that the U.S. Food & Drug Administration (FDA) has cleared a set of software enhancements to its Pivot insulin delivery system, further expanding the system's functionality and providing users with greater flexibility and customization options in bolus dosing, an enhanced user-interface (UI), and other software upgrades.”
Here are some of the company’s comments from this press release:
"We are pleased that this clearance was received in advance of our planned fourth quarter launch. The cleared improvements represent the first in a series of enhancements and upgrades to the Pivot platform and were designed to expand the functionality and flexibility of Pivot for users, including the ability to customize the amount of insulin delivered with each button push. We are proud of the team's performance in obtaining this clearance and look forward to bringing these enhanced capabilities to customers," said Jeb Besser, Chief Executive Officer of Modular Medical.
Most recently, the company announced:
“Modular Medical Announces Contract with National U.S. Pharmacy Benefit Manager, Expanding Access to Pivot Tubeless Patch Pump”
MODD “announced that it has secured a contract with a national U.S. pharmacy benefit manager (PBM) in the United States. Pursuant to the contract, the Company's Pivot insulin delivery system is now available through the national PBM. The Company believes the engagement with this national PBM represents a significant step forward in broadening patient access to the Company's Pivot tubeless patch pump and will further validate the Pivot pump as an accessible therapeutic option for people living with diabetes.”
Jeb Besser, Chief Executive Officer of Modular Medical commented:
"We believe this agreement with a national PBM, one of the largest in the country, represents an important commercialization milestone for our Pivot patch pump," said Jeb Besser, Chief Executive Officer of Modular Medical. "PBMs play a critical role in enabling patient access to therapies and medical technologies. We believe this relationship positions us to reach more patients who could benefit from a simpler, more approachable insulin-delivery solution."
Expanding Patient Access Through PBM Partnerships
Pharmacy benefit managers serve a central role in the U.S. healthcare ecosystem by working with health plans, employers, pharmacies, and manufacturers to manage prescription drug benefits and improve access to care. PBMs help evaluate clinical value, negotiate reimbursement arrangements, and facilitate formulary placement, enabling patients to access therapies through their existing healthcare benefits.
For innovative diabetes technologies, PBM partnerships can be an important driver of adoption by helping reduce barriers to access, increasing provider awareness, and streamlining reimbursement pathways. As healthcare stakeholders continue to focus on improving outcomes while managing costs, solutions that offer ease of use, patient satisfaction, and effective diabetes management are increasingly attracting attention.
We believe MODD could be positioned for big upside potential.
Make sure to do your own due diligence.
Sources: Presentation, PR1, PR2, PR3, PR4, PR5, PR6, PR7, PR8, PR9, PR10, PR11, PR12, PR13, Website, Chart
Happy Trading!
SmallCapStocks Team
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