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Modular Medical Announces Completion of MODD1 Cartridge Production and Commencement of Pivot Conversion

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Modular Medical (NASDAQ:MODD) has announced the successful completion of its MODD1 cartridge production with over 6,000 units manufactured. The company is now transitioning its manufacturing line to produce cartridges for its upcoming Pivot product, which is expected to be submitted for FDA clearance in October 2025.

The Pivot will be pioneering as the first tubeless, removable 3 milliliter patch pump in the market. The company's manufacturing platform was specifically designed for high-volume production, addressing the increased demand requirements for patch pumps. Product launch is anticipated in Q1 2026, targeting adult "almost-pumpers" with its user-friendly and affordable design.

Modular Medical (NASDAQ:MODD) ha comunicato di aver completato con successo la produzione delle cartucce MODD1, superando le 6.000 unità realizzate. Ora l’azienda sta riconvertendo la linea produttiva per fabbricare le cartucce destinate al prossimo prodotto Pivot, la cui richiesta di autorizzazione alla FDA è prevista per ottobre 2025.

Il Pivot sarà il primo patch pump rimovibile e senza tubo da 3 millilitri sul mercato. La piattaforma produttiva è stata ideata per produzioni ad alto volume, rispondendo alla crescente domanda per questo tipo di dispositivi. Il lancio commerciale è atteso per il Q1 2026, rivolto ad adulti "quasi-pumpers" grazie a un design semplice e accessibile.

Modular Medical (NASDAQ:MODD) ha anunciado la finalización exitosa de la producción del cartucho MODD1, con más de 6.000 unidades fabricadas. La compañía está migrando ahora su línea de producción para fabricar cartuchos para su próximo producto Pivot, cuya solicitud de aprobación ante la FDA está prevista para octubre de 2025.

El Pivot será pionero como el primer parche bomba extraíble y sin tubo de 3 mililitros en el mercado. La plataforma de fabricación fue diseñada para producciones de gran volumen, cubriendo la creciente demanda de este tipo de bombas. Se espera el lanzamiento comercial en el Q1 2026, dirigido a adultos "casi-pumpers" con un diseño fácil de usar y asequible.

Modular Medical (NASDAQ:MODD)MODD1 카트리지 생산을 성공적으로 완료했으며 6,000개 이상의 제품을 제조했다고 발표했습니다. 회사는 현재 제조 라인을 다음 제품인 Pivot용 카트리지 생산으로 전환하고 있으며, FDA 승인 신청은 2025년 10월에 예정되어 있습니다.

Pivot은 시장에서 처음으로 선보이는 튜브 없는 탈착식 3밀리리터 패치 펌프가 될 것입니다. 제조 플랫폼은 대량 생산을 염두에 두고 설계되어 패치 펌프에 대한 증가하는 수요를 충족합니다. 제품 출시는 2026년 1분기로 예상되며, 사용이 간편하고 가격 경쟁력이 있는 설계로 성인 '거의 펌프 사용자'를 주요 대상으로 합니다.

Modular Medical (NASDAQ:MODD) a annoncé avoir achevé avec succès la production des cartouches MODD1, avec plus de 6 000 unités fabriquées. L’entreprise est désormais en train de reconvertir sa ligne de production pour fabriquer les cartouches destinées à son futur produit Pivot, dont le dossier auprès de la FDA devrait être déposé en octobre 2025.

Le Pivot sera le premier patch‑pump amovible et sans tubulure de 3 millilitres sur le marché. La plateforme de fabrication a été conçue pour une production à grand volume afin de répondre à la demande croissante pour ce type de pompe. Le lancement commercial est attendu au 1er trimestre 2026, ciblant les adultes « almost‑pumpers » avec un design simple et abordable.

Modular Medical (NASDAQ:MODD) gab bekannt, die Produktion der MODD1-Kartuschen erfolgreich abgeschlossen zu haben und über 6.000 Einheiten gefertigt zu haben. Das Unternehmen stellt nun seine Fertigungslinie um, um Kartuschen für das kommende Produkt Pivot herzustellen; die FDA-Zulassungsanfrage ist für Oktober 2025 vorgesehen.

Der Pivot wird als erster schlauchloser, abnehmbarer 3‑Milliliter‑Patch‑Pump auf den Markt kommen. Die Produktionsplattform wurde für hohe Stückzahlen ausgelegt, um der steigenden Nachfrage nach Patch‑Pumpen gerecht zu werden. Der Produktstart ist für das Q1 2026 geplant und richtet sich an erwachsene "almost-pumpers" mit einem benutzerfreundlichen und erschwinglichen Design.

Positive
  • Successful production of over 6,000 MODD1 cartridges demonstrates manufacturing capability
  • First-mover advantage with tubeless, removable 3ml patch pump design
  • Manufacturing platform specifically designed for high-volume production
  • FDA submission planned for October 2025 with potential launch in Q1 2026
Negative
  • FDA clearance still pending and subject to regulatory uncertainty
  • Market acceptance of new pump technology remains unproven

Insights

Modular Medical hits manufacturing milestone for insulin pump cartridges, setting stage for Q1 2026 product launch pending FDA approval.

Modular Medical has achieved a significant operational milestone by completing production of over 6,000 MODD1 cartridges and validating its manufacturing process. This is a critical step in the company's development timeline as they now transition their production line to focus on their upcoming Pivot product - which they plan to submit to the FDA in October 2025 with anticipated clearance in time for a Q1 2026 launch.

The manufacturing capability demonstrated here addresses one of the most challenging aspects of insulin pump commercialization: scaling production efficiently while maintaining quality. The company's design philosophy of creating a simple, low-cost platform specifically engineered for high-volume manufacturing is particularly noteworthy in an industry where production constraints have historically limited adoption.

What makes this development particularly significant is that the Pivot will be the first tubeless, removable 3 milliliter patch available to consumers once cleared. The larger insulin reservoir represents a meaningful advantage over typical patch pumps that hold 2 milliliters or less, potentially reducing the frequency of cartridge changes for users. The tubeless design eliminates a major usability barrier that has prevented many insulin-dependent patients from adopting pump therapy, while the removable nature provides flexibility not found in all patch options.

Manufacturing readiness at this stage suggests the company is executing on schedule for their regulatory timeline, though the ultimate commercial success will depend on both FDA clearance and market acceptance of their "user-friendly and affordable" approach to insulin delivery technology.

-More than 6,000 MODD1 cartridges produced

- Conversion to Pivot-ready manufacturing in preparation for product launch in 1Q26

SAN DIEGO, CA / ACCESS Newswire / August 26, 2025 / Modular Medical, Inc. (Nasdaq:MODD) ("Modular Medical" or the "Company"), an insulin delivery technology company with the first FDA-cleared patch pump designed specifically to target all adult "almost-pumpers" with its user-friendly and affordable design, today announced that the MODD1 product cartridge production run has been completed and its manufacturing line is being converted to production for its Pivot product.

"I want to congratulate our operational team for the successful validation of our MODD1 manufacturing process and production of human use cartridges," said Jeb Besser, CEO of Modular Medical. We will now begin converting our cartridge line to Pivot production, and we expect it to be ready to produce cartridges for our Pivot product upon receipt of clearance from the U.S. Food and Drug Administration (the "FDA"). We expect to submit the Pivot product to the FDA for clearance in October 2025.

"The Pivot will be the first tubeless, removable 3 milliliter patch to be available to the consumer when it is cleared. Along with these features, the ability to scale production is a key differentiator in the pump space, especially given the much higher volumes required for a patch pump. Modular Medical's simple, low-cost platform was designed from the ground up for high volume manufacturing."

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statements contained in this press release, including, but not limited to, the timing of the Company's manufacturing line producing human-use cartridges for its Pivot product; the timing of the Company's submission of the Pivot product to the FDA; the Company's ability to convert patients to use its MODD1 pump; successful development of Modular Medical's proprietary technologies; whether the market will accept Modular Medical's products and services; anticipated consumer demand for the Company's products; whether Modular Medical can successfully manufacture its products at high volumes; the occurrence of future events or circumstances; general economic, and industry or political conditions in the United States or internationally; as well as other risk factors and business considerations described in Modular Medical's SEC filings, including its annual report on Form 10-K. Any forward-looking statements in this press release should be evaluated in light of these important risk factors. In addition, any forward-looking statements included in this press release represent Modular Medical's views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. Modular Medical assumes no obligation to update these forward-looking statements, except as required by law.

About Modular Medical

Modular Medical, Inc. (Nasdaq:MODD) is a development-stage medical device company that intends to launch 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. Our 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."

Modular Medical 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. More information is available at https://modular-medical.com.

All trademarks mentioned herein are the property of their respective owners.

CONTACT:
Jeb Besser
Chief Executive Officer
Modular Medical, Inc.
+1 (617) 399-1741
IR@modular-medical.com

SOURCE: Modular Medical, Inc.



View the original press release on ACCESS Newswire

FAQ

How many MODD1 cartridges has Modular Medical (NASDAQ:MODD) produced in their latest production run?

Modular Medical has produced over 6,000 MODD1 cartridges in their latest production run.

When will Modular Medical submit the Pivot product for FDA clearance?

Modular Medical expects to submit the Pivot product to the FDA for clearance in October 2025.

What makes Modular Medical's Pivot pump unique in the market?

The Pivot will be the first tubeless, removable 3 milliliter patch pump available to consumers, featuring a user-friendly and affordable design specifically targeting adult 'almost-pumpers'.

When is the expected launch date for Modular Medical's Pivot product?

The company is preparing for a product launch in Q1 2026, pending FDA clearance.

What is Modular Medical's manufacturing advantage for the Pivot product?

Modular Medical's platform was designed from the ground up for high volume manufacturing, with a simple, low-cost approach that can scale production to meet the higher volumes required for patch pumps.
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