Modular Medical Announces MODD1 Cartridge Line Validated for Human-Use Production
Modular Medical (NASDAQ:MODD) has achieved a significant milestone by validating its MODD1 cartridge line for human-use production in the United States. The line has been operational since early July and will continue production until late August before transitioning to Pivot manufacturing.
The company's CEO Jeb Besser confirmed that despite initial equipment shipment delays to their Mexican manufacturing site, the controller line installation is progressing with validation expected in October 2025, followed by the MODD1 commercial pilot launch. The company's insulin delivery platform is specifically designed for high-volume manufacturing, targeting adult "almost-pumpers" with its user-friendly and affordable design.
Modular Medical (NASDAQ:MODD) ha raggiunto un traguardo importante con la convalida della sua linea di cartucce MODD1 per la produzione destinata all'uso umano negli Stati Uniti. La linea è operativa da inizio luglio e continuerà la produzione fino a fine agosto, prima di passare alla produzione Pivot.
Il CEO dell'azienda, Jeb Besser, ha confermato che, nonostante i ritardi iniziali nella spedizione delle attrezzature al sito di produzione in Messico, l'installazione della linea di controllo sta procedendo e la validazione è prevista per ottobre 2025, seguita dal lancio del pilota commerciale MODD1. La piattaforma per la somministrazione di insulina dell'azienda è progettata specificamente per una produzione ad alto volume, rivolta agli adulti "quasi-pumpers" grazie a un design facile da usare e accessibile.
Modular Medical (NASDAQ:MODD) ha alcanzado un hito importante al validar su línea de cartuchos MODD1 para producción de uso humano en Estados Unidos. La línea ha estado operativa desde principios de julio y continuará en producción hasta finales de agosto, antes de pasar a la fabricación Pivot.
El CEO de la compañía, Jeb Besser, confirmó que, a pesar de los retrasos iniciales en el envío del equipo a su planta de fabricación en México, la instalación de la línea de control avanza y se espera la validación para octubre de 2025, seguida del lanzamiento piloto comercial de MODD1. La plataforma de administración de insulina de la empresa está diseñada específicamente para la fabricación a gran escala, dirigida a adultos "casi usuarios de bombas" con un diseño fácil de usar y asequible.
Modular Medical (NASDAQ:MODD)는 미국에서 인간 사용용 MODD1 카트리지 라인의 생산 검증이라는 중요한 이정표를 달성했습니다. 이 라인은 7월 초부터 운영 중이며 8월 말까지 생산을 계속한 후 Pivot 제조로 전환될 예정입니다.
회사의 CEO Jeb Besser는 멕시코 제조 현장으로의 초기 장비 배송 지연에도 불구하고 컨트롤러 라인 설치가 진행 중이며, 2025년 10월에 검증이 완료될 것으로 예상되며, 이후 MODD1 상업용 파일럿 출시가 이어질 것이라고 확인했습니다. 회사의 인슐린 전달 플랫폼은 사용자 친화적이고 저렴한 디자인으로 고용량 제조를 목표로 하며, 성인 '거의 펌프 사용자'를 대상으로 설계되었습니다.
Modular Medical (NASDAQ:MODD) a franchi une étape importante en validant sa ligne de cartouches MODD1 pour la production destinée à un usage humain aux États-Unis. La ligne est opérationnelle depuis début juillet et continuera la production jusqu'à fin août avant de passer à la fabrication Pivot.
Le PDG de l'entreprise, Jeb Besser, a confirmé que malgré des retards initiaux dans la livraison des équipements sur leur site de fabrication au Mexique, l'installation de la ligne de contrôle progresse et la validation est prévue pour octobre 2025, suivie du lancement pilote commercial de MODD1. La plateforme de délivrance d'insuline de l'entreprise est spécifiquement conçue pour la production en grande série, ciblant les adultes "presque utilisateurs de pompe" avec un design convivial et abordable.
Modular Medical (NASDAQ:MODD) hat einen bedeutenden Meilenstein erreicht, indem es seine MODD1-Kartuschenlinie für die Produktion für den menschlichen Gebrauch in den Vereinigten Staaten validiert hat. Die Linie ist seit Anfang Juli in Betrieb und wird bis Ende August weiterproduzieren, bevor sie auf die Pivot-Produktion umgestellt wird.
Der CEO des Unternehmens, Jeb Besser, bestätigte, dass trotz anfänglicher Verzögerungen bei der Auslieferung der Ausrüstung an ihren Produktionsstandort in Mexiko die Installation der Steuerungslinie voranschreitet. Die Validierung wird für Oktober 2025 erwartet, gefolgt vom kommerziellen Pilotstart von MODD1. Die Insulinabgabeplattform des Unternehmens ist speziell für die Massenproduktion konzipiert und richtet sich mit ihrem benutzerfreundlichen und erschwinglichen Design an erwachsene "Fast-Pumpen".
- None.
- Significant delays in initial equipment shipment to Mexican manufacturing site
- Controller line validation still pending, pushing commercial pilot launch to after October 2025
Insights
Modular Medical's MODD1 cartridge validation enables commercial launch timeline despite equipment delays; manufacturing scalability will be key for market success.
Modular Medical has achieved a critical manufacturing milestone with the human-use validation of its MODD1 cartridge production line. This development, while occurring later than optimal due to cited equipment shipping delays to their Mexico facility, keeps the company on track for its commercial pilot launch following controller line validation targeted for October 2025.
The validation of cartridge manufacturing represents a significant hurdle cleared in the complex regulatory pathway for insulin delivery devices. FDA requirements for insulin delivery systems are extraordinarily stringent, demanding consistent, precise manufacturing protocols to ensure patient safety. The timing of this validation suggests Modular Medical has navigated these challenges successfully for a key component of their system.
Manufacturing scalability is particularly crucial in the insulin pump market. Traditional pumps have relatively lower production volumes, but patch pumps require substantially higher manufacturing capacity due to their disposable nature. Modular's announcement specifically emphasizes their platform was "designed from the ground up for high volume manufacturing" – addressing a critical competitive factor in the patch pump segment dominated by established players with mature manufacturing infrastructure.
While the cartridge line is now validated, the company still faces the challenge of completing controller line validation before their commercial pilot can proceed. The controller component typically houses the electronics and algorithms that manage insulin delivery, representing more complex manufacturing and validation requirements than the cartridge component. The October timeline for this validation will be critical to watch as it directly impacts their market entry schedule.
-Line has been in production at risk since early July
- Production to continue until late August when conversion to Pivot manufacturing will begin
SAN DIEGO, CA / ACCESS Newswire / August 4, 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, announced that the MODD1 cartridge line has been validated for human-use production in the United States.
"This is an important milestone for scaling up our manufacturing infrastructure to support our commercial pilot for MODD1 and, eventually, our 3ml Pivot tubeless patch pump launch," stated Jeb Besser, CEO of Modular Medical. "While we encountered significant delays with the initial shipment of equipment for the manufacturing line to our contract manufacturing site in Mexico, all equipment for the controller line has been installed and validation is underway. We continue to target controller line validation in October for MODD1 with the commercial pilot for MODD1 to follow immediately thereafter."
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 Company's ability to obtain the validations required to manufacture products for human use; the timing of achievement of such validations, if at all; the Company's ability to convert patients to use its pump products; and the occurrence of future events or circumstances, 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, 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
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