Modular Medical Announces Successful Validation of Controller Line for Pivot Insulin Delivery System
Modular Medical (Nasdaq:MODD) announced successful validation of its Pivot controller line, a manufacturing milestone supporting planned Q1 2026 commercial launch for the Pivot tubeless, removable 3 milliliter patch pump. The company said the validated line demonstrates readiness for high-volume human-use production and aims to address a roughly $3 billion market for adult “almost-pumpers” with an affordable, easy-to-learn design. Modular Medical described the validation as derisking its path to commercial manufacturing, while noting Pivot is not currently cleared by the FDA and the launch remains subject to forward-looking risks.
Modular Medical (Nasdaq:MODD) ha annunciato la validazione riuscita della sua linea di controllori Pivot, una pietra miliare della produzione che sostiene il lancio commerciale pianificato per Q1 2026 del patch pump Pivot senza serbatoio, removibile 3 millilitri. L'azienda ha dichiarato che la linea validata dimostra la preparazione per una produzione ad alto volume per uso umano e mira a indirizzare un mercato di circa $3 miliardi per gli adulti “quasi-pompe” con un design accessibile e facile da imparare. Modular Medical ha descritto la validazione come un derisking del proprio percorso verso la produzione commerciale, mentre osserva che Pivot non è attualmente approvato dalla FDA e il lancio resta soggetto a rischi prospettici.
Modular Medical (Nasdaq:MODD) anunció la validación exitosa de su línea de controladores Pivot, un hito de fabricación que respalda el lanzamiento comercial planificado para el primer trimestre de 2026 del parche bomba Pivot sin cánula, desmontable de 3 mililitros. La empresa dijo que la línea validada demuestra la capacidad para la producción en alto volumen para uso humano y apunta a abordar un mercado de aproximadamente 3 mil millones de dólares para adultos “casi bombas” con un diseño asequible y fácil de aprender. Modular Medical describió la validación como una reducción de riesgos en su camino hacia la fabricación comercial, al tiempo que señaló que Pivot no está actualmente aprobado por la FDA y el lanzamiento sigue sujeto a riesgos futuros.
Modular Medical (나스닥:MODD)는 Pivot 컨트롤러 라인의 성공적인 검증을 발표했으며, 이는 2026년 1분기 상용 출시를 지지하는 제조상의 이정표인 피봇 튜블리스 제거식 3밀리리터 패치 펌프의 계획에 힘을 실었습니다. 회사는 검증된 라인이 인간 사용을 위한 대량 생산에 대한 준비가 되었음을 보여주며, 합리적이고 배우기 쉬운 설계로 성인용 ‘거의-펌프’로 불리는 약 30억 달러 규모의 시장을 겨냥한다고 밝혔습니다. Modular Medical은 이 검증을 상용 제조로의 경로를 리스크를 줄였다고 설명했으며, Pivot은 현재 FDA 승인을 받지 않았다는 점과 출시가 전망상 리스크에 좌우된다는 점을 언급했습니다.
Modular Medical (NASDAQ:MODD) a annoncé la validation réussie de sa ligne de contrôleurs Pivot, une étape clé de fabrication soutenant le lancement commercial prévu pour le 1er trimestre 2026 du patch pump Pivot sans réservoir, amovible de 3 millilitres. L'entreprise a déclaré que la ligne validée démontre la préparation à une production en grand volume pour un usage humain et vise un marché d'environ 3 milliards de dollars pour les adultes « presque-pompes » avec un design abordable et facile à apprendre. Modular Medical a décrite cette validation comme une réduction des risques sur le chemin de la fabrication commerciale, tout en notant que Pivot n’est pas encore approuvé par la FDA et que le lancement demeure soumis à des risques futurs.
Modular Medical (Nasdaq: MODD) kündigte die erfolgreiche Validierung seiner Pivot-Controller-Linie an, ein Fertigungsmilestone, der den geplanten Q1 2026 kommerziellen Start des Pivot-Tubeless, abnehmbarer 3-Milliliter Patch-Pumpe unterstützt. Das Unternehmen sagte, die validierte Linie zeige die Bereitschaft für eine hochvolumige Produktion für den menschlichen Gebrauch und zielt auf einen Markt von rund 3 Milliarden USD für erwachsene „fast-Pumpen“ mit einem erschwinglichen, leicht zu lernenden Design. Modular Medical beschrieb die Validierung als Risikominderung auf dem Weg zur kommerziellen Fertigung, wies jedoch darauf hin, dass Pivot derzeit nicht von der FDA freigegeben ist und der Start Risiken unterliegt.
Modular Medical (ناسداك: MODD) أعلنت عن التحقق الناجح من سلسلة Pivot Controller، وهو معلم تصنيع يدعم الإطلاق التجاري المخطط في الربع الأول 2026 لـ Pivot، مضخة لصقة قابلة للإزالة، بدون أنبوب، بسعة 3 مل. قالت الشركة إن السلسلة المعتمدة تُظهر جاهزية الإنتاج عالي الحجم للاستخدام البشري وتستهدف سوقاً يقارب 3 مليارات دولار لـ“مستخدمي شبه المضخة” من البالغين بتصميم ميسور التكلفة وسهل التعلم. وصفت Modular Medical التحقق بأنه تخفيض للمخاطر في طريقها نحو التصنيع التجاري، مع الإشارة إلى أن Pivot ليس مُعتمداً حالياً من FDA وأن الإطلاق يظل عرضة للمخاطر المستقبلية.
- Pivot controller line validated for human-use production
- Product targets Q1 2026 market launch
- Pivot is a 3 milliliter removable tubeless patch pump
- Company cites high-volume manufacturing readiness for scaling
- Pivot insulin delivery system is not cleared for sale by the FDA
- Planned Q1 2026 launch is subject to forward-looking risks
- Market conversion and commercial acceptance remain uncertain
Insights
Validated controller line supports planned Q1 2026 launch and signals manufacturing readiness for Pivot's commercial scale-up.
The successful validation of the Pivot controller line shows that Modular Medical has completed a manufacturing gate required to produce human-use units at scale. The Pivot is described as a removable, tubeless 3 milliliter patch pump targeting adult "almost-pumpers" and a stated <$money>3 billion market segment; validation therefore directly links to the company’s ability to supply early commercial demand.
Execution depends on regulatory clearance and sustained manufacturing performance; the release explicitly states the Pivot is not cleared for sale by the FDA. Validation reduces manufacturing risk but does not remove regulatory or market-acceptance risks. The company’s claims about low-cost, high-volume readiness matter only if regulatory clearance is obtained and yield/quality remain consistent.
Watch for three concrete milestones: receipt of any regulatory clearance, demonstration of consistent production yields during pre-launch runs, and the planned
Key Highlights:
Pivot Controller Line Validated: Manufacturing line has now been validated for human-use production in support of expected Q1 2026 market launch.
Pivot will be First Two-Part Tubeless Patch Pump: Pivot, a 3 milliliter removable patch pump, targets the
$3 billion dollar market for adult "almost-pumpers" with its affordable, user-friendly, easy-to-learn design.
High-Volume Manufacturing Readiness: Modular Medical's scalable platform positions it to target a significant share of the insulin pump market.
SAN DIEGO, CA / ACCESS Newswire / November 3, 2025 / Modular Medical, Inc. (Nasdaq:MODD) ("Modular Medical" or the "Company"), a leader in innovative insulin delivery technology, today announced the successful validation of its Pivot controller line, a critical milestone in preparing for the commercial launch of its Pivot patch pump targeted for Q1 2026. The Pivot controller line validation further demonstrates manufacturing readiness for high-volume production, positioning Modular Medical to meet the growing demand in the diabetes treatment market for advanced technology.
Transforming Diabetes Management - The Pivot is the first tubeless, removable 3 milliliter patch pump designed for adult "almost-pumpers" - individuals with diabetes who hesitate to adopt traditional insulin pumps due to cost, complexity, or design. With its user-friendly interface and affordability, the Pivot expands the insulin pump market to an underserved segment.
"Validating the Pivot controller line further evidences our ability to scale production efficiently, which is a key differentiator in the patch pump space. We remain on track for a Q1 2026 market launch, as we look to introduce our Pivot product to millions of patients who deserve better diabetes management options," said Jeb Besser, CEO of Modular Medical.
Market Impact and Investor Opportunity - The successful validation derisks Modular Medical's path to commercial manufacturing, ensuring reliability and scalability for the launch of the Pivot product. The Company's low-cost, high-volume, manufacturing optimized platform is designed to support the Company's goal to capture significant market share, for the benefit of both patients and investors. Modular Medical's focus on accessibility and innovation positions it as a leader in the rapidly expanding diabetes technology market.
The Pivot insulin delivery system is not currently cleared for sale by the United States Food and Drug Administration (the "FDA").
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 expected launch to the market of the Pivot insulin delivery system in the first calendar quarter of 2026; the Company's ability to convert patients to use its Pivot pump product and gain market share; 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. 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."
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.
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
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