Modular Medical Receives IRB Approval to Deliver Insulin Using Pivot Patch Pump
Modular Medical (NASDAQ:MODD) announced IRB approval on November 17, 2025 to run an in-house study delivering insulin with its next-generation Pivot™ tubeless patch pump to adult participants wearing continuous glucose monitors.
The Study will simulate real-world conditions to collect device function, usability data, and participant feedback while the company awaits FDA feedback on a recent Pivot 510(k) submission. The Pivot system is not currently cleared for sale by the FDA.
Modular Medical (NASDAQ:MODD) ha annunciato l''approvazione IRB il 17 novembre 2025 per condurre uno studio interno che somministrerà insulina con la sua pompa Pivot™ patch senza tubi di nuova generazione a partecipanti adulti che indossano monitor CGM.
Lo studio simulerà condizioni reali per raccogliere dati sul funzionamento del dispositivo, sull''usabilità e sui feedback dei partecipanti, mentre l''azienda attende il feedback della FDA su una recente presentazione Pivot 510(k). Il sistema Pivot non è attualmente autorizzato per la vendita dalla FDA.
Modular Medical (NASDAQ:MODD) anunció la aprobación IRB el 17 de noviembre de 2025 para realizar un estudio interno que entregará insulina con su bomba Pivot™ sin parche tubeless de próxima generación a participantes adultos que usan monitores continuos de glucosa.
El estudio simulará condiciones del mundo real para recopilar datos de funcionamiento del dispositivo, usabilidad y comentarios de los participantes, mientras la empresa espera comentarios de la FDA sobre una reciente presentación Pivot 510(k). El sistema Pivot no está actualmente autorizado para su venta por la FDA.
Modular Medical (NASDAQ:MODD)는 2025년 11월 17일 IRB 승인을 받아 성인 참가자들이 지속 혈당 측정기(CGM)를 착용하고 있는 가운데 차세대 Pivot™ 무관 패치 펌프를 이용해 인슐린을 전달하는 내부 연구를 실시합니다.
연구는 실제 환경 조건을 시뮬레이션하여 기기 기능, 사용성 데이터 및 참가자 피드백을 수집하는 동안 회사는 최근 Pivot 510(k) 제출에 대한 FDA 피드백을 기다리고 있습니다. Pivot 시스템은 현재 FDA의 판매 승인을 받지 않았습니다.
Modular Medical (NASDAQ:MODD) a annoncé l''approbation IRB le 17 novembre 2025 pour mener une étude interne délivrant de l''insuline avec sa pompe Pivot™ patch sans tubule de nouvelle génération à des participants adultes portant des moniteurs de glucose en continu.
L''étude simulera des conditions réelles pour collecter des données sur le fonctionnement de l''appareil, l''utilisabilité et les retours des participants, tandis que l''entreprise attend les retours de la FDA sur une récente soumission Pivot 510(k). Le système Pivot n''est pas actuellement autorisé à être vendu par la FDA.
Modular Medical (NASDAQ:MODD) gab am 17. November 2025 die IRB-Zustimmung für eine interne Studie bekannt, die Insulin mit ihrem Pivot™ tubeless Patch-Pump der nächsten Generation an erwachsene Teilnehmer liefert, die kontinuierliche Glukosemessgeräte tragen.
Die Studie wird realweltliche Bedingungen simulieren, um Funktionen des Geräts, Benutzungsdaten und Feedback der Teilnehmer zu sammeln, während das Unternehmen auf Feedback der FDA zu einem jüngsten Pivot 510(k)-Antrag wartet. Das Pivot-System ist derzeit von der FDA nicht für den Verkauf freigegeben.
Modular Medical (NASDAQ:MODD) أعلن عن اعتماد IRB في 17 نوفمبر 2025 لإجراء دراسة داخلية تستخدم Pivot™ اللاسلكية من الجيل التالي لإيصال الأنسولين إلى مشاركين بالغين يرتدون أجهزة مراقبة الجلوكوز المستمرة.
ستحاكي الدراسة ظروف العالم الواقعي لجمع بيانات حول وظيفة الجهاز وقابلية الاستخدام وتغذية راجعة من المشاركين، بينما تنتظر الشركة تعليقات الهيئة FDA على تقديم Pivot 510(k الأخير. نظام Pivot غير مصرح حاليًا بالبيع من FDA.
- IRB approval to deliver insulin to adult testers (Nov 17, 2025)
- Study will collect real-world device function and usability data
- Product targets a $3 billion adult "almost-pumpers" diabetes market
- Pivot not cleared for sale by the FDA
- Study results and commercial timing depend on pending FDA 510(k) feedback
Insights
IRB approval enables in‑house insulin delivery testing; useful early evidence but final market access depends on FDA 510k clearance.
The IRB approval on
Key dependencies and risks include obtaining satisfactory FDA feedback on the pending 510(k), the representativeness of in‑house testers versus the broader user population, and any safety or usability issues that emerge during the Study. The company explicitly notes the Pivot system is not cleared for sale by the FDA, so regulatory outcome remains the gating factor.
Concrete items to watch: Study enrollment and completed usability metrics, any reported device malfunctions or safety events, and formal FDA feedback and clearance timing; these milestones will determine whether early positive user data translates into market access and adoption within a short to medium horizon.
Study to Deliver Insulin to Internal Testers Wearing Continuous Glucose Monitors
SAN DIEGO, CA / ACCESS Newswire / November 17, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), a leader in innovative insulin delivery technology targeting the
Modular Medical's Pivot tubeless patch pump aims to enhance accessibility for underserved patients with diabetes and drive market penetration and expansion.
Key objectives and potential impacts of the Study include:
Assess usability and the patient experience
Collect participant feedback to optimize design for everyday diabetes management
"This IRB approval marks another important milestone in advancing our tubeless insulin pump technology toward market readiness," said Jeb Besser, CEO of Modular Medical. "We now have approval to gather real-world data delivering insulin to adult test subjects in a controlled environment, as we await FDA feedback on our recent Pivot 510k submission. Once FDA clearance is achieved, we believe our Pivot pump will be well positioned to achieve rapid adoption in the growing wearable diabetes technology sector."
The Pivot insulin delivery system is not currently cleared for sale by 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 performance of the Company's products; expected deployments of the Company's pump products to persons with diabetes; the Company's ability to convert patients to use its pump products; 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; and general economic, industry and 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 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.
Pivot is a trademark of Modular Medical. All other 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
What did Modular Medical (MODD) announce on November 17, 2025?
What will the MODD Pivot study measure and why does it matter?
Is the Pivot pump cleared by the FDA for sale (MODD)?
How does the MODD study relate to the company’s 510(k) submission?
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