Modular Medical Receives IRB Approval for Pivot Insulin Delivery System Feasibility Study
Modular Medical (NASDAQ:MODD) has received IRB approval to conduct a feasibility study for its next-generation Pivot insulin delivery system. The study will evaluate the device's usability and extended wear performance by delivering sterile saline to adult participants for up to 90 days.
The Pivot pump builds upon MODD's FDA-cleared first-generation MODD1 patch pump, targeting the $3 billion adult "almost-pumpers" diabetes market. The company plans to use study insights to refine the Pivot pump before its anticipated 510(k) submission to the FDA in October 2025. The study aims to assess usability, identify wear challenges, and collect participant feedback to optimize design for everyday diabetes management.
Modular Medical (NASDAQ:MODD) ha ricevuto l'approvazione IRB per uno studio di fattibilità sul suo sistema Pivot di somministrazione dell'insulina di nuova generazione. Lo studio valuterà l'usabilità del dispositivo e la sua capacità di indossarlo per periodi prolungati fornendo soluzione salina sterile a partecipanti adulti per un massimo di 90 giorni.
La pompa Pivot amplia la patch pump MODD1 di prima generazione, già approvata dalla FDA, e si rivolge al mercato diabetologico adulto, stimato in circa 3 miliardi di dollari per i “quasi-pompe” nel trattamento del diabete. L'azienda intende utilizzare le indicazioni dello studio per perfezionare la pompa Pivot prima della prevista presentazione 510(k) alla FDA entro ottobre 2025. Lo studio mira a valutare l'usabilità, identificare le sfide di indossamento e raccogliere feedback dei partecipanti per ottimizzare il disegno per la gestione quotidiana del diabete.
Modular Medical (NASDAQ:MODD) ha obtenido aprobación IRB para realizar un estudio de viabilidad de su sistema Pivot de administración de insulina de próxima generación. El estudio evaluará la usabilidad del dispositivo y su rendimiento de uso prolongado al entregar solución salina estéril a participantes adultos durante un máximo de 90 días.
La bomba Pivot amplía la parche pump MODD1 de primera generación, ya aprobada por la FDA, y se dirige al mercado de diabetes en adultos, estimado en unos 3 mil millones de dólares para los “casi-pompes”. La empresa planea usar los hallazgos del estudio para refinar Pivot antes de su esperada presentación 510(k) ante la FDA en octubre de 2025. El estudio busca evaluar la usabilidad, identificar desafíos de uso y recopilar comentarios de los participantes para optimizar el diseño para la gestión diaria de la diabetes.
Modular Medical (나스닥: MODD)가 차세대 Pivot 인슐린 전달 시스템에 대한 타당성 연구를 수행하기 위한 IRB 승인을 받았습니다. 이 연구는 성인을 대상으로 멸균 생리식염수를 최대 90일간 제공하여 기기의 사용 편의성과 착용 시 성능을 평가합니다.
Pivot 펌은 FDA 승인된 1세대 MODD1 패치 펌프를 바탕으로 성인용 "거의 펌펌인" 당뇨병 시장의 약 30억 달러를 겨냥합니다. 회사는 이번 연구의 통찰을 바탕으로 Pivot 펌프를 다가오는 2025년 10월 FDA 510(k) 제출 전까지 다듬을 계획입니다. 이 연구는 사용 편의성 평가, 착용 시 제약 파악, 참가자 피드백 수집을 통해 일상적인 당뇨 관리에 적합한 설계를 최적화하는 것을 목표로 합니다.
Modular Medical (NASDAQ:MODD) a reçu l'approbation IRB pour réaliser une étude de faisabilité sur son système Pivot d'administration d’insuline de nouvelle génération. L'étude évaluera l'utilisabilité du dispositif et sa performance en port prolongé en administrant une solution saline stérile à des participants adultes pendant jusqu'à 90 jours.
La pompe Pivot s'appuie sur la première génération de patch pompe MODD1, déjà approuvée par la FDA, et vise le marché diabète adulte, estimé à environ 3 milliards de dollars pour les « quasi-pompes ». L'entreprise prévoit d'utiliser les enseignements de l'étude pour affiner la pompe Pivot avant sa présentation 510(k) à la FDA en octobre 2025. L'étude cherche à évaluer l'utilisabilité, à identifier les défis de port et à recueillir les retours des participants afin d'optimiser le design pour la gestion quotidienne du diabète.
Modular Medical (NASDAQ:MODD) hat die IRB-Genehmigung erhalten, eine Machbarkeitsstudie für das Pivot-Insulinabgabesystem der nächsten Generation durchzuführen. Die Studie wird die Bedienfreundlichkeit des Geräts sowie dessen Langzeiteinsatz bewerten, indem steriles Kochsalzlösungen bis zu 90 Tagen den erwachsenen Teilnehmern verabreicht werden.
Die Pivot-Pumpe baut auf dem FDA-geprüften MODD1 Patch-Pump der ersten Generation auf und richtet sich an den etwa 3 Milliarden US-Dollar großen Markt für erwachsene „fast-Pumpen“ mit Diabetes. Das Unternehmen plant, die Studienerkenntnisse zu nutzen, um die Pivot-Pumpe vor der erwarteten 510(k)-Einreichung bei der FDA im Oktober 2025 zu verfeinern. Die Studie zielt darauf ab, die Bedienbarkeit zu bewerten, Wear-Challenges zu identifizieren und Feedback der Teilnehmer zu sammeln, um das Design für das alltägliche Diabetesmanagement zu optimieren.
Modular Medical (المدرجة في ناسداك: MODD) حصلت على موافقة IRB لإجراء دراسة جدوى لنظام Pivot لإيصال الأنسولين من الجيل التالي. ستقيّم الدراسة سهولة استخدام الجهاز وأداء ارتدائه لفترة طويلة من خلال توصيل محلول ملحي معقم للمشاركين البالغين لمدة تصل إلى 90 يومًا.
يعتمد Pivot Pump على الإصدار الأول MODD1 Patch Pump المعتمد من FDA، ويستهدف سوق مرضى السكري البالغين الذي يقدّر بنحو ثلاثة مليارات دولار—فئة “الهيئات شبه المضخات”. تخطط الشركة لاستخدام نتائج الدراسة لصقل Pivot قبل المتوقع تقديم 510(k) لFDA في أكتوبر 2025. وتهدف الدراسة إلى تقييم سهولة الاستخدام وتحديد تحديات الارتداء وجمع ملاحظات المشاركين لتحسين التصميم لإدارة مرضى السكري يوميًا.
Modular Medical（纳斯达克代码：MODD） 已获IRB批准就其下一代 Pivot 胰岛素给药系统开展可行性研究。该研究将评估设备的可用性和长期佩戴性能，向成年参与者输送无菌生理盐水，最长可达 90 天。
Pivot 泵在获得 FDA 批准的第一代 MODD1 补贴泵基础上开发，目标是约 30亿美元的成年糖尿病“几乎是泵”的市场。公司计划利用研究所得来在预计于 2025 年 10 月向 FDA 提交 510(k) 申请前优化 Pivot 泵。研究旨在评估可用性、识别佩戴方面的挑战，并收集参与者意见，以便为日常糖尿病管理优化设计。
- Targeting large $3 billion market opportunity in adult diabetes care
- Building on existing FDA-cleared first-generation product (MODD1)
- Clear regulatory pathway with 510(k) submission planned for October 2025
- Extended 90-day wear testing period demonstrates product durability focus
- Pivot insulin delivery system not yet FDA-cleared
- Product still in feasibility study phase, indicating lengthy path to commercialization
Insights
Modular Medical's IRB approval for Pivot pump feasibility study marks critical regulatory progress toward their October 2025 FDA submission.
This IRB approval represents a significant regulatory milestone in Modular Medical's development pathway. The approved feasibility study will gather 90-day extended wear data using sterile saline to simulate real-world conditions - crucial information that will inform their 510(k) submission planned for October 2025. This timing suggests they're maintaining their development schedule for their second-generation tubeless insulin delivery platform.
The study design demonstrates regulatory savvy by focusing on three critical areas: usability assessment, prolonged wear performance, and user feedback. These elements directly address key FDA concerns for wearable insulin delivery systems, particularly regarding safety and effectiveness in extended use scenarios. The IRB approval indicates the study protocol meets ethical and scientific standards required for human subject research.
Contextually, this builds upon their first-generation MODD1 patch pump that already received FDA clearance, which strengthens their regulatory position. The 510(k) pathway they're pursuing is appropriate for this device type, suggesting they're positioning the Pivot as substantially equivalent to predicate devices while offering improvements. This approach typically offers a more predictable regulatory timeline than more stringent approval pathways.
The company's focus on the
-Study to Evaluate Usability and Extended Wear for Next-Generation Tubeless Patch Pump
SAN DIEGO, CA / ACCESS Newswire / September 15, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), a leader in innovative insulin delivery technology targeting the
Modular Medical's second-generation tubeless platform, its Pivot pump, builds on the Company's FDA-cleared first-generation patch pump, the MODD1, and aims to continue to enhance accessibility for underserved patients with diabetes and drive market expansion. The insights derived from the Study will be used to refine the Pivot pump ahead of its 510(k) submission to the FDA, which is anticipated in October 2025.
Key objectives and potential impacts of the Study include:
Assess usability and identify challenges in prolonged wear scenarios;
Collect participant feedback to optimize design for everyday diabetes management; and
Support regulatory pathways, potentially unlocking new markets and revenue streams.
The Pivot insulin delivery system is not currently cleared for sale by the FDA.
"This IRB approval marks another significant milestone in advancing our tubeless insulin pump technology toward market readiness," said Jeb Besser, CEO of Modular Medical. "By testing extended wear in real-world simulations, we expect to gather invaluable data to make our Pivot pump more intuitive and reliable for adults with diabetes. 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. This progress underscores our commitment to innovation, as we look to achieve long-term growth in the expanding diabetes care landscape and bring value to the Company's shareholders."
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 submission of its Pivot product to the FDA; 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 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.
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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