Modular Medical Announces First Human Use of MODD1 Pump Delivering Insulin
Modular Medical (NASDAQ:MODD) has achieved a significant milestone with the first human use of its MODD1 insulin pump in a real-world setting. The device, which received FDA clearance, is specifically designed for the estimated $3 billion adult "almost-pumpers" market.
Under FDA institutional review board approval, the MODD1 pump is currently delivering insulin to a clinician with Type 1 diabetes. The company plans to expand testing to multiple clinicians across multiple sites in mid-August 2025. The MODD1's pump controller module, which is identical to their tubeless Pivot model, has successfully demonstrated insulin delivery capabilities.
Modular Medical (NASDAQ:MODD) ha raggiunto un traguardo importante con il primo utilizzo umano della sua pompa per insulina MODD1 in un contesto reale. Il dispositivo, che ha ottenuto l'autorizzazione della FDA, è stato progettato appositamente per il mercato stimato di 3 miliardi di dollari degli adulti "quasi-pompa".
Con l'approvazione del comitato etico istituzionale della FDA, la pompa MODD1 sta attualmente somministrando insulina a un medico con diabete di tipo 1. L'azienda prevede di estendere i test a più medici in diverse sedi a metà agosto 2025. Il modulo di controllo della pompa MODD1, identico al loro modello senza tubi Pivot, ha dimostrato con successo la capacità di erogazione dell'insulina.
Modular Medical (NASDAQ:MODD) ha alcanzado un hito significativo con el primer uso humano de su bomba de insulina MODD1 en un entorno real. El dispositivo, que recibió la aprobación de la FDA, está diseñado específicamente para el mercado estimado de 3 mil millones de dólares de adultos "casi usuarios de bomba".
Bajo la aprobación del comité institucional de revisión de la FDA, la bomba MODD1 está actualmente administrando insulina a un médico con diabetes tipo 1. La empresa planea ampliar las pruebas a múltiples médicos en varios sitios a mediados de agosto de 2025. El módulo controlador de la bomba MODD1, idéntico a su modelo Pivot sin tubos, ha demostrado con éxito la capacidad de administración de insulina.
Modular Medical (NASDAQ:MODD)는 실제 환경에서 MODD1 인슐린 펌프의 최초 인간 사용이라는 중요한 이정표를 달성했습니다. FDA 승인을 받은 이 장치는 약 30억 달러 규모의 성인 "거의 펌프 사용자" 시장을 위해 특별히 설계되었습니다.
FDA 기관 심사위원회 승인 하에 MODD1 펌프는 현재 제1형 당뇨병을 가진 임상의에게 인슐린을 전달하고 있습니다. 회사는 2025년 8월 중순에 여러 장소에서 여러 임상의로 테스트를 확대할 계획입니다. MODD1의 펌프 제어 모듈은 무튜브 Pivot 모델과 동일하며, 인슐린 전달 능력을 성공적으로 입증했습니다.
Modular Medical (NASDAQ:MODD) a atteint une étape importante avec la première utilisation humaine de sa pompe à insuline MODD1 dans un contexte réel. L'appareil, qui a reçu l'autorisation de la FDA, est spécialement conçu pour le marché estimé à 3 milliards de dollars des adultes "presque utilisateurs de pompe".
Avec l'approbation du comité d'examen institutionnel de la FDA, la pompe MODD1 administre actuellement de l'insuline à un clinicien atteint de diabète de type 1. L'entreprise prévoit d'étendre les tests à plusieurs cliniciens sur plusieurs sites à la mi-août 2025. Le module de contrôle de la pompe MODD1, identique à leur modèle tubeless Pivot, a démontré avec succès ses capacités de délivrance d'insuline.
Modular Medical (NASDAQ:MODD) hat einen bedeutenden Meilenstein erreicht mit der ersten Anwendung seiner MODD1-Insulinpumpe am Menschen in einer realen Umgebung. Das Gerät, das von der FDA zugelassen wurde, ist speziell für den geschätzten 3-Milliarden-Dollar-Markt der erwachsenen "Fast-Pumpen-Nutzer" konzipiert.
Unter Genehmigung des institutionellen Überprüfungsausschusses der FDA liefert die MODD1-Pumpe derzeit Insulin an einen Kliniker mit Typ-1-Diabetes. Das Unternehmen plant, die Tests bis Mitte August 2025 auf mehrere Kliniker an verschiedenen Standorten auszuweiten. Das Pumpensteuerungsmodul der MODD1, das identisch mit ihrem schlauchlosen Pivot-Modell ist, hat die Fähigkeit zur Insulinabgabe erfolgreich demonstriert.
- None.
- Product still in early clinical validation phase
- Further regulatory approvals may be needed for full commercialization
- Faces market adoption uncertainty and competitive pressures
Insights
Modular Medical achieves crucial milestone with first human insulin delivery via MODD1 pump, signaling advancement toward commercialization.
This first human use of the MODD1 insulin pump represents a critical developmental milestone in Modular Medical's commercialization journey. The company has successfully transitioned from bench testing to delivering insulin to a human subject—specifically a clinician with Type 1 diabetes—under proper FDA institutional review board approval. This progression follows the typical medical device development pathway and signals that the core technology is functioning as intended in a controlled human application.
The announcement carries particular significance as it validates the controller module that powers both the MODD1 and the company's tubeless Pivot product. This shared technology platform approach is strategically important, as it allows Modular Medical to leverage core technology across multiple product lines, potentially accelerating development timelines and reducing costs.
The planned expansion to multiple clinicians across multiple sites in mid-August indicates confidence in the initial results and represents the next logical step in clinical validation. This methodical approach—starting with a single clinician before expanding—aligns with best practices in medical device development by allowing for controlled assessment before broader deployment.
Modular Medical is targeting what they estimate as a
With the company's FDA clearance already secured, this human testing phase represents one of the final steps before potential commercial deployment, though regulatory requirements for expanded use will need to be satisfied before full market release.
- Use of MODD1 on clinician with Type 1 diabetes
- Modular Medical intends to deploy the MODD1 on a larger number of clinicians in mid August
SAN DIEGO, CA / ACCESS Newswire / August 6, 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 the estimated
"This is another step in the maturation of the Modular Medical patch pump delivery platform. The pump controller module for MODD1 and the tubeless Pivot are identical, and the successful delivery of insulin has been a milestone we have anticipated since we began development," said Jeb Besser, CEO of Modular Medical.
Modular Medical intends to deploy its insulin units on multiple clinicians at multiple sites in a trial in the middle of August and looks forward to updating the market further on future developments.
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 product to persons with diabetes, the Company's ability to convert patients to use its MODD1 pump; 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, 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
What milestone did Modular Medical (NASDAQ:MODD) achieve with its MODD1 insulin pump in August 2025?
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What are Modular Medical's plans for MODD1 clinical testing in August 2025?
How does the MODD1 pump controller compare to Modular Medical's Pivot model?
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