Modular Medical Receives FDA 510(k) Clearance for Pivot Tubeless Insulin Patch Pump

NYSE - LSE

RBGPF	1.9%	69.89	$
BTI	-0.43%	56.47	$
CMSC	0.52%	21.34	$
CMSD	0.94%	21.26	$
BCE	-1.1%	23.59	$
AZN	1.74%	169.66	$
GSK	0.56%	52.07	$
RIO	1.88%	106.81	$
BP	-2.05%	42.86	$
NGG	0.92%	81.17	$
RELX	-1.42%	35.88	$
RYCEF	2.64%	20.8	$
VOD	0.93%	16.13	$
BCC	-1.48%	81.04	$
JRI	0.88%	12.48	$

Modular Medical Receives FDA 510(k) Clearance for Pivot Tubeless Insulin Patch Pump

BOULEVARD 09.04.2026

First Removable 2-Part Design Targets $3 Billion "Almost-Pumper" Market with Expected Q2 2026 initial deployment.

Key Milestones & Investment Highlights:

FDA 510(k) Clearance Achieved: Pivot^™ pump now cleared for commercial sale in the U.S. - major de-risking event unlocking revenue path.
First-in-Class Removable Tubeless Patch Pump: 3 mL detachable reservoir; no battery recharging required; removable for showering, sports or discretion; quick bolus button without a separate controller.
Targets Massive Underserved Market: ~70% of insulin-dependent adults remain on multiple daily injections (MDI) due to complexity, cumbersomeness and cost - Pivot addresses the "3 Cs" for "almost-pumpers" with its 2-part reusable pump.
Manufacturing Readiness: Production validation lots well underway; initial capacity supports ~6,000 users with scalable low-cost platform enabling a rapid production ramp-up.
Commercial Timeline: Initial customers expected by end of Q2 2026; software enhancements (e.g., variable bolus, improved alarms, ACE/AID compatibility) in development; CE Mark targeted Q4 2026/Q1 2027.

Text size:

SAN DIEGO, CA / ACCESS Newswire / April 9, 2026 / Modular Medical, Inc. ("Modular Medical" or the "Company") (NASDAQ:MODD), a leader in innovative, patient-centric insulin delivery, today announced U.S. Food and Drug Administration ("FDA") 510(k) clearance for its next-generation Pivot tubeless insulin patch pump. This milestone clears the path for commercial availability, with initial customer shipments planned by the end of Q2 2026.

The Pivot is the first two-part tubeless patch pump featuring a removable 3 mL reservoir, disposable battery, smartphone connectivity for bolus and monitoring, and true electronic accuracy without tubes or constant wear. Designed specifically for "almost-pumpers" - adults with type 1 or type 2 diabetes hesitant about traditional pumps - Pivot offers simplicity, affordability, and flexibility to improve adoption and long-term outcomes while potentially reducing healthcare costs.

Jeb Besser, CEO of Modular Medical, said: "FDA clearance for Pivot represents years of focused innovation to deliver a truly differentiated tubeless patch pump. By addressing the key barriers - complexity, bulkiness, and high cost - we believe we are positioned to convert millions still on injections to pump therapy. With manufacturing on track and our software roadmap advancing toward automated insulin delivery ("AID") features, we believe this clearance significantly de-risks our commercial launch and opens a clear path to capturing share in the growing diabetes technology market.

"We thank our team, stakeholders, and shareholders for their support. We now shift focus to our rapid commercialization strategy, additional software enhancements, and European CE Mark progress in the second half of 2026. We look forward to providing operational and adoption updates in the coming months."

For more information on the Pivot system, visit the dedicated site: PivotPump.com.

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 convert patients to use its Pivot pump product; whether the Company will have initial users by June 30, 2026; whether the Company can obtain the C.E. Mark for its Pivot product to allow it to sell in European and other international markets; 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.

Pivot is a trademark of Modular Medical in the United States. 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
[email protected]

SOURCE: Modular Medical, Inc.

View the original press release on ACCESS Newswire

J.Gomez--AT

Arizona Tribune - Modular Medical Receives FDA 510(k) Clearance for Pivot Tubeless Insulin Patch Pump

Modular Medical Receives FDA 510(k) Clearance for Pivot Tubeless Insulin Patch Pump

Featured

Nepal floods at China border kill 8, cause 'major casualties' in Tibet

France eases cow diets as cheesemakers sweat

'Black smoke' chokes Pakistan maternity ward as hospital fire kills 14 infants

French flight attendant wins landmark breast cancer ruling