Modular Medical Announces FDA Clearance of the MODD1 Insulin Pump

Rhea-AI Summary

Modular Medical (NASDAQ:MODD) has received FDA clearance for its MODD1 insulin pump, designed for all adults with Type 1 and Type 2 diabetes. The MODD1 aims to be simpler and more affordable, expanding access to diabetes technology for underserved communities. Commercial availability is expected in early 2025, with manufacturing infrastructure largely in place.

CEO Jeb Besser emphasized the goal of making pump therapy less intimidating and more accessible, targeting users beyond the current market. The company's mission is to provide 'diabetes care for the rest of us', addressing the needs of all patients and clinicians. A conference call to discuss the clearance and future milestones will be announced soon.

Positive

• FDA clearance received for MODD1 insulin pump
• MODD1 designed for both Type 1 and Type 2 diabetes patients
• Aims to expand market access with simpler and more affordable technology
• Commercial availability expected in early 2025
• Manufacturing infrastructure substantially established

Negative

• Commercial availability not until early 2025, potentially allowing competitors to gain market share

Insights

Medical Device Expert

The FDA clearance of Modular Medical's MODD1 insulin pump marks a significant milestone in diabetes management technology. This approval paves the way for a more accessible and user-friendly insulin delivery system, potentially expanding the market for pump therapy. The MODD1's design, focusing on simplicity and affordability, could address the long-standing barriers of cost and complexity that have pump adoption.

Key points to consider:

• The pump is designed for both Type 1 and Type 2 diabetes patients, broadening its potential user base.
• Commercial availability is slated for early 2025, giving the company time to establish manufacturing and distribution channels.
• The emphasis on accessibility and affordability could disrupt the current insulin pump market, potentially leading to increased competition and innovation in the sector.

While the FDA clearance is promising, the true test will be in the pump's performance, user adoption and reimbursement landscape upon market entry.

Market Analyst

Modular Medical's FDA clearance for the MODD1 insulin pump could significantly impact the diabetes care market. The company's focus on underserved communities and affordability addresses a important gap in the current market landscape. Key financial implications include:

• Potential for market share growth by targeting previously untapped segments of diabetes patients
• Possible pressure on competitors to innovate or adjust pricing strategies
• Opportunity for increased revenue streams if the pump gains widespread adoption

However, investors should note that commercial availability is not expected until early 2025, indicating a significant period before potential revenue realization. The company's ability to execute its manufacturing and distribution strategy will be important for capitalizing on this regulatory win. Additionally, the success of MODD1 will depend on factors such as reimbursement policies, healthcare provider acceptance and patient education initiatives.

Healthcare Policy Expert

The FDA clearance of Modular Medical's MODD1 insulin pump aligns with broader healthcare policy goals of improving access to medical technologies and reducing healthcare disparities. This development could have several policy implications:

• Expanded access to pump therapy may lead to better health outcomes for a wider range of diabetes patients, potentially reducing long-term healthcare costs.
• The focus on affordability could prompt discussions about insurance coverage and reimbursement policies for diabetes management devices.
• Success of this model might encourage innovation in other areas of medical technology to address accessibility issues.

Policymakers and healthcare organizations will likely monitor the MODD1's impact on patient outcomes and healthcare utilization. If successful, this could lead to changes in guidelines for diabetes management and potentially influence future healthcare policies aimed at technology accessibility.

• MODD1 is a patch pump for ALL adults with Type 1 and Type 2 diabetes

• Designed to be simpler and more affordable to expand access to diabetes technology for previously underserved communities

• Commercial availability expected in early 2025

SAN DIEGO, CA / ACCESSWIRE / September 4, 2024 / Modular Medical, Inc. (the "Company" or "Modular Medical") (NASDAQ:MODD), an insulin delivery system technology company preparing to launch a market expansion product with a more accessible, easier to prescribe, and easier to pay for and live with technology, today announced it has received U. S. Food and Drug Administration ("FDA") clearance to market and sell its MODD1 pump in the United States. With its commercial manufacturing infrastructure substantially established, the Company anticipates the MODD1 should be available for sale in early 2025.

"For too long, the benefits of superior glycemic control achieved by insulin pumps have, due to cost and complexity, been restricted to only the most sophisticated, motivated and well-insured users. The goal of Modular Medical has always been to change this by making diabetes technology accessible and affordable to underserved communities. We seek to make the experience of going ‘on a pump' simpler and less intimidating and to widen the base beyond the current pump users," said Jeb Besser, CEO of Modular Medical.

"I want to thank our employees for their hard work and dedication in bringing this product to the market and our shareholders for their ongoing support of the Company. We will continue to deliver on our mission of enabling ‘diabetes care for the rest of us' and delivering on the needs of all patients and clinicians," added Paul DiPerna, Chairman and President of Modular Medical.

Modular Medical will hold a conference call to discuss the clearance of the MODD1 pump, as well as next steps and milestones. Details for the conference call will be announced when available.

About Modular Medical

Modular Medical, Inc. (Nasdaq:MODD) is a medical device company that will launch the next generation of insulin delivery technology. Using its patented technologies, the Company seeks to eliminate the tradeoff between complexity and clinical efficacy, thereby making top quality insulin delivery both affordable and simple to learn. The Company's 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 MODD, 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.

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. These factors include, but are not limited to, the expected timing of commercial availability for the Company's MODD1 product, market and other conditions, whether the Company can successfully develop its proprietary technologies, whether the market will accept the Company's products and services, whether the Company can successfully manufacture its products at high volumes, general economic, industry or political conditions in the United States or internationally, as well as other risk factors and business considerations described in the Company'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 the Company'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. The Company assumes no obligation to update these forward-looking statements, except as required by law.

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 accesswire.com

FAQ

What is the MODD1 insulin pump by Modular Medical (NASDAQ:MODD)?

The MODD1 is an FDA-cleared insulin pump designed by Modular Medical for all adults with Type 1 and Type 2 diabetes. It aims to be simpler and more affordable, expanding access to diabetes technology for underserved communities.

When will the MODD1 insulin pump be commercially available?

Modular Medical (NASDAQ:MODD) expects the MODD1 insulin pump to be commercially available in early 2025.

What makes the MODD1 insulin pump different from other pumps?

The MODD1 is designed to be simpler, more affordable, and easier to prescribe, pay for, and live with. It aims to make pump therapy less intimidating and more accessible to a wider range of users beyond the current market.

Has Modular Medical (NASDAQ:MODD) received FDA clearance for the MODD1 pump?

Yes, Modular Medical announced on September 4, 2024, that it has received FDA clearance to market and sell its MODD1 pump in the United States.