8-K
Modular Medical, Inc. (MODD)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934
Date of Report (Date of earliest event Reported):
September 4, 2024
MODULAR MEDICAL, INC.
(Exact Name of Registrant as Specified in Charter)
001-41277
(Commission File Number)
| Nevada | 87-0620495 |
|---|---|
| (State or Other Jurisdiction<br><br>of Incorporation) | (I.R.S. Employer<br><br>Identification Number) |
10740 Thornmint Road
San Diego, California 92127
(Address of principal executive offices, with zip code)
(858) 800-3500
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities<br>Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange<br>Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b)<br>under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c)<br>under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock | MODD | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On September 4, 2024, Modular Medical, Inc. issued a press release announcing that it had received U.S. Food and Drug Administration clearance to market and sell its MODD1 pump in the United States. A copy of this press release is filed herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
Item 9.01 FinancialStatements and Exhibits
(d) Exhibits
The following exhibits are filed with this report:
| ExhibitNumber | Exhibit Description |
|---|---|
| 99.1 | Press Release dated September 4, 2024 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MODULAR MEDICAL, INC. | ||
|---|---|---|
| Date: September 5, 2024 | By: | /s/ James E. Besser |
| James E. Besser | ||
| Chief Executive Officer |
2
Exhibit 99.1
Modular Medical Announces FDA Clearance of theMODD1 Insulin Pump
| ● | MODD1is a patch pump for ALL adults with Type 1 and Type 2 diabetes |
|---|---|
| ● | Designedto be simpler and more affordable to expand access to diabetes technology for previously underserved communities |
| --- | --- |
| ● | Commercialavailability expected in early 2025 |
| --- | --- |
**SAN DIEGO, CA / ACCESSWIRE / Sept. 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