Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 19, 2024

MODULAR MEDICAL, INC.

(Exact name of registrant as specified in its chapter)

Nevada		001-41277		87-0620495
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

10740 Thornmint Road, San Diego, California		92127
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (858) 800-3500

(Former name or former address, if changed since last report)

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 Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) 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 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 January 19, 2024, Modular Medical, Inc. (the “Company”) issued a press release (the “Press Release”) announcing the premarket submission of the Company’s MODD1 next-generation insulin pump to the United States Food and Drug Administration for 510(k) clearance. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 8.01 and in Exhibit 99.1 is summary information that is intended to be viewed in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in the Press Release, except as required by law. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases, or through other disclosure.

The information provided under this Item 8.01 of this Current Report on Form 8-K, including Exhibit 99.1, is “furnished” and shall not be deemed “filed” with the SEC or incorporated by reference in any filing under the Securities Exchange Act of 1934 or the Securities Act of 1933.

Item 9.01. Financial Statements and Exhibits.

(d)

Exhibits:

Exhibit No.		Description
99.1		Press release dated January 19, 2024

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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, thereunto duly authorized.

	MODULAR MEDICAL, INC.

Date: January 19, 2024	By:	/s/ James E. Besser
		James E. Besser
		Chief Executive Officer

Exhibit 99.1

Modular Medical Announces 510(k) Submission of MODD1 Insulin Pump

SAN DIEGO, CA / ACCESSWIRE / January 19, 2024 / Modular Medical, Inc. (Nasdaq:MODD) (“Modular Medical” or the “Company”), a development-stage, insulin delivery technology company seeking to launch the next generation of user-friendly and affordable insulin pump technology, today announced the premarket submission of its MODD1 next-generation insulin pump to the FDA for 510(k) clearance.

“This is an exciting milestone for the Company, as we seek to change the diabetes market. Almost 30 years after the introduction of the first insulin pump, more than three quarters of those who could benefit from wearing a pump do not wear one. It is our belief that our simplified design will encourage many “almost-pumpers” to adopt technology to aid in their diabetes management, without the complexity and expense required by many of the current solutions,” said Paul DiPerna, Chairman and CTO of Modular Medical.

Jeb Besser, CEO of Modular Medical, stated “Getting a person who requires daily insulin to adopt a pump instead of multiple daily injections can reduce healthcare costs and improve long-term patient outcomes. Pump adoption has been impeded by the ‘three-Cs:’ they are too complex, cumbersome and costly. The MODD1 was designed to be simple and affordable with an attractive form factor. We believe our two-part patch pump design, easy to learn interface and scalable manufacturing will all contribute to a differentiated and lower cost marketing approach.”

Besser continued, “On behalf of the board of directors, I would like to thank the entire Modular Medical team, and all of our stakeholders and shareholders for their support in reaching this point. We expect to receive initial questions from the FDA during the quarter ending June 30, 2023, and we will provide updates, as appropriate.”

While working with the FDA to gain US clearance, our regulatory effort will now turn to preparing applications to obtain the UKCA mark to enable us to market the MODD1 in the United Kingdom. Operationally, we will move our pilot production line to our manufacturing partner to prepare for commercial launch.”

Modular Medical will hold a conference call on the 510(k) submission at 9:00 a.m. Eastern Time on January 19, 2024, hosted by Jeb Besser and Paul DiPerna.

Conference Call and Webcast Information

Date: Friday, January 19, 2024

Time: 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time)

Conference Call Number: 1-888-506-0062

International Call Number: +1-973-528-0011

Passcode: 793376

Webcast: https://www.webcaster4.com/Webcast/Page/3015/49730

For those unable to listen to the live Web broadcast, an archived webcast can be accessed by visiting the Company’s investor relations page at www.modularmedical.com. A replay of the conference call will also be available through February 2, 2024, and can be accessed by calling 1-877-481-4010 and using passcode 49730. International callers should dial 1-919-882-2331 and enter the same passcode at the prompt.

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, whether Modular Medical can successfully develop its proprietary technologies, whether the market will accept Modular Medical’s products and services, the timing of responses from the FDA on the 510(k) submission for the MODD1 pump, Modular Medical’s ability to obtain FDA clearance and the UKCA mark for its MODD1 product, anticipated consumer demand for its products, whether Modular Medical 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 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.

Cover	Jan. 19, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 19, 2024
Entity File Number	001-41277
Entity Registrant Name	MODULAR MEDICAL, INC.
Entity Central Index Key	0001074871
Entity Tax Identification Number	87-0620495
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	10740 Thornmint Road
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92127
City Area Code	858
Local Phone Number	800-3500
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	MODD
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false