Modular Med Stock Price, News & Analysis

Modular Medical, Inc. (Nasdaq: MODD) is a development-stage medical device company focused on insulin delivery technology for people with diabetes. Classified within surgical and medical instrument manufacturing, the company is working to launch what it describes as the next generation of insulin delivery technology, with an emphasis on user-friendly, affordable patch pumps designed to simplify insulin therapy.

According to the company, its patented technologies are intended to eliminate what it sees as a tradeoff between complexity and efficacy in insulin delivery. By aiming to make high-quality insulin delivery both affordable and simple to learn, Modular Medical seeks to improve access to a high standard of glycemic control for people with diabetes. The company specifically states that its mission is to take diabetes care beyond so‑called "superusers" of advanced technology and provide "diabetes care for the rest of us."

Business focus and target users

Modular Medical describes itself as an insulin delivery technology company targeting the adult "almost‑pumpers" diabetes market. In several of its communications, it refers to this market as a multibillion‑dollar opportunity consisting of adults with diabetes who have not adopted traditional insulin pumps, often due to concerns about cost, complexity, or design. The company highlights this group as underserved and a core focus for its product development and commercialization plans.

The company has developed a patch pump platform and refers to its first‑generation patch pump, the MODD1, as FDA‑cleared. Building on this, it is advancing a second‑generation, tubeless platform known as the Pivot insulin delivery system. Modular Medical describes Pivot as a tubeless, removable patch pump with a three milliliter reservoir, designed for adults who may be hesitant to adopt conventional pump systems.

Pivot tubeless insulin patch pump

In its public disclosures, Modular Medical presents the Pivot system as its next‑generation insulin delivery platform. The company has announced a 510(k) premarket submission for Pivot to the U.S. Food and Drug Administration and has stated that the Pivot insulin delivery system is not currently cleared for sale by the FDA. It has also reported Institutional Review Board (IRB) approvals to conduct in‑house studies of Pivot, including feasibility and insulin‑use studies with adult participants, in order to gather data on usability, extended wear, device function, and user feedback under simulated real‑world conditions.

Modular Medical characterizes Pivot as a two‑part, tubeless patch pump with a removable three milliliter reservoir. In its descriptions, the company notes features such as the ability to detach the pump for certain activities and to deliver insulin boluses without a separate controller, while still aiming to maintain the accuracy, communications, and clinical reporting associated with an electronic pump. The company links these design choices to its goal of addressing what it calls the "3 Cs" of traditional pumps for many adults with diabetes: complex, cumbersome, and costly.

Development stage and regulatory pathway

The company repeatedly describes itself as a development‑stage medical device company. It has emphasized that the Pivot insulin delivery system is not cleared for sale by the FDA and, in some communications, that it is not cleared in other markets outside the United States. To support its regulatory and commercialization plans, Modular Medical has reported progress on several fronts, including IRB‑approved human‑subject studies, preparation and submission of a 510(k) filing for Pivot, and activities related to quality management and international regulatory requirements.

For potential European Union commercialization, the company has disclosed that it is progressing toward CE Mark certification under the European Union Medical Device Regulation (EU MDR 2017/745). It has reported successful completion of a Stage 1 ISO 13485:2016 audit of its quality management system by its notified body and registrar, with a Stage 2 audit planned as the next step toward ISO 13485 certification and CE technical documentation review.

Manufacturing readiness and platform approach

Modular Medical has communicated that it is preparing manufacturing capabilities to support anticipated commercial launch of its Pivot patch pump, subject to regulatory clearance. The company has announced validation of its Pivot controller manufacturing line for human‑use production, describing this as a key milestone toward high‑volume manufacturing readiness. It refers to its platform as being optimized for low‑cost, high‑volume production and indicates that validation of the controller line is intended to support reliable and scalable output of the Pivot product.

The company links its manufacturing plans to its strategic focus on affordability and accessibility. By emphasizing a platform designed for high‑volume production, Modular Medical states that it aims to support broader adoption of patch pump technology among adults with diabetes who may have avoided traditional pumps.

Capital markets, financing, and listing status

Modular Medical’s common stock trades on the Nasdaq Capital Market under the ticker symbol MODD. The company has disclosed multiple capital markets transactions, including underwritten public offerings of common stock and accompanying warrants, as well as warrant inducement arrangements. These transactions have involved the issuance of new warrants, adjustments to exercise prices for existing warrants, and the registration of underlying shares on shelf registration statements on Form S‑3 and other registration statements filed with the U.S. Securities and Exchange Commission (SEC).

The company has also reported receiving a notice from Nasdaq indicating that the closing bid price of its common stock had fallen below the minimum $1 per share requirement for continued listing on the Nasdaq Capital Market. In that notice, Nasdaq granted the company an initial 180‑day period to regain compliance by achieving a closing bid price of at least $1 per share for a minimum of ten consecutive business days. Modular Medical has disclosed that it is monitoring the closing bid price of its common stock and considering available options in connection with this requirement.

Subsequently, the company announced that Nasdaq granted a further 180‑day extension to regain compliance with the minimum bid price rule. Modular Medical has stated that its common stock continues to trade on the Nasdaq Capital Market under the MODD symbol during this extension period and that, if it does not regain compliance, Nasdaq may initiate delisting procedures, subject to potential appeal.

Corporate background

Modular Medical is incorporated in Nevada, as indicated in its SEC filings, and lists San Diego, California as the location of its principal executive offices. The company was founded by Paul DiPerna, whom it describes as a seasoned medical device professional and microfluidics engineer. In its public materials, Modular Medical notes that, prior to founding the company, Mr. DiPerna founded Tandem Diabetes in 2005 and invented and designed its t:slim insulin pump.

Across its public statements, Modular Medical consistently emphasizes its mission to broaden access to advanced insulin delivery by focusing on simplicity, affordability, and usability for adults with diabetes who have not yet adopted pump therapy. Its development activities, regulatory filings, and manufacturing preparations are presented as steps toward commercializing its patch pump platforms, including the FDA‑cleared MODD1 and the development‑stage Pivot system.

Key themes for investors and observers

• Development‑stage status: The company identifies itself as a development‑stage medical device company, with its next‑generation Pivot system not yet cleared for sale by the FDA.
• Insulin delivery focus: Modular Medical concentrates on insulin delivery technology, particularly patch pumps for adults with diabetes.
• Target market: The company repeatedly references the adult "almost‑pumpers" market and describes it as a multibillion‑dollar opportunity in diabetes technology.
• Regulatory and quality efforts: Activities include FDA 510(k) submissions, IRB‑approved human‑subject studies, and steps toward ISO 13485 certification and CE Mark under EU MDR.
• Nasdaq listing considerations: The company has received Nasdaq notices related to the minimum bid price requirement and has been granted time to regain compliance while its shares continue to trade under the MODD symbol.