SAN DIEGO – Modular Medical, Inc. (NASDAQ:MODD) has received clearance from the U.S. Food and Drug Administration (FDA) to market its new MODD1 insulin patch pump in the United States, the company announced today. The product is designed to cater to all adults with Type 1 and Type 2 diabetes and aims to simplify and reduce the cost of diabetes care technology.
The FDA's approval marks a significant milestone for the company, which plans to make the MODD1 available for sale in early 2025. Modular Medical's device is intended to broaden access to diabetes management technology, particularly for underserved communities that have historically faced barriers due to the complexity and expense of such systems.
Jeb Besser, CEO of Modular Medical, emphasized the company's commitment to changing the status quo by making diabetes technology more accessible and affordable. The MODD1 pump is designed to be simpler to prescribe and use, with the aim of expanding the user base beyond those who are currently using insulin pumps.
The company's approach has been to focus on eliminating the trade-off between complexity and clinical efficacy, striving to offer top-quality insulin delivery in a format that is both affordable and easy to learn. Modular Medical was founded by Paul DiPerna, who has a background in medical device innovation and microfluidics engineering.
With the commercial manufacturing infrastructure largely in place, Modular Medical is preparing for the next steps in bringing the MODD1 pump to market. Further details regarding the product launch and milestones will be discussed in an upcoming conference call, the details of which will be announced at a later date.
This development is based on a press release statement and is a forward-looking announcement subject to risks and uncertainties. These could include delays in the product's commercial availability, market acceptance, manufacturing at high volumes, and general economic or political conditions. Modular Medical cautions that these forward-looking statements are subject to change and recommends referring to their SEC filings for a more comprehensive understanding of potential risks.
In other recent news, Modular Medical Inc. reported changes in executive compensation and option grants after failing to achieve a significant regulatory milestone. The company's Board of Directors granted new stock options to executive officers and non-executive employees, contingent on receiving FDA clearance for its initial insulin pump product, MODD-1, by the end of the year. In parallel, Benchmark has upgraded its price target for Modular Medical's shares, maintaining a Speculative Buy rating. The firm anticipates the company's focus on obtaining 510(k) clearance for the MODD-1 insulin pump this quarter and highlights the potential of the pump to reach a broader patient base. Additionally, Modular Medical has initiated a manufacturing transfer to Phillips Medisize facilities in Mexico, marking a significant step towards high-volume production. This move coincides with the FDA's ongoing review of the MODD1 Insulin Delivery System, with production expected to start early next year.
InvestingPro Insights
As Modular Medical, Inc. (NASDAQ:MODD) celebrates its recent FDA clearance for the MODD1 insulin patch pump, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Modular Medical currently holds a market capitalization of $59.91 million. Despite the positive news, the company's P/E ratio stands at -2.48, reflecting challenges in profitability, with an adjusted P/E ratio for the last twelve months as of Q1 2023 reaching -3.57.
InvestingPro Tips indicate that Modular Medical is quickly burning through cash and suffers from weak gross profit margins. Additionally, the company is not expected to be profitable this year, which aligns with the negative P/E ratio. However, it's worth noting that the company has had a high return over the last year, with a 1-year price total return of 58.62%. This suggests that despite current profitability challenges, investors have seen substantial growth in their holdings over the past year.
Another key metric to consider is the Price/Book ratio, which, as of the last twelve months of Q1 2023, stands at 7.96, indicating that the stock is trading at a premium compared to the company's book value. This could be a reflection of investor confidence in the company's future growth prospects, particularly following the FDA approval of its insulin patch pump.
For those considering an investment in Modular Medical, or for current shareholders looking to deepen their analysis, InvestingPro offers additional insights and tips. There are 12 more InvestingPro Tips available for MODD, which can provide further guidance on the company's financial position and market performance. Accessing this detailed information could be crucial for making informed investment decisions, especially in the dynamic healthcare technology sector.
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