Business
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
About this update from Modular Medical, Inc.
[{"type":"text","content":"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 InformationDate: Friday, January 19, 2024Time: 9:00 a.m. Eastern Time...