Wednesday, September 4, 2024

Todays Profile Exploded but This One Just Got FDA Approval

 

 

FDA Approval stock image

Hello Everyone,

How about today's profile?

It was a tremendous move, hitting 3.25 after opening at 2.38. It was still chugging up over 3 bucks as the after hours market shut down at 8.

Congrats those who took a bite out of that apple.

Pull up MODD Immediately.  

You might remember this one from back in January.

We brought it to your attention at 1.87.

Since then it had been hovering between 1.50 and showing a lot of support closer to 2 bucks.

The company just announced FDA approval after the bell on Wednesday and we saw it rocket up past 2.50 on tremendous interest.

I am certain that there are going to be a lot of eyes watching this one and there is really no telling where it could move to so we are going to keep it front and center, Number 1 on our screen.

Did I mention that the Insiders are excited about this one?

FDA approval puts these guys on the map immediately. Just last year, Medtronic was willing to acquire insulin patch maker EOFlow for $738M before the deal fell through. Now that the approval has been granted, MODD may catch the eyes of some of the big industry players who can easily scale the manufacturing part of the business.

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. Their 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.

The American Diabetes Association says that “In 2021, 38.4 million Americans, or 11.6% of the population, had diabetes.” It released a report in 2022 that estimated the annual cost of diabetes to be $412.9 billion.

“People with diagnosed diabetes now account for one of every four health care dollars spent in the U.S.” the report noted.

Citing 2020 data from the Centers for Disease Control and Prevention, MODD points out that 3.6 million Americans require daily insulin — that includes 2.9 million who use multiple daily injections (MDI) and 670,000 who use insulin pumps:

Of those who use MDI, research firm Seagrove Partners has found that about 25% are “almost pumpers” — “meaning that they have considered going on a pump, understand pump therapy benefits, but want something simpler that doesn’t have all the ‘bells and whistles’.”

That’s where MODD expects to come in. The company believes that existing insulin pumps are geared toward “superusers” and are “prohibitive for many to learn and manage.”

The pumps have too many complicated features that most diabetics don’t need. This increases costs and puts them out of reach for many. As the tagline on MODD’s website reads, it aims to provide “diabetes care for the rest of us.”

Modular Medical Announces FDA Clearance of the MODD1 Insulin Pump

  • MODD1 is a patch pump for ALL adults with Type 1 and Type 2 diabetes
  • Designed to be simpler and more affordable to expand access to diabetes technology for previously underserved communities
  • Commercial availability expected in early 2025

SAN DIEGO, CA / ACCESSWIRE / September 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.

You can research the company herehttps://www.insiderfinancial.com/profile/modd-2-copy

Sincerely,  

              

            

 

 

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