$MODD Due Diligence — A brand new FDA-Cleared Insulin delivery system

I have been digging into Modular Medical ($MODD), and I think it is one of the most interesting medtech setups right now. However, the market has been brutal to them, giving them no credit and keeping them undervalued.

This is **not** a "FDA approval is coming someday" story anymore. The device is cleared, production exists, initial patients are using it, and the real commercial launch starts in October.

At the same time, MODD is burning cash and has been issuing a lot of stock.

So I think there is a legitimate bull case here, but also an obvious reason why the market is assigning such a low valuation.

**What is Modular Medical?**

Modular Medical is developing insulin delivery systems, with its current commercial product being the **Pivot tubeless insulin patch pump**.

The FDA cleared Pivot through 510(k) in April 2026 . Initial U.S. shipments started in June.

Pivot isn't just another traditional insulin pump.

Its main features are:

* tubeless patch design (Insulet Omnipod is the only other tubeless patch pump for now in the market)
* reusable/removable pump portion ( only removable pump in market)
* disposable cartridge worn for roughly three days
* 300-unit insulin capacity ( Omnipod only has 200-unit)
* basal insulin delivery
* physical button for meal-time boluses(not dependent on a phone)
* optional smartphone/Bluetooth/NFC connectivity
* removable during the wear period instead of throwing the entire electronics package away

 

No Automatic Insulin delivery (AID) though , but it is coming in the future.

The pump snaps onto a disposable cartridge containing the infusion set and battery. MODD designed it specifically around simplicity rather than packing every possible feature into the product.

That distinction is central to the investment thesis.

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**Who is MODD actually targeting?**

MODD calls its target population **"Almost Pumpers."**

These are insulin-dependent patients who know pumps exist and may want better glucose control but continue using multiple daily injections because existing pumps are perceived as:

* too complicated
* too expensive
* too cumbersome
* too difficult to learn
* too time-consuming

MODD's thesis is essentially:

Don't fight Insulet, Tandem and Medtronic solely for existing sophisticated pump users. Convert people who aren't using pumps at all.

 

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**Why I find the concept interesting**

There is already evidence that simpler insulin delivery products can find customers.

MODD's own 10-K points out that:

* CeQur had disclosed **15,000+ users**
* Beta Bionics had approximately **35,000 users by the end of 2025**

CeQur is particularly interesting as a comparison because its Simplicity patch targets insulin users who want something easier than conventional pump therapy.

But CeQur only provides **bolus insulin**.

Pivot provides both **basal + bolus insulin**, making it potentially a more complete replacement for MDI.

The real question is whether MODD can acquire thousands of patients with a much smaller commercialization budget.

If Pivot eventually gets even several thousand active users, the investment thesis looks very different from where the company is valued today.

 

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**Management deserves some attention**

One thing I don't think gets enough attention is Paul DiPerna.

DiPerna founded **Tandem Diabetes Care in 2003** and was involved in designing and developing Tandem's original insulin pump -> t:slim

Insulet former CEO Duane Desisto is in Board of Directors. David Bosshard Head of International Operations, launched Omnipod in Europe. Diabetes care expert Robert Gabbay, MD, PhD, FACP runs the Pivot Innovation Council.

That doesn't guarantee success, but this is not a management team entering insulin delivery with zero domain experience.

Also, Jeb Besser, the CEO, works for 1 dollar, has personally invested a lot of money in the past, also the largest shareholder.

**Manufacturing is already established**

MODD has partnered with **Phillips Medisize**, a Molex company, for manufacturing.

MODD says its production architecture was designed for highly automated manufacturing, and its initial production-line milestone was designed around capacity for approximately **6,000 patients**.

That's relevant because one common microcap medtech failure mode is:

FDA clearance → demand appears → company can't manufacture reliably.

MODD still needs to prove large-scale manufacturing, but outsourcing to an established medical-device manufacturer reduces some of that execution risk.

 

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**The valuation is why this gets interesting**

MODD closed around **$3.54 on August 21**.

The company reported **8.15 million shares outstanding as of August 14**, putting the rough equity value around:

**$29 million.**

For an FDA-cleared commercial insulin-delivery company, that's tiny.

If Pivot fails commercially, $29M may not be cheap at all.

But if Pivot proves it can acquire several thousand recurring users, the current valuation could look very different.

That's the asymmetric part of the thesis.

**Advantages of Pivot pump**

It has only 6 features so the training is easy, 20 minutes is all you need. So clinicians/endocrinologist/educationist can train new users rather than sales person from pump company like it is done today. It is huge deal because the company don't need any 100 person sales force. They also have a game app, similar to Level Ex game to train users faster.

The Multiple Daily Injection ( MDI) users who has said no to other pumps because of its complexity, cumbersomeness and cost, might find Pivot as a really good option.

Majority of the new pump users are patch pump users, so only Pivot is the only one available patch pump other than Omnipod.

It is the only tubeless patch pump with 300 units(Omnipod only has 200 units) in the market right now, which is a huge deal as many patch pump users especially type 2, need more than 200 unit in 3 days. Upcoming patch pumps Tubeless Mobi from Tandem and Beta Bionics Mint pump are also 200 unit. Upcoming Minimed Fit is 300 unit though.

Omnipod throws away the entire pump every three days, Pivot can retain the pump part ( which has the controller, chips) for 90 days ( will extend to 180 days in future). So that is a huge advantage cost wise.

[Omnipod and Pivot](https://preview.redd.it/9ac1jq9256lh1.png?width=1115&format=png&auto=webp&s=6a6ef2497b3f94cdcb6ea854f78a69d0a507e0bc)

 

Pivot is going to be in pharmacy benefits which is what most users prefer

They have conducted proof-of-concept trials evaluating the use of its patch pump technology to deliver GLP-1 receptor agonists. They also have a dual chamber design in works for delivering more than one drug. 

**Now the ugly part: cash and dilution**

This is the single biggest risk in MODD, in my opinion.

As of June 30:

* Cash: **$3.92M**
* Quarterly net loss: **$6.49M**
* Operating cash used during the quarter: **\~$5.97M**

And they have been raising money.

The company raised:

* \~$3M net from an April registered direct offering
* \~$0.7M through its ATM during Q2

This cannot be ignored.

 **Another risk: Pivot isn't Omnipod 5**

People should understand what they are buying.

Pivot's initial pitch is **simplicity and affordability**.

That's different from advanced automated insulin-delivery systems that tightly integrate CGM readings and algorithms.

For a sophisticated Type 1 pump user who wants maximum automation, an established system from Insulet/Tandem/Medtronic may remain more attractive.

MODD is basically betting that millions of people don't want all that complexity.

That could be brilliant.

Or it could turn out that patients ultimately want **both simplicity AND automated insulin delivery**, forcing MODD to add functionality faster than expected.

The company has already discussed future software enhancements and AID/ACE-related development.

 

**Competition is brutal**

MODD is entering a market dominated by companies with vastly greater resources.

MODD's 10-K estimates U.S. market shares of approximately:

* Insulet: 43%
* Tandem: 34%
* Medtronic MiniMed: 21%

Whether those exact percentages remain stable isn't the important point.

MODD doesn't need to beat them.

But it does need to prove that the "Almost Pumper" market is genuinely distinct enough that established products haven't already solved the problem.

 

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**Bull case**

Pivot proves that there is a large population of insulin-dependent patients who want something simpler than existing pumps.

The October launch produces meaningful prescriptions.

Insurance coverage expands.

MODD reaches several thousand users.

Recurring cartridge revenue begins scaling.

Manufacturing economics prove attractive.

At that point, a \~$30M valuation would probably make very little sense for a successfully growing insulin-pump company.

There could also eventually be strategic value to a larger diabetes/device company.

**Bear case**

Doctors and patients like Pivot in surveys but don't actually switch.

Insurance coverage takes longer than expected.

MODD burns $5M-$6M per quarter while producing limited revenue.

The ATM keeps running.

The share count continues climbing.

Existing competitors simplify their own products or offer better automated systems.

MODD eventually has a commercially viable device but shareholders capture much less of the upside because of years of dilution.

That's a very realistic risk.

**My view**

I don't think MODD should be viewed as an FDA binary anymore.

**FDA risk has largely been replaced by commercialization risk.**

And that's actually what makes the setup interesting.

The market is currently valuing MODD like commercialization may fail.

If Pivot adoption starts showing up in real patient numbers and revenue, the stock could re-rate dramatically because the starting valuation is so small.

But the balance sheet means the clock is running.

The two questions that matter now are:

**Can Pivot acquire patients quickly enough?**

and

**Can MODD reach meaningful commercial scale before dilution overwhelms existing shareholders?**

If the answer to both is yes, I think there's significant upside.

If only the first is yes but it takes years and hundreds of millions of dollars to scale, the business could succeed while today's shareholders still get diluted heavily.

That's the trade.

 

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**My view** ( my personal view )

**They have diluted a lost in the past and have spent millions of dollars on this patch pump, but everything they have done is to reach to this point, and now is the time to reap the rewards.**

 I will watch how the October launch in 5 cities turns out , if they can acquire customers very cheaply and prove "Almost Pumpers" exist, then there will be a re-rating

 I think they have really good hardware design needed for an insulin pump(Tandem founder Diperna designed it), now they need to add the software on top. I believe making the hardware cheaper/easier to manufacture will give them a really good cost advantage when  manufactured at scale. The catridge they use only has 12 plastic pieces with a coin cell battery that is thrown away every three days.

**Some people dismiss them because there is no AID algorithm(for now), but if they can prove that there are other MDI users who are willing to try a simpler pump that is easy to use and easy to learn, it will be a game changer. I believe that could be the case as most people who need to use a pump are not wearing one years after AID has come to market.**

The CEO Jeb Besser, only makes 1 dollar, his company Manchester Management Co LLC, has poured millions of dollars in to it. So they have skin in the game.

Not financial advice. This is a speculative microcap medtech with execution and funding risk. Do your own DD.

**TL;DR:**

$MODD is no longer an FDA-clearance gamble — Pivot is FDA-cleared and commercialization is underway. The bull case is that Modular Medical can convert insulin users who avoid traditional pumps because they are too complex or expensive, potentially creating a meaningful recurring-revenue business from a very small current valuation. The biggest upcoming proof point is whether the October 2026 broader launch produces real patient adoption, prescriptions, reimbursement coverage, and repeat cartridge usage.

The major risk is dilution. MODD is still burning cash, has stated it needs additional financing, and its share count has increased in a short period.

So the key question is not just whether Pivot is a good product — it is whether MODD can scale adoption fast enough that revenue growth starts outrunning cash burn and shareholder dilution.

**Bull case:** thousands of users + payer coverage + recurring consumable revenue → major re-rating.

**Bear case:** slow adoption + continued $5M–$6M quarterly cash burn + ATM usage → high dilution even if the product ultimately succeeds.

High-risk, high-upside microcap medtech. Not financial advice.