Cardia Loop Series A
Medical device pitch deck, clearance path and unit economics
A device investor is buying two things at once: a regulatory calendar and a manufacturing cost. Cardia Loop is invented, and its ten slides put the 510(k) dates and the cost of one patch on their own slides rather than leaving either to the appendix.
Every slide, in order
The whole deck as it renders, one slide after another. Read it the way the audience would.
The structure
What each slide is doing, so you can reuse the order even with different content.
- Slide 1cover
- Name the device and the claim in one line, with the clearance date on the cover.
- Slide 2intro
- The problem framed from the missed diagnosis rather than from the device market.
- Slide 3pillars
- What the product actually is, in five plain statements, so nobody asks what is in the box.
- Slide 4comparison
- The patch against the incumbent test on the four things a cardiology clinic buys on.
- Slide 5metrics
- The pilot in six numbers, including the two a regulator will ask about.
- Slide 6process
- The regulatory path with real dates, because a device with no clearance date has no plan.
- Slide 7pricing
- Two ways to buy the same patch, so a clinic sees the volume case beside the single episode price.
- Slide 8metrics
- Where the 380 dollars goes, so the margin question is answered before it is asked.
- Slide 9investment
- The eight million split four ways, each tied to a step on the regulatory path.
- Slide 10closing
- Close on the clearance date and leave three ways to get the submission file.
Slide by slide
Slide one names the device and the claim in one line. Slide two frames the problem as a missed diagnosis rather than a market. Slide three lists what is in the box in five statements. Slide four compares the incumbent test with the patch on four buying measures. Slide five reports the 1,240 patient pilot in six numbers. Slide six is the regulatory path in five dated steps, two of them already done. Slide seven gives a clinic two ways to buy. Slide eight takes the 380 dollar price apart line by line. Slide nine splits the eight million ask across clearance, manufacturing, commercial and working capital. Slide ten closes on the clearance date and three ways to reach the founder.
How to adapt this deck
A device that needs a full premarket approval rather than a clearance moves the regulatory slide to third and doubles its length, because the calendar is then the main risk in the business. A diagnostic sold to laboratories rather than clinics swaps the pricing slide for a reimbursement slide, since the payer decides the price and the laboratory only decides the volume. A company already cleared and selling cuts the path slide to one line and gives the space to sales velocity, which is the number that replaces clearance as the thing being bought.
What this audience asks for
The United States regulator publishes what a premarket notification has to contain and how the review clock runs, and the Australian regulator publishes the equivalent for devices supplied here. Both are worth reading before a timeline slide is drawn, because both describe the point at which a reviewer can stop the clock and ask for more, which is the event most device timelines quietly omit. An investor who has funded devices before will look for that gap first, and a deck that has already put it on the chart does not have to defend the rest of the dates.
What makes this deck work
The information request is budgeted, not hoped against
Slide six puts an expected additional information request in July 2027 between submission and clearance, with 90 days of response time inside the plan. Every device founder knows it is coming. Putting it on the timeline is the difference between a schedule and a wish, and it is what makes December 2027 readable as a date.
The comparison uses pilot numbers, not brochure numbers
Slide four sets 48 hour monitoring against the patch on four measures, and the patch column comes from the pilot: 12.6 median days worn, 61 percent diagnostic yield. The subtitle says so. A comparison slide where only one side is measured is a claim with a table around it.
The margin is shown before it is asked for
Slide eight takes 380 dollars apart into six lines and lands on 179 of contribution at 47 percent, with the cardiologist over read named as the largest cost and the first to fall. Answering the margin question on your own slide is worth more than answering it well in the room.
Questions people ask
What is different about a medical device pitch deck?
Two slides that a software deck does not carry: the regulatory path with dates, and the cost to build one unit. Everything else is recognisable. This example gives each of those a full slide and puts the clinical pilot between them, because the pilot is what the submission rests on.
Where does the regulatory slide go?
After the clinical evidence and before the pricing. An investor has to believe the data before the dates mean anything, and has to believe the dates before the price is worth discussing. In this deck the pilot is slide five, the path is slide six and pricing is slide seven.
How much clinical detail belongs in the deck?
Enough to state sensitivity, specificity and the sample, with the clinic count and the dates. This deck uses six numbers on one slide. The full protocol, the statistical plan and the site list go in the data room, which the closing slide offers rather than promises.
Should I show unit cost to investors?
Yes. A device company is a manufacturing company, and an investor who cannot see the bill of materials will assume the worst. This example shows 96 dollars of build inside a 380 dollar price and names the line that falls with volume, which is the over read rather than the hardware.
How long should a device deck be?
Ten to twelve slides. This one is ten. The temptation is to add engineering detail, and the fix is to move it to an appendix that the technical diligence session uses. The main deck has to survive being read by a generalist partner in eight minutes.
What do I put on the pricing slide before clearance?
The price you intend to charge and the two shapes a buyer can take it in. This deck shows 380 dollars per episode and a 2,900 dollar monthly plan for ten. Pricing before clearance is a statement of intent, and saying so is better than leaving the slide out.
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