PROMPTly

Summary

Clinical Certainty, Delivered at Home!

An integrated diagnostic pad for the immediate detection of Premature Rupture of Membranes (PROM), empowering expectant mothers with a reliable, non-invasive safety net.

The Problem

1 in 10 pregnancies suffer from PROM. Currently, mothers are forced to rely on inaccurate "look and smell" tests or face $1,800+ unnecessary ER visits for false alarms.

What is PROM?

Premature Rupture of Membranes (PROM) is a medical complication affecting over 1 in 10 pregnancies (over 360,000 women annually in the U.S.). It occurs when the amniotic sac ruptures before the onset of labor. Because the leaked amniotic fluid looks and feels strikingly similar to common urinary incontinence or standard discharge, it is incredibly difficult to confidently identify at home.

The Anxiety of the "Look and Smell" Test

Currently, there are no accurate at-home tests for PROM. Expectant mothers are forced to rely on a subjective and highly unreliable "look and smell" test. This diagnostic ambiguity leaves women in a constant state of anxiety, trying to guess if they are experiencing normal late-pregnancy symptoms or a dangerous medical emergency.

The Danger of Staying Home

If a mother decides to stay home to avoid hospital bills, she risks a missed diagnosis. If an amniotic rupture goes unnoticed for too long, it can lead to catastrophic clinical consequences, including intrauterine infection, umbilical cord compression, neonatal sepsis, and even fetal death.

The Cost of a False Alarm

If a mother goes to the ER to know for certain, she faces a steep financial burden. An ER visit just to rule out PROM costs upwards of $1,800. Astonishingly, studies have shown that over 80% of these ER visits turn out to be false alarms.

A Personal Mission

For our concept founder, Francisco, this isn't just a statistic. His own mother experienced this exact trauma: ignoring a late-night leak because of the anxiety and cost of the hospital, only to find herself severely ill days later facing dangerously high blood pressure and an emergency C-section. Thankfully, both are healthy today, but no mother should ever have to make that choice. We built PROMPTly so they won't have to.

Technical Approach/Methodology

The Solution

A non-invasive, passive diagnostic pad leveraging proprietary paper microfluidics and the clinical gold-standard PAMG-1 biomarker to deliver immediate certainty at home.

Clinical Certainty at Home

PROMPTly transforms a standard hygiene product into a powerful diagnostic tool. By integrating paper microfluidics and a lateral flow immunoassay into an absorbent pad, we provide expectant mothers with immediate clinical certainty regarding fluid leakage without requiring invasive swabs or a change in daily routine.

1. The Architecture (Layered Design)

Fluid passes through our soft upper mesh layer to enter the device. Beneath this, our conjugate layer, where our proprietary Cellulose Paper microfluidic channels take over, routing the fluid to a central embedded Lateral Flow Test Strip. Finally, a highly absorbent Sodium Polyacrylate (SAP) base layer safely absorbs any excess fluid, ensuring the diagnostic strip is never washed out or oversaturated. At the bottom, an impermeable layer of PET keeps everything contained in a nice package.

2. Fluid Dynamics & Microfluidics

Relying on capillary flow, our wedge-shaped, non-branching radial channel geometry accelerates fluid delivery directly to the testing strip. We optimized the pore radius and contact angle to ensure consistent assay activation in under two minutes, eliminating backflow and routing the sample perfectly every time.

3. The Science (PAMG-1 Biomarker)

At the center of the device lies a Lateral Flow Test (LFT). This immunoassay is specifically calibrated to detect the presence of PAMG-1, the clinical gold-standard biomarker for amniotic fluid. This biochemical validation shifts the burden of diagnosis from a patient’s intuition to a proven scientific mechanism.

Outcomes

Easy as 1-2-3!

Our device is very easy to use: the mother just wears the pad daily during the last month of pregnancy, like she would a normal sanitary pad. If there is fluid leakage, the pad automatically collects the fluid. After a maximum wait time of 15 minutes, she interprets the results using a universally recognized standard (similar to an at-home COVID-19 or pregnancy test):

One Line (Control): The test functioned properly, but no amniotic fluid is present (Negative). The mother can safely stay home.
Two Red Lines: Positive detection of the PAMG-1 biomarker. A clear signal to the mother that it is time to go to the hospital.

If this 15 minute test had been available, Francisco’s mom wouldn’t have had to risk hers and her son’s life, then worry about hundreds of thousands of dollars in medical bills.

Go-To-Market Timeline

Phase 1: Direct-to-Consumer (DTC)

Initial launch via e-commerce targeting high-risk, anxious mothers. Generates early revenue to fund extensive multi-center clinical trials. Our OB/GYN partners recommend PROMPTly to their patients, earning a small commission and reducing their own clinical workload.

Phase 2: Clinical Trials & Conferences

With our revenue stream established, we begin multi-center prospective, paired-comparison clinical trials demonstrating non-inferiority against the AmniSure gold standard at a lower cost. This data, along with our historical sales data and voluntary registry, provides evidence to present at clinical conferences such as the American College of Obstetrics & Gynecology (ACOG), elevating our standing in the medical community and expanding our pool of physician partners.

Phase 3: Broad Insurance & International

Our clinical data grants us HCPCS diagnostic reimbursement codes to unlock national scale, followed by expansion into high-GNI international markets.