Pulsera

The goal is to finalize the prototype by May 2024 to begin pilot studies at local hospitals. The information and data used from the pilot studies can be used when filing for FDA approval, which will hopefully be approved by June of 2025. In October, we will launch limited supplies to local hospitals in Orange and Los Angeles County. From there, we will do a post-launch marketing and scale up the production of the device.

We will begin selling the device to a small market of about 300 customers at the start of the final quarter of 2025. The device will cost $300 per device, leading to around $200 profit for every device. The device will be sold via healthcare providers and targeted social media and Google ad space marketing. To ensure the device reaches all demographics, it will fall under specific CPT codes that cover risk monitoring. This will help cover the cost and keep the device accessible. Finally, an optional premium app provides specialized assistance to those willing to pay for it. Our goal for this device is to break even by 2028 based on assumed market growth.

The market space this device has the potential to take over is the maternity care market, worth $3,000,000,000. The more readily available and realistic market will likely be preeclampsia diagnostics, mostly involving blood and urine testing, and is worth $390,000,000 a year. As for patentability, the device utilizes several FDA-approved sensors, which can impede the complete device’s patentability. However, the form factor of using an automatic applanation cuff to register continuous monitoring and the device’s slipper form will also be patentable.