The design for our iOP-Connect autonomous implantable IOP sensor is based on proven sensor technology. The device measures less than two cubic millimeters in volume (smaller than a grain of rice), is delivered by injection, and is self-anchoring. The silicon sensor is self-packaged, meaning it requires no further encapsulation. As it relies on semiconductor manufacturing techniques, volume production can scale into millions of units per year. The technology is supply chain-validated and supply chain-ready and we are shipping parts to strategic partners for testing.
Each wafer contains 14,000-plus devices, similar to how ultra-small components for cell phones are produced. Its size is one of its greatest advantages: during testing the implant is so small the animal subjects were unaware of its presence. With no intervention required for data collection, and using wireless data downloads weekly or daily, we were able to obtain highly accurate data over an extended period of time in a consistent manner. Data with a unique patient/animal ID was encrypted and stored in a cloud database.
The device itself is built with the same technology that lets you buy groceries with Apple Pay. A tiny antenna inside the implant is coupled with an external antenna, paired to a wearable reader – a mechanism we use to remotely deliver power to the device and extract data. Even with the solid state micro battery it is ultra-low power, operating at a nanowatt power level, which makes it harmless to the body.
The device is polymer-free, biocompatible (a well-understood foreign body response) and fully hermetic, so that it can operate for decades inside the body. A physician can implant the device and will only need to remove it – a simple surgical explant procedure – in the event of a chronic infection. The design allows the device to be delivered in-office, avoiding the cost of an operating room procedure.
