SBIR/STTR Award attributes
Project Summary The iOP-Connect system is a medical device that incorporates novel microelectronics technology and data science to revolutionize glaucoma patient care by enabling long-term continuous monitoring of glaucoma therapy effectiveness. The iOP-Connect is the only continuous IOP-monitoring system technology to receive a Breakthrough Device Program designation from FDA. The goal of this Phase II project is to build on prior successful “Feasibility” outcomes (Phase I equivalent) by implementing innovative advancements in the iOP-Connect system design to achieve a final product configuration and prepare for future pivotal clinical study(s). The outcomes will inform and drive the rigorous GLP animal and clinical studies roadmap to generate safety and effectiveness data to support FDA approval. The iOP-Connect system innovates IOP measurement/monitoring beyond the current gold standard and, for the first time, enables real-time (e.g., daily remote) assessment of IOP-reduction effectiveness for glaucoma treatment. Injectsense enables this product by engineering innovative product features such as: 1) long-term ocular implant (IPM) with in-vivo safety and pressure sensor stability, 2)direct measurement of true IOP intravitreally, and 3) microbattery-enabled autonomous (non-disruptive) continuous logging of uninfluenced IOP. The IPM is the core enabling innovation of the system and is built on Injectsense’s proprietary microfabrication technology. The IPM is a millimeter-scale, long-term implantable device. It combines a capacitive microelectromechanical system (MEMS) pressure sensor, a sampling and digitizing application-specific integrated circuit (ASIC), an energy storage layer (battery), and a telemetry coil integrated and enclosed in an injectable carrier. In Feasibility studies, Injectsense used fundamentally novel miniaturization and packaging technologies to develop a functional implantable prototype (without the microbattery). Short-term non-GLP animal studies demonstrated: 1) the prototype can be safely implanted in the eyeball using a minimally invasive procedure with no adverse effects, 2) the prototypes were able to transmit IOP data on demand for one week, and 3) the IOP measurements were within 3mmHg of a reference tonometer. The Phase II objective is to develop a production-ready system that performs autonomous continuous measurement and logging of IOP data and telemetrically transmits the data via IOP-Connect. Aim 1 is to design, develop and build an implantable autonomous IOP sensor module, where the existing pressure sensing module incorporates: 1) a custom LiPON (lithium phosphorus oxynitride) solid-state microbattery for autonomous IOP data collection, and 2) an embedded ceramic inductor to improve reliability and stability of power transfer and telemetry. Aim 2 is to conduct non-GLP animal testing to verify in-animal autonomous system efficacy.
