Injectsense, a sensor-enabled digital health company, has announced it has been awarded a two-year $1.7M Small Business Innovation Research (SBIR) grant from the National Eye Institute of the National Institutes of Health.
This news comes after receiving the FDA Breakthrough Device Program designation for its innovative (intraocular pressure) IOP-Connect device which is smaller than a grain of rice.
The funding will be used to support the integration of advanced technologies for the final product assembly. It will also cover the second round of bench testing and animal testing managed by the Johns Hopkins Wilmer Eye Institute. The data from these will be used to inform a pilot human study in Chile.
The utility of sensor-enabled digital health solutions
Implantable sensors have recently emerged to offer a data-driven solution that may improve outcomes for patients by providing real-time data on the fluctuation of chronic disease indicators and risk factors.
They have greatly assisted physicians in easily obtaining data, identifying priority patients, understanding optimal dosages and identifying drug interference. This has cumulatively led to better disease insight and improved the survival outcomes for patients.
These technologies also expect to reduce patient office visits, as sensors offer ideal “anytime, any day” communications link that provides doctors with the most recent health data. As such, telemedicine consultations are becoming increasingly effective and common.
Smaller than a grain of rice
IOP-Connect is based on an implantable intraocular pressure (IOP) sensor platform that’s smaller than a grain of rice, which for the first time is expected to provide continuous and autonomous long-term IOP data from inside the eye of a glaucoma patient.
Glaucoma is the second leading cause of blindness worldwide, and the leading cause of blindness in the U.S., where it affects about 4 million people. Worldwide, glaucoma cases are projected to steadily increase from 57.5 million to over 111.8 million by 2040.
IOP-Connect will offer chronic continuous IOP monitoring within a digital health framework, enabling doctors for the first time to derive clinically actionable IOP data between patients’ office visits. The implant is delivered in a five minute minimally invasive procedure and is designed to be patient-friendly, with no impact on lifestyle, offering a low threshold for adoption. Patients and doctors will see IOP data trends and alerts through a mobile app and a data subscription model.
“There is a misperception that its primarily later stage glaucoma patients who require more frequent monitoring and intervention,” said Dr Iqbal K. Ahmed, Professor of Ophthalmology at the University of Utah, and a member of the Injectsense Medical Advisory Board. “In reality, the need is much broader. Millions of patients, even with mild to moderate disease, are unstable and their glaucoma progresses despite what is felt to be “controlled” IOP as measured in the office. By identifying these patients, early intervention and more effective therapy can slow vision loss. We look forward to seeing the research results of the NEI grant.”
An overview of Injectsense
The start-up was founded in 2014 by Ariel Cao and Enrique Malaret and is based in Emeryville California, with the aim of pioneering technologies that enables the tracking of progressive disease indicators and assessment of therapy effectiveness. The company’s teams combine cutting-edge advances in microelectronics with best-in-class medical device development and expertise.
Injectsense received Series B funding in April 2019 and is expecting to close a Series C round this year. Injectsense currently has development revenue from a major non-ophthalmic device company, has secured supply chain capabilities with the capacity for hundreds of thousands of devices per month and is exploring manufacturing in Europe. The device is currently for clinical investigation only and is not commercially available yet.
