Injectsense, a sensor-enabled digital health company, has been awarded a two-year, $1.7 million Small Business Innovation Research (SBIR) grant from the National Eye Institute of the National Institutes of Health, for the IOP-Connect system.
IOP-Connect is based on an implantable intra-ocular pressure (IOP) sensor platform smaller than a grain of rice, that is expected to provide continuous and autonomous long-term IOP data from inside a glaucoma patient's eye.
The funding follows IOP-Connect's FDA Breakthrough Device Program (BDP) designation in 2020 and covers two activities: the integration of advanced technologies for the final product configuration -- including a rechargeable, thin-film microbattery; and a second round of bench testing and animal testing this year that will be managed by the Johns Hopkins Wilmer Eye Institute. The results will inform GLP studies in animals and pilot human studies, scheduled for this year, as the company prepares for a CE mark and an FDA Investigational Device Exemption (IDE) submission.
Ariel Cao, president and CEO, Injectsense Inc, said: "Continuous IOP monitoring represents the beginning of a paradigm shift towards evidence-based diagnostics for healthcare providers and payors who will see the economic value of earlier intervention in slowing vision loss and improving quality of life. Under the current standard of care, clinicians have only limited visibility into patients' changing IOP and their IOP responses to drug therapy. The SBIR grant for IOP-Connect integration offers a path to effective IOP monitoring and control so that we can begin to determine what other factors affect glaucoma progression and vision loss."
Dr. Iqbal "Ike" K. Ahmed, professor of ophthalmology at the John Moran Eye Center, University of Utah, and a member of the Injectsense Medical Advisory Board, said: "There is a misperception that it's primarily later stage glaucoma patients who require more frequent monitoring and intervention. 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."
The company plans to launch AI-based analytics that will assist in assessing the glaucoma disease model and IOP fluctuation patterns across at-risk populations. Injectsense also expects to reduce patient office visits, as the wireless sensor offers an "anytime, any day" communications link that provide doctors with the most recent IOP history during telemedicine consultations.
The implant will be delivered in a five-minute procedure in the doctor's office and has been designed to be patient-friendly, with no impact on lifestyle, offering a low threshold for adoption. Patients and doctors will see IOP trends and alerts through a secure mobile app, using a data subscription model.
