Injectsense Awarded $1.7M SBIR Grant from NIH for Implantable Autonomous IOP Sensor
Injectsense Inc., a sensor-enabled digital health company, today 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, 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 for the first time 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 2 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.
“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,” said Ariel Cao, president and CEO, Injectsense Inc. “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.”
“There is a misperception that it’s primarily later stage glaucoma patients who require more frequent monitoring and intervention,” said 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. “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.”
Injectsense’s BDP designation will enable early conversations with both the FDA and the Centers for Medicare & Medicaid Services (CMS) about the economic advantages of the technology and its business model, and the designation may also enable 4 years of immediate CMS payment following FDA approval, pending CMS review of the rules. 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 ideal “anytime, any day” communications link that provides doctors with the most recent IOP history during telemedicine consultations.
The minimally invasive 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.
In prior work, non-GLP animal studies demonstrated that the IOP-Connect prototype can be safely implanted in the eye using a minimally invasive procedure with no adverse effects and that the prototype sensors were able to transmit IOP data on demand for one week. The next steps are to advance the product by developing an autonomous and production-ready version of the system that enables continuous logging of IOP data without patient interaction. The development incorporates novel capabilities into the module, including a custom miniaturized LiPON (lithium phosphorus oxynitride) solid-state battery for autonomous IOP data collection; and new capabilities to improve the reliability and stability of power transfer and telemetry. Preclinical data will be collected by Johns Hopkins investigators, who will perform testing to verify autonomous IOP monitoring.