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Injectsense First-in-Human Glaucoma Device Study Approved by Ethics Committee at Centro de la Vision Clinic

 

Dr. Juan Jose Mura leads 20-patient study to confirm safety and efficacy for IOP Measurement

 

EMERYVILLE, Calif., May 6, 2024 /PRNewswire/ -- Injectsense Inc., a sensor-enabled digital health company, announced that the ethics committee at the Centro de la Vision Clinic in Santiago, Chile, has approved a 20-patient study that will confirm safety and effectiveness of the company's ultra-miniature wireless pressure sensor, designed to continuously measure intra-ocular pressure (IOP) for glaucoma.

 

The study will be led by Dr. Juan Jose Mura, a glaucoma specialist at the clinic and an ophthalmologist at the University of Chile. His research interests include surgical reconstruction of the anterior segment of the eye as well as cataract and glaucoma procedures. Dr. Mura has already begun recruiting patients for the study. 

 

The study follows on the heels of the company's FDA Breakthrough Device Program designation in 2020, an SBIR/NIH grant of $1.7M in 2022, and combined funding of $9.4M in 2023 for Injectsense and its sister company Injectpower, a medical microbattery producer.

 

IOP is a key physiological marker that helps determine glaucoma risk and chances for disease progression. Injectsense's iOP-Connect™ implantable sensor offers doctors the unprecedented ability to see a patient's continuous diurnal IOP activity over decades -- without patient intervention. The measurements enable physicians to determine whether there have been pressure excursions outside of the patient's normal baseline and whether the patients are in an unstable or progressing state of glaucoma. These insights will make it possible to manage therapy effectiveness. 

 

"Injectsense has already established a safety baseline for iOP-Connect over 9 months of animal testing at a major U.S. eye research institute, with no adverse events," said Ariel Cao, president and CEO, Injectsense. "The human study is part of Injectsense's continued focus on safety and effectiveness as it moves toward final product development, supply chain readiness, and an Investigational Device Exemption (IDE) prior to obtaining a CE mark. The company is ramping up its volume of the current generation of sensors with established manufacturing partners in the US and Europe." 

 

"IOP insight can be challenging without visibility into the fluctuations that occur daily, at night, and over time," said Dr. Juan Jose Mura. "Injectsense's iOP-Connect, with its continuous monitoring capability, has the potential to be a game-changing technology for glaucoma. I am very excited to coordinate the first human pilot study that will ascertain safety and generate the first human data directly from the eye using this minimally invasive approach." 

 

"This study represents a gateway to a new era of glaucoma management and continues the external validation milestones of the past few years," said Dr. Myron Yanoff, MD, FAAO, Adjunct Professor, Department of Ophthalmology at the University of Pennsylvania, and former Director of the Scheie Eye Institute. "Once the technology is shown to be safe and effective in transmitting IOP from human patients, we expect to see a surge of interest from the medical and research community that will build on the strong involvement of an ecosystem of leaders who are helping direct this technology towards pre-market approval (PMA) by the FDA."

 

Following the human study, Injectsense will continue its cooperation with key medical institutions and medical advisors to prepare post-IDE data development plans with a view towards patient enrollment.

 

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