Injectsense Receives Breakthrough Device Program Designation from FDA, Highlights Eye Sensor Performance and Path to Human Studies
EMERYVILLE, Calif., September 1, 2020 -- Injectsense, a company focused on sensor-enabled digital health, announced it has received a Breakthrough Device Program (BDP) designation from the U.S. Food and Drug Administration (FDA) for its chronic continuous IOP monitoring system for glaucoma patients. The company’s IOP Connect™ system is based on a long-term implantable sensor, smaller than a grain of rice, that is delivered to the eye by injection during a five-minute in-office procedure.
The BDP designation is intended to help patients and physicians receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Injectsense with priority review and interactive communication regarding device development and clinical trial protocols, all the way through to commercialization decisions. IOP-Connect is still in research and development and is not available for sale anywhere in the world.
Importance of continuous IOP monitoring
Today, ophthalmologists have no way of knowing how individual IOP varies over a 24-hour period. Measurements using tonometry are only static snapshots taken in the doctor’s office a few times a year during office hours lacking months of crucial IOP information in between doctor visits. However, IOP is known to fluctuate significantly throughout the day, especially at night, and with certain kinds of physical activity.
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 for 4 million US patients between office visits. Unlike other proposed sensors, the Injectsense device minimizes patient intervention through its autonomous data collection.
“The ophthalmology community needs a device that can be placed in the eye to monitor IOP, day and night, continuously for the lifetime of a patient. This will allow clinicians to better measure compliance and the effectiveness of every glaucoma therapy, enhancing outcomes.” said Dr. Richard Lindstrom, founder and attending surgeon at Minnesota Eye Consultants. “The designation of IOP Connect as a breakthrough device by the FDA is also a significant step forward and will help speed market access to the Injectsense system, as will the recent CMS proposal to provide national Medicare coverage for breakthrough devices for four years starting on the day of FDA market authorization.”
“The Injectsense team has its feet in both semiconductor and medical systems expertise and has worked hard to develop a miniature sensor that blends high performance with expected safety and efficacy,” said Ariel Cao, president and CEO of Injectsense Inc. “With the BDP designation in hand, we look forward to moving on to in-depth animal and human studies.”
The company laid out its intended safety and efficacy objectives as it approaches human studies. The company conducted successful in-vivo functionality testing in animals in 2019, sending IOP data from eyes to a cloud database. Injectsense is now focused on the path to full GLP animal studies, pilot human studies, and IDE submission.
Injectsense is working closely with its medical advisory board on safety for its injectable sensor delivery system. The injection procedure is very similar to a standard intravitreal eye injection for wet AMD, which is now more common than cataract surgery. These injections are administered several million times every year worldwide.
Sensor Performance Testing: 3 Month Results Show High Stability
The company also released in-vitro stability test results and outlined its intended safety path to in-human studies that are expected to start next spring. The test of sensor accuracy in saline (BSS) over 3 months confirmed a measured drift of only 0.006 mmHg/month. Most sensors are subject to performance degradation over time. Injectsense’s sensor platform relies on advanced integration to significantly reduce drift and is expected to offer long-term pressure accuracy within +/- 1mmHg or below, at system level. Injectsense will continue executing stability testing in order to accumulate statistical data from thousands of units. This testing will ensure that every sensor has predictable performance and accuracy for years.
Secured Global Supply Chain
In parallel Injectsense has secured its manufacturing supply chain and has already produced tens of thousands of prototype devices for use in testing. “Scalability for the market is a primary objective, with 4 million glaucoma patients in the US alone and more than 14 million in Europe,” said Cao. “We already have the capacity for hundreds of thousands of devices per month using high-yield semiconductor wafer technology with advanced automation.”
Injectsense will also focus on supply chain validation as suppliers stabilize their processes and capabilities (SPC), which is an imperative for the FDA and strategic partner(s). The company’s forward-looking supply chain approach was implemented at the beginning of product development and incorporates design for test (DFT) and design for manufacturing (DFM) to ensure a smooth design transfer to production.
IMPLANTABLE SENSORS OFFER DATA-DRIVEN TELEMEDICINE FOR VULNERABLE POPULATIONS IN AN ERA OF COVID19
Injectsense in-vivo sensors aim to keep patients out of clinics while helping physicians improve quality of care
EMERYVILLE, Calif., April 21, 2020 – Americans spend 2.4 billion hours on doctor visits. This means that in normal times, thousands of patients a month go to a doctor’s office for routine evaluation of chronic conditions that could easily be monitored through sensor-enabled digital health. In times such as these, where the novel coronavirus requires all medical staff on deck, remote monitoring via implantable sensors can perform double duty and help save lives.
First, it can provide a telemedicine solution that keeps non-urgent but vulnerable populations out of clinics and emergency wards to make room for priority cases. Second, compared to periodic office visits, it offers a superior solution for managing therapy effectiveness, as well as the opportunity to reduce costs. Equally important, sensor-enabled digital health opens a new era of telemedicine, where physician access to continuous diagnostic data will add clinically actionable information to routine virtual health appointments.
Sensor-enabled digital health solutions: how they work
By periodically uploading continuous data to the cloud, implantable sensors offer a reimbursable, data-driven solution that may improve outcomes, providing an unprecedented window on fluctuation of chronic disease indicators and risk factors. Physicians will be able to easily mine data, receive alerts on priority patients, understand how to optimize dosage, and identify drug interference. Ultimately, they will have the capability to monitor multiple parameters at once for greater disease insight.
As an example of such a system, Injectsense has developed a miniature implantable sensor smaller than a grain of rice for continuous data monitoring. It can be injected or implanted in the doctor’s office, and measures different parameters, including pressure, temperature, body position, motion, and other variables that provide information on chronic disease.
Injectsense’s first application is measurement of intraocular pressure (IOP), a glaucoma progression risk indicator. The IOP sensors, which have been tested in live animals, periodically send data to the cloud, providing physicians with clinically actionable information, keeping typically vulnerable glaucoma patients out of the doctor’s office for routine IOP evaluations. The company’s strategic partner and major investor saw the advantages of the system early on for use in the monitoring of glaucoma patients.
“It’s extremely difficult to know how IOP fluctuates from hour to hour,” said Iqbal “Ike” Ahmed, MD, FRCSC, research director and professor at the Kensington Eye Institute of the University of Toronto. “The ability to see what’s actually going on during a 24-hour cycle for an individual patient’s IOP will contribute enormously to therapy effectiveness.”
Telemedicine Benefits of Sensor-Enabled Digital Health during a Pandemic
“The availability of a sensor-based monitor would make following a patient’s glaucoma much more complete,” said Jason Bacharach, MD, FAAO, founding partner and medical and research director at North Bay Eye Associates. “A clinician would be able to visualize a 24-hour IOP curve and identify peaks and the ability to assess for disease stability as well as therapeutic effectiveness would be enhanced. We could do this remotely, reducing the need for in-person visits, which would be particularly beneficial during stay-at-home orders with the COVID-19 pandemic.”
“When we developed the idea for this injectable platform six years ago, we saw it as essential to reducing the cost of unnecessary office visits across multiple medical domains -- ophthalmology, neurosurgery and other fields,” said Ariel Cao, CEO and president, Injectsense Inc. “Now the system can offer a highly viable approach to keeping physicians, clinics and hospitals available for priority patients during a time of need, while still providing doctors with a means to measure therapy effectiveness and receive reimbursement.”
Bringing Sensor-Enabled Health to Market for Maximum Value
The company is now heavily investing in a safe and effective sensor injection system as it moves towards first-in-human studies. Injectsense is targeting an accelerated path to market with support from its own strategic partners and investors in order to bring to market a solution that can protect the most vulnerable in today’s new reality.
INJECTSENSE DEMONSTRATES ANIMAL TO CLOUD IOP SENSING PATHWAY
Injectable Pressure Sensor Offers Platform for Multiple Medical Domains
San Francisco, October 9, 2019, AAO – Injectsense, a sensor-enabled digital health company, today announced completion of a successful in-vivo animal study of the first implantable sensor and monitoring system designed to collect long-term intraocular pressure (IOP) data. The Injectsense IOP-Connect system creates an organ-to-cloud data connection that enables the clinician to assess glaucoma therapy effectiveness at any time. The system is expected to provide unprecedented visibility into the IOP profile of the patient over time, and into previously unobserved changes that may affect glaucoma progression.
As part of the study, researchers at an accredited US research organization were able to implant the self-anchoring sensor safely and collect accurate pressure readings – in agreement with tonometry measurements – for the week-long test period. No device-related adverse events were reported.
“One of the challenges in addressing glaucoma is the lack of visibility into continuous IOP changes,” said Dr. Myron Yanoff, MD, FAAO, Chair Emeritus, Department of Ophthalmology at Drexel University and Adjunct Professor, Department of Ophthalmology at the University of Pennsylvania. “The product being developed by Injectsense is a game changer in how and when to regulate the treatment of glaucoma. It offers a tangible path to clinically actionable information, enabling new insights into the true relationship between IOP, glaucoma, and therapy effectiveness. It also opens a world of possibilities into basic research on the inherent changes in the mechanisms of glaucoma.”
Beyond ophthalmology, the sensor-enabled digital health platform is highly versatile, potentially enabling diagnostic and therapeutic applications in many different domains, from intracranial, urological, and various cardiovascular pressure parameters to neurosurgery and fluidic applications.
Injectsense is a sensor-enabled digital health company that enables tracking of progressive disease indicators and assessment of therapy effectiveness. It provides continuous, clinically actionable information through an injectable ultra-miniature sensor coupled with a secure digital health platform. Injectsense received Series B funding in April 2019 and is expecting to close a Series C round by year end. The company's Silicon Valley and Twin Cities product teams combine cutting-edge advances in microelectronics with best-in-class medical device development and expertise. The device is currently for clinical investigation only and is not commercially available. For more information regarding Injectsense’s business, visit injectsense.com.
INJECTSENSE ADDS EXPERTS TO MEDICAL ADVISORY BOARD
EMERYVILLE, Calif., March 2, 2017 – Injectsense, Inc. an innovative medical device firm that develops sensor-enabled digital health systems to measure therapy effectiveness, announced today additional members of its medical advisory board. The board, which includes world renowned specialists and surgeons in the ophthalmic field, provides valuable feedback on device requirements, procedures, risk mitigation, and regulatory issues. Ophthalmology is the company's initial market.
New members of the medical advisory board include Richard Lindstrom, M.D., founding member and attending surgeon at Minnesota Eye Consultants; and Kuldev Singh, M.D., Professor of Ophthalmology and Director of the Glaucoma Service at Stanford University, who serves on the FDA Advisory Committee for Ophthalmic Devices. Other members of the medical advisory board include Dr. Myron Yanoff, M.D., author or co-author of 30 textbooks on ophthalmology including the standard textbook Ophthalmology; Dr. Arthur Sit, Associate Professor and Vice Chair of Ophthalmology at the Mayo Clinic; Dr. Iqbal "Ike" Ahmed, M.D., who developed the field of micro-invasive glaucoma surgery (MIGS); Dr. Ernesto Collazo, a leader in laser eye surgery and advanced technology in healthcare; Dr. Jason Bacharach, founder and director of research at North Bay Eye Associates, specializing in pharmaceutical and device studies; Dr. Stephen Sinclair, owner and director of Sinclair Retinal Associates and adjunct professor at the Drexel University School of Medicine; and Dr. William Daney, a clinical emergency medicine specialist, medical director and instructor, with a focus on cardiology.
"We are extremely fortunate to have secured the commitment and ongoing strategic feedback from highly recognized medical professionals who understand the urgent need for continuous monitoring and clinically actionable information," said Ariel Cao, CEO and president, Injectsense, Inc. "This continuous data, when filtered, will enable earlier treatment for progressive disease."
CAUTION - Investigational Device. Limited by Federal law to investigational use.