09.01.20

Injectsense Receives Breakthrough Device Program Designation From FDA for IOP Monitoring System

Source: Injectsense

Injectsense announced it has received a breakthrough device program (BDP) designation from the 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 5-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.

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, according to a company news release.

“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,” Richard Lindstrom, MD, founder and attending surgeon at Minnesota Eye Consultants, said in a company news release. “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. “With the BDP designation in hand, we look forward to moving on to in-depth animal and human studies.”

Regulatory Roadmap

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 +/- 1 mmHg 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 Mr. 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.

 

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