Devices & Diagnostics, Diagnostics

Third Eye Diagnostics charts progress with noninvasive device to measure intracranial pressure (Updated)

Third Eye Diagnostics developed a handheld device to make the process of assessing intracranial pressure for the severity of traumatic brain injury and hydrocephalus easier and faster.

 

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This post has been updated to include an emailed comment from Terry Fuller, Third Eye Diagnostics CEO.

Third Eye Diagnostics developed a handheld device to make the process of assessing intracranial pressure for the severity of traumatic brain injury and hydrocephalus easier and faster.

CEO Terry Fuller reviewed the progress the company has made with its CerePress tool in an interview at the Mid Atlantic Diamond Ventures annual fall forum of technology and health tech startups in suburban Philadelphia. There, it sought to raise another $2.5 million to bring the device to market. The company has raised $2.81 million to date through investors including Ben Franklin Technology Partners of Northeast Pennsylvania, the National Science Foundation, and angel investors.

The device is designed to be an alternative to the current practice of drilling a hole in the skull and using a catheter to help assess intracranial pressure. CerePress measures blood pressure in the eye’s central retinal vein because there’s a high correlation to intracranial pressure. It also uses sterile disposable components to perform these tests.

The company is planning to do a safety study of the CerePress device at the Hospital for the University of Pennsylvania when it secures an investigational device exemption with the U.S. Food and Drug Administration.

CerePress device to measure intracranial pressure through the central retinal vein  by Third Eye Diagnostics

Third Eye’s handheld diagnostic device is designed to complement existing intra-cranial monitors, not replace them, Fuller noted. The value of its noninvasive device is that it can monitor changes in intracranial pressure so if a patient’s condition worsens, physicians can do more invasive tests. Early detection and intervention are critical to lowering death and disability rates.

Hospital emergency room staff are the initial market for the device, because they contain the highest number of brain injuries, Fuller said. When the device gains traction with emergency room physicians, Fuller believes it will be more readily embraced by first responders.

“Until we get traction in the ER, the first responder market will be tough,” Fuller said.

Update When Fuller talked about the CerePress device in 2013, Third Eye was preparing the groundwork to start clinical studies. In a follow-up email this week, he detailed a couple of the manufacturing setbacks experienced by the business that also offers a window into some of the fundamental technical challenges of developing novel medtech.

“We engaged several vendors who claimed the requisite skill, but they ultimately failed to deliver. In one instance, we required sensors that did not exist with the required specifications. In the end, we were forced to develop the needed components and assemblies internally. We gained a lot of expertise but lost a great deal of time and money,” Fuller said.

Third Eye’s business model involves using a medical device distributor network to sell its diagnostic tool to hospitals.

The company has plenty of competition with rivals enlisting technologies such as transcranial and transorbital doppler ultrasound, intracranial tissue resonance optic nerve sheath diameter, tympanic membrane displacement, biomarker assays and using data analysis, according to a Third Eye document.

So great is the competition to get a concussion detection device to market that some companies, under pressure from the FDA, have had to retract marketing claims such as SyncThink and

Photo: monsitj, Getty Images

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