Normally, cerebrospinal fluid (CSF) surrounds our brain and spinal cord, providing numerous benefits from injury protection and nutrient delivery to waste removal. Hydrocephalus, or “water on the brain,” occurs when this this fluid is obstructed, poorly absorbed, overproduced, or unable to drain properly. While hydrocephalus is treatable with endoscopic third ventriculostomy surgery or shunt implantation, around 40% of hydrocephalus shunts fail by the end of the first year, reaching 98% within 10.

According to Penn State News, a startup organization called Cranial Devices Inc. (CDI) is working to improve treatment efficacy and accessibility for patients with normal pressure hydrocephalus (NPH). Together, Barry Fell and Dr. Randy Haluck formed CDI to advance treatments and research within this field. The pair, alongside Dr. Sprague Hazard and Dr. Elias Rizk of the Penn State College of Medicine, created the HydroFix technology to address the current shunt failures and improve patient outcomes.

Cranial Devices Inc. (CDI)

For years, Fell and Haluck have worked to improve treatments within the medical realm. In addition to CDI, the pair also created SIG Medical Corporation. In 2016, Fell and Haluck created novel technology allowing doctors to fix broken or damaged ribs in a less invasive way. By 2019, the pair had commercialized this device, now used by Zimmer-Biomet.

In November 2020, Fell and Haluck co-founded CDI. For their first project, they focused on creating more effective therapies for patients with NPH. Since currently available shunts have such a high rate of failure, nearly 3/4 of patients require additional surgical interventions within the first year of their shunt placement. Thus, the pair sought to create a new CSF drain that is:

• Safer
• More durable and long-lasting
• Cost-effective
• Designed to reduce the current risks and complications associated with currently-available shunts, such as CSF overdrainage

Recently, CDI participated in the 2021 Invent Penn State Venture & IP Conference Tech Tournament. Altogether, eight innovative and early-stage startups participated. During the tournament, each company had the opportunity to pitch its technology to a panel of three judges. Ultimately, CDI came out on top, with its novel CSF drain gaining the company $75K in funding.

Moving forward, CDI hopes to license the HydroFix technology from Penn State so that the technology can be brought to market. In doing so, CDI could potentially fulfill an unmet need in patients with hydrocephalus. Additionally, the company will participate in the 2021 Board of Advisors program, headed by the Startup Leadership Network. Ultimately, this will allow Fell and Haluck to gain mentorship and assistance, as well as to build their own knowledge.

Hydrocephalus

Normally, CSF flows through ventricles (brain cavities), providing a host of benefits to the brain and spinal cord. Hydrocephalus occurs when this CSF is imbalanced (either overproduced or under absorbed), causing excess fluid accumulation. Ultimately, this places additional pressure on the brain, causing health issues and (in some cases) brain damage. Typically, those affected by hydrocephalus are either infants or older adults. Because of this, signs, symptoms, and even onset appear differently. In infants and children, hydrocephalus symptoms include:

• Irritability
• Extreme sleepiness
• An unusually large head OR a rapidly increasing head size
• Bulging or tense spot on the top of the head
• Vomiting
• Eyes fixed downward
• Failure to thrive
• Poor coordination
• Loss of muscle tone
• Seizures

In infants and young children, hydrocephalus is usually congenital or acquired. Alternately, in older adults, patients usually have NPH. Symptoms include:

• Memory loss
• Changes in balance and coordination
• Vision impairment
• Loss of bladder control and/or frequent urination
• Headache
• Changes in vision (blurring, double vision)
• Nausea and vomiting
• Developmental regression
• Poor balance and coordination
• Irritability
• Changes in behavior and personality
• Difficulty walking

Learn more about hydrocephalus.