On this episode of Investor Connect, Hall welcomes Barry, who presents a medical device focused on improving treatment for hydrocephalus, a condition caused by excess fluid in the brain. Barry describes the current standard approach—ventricular-peritoneal shunts that drain fluid from the brain to the abdomen using a long rubber tube—and outlines key issues including infection, clogging, and siphoning that can over-drain the brain. He notes a 40% first-year reintervention rate, with roughly $1B in first-year reintervention costs and about $3B in annual overall health system costs, and explains that patients typically face a lifetime of revisions averaging about 10 surgeries. Barry explains their alternative approach, “physiologic shunting,” which drains cerebrospinal fluid into part of the venous system and is placed entirely on the cranium, avoiding the long-tube failure points.

The procedure is described as a 15–30 minute implant that can be done under local anesthesia, requires no navigation/robotics, uses standard neurosurgical tools, and is designed for constant, self-regulating flow. He positions the device as a Class II de novo/510(k) pathway and says the team has had two FDA pre-submission meetings, is currently in sheep animal studies, and plans a GLP study later in the year to support an IDE for human use. Barry shares market context: the U.S. hydrocephalus shunt market is about $170M annually with around 100,000 surgeries per year, including about 70,000 revisions; worldwide the market is about $500M. He argues a more reliable device could rapidly capture the revision market and notes the current market is dominated by Medtronic and Integra. He also discusses an additional opportunity in normal pressure hydrocephalus (NPH) in patients over 65, stating there are about 700,000 diagnosed in the U.S. and only 1% receive shunts despite symptom improvement. Barry states the company has raised $2.5M to date and is seeking an additional $2.5M via convertible note to reach a first-in-human pilot targeted around 2025, with initial offshore pilots potentially in South America or Australia.

Barry is a medical device industry professional who presents a cranial implant designed to simplify hydrocephalus management and reduce revision surgeries. He emphasizes the device’s ease of training for neurosurgeons, multiple cranial placement locations, and a “no bridges burned” approach where the implant can be removed and replaced through a small skin incision if needed. Barry describes a competitive landscape that includes one competitor pursuing an endovascular technique, while his team’s approach is a surgical technique intended to be safer, simpler, and not dependent on specialized equipment. He also discusses manufacturing readiness, stating a supplier/contractor has been identified and that devices used in animal studies meet sterility and related standards. Barry discusses the shortcomings of current shunts, the company’s physiologic shunting approach, the regulatory and study plan toward first-in-human use, the funding raise, and the market opportunity—especially capturing the large revision segment and potential expansion into normal pressure hydrocephalus. 

 

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Hall T Martin is the director of Investor Connect, which is a 501(c)(3) nonprofit dedicated to the education of investors for early-stage funding. All opinions expressed by Hall and podcast guests are solely their own opinions and do not reflect the opinion of Investor Connect. This podcast is for informational purposes only and should not be relied upon for the basis of investment decisions.