Hydrocephalus is the most common childhood brain disorder, affecting 1 in 500 children worldwide, and an additional one million adults suffer from adult-onset hydrocephalus. The most common course of treatment is a ventriculoperitoneal shunt, but these shunts have a 70% failure rate over a patient’s lifetime. Symptoms of shunt failure are extremely vague, including fever, headache, and vomiting. Doctors struggle to diagnose shunt malfunctions without ordering multiple CT scans, MRIs, or performing exploratory brain surgery. Not only are these procedures expensive, risky, and expose the patient to radiation, they may be unnecessary if the shunt is not the source of the symptoms. Doctors need a way to non-invasively and definitively diagnose a shunt malfunction, and that is why the CatheSure was created.
The CatheSure consists of two electronic modules that are integrated into the shunt system, and an external device. One internal module contains a pressure sensor, which detects the intracatheter pressure and wirelessly transmits this data via a second electronic module located just below the skin at the clavicle. The physician holds the external receiver to the patient’s clavicle, and a pressure value will be displayed on the screen within five minutes. If and when a patient returns with vague symptoms, potentially a shunt malfunction, the physician will use the CatheSure to reach a definitive diagnosis in under five minutes.
The current shunt market is valued at over $300 million with a 2.8% CAGR. With 30,000 shunts placed each year and the 70% failure rate, there is a high market potential for the CatheSure, especially given the lack of comparable competitor devices. The leading competitor is the Camino ICP monitor, which is wired, requires an additional implantation surgery, and can only be used for four days due to electronic drift. Due to the lack of additional surgeries and the lifelong, wireless nature of the CatheSure, it represents a significant improvement over current devices.
We plan to partner with an existing shunt manufacturer to streamline the testing and manufacturing process. This allows for faster time to market, an increase in production, and a decrease in costs. Additionally, this allows the CatheSure to be integrated into the shunt during production and be sold as one cohesive unit to physicians.
The CatheSure costs approximately $5,000 per device. This replaces up to $6,000 in CT scans per year that the average patient would receive. Within one year, the CatheSure pays for itself.
Several verification tests have been performed with a 90% success rate. Additionally, a physician validation test reported that 83% of the physicians believed the device would be extremely easy to integrate into the shunt diagnosis process, and 100% of physicians found the CatheSure to be extremely useful for shunt malfunction diagnosis.
With the CatheSure, patients avoid up to $100,000 in hospital costs, any additional implantation surgeries, risks due to exploratory brain surgery, and repeated radiation exposure. With a decrease from 5 hours to 5 minutes - patients get a diagnosis 98% faster. Be sure, with the CatheSure.