For this week’s startup spotlight we spoke to Tom Clement, CEO of Aqueduct Critical Care, Inc. The Aqueduct Critical Care team is developing devices to manage acute and chronic Cerebral Spinal Fluid (CSF) problems.
Clement is a seasoned medical device veteran and has brought eight medical devices to market and started a number of medical device companies including Pathway Medical Technologies and Cardiac Insight. He recently helped launch the medical device incubator Mercury, an initiative of the Biomedical Innovation Partnership Zone in Bothell, Washington.
Challenging the Status Quo
Aqueduct’s technology is an innovation on traditional gravity fed temporary CSF drains. The technology currently used for drains is passive and largely unchanged for decades. Adjustments have to be made manually resulting in the need for constant monitoring from a skilled nurse. Aqueduct aims to change this industry standard.
“If a patient sits up as little as two inches and their CSF drain isn’t adjusted, it can make them sick, and from there they can go downhill pretty quickly,” explained Tom Clement.
Aqueduct’s technology, consisting of a single use Smart External Drain (SED) cartridge, and the SED console, eliminates the need for constant monitoring. The SED automatically adjusts for patient movement while maintaining the physician-prescribed settings. The technology will both increase the ease of use and safety when managing patients with external CSF drains.
The IP behind Aqueduct was spun out of the University of Washington in 2013. Aqueduct has since received FDA clearance, with two 510(k)s completed and a third in progress.
“In my 35 years of experience this is the fastest I’ve seen a product get into the clinic,” said Clement.
Due to the nature of the product, the FDA didn’t require clinical testing. However, Aqueduct is conducting its own post market study and is currently enrolling patients at multiple sites under a protocol that compares current technology to Aqueduct’s SED in a clinical setting.
A Market Changer
The CSF drain market is dominated by two companies with virtually the same technology. Aqueduct represents the first major change in gravity based CSF drains in 60 years.
“We expect [our SED] to become the standard of care for all patients being managed on temporary CSF drains. If someone gets sick on the current technology, and the hospital gets sued, they will be asked “why wasn’t the patient on Aqueduct technology?” claimed Clement.
Aqueduct is currently focusing on expanding its reach and confirming its value proposition for hospitals across the country.
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Image Credit: Aqueduct