YARDLEY, PA  May 27, 2020 – The results of a clinical study conducted by Dr. Joseph R. Madsen and co-investigators was published in Neurosurgery (published online ahead of print, 2020 May 27).  The article can be found at https://academic.oup.com/neurosurgery/advance-article/doi/10.1093/neuros/nyaa128/5847860.

This ten-center, 406 subject study evaluated ShuntCheck, which uses thermal dilution technology to detect flow in the CSF shunts of hydrocephalus patients, as a rule-out test for suspected shunt obstruction.

The two-arm study tested alternative ShuntCheck protocols – one including a shunt flow-enhancing technology and one which evaluated natural, unenhanced flow.  The “Natural Flow” method proved to be superior with 100% Sensitivity,  100% Negative Predictive Value in ruling out the need for shunt revision surgery and non-inferiority to neuro-imaging.

The study concluded that ShuntCheck can be used in conjunction with clinical judgment to rule out shunt malfunction and reduce the need for imaging, admissions for observation and invasive testing in symptomatic pediatric hydrocephalus.

“We thank Dr. Madsen and his colleagues for their commitment to this study,” said Frederick J. Fritz, NeuroDx founder and CEO. “These results support the use of ShuntCheck as a confirmatory Rule Out test for symptomatic pediatric hydrocephalus patients,” he said.

NeuroDx Development (www.neurodx.com) is a privately-held diagnostic device company focused on addressing unmet clinical needs in the neurosurgery market. NeuroDx is headquartered in Yardley PA.

YARDLEY, PA  July 2, 2018 – The results of a clinical study conducted by Drs. Mustafa Q. Hameed, Joseph R. Madsen and their colleagues at Boston Children’s™ Hospital was published in Neurosurgery (Neurosurgery 0:1-10, 2018).  A summary of the article can be found at https://doi.org/10.1093/neuros/nyy246​.

This single-center, 71 subject study found that ShuntCheck, which uses thermal dilution technology to detect flow in the CSF shunts of hydrocephalus patients, had a 94.2% Negative Predictive Value in ruling out the need for shunt revision surgery.  Importantly, the three “false negative” surgery patients did not have obstructed shunts – one was a case of symptomatic over-drainage, another required valve replacement following mechanical failure of an adjustable shunt, and the third required repair of a detached Rickham reservoir.  ShuntCheck therefore demonstrated 100% Sensitivity and 100% Negative Predictive Value for ruling out shunt obstruction.

The Boston study preceded and informed the prospective, multi-center ShuntCheck Pediatric Outcomes Study.  The multi-center study, which was reported at the AANS Plenary Session, also found that ShuntCheck, when used in conjunction with physician judgment or imaging results, was 100% accurate in ruling out shunt obstruction.  The study concluded that ShuntCheck can reduce the need for CT Scans, Admissions for Observation and invasive testing in symptomatic pediatric hydrocephalus.

“We thank Drs. Hameed and Madsen and their colleagues for their dedication to this study,” said Frederick J. Fritz, NeuroDx founder and CEO. “These results and the results of the larger ShuntCheck Pediatric Outcomes Study support the use of ShuntCheck as a confirmatory Rule Out test for symptomatic pediatric hydrocephalus patients,” he said.

NeuroDx Development (www.neurodx.com) is a privately-held diagnostic device company focused on addressing unmet clinical needs in the neurosurgery market. NeuroDx is headquartered in Yardley PA.

CHICAGO IL May 5, 2016 – Dr. David M. Frim, Chief of Neurosurgery at The University of Chicago Medical Center and a Principal Investigator of the ShuntCheck Pediatric Outcomes Validation Study, presented final study findings in a Plenary session at the American Academy of Neurological Surgeons (AANS) annual conference.

ShuntCheck, a non-invasive test for CSF flow in shunted hydrocephalus patients, achieved its clinical study endpoints. The prospective, blinded multi-center study demonstrated that ShuntCheck was equal to neuroimaging in ruling out shunt obstruction in symptomatic pediatric patients clinically judged “unlikely to require surgery” and showed that concordant ShuntCheck-plus-Imaging results were more accurate than Imaging-alone results.

“Our study indicates that ShuntCheck can reduce the need for CT Scans, Admissions for Observation and invasive testing in symptomatic pediatric hydrocephalus,” said Dr. Frim. “I should disclose that I was a skeptic when I first heard of the ShuntCheck technology but I must be true to the data and admit that my concerns were unfounded.”

“ShuntCheck was honored to be chosen for a Plenary presentation. 1500 abstracts were submitted to the AANS but only 13 were chosen for the Plenary. We thank Dr. Frim and Dr. Joseph Madsen for preparing the winning abstract and Dr. Frim for presenting study findings,” said Frederick J Fritz, NeuroDx founder and CEO. “Positive study results support the use of ShuntCheck as a first line diagnostic test in Children’s Hospitals,” he said.

NeuroDx Development (www.neurodx.com) is a privately held diagnostic device company focused on addressing unmet clinical needs in the neurosurgery market. NeuroDx is headquartered in Yardley PA.

PRINCETON, NJ January 14, 2016 – Dr. Joseph R. Madsen, Pediatric Neurosurgeon at Boston Children’s Hospital and the Principal Investigator of the ShuntCheck Pediatric Outcomes Validation Study, presented interim findings (280 patients) at the American Society of Pediatric Neurosurgeons (ASPN) annual meeting.

ShuntCheck, which uses thermal dilution technology to detect flow in the CSF shunts of hydrocephalus patients, achieved its two clinical study endpoints. The prospective, blinded multi-center study demonstrated that ShuntCheck was equal to neuroimaging in ruling out shunt obstruction in symptomatic pediatric patients clinically judged “unlikely to require surgery”. It also showed that concordant ShuntCheck-plus-Imaging results were superior to Imaging results.

“These results suggest that adding ShuntCheck to the shunt malfunction diagnostic protocol can reduce the need for CT Scans, Admissions for Observation and invasive tests” said Dr. Madsen.

“We are very grateful to Dr. Madsen for his leadership and to investigators at nine other US Children’s Hospitals for their dedication to this study,” said Frederick J Fritz, NeuroDx founder and CEO. “These positive interim results support the use of ShuntCheck as a diagnostic tool for physicians who care for children with hydrocephalus,” he said.

NeuroDx Development (www.neurodx.com) is a privately held diagnostic device company focused on addressing unmet clinical needs in the neurosurgery market. NeuroDx is headquartered in Yardley PA.