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.

BENSALEM, PA, April 1, 2013 – NeuroDx Development has been awarded a $1 million, 2-year Phase II SBIR grant by the National Institute of Neurological Disorders and Stroke, a division of the National Institutes of Health (NIH), to support product development of Continuous Real Time ShuntCheck, an advanced version of the ShuntCheck thermal dilution test which allows for continuous monitoring of cerebrospinal fluid (CSF) shunt flow in hydrocephalus patients.

Hydrocephalus is a condition in which CSF accumulates in the brain. It is corrected by placing a shunt that drains excess CSF to the abdomen. Shunts frequently malfunction, potentially leading to brain damage and death. Diagnosis of shunt malfunction is expensive and presents risks such as exposure to radiation from CT Scans. Additionally, the clinical management of shunted patients is complex due to a lack of tools for investigating shunt function.

“Continuous Real Time ShuntCheck is like a ‘Holter Monitor’ for shunts, allowing physicians to monitor shunt flow over an extended period of time,” said NeuroDx founder and CEO, Frederick J Fritz. “Our clinical advisors have indicated that shunt flow monitoring will be useful in investigating a number of shunt function issues such as suspected overdrainage.”

“We are very grateful for NIH support for this project, allowing us to develop a new technology which can help physicians care for their hydrocephalus patients,” he said.

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

BENSALEM, PA, March 7, 2013 ‐ NeuroDx Development, a privately held medical device company, has received U.S. FDA 510(k) premarket notification clearance for the latest generation of its CSF shunt flow detection system, ShuntCheck III.

“FDA clearance of ShuntCheck III is a major milestone in the development of our technology,” said NeuroDx founder and CEO, Frederick J Fritz. “ShuntCheck III features an improved sensor and more user friendly software which runs on Windows 7 tablet or laptop computers, but most importantly, ShuntCheck III includes Micro-Pumper, a component which generates a temporary increase in shunt flow in patent but temporarily non-flowing shunts.”

“We are excited to bring this new, improved clinical tool to the US market later this year,” said Fritz.

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

BENSALEM, PA, October 15, 2012 – The National Institute of Neurological Disorders and Stroke, a division of the National Institutes of Health (NIH), has awarded a Phase I SBIR grant to NeuroDx Development to support the development of ICPCheck™, the first long term implantable, non-invasively readable intracranial pressure (ICP) monitor for hydrocephalus patients.

Hydrocephalus is a condition in which CSF accumulates in the brain. It is corrected by placing a shunt that drains excess CSF to the abdomen. Shunts frequently malfunction, usually by obstruction, leading to a life-threatening elevation of pressure in the brain. Diagnosis of shunt malfunction is expensive and presents risks such as exposure to radiation from CT Scans, and clinical management of shunted patients is complex due to a lack of tools for investigating shunt function.

“There are currently no non-invasive, non-radiologic technologies for detecting elevated ICP caused by shunt malfunction,” said NeuroDx founder and CEO, Frederick J Fritz. “ICPCheck, which will be placed during shunt surgery and can be interrogated non-invasively thereafter, will provide an important new clinical tool for investigating a number of shunt function issues. We are very grateful for NIH support for this project, allowing us to develop a new technology which can help physicians care for their hydrocephalus patients,” he said.

NeuroDx Develop (www.neurodx.com) is a privately held, development stage, diagnostic device company focused on addressing unmet clinical needs in the neurosurgery market. NeuroDx is headquartered in Bensalem, PA.

Celsion Announces Management and Board Appointments
Added Capabilities Support Maturing Development Program, Commercialization Efforts
COLUMBIA, MD — (MARKET WIRE) — 07/12/11 — Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced the appointment of Gregory Weaver, a Director of Celsion Corporation since 2005, to the role of Senior Vice President and Chief Financial Officer, and the promotion of Jeffery Church, currently Vice President and Chief Financial Officer, to the newly created role of Senior Vice President, Strategy and Investor Relations. Adding experience and depth to its Board, the Company also announced the appointment of Frederick Fritz as a Director. In joining the management team, Gregory Weaver resigned from Celsion’s Board. The appointments were effective on July 8, 2011.

Regarding the management appointments, Celsion President and Chief Executive Officer Michael H. Tardugno said: “These appointments leverage the strengths of two individuals who have shown enormous commitment and capability in their contributions to Celsion, adding greater depth of expertise to the management team as we approach a period of significant transformation at the Company. Greg brings a deep knowledge of Celsion and a wealth of financial expertise from his career as a financial officer in the biotech and healthcare industries, while Jeff, who has been instrumental in strengthening the Company’s balance sheet, will play a significant role supporting the execution of our business and commercial strategies as well as our commitment to our shareholders. We look forward to their contributions in their new roles.”

Regarding the Board appointment, Mr. Tardugno added: “I am delighted to announce the addition of Fred Fritz to our Board. Fred is an extraordinary talent who brings more than 30 years of executive and general management experience to Celsion’s Board, with expertise in financing, regulatory, and commercialization. He will be a trusted advisor for our management and Board members.”
“I am excited to join Celsion as a Director and look forward to the opportunity to work with the Company’s Board and executive management team,” noted Mr. Fritz. “I believe that the Company has an outstanding opportunity to deliver a paradigm-changing therapy to areas of significant unmet medical need in cancer. The promise of ThermoDox®, and the technology platform used to develop it, provides a base from which to build an enduring oncology drug development company.”

Mr. Fritz is currently the CEO & Founder of NeuroDx, a development stage diagnostic device company focused on the neurosurgery market. Mr. Fritz joined NeuroDx from Valeo Medical, a biotech company he founded in 2003 to develop the world’s first non-invasive diagnostic test for endometriosis. Prior to that, Mr. Fritz was President and CEO of Songbird Hearing, a medical device spin out of Sarnoff Corp. He is a University of Illinois engineer (summa cum laude) and a Harvard MBA. Mr. Fritz began his career in marketing management and new product development. He joined Schering Plough’s Wesley Jessen in 1985 as VP Marketing and Sales in 1986. He was promoted to general manager of Schering’s Over the Counter pharmaceutical business in 1988 and of the podiatric products business in 1990. He was President of Coleman North America from 1995-1997.

About Celsion
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has licensed ThermoDox® to Yakult-Honsha for the Japanese market and has a partnership agreement with Phillips Medical to jointly develop its heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.

For more information on Celsion, visit our website: http://www.celsion.com.

Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission.
Investor Contact

David Pitts

Argot Partners

212-600-1902

BENSALEM, PA, July 1, 2011 – NeuroDx Development has been awarded a $3 million, 3-year Phase II SBIR grant by the National Institute of Neurological Disorders and Stroke, a division of the National Institutes of Health (NIH), to support product development and clinical trials of the company’s non-invasive test of shunt function in hydrocephalus patients, ShuntCheck.

Hydrocephalus, a condition in which cerebrospinal fluid (CSF) accumulates in the brain, potentially leading to brain damage and death, affects 300,000 Americans and is associated with $2 billion in annual US healthcare costs. It is corrected by placing a shunt that drains excess CSF to the abdomen. Shunts frequently malfunction, usually by obstruction, but the symptoms of shunt failure are non-specific (headache, nausea). Diagnosis of shunt malfunction by conventional means is difficult, expensive, and associated with risks to the patient such as repeated exposure to radiation from CT Scans.

ShuntCheck was developed to provide an alternative method for testing shunt function, using thermal dilution technology to detect CSF flow in the shunt.  Initial clinical testing of ShuntCheck identified that shunts do not flow continuously, so ShuntCheck tests conducted during temporary periods of no-flow incorrectly suggest shunt problems.  To address this, NeuroDx developed the Micro-Pumper™, a non-invasive device which generates a temporary increase in CSF flow in patent, but not in occluded, shunts.  ShuntCheck can detect this increase in CSF flow and differentiate between flowing and blocked shunts.

NeuroDx founder and CEO, Frederick J Fritz, commented “This NIH grant will enable us to complete the development of Micro-Pumper and to conduct a multi-center clinical study to assess the accuracy and clinical utility of the ShuntCheck-Micro-Pumper test.  NeuroDx will undertake the study with collaborators at Children’s Hospital Boston, Johns Hopkins Hospital, University of Chicago Comer Children’s Hospital, Miami Children’s Hospital and LeBonheur Children’s Hospital.

“We are very grateful for NIH support for this project, which will allow us to bring forward an important clinical tool for the care of hydrocephalus patients” he said.

NeuroDx Develop (www.neurodx.com/) is a privately held, development stage, diagnostic device company focused on addressing unmet clinical needs in the neurosurgery market.  NeuroDx is headquartered in Bensalem, PA.

BENSALEM, PA, April 22, 2011 – The National Institute of Neurological Disorders and Stroke, a division of the National Institutes of Health (NIH), has awarded a Phase I SBIR grant to NeuroDx Development to support the development of Continuous Real Time ShuntCheck, an advanced version of the ShuntCheck thermal dilution test which allows for continuous monitoring of cerebrospinal fluid (CSF) shunt flow in hydrocephalus patients.

Hydrocephalus is a condition in which CSF accumulates in the brain. It is corrected by placing a shunt that drains excess CSF to the abdomen. Shunts frequently malfunction, potentially leading to brain damage and death. Diagnosis of shunt malfunction is expensive and presents risks such as exposure to radiation from CT Scans, and clinical management of shunted patients is complex due to a lack of tools for investigating shunt function.

“Our first generation ShuntCheck only partially addresses this clinical need because it provides a five minute “snap shot” assessment of CSF shunt flow.” said NeuroDx founder and CEO, Frederick J Fritz.  “Continuous Real Time ShuntCheck will monitor shunt flow over an extended period of time – like a “Holter Monitor” for shunts.  Our clinical advisors have indicated that shunt flow monitoring will be useful in investigating a number of shunt function issues.”

“We are very grateful for NIH support for this project, allowing us to develop a new technology which can help physicians care for their hydrocephalus patients” he said.

NeuroDx Develop (www.neurodx.com/) is a privately held, development stage, diagnostic device company focused on addressing unmet clinical needs in the neurosurgery market.  NeuroDx is headquartered in Bensalem, PA.

BENSALEM, PA, March 21, 2011 – The National Institute of Neurological Disorders and Stroke, a division of the National Institutes of Health (NIH), has awarded a Phase I SBIR grant to NeuroDx Development to support a clinical study of ShuntCheck in Normal Pressure Hydrocephalus (NPH) patients.

NPH, a buildup of cerebrospinal fluid (CSF) in the brain, afflicts an estimated 700 thousand older adults in the US, causing gait impairment, urinary urgency and incontinence. It is corrected by placing a shunt that drains excess CSF to the abdomen. Shunts frequently malfunction, leading to the insidious return of the original symptoms over an interval of weeks to months, making shunt failure challenging to diagnose. Suspected shunt failure in NPH patients is typically investigated using a radionuclide shunt patency study, an invasive and expensive procedure which carries the risk of infection.

ShuntCheck was developed to provide an alternative method for testing shunt function, using thermal dilution technology to detect CSF flow in the shunt.

“This NIH grant funds a clinical study which will compare ShuntCheck with the radionuclide shunt patency study in assessing shunt function in NPH patients” said Frederick J Fritz, NeuroDx founder and CEO.  “If the study demonstrates that ShuntCheck provides comparable accuracy, it will support clinical use of our non-invasive option to the current gold standard” he said.  NeuroDx will undertake the study with Michael A. Williams MD FAAN and his colleagues at Sinai Hospital of Baltimore.

“We are very grateful for NIH support for this study, which will provide important information to neurosurgeons who care for Normal Pressure Hydrocephalus patients” he said.

NeuroDx Develop (www.neurodx.com/) is a privately held, development stage, diagnostic device company focused on addressing unmet clinical needs in the neurosurgery market.  NeuroDx is headquartered in Bensalem, PA.

BENSALEM, PA, May 6, 2010 – NeuroDx Development has been awarded a 2-year Phase I SBIR grant by the Eunice Kennedy Shriver National Institute of Child Health & Human Development, a division of the National Institutes of Health (NIH), to support product development and clinical testing of ShuntCheck, the company’s non-invasive test of shunt function in hydrocephalus patients.

Hydrocephalus is a condition in which cerebrospinal fluid (CSF) accumulates in the brain, potentially leading to brain damage and death. It is corrected by placing a shunt that drains excess CSF to the abdomen. Shunts frequently malfunction, usually by obstruction, a life threatening medical condition. Shunt malfunction in children is usually diagnosed by a CT Scan of the brain.  Repeated exposure to radiation from CT Scans has been a growing concern for pediatric neurosurgeons,

This concern was the driving force for the development of ShuntCheck as an alternative method for testing shunt function, using thermal dilution technology to detect CSF flow in the shunt.

Frederick J Fritz, NeuroDx founder and CEO, commented “This NIH grant supports important product development and clinical validation work including a clinical study comparing ShuntCheck with an MRI-based test of shunt flow, a study of shunt flow intermittency and the development and initial testing of “Micro-Pumper”, a non-invasive device which temporarily increases shunt flow and which will be used in conjunction with ShuntCheck.  NeuroDx will collaborate with Joseph R, Madsen MD and his colleagues at Children’s Hospital Boston on this program.”

“We are very grateful for NIH support for our work to create clinical tools for the care of children with hydrocephalus” he said.

NeuroDx Develop (www.neurodx.com/) is a privately held, development stage, diagnostic device company focused on addressing unmet clinical needs in the neurosurgery market.  NeuroDx is headquartered in Bensalem, PA.

The Bensalem, Pa., company plans to use the funding to help improve the treatment of patients with hydrocephalus, which is essentially “water in the brain” that can exist because of a birth defect or as the result of brain injury.

Patients with hydrocephalus are treated with an implanted shunt that drains fluid from their brain. The shunts, however, eventually fail. That failure currently can only be detected by a CAT scan and repeated CAT scans expose patients to additional levels of radiation.

NeuroDx is developing a non-invasive, alternative method to test that a shunt is still functioning properly, without exposing a patient to potentially harmful levels of radiation. The company is also developing a device to help doctors diagnose brain injury by non-invasively measuring intracranial pressure.

“This grant supports the vital research that NeuroDx is conducting to help those suffering from this brain condition, as well as supporting employment in this cutting-edge field,” said U.S. Rep. Patrick Murphy, D-Bucks, who helped the company secure the funding. “The work they are doing will improve the treatment safety for the 1.4 million Americans who currently suffer from traumatic brain injury every year.