CELDA used for assessing the cerebrospinal fluid granted CE marking

Sep 4 2009

LinkMed’s (STO:LMED) portfolio company Likvor has been granted CE marking for its instrument for better and safer identification and diagnosis of Normal Pressure Hydrocephalus (NPH). The instrument, CELDA, was developed to assess the dynamics – pressure, flow and resistance – of cerebrospinal fluid (CSF) surrounding the brain and spinal cord. CELDA facilities greater understanding and enhanced diagnosis of NPH, a condition that is often mistaken for dementia. CE marking opens up the European market for the product.

CELDA(TM) is the first commercially approved instrument for assessing the flow of CSF fluid that surrounds the brain and spinal cord. It increases the possibility for patients who suffer from NPH to receive a correct diagnosis and therefore the appropriate treatment in the form of a shunt implant that diverts and regulates CSF pressure and flow. An accurate diagnosis means large gains for the patient and family, but also for society as a whole.

”CE marking is an important milestone for us at Likvor. Now we can offer the healthcare industry an instrument that will give them the opportunity to better help this patient group,” says Likvor’s CEO Kjell Öberg. “Today many people receive the wrong diagnosis and therefore also the wrong treatment. Correct diagnosis and treatment of NPH means that patients can make a complete recovery.”

Hidden disease of old age
Normal Pressure Hydrocephalus (NPH) is a relatively unknown disease that is often mistakenly diagnosed as dementia, Alzheimer’s or Parkinson’s. The is because the symptoms, including disturbances in gait, confusion and urinary incontinence, are similar to those of dementia, plus that NPH is a condition that mainly occurs in people over the age of 55.

Studies have shown that up to 10 percent of dementia patients may actually be suffering from NPH. In Sweden it is estimated that over 7,000 Swedes suffer from the disease – most of them unnecessarily. In the U.S., the corresponding figure is well over 375,000. NPH is a condition that is relatively easily treated by the insertion of a shunt, which helps the patient to regulate CSF flow and pressure. Patients receiving the correct diagnosis can resume a normal life after treatment. The leading shunt manufacturers Medtronic, Codman and Integra Life Science have all shunts for this patient group.

For better, safer diagnosis and follow up
CELDA makes it easy for doctors to assess CSF dynamics such as pressure, flow, conductance and resistance, which are factors that can be regulated by a shunt. Likvor’s instrument is the first commercially available instrument that provides a safe and easy way to assess CSF dynamics. This will help healthcare centers in the diagnosis of NPH and in the control of the functionality of a patient’s shunt. CELDA is the only instrument designed to verify the functionality of a shunt inserted into a patient as well.

The technology behind Likvor’s instrument is based on many years of clinical research at the Norrland’s University Hospital and Umeå University.

The instrument will be presented at the Hydrocephalus 2009 conference, September 16 - 19, in Baltimore, U.S. Hydrocephalus 2009 is the largest scientific conference in this field.