Press release

Malmö, Sweden December 17, 2018

Acarix reports first patient enrollment in new clinical investigation exploring heart failure detection

Acarix has initiated a new explorative clinical study to develop a diagnostic algorithm possibly leading to a new functionality for early detection of heart failure using the CADScor®System.

In the investigation, titled "Identification of heart failure patients by seismocardiography" (SCG-HF), a total of 200 patients referred on the suspicion of heart failure are planned to be consecutively enrolled at Aalborg University Hospital (AAU), Denmark and Odense University Hospital (OUH), Denmark. All patients will undergo a standardized assessment, including a clinical examination and echocardiography for assessment of structural heart disease.

"I have been involved from very early on in the concept study and now the larger exploratory study and I am impressed by the dedication to pursue a new solution for early identification of heart failure. Adopting an easy handheld medical device for early detection of heart failure could potentially save patients from the long period of uncertainty before diagnosis and treatment", said Professor Peter Søgaard, Aalborg University Hospital (AAU), Denmark.

Heart failure is a global pandemic affecting at least 40 million people worldwide and is increasing in prevalence. Due to this, the global economic burden of heart failure is estimated at more than $100 billon per annum. Moreover, large numbers of patients are treated for heart failure without a confirmed diagnosis. There is often a substantial delay from onset of symptoms to final diagnosis of heart failure.

Several reasons for this delay are obvious and include both referral delay from the general practitioner as well as delays in timing of appropriate specialist evaluation. Thus, there is a substantial need for a simple and reliable tool to guide the general practitioners in their evaluation of patients with impaired myocardial performance.

"Being able to investigate future applications of the CADScor®System is essential for maintaining a long-term pipeline. The commitment to adopt the Acarix technology to relevant clinical cardiac problems will only make our product even more relevant in doctors' offices," said Acarix's CEO Per Persson.

 

For further information, please contact:

Per Persson, CEO, E-mail: seppe@acarix.com, Phone: +46 73 600 59 90

About the study:

In the new explorative clinical investigation titled "Identification of heart failure patients by seismocardiography" (SCG-HF), a total of 200 patients referred on the suspicion of heart failure are planned to be consecutively enrolled to either Aalborg University Hospital (AAU), Denmark or Odense University Hospital (OUH), Denmark. All patients will undergo a standardized assessment including a clinical examination and echocardiography for assessment of structural heart disease. In addition, a blinded seismocardiographic measurement will be performed. Primary Investigators are Professor Peter Søgaard, MD and Professor Jacob Eifer Møller, MD. The first patients have been included into the clinical investigation, and the patient inclusion is expected to run for 12 months at the two clinical sites. A one-year post-inclusion period for data evaluation is expected.

 

About Acarix:
Acarix was established in 2009 and is listed on Nasdaq First North Premier. Acarix's CADScor®System uses an advanced sensor placed on the skin above the heart to listen to the sounds of cardiac contraction movement and turbulent flow. It has been designed to be an all-in-one system in the sense that the heart signal will be recorded, processed, and displayed as a patient specific score, the CAD-score, on the device screen. Readout is obtained in less than eight minutes. Safe and suitable for use in both out- and inpatient settings, the CADScor®System thus has the potential to play a major role in patient triage, avoiding the need for many patients to undergo stressful invasive diagnostic procedures. Wildeco Ekonomisk Information AB is the company's Certified Adviser. For more information please visit www.acarix.com.