Imaging support for cardiac stemcell therapy
CARTBox is an imaging technology developed to optimize the targeting of stem-cell therapy for patients with e.g. end-stage heart failure who otherwise might require cardiac transplantation. Stem-cell products are currently under development for direct administration into the heart using dedicated catheters which are inserted in a peripheral artery. However, the accuracy and efficiency of the current cardiac stem-cell techniques is low and CARTBox has been designed to improve the procedure in a number of ways.
CARTBox integrates standard medical imaging techniques (e.g. MRI and fluoroscopy) to identify therapeutic delivery sites in the border zone between infarcted and healthy tissue in the heart. The technology provides combined visualization of the target areas and the myocardial catheter during injection procedures in a single screen. No additional hardware is required, which is perceived as a great advantage over currently used techniques. Also, the total procedure time can be limited by more than 50%.
The company is well on track to get regulatory approval for CARTBox as a medical device In the EU under the CE mark system later this year. Research co-operations are ongoing with Philips Research and Cook Medical Technologies LLC in the areas of imaging and (cardiac) catheter technology respectively.
Imaging support for CRT placement
The company is also developing CARTBox as an imaging technology for the placement of high-end cardiac pacemakers, so-called CRT (Cardiac Resynchronisation Therapy) devices. In this area, CART-Tech can reach the stage of market introduction earlier than for the stem-cell area.
We estimate that the current market of CRTs worldwide has a value of over € 1.5 Billion. While this is generally considered as a standard and effective therapy, only 45% of patients undergoing the procedure will not respond to therapy due to incorrect placement of the device. Considering the price of about € 24.000 per treatment (in the Netherlands) a large amount of resources is currently wasted.
Selecting the optimal site for CRT is currently a more or less a trial and error process and CARTBox can add a lot of value for patients, hospitals and companies active in this field by combining information acquired from standard medical imaging, and make the procedure more accurate and reproducible and less time consuming.
The aim is to place the CRT device in a coronary vein in an area of the heart with a delayed contraction in comparison to neighboring tissue. Targeting this area will result in a more synchronous contraction and a better pump function of the heart.
In addition, when placing the CRT, areas like the infarcted issue and its border zone are to be avoided.
CARTBox includes both aforementioned features as obtained from MRI and
this data is combined with fluoroscopy data from a venogram (to visualize the catheter and the vein selected for placement) in a single screen. This will facilitate the CRT placement procedure, making it more effective and safe with a shorter procedure time.
A first pilot clinical study will start at UMC Utrecht in the second half of 2016 with Dr. Mathias Meine as the Principle Investigator, with the aim to provide first clinical proof-of-principle for CARTBox.