Describe your device and how it will benefit healthcare.
A proprietary nanoparticle-coated protective face mask (disposable) with unparalleled, broad spectrum efficacy against harmful pathogens such as avian influenza (H9N2), Human influenza A (H3N2), S. Aureus (MRSA), S. Pneumoniae, H-flu, and swine flu.
Acutus Medical is developing the AcQMap High Resolution Imaging and Mapping System. This technology is able to create a real-time, 3-D map of the heart chamber to truly visualize the source of atrial fibrillation (AFIB).
AFIB is extremely difficult to treat due to antiquated mapping technologies. Currently, the rate of successful procedures (ablations) is around 50%.
AcQMap solves this by creating a more precise map of the heart that will inform more accurate treatment decisions on behalf of the physician. This has the potential to lead to better patient outcomes and reduced costs associated with repeat ablation procedures.
How does your product differ from the competition?
Complete and total eradication of these pathogens on the surface of the protective mask proven effective against these aerosolized pathogens.
AcQMap differs from other imaging and mapping systems like Topera, Carto, and NavX primarily due to its ability to accurately visualize the source of an arrhythmia. Presently, electrophysiologists (EPs) can only map the inside of the heart chamber with existing technologies by actually touching the heart wall with a catheter one location at a time. This limitation prevents them from truly seeing the AFIB in a complete, full-chamber, high-resolution view, leading them to treat the patient via an empirically-based approach versus an evidence-based approach. The key differentiator of the AcQMap System is its ability to truly map AFIB and other complex arrhythmias, identify the mechanism of those arrhythmias and provide a guide for ablation therapy. In addition, AcQMap can show the EP the effectiveness of the therapy in real-time. After the ablation has been delivered and upon the next heartbeat, a new complete map is rendered to confirm how the therapy changed the electrical pattern inside the heart. This real-time feedback loop can continue until the EP is satisfied that the therapy and the procedure have been successful.
Do you have customers yet?
Functional pilot plant to demonstrate the production scalabilty of NanoFense coating. Pilot launch in planning stages targeting Southeast Asia consumers and hospitals.
AcQMap received a CE Mark in May of 2016 and is currently being evaluated in the UNCOVER-AF trial, a multi center clinical study evaluating its efficacy in patients with persistent AFIB.
How much money have you raised?
Acutus has raised approximately $100M to date.
Who are your investors?
Private placement shareholders
Advent Life Sciences, Deerfield, GE Ventures, Index Ventures, OrbiMed, Undisclosed investor
What is the next milestone for your device?
Pilot product launch
Acutus is seeking FDA clearance of AcQMap in the second half of 2017. In addition, the UNCOVER-AF trial in Europe is underway and will be concluding in the second half of 2017.