Describe your device and how it will benefit healthcare.
PAVmed is a multiproduct medical device company founded in June 2014 with a robust pipeline of 6 products. One of our most exciting products is CarpX a percutaneous device to treat carpal tunnel syndrome (CTS). CTS is the most common cumulative trauma syndrome and accounts for billions of dollars of workman's compensation and lost productivity annually. Each year 600,000 patients undergo invasive carpal tunnel surgery and over 1M are diagnosed but choose to avoid surgery and suffer in silence. Traditional open surgery, which involves cutting the transverse carpal ligament (TCL) in the hand to eliminate pressure on the nerve, typically requires months of recuperation. The endoscopic approach remains invasive and has had limited penetration due to higher nerve injury and incomplete transection rates.
CarpX is a purely percutaneous, transcatheter device to treat CTS by transecting the TCL without the need for open surgey. The device consists of a balloon catheter with a pair of bipolar radiofrequency cutting electrodes. The balloon is inserted through a puncture in the forearm and advanced over a wire so that it is positioned and inflated within the carpal tunnel using ultrasound and fluoroscopic guidance, creating tension in the TCL at the point of OF contact with the electrodes. This also pushes the nerve and tendons away from the electrodes. After a brief stimulation protocol to confirm the above, the cutting electrodes are activated for several seconds. Complete cutting is confirmed flourscopically and by monitoring a drop in the balloon pressure.
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?
As a strictly percutaneous device it does not require a surgical incision and the associated recuperation. We expect the recover period to be on the order of days to weeeks instead of months. We also expect fewer complications and more effective cutting as a result of the ballon inflation distracting critical structures and generation greater lateral dissection than the open surgical approach. We also expect it to be more cost effective by shifting care to less expensive venues--initially the interventional suite and eventually the office setting.
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?
The product is in presubmission verification and validation testing. It has been utilized successfully in dozens of cadavers, effective and consistently cutting the ligament in a 10-15 min procedure.
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?
PAVmed as a whole has raised approximately $10M since its founding in June 2014.
Acutus has raised approximately $100M to date.
Who are your investors?
Two pre-IPO private placements, $2.2M; IPO (Nasdaq:PAVM), $5.3M; post-IPO private placement, $2.5M
Advent Life Sciences, Deerfield, GE Ventures, Index Ventures, OrbiMed, Undisclosed investor
What is the next milestone for your device?
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.