Nexeon Medsystems

vs.

PAVmed

Describe your device and how it will benefit healthcare.

Our Synapse system is a neurostimulation device based on precision lead stimulation with recording capabilities. This recording capability will enable adaptive neuromodulation which can be used to monitor disease progression and therapy efficacy; it eliminates the need for an iterative approach to pulse setting optimization and instead facilitates expedited, patient-specific programming that can be adapted to demand over time.

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.

How does your product differ from the competition?

Our device has 16 individually addressable stimulation channels and the ability to record with an industry leading signal to noise ratio.

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.

Do you have customers yet?

We have implanted the device in a patient suffering from Parkinson's Disease who has performed very well for nearly 4 years, we are also manufacturing devices for Galvani Bioelectronics (GSK) as part of their bioelectronics initiative.

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.

How much money have you raised?

$4.3M

PAVmed as a whole has raised approximately $10M since its founding in June 2014.

Who are your investors?

Boston Scientific, Surmodics, Abbott Ventures, Santa Maria Investments, Yorkville MGB Investments, Ballard Investments, Unidym, and HealthTech Wildcatters Fund 1

Two pre-IPO private placementa, $2.2M; IPO (Nasdaq:PAVM), $5.3M; post-IPO private placement, $2.5M

What is the next milestone for your device?

We hope to begin sales of the product in Europe in early 2018

FDA approval