Hotspur announces successful completion of GPSCath Catheter in peripheral angioplasty surgery

Hotspur Technologies, Inc. announced today that Dr. Greg Sampognaro, Interventional Cardiologist at P & S Surgical Hospital in Monroe, Louisiana, successfully completed the first use of the GPSCath™ Balloon Dilatation Catheter in an intervention to treat a blocked peripheral artery.  Successful use of the GPSCath Catheter in this type of procedure confirms the ability of this device to assist patients who suffer from peripheral arterial disease (PAD).

Hotspur's GPSCath Catheter, a two-in-one device that performs high-pressure angioplasty with a semi-compliant balloon, while also offering the ability to inject physician-specified fluids through Hotspur's proprietary VisioValve™ injection system, has already been commercially used in dialysis access procedures.  However, this expanded utilization of the device shows Hotspur's ability to target additional markets with devices that are already commercially available, while working within the devices' indications for use.

During the procedure, Dr. Sampognaro utilized a 6mm GPSCath balloon to cross and successfully dilate two high-grade stenoses in the patient's distal superficial femoral artery.  After this balloon inflation, the VisioValve system on the balloon was opened, and an angiogram was performed to assess the angioplasty results without requiring removal of the balloon or adjustment of the guidewire.  After subsequently placing a stent to treat the remaining blockage, Dr. Sampognaro reinserted the GPSCath balloon to further expand the stent before again utilizing the balloon's VisioValve system to inject contrast to perform the case's final angiogram.

"The ability to inject contrast through the catheter without having to remove the balloon from the artery or adjust the wire saved a lot of time, produced excellent contrast injection quality, and simplified the procedure overall," said Dr. Sampognaro.  He also added that the GPSCath's balloon exhibited "nearly instantaneous inflation and deflation unlike any previous balloon that I have used."

Today's case indicates Hotspur's entry into the PAD market, a rapidly growing market that affects one in five Americans 65 and older.  PAD-related treatments resulted in $21 billion in annual spending in the United States alone.  Hotspur's GPSCath device assists both patients suffering from PAD and physicians performing these procedures by combining multiple functions into a single device.  This multi-functionality can potentially enable cases to be completed more quickly by reducing the need for catheter exchanges, subsequently reducing patient's contrast and radiation exposure.

"This exciting use of the GPSCath Catheter shows Hotspur's ability to treat lesions in the peripheral vascular system," said Gwen Watanabe, President & CEO of Hotspur Technologies. "We look forward to expanding our presence in this growing market segment to enable more physicians and patients to benefit from this compelling technology."

The GPSCath Balloon Dilatation Catheter is one of three Hotspur devices that have received US Food and Drug Administration 510(k) clearance. The other commercially available products are the IQCath™ device, which allows the doctor to perform angioplasty, embolectomy, and fluid injection with the same catheter while maintaining guidewire position.  Hotspur has also received FDA 510(k) clearance on its Keeper™ Embolectomy Catheter, which is a specialty two-in-one device that integrates an embolectomy balloon with the ability to inject physician-specified fluids while maintaining guidewire position.

These three products are commercially available in the United States, and share the revolutionary foundation of Hotspur's proprietary VisioValve™ injection system. This unique system utilizes a custom-designed valve to allow users to inject physician-specified fluids. The Company plans to use this technology in a number of applications that will help both physicians and patients.