Garwood Medical Granted FDA Breakthrough Device Designation for Biofilm Tool

By Julie A. Vetalice

Garwood Medical Granted FDA Breakthrough Device Designation for Biofilm Tool

Garwood Medical Devices was granted a Breakthrough Device designation from FDA for the BioPrax™ device, a minimally invasive electrical stimulation tool in development to help eliminate biofilm infections on knee implants during early intervention procedures. Garwood plans to expand the technology for applications on all artificial joints, bone screws and plates.

Garwood uses a biofilm eradication technology that is licensed exclusively from the University at Buffalo. The device provides a low-voltage electrical treatment to the implant surface, creating an environment that kills bacteria associated with biofilm infections. Studies have shown that BioPrax reduced viability of clinical biofilms by up to 99.9%, in multiple combinations of bacterial strains and metal types.

Garwood holds U.S. Patent Number 9,616,142 for a technology that describes a method of reducing or preventing the growth of microbes on the surface of an object, where the object is made of such material that it can act as a working electrode. The method provides a counter electrode and a reference electrode. The object (such as the implant) is used as the working electrode. Electrical current is passed through the working and counter electrodes. The current through the counter electrode is varied such that the electric potential of the working electrode is constant relative to the electric potential of the reference electrode. (Also described in the patent is an apparatus for reducing or preventing microbes on an object using a potentiostatic device.)

The company has also developed the EnerAid® Wound Care Device, an active wound care bandage to stimulate healing. The wound care bandage can be monitored and controlled wirelessly.

Garwood Medical closed a $3.6MM Series A funding in 2016, and expects to close a $3MM Series B round by year-end.

Product Labels: Knee Replacement

Tags: Regulatory