NEW JERSEY - Wednesday, October 9th 2013 [ME NewsWire]
(BUSINESS WIRE) The electroceuticals healthcare company, electroCore, has expanded its portfolio of vagus nerve stimulation (VNS) delivery technologies by signing a development agreement with waveCore – the pioneers of externally powered VNS (xVNS) technology. waveCore has agreed to pay electroCore $14 million based on development milestones.
waveCore has the rights to a technology capable of transmitting both the signal and power from a transmitter outside the body to a miniature implanted vagus nerve electrode. waveCore, which initially secured the rights to the technology in May 2013, is a company owned by the founding shareholders of electroCore.
The first milestone payment of $2 million will be paid immediately to electroCore, to achieve the first in man pilot study. Following this milestone, a second $4 million payment will be made to achieve FDA approval of pivotal study, and the final $8 million will become due when a PMA approval is granted.
electroCore, a leader in the field of electroceuticals, developed a technological breakthrough in VNS through the production of a non-invasive vagus nerve stimulation (nVNS) device that patients use to self administer their therapy. Vagus nerve stimulation has been proven to release inhibitory neurotransmitters in the nervous system, including norepinephirine, serotonin and GABA, which are believed to play a pivotal role in a wide range of conditions including headache, bronchoconstriction, epilepsy, gastric motility disorders, depression and anxiety.
JP Errico, CEO of electroCore, explains the deal: “While our non-invasive vagus nerve stimulation is expected to be the answer for the majority of VNS-responders, for those patients who are not able to self administer the therapy waveCore’s technology offers an ideal minimally invasive option. There are also some patients who will require more frequent dosing of the therapy to be effective, which may become impractical with our hand held device. We want to be able to offer a complete set of solutions in the VNS area and this partnership helps achieve that goal”.
waveCore’s xVNS device comprises an implanted passive cuff electrode, to be placed around the vagus nerve, and a tiny receiver component. The surgical procedure to implant the device is a very simple percutaneous outpatient procedure which can be carried out under local anesthesia. The transmitter (which wirelessly powers the implanted receiver) is typically worn around the neck as a pendant, placed in a pocket, or clipped to clothing.
Compared with other surgical VNS systems, waveCore’s xVNS system is simple, straightforward and eliminates the requirement for surgical tunnelling of the leads and the creation of a pocket in the body for the implanted signal generation device. There is also no need for further surgical procedures to replace the batteries.
The transmitter is programmed according to each individual patient’s need from delivering 120 seconds of VNS therapy from once a day to every five minutes. By simply removing the transmitter from the proximity of the patient, the stimulation can be immediately terminated. An acute treatment can be triggered on demand by the simple press of a button.
The wireless power and signal transmitter is easily recharged at a recharging base which has a greater range of transmission – up to four feet – so that patients can sleep without having to wear the transmitter.
JP continues “As with our gammaCore non-invasive VNS device, which is simple to use and has brought the benefits of vagus nerve stimulation to the broader population of patients, waveCore’s xNVS technology will expand the availability of vagus nerve stimulation therapy among patients who require an automated delivery of their therapy”.
Simon Vane Percy