Endonovo Therapeutics Inc (ENDV)

[Biotech_Tradez]

Electroceuticals: the 'bonkers' gamble that could pay off for GlaxoSmithKline

“Maybe over the next 12 months we’ll have one [a device],” Famm tells the Guardian in an interview at Galvani’s base in Stevenage, Hertfordshire. It will then be tested in initial human trials involving five to 10 people. The device must be easy to implant in the body via keyhole surgery, as well as being leak- and corrosion-proof and with enough battery power to avoid frequent charging.

The fact that it is an implant will always make it inferior to wearable, non-invasive devices like ENDV's

Famm believes in a “brave new future” that will mean bioelectronics becomes a mainstay of medical treatment over the next two decades, benefiting up to 2 billion people – a quarter of the global population – who are suffering from chronic diseases. He likens it to the way mobile phones have changed our lives in the past 20 years.

GSK is the only big pharma company working on the development of bioelectronics, and is competing with a number of smaller firms. Critics argue that bioelectronics is too risky, will take too long and is “a bit bonkers”.

Aside from developing the implantable devices, the other major challenges include mapping the nervous system and understanding which nerves control bodily functions. Famm says some progress has been made but much more work needs to be done.

Bioelectronic devices in the form of a cuff, bristling with electrodes, will be attached to nerve bundles to alter the electrical signals sent between the brain and the other organs in the body. Initially they are likely to be the size of a pill or a pen, but the aim is to make them as small as a grain of rice.

Essentially, it’s a matter of rewiring the body if signals go awry, Famm explains, describing the nervous system as a “switchboard with phone cables going out to different houses”.

“Think of it as a little volume control on a nerve that controls an organ like the liver, pancreas, kidneys or spleen,” he says. “By changing the volume, the signals that go into the nerve, up or down, you can control what the organ does: whether it produces less or more of a particular hormone or affects the constriction of the airways.”

A better way is to stimulate the entire organ from outside using an electromagnetic field, which itself creates a small electric field in the organ or tissue targeting the inflammatory response.

“Most people who get into devices don’t realise how difficult it is to get to a human trial. There are so many issues you have to worry about. For our first trial we sent 14 boxes of paper off to the FDA [US drug and device regulator] ... And if it works in animals it doesn’t mean it works also in humans.”

Good thing ENDV is not pursuing an implant that automatically puts it into Class III, which requires a lengthy PMA rather than a 510(k) or a De Novo reclassification into Class II. Bottom line is that GSK has nothing as evidenced by my post on them licensing Enteromedics' vagus nerve stimulator to conduct pre-clinical studies.