Electro-detox

Non-addictive and non-implantable medical device for opiate and opioid withdrawal pain.

Non-drug solution for opiate (heroin) and opioid (oxycontin, methadone, suboxone) addicts needing help during detoxification.

Introducing
Electro-detox
by Soterix Medical

The Electro-Detox System is a FDA cleared percutaneous electrical nerve field stimulator (PNFS) for use in helping to reduce the symptoms of opioid withdrawal. The Electro-Detox device is a battery-powered wearable device placed behind the patient’s ear that emits electrical pulses to stimulate branches of certain cranial nerves. Patients use for the device for up to five (5) days during the acute physical withdrawal phase. In the study leading to marketing approval, patients reported a symptom reduction of 62.7% within 20 minutes of using the device. After five days of using the device, 88% transitioned to medication assisted therapy (MAT).

Immediate effect

62.7%

symptom reduction in 20 min

84.6%

symptom reduction in 60 min

97.1%

symptom reduction in 5 days

Transition to MAT

88.8%

of patients transitioned to secondary therapy (like long-term injectable naltrexone)

The compelling electro-detox advantage

It is known that discontinuation of opioid use by an opioid-dependent patient first requires an induction-phase with medical supervision to effectively control symptoms. Then a successful supervised withdrawal is needed to safely and successfully transition the patient to medication assisted treatment. Drugs have been the only option for the induction-phase treatment but have shown varying degrees of success. Furthermore, expanding treatment options for opioid addiction have been held back due to limited percentage of licensed physicians that can prescribe pharmacotherapy and prescription of certain opioid receptor antagonists is only possible after satisfactory completion of medically supervised withdrawal due to risk of precipitated withdrawal. As a result, only ~18% of patients with opioid use disorder receive specialty treatment. Electro-detox effectively increases access as it: requires minimal training and is therefore not only available to physicians but physician extenders, removes fear of inducing precipitated withdrawal, has basically no side-effects, and is cost-effective.

What is opioid withdrawal?

Opioid withdrawal causes acute physical withdrawal symptoms including drug craving, anxiety, sweating, gastrointestinal upset, agitation, insomnia joint pain, diaphoresis and tachycardia.

What is PNFS (percutaneous electrical nerve field stimulator)?

PNFS utilizes acupuncture-like needle probes positioned in the soft tissues and /or muscles to stimulate nerves. The procedure is similar to TENS, but involves the insertion of electrode needles underneath the skin. Once the needles are inserted they are connected to a stimulator device with appropriate settings.

Device Description

Electro-Detox is a wearable, light-weight (6 gm), battery-operated device that is designed to administer periodical weak current pulses to the ear over five days / 120 hours (2 hours ON / 1 minute OFF) from the time of activation of the device. These pulses are delivered to the branches of cranial nerves on the ear through a set of four stimulation needles and wire assembly. The device is powered by three zinc air batteries that provide the required energy for a maximum of 120 hours. Three stimulation needles are inserted at three specific points while the ground electrode is inserted at one specific point which forms the functional earthing to the device.

How does it work for opioid withdrawal?

The auricular branches of four cranial nerves (V,VII, IX and X) in the external ear have projections to the brainstem, in particular, the nucleus tractus solitaris (NTS). Electro-detox therefore probably modulates the NTS which broadcasts to higher brain structures involved in autonomic control and nociception, including the rostral ventral medulla, hypothalamus and the amygdala. The amygdala regulates fear and is a key component in reward-seeking behavior related to addiction.

Contraindications

The device is contraindicated for patients with cardiac pacemakers or similar biomedical implants, during pregnancy (unless medically advised), patients with hemophilia, patients diagnosed with psoriasis vulgaris, or patients with diminished mental capacity or physical competence about the handling of the device.