The S.T. Genesis is a percutaneous nerve field stimulator that supports the reduction of opioid withdrawal symptoms by targeting the areas of the brain responsible for pain and anxiety. The device is applied behind the ear and connects to the branches of the cranial nerves V, VII, IX, X, and the occipital nerves. The noninvasive lightweight device administers treatment for 120 hours or five days.
Despite extensive research regarding the addictive properties of opioid medications, the number of opioid overdose-related deaths continues to plague the country. The CDC reported 93,000 overdose deaths in 2020 and no sign of slowing down in 2021. The experts cited lockdowns and other pandemic restrictions, which isolated those with drug addictions and made treatment harder to seek.
The opioid epidemic cost the U.S. economy at least $631 billion from 2015 to 2018, according to The Society of Actuaries' analysis of non-medical opioid use during this timeframe. Many people seeking treatment for opioid addiction are unsuccessful due to severe withdrawal symptoms that may relapse. These inherent challenges lead many to seek non-opioid drug treatments to break the cycle of addiction—this is where the S.T. Genesis can help.
Neuromodulation with percutaneous electrical nerve field stimulation is associated with a reduction in the signs and symptoms of opioid withdrawal in a multisite, retrospective assessment.
Percutaneous Nerve Field Stimulation is a low-risk, non-invasive therapy that has been shown to reduce opioid withdrawal symptoms and associated Clinical Opioid Withdrawal Scale (COWS) scores.
Clinical evidence is available utilizing a device that functions similarly to the S.T. Genesis device to stimulate peripheral cranial neurovascular bundles in the external ear. The data shows that nearly all adult patients included in the study successfully transitioned from the use of the device during detoxification (medically supervised opioid withdrawal) to medication-assisted therapy (MAT). A reduction in COWS scores was noticeable within 20 minutes of device placement, with scores continuing to drop over the five-day duration of opioid withdrawal treatment. This effective approach has been shown to allow patients to progress with recovery with the support of physician follow-up along with MAT.
Device Name: ST Genesis
Manufacturer: Speranza Therapeutics
FDA Cleared: May 2, 2018
S.T. Genesis is a Percutaneous Nerve Field Stimulator (PNFS) that supports reduction of opioid withdrawal symptoms through application to branches of cranial nerves V, VII, IX, and X as well as the occipital nerves
OVERVIEW OF DISEASE STATE
Disease State: Opioid use disorder (OUD) is the condition in which an individual continues persistent use of opioids despite the harmful consequences of its use. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), defines OUD as “a problematic pattern of opioid use leading to clinically significant impairment or distress.”
Diagnosis: The diagnosis of OUD is made using the International Classification of Diseases 11th revision or Diagnostic and Statistical Manual of Mental Disorders 5th edition criteria (DSM-5). Clinicians also evaluate the OUD severity using the DSM-5; presence of 2–3 criteria is considered mild, 4–5 moderate, and 6 or more is severe on the OUD spectrum.
Treatment: There are effective psychosocial and pharmacological interventions for opioid use disorders. Psychosocial therapies such as cognitive behavioral therapies, relapse prevention, contingency management and motivational enhancement therapy can be used by themselves or in combination with a pharmacotherapy. Pharmacotherapy options include opioid agonists, partial agonists and antagonists, as well as alpha-2-adrenergic agonists, which are used to manage symptoms of opioid withdrawal syndrome.
Medication-assisted treatment (MAT) is the use of medications with counseling and behavioral therapies to treat opioid use disorders and prevent overdose. Conventional MAT includes the medications methadone, buprenorphine, Naloxone and Naltrexone, and Lofexidine (Lucemyra).
Opioid Withdrawal is an obstacle to treatment among individuals with OUD. Abrupt cessation of opioids after repeated use leads to opioid withdrawal symptoms, which are frequently severe, and may prompt patients to restart opioids in the early days after opioid discontinuation or prevent them from attempting to stop discontinue use of opioids at all. These symptoms can also lead to opioid seeking in pain patients in whom acute opioid withdrawal is not effectively managed.
The ST Genesis is changing how we treat OUD Patients. No more horrible side effects from using Opioids as a part of the recovery process. Improve patient OUD outcomes and while lowering clinical costs.
Device Name: Drug Relief (S.T. Genesis)
Classification Product Code: PZR
Device Class: 2
Regulation Number: 882.5896
Regulation Medical Specialty: Neurology
510(K) Number: K173861