Quell relief

Quell is wearable device developed in purpose to provide palliative treatment for people suffering from chronical pain. Quell is commercially available, thus customers don't need any prescription from a doctor. In present, it is the only palliative wearable, which si approved by FDA to be used during sleep. Quell wearable is presented by two technological improvements, which is OptiTherapy™ electrode and transcutaneous electrical nerve stimulation (TENS), method allowing sending electrical pulses into afferent nerves through the skin.

QUELL RELIEF
Category	Therapeutic wearables
Developer	NeuroMetrix
Announced	Oct 2015
Released	Consumers: 2015
Price	249 USD
Weight	62 g
Dimensions	98 x 74 x 11 mm
Controls	smartphone
Standalone
https://www.quellrelief.com/product

Main characteristics

Components

The basic product a customer can buy, called Quell wearable pain relief - starter kit, includes one piece of Quell device, adjustable sports band, charger cable, and charger adapter, and two 2 electrodes (company claims one month supply).

User have to buy accessories in addition like travel bag, spare cables, charger adapter, sports band. And also two electrodes, user has to buy regularly, and which are currently available in two kinds of packages: one package of two electrodes for 29.95$, or three packages of two electrodes for 89.85$.

A) A therapy pod, B) An electrode array, C) A Band, D) An example of usage on upper calf, place of effect

Usage

Regardless which part of body is in pain, Quell is always placed on upper calf (no matter which side). The reason is that there is better contact with nerves, on which are impulses sent to medulla. After the devices is fastened around the calf, user needs only to press the button on it.

For easier control it is possible to download Quell application for iOS or Android.

Principle

Electrodes should stimulate clusters of afferent senzoric nerves and this should trigger inhibition of pain in brainstem. Inhibition comes up due to cascade neurotransmitter release. This descending process starts in periaqueductal gray matter, continuing to medulla and then into spinal cord (its dorsal horn). Within-body-produced opioids, enkephalins, causes inhibition of pain signal transmission, while activate δ-opioid receptors.

Official webpage depictures the process of how pain is blocked in medulla.

Purpose

Quell wearable is device designated for treatment of chronic pain, nerve deseases and disrupted sleep. It works on principle of transcutaneous electrical nerve stimulation, which causes release of endogenous opiates affecting pain relief.

Company & People

Neurometrix is company directed on developing health-care wearable technology with main effort on sleep disorders, chronical pain, and nerve deseases treatment. The company, having a seat in Waltham Massachusetts, was founded in 1996 as a spinoff of the Harvard-MIT partition of Health Sciences and Technology.

Currently Neurometrix offers four products in total:

Quell™ - Wearable device for palliative purpose

SENSUS® - Therapy device available on prescription. It is based on TENS technology also for pain relief without any drug usage.

DPNCheck® - Nerve conduction test for evaluating systemic neuropathies such as diabetic peripheral neuropathy (DPN), its detection and monitoring.

ADVANCE™ System

Directors of Neurometrix:

Shai N. Gozani, M.D., Ph.D.

Allen Hinkle, M.D.

David E. Goodman, M.D

Timothy R. Surgenor

Nancy E. Katz

David Van Avermaete

Neurometrix stated also contact persons for media, which is Laura Wagstaff, and Thomas T. Higgins as contact person for investor relations.

Important Dates

1965 - Melzack and Wall proposed first conceptual model for mechanism which could lead to pain relief. They rationalized that harmful signals may be inhibited by peripheral afferents of large diameter.

1970s - Developement of TENS (Transcutaneous electrical nerve stimulation)

1996 - Establishment of Neurometrix

2014 - FDA gives a clearance to release Quell wearable device.

Health Risks

Official statement from Neurometrix about side effects is that there are none[1]. Usage is 100% drug free, with clearance by FDA (Food and Drug Administration) received in 2014. Despite claimed no side effects mentioned are some contradictions that patients with cardiac pacemakers or with implanted defibrillator should not use Quell, neither people with implated metallic or electronic devices. At least, patient should consult the using with a doctor. On the other hand no medication doesn't restrict Quell-using . However, there are another information sources which discuss TENS technology. For example they claim, that TENS method is surely inexpensive and safe, but there are risk with using electrodes on damaged skin, or over area of malignancy , or it could trigger a seizure in epileptic patient in case that electrodes will be put near patient's head or neck. Regarding these risks, most of them patients may avoid as Quell is used only on an upper calf.

Enhancement/Therapy/Treatment

Quell wearable device has primarily therapeutical function. It was developed on purpose to palliate chronical pain which basically has origin in these four diseases:

• Painful Diabetic Neuropathy (PDN)
• Fibromyalgia
• Osteoarthritis
• Sciatica

Although Quell was not created primarily to enhance cognitive or physical condition in humans, it may have secondary impact on physical and mental health (e.g. emotional stability, better memory) due to stress release, better sleep periods, and ability to be more concentrated if pain disappears. As a result should be quality of life enhanced generally.

Public & Media Impact and Presentation

Products of Neurometrix are presented on the official Neurometrix websites, and also each of them has its own webpage. Available on internet is also official launch video found right on the Quell product website. In the year 2014 Quell official facebook page was put into operation.

Except of company's official presentation, many users share their experiences with the device on their blogs or Facebook posts, comments, ratings etc.

Public Policy

Quell received clearance from Food and Drug Administration, which is federal agency as part of Department of Health and Human Services. FDA is connected to the database on U.S. Government Publishing Office, Electronic Code of Federal Regulations (eCFR). This eCFR contains also of three chapters (I. Food and Drug Administration, Department of Healt and Human Services; II. Drug Enforcement Administration, Department of Justice; III. Office of National Drug Control Policy), where medical devices are sorted and classified according to specific properties, difficulties of usage, dangerousness, etc. It the chapter I, Quell description consists of a) identification and b) classification. Quell is kept under regulation number: 882.5890, and it is identified as "A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain" . Further, it is classified with a "Class II (performance standards)". The latter category features most of medical devices (FDA stated 43%), including for example wheelchairs of pregnancy test kits.