Epios

The Epios device represents a category defining breakthrough in the effective treatment of pain without the use of drugs.

What is TENS

Transcutaneous electrical nerve stimulation (TENS) is a simple, non-invasive analgesic technique that is used extensively in health-care settings by physicians and physical therapists. It can be administered in the clinic by health-care professionals or at home by patients who have purchased a TENS device directly from manufacturers. TENS is mainly used for the symptomatic management of acute and non-malignant chronic pain. During TENS, pulsed currents are generated by a portable pulse generator and delivered across the intact surface of the skin via conducting pads called electrodes. The conventional way of administering TENS is to use electrical characteristics that selectively activate large diameter touch fibers (A) without activating smaller diameter nociceptive fibres (A and C). Evidence suggests that this will produce pain relief in a similar way to rubbing the pain better.In practice, conventional TENS is delivered to generate a strong but comfortable paraesthesia within the site of pain. In medicine, TENS is the most frequently used electrotherapy for producing pain relief. It is popular because it is non-invasive, easy to administer and has few side-effects or drug interactions. As there is no potential for toxicity or overdose, patients can administer TENS themselves and titrate the dosage of treatment as required. TENS effects are rapid in onset for most patients so benefit can be achieved almost immediately. In addition, TENS is extremely cost effective when compared with long-term drug therapy .
Under normal physiological circumstances, the brain generates pain sensations by processing incoming noxious information arising from stimuli such as tissue damage. In order for noxious information to reach the brain, it must pass through a metaphorical pain gate located in lower levels of the central nervous system. The pain gate can be closed by activation of mechanoreceptors. This generates activity in large diameter afferents, which inhibits the onward transmission of noxious information and reduces the sensation of pain.

Epios

What Is Epios

Epios a series of products based on TENS medical technology and proprietary, patent-protected technologies, form, and techniques. The purpose of these products is to reduce or eliminate pain through the emission of controlled and focused electrical signals. This product is for use primarily on legs, arms, lower back and shoulders for the relief of acute and chronic pain. The series, when completed, will include products designed for over-thecounter sale to consumers and configured for specific sites on the body plus additional products with higher power levels designed for use by and under the supervision of medical professionals.

The project described in these slides is for the production design, manufacture, and packaging of the first product in the Epios series, herein called Epios 1.

Positive Market trends

Recently, in 2010, the FDA has given guidelines for TENS devices to be used in nonprescription, over the counter purchase by consumers. (Draft Guidance for Industry and FDA Staff: Industry analysis of the Pain Management Market continues to document the area as one of the most Pain is the single most common reason patients seek medical care, accounting for approximately half of all physician office visits in the U.S.

Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use, April, 2010).

The estimated economic impact of pain in the U.S., including disability and lost productivity costs, totals approximately $100 billion annually. In 2010, combined U.S. sales of pain management products pharmaceuticals and devices), totaled approximately $33.1 billion. Total sales of pain management products are expected to increase at a compound annual rate of 3.7%, reaching approximately $38.2 billion in the year 2014. (U.S. Markets for Pharmacologic and Device-Based therapeutic approaches to
pain management, Life Sciences Intelligence report, 2011 Analysis).

Epios

Areas of potential use

Arthritis Dysmenorrhea Low back pain Muscle aches & pains Osteoarthritis Sciatic pain Knee pain Shoulder pain Post surgical pain Joint pain

Medication delivery system Aspirin Menthol Other drugs Various shapes and sizes

Initial Key Physical Design Goals/Criteria Buttons:

Device has single on-off button

Initial Key Physical Design Goals/Criteria

Product Energy Source: 3 volt CR2025 lithium Cell Intensity Epios: 15mA Intensity EpiosMax: 30 mA Mode: Conventional (non-pulse, steady

Summary: Epios

Origonal prototype

Size: 6 inches X 2 inches

Technology Used: TENS

Indications For Use: - Adjunctive treatment of post-surgical and post-traumatic acute pain. - Symptomatic relief and management of acute and chronic intractable pain. Simulation Mode: -- CONSTANT (Conventional): The most commonly used TENS Mode. Produces a continuous tingling sensation and should be set at a level below muscle contraction. Recommended for the initial perception of stimulation.