Clinical Study Protocol

Phase I of the clinical study for the evaluation of a novel device for temporary pain relief using pulsed electronic neuromuscular stimulation, and the safety and efficacy of the StimPad™ Neuromuscular Stimulation System.

Introduction:

By Dr. Steven B. Inbody, M.D., P.A.

Electronic neuromuscular stimulation has been the mainstay of Physical Therapists for more than 100 years. These stimulatory devices have been used to either activate peripheral sensory nerves (TENS units) or motor nerves (EMS units). The latter device has been theorized to work by producing rhythmical muscle contractions, which increased local blood flow through the muscle. Alternatively, the stimulation is believed to interrupt the pain/contraction cycle. Despite its efficacy, real limitations on the use of the EMS exist. Unresolved problems include the inconsistencies of technicians in selecting stimulation parameters and placing the electrodes. Additionally, the high cost of supervision and training has not been offset by the convenience of portable devices which remain prohibitively expensive. Nevertheless, the efficacy of this modality of therapy for those patients with chronic musculoskeletal pain demands a solution to these problems. The development of the StimPad™ and its protocol for application is the first such device to offer viable solutions to these limitations.

Background:

Electronic neuromuscular stimulation has been the mainstay of Physical Therapists for more than 100 years. These stimulatory devices have been used to either activate peripheral sensory nerves (TENS units) or motor nerves (EMS units). The latter device has been theorized to work by producing rhythmical muscle contractions, which increased local blood flow through the muscle. Alternatively, the stimulation is believed to interrupt the pain/contraction cycle. Despite its efficacy, real limitations on the use of the EMS exist. Unresolved problems include the inconsistencies of technicians in selecting stimulation parameters and placing the electrodes. Additionally, the high cost of supervision and training has not been offset by the convenience of portable devices which remain prohibitively expensive. Nevertheless, the efficacy of this modality of therapy for those patients with chronic musculoskeletal pain demands a solution to these problems. The development of the StimPad™ and its protocol for application is the first such device to offer viable solutions to these limitations.

Purpose:

The purpose of this study is to evaluate the safety and efficacy of the StimPad™ system as a novel alternative to traditional EMS units and their attendant limitations. Utilizing a patented, new low intensity pulsed electronic neuromuscular stimulator for the treatment of minor musculoskeletal aches and pain, 100 volunteer subjects will be studied. Patients with confirmed ICD-9 diagnoses consistent with pain of musculoskeletal origin, and the duration of symptoms for more than one month will be enrolled in the study. Following the initial instructive treatment, the study subjects will begin a 30 day trial utilizing the StimPad™ and the recommended treatment protocol. Subjects will self apply the device 3 times daily, recording their pre and post treatment pain levels on the validated pain assessment questionnaire, the visual analogue scale (VAS). Study monitors will meet with the subjects weekly to assess compliance with the treatment protocol and accuracy of the documented responses. The targeted data points of the study will include the individual percentage of pain relief and the safety and ease of use of the StimPad™ device.

Eligibility:

Study participants of either gender, and at least 18 years of age, will be enrolled in the study if they meet the established inclusion and exclusion criteria. Subjects must have an accepted ICD-9 diagnosis and complete the pretreatment pain questionnaire and a baseline VAS score.

Inclusion Criteria:

Participants must be able to read, understand and voluntarily sign the written informed consent document prior to beginning. Participant must be willing and able to comply with the Study protocol, and maintain the daily diary provided

Exclusion Criteria:

Subjects with known contraindications to EMS devices such as cardiac pacemakers or implanted stimulation devices, epilepsy or pregnancy are excluded.

Expected Total Enrollment:

50 subjects

Duration:

The Study will last 30 days

Study Design:

Participants will be reviewed after each week throughout the 30-day study. The procedure will be repeated (a minimum) of three times per day. The subject self-administers the StimPad™ in the area of the pain site. The subject places the stimulation points indicated for the various areas of pain, as per the attached instruction sheet, and the area of pain is encircled. Before treating the pain, the participant places a square over the level of pain, and after treating the area of pain, the subject records the level by placing a circle over the corresponding number.

The StimPad™ protocol can be used for arm, hand, shoulder, neck, leg, foot, rear leg, upper back and lower back areas of the body. Specific stimulation points will be provided for each area of pain.

The 1^st application on day 1 is supervised. The participant follows the daily regimen to relieve temporary pain - up to three times per day, identifying the area that is treated, and the results scaled.

Evaluations: At baseline (day 1) then again on day 8, 15, 23 and 31

The Product:

The StimPad™ is a simple to use, water resistant, recyclable electronic muscle-skeletal stimulation device, used for the symptomatic relief and management of minor muscle aches and pains and mild muscle tension associated with stress. The StimPad™ system utilizes a safe electronic frequency pre-calibrated at our manufacturing facility for optimal pain relief and user safety and transmitted through self contained electrodes embedded into the device, providing immediate temporary relief form muscle-skeletal pain. The only adjustment required is to set the intensity (low, medium, high) for maximum comfort level. The study coordinators will review with each patient those areas of the body on which use of the StimPad™ device could be hazardous, including the anterior neck over the carotid artery or the pectoral region over the heart. A signed acknowledgment by the study participant of these precautions will be obtained.

• In this phase of the trial, 50 StimPad™ units were distributed to participants that were all between the ages of 65 — 85 y/o, with approximately a 50 / 50 ratio of male and female.
• The primary reasons for participation were pain levels higher than a 5/10 scale ? due to chronic cervical lower back or joint (OA) pain.
• Of the 50 units distributed, 23 participants did not complete the study. These units were returned due to inability to understand directions due to cognitive issues (7) no discern able change in pain levels (11) or hand dexterity and ability to manipulate / operate the StimPad™.

It should be noted that the majority of participants at Rudi Ide & Associates have major, chronic pain and neurologic issues.

27 participants completed the study. The individual study materials are [available for review to investors under confidentiality agreement at AEMED, Inc.) . There was an overwhelming positive response to the StimPad™, its ease of use and effectiveness in reducing pain.

CONCLUSIONS:

Virtually every application made the subject feel better and in many cases, the pain relief was immediate. The pain decreased consistently throughout the study. In subject #11, the PRE pain was highest at level 8, and lowest at level 3, while POST pain was at the highest 8 and lowest 2.