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Alpha-Stim ® LET NOTHING STOP THEM. Alpha-Stim M When they’re in pain

When they’re in pain -  · The Alpha-Stim M is a device that provides Microcurrent Electrical Therapy (MET)*. It features a patented waveform—the basis for Alpha-Stim technology—to

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Page 1: When they’re in pain -  · The Alpha-Stim M is a device that provides Microcurrent Electrical Therapy (MET)*. It features a patented waveform—the basis for Alpha-Stim technology—to

Alpha-Stim®

LET NOTHING STOP THEM.™

Alpha-Stim M

When they’re in pain

Page 2: When they’re in pain -  · The Alpha-Stim M is a device that provides Microcurrent Electrical Therapy (MET)*. It features a patented waveform—the basis for Alpha-Stim technology—to

TREAT PAIN. No matter the source, your patients need relief.

Give your patients sustainable pain relief, quickly and safely,

with Alpha-Stim®.

The Alpha-Stim M is a device that provides Microcurrent Electrical

Therapy (MET)*. It features a patented waveform—the basis for

Alpha-Stim technology—to deliver low-level electrical current

that has been proven to effectively reduce acute, chronic, and

post-traumatic pain.

• Alpha-Stim M can be used as a first-line therapy, or as an adjunct

to pharmacotherapy (without polypharmacy effects)

• Alpha-Stim technology is safe, with no serious adverse events

reported in over 30 years of clinical use

• Alpha-Stim treatments are cumulative; however,

most patients show at least some improvement after

the first treatment

The Alpha-Stim M system includes probes for site-specific

pain therapy, as well as earclips that provide Cranial Electrotherapy

Stimulation (CES)—to relieve common comorbidities associated with

pain (anxiety, depression, and insomnia) following pain treatment.

*Alpha-Stim has an extensive safety record, with few side effects (less than 1%) and considerable scientific evidence of the significant results patients can achieve.

Page 3: When they’re in pain -  · The Alpha-Stim M is a device that provides Microcurrent Electrical Therapy (MET)*. It features a patented waveform—the basis for Alpha-Stim technology—to

THE FUNDAMENTALS: An Electrical Intervention• The brain and nervous system function electrochemically and can be readily modulated by

electrical intervention1,2

• The patented waveform provides a wide range of biological frequencies that no other

device can emulate

• Alpha-Stim impacts electrochemical function at the cellular level to reduce pain related to a

variety of causes

THE ALPHA-STIM ADVANTAGE: A Patented Waveform• Effectively targets cell receptors, activating them through frequency matching in a manner

similar to chemical ligands

• Delivers a very low level of current in pulsed microcurrents of less than one milliampere

• The only rigorously tested waveform designed and refined to improve effectiveness

THE RESULTS: Significant Improvement, Quickly, with Lasting EffectAs a leader in electrotherapy, Alpha-Stim has helped clinicians around the world offer fast,

safe, and effective relief for patients suffering from pain from multiple sources–even when

nothing else has worked.

Page 4: When they’re in pain -  · The Alpha-Stim M is a device that provides Microcurrent Electrical Therapy (MET)*. It features a patented waveform—the basis for Alpha-Stim technology—to

Alpha-Stim CES Treatment Sessions

Redu

ctio

n in

Pai

n Le

vels

35%

45%

55%

65%

75%

1 2 3 4 5

42%

50%54%

64%

71%

PAIN REDUCTION LEVELS

General Anxiety Disorder, HAM-A, 5 Weeks, N=108Liberty and Stetson Universities

Mea

n An

xiet

y Sc

ores

10

15

20

25

30

BASELINE WEEK 1 WEEK 3 WEEK 5

29.5

27.6

19.9

22

16.1

19.9

13.4*

20

*p<0.001 d=0.94

Active Sham

MEAN ANXIETY SCORES OVER 5 WEEKS VAS SCALES

Dental Anxiety, Visual Analog Scale, 1 Treatment, N=33TMD and Facial Pain Clinic at New York Eye and Ear Infirmary

Grou

p M

eans

Dentist SubjectsPRE DURING POST PRE DURING POST

Active Sham

15.00

20.00

25.00

30.00

35.00

40.00

45.00

50.00

55.00

Length of Treatment

Satis

fact

ion

with

Tre

atm

ent

56%

85%

0%

20%

40%

60%

80%

100%

6 MONTHS3 MONTHS

SATISFACTION WITH TREATMENT

Active Sham Usual Care

Pain

Impa

ct Q

uest

ionn

aire

50%

55%

60%

65%

70%

45%BASELINE 8 WEEKS

68.9%

64.2%62.5%

66.3%

61.2%

49.9%

TOTAL CHANGE

CES: -12.6Sham: +2.1Usual Care: -7.7

TOTAL CHANGE IN AMOUNT OF PAIN

Significant Pain Reduction: In a study of severe pain patients, Alpha-Stim significantly reduced pain by an

average of 71% after only 5 treatments3

Clinical Results: After 5 weeks of treatment, the active Alpha-Stim CES group reported an average decrease of 94% in their anxiety6

Great Patient Satisfaction: In a post traumatic pain study, 56% of patients at 3 months and 85% at 6 months were

somewhat or very satisfied with the device4

Improved Functionality: Chronic pain patients using Alpha-Stim reported significantly improved functionality

than the usual care and sham group5

Proven Anxiety Reduction: Using Alpha-Stim during procedures, dental patients reported an average of 61% less anxiety7

PROVEN: Alpha-Stim Significantly Reduces Pain

PROVEN: Alpha-Stim Significantly Reduces Mood Disorders Commonly Associated With PainReduced Anxiety

Page 5: When they’re in pain -  · The Alpha-Stim M is a device that provides Microcurrent Electrical Therapy (MET)*. It features a patented waveform—the basis for Alpha-Stim technology—to

CHANGE IN TOTAL SLEEP TIME

Total Sleep Time, 5 Days, N=57Walter Reed National Military Medical Center

Chan

ge in

Tot

al S

leep

Tim

e 43

-19

-30

-20

-10

0

10

20

30

40

50

SHAM

CES

MEAN IMPROVEMENT IN DEPRESSION

Active Sham

6789101112131415

WEEK 5WEEK 3WEEK 1BASELINEDepr

essi

on M

ean

Impr

ovem

ent 14.5

13.2

9.6

10.2

8.1

9.9

6.5*

10

*p<0.001 d=0.75

Depression Patients, HAM-D17, 5 Weeks, N=108Liberty and Stetson Universities

IMPROVED SLEEP QUALITY

Quality of Sleep Rating Scale, 3 Weeks, N=60Robert Wood Johnson Medical Center

Adju

sted

Mea

ns

Slee

p Q

ualit

y

5.2*

3.3

3.3

SHAMACTIVE

*p=0.02

0.00

1.00

2.00

3.00

4.00

5.00

6.00

REDUCED DEPRESSION SCORES

Mea

n De

pres

sion

Sco

res 10.5

6*

5

6

7

8

9

10

11

ENDPOINTBASELINEDepression Patients, HAM-D17, 6 Weeks, N=9University of California at Los Angeles

Increased Sleep Time: Alpha-Stim CES recipients demonstrated an average increase of 43 total minutes of sleep time after only 5 treatments**8

Significant Mood Improvement: After 5 weeks of treatment, the active Alpha-Stim CES group reported an average decrease of 75% in their depression6

Improved Sleep Quality: The number of subjects rating their quality of sleep as poor dropped from 60% at study start to 5%**9

Long-term Effectiveness: After 6 weeks of treatment, Alpha-Stim users experienced 42.8% improvement10

Reduced Insomnia

Reduced Depression

Page 6: When they’re in pain -  · The Alpha-Stim M is a device that provides Microcurrent Electrical Therapy (MET)*. It features a patented waveform—the basis for Alpha-Stim technology—to

USING ALPHA-STIMAlpha-Stim M is safe and easy for use clinically,

at home, or on the go. Small and portable,

patients can apply Alpha-Stim therapy

while relaxing, reading, using a computer,

or watching TV. Built-in safety features

automatically stop treatment if the device is

not functioning properly.

Alpha-Stim can be applied with the handheld probes,

attachable electrodes, or earclips.

For effective relief of pain, the probes or

electrodes should be positioned on either

side of the affected area, enabling the

waveform to pass through the painful

area. Following the pain treatment, CES

via earclip electrodes should be applied

to relieve common comorbidities associated

with pain (anxiety, depression, and insomnia).

By testing different positions and treatment

times using our protocols, patients

can easily identify the most impactful

treatment. An included instructional DVD

and Owner’s Manual provides step-by-step

instructions to help patients get started.

Page 7: When they’re in pain -  · The Alpha-Stim M is a device that provides Microcurrent Electrical Therapy (MET)*. It features a patented waveform—the basis for Alpha-Stim technology—to

ALPHA-STIM AND MEDICATION?The patented Alpha-Stim waveform is proven safe in over 30 years of use by itself or with medications.

For patients looking to reduce or eliminate dependence on medication, the proven pain relief of Alpha-Stim may be

an effective way to reduce or eliminate dependence on pharmacotherapy.

For patients with increasing tolerance and diminished effect from medications, Alpha-Stim can be

used in conjunction with medication to provide improved pain relief.

�u The proprietary Alpha-Stim waveform is supported by more scientific research than any therapeutic medical device in its class. For additional clinical research, contact your Alpha-Stim representative.

LET NOTHING STOP THEM.™Help for your patients suffering from pain is here.

To offer Alpha-Stim to your patients, contact your Alpha-Stim representative or visit

Alpha-Stim.com. We offer free trials to licensed practitioners. Typically, an in office or

clinic trial can identify those individuals who readily respond to treatment.

Ordering through Alpha-Stim.com is easier than ever. You or your patients can fulfill your order

for Alpha-Stim through our online store, through your local authorized Alpha-Stim representative,

or by calling our customer service center. Our knowledgeable staff is available to answer

questions, should your patients need support.

Safe and easy for patients to use in the office or at home, Alpha-Stim is cost-effective compared

with drugs and other devices used to treat similar symptoms.

Page 8: When they’re in pain -  · The Alpha-Stim M is a device that provides Microcurrent Electrical Therapy (MET)*. It features a patented waveform—the basis for Alpha-Stim technology—to

Electromedical Products International, Inc. (EPI) was founded in 1981 by Dr. Daniel L. Kirsch, a world-renowned neurobiologist, who developed a safe and effective solution for the treatment of pain, sleep, and mood disorders with Alpha-Stim technology. He was the recipient of the 2008 prestigious Richard S. Weiner Pain Educator of the Year Award from the American Academy of Pain Management. EPI was a recipient of the 2013 Best of Business Award in the Surgical and Medical Instruments category by the Small Business Commerce Association (SBCA), and holds multiple patents. Today, EPI is a global enterprise with representatives throughout the world, with staff dedicated to the pursuit of excellence in the treatment and diagnosis of medical and healthcare-related issues.

EPI is a FDA-registered establishment with operations certified by an independent third party to the International Standards Organization (ISO) 13485:2003 standards for quality in medical devices. Alpha-Stim products earned and maintain the CE mark through the European Medical Device Directive and are FDA-cleared for marketing.

ABOUT ELECTROMEDICAL PRODUCTS INTERNATIONAL, INC: A Dedicated Company You Can Trust

REFERENCES1. Heffernan M. Comparative effects of microcurrent stimulation on EEG spectrum and correlation dimension. Integrative Physiological and Behavioral Science. 1996;31(3):202-209.

2. Kennerly R. Changes in quantitative EEG and low resolution tomography following cranial electrotherapy stimulation. PhD Dissertation, the University of North Texas. 2006;529 pp., 81 tables, 233 figures, 171 references.

3. Holubec JT. Cumulative response from Cranial Electrotherapy Stimulation (CES) for chronic pain. Practical Pain Management. 2009;9(9):80-83.

4. Tan G, Rintala D, Jensen MP, et al. Efficacy of Cranial Electrotherapy Stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase. Journal of Spinal Cord Medicine. 2011;34(3):285-296.

5. Taylor AG, Anderson JG, Riedel SL, et al. Cranial Electrotherapy Stimulation improves symptoms and functional status in individuals with fibromyalgia. Pain Management Nursing. 2013 Dec;14(4):327-335.

6. Barclay TH, Barclay RD. A clinical Trial of cranial electrotherapy stimulation for anxiety and comorbid depression. Journal of Affective Disorders. 2014;164:171-177. Presented at the American Psychological Association National Conference, Honolulu, July 2013.

7. Winick RL. Cranial electrotherapy stimulation (CES): a safe and effective low cost means of anxiety control in a dental practice. General Dentistry. 1999;47(1):50-55.

8. Lande RG, Gragnani C. Efficacy of cranial electric stimulation for the treatment of insomnia: A randomized pilot study. Complementary Therapies in Medicine. 2013;21(1):8-13.

9. Lichtbroun, AS, Raicer MMC, Smith RB. The treatment of fibromyalgia with cranial electrotherapy stimulation. Journal of Clinical Rheumatology. 2001;7(2):72-78.

10. Bystritsky A, Kerwin L, Feusner J. A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder. Journal of Clinical Psychiatry. 2008;69:412-417. Presented at the American Psychiatric Association meeting, San Fransicso, 2009.

Manufactured and marketed by:

Electromedical Products International, Inc. 2201 Garrett Morris Parkway • Mineral Wells, TX • 76067-9034 • USA

1-800-FOR-PAIN (367-7246) in USA

Tel: + (940) 328-0788 (Outside USA) • Fax: (940) 328-0888

www.Alpha-Stim.com

Alpha-Stim AIDAlpha-Stim M

Authorized Representative for the European Union: MediMark Europe11, rue Émile Zola – BP 2332/38033 Grenoble Cedex2– FranceTél: +33 (0)4 76 86 43 22 / Fax: +33 (0)4 76 17 19 82E-Mail: [email protected]

Alpha-Stim and the Alpha-Stim logo are registered trademarks, and LET NOTHING STOP THEM is a trademark of Electromedical Products International, Inc. © 2014 Electromedical Products International, Inc. All rights reserved. Manufactured under US Patents 8,612,008; 8,457,765; and 8,463,406.

REV A

Type B Equipment. This stimulatoris internallypowered only.

See instructions for use. Read the manual thoroughly before using.