SENERGY MEDICAL GROUP TO CONDUCT IRB WOUND STUDY USING TENNANT BIOMODULATOR® DEVICES AS ADJUNCT

THERAPY TO ACCELERATE CHRONIC WOUND HEALING,REDUCE PAIN AND INCREASE PERFUSION POTENTIAL

APPROVED AUGUST 21, 2017, INTEGREVIEW IRB

WE INVITE YOU TO BE A PARTICIPANT

Please complete the application on the inside page to determine if you qualify for the study.

For more information, contact:Senergy Medical Group

Scott Tennant - 972.580.0545woundstudy@senergy.us

If the answer is YES, you may be eligible to participate in an IRB clinical study conducted by Senergy Medical Group at no additional cost to you.

How will the study be conducted?

1. Participants will be given non-invasive, hand-held, battery operated, microcurrent device kits to use during the study. The kit consists of the Tennant Biomodulator® Plus, pads and lead wires. After you complete the study, the device will be yours to keep to continue your wound healing process.

2. The microcurrent stimulation, using the devices, will be used as additional treatment to participants current standard of care treatment.

3. The study will last approximately 4 weeks with one follow up visit 30 days after the participant’s final treatment visit.

4. Participants are required to schedule weekly visits for the duration of the study. These visits can be combined with the existing appointments. The remainder of the daily treatments can be done at home.

What is microcurrent stimulation?Microcurrent stimulation uses electrical energy that passes into the tissue, stimulating internal electrical and chemical processes around the chronic wound tissue. The treatment is thought to be effective in improving circulation, accelerating tissue regeneration and reducing inflammation.

The Potential Benefits to Participants Are:

• Narcotic-Free Pain Relief The devices are FDA cleared for pain management.

• Wound Healing The devices use electrical energy that passes into tissue, stimulating internal electrical and chemical processes. The treatment might be effective in improving circulation, accelerating tissue regeneration and reducing inflammation.

• Mobility Some patients find that chronic wound pain makes daily tasks difficult. The device might cause reduction in pain and wound size so that some patients might be able to resume their daily activities.

IRB Wound Study Conducted By Senergy Medical Group

Using Tennant Biomodulator® Microcurrent DevicesAPPROVED AUGUST 21, 2017 INTEGREVIEW IRB

Wound Study Qualifying Application APPROVED AUGUST 21, 2017 INTEGREVIEW IRB

INCLUSION CRITERIA (If you answered “yes” to all inclusions criteria you many qualify to participate)

1. Age ≥ 40 and ≤70 years of age o Yes o No

2. Has a chronic wound that has not healed in last 30 days o Yes o No

3. Wound area is ≥0.5 cm2 and ≤22 cm2 o Yes o No

4. Willing and able to comply with weekly visits to clinic (e.g., reliable transportation) o Yes o No

5. Willing and able to perform microcurrent treatment at home on a daily basis o Yes o No

6. For females of reproductive potential, a recorded statement that they are not pregnant nor

they become pregnant during the conduct of the study (refer to Informed Consent) o Yes o No

EXCLUSION CRITERIA (If you answered “No” to all exclusions criteria you many qualify to participate)

1. Use of any microcurrent device in the past six (6) months prior to enrollment in the study o Yes o No

2. Patient is experiencing a medical emergency o Yes o No

3. Presence of an electrical implant such as a cardiac pacemaker or neural stimulator o Yes o No

4. Patient is diagnosed with hypotension o Yes o No

5. Patient is diagnosed with neuropathy from sources other than diabetes, such as heavy metal, xenobiotic toxicity o Yes o No

6. Patient is diagnosed with Charcot-Marie-Tooth or similar genetically inheritable neuropathic disease(s) o Yes o No

7. Patient is diagnosed with an untreated vitamin deficiency o Yes o No

8. Patient is diagnosed with end-stage kidney disease/dialysis or severe kidney insufficiency o Yes o No

9. Patient is diagnosed with an HIV/AIDS o Yes o No

10. Patient exhibits active drug, alcohol or substance abuse o Yes o No

11. Patient is diagnosed with malignancies (cancers) undergoing treatment o Yes o No

12. Patient has a history of malignancies (in remission or not) with involvement of the musculoskeletal system o Yes o No

13. Patient is currently pregnant, possible pregnant or breast-feeding o Yes o No

14. Patient has a BMI ≥40 o Yes o No

Have questions or concerns, contact Scott Tennant at Senergy Medical Group for more information - 972.580.0545

About Senergy Medical Group

The Senergy Team is made up of a group of health and wellness industry professionals dedicated to supporting patients interested in self-care, as well as, practitioners looking for alternative, integrative, holistic medical solutions. As the sole source distributor, Senergy Medical Group is responsible for the worldwide distribution, education and customer service of the Tennant Biomodulator®. In addition, Senergy distributes and provides customer service for other integrative products that Dr. Tennant recommends for health and wellness.

Our knowledgeable, caring staff is here to help with the purchase and understanding of the Tennant Biomodulator® and other products. In addition, Senergy schedules and presides over monthly health conferences and Biomodulator training. Taught by Dr. Tennant, the conferences and training are designed to help clients understand how to use their Biomodulator in conjunction with Dr. Tennant’s theories on healing and voltage to obtain better health and wellness.

To learn more about the products and programs offered by Senergy Medical Group, please call our corporate offices and speak to a member of the Senergy team. Each member of our team is committed to helping individuals achieve their integrative health and well-being goals and provide professionals with the tools to assist their patients with symptomatic relief and management of pain.

Contact us at www.senergy.us or 972.580.0545 to begin your journey to health and wellness. Please Note:Senergy Medical Group is the exclusive distributor for the Tennant Biomodulator® and other products recommended by Dr. Tennant. Senergy can only provide information about these products. Senergy is not a medical office and cannot provide any medical advice or diagnosis.

9901 Valley Ranch Pkwy East, Ste 1009 Irving, TX 75063 USAPhone: 972.580.0545

Toll Free (in the USA): 866.514.8221 Fax: 214.260.7765

Business Hours:Monday through Friday, 9AM - 7PM,

Central Time