Determination of Device Safety

Since the magnetic energy that is produced by this device is in the pico-Tesla range, the magnetic energy that is delivered to the body is a fraction of the magnetic energy produced by the earth on a constant basis. There are no other hazards identified with this device. The device is not intended as an implant, it is not purported or represented to be for a use in supporting or sustaining life, and it is not for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health.

For more information, please refer to the ‘Non-Significant Risk Determination’ report contained in Appendix A of this clinical trial protocol.

IRB Determination of Non-Significant Risk (NSR) Status

Independent Review Consulting, Inc.’s Institutional Review Board determined the Resonator™ device to be a non-significant risk (NS) device when applied to Parkinson's disease patients for three independent studies, as follows:

1. Jacobson Resonator™: Efficacy of the Application of Magnetic Fields to the Treatment of Parkinson’s Disease Pilot Study Protocol, APPLIED MAGNETICS, LLC. Version 1.6, February 20, 2007. IRC # 07021-02.
2. Jacobson Resonator™: A double-blind, sham-stimulation controlled study of the application of magnetic fields using the Jacobson Resonator™ for the treatment of Parkinson’s Disease: phase two pilot study protocol. Version 2.5, Oct 2007.  IRC# 07102-01
3. An open label extension study for subjects previously treated in either pilot I or pilot II studies of the application of magnetic fields using the Resonator™ device for the treatment of Parkinson's disease: Extension pilot study protocol, Version 4.0, March 14, 2008.            IRC# 06052-01.

• IRC Resonator™ Device NSR#: DAM-003.

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The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the Magneceutical^®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.

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Other Forms of Deep Brain Stimulation

Doctors located in Arapahoe, Denver, Jefferson, Douglas, Adams, or Boulder County of Colorado, who have patients living with Parkinson’s disease, should know that Pico-Tesla Magnetic Therapies is currently conducting clinical trials. They are testing a new Resonator® device which uses a form of pulsed magnetic therapy. This clinical trial involves the use of low strength magnetic fields in hopes of diminishing the symptoms of Parkinson’s. This is a paid clinical trial for all patients who qualify for and complete the procedure.

Pico-Tesla is holding these clinical trials in their Clearwater, FL office. Any interested party can contact Pico-Tesla for more information.