Frequently Asked Questions

Transcription

1 Frequently Asked Questions Q. What illnesses/indications are Nexalin cleared to treat here in the United States? A. Nexalin is fully FDA cleared to safely and effectively treat Anxiety, Depression and Insomnia. Nexalin Therapy offers approximately 100 hundred million Americans affected by these illnesses a drug free alternative. Q. Is Nexalin a drug that requires taking pills or shots? A. NO Nexalin is a non-invasive safe medical device. Q. Does Nexalin require surgery in any way? A. NO A patient will sit in a comfortable chair or medical chair for each treatment. Q. Is Nexalin cleared internationally? A. Yes, in all of the European Union, as well as the Russian Federation and Australia. A total of 32 countries around the world have already cleared Nexalin for use. Q. What illnesses/indications? A. In the European Union, all forms of arthritis and musculoskeletal illnesses. In the Russian Federation and Australia all forms of arthritis and musculoskeletal illnesses plus Parkinson s disease. Q. Is Nexalin Therapy patented? A. Yes, here in the United States since Q. Does Nexalin have any international patents? A. Yes, in all of the countries where we feel we need to insure the value of our technology. Q. Is Nexalin safe? A. Yes, Nexalin is safe. Our warning label in the over 30 countries we re cleared to treat patients is a simple four words, No Serious Side Effects. The side effects of Nexalin are similar to Placebo. In fact, unlike anti-depressants, which warn of the risk of suicide by minors, we re cleared to treat children without any special warning. Unlike most medical devices, it is noninvasive, involving no surgery, and therefore has none of the risks associated with surgical complications. Q. Is treatment effective? A. Yes, over 80% of patients in studies and at Nexalin Treatment Centers have reported positive results with an average improvement of over 80% in their symptoms, unlike antidepressants, where many researchers report results little better than a placebo. Q. Is Nexalin Therapy effective? A. In recent studies, patients report on average better than 80% of sustained improvement in all symptoms. Q. How many Americans can Nexalin help? A. Anxiety 41 Million Depression 40 Million Insomnia 70 Million

2 Q. Can Nexalin help those that suffer from alcohol and substance abuse and dependency? A. Nexalin can help with Anxiety, Depression and Insomnia allowing the sufferer or a trained therapist the opportunity to work on the core issue(s) that brought the problem on. Alcohol-1 in 12 adults suffer from alcohol abuse or dependence. Drugs 20% of the United States population use prescription drugs for non-medical reasons. An estimated 20 Million Americans have used an illegal drug in the past 30 days. Q. Is Nexalin an alternative to currently available treatments? A. Yes, as you may know if you watch any of the leading pharmaceutical direct to consumer advertising, drugs used to treat Anxiety, Depression and Insomnia come with potentially serious side effects, including death. Our competitor s implanted medical devices are both expensive and according to their own warning label are also dangerous, including again potentially death; in large part because many of the medical devices now available are invasive, meaning they come with all the risks associated with surgery and in some cases anesthesiology. Q. Do patients having Nexalin Therapy suffer from any adverse symptoms upon discontinuing treatment? A. Another major advantage of Nexalin is the absence of withdrawal upon discontinuing therapy; patients do not and cannot become dependent upon Nexalin. Q. When can the patient expect results and how long lasting are the benefits? A. Every patient is different, but many patients experience benefits after the first treatment, others not until several treatments. The benefits continue long after the last treatment, in some cases for many years thereafter. Q. Is Nexalin expensive? A. No. Nexalin treatments for Anxiety, Depression or Insomnia can be very inexpensive when compared to the long-term costs associated with competitors pharmaceutical products. When compared to a potential lifetime prescription for drug therapies, even where covered by insurance, Nexalin Therapy is cost effective. The same is true when Nexalin Therapy is compared with medical devices, especially implanted medical devices, again even where much of the expense is covered by insurance. Q. How is Nexalin Therapy administered? A. Patients sit in a comfortable chair in a soothing atmosphere. A safe patented frequency and waveform are sent to the mid-brain for 40 minutes per session. Three contact pads are placed gently on the forehead and the mastoid area behind each ear after first being first wiped with an alcohol swab and then wiped with a tens sticky pad. The stimulating waveform is virtually undetectable, and the treatment is soothing and relaxing. Most patients report a relaxing experience during each treatment. During the last 10 seconds of the treatment the machine will start to beep as the timer counts down until the treatment is over. The technician will remove the three pads, dispose of them correctly and the patient is now ready to leave. Q. How does Nexalin Therapy work? A. The Nexalin device creates a frequency waveform that seems to affect key brain structures involved in the regulation of its neurochemistry. Data suggests the Nexalin waveform effectively resets the hypothalamus, without the introduction of pharmaceutical medication. Clinical research indicates that normalizing the production of various neurotransmitters, including Dopamine, Serotonin, and Norepinephrine begins at the beginning of the initial treatment protocol. During treatment, clinical evidence suggests the hypothalamus and mid-brain are gently stimulated with a

3 repetitive wave form that seems to support certain brain function resets. Further research indicates that the treatment is long lasting with no harmful or serious side effects. Q. Who may administer Nexalin Therapy? May my family physician treat me using Nexalin Therapy? A. Nexalin Therapy is only available in a clinical setting and when administered by a trained Certified Nexalin Technician. However, your family physician, or a healthcare practitioner in his or her office, may easily qualify after study, as a Certified Nexalin Technician. All members of the office staff including the receptionist can be trained to be excellent certified technicians. Q. How many Americans suffer from Anxiety? A. Anxiety is a major issue throughout the world. In the U.S. alone, 18% of the adult population (nearly one in five adults) suffers from an anxiety disorder in one form or another with 4% of the population classified as severe. Q. How does Anxiety affect one s ability to function? A. The five major types of anxiety disorders include General Anxiety Disorder, Obsessive- Compulsive Disorder (OCD), Panic Disorder and Social Phobia (Social Anxiety Disorder). Each of these disorders can become debilitating when not treated. While there are several types of anxiety disorders, they all have a similar effect, often making it difficult to cope with everyday activities, making small and simple things unbearable. It can have a major impact on work and family life, putting stress on relationships with your partner, children, and professional relationships. It can also affect your ability to work or take care of essential tasks, making it hard to get out of bed in the morning. According to the National Institute of Mental Health (NIMH) when Anxiety becomes an excessive, irrational dread of everyday situations, it has become a disabling disorder. Q. What treatments are currently available to treat Anxiety? A. While there are currently several treatment methods available most of them require taking a pill every day, which can be costly and unpleasant. Nexalin is an alternative therapy that is effective and drug-free. The NIMH defines major depressive disorder as, characterized by a combination of symptoms that interfere with a person s ability to work, sleep, study, eat, and enjoy oncepleasurable activities. Major depression is disabling and prevents a person from functioning normally. Q. What are the forms of Depression? A. The depression that can ruin lives and families we all see in many of our friends and loved ones comes in many forms, including major depressive disorder; dysthymic disorder which is characterized by long-term symptoms that don t necessarily disable a person, but prevent normal functioning and feeling well; minor depression which can last two weeks or longer but does not meet the full criteria for major depressive disorder; psychotic depression which occurs when someone experiences depression in conjunction with psychosis such as disturbing false beliefs, delusions or hallucinations; postpartum depression in women after child-birth; seasonal affective disorder which occurs when there is less natural sunlight; bipolar disorder where people experience extreme emotional highs and lows; and perhaps common most recently Post-traumatic Stress Disorder (PTSD) suffered by both active military and veterans as a result of tours in Iraq and/or Afghanistan.

4 Q. What are the forms of Insomnia? A. In most cases, insomnia is a secondary or co-morbid disorder. It often accompanies other disorders such as Anxiety Disorders and Depression, or because of medicines or other substances. On the other hand, primary insomnia forms independent of other disorders and is, in effect, its own disorder. Primary insomnia can result from long-lasting stress, emotional upset or from certain lifestyle choices. Q. What illnesses or indications does Nexalin Therapy address? A. Nexalin is a new safe and effective solution for Anxiety, Depression and Insomnia. Q. What size and type of facility is necessary to administer Nexalin Therapy? A. A Nexalin Treatment Center will require an open space, 7ft. by 7ft. or larger. This can be an office, a store front, or a room in your home if you will be offering traveling service for Nexalin. Q. What computer related requirements are necessary? A. The server must be connected to the Internet, and the device connected to the server so that it can be checked for delivery of the proper frequency and waveform. The device must also be connected to the server to ensure you are billed for the correct number of treatments. The device may be disconnected from time to time to allow for traveling treatments at outside locations. Q. What review of the patient is necessary before, during and after treatment? A. You should personally take a before and after visual survey of the patients you treat using the Nexalin Technician Personal Client Survey. You should survey the patient or anyone accompanying them about the visual and physical difference seen or witnessed before and after treatments. Q. What marketing preparation is advisable, if not mandatory, prior to opening a Nexalin Treatment Center? A. Marketing preparation includes both Nexalin press releases and clinic press releases approved by Nexalin; Internet marketing; and use of informing your clients, family, friends, and colleagues of your new Nexalin service that safely treats Anxiety, Depression and Insomnia. Q. Who should not partake of Nexalin Therapy? A. Those that should not take Nexalin Therapy include those patients with a history of seizures, epilepsy, hydrocephalus, or tumors of the central nervous system, acute brain injuries and infections, break in skin integrity at the areas of electrode placement (forehead and behind each ear), sensitivity to electrode gels or adhesives, presence of any implanted electronic stimulators, pregnant or may be pregnant at the time of therapy and less than 13 years old. Potential patients must sign off warranting they understand that the presence of any of the above conditions precludes them from participating in Nexalin Therapy. Q. How many treatments over what period is optimum? A. Clinical studies were conducted giving 10 to 15 treatments over 2 or 3 five-day periods covering from 12 to 17 days. Nexalin Treatment Center location studies have shown the same results giving multiple treatments consecutively over a shorter number of days. Q. How long is Nexalin Therapy regimen? A. Nexalin Therapy regimen consists of: total of 10 sessions, 5 consecutive treatments, Monday through Friday, two weeks and each Nexalin session lasts 40 minutes.

5 Q. Is Nexalin Therapy covered by Insurance? A. Presently no major insurance plans cover Nexalin. However, Nexalin, even without insurance coverage is no more expensive than long term use of antidepressants or competing medical devices with insurance coverage that are dangerous and less effective than Nexalin. Q. Will I feel anything during the treatment session? A. Most people feel nothing at all; however, there is a possibility that you may feel a warm sensation as your microcirculation increases. This is part of the body s natural healing process that can begin during the therapy. Q. What happens if I miss a Nexalin Therapy session? A. Studies have shown that maximum benefit is received from 10 days of therapy. If you are unable to make your scheduled appointment one day, the clinic will make every effort to fit you in at another time that day. If you must miss one session, continue your treatments for the remainder of the therapy. If circumstances arise where you must miss more than one session, it is highly recommended that you reschedule your therapy for another time. Q. When should I feel results? A. Every individual is physiologically different and therefore each body reacts to Nexalin Therapy in its own unique way. Many people notice a change in how they feel within the first 24 hours and continue to improve over the course of the therapy. Others may not feel results until the therapy is completed, or even until days afterwards. Because Nexalin Therapy provides long-term relief, you may experience improvements weeks or months after completion of your sessions. Q. How long will the results of my therapy last? A. Patients involved in two clinical studies were followed, one set for 14 weeks and the other for 6 months. The results showed that there was no significant drop in effectiveness after 14 weeks. The 6-month group also continued to show a significant effect from the therapy. We believe the therapy will provide relief for more than 6 months. It is our plan to continue monitoring patients to better understand the lasting effects of Nexalin Therapy. Q. Will this treatment affect the way I take my medications? The use of medication after Nexalin Therapy is a personal decision that must be made by you and your physician. However, the long-term relief offered by Nexalin Therapy may allow adjustments in your medications. Q. Will Nexalin cause damage to my brain or other structures in my head? A. No. In all the clinical studies using Nexalin Therapy, there have been no serious side effects as a result of the therapy. The patented waveform of the Nexalin Device focuses its stimulating energy solely on the area of the brain involving the antinociceptive system (including the hypothalamus and associated structures). Q. How long has this therapy been available? A. The first Nexalin Therapy sessions for pain were provided in January 2007 at the Fachklinik St. Georg in Bad Soden-Salmunster, Germany, although clinical trials began in The first Nexalin Therapy sessions for Anxiety, Depression, and Insomnia occurred in October 2007 in Bad Nauheim, Germany. The first American Therapy Center open to treat Anxiety, Depression, and Insomnia was opened on April 1, 2008 in Huntington Beach, California. The business plan to expand across American started in mid 2012 and has grown to over 100 devices being used in 22 states and 4 foreign country as of January 2017.

6 Q. Will the current resulting from the treatment continue after a session? A. No. Just like a light switch, once the session ends the current is turned off and the patient is disconnected from the Nexalin device. The current does not accumulate or linger in the brain. Q. Can I safely drive immediately after Nexalin Therapy? A. Nexalin Therapy will not interfere with your ability to drive. Q. What do I do if I feel an unusual experience after my treatment? A. Immediately contact the Nexalin Therapy Center if you have any unusual symptoms or sensations following a Nexalin Therapy session. Q. Will Nexalin Therapy affect my memory? A. Nexalin Therapy will not negatively affect your memory. However, some patients treated with Nexalin Therapy have reported an improvement in their cognitive thinking and reported feeling more alert. Q. If I like the effects of Nexalin Therapy, when may I safely receive therapy again? A. There is no danger in receiving consecutive therapies. However, it is recommended that you give your body the opportunity to adjust following your Nexalin Therapy. Q. Why are the electrodes put on the forehead and behind the ears? A. The placement of the electrodes (one on the forehead and one on each mastoid area) maximizes the effect of the patented Nexalin waveform which focuses its stimulating energy solely on the area of the brain involving the antinociceptive system (including the hypothalamus and associated structures). Q. Is there anything special about the electrodes used during the Nexalin Therapy? A. Yes. The Nexalin Electrodes are specifically manufactured to be compatible with the Nexalin device and include a gel and adhesive that minimize the potential for skin irritation. The electrodes have been rigorously tested to meet high quality standards to ensure consistent performance.