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1 Hello, Enclosed you will find some information on the Bridge device. Please read through the material thoroughly and watch the video. As you are reading the information and viewing the video, write down all of your questions and concerns so you can discuss them with your provider. It is important for you to work closely with your physicians and counselors and follow their instruction. Working together will empower you with the information and support you need to be successful! Below is a link to a testimonial video so you can see how the device works:
2 Introduction The acute pain of withdrawals as measured by C.O.W.S (Clinical Opiate Withdrawal Scale) is one of the greatest barriers to detoxification and rehabilitation in the industry. While most in-patient and out-patient facilities have protocols in place, many who suffer from this acute and painful time need access to new, safe, non-narcotic options in pain management. Market Validation Protocol Advantage Be a facility that offers pain reduced Detox. Offer your patients a more humane path, using the BRIDGE. Distribution IHS, Inc. 829 S. Adams St. Versailles, IN Tel: Fax: Manufacturer Key Electronics, Inc Centennial Blvd. Jeffersonville, IN Used post surgically and by the VA for acute & chronic pain. Double blind studies and abstracts support the science. Over 30,000 applications of this technology. Researched by Arturo Taca MD 1. President of ASAM, Mid-west. Presently being used as part of other detox treatment programs. Problem Opioid and Heroin detox is painful and can take days or weeks to complete. Patients frequently quit before they can be moved to Medication Assisted Treatment (M.A.T.) due to pain. It is very difficult to get patients to Naltrexone/Vivitrol or similar M.A.T. due to pain and length of withdrawals. The Solution Innovative Health Solutions, Inc., has created a medical device, which offers acute pain patients an alternative to the pain and time of withdrawals. The BRIDGE device, part of the Neuro-Stim System (NSS), is an auricular peripheral nerve field stimulator. This low risk procedure, which provides neuro-modulating signals over 96 hours for a 4-5 day time period is a non-narcotic alternative to address the acute pain of withdrawal. Here are points identifying the benefits of the BRIDGE. 1. More humane treatment of patients. 2. More patients willing to complete the transition to rehabilitation. 3. An option, previously unavailable. Defensibility The BRIDGE device and technique methods are Patent Pending. IHS products have FSS, DAPA, DLA and ECAT contracts and agreements with the VA and Military. Our products are performing well in many rehab programs around the US. Market Opportunity Innovative Health Solutions, Inc. is the first to market anything like this in the detox arena. Our product is FDA a 510(K) cleared medical device 1. It has the potential to make a tremendous improvement in detox and rehab protocols. Why Test The NSS/BRIDGE? Let us show you that this works as stated. Allow us to help you improve your care and improve your bottom line, by doing an in-office test. Once you see, with your own eyes, that this works, you will want it in your detox and rehab system. 1 Dr. Taca is not financially compensated by IHS and is not paid for his research. Dr. Taca is a speaker for Vivitrol. 2 FDA 510(K)
3 How long do I wear the device? The device should be left on for the period of time recommended by your treating clinician. The device is designed to provide neuro-modulating signals for 96 hours over 4-5 days. How many treatments will I need? The BRIDGE is designed for a single use, for ACUTE pain. In rare situations a second device may need to be placed. Please discuss with your provider. How soon will I see results from the treatment? Acute pain will begin to diminish significantly in less than 30 minutes in most cases. What if my pain returns? If you begin to feel increased pain, that is significant, the most likely reason, is that your needle implants have become loose. Do the pinch test to reseat them. You may need to place new circle bandages in some situations. If after you have done this and waited 15 minutes, and your pain persists, contact your provider. Your provider may have non-narcotic medications that will assist you. What if I don t feel the pulsing? Should I take the device off? No. Your body will become attenuated or used to the pulsing so you may not always feel it. Just because you don t feel it does NOT mean it isn t working. If you have any questions call your provider and discuss this with them. What if my ear starts hurting during treatment? On rare occasions a patient may feel a stinging sensation where the electrodes are implanted. This is only a sensation and you will not get burned. If this happens, a gentle squee e with your fingers (Pinch Test) will help take care of the problem. If you try this and the pain continues please call your treatment provider. Are there any normal precautions? Yes. You need to take special care to not get the device wet while showering or washing your hair. Do not go swimming with the device in place. Do not immerse in water. It is an extremely safe, water resistant, low voltage electronic device that will simply stop working if the batteries get wet. And NO, you won t get shocked if it gets wet. How do I keep from getting the device wet when showering? Holding a dry washcloth over the device while showering or washing your hair works very well. We ve also had patients tell us they use a small empty margarine bowl with a dry cloth inside to hold over the device. Are there any side effects? Although extremely rare, there may be some side effects, which may include: Skin irritation Bleeding or infection at the site of implantation Pain at the site of implantation A sore ear Allergic reactions to the tape and adhesive Di iness Fainting Once the device treatment is over what do I do with the device? Place the device in waste bag provided by your treating clinician. Be sure to bring the waste bag containing the used device with you to your next treatment date. The clinician will properly dispose of it. We hope we have addressed any questions you may have about your treatment and what to expect. If you have any further questions please to be sure to ask your healthcare provider. Rev:3/16
4 Ask About Treatment With The BRIDGE is FDA cleared, applied in a simple 15 minute procedure and worn for 5 days, outpatient, at home. The BRIDGE is a safe and effective treatment to reduce or eliminate withdrawal pain with no narcotics and little or no side effects.
5 Bridge Recovery Program 1 Reduces withdrawal pain within minutes Relief lasts for up to 5 days while opiates leave system Ideal for people who can not go to inpatient treatment Can resume normal activities such as work, school, and family 2 Vivitrol/Naltrexone Completely blocks opiate receptors so heroin/pain pills are ineffective at producing high effect Lasts for up to 28 days so no daily dosing needed Non-addictive so no detox when ready to stop the medication Allows the brain time to heal Likely covered by insurance 3 Ongoing Counseling Flexible options included intensive outpatient, one on one, and group sessions Address the issues that led to addiction Learn how to build a new life post addiction Likely covered by insurance Contact Us For More Info Web: Phone: (812)
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