Natural Healing Patient Information Guide. Customized Platelet Plasma Products PRC PLC PCP

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Allan Atkinson
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1 TriCell Customized Platelet Plasma Products Natural Healing Patient Information Guide Natural Selection & Natural Retention Platelet Lite Concentrate Accelerate Natural Recovery Platelet Rich Concentrate PRC PCP PLC Platelet Conditioned Plasma Retain Natural Beauty

2 COMPOSITION OF WHOLE BLOOD: WHAT DO I NEED TO KNOW? Plasma: Constitutes about 52-62% of whole blood. Plasma is a fluid, composed of ~92% water, 7% vital proteins such as albumin, gamma globulin, clotting factors, and 1% mineral salts, sugars, hormones, fats, and vitamins. Buffy Coat: Contains White Blood Cells (WBC) and Platelets, which constitute less than 1% (each) of whole blood. WBC, or leukocytes, are one of the body s defenses against disease. Platelets, or thrombocytes, are small, colorless cell fragments in the blood whose main function is to interact with clotting proteins to stop or prevent bleeding. Platelets also contain growth factors, necessary for stem cell attraction. Red Blood Cells (RBC): RBC, or erythroctes, constitute approx % of whole blood. These cells carry oxygen from the lungs to the body s tissue and take carbon dioxide back to the lungs to be exhaled. What Is Platelet Rich Plasma (PRP)? Platelet Rich Plasma is a concentration of platelets and growth factors created from a small amount of your own blood or bone marrow. Increased levels of growth factors have the potential to improve signaling and recruitment of cells. The Natural Healing Power of PRP The human body has a remarkable capacity to heal itself. Regeneration of new tissue is accomplished by stem cells and is fostered by growth factors and hormones. PRP is an emerging treatment modality integrated in many medical specialties: i.e. Orthopedics, Wound Healing, Surgery, Aesthetic & Sexual Medicine. Healing after an injury involves a well-orchestrated and complex series of events whereby proteins in the blood act as messengers to regulate the entire process. Many proteins involved in the healing process are derived from platelets. They are formed in the bone marrow and are freely passing through the bloodstream in a resting state. However, when an injury occurs, platelets become activated and start to gather at the injury site to release beneficial proteins called Growth Factors. This is the beginning of the healing process. Healing Cascade: How Does the PRP Process Work? The body signals platelets and other components in our blood supply to migrate to the site of injury. Platelets are the injury s first responders. Under normal conditions these platelets release various factors that initiate and subsequently stimulate bone and cartilage regeneration and repair, promote new blood vessel development to accelerate tissue regeneration, and stop bleeding. Platelets release many other bioactive proteins responsible for attracting macrophages, mesenchymal stem cells, and osteoblasts. Platelets contain two types of granules, alpha granules and dense bodies. Alpha granules contain growth factors that are released during the healing process. Growth Factors & Cytokines (proteins) found in platelets: Platelet-Derived Growth Factor (PDGF) Transforming Growth Factor (TGF) Fibroblast Growth Factor (FGF) Insulin-Like Growth Factor (IGF) 1&2 Vascular Endothelial Growth Factor (VEGF) Epidermal Growth Factor (IGF) Interleukin-8 Keratinocyte Growth Factor (KGF) Connective Tissue Growth Factor (CTGF) Source: American Red Cross Image shows TriCell PRP Kit after 1st centrifugation Injury Hemostasis Inflammation

Considerations Prior to PRP Treatment Certain factors (e.g. Smoking and/or Alcohol) diminish stem cell release. Avoiding these will increase the success of the PRP procedure.

3 Considerations Prior to PRP Treatment Certain factors (e.g. Smoking and/or Alcohol) diminish stem cell release. Avoiding these will increase the success of the PRP procedure. Platelets work by evoking an inflammatory reaction. If this inflammatory reaction is diminished, the clinical outcome can be compromised. For this reason, the use of anti-inflammatory medications after the procedure is not recommended. This restriction, in consultation with your physician, may remain in place for about 1 to 2 weeks. Preparation of PRP A small amount of blood is drawn from the patient s arm. The blood is then placed in the TriCell Process Kit and then centrifuged to separate the platelets from the rest of the blood components. A typical baseline blood platelet count is ~ per microliter; therapeutic TriCell PRP concentrate the platelets roughly 5-9 fold. The entire process takes less than 15 minutes and increases the concentration of platelets and growth factors up to 600%, along with an inherent rise in human stem cell proliferation due to exposure to concentrated platelets up to 10 times above native levels. The concentrated PRP is then applied or injected into and around the affected area, jump-starting and significantly strengthening the body s natural healing signals. Not all PRP Systems are Equivalent Proponents of PRP therapy argue that negative clinical results are associated with poor-quality PRP harvest or concentration by inadequate devices. Variability in platelet concentrating techniques may alter platelet degranulation characteristics, which could negatively affect clinical results. Proper concentration and handling to minimize manipulation steps will yield the best results. Who Should Not Have PRP Treatment? Although PRP is a promising therapy for most patients, there are a few special considerations. Contraindications include the following: Heavy Nicotine, Drug, and Alcohol Consumption Chronic Pathological Conditions of the Liver Severe Metabolic and Systemic Disorders Systemic Lupus Erythematosus Platelet Dysfunction Syndrome Acute and Chronic Infections Critical Thrombocytopenia Hemodynamic Instability Anticoagulation Therapy Cancer/Chemotherapy Hypofibrinogenemia Porphyria Sepsis Tissue Regeneration Tissue Remodeling Healed

ORTHOPEDIC / SPORTS RELATED INJURIES Remain Active Whether you have experienced a Sports Related Injury, suffering from Arthritis, or require some form of Orthopedic or Dental Surgery, the use of

Hair ENT Facial Shoulder Eye Dental Hip Elbow Knee Ankle Heel Wrist Knuckle Typical Orthopedic Conditions Treated with PRP PRP Injections can treat a number of conditions for the hip, knee, arm,

4 ORTHOPEDIC / SPORTS RELATED INJURIES Remain Active Whether you have experienced a Sports Related Injury, suffering from Arthritis, or require some form of Orthopedic or Dental Surgery, the use of your own Healing Factors can accelerate your healing process. Hair ENT Facial Shoulder Eye Dental Hip Elbow Knee Ankle Heel Wrist Knuckle Typical Orthopedic Conditions Treated with PRP PRP Injections can treat a number of conditions for the hip, knee, arm, shoulder, lower leg, and feet. Typical conditions that can be treated with PRP are: Acute Muscle Tears & Strains Chronic Tendinopathies (Tennis Elbow, Achilles Tendon, Patellar Tendon & Totator Cuff) Ligament Injuries (Medial or Lateral Collateral Ligament MCL/LCL) Osteoarthritis. Outcomes Patients can expect to see significant improvement in symptoms over the course of healing time. This procedure may eliminate the need for further invasive treatments, such as surgery or prolonged use of medication. Other treatments such as corticosteroid injections may provide temporary relief and stop inflammation, but can be quite debilitating over the long-term. PRP injections stimulate healing over a shorter time period with less side effects. Patients typically report a gradual improvement in symptoms and return of function. Many patients require two to three treatments to obtain optimal results and may even experience a dramatic return of function and relief within 2-3 months. Recovery After Treatment The anesthetic used to numb the skin generally wears off in 1-2 hours. Mild pain and swelling may occur at the injection site. However, the majority of patients are able to return to usual activities with NO down time. Post Treatment Care You must be particularly careful not to traumatize the area during this post-treatment time frame. Initially the procedure may cause some localized soreness and discomfort. Patients can apply ice and elevation as needed. After a week the patient will likely begin a rehabilitation program with physical therapy. Pain medication will be prescribed if needed. Technique is Critical Proper diagnosis and implementation of ultrasound imagery will substantially facilitate accurate administration of PRP thereby maximizing therapeutic effectiveness. Aging is Natural Accelerate Natural Recovery

5 ELECTIVE COSMETIC PROCEDURES Retain Youthful Appearance Aging effects cells and dermal layers, leading to a deterioration of skin appearance and texture. This is characterized by sagging jowls, thinning of the skin, puffiness, age spots and wrinkling. Typical Aesthetic Conditions Treated with PRP PRP has been used to treat Acne, Scarring, and Alopecia. It is also effective for Skin Rejuvenation and tightening around the eyes (for thin crepe-like skin & fine lines) and in the following areas: Cheeks, Midface, Jawline and Sub-Malar Regions Thinning Skin on the Neck, Décolleté Back of Hands Other, i.e. Knees, Elbows, Upper Arms, as well as Post-Pregnancy Skin Laxity. Outcomes PRP is injected by multiple tiny punctures under the dermis, with or without topical local anesthesia. The process is painless with topical anesthesia. When PRP is injected into the damaged area, it stimulates the tissue, causing mild inflammation that triggers the healing cascade. As a result, new collagen begins to develop. As this collagen matures, it begins to shrink and tightens and strengthens the skin. Improvement in skin texture and tone is typically noticeable within 3 weeks. Full collagen regeneration typically requires 3 months. Topical skin care and light therapies can enhance these results. Recovery After Treatment PRP treatments can be used on all skin types and tones. Minimal swelling, bruising, and redness for the initial 12 to 24 hours can be expected. A slight bruise at the needle-stick site may be visible for 2 to 3 days. Swelling from the fluid is what the patient will notice first. During several weeks, platelets stimulate growth factors, which assists in collagen stimulation. Treatment results vary but last up to 18 months in most patients. Bi-annual touch-up treatments will maintain the results. As an initial treatment strategy, up to 3 injections may be given within a 6-month time frame, performed 2 to 3 weeks apart. Technique is Critical PRP application is an adjunctive tool in Dermatology. It can be used as part of a multi-faceted and synergistic approach. Improved clinical outcomes can be obtained with concomitant use of Laser, Hyaluronic Acid/Fillers, Adipose/Collagen & Mesotherapy. Aging is Natural Retain Natural Youth Forehead Glabellar Crow s Feet Under-Eye Cheeks Smile Lines Lips Chin Neck Skin Neckline Breast Finger & Hand

FREQUENTLY ASKED QUESTIONS Is PRP Treatment Painful? Patients usually tolerate the injection well. However, there can be soreness after the injection due to the PRP-induced inflammatory response.

Most patients see some improvement within 2-6 weeks. The pain diminishes as the weeks pass with most clinical trials reporting improvement up to 6-9 months post injection.

Are You a Candidate for Treatment with TriCell PRP? Talk to your doctor or physician and ask if TriCell PRP is right for you.

6 FREQUENTLY ASKED QUESTIONS Is PRP Treatment Painful? Patients usually tolerate the injection well. However, there can be soreness after the injection due to the PRP-induced inflammatory response. You may expect swelling and soreness during the first 48 hours post injection and may be given pain medication to help alleviate the discomfort. How Quickly Does PRP Work? Most patients see some improvement within 2-6 weeks. The pain diminishes as the weeks pass with most clinical trials reporting improvement up to 6-9 months post injection. Is PRP Reimbursed by Insurance? PRP is not typically covered by medical health care providers. Please speak with your health care consultant concerning financial aspects of the use of PRP. Are You a Candidate for Treatment with TriCell PRP? Talk to your doctor or physician and ask if TriCell PRP is right for you. Your physician will perform an examination to make a determination if the use of PRP will benefit you. If you are taking anti-inflammatory medications or blood thinners, your physician may temporarily discontinue the use of these until your treatment has taken place. What Is The Future of PRP? As people seek out alternative options to surgery for injuries and other conditions, therapies such as PRP will become more in demand. Not only are patients excited about it but physicians are as well as it gives them more options to offer their patients. Treating patients with their own biologic components is revolutionary and more than likely just the beginning of these forms of treatment options. Accelerate Natural Recovery

Depending on your treatment requirements, TriCell allows your physician to produce a plasma product with high or low counts of

100% Customizable allows to adjust the required cell composition Natural Selection & Natural Retention 100% Natural utilizes only the

7 WHAT IS TRICELL PLATELET PLASMA? The TriCell Platelet Plasma Kit is designed to produce a Platelet Plasma Product that can be individualized to meet your specific needs. Depending on your treatment requirements, TriCell allows your physician to produce a plasma product with high or low counts of Platelets, White Blood Cells and/or Red Blood Cells. 100% Customizable allows to adjust the required cell composition Natural Selection & Natural Retention 100% Natural utilizes only the patient s own blood Accelerate Natural Recovery Platelet Rich Concentrate PRC Platelet Lite Concentrate PCP PLC Platelet Conditioned Plasma Retain Natural Beauty 100% Volume Control allows to dial-in the required final volume 0% Contamination sterile single use disposable, closed system < 10min Process rapid point of care processing

8 TriCell Customized Platelet Plasma Products Distributed by: REV-MED International GmbH Einsteinstraße Munich, Germany EC REP REV-MED International GmbH Einsteinstraße Munich Germany Tel.: Fax: REV-MED Inc. #301 Joongil Eines Plaza 464 Dunchon-daero Jungwon-gu, Seongnam-si Gyonggi-do ZIP South Korea e-brochure: The information provided is for general background reading only and should not be relied upon for treatment. Advice should always be taken from a registered medical practitioner for individual circumstances and for treatment of any patient in any circumstances. No liability is accepted by REV-MED in respect of the content or omission or for any reason or as a result of treatment in individual circumstances. This information is not for use in the USA. All trademarks herein are the property of REV-MED unless otherwise indicated. DOC RM004-A 03/17

Arizona Natural Medicine Physicians, PLLC

Arizona Natural Medicine Physicians, PLLC PRP CONSENT FORM DESCRIPTION OF PRP PROCEDURES The SkinPen FDA approved Microneedling device is used for Microneedling skin microneedling system, or Collagen Induction Therapy (hereinafter referred to