the group EPIVOLVE™ TRIPLE-DOSE EPINEPHRINE AUTO- INJECTOR DEVICE COMPONENTS 2 CLINICAL PROBLEMS 3 THE EPIVOLVE™ SOLUTION 4 PROCEDURE 5 FDA CLASSIFICATION 6 IMPORTANT PRODUCT INFORMATION 7
2 EPIVOLVE™ Epinephrine Auto-Injector Device ComponentsCOMPONENTS AND DIMENSIONS 1 in ch es n ch i 4 1/ 4 Injection Dial Interchangeable Tri-Dose Epinephrine Cartridge ch Outer Customizable Shell in 2 1/ NeedleDIMENSIONS Outer Unit: 4 1/4 in by 1 in Inner Cartridge: 3 in by 3/4 in Ejected Needle: 1/2 in
3 EPIVOLVE™ Epinephrine Auto-Injector Clinical ProblemsCLINICAL PROBLEMSANAPHYLAXISA GROWING CONCERNOver the past two decades,anaphylaxis in children, teens andadults has risen dramatically, growingby 27% from 1998 to 2008 accordingto the CDC (graph right.)In the United States and Europealone, estimates put the currentpopulation at risk for anaphylaxis atclose to 100 million.EPI-PENS Rise in hospital discharges related to anaphylactic reactions from 1996 to 2006¹.A LACK OF ATTRACTION5 out of 6 fatal anaphylactic reactionsoccur outside of one’s home and lacka dose of epinephrine.In a national survey, 87% ofanaphylaxis victims admitted theychoose to not epinephrine simplybecause they are embarrassed to becarrying around the device.²Because 1 in 2 anaphylaxis victimswill need a second injection beforemedical attention arrives, it requiresmultiple devices to be carried atonce.Devices on the market today offeringmore than one injection per deviceare difﬁcult to use and require stepsthat may be difﬁcult for a person in Epinephrine devices are lot to carry around on a daily basis.anaphylactic shock to complete.1. Center for Disease Control/National Health Interview Survey, September 2008.2. American Academy of Allergy Asthma and Immunology Survey, June 2005.
4 EPIVOLVE™ Epinephrine Auto-Injector The Epivolve™ Solution EPIVOLVE™ VS. COMPETITION EPIVOLVE™ EPI-PEN™ TWINJECT™ Dosages per unit 3 1 2 Interchangeable ✔ Cartridges 4 1/4 inches by 5 1/2 inches by 6 inches by Unit Size 1 inch 3/4 inch 1/2 inch Customizable ✔ Enclosure Retractable Needle ✔ ✔ FDA Class II II II Cost Per Injection $26 $58 $39 WHAT MAKES EPIVOLVE™ DIFFERENT? INTERCHANGEABLE THREE DOSE CUSTOMIZABLE ENCLOSURE SLEEK DESIGN CARTRIDGE Epivolve™ allows its user to create customized The days of carrying a bulky auto-injector are Our patented triple dose cartridge supplies shells through our online website, giving users over. Epivolve™ features a lighter, smaller three measured does of epinephrine in case the freedom to create an Epivolve™ all their frame than its competition. Because it’s no multiple injections are necessary. Unlike other own. No longer will people feel embarrassed to bigger than a ballpoint pen, the device can be systems, the Epivolve™ requires only a simple carry around a bulky, plastic device. brought anywhere with little discomfort or dial turn to ready a new dose. And when all embarrassment. three are used, the cartridge can be simply removed and reﬁlled by your doctor.
5 EPIVOLVE™ Epinephrine Auto-Injector ProcedurePROCEDURE STEP 1 STEP 2 STEP 3 REMOVE EPIVOLVE™ FROM CASE PULL BLUE TAB GRIP EPIVOLVE FIRMLY IN HAND Remove the Epivolve from its accompanying At the top of the Epivolve, there is a blue tab Grip the Epivolve ﬁrmly in hand with the orange case. If no case, skip this step. that must be pulled before injection. No not end pointing towards your body. touch the orange end. STEP 4 STEP 5 THRUST DEVICE AT RIGHT ANGLE INTO SEEK MEDICAL ATTENTION THIGH. HOLD FOR 5 SECONDS. Medical attention is still necesary immediately Thrust your Epivolve into your upper thigh and following injection. Dial 911 or have another hold in for 5 seconds to let medicine inject. person take you to a hospital IMMEDIATELY. If After ﬁve seconds, remove from leg and turn another anaphylactic shock is to come on knob at top of device. again, repeat steps for another injection.
6 EPIVOLVE™ Epinephrine Auto-Injector FDA ClassiﬁcationFDA CLASSIFICATIONCLASSIFICATIONEpivolve™ has been registered as a Class II medical device by the Food and Drug Administration. The device has a mildrisk for side effects (listed below) and requires users to seek contact of medical help IMMEDIATELY after injection.INDICATIONEpivolve™ (epinephrine injection, USP 1:1000) is indicated in the emergency treatment of severe allergic reactions (TypeI) including anaphylaxis to stinging insects (e.g. order Hymenoptera, which includes bees, wasps, hornets, yellow jacketsand ﬁre ants), and biting insects (e.g. triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testingsubstances (e.g. radiocontrast media), and other allergens, as well as anaphylaxis to unknown substances (idiopathicanaphylaxis) or exercise-induced anaphylaxis.SAFETY INFORMATIONEpivolve™ should only be injected into the anterolateral aspect of the thigh. Accidental injection into the hands or feetmay result in loss of blood ﬂow to the affected area and should be avoided. DO NOT INJECT INTO BUTTOCK. DO NOTINJECT INTRAVENOUSLY.Epinephrine should be administered with caution to patients with cardiac arrhythmias, coronary artery or organic heartdisease, or hypertension. In patients with coronary insufﬁciency or ischemic heart disease, epinephrine may precipitateor aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence ofthese conditions is not a contraindication to epinephrine administration in an acute life-threatening situation.Adverse reactions to epinephrine may include ﬂushing; apprehension; syncope; tachycardia; thready pulse with a fall inblood pressure; convulsions; respiratory difﬁculties; vomiting, diarrhea or cramps; pruritus; or angioderma. Epivolve™ isdesigned as an emergency supportive therapy only and is not a replacement or substitute for immediate medical care.Since the doses of epinephrine delivered from Epivolve™ are ﬁxed, the physician should consider other forms ofinjectable epinephrine if doses lower than those available from Epivolve™ are felt to be necessary (e.g., patients whoweigh less than 15 kilograms approximately 33 pounds). IN ALL CASES, THE PHYSICIAN SHOULD INSTRUCT THEPATIENT AND/OR ANY OTHER PERSON WHO MIGHT BE IN A POSITION TO ADMINISTER THE EPINEPHRINE, IN THEPROPER USE OF EPIVOLVE™.
7 EPIVOLVE™ Epinephrine Auto-Injector Important Product InformationIMPORTANT PRODUCT INFORMATIONWHO SHOULD NOT USE EPIVOLVE™?There are no absolute contraindications to the use of Epivolve™ in a life-threatening allergic reaction. People with certainmedical conditions have a higher chance of getting serious side effects from Epivolve™. Tell your doctor about all yourmedical conditions, but especially if you:• have heart disease or high blood pressure• have diabetes• have thyroid conditions• have asthma• have depression or other mental disease• have Parkinson’s disease• are pregnant• are allergic to any of the ingredients in Epivolve™Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, andherbal supplements. Some medicines may cause serious side effects if taken while you use Epivolve™. Some medicinesmay affect how Epivolve™ works, or Epivolve™ may affect how your other medicines work. Diabetic patients may needto adjust the dose of their diabetes medicines or insulin after using Epivolve™.STORAGEThe medicine in Epivolve™ can be damaged by light. Therefore, keep it in an area of general low light. Keep it at roomtemperature and protect it from freezing. Do not refrigerate. Keep Epivolve™ with you at all times. Check your Epivolve™regularly to be sure:• it has not expired• the medicine in Epivolve™ is not cloudy, discolored, or has particles in it.Replace the Epivolve™ if needed.
8 EPIVOLVE™ Epinephrine Auto-Injector Important Product InformationSIDE EFFECTSOverdosage can cause dangerously high blood pressure, stroke, or death. If you take certain medicines, you maydevelop serious life-threatening side effects from the epinephrine in Epivolve™. Be sure to tell your doctor about allthe medicines you take, especially medicines for asthma.Patients with certain medical conditions, or who take certain medicines, may get more side effects from Epivolve™,or the side effects may last longer. This includes patients who take certain types of medicines for asthma, allergies,depression, hyperthyroidism, high blood pressure, and heart disease. Patients with heart disease may feel chestpain (angina). Patients with mental disease or Parkinson’s disease may have worsening symptoms of their illness.Epivolve™ (epinephrine) can cause the following reactions. Some reactions can be serious. They usually go awaywith rest. Common side effects include, but not limited to:• fast, irregular heartbeat• throbbing headache• paleness• feelings of over excitement, anxiety, or fear• weakness or shakiness• dizziness• nausea and vomiting