EPIVOLVE™ TRIPLE-DOSE EPINEPHRINE AUTO-INJECTOR

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AS DESCRIBED BY: Sonya RaabJillian HughesStephen Ellias Nolan Flaherty

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© 2012 The Nuvu Group, Cambridge, MA. All rights reserved.

This product may be covered by some or all of the following patents, patent applications and foreign equivalents thereof: U.S. Patent Nos. 5,358,489; 5,540,664; 5,665,071; and 7,297,136 and other pending U.S. Patent applications

Rx Only Manufactured and Distributed by:The Nuvu Group Cambridge, MA 02139 USA

DEVICE COMPONENTS 2

CLINICAL PROBLEMS 3

THE EPIVOLVE™ SOLUTION 4

PROCEDURE 5

FDA CLASSIFICATION 6

IMPORTANT PRODUCT INFORMATION 7

EPIVOLVE™ TRIPLE-DOSE EPINEPHRINE AUTO-INJECTOR

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2 EPIVOLVE™ Epinephrine Auto-Injector Device Components

COMPONENTS AND DIMENSIONS

4 1/4 inches

1 inch

1/2 in

ch

Needle

Outer Customizable Shell

Interchangeable Tri-Dose Epinephrine Cartridge

Injection Dial

DIMENSIONSOuter Unit: 4 1/4 in by 1 inInner Cartridge: 3 in by 3/4 in Ejected Needle: 1/2 in

ANAPHYLAXISA GROWING CONCERNOver the past two decades, anaphylaxis in children, teens and adults has risen dramatically, growing by 27% from 1998 to 2008 according to the CDC (graph right.)

In the United States and Europe alone, estimates put the current population at risk for anaphylaxis at close to 100 million.

EPI-PENSA LACK OF ATTRACTION5 out of 6 fatal anaphylactic reactions occur outside of one’s home and lack a dose of epinephrine.

In a national survey, 87% of anaphylaxis victims admitted they choose to not epinephrine simply because they are embarrassed to be carrying around the device.²

Because 1 in 2 anaphylaxis victims will need a second injection before medical attention arrives, it requires multiple devices to be carried at once.

Devices on the market today offering more than one injection per device are difficult to use and require steps that may be difficult for a person in anaphylactic shock to complete.

3 EPIVOLVE™ Epinephrine Auto-Injector Clinical Problems

CLINICAL PROBLEMS

Epinephrine devices are lot to carry around on a daily basis.

Rise in hospital discharges related to anaphylactic reactions from 1996 to 2006¹.

1. Center for Disease Control/National Health Interview Survey, September 2008. 2. American Academy of Allergy Asthma and Immunology Survey, June 2005.

EPIVOLVE™ EPI-PEN™ TWINJECT™

Dosages per unit 3 1 2

Interchangeable Cartridges ✔

Unit Size 4 1/4 inches by 1 inch

5 1/2 inches by 3/4 inch

6 inches by 1/2 inch

Customizable Enclosure ✔

Retractable Needle ✔ ✔

FDA Class II II II

Cost Per Injection $26 $58 $39

EPIVOLVE™ VS. COMPETITION

4 EPIVOLVE™ Epinephrine Auto-Injector The Epivolve™ Solution

INTERCHANGEABLE THREE DOSE CARTRIDGEOur patented triple dose cartridge supplies three measured does of epinephrine in case multiple injections are necessary. Unlike other systems, the Epivolve™ requires only a simple dial turn to ready a new dose. And when all three are used, the cartridge can be simply removed and refilled by your doctor.

CUSTOMIZABLE ENCLOSUREEpivolve™ allows its user to create customized shells through our online website, giving users the freedom to create an Epivolve™ all their own. No longer will people feel embarrassed to carry around a bulky, plastic device.

SLEEK DESIGNThe days of carrying a bulky auto-injector are over. Epivolve™ features a lighter, smaller frame than its competition. Because it’s no bigger than a ballpoint pen, the device can be brought anywhere with little discomfort or embarrassment.

WHAT MAKES EPIVOLVE™ DIFFERENT?

THRUST DEVICE AT RIGHT ANGLE INTO THIGH. HOLD FOR 5 SECONDS.

Thrust your Epivolve into your upper thigh and hold in for 5 seconds to let medicine inject.

After five seconds, remove from leg and turn knob at top of device.

SEEK MEDICAL ATTENTIONMedical attention is still necesary immediately following injection. Dial 911 or have another

person take you to a hospital IMMEDIATELY. If another anaphylactic shock is to come on again, repeat steps for another injection.

REMOVE EPIVOLVE™ FROM CASERemove the Epivolve from its accompanying case. If no case, skip this step.

PULL BLUE TABAt the top of the Epivolve, there is a blue tab that must be pulled before injection. No not touch the orange end.

GRIP EPIVOLVE FIRMLY IN HANDGrip the Epivolve firmly in hand with the orange end pointing towards your body.

5 EPIVOLVE™ Epinephrine Auto-Injector Procedure

PROCEDURE

STEP 1 STEP 2 STEP 3

STEP 5STEP 4

6 EPIVOLVE™ Epinephrine Auto-Injector FDA Classification

FDA CLASSIFICATION

CLASSIFICATION Epivolve™ has been registered as a Class II medical device by the Food and Drug Administration. The device has a mild risk 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 (Type I) including anaphylaxis to stinging insects (e.g. order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g. triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g. radiocontrast media), and other allergens, as well as anaphylaxis to unknown substances (idiopathic anaphylaxis) or exercise-induced anaphylaxis.

SAFETY INFORMATION Epivolve™ should only be injected into the anterolateral aspect of the thigh. Accidental injection into the hands or feet may result in loss of blood flow to the affected area and should be avoided. DO NOT INJECT INTO BUTTOCK. DO NOT INJECT INTRAVENOUSLY.

Epinephrine should be administered with caution to patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence of these 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 in blood pressure; convulsions; respiratory difficulties; vomiting, diarrhea or cramps; pruritus; or angioderma. Epivolve™ is designed 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 of injectable epinephrine if doses lower than those available from Epivolve™ are felt to be necessary (e.g., patients who weigh less than 15 kilograms approximately 33 pounds). IN ALL CASES, THE PHYSICIAN SHOULD INSTRUCT THE PATIENT AND/OR ANY OTHER PERSON WHO MIGHT BE IN A POSITION TO ADMINISTER THE EPINEPHRINE, IN THE PROPER USE OF EPIVOLVE™.

7 EPIVOLVE™ Epinephrine Auto-Injector Important Product Information

IMPORTANT PRODUCT INFORMATION

WHO SHOULD NOT USE EPIVOLVE™? There are no absolute contraindications to the use of Epivolve™ in a life-threatening allergic reaction. People with certain medical conditions have a higher chance of getting serious side effects from Epivolve™. Tell your doctor about all your medical 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, and herbal supplements. Some medicines may cause serious side effects if taken while you use Epivolve™. Some medicines may affect how Epivolve™ works, or Epivolve™ may affect how your other medicines work. Diabetic patients may need to 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 room temperature 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.

SIDE EFFECTS Overdosage can cause dangerously high blood pressure, stroke, or death. If you take certain medicines, you may develop serious life-threatening side effects from the epinephrine in Epivolve™. Be sure to tell your doctor about all the 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 chest pain (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 away with 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

8 EPIVOLVE™ Epinephrine Auto-Injector Important Product Information