1. What is the Lifeshirt® System?
2. What is continuous ambulatory monitoring?
3. How does the LifeShirt® System work?
4. What type of data does the LifeShirt® System collect?
5. What is inductive plethysmography?
6. How does inductive plethysmography differ from other monitoring techniques such as impedence plethysmography?
7. How is the LifeShirt® System different from other ambulatory respiratory and cardiac monitoring systems?
8. What are the intended markets for the LifeShirt® System?
9. In what types of settings can the LifeShirt® System be used?
10. Is the LifeShirt® available now?
11. How was the LifeShirt® System developed?
12. Where can I get the LifeShirt® ?
13. Is the LifeShirt® equivalent to polysomnography (PSG)?
14. What size does the LifeShirt® come in?
15. When will we receive the VivoLogic® reports?

1. What is the LifeShirt® System?
The LifeShirt® System is the first non-invasive, continuous ambulatory monitoring system that can collect data on pulmonary, cardiac, and other physiologic data, and correlate them over time. The LifeShirt® System gathers data during the subject's daily routine, so pharmaceutical and academic researchers get a continuous "movie" of the subject's health in real-life situations (work, school, exercise, sleep), rather than the "snapshot" generated during a typical clinic visit.

VivoMetrics® has received the following market clearances and certifications for the LifeShirt® System: US FDA 510(k) market clearance, Health Canada market clearance, European CE Mark certification, ISO 13485 registration. VivoMetrics® has more than 13 patents covering wearable sensor design and proprietary software algorithms.

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2. What is continuous ambulatory monitoring?
Continuous ambulatory monitoring is the observation of a patient's physiologic data over time while that patient is outside the clinical setting (e.g., while the patient is at home or at work).

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3 . How does the LifeShirt® System work?
At the heart of the LifeShirt® System technology is a respiratory monitoring method called inductive plethysmography, which enables researchers to capture a highly accurate view of a subject's breathing. Protected by multiple patents and based on clinically proven, hospital-tested technology, the LifeShirt® System includes the following components:

• LifeShirt® garment: The central component of the system is the LifeShirt® Garment - a lightweight (8 oz.), comfortable, machine-washable, easy-to-use shirt which is worn by the subject during daily activities, such as going to work or school, exercise and sleep. To measure pulmonary function, sensors are woven into the shirt around the subject's chest and abdomen. A single-channel ECG measures cardiac function, and a dual-axis accelerometer records subject posture and physical activity.
• Optional peripheral devices measure blood pressure, blood oxygen saturation, EEG, EOG, periodic leg movement, core body temperature, skin temperature, end tidal CO2 and a throat microphone records cough/snore sounds.
• VivoLogic® software: The recorded data are decrypted and processed using VivoLogic® software's patented algorithms. The resulting full-disclosure, high-resolution waveform data can be easily integrated into Oracle clinical, SAS or custom databases.
• VivoMetrics® Data Center: Data can be uploaded via the Internet or data cards can be sent by courier to the VivoMetrics® Data Center, where analysts and database specialists process and score the incoming data using VivoLogic® software. Optional physician overreads are done as needed. The Data Center staff also provides technical support for customers using VivoLogic® software on their personal computers.
• Data and Report Formats: Because data can be formatted for Oracle clinical, SAS or can be customized, researchers can easily integrate them into their master clinical trial database. Sites can choose to receive reports and data sets on a daily basis or at the completion of the study via ftp, e-mail, fax or courier.

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4. What type of data does the LifeShirt® System collect?
The LifeShirt® System is able to collect patient data through various sensors, including respiratory bands (which measure pulmonary function) and an ECG (which records electrical activity of the heart). It also tracks and records posture and activity information. The system includes an electronic patient diary, the VivoLog® Digital Diary, to record subjective patient data about mood, symptoms and activity.

Using the optional Serial Expansion Module, the system can also collect data from up to six third-party peripheral devices, including:

• Oxford BioSomnia EEG Device
• PAM-RL Leg Activity Monitor
• Nonin XPod Pulse Oximeter
• Oridion VitalCap Capnograph
• Critikon Dinamap Pro 100 Noninvasive Blood Pressure Monitor
• Exacon Scientific A/S Tympanic Membrane Temperature Sensor
• CON-SPACE Throat Microphone (Note: the microphone is validated to be used alone, not with any other peripheral device)

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5. What is inductive plethysmography?
Respiratory inductive plethysmography (RIP) is the gold standard for respiratory monitoring. Used in more than 1,000 hospital intensive care units worldwide, IP is ideal for monitoring accurate tidal volume of all subjects, including those who are unable to use spirometers due to age or other factors.

As deployed in the LifeShirt® System, IP measures changes in the cross sectional area of the rib cage and abdomen over time and applies a series of proprietary algorithms to the data to calculate the amount of air either inhaled or exhaled during respiration. Two parallel, sinusoidal arrays of insulated wires embedded in elastic bands are woven into the LifeShirt®, surrounding the rib cage and abdominal areas of the torso. Extremely low voltage electrical current is passed through the wire creating an oscillating circuit. As the two body chambers expand and contract, the electrical sensors generate different magnetic fields that are converted into proportional voltage changes over time (i.e., waveforms).

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6. How does inductive plethysmography differ from other monitoring techniques such as impedence plethysmography?
As incorporated into the LifeShirt®, inductive plethysmography provides robust respiratory measures even when subjects are in motion. It does not depend on precise electrode placement for repeatable results from monitoring session to monitoring session, and, in contrast to impedance pneumography, no electricity passes through the monitored individual. It reduces the signal interference and distortion that is often associated with other monitoring technologies, enabling clinicians to obtain more accurate measurements or respiration.

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7. How is the LifeShirt® System different from other ambulatory respiratory and cardiac monitoring systems?
Inductive plethysmography, which is the LifeShirt® foundation, surpasses other measurement techniques because of its ability to measure respiratory volumes quantitatively and to detect both central and obstructive apneas (breathing cessation). While there are ambulatory technologies capable of measuring one parameter at a time, the LifeShirt® System is the only non-invasive continuous ambulatory monitoring system that can simultaneously collect data on cardiopulmonary and other parameters, subjective patient experiences and data from third-party peripheral devices and correlate them over time.

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8. What are the intended markets for the LifeShirt® System?
Originally developed to serve researchers in the pharmaceutical industry in need of improved monitoring during clinical studies, the value of the platform technology underlying the LifeShirt® system was quickly identified by the company and external audiences.

Today, the company's core market customers are: first responder and biohazard personnel, athletic trainers and coaches, and preclinical, clinical and academic and corporate researchers.

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9. In what types of settings can the LifeShirt® System be used?
Subjects can wear the LifeShirt® System virtually anywhere and anytime. For instance, LifeShirt® has been worn on Mount Everest, in auto races, on the International Space Station, during 1000 degree flashover exercises and in the Sahara.  It has been certified for use on commercial airplanes. LifeShirt® can be used during normal everyday activities at work, home, play and during sleep – but not while swimming or bathing.

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10. Is the LifeShirt® available now?
Yes, the LifeShirt® is incorporated into the product lines of resellers and is carried by international distributors. It is also available directly from VivoMetrics. For more information please call 805-667-225 and ask for sales or email info@vivometrics.com.

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11. How was the LifeShirt® System developed?
Inductive plethysmography was originally developed in the mid 1970s by Marvin Sackner, M.D. for the Respitrace® System, which monitors respiration in a hospital setting. In 1999, VivoMetrics® acquired key patents encompassing wearable sensor design and software algorithms pertaining to inductive plethysmography technology, and established a team of biomedical engineers and medical device specialists to adapt inductive plethysmography for ambulatory applications. The company then integrated inductive plethysmography with other ambulatory physiologic sensors, developed accompanying data analysis software and brought all of these components together to produce the LifeShirt® System.

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12. Where can I get the LifeShirt® Preclinical and Clinical Systems?
The LifeShirt® is incorporated into the product lines of resellers and is carried by international distributors. It is also available directly from VivoMetrics. For more information please call 805-667-225 and ask for sales or email info@vivometrics.com.

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14. Is the LifeShirt® equivalent to polysomnography (PSG)?
The LifeShirt® System is equivalent to PSG for the detection of apneas and hypopneas. We are currently conducting validation studies to show equivalence to other PSG parameters.

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15. What size does the LifeShirt® come in?
The LifeShirt® Clinical System is available in 15 sizes, ranging from Pediatric (for ages 5-17) to 5XL. The LifeShirt® Preclinical is avialable for non-human primates, canines, and swine in a variety of sizes.

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16. When will we receive the VivoLogic® reports?
VivoLogic® reports are produced by software distributed by VivoMetrics® for use in conjunction with the LifeShirt® . Researchers can produce these reports as soon as data had been acquired by the LifeShirt®. In the case of pharmaceutical drug trials where the Company is providing a turn-key service to trial sponsors, reports are issued within 48 hours of data upload of each subject's data from investigator sites. These individual reports are followed-up by consolidated data sets once all subject data has been uploaded.