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Q:Is FibroTouch equivalent to ultrasound system?

A:

1. FibroTouch consists of two modules, namely ultrasound detection module and elasticity detection module.
2. FibroTouch is not a simple combination of ultrasound detection and elasticity detection functions. It collects data from information sources and provides the comprehensive detection solution to liver tissue morphology, liver fibrosis level and fatty degeneration of liver with the patented transient elastography. It processes information from different sources, increases the detection speed 6 to 7 times as fast as competitors and presents more accurate results.

Q:What is the dynamic broadband technology used in FibroTouch?

A:

1. The term “dynamic” indicates that the range of liver elasticity is determined dynamically. Among signals received by fiber scanning probe, the cortex signal is obviously different from the liver signal. The cortex signal amplitude is larger and concentrated while the liver signal amplitude is smaller and uniform between layers. With proprietary algorithm, FibroTouch can identify the interface between liver and cortex among different patients dynamically and then select liver tissues 1cm to 5cm below the interface to calculate the liver elasticity. So, it is said that FibroTouch provides a dynamic detection range of liver fibrosis for various patients.

2. When it comes to the broadband technology, FibroTouch utilizes the broadband probe technology to send ultrasound signals within a frequency range wider than traditional ones (2.5Mhz or 3.5Mhz). And these ultrasound signals contain both low-frequency and high-frequency ultrasound signals. Low-frequency signals can guarantee the depth of signal while high-frequency signals can assure the spatial resolution. Therefore, FibroTouch can apply one probe to different patients, even to obese patients. The reason is that the broadband technology reduces the attenuation of signal and maintains the success rate of detection.

Q:Will the cortex thickness affect the fat attenuation parameter?

A:

The fat attenuation parameter is the relative attenuation measurement of sound energy in certain liver tissues. In other words, it compares the attenuation of sound energy in 4cm-depth liver tissues in the beginning of detection to that at the end of detection. So, the fat attenuation parameter is not related to the cortex thickness.

Q:What is the measurement principle of fat attenuation parameter?

A:

Normally there is no or merely few lipid droplet in parenchyma cells except for fat cells. If there is an increase of lipid droplets, it is called fatty degeneration or fatty change. Density of lipid droplet varies with liver cells at different levels of fatty change. Ultrasound waves will scatter and reflect on the interface of lipid droplet when they are propagated in liver tissues. In liver tissues with denser lipid droplet, ultrasound waves reflect strongly on the propagation path. For this reason, attenuation of sound energy and measured sound attenuation parameter become higher than those tissues with thinner lipid droplet when the travel of ultrasound waves is same. So, the sound attenuation parameter of FibroTouch is directly related to density of lipid droplet in liver tissues and reflects the fatty change level.

Q:What are FibroTouch advantages?

A:

1. We have applied the patented transient elastography in the world's first integrated image-guided detection system for level of liver fibrosis and fatty liver.
2. Provide an integrated and comprehensive diagnosis solution to liver tissue morphology and level of liver fibrosis and fatty liver.
3. Our patented technology collects data from information sources and processes them systematically to give results accurately and quickly.

Q:What are the repeatability and accuracy of FibroTouch?

A:

FibroTouch performs excellent in the aspect of accurate and repeatable detection of tissue elasticity.
1. We used FibroTouch to measure calibrated standard elastic phantoms of different hardness. Measured results were very consistent with calibrated values.
2. When it is used for human body, FibroTouch also provides satisfactory repeatability in the detection of liver elasticity. The reason is that normal liver tissues and most of fibrosis liver tissues are almost distributed evenly. It leads to similar liver elasticity values. Nevertheless, elasticity values may deviate from one area to another area because liver tissues are uneven (e.g. uneven nodule, cyst or fibrosis) among minority of patients.
3. When it is used for human body, FibroTouch measures the tissue elasticity 10 cycles and takes the median. Meanwhile variance must be smaller than 1/3 of median. Then the success rate will be higher than 60%. So, the measured elasticity value is the liver elasticity value statistically.

Q:Has FibroTouch been validated clinically?

A:

1. Our product is based upon transient elastography that measures the physical stiffness. The level of liver fibrosis depends on the stiffness of liver tissues. And the transient elastography just measures the liver stiffness.
2. Now a great deal of clinical research literature and some criteria on non-invasive liver fibrosis diagnosis actually discuss the relationship between liver elasticity value and level of liver fibrosis. And all guidelines refer to the transient elastography. 
3. Furthermore, our technology assures an accurate measurement of elasticity, when comparing the measured result to that obtained from elastic phantoms of same stiffness standard or similar products on the market.

Q:How is the test success rate of FibroTouch in obese patients

A:

The transient elasticity detection captures the propagation speed of shear wave with ultrasound wave. The fat attenuation is sensitive to ultrasound signals. The attenuation becomes more obvious when the frequency increases. Thick fat on the abdominal wall of obese patients causes a serious attenuation of ultrasound signal when low-frequency shear waves are captured. Then it is impossible to capture the speed of shear wave. It explains the high failure rate of foreign technologies. Our dynamic broadband probe applies ultrasound signals within a wide frequency range (e.g. 1.5M-5Mhz, compared to 3.5Mhz of fibroscan). With such probe, sufficient signals will go deep and return even though the fat layer is thick. It prevents signals attenuating with fat, detects the propagation of shear wave more sensitively and improves the success rate among obese patients.

Q:Has FibroTouch been approved in any key market?

A:

We have obtained the registration certificate issued by State FDA in May, 2012. Our FibroTouch is the first image-guided non-invasive liver fibrosis diagnostic system with transient elastography around the world.

Q:What is the size of liver that FibroTouch measure for liver stiffness?

A:

4cm3 area in the liver is used for collection of liver stiffness.

Q:What is ultrasound E Mode?

A:

Ultrasound E is elasticity ultrasound and it can reflect the propagation of shear wave in the liver. The longitudinal axis represents the propagation depth and the lateral axis indicates the propagation duration. Black and white strips show peaks and valleys of shear wave when signals are propagating in different depths of liver. Slope of the green bias identifies the speed of shear wave.

Q:What is ultrasound M Mode?

A:

Ultrasound M is a collection of ultrasound A signals during a period of time. So, it is a one-dimensional image. Adopt the gray modulation method. Then all interfaces in different depths will produce echoes. Mark these echoes with highlighted points on the vertical scanning line of display. When the organ is moving, points on the vertical scanning line change their positions to sample these echoes at an interval and show them line by line on the screen chronologically. The curve distance changes with the movement of organ. If one interface in the organ is static, its curve will be a straight line.

Q:What is ultrasound A Mode?

A:

Ultrasound A represents signals of liver tissue collected by sensor at a single time point. So, it is a line. Place a transducer that produces ultrasound pulses on one point of body surface. Sound beams are sent into the body and the signal amplitude returned from the interface of tissue is shown on the screen. The Y-axis indicates the propagation duration of ultrasound, i.e. detection depth while the X-axis represents the amplitude of echo pulse. Therefore, acquire the information on thickness of organ as well as depth and size of focus according to echo locations reflected by ultrasound from probe (transducer). It is also possible to conduct certain qualitative analysis of focus in light of other features of echo, including amplitude and density.

Q:Does the level of liver fibrosis affect the measurement of fatty liver?

A:

The fat attenuation and the liver stiffness are two different calculated indexes according to signals of liver tissues. Calculation of these indexes is separate. We will do more clinical study to determine if they are related.

Q:How long is the service life of FibroTouch? What about the probes?

A:

 The service life of system is longer than 5 years. Probes require the periodic calibration and must be corrected every 30,000 cycles.

Q:Does FibroTouch have the same function as common ultrasound B? Can it be used as ultrasound B?

A:Yes. You can use it as ultrasound B if you master the operating skill of ultrasound. Operator is advised to select an interested examination position by using the image guidance.

Q:How do you develop your quantitative standard of fatty liver? Has it been approved?

A:We have developed a preliminary standard of fatty liver. It includes three boundary values, i.e 240, 265 and 295. A liver is regarded as normal if the value is below 240; slight fatty liver is recognized if the value is between 240 and 265; moderate level of fatty liver is recognized if the value is between 265 and 295; and level of fatty liver is considered serious if the value is above 295. The standard is a preliminary version and obtained by comparison to Doppler ultrasound. Now we are engaged in the comparison to clinical benchmark--liver biopsy.

Q:Why do you define the scanning depth to be 8.5cm?

A:    To cover most of population. Subcutaneous tissues of obese patients may be as thick as 4cm. We define the scanning depth to be 8.5cm in order to meet the sampling requirement of liver tissue (i.e. 4cm area).

Q:How is FibroTouch probe self-adaptive dynamically?

A:    Dynamic broadband probes work within a wider frequency range. For population with different figure, the system selects the most suitable frequency range to collect signals of tissues by detecting the signal attenuation within various frequency ranges.

Q:What does FibroTouch broadband probe indicate?

A:    The term "broadband" indicates the broadband of ultrasound from fiber scanning probe. Adjust the working frequency automatically to population with different figure. Normally, a higher frequency means better definition yet poorer penetration while a lower frequency means stronger penetration yet worse definition.

Q:Is it possible to measure if tumor exists or an excision was done between the 7th and 9th?

A:    We suggest you finding the best position between the 7th and the 9th ribs at first. If it is unavailable, you can find an appropriate position between other ribs. Such selection is made according to clinical conditions of patients.

Q:How does FibroTouch sample the liver tissues?

A:    Probes send signals to liver tissues via subcutaneous tissues. Our 3rd-generation transient elastography can distinguish subcutaneous tissues from liver tissues and extract liver tissues automatically to determine the sampling range.

Q:Which factors may lead to a sudden and sharp increase of liver stiffness?

A:    Transient increase of transaminase and bilirubin indexes, biliary tract inflammation and jaundice will result in a sudden increase of liver elasticity. When these factors return to normal, the value of liver elasticity will decrease.

Q:What is the contraindication of FibroTouch?

A: Please use it with caution for pregnant women or patients who have a heart bypass or carry a cardiac pacemaker.

Q:What are primary uses of FibroTouch?

A: It can be used to detect the liver fibrosis level and fatty degradation. It is applicable for both healthy people and patients.

Q:Which departments are FibroTouch applicable for?

A:    FibroTouch is applicable for examinations of gastroenterology department, liver department, infectious disease department, physical examination department and other departments because it can detect both liver fibrosis and fatty liver. It is also applicable for clinical and ward check-ups.