Both companies developed extensive know how and technologies in Pulmonary Acoustics. KSI is a leader in detection and signal processing of normal and pathological breath sounds such as wheezes and cough. KSA's proprietary core technology is based on introduction of specially designed sound structures into the mouth or nose and detecting its transmission to the chest surface. The attenuation of the sound and its filtration by the thorax and lungs is indicative of the well being of the structures beneath. Noverl sensors and advanced algorithms are the basis for the patented technologies of the Companies.
Quantitative wheeze detection, wheeze duration and the Wheeze Rate
The sonogram and the wheezogram™
Acoustic flow-volume spirometry
Validation methods
The WIM-PC platform
The WIM Platform
It is KS' aim to provide novel tools for Acoustic Asthma Management to the clinical market. It is doing so by providing a simple, yet highly accurate and relevant measure of asthma – the Wheeze Rate (Wz%). When coupled with measuring the Cough Count, the Wz% is an objective and quantitative indicator of the extent of the airway narrowing at any given moment. It is calculated as the duty cycle of wheeze activity as % of the elapsed time and as such should be controlled at nearly zero by proper treatment during day and night. Obtaining the Wz% only requires that the patient will breathe at the rate and depth of convenience. No imposition is made on the patient and no cooperation is needed. KS'is set forth to provide a full range of products, all based on its core technology, but implemented in the configuration that is most appropriate for its use – from the patient's home all the way to the Intensive Care Unit.
The WIM-PC
First to come to market are the three devices that are based on the WIM Platform. These consist of a small pod containing the signal conditioning electronics and an ambient noise microphone, an essential component in the defense against environmental noise interferences. Two Phonopneumography (PPG) breath sounds sensors and a chest expansion belt for monitoring the breathing activity connect to the patient to the pod. The signals are then digitized into a computer and the rest of the analysis is performed by calibrated algorithms that automatically detect wheezes, cough and respiration.
The WIM family of products includes the WIM-PC for use in primary care, pediatric, asthma and allergy and occupational clinics and in pulmonary function testing (PFT) laboratories. The WIM-PC™ will be launched before the end of Q1 2007. The second member of the group is the Spiro-WIM™, a combination of a spirometer and the WIM technology. This product is specifically intended for the assessment and management of Vocal Cord Dysfunction, a wheezing disorder that is of emotional origin and must be sharply distinguished form Asthma. The third device is the WIM-Nocturnal™, a wheeze, cough and respiration monitor for home and sleep-lab evaluation of asthma activity during a night sleep. It is capable of collecting data for up to 8 hours and will be equipped with wireless technology to avoid the need for dealing with the sensor wires during sleep studies.
Figure: The Wheezogram™ of an Asthma patient, top, and the respiratory activity, bottom, as well as in the bar diagram on the right showing the inspiratory (red) and expiratory (blue) wheeze rate (Wz%).
PPG Sensors
The AirwayClear platform
Following the introduction of the 3 members of the WIM platforms, KS will bring to the Asthma management market two additional products: (i) the Personal Wheezometer™, a stand alone miniature wheeze detector for home use; and (ii) the Acoustic Severe Asthma Monitor. The latter is intended for emergency medicine and for ICU monitoring of the acute severe asthma attack. Since the airways in acute severe asthma are often so constricted, to the point where they stop wheezing, it is necessary to utilize KSA's sound transmission technology to monitor these patients.
Regulatory
Regulatory (FDA)
The PulmoTrack 1010 was granted FDA approval as Class II device under classification as "Calculator, Pulmonary
Function Interpretator (Diagnostic) in the Anesthesiology Medical Specialty. The FDA should be notified about the resumption of KMAT's activities.
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activity as % of the elapsed time and as such should be controlled at nearly zero by proper treatment during day and night. Obtaining the Wz% only requires that the patient will breathe at the rate and depth of convenience. No imposition is made on the patient and no cooperation is needed. KS'is set forth to provide a full range of products, all based on its core technology, but implemented in the configuration that is most appropriate for its use – from the patient's home all the way to the Intensive Care Unit.
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