Important health monitoring technology available for license or acquisition.

Used daily upon waking, the Biosymtec Monitor will detect and predict developing:
• non-respiratory infections,
• reductions in lung function (exacerbations), and
• respiratory infections (differentiating between the three), all before symptoms and clinical signs, such as a fever, occur.

The Biosymtec Monitor detects infections including, but not limited to:
• urinary tract infections,
• bronchitis,
• influenza,
• pneumonia,
• COVID-19 and variants,
days before symptoms, allowing for early medical intervention including the use of antivirals and antibiotics, when they are most effective.

The Biosymtec Monitor is kept by the bedside so that it can be used by this asthma patient upon waking, before getting out of bed. The dual probes are placed under the tongue, straddling the frenulum. A special core temperature is taken. Upon rising the patient blows hard and long through the monitor.

An embedded AI algorithm called Aila™ instantly analyzes the patient's results, compares them to her historical data, and this time, warns the patient of an impending respiratory infection days before symptoms appear, such as a fever.

Aila was validated through research studies using discrete devices supplied by Becton, Dickinson and Company (BD) and Philips Respironics (each supplied 300 devices). Studies were conducted across five health clinics in Hong Kong, Tianjin Haihe Hospital in mainland China, and a volunteer community in south-central Pennsylvania, involving a total of 218 participants. The results were definitive: Sensitivity — 96.7%. Specificity — 96.8%. Aila is accurate.

The patient can promptly contact her healthcare provider for an appointment, achieving early medical intervention, when antibiotics and antivirals are most effective.

The Pennsylvania Research Study doctor, Dr. James A. Wilson, produced this chart (click to enlarge) showing the faster recovery possible when using the Biosymtec Monitor.

Now, if the patient also has a Biosymtec Gateway, attached to her Biosymtec Monitor, she will be able to see on her laptop a special graph produced by the Biosymtec Monitor, covering a 50-day period.

Despite feeling well, the graph confirms she is developing a respiratory infection (graph is from an actual patient).

When she contacts her healthcare provider, they may have already reviewed her graph. After asking a few questions, the doctor may proceed and prescribe a medication which she can pick up at her local pharmacy. That’s early medical intervention, when medications are most effective.

This is an actual Biosymtec Graph of a patient later suspected of having one of the first cases of COVID-19 in the U.S.   He acquired the infection on a train ride between Lancaster and Philadephia, Pennsylvania.   Like COVID-19, it began with a cough, then a fever developed, followed by a respiratory infection on October 30.   On the left is a Biosymtec Monitor displaying a respiratory infection.

Regarding the FDA: Although the Biosymtec Monitor can alert the patient to contact their healthcare provider, achieving early medical intervention, the device does not diagnose. Nor does the graph, forwarded by the Biosymtec Gateway, in any way, provide a diagnosis. When the original research team, including from left to right, Joseph Johnson, a biochemist, John Beiswenger, a product research engineer and Dr. James Wilson, a medical doctor, went to Washington DC to meet with the FDA, the FDA’s conclusion was, that if the device does not diagnose, is used strictly in the home, they will not regulate it. [Note: If features are added to the Biosymtec Monitor, FDA 510(k) clearance may be required.]

The Biosymtec Monitor will actually replace the thermometer and peak-flow meter used now by pulmonary patients. Unlike the thermometer and peak-flow meter, the Biosymtec Monitor can also forward results to the patients’ physicians.

Will the patient still need a thermometer to check for a fever? No, the Biosymtec Monitor will serve also as a unique fever thermometer, indicating low grade or high grade fevers.

Cleaning the spirometer assembly is easy. It can be removed from the bottom of the Biosymtec Monitor, washed in soapy water, rinsed and air dried before being returned. The replaceable power cell is thereby also made accessible.

The Biosymtec Monitor was designed as an oral platform to acquire and analyze vital data non-invasively. The technology is based on the discovery that sublingual and pulmonary data, acquired from an individual upon waking and correlated by a proprietary algorithm, can determine the onset of an illness, days before symptoms or clinical signs such as a fever.

• Detects non-respiratory infections before symptoms
• Detects lung function issues before exacerbations
• Detects respiratory infections before symptoms, keeping COPD and asthma patients (and others) out of the hospital.

Those will be the first three initial capabilities of the Biosymtec Monitor. The following are planned. FDA 510(k) clearance will be required.

• Read and produce patient's electrocardiogram (Two lead EKG)
• Measure Forced Expiratory Volume at 1 second (FEV1)
• Measure Forced Vital Capacity (FVC)
• Measure Fractional Exhaled Nitric Oxide (FeNO)
• Measure Exhaled Oxygen percentage (eO%)
• Measure waking Heart Rate (HR)
• Measure Blood Oxygen Saturation (SpO2)
• Measure Respiration Rate (RR), and possibly
• Read Blood Sugar levels with transmissive technology (others are working on it),

Biosymtec Monitor

• Easy-to-read, multi-color graphic display on front
• Temperature is taken near the sublingual artery, correlating closely with the body's core temperature
• Airflow is measured physically and electronically with a turbine
• Product forwards data for a 50-day graph of basal temperature, peak-flow percent of best and other data
• Predicts likelihood of respiratory and non-respiratory infections up to two or more days before symptoms occur.

MouthLab

• Future numeric display on back
• Temperature taken at the lip
• Peak-flow percentage of best is not obtained
• Airflow is measured with a microphone
• Provides data for a graph only of current data. Basal data is not considered
• No predictive capability available to user.

Markets for the Biosymtec Monitor

The graphic on the left shows the primary markets for the Biosymtec Monitor. Patients with COPD, including chronic bronchitis, emphysema, and asthma must be treated early to avoid respiratory infections developing into pneumonia. They must be treated by their physicians before their symptoms get so bad they find themselves in a hospital ER.

There are over 40 million in the U.S. with COPD and asthma,
300 million worldwide, and the numbers are growing. During the research studies done in China, a Health Bureau physician said emphatically, after we commented on the local air polution, "In 10 years, everybody sick, in 10 years, everybody sick."

There are many other markets.

Heart Failure (CHF) patients must learn early if they have aquired an infection, because infections further weaken their hearts.

Cystic Fibrosis (CF) primarily affects the lungs, and these patients are therefore prone to lung infections. Early detection and early treatment are key.

The suggested retail pricing of the Biosymtec Monitor and Biosymtec Gateway are based on an estimated cost for the Biosymtec Monitor of under $45.00, and an estimated cost for the Biosymtec Gateway of under $15.00 (both estimated assuming 100K production quantities).

The product research engineering of the Biosymtec Monitor has been completed, by Beiswenger and Associates, Inc., and the project is ready for the Final Design Phase, resulting in a first functional prototype. The cost of the Final Design Phase, including the electronics, is estimated to be $170,000 (excluding the Biosymtec Gateway).

A U.S. Utility Patent was issued on October 9, 2014, covering a very early design of the Monitor, which was operated by two AA cells, used a telephone connection to transmit results, and included no display.

The significantly advanced Biosymtec Monitor, is button cell powered, forwards results through Bluetooth® technology, includes a full-color display, is controled by an AI algorithm and is EKG capable. A new Patent Application has been prepared, waiting for the completion and testing of a prototype.

Beiswenger and Associates, Inc. holds full Intellectual Property Rights to all Biosymtec-related technologies, including the Biosymtec Monitor and Biosymtec Gateway depicted on the left. The company also owns the rights to the Aila™ algorithm and retains the copyright to the Biosymtec Graph on the right. Other related intellectual properties are also owned by Beiswenger and Associates (https://beiswenger.com).

Beiswenger and Associates has incorporated the name, Biosymtec Technologies, Inc., acquired the domain names Biosymtec.com and Biosymtectechnologies.com, prepared a preliminary website (click on the image on the right) all in the event the licensee or acquirer wishes to use the name Biosymtec and/or launch a separate company (Biosymtec Technologies, Inc,) with which to promote the licensed Biosymtec intellectual properties. There is also a narrated video to promote the new company and/or the Biosymtec Technology.

License available: Terms and Provisions negotiable.

Available for Acquisition: Terms negotiable.

Project Support Offer: John L. Beiswenger, product research engineer with 50+ year career, will provide technical support of the licensed products (remote, if beyond daily driving distance) for a period of one year.

    and Associates, Inc.
    1542 Millport Rd.
    Lancaster, PA 17602
https://beiswenger.com