APG is a measurement tool using a pulse wave method that shows the aging degree of blood vessels and therefore used to detect arteriosclerosis. As the vessel wall pressure and blood vessel diameter change according to the cardiac cycle, the peripheral sides are affected, which is clinically significant for understanding the mechanical movement of the heart and blood circulation.

Although AVACEN Medical launched our FDA Cleared CSS device in 2022, photoplethysmography technology has been used extensively for decades all over the world. There are hundreds of clinical papers supporting the accuracy of the technology.

According to the CDC and WHO (World Health Organization), heart disease is the leading cause of death in both men and women:

• “One person dies every 34 seconds in the United States from cardiovascular disease” (CDC, 2022, Heart Disease Facts).
• “Cardiovascular diseases (CVDs) are the leading cause of death globally, taking an estimated 17.9 million lives each year” (WHO, 2023, Cardiovascular Diseases).

The CSS device uses both APG and HRV (Heart Rate Variability) to establish scores for cardiovascular health and stress. It can quickly establish a quantified baseline, printable in a 2-page color report for clinician review and patient discussion. Outside of cardiovascular disease, stress is also considered a leading cause of a variety of diseases, up to and including CVD.

Early prediction and progress of arteriosclerosis caused by peripheral blood circulation problems.

• Monitoring the progress of arteriosclerosis..
• Observing the aging condition of blood vessels.
• Predicting cardiovascular problems such as myocardial infarction.
• An indicator of overall health status.

While a specialist can absolutely use the CSS, it is designed for general healthcare practitioners. The test is easy to run, noninvasive, and can be administered by trained professionals, not just specialists. The CSS provides a printable, easy-to-read, two-page color report at the end of each testing schedule. Included in the report is a suggested healthcare section. AVACEN Medical also provides training on how to interpret the reports, including a breakdown of each section of the report.

According to a recent medical study, heart disease diagnosis can be missed up to 68% of the time by physicians due to a multitude of reasons (Vaso Labs, 2022, “Heart Disease”). The CSS is an FDA Cleared, Class II noninvasive cardiac diagnostic device that provides a comprehensive overview of cardiovascular health and stress levels through the use of accelerated plethysmography (APG). The HRV aspect is backed by over 25,000 clinical papers as well. It is a well vetted technology to support physicians and healthcare professionals in diagnosing heart disease.

The CSS is an FDA Cleared, Class II device. It is also noninvasive with only the sensor probe situated around the subject’s finger. It is considered extremely safe.

Studies demonstrate that HRV and APG readings have a + accuracy of 2% for the measurements the device captures. It is suggested that a 5-minute test is the most accurate timed test for the various measurements captured.

The CSS is an FDA Cleared, Class II easy-to-use device that is noninvasive. The device supports 6 languages (English/German/Chinese/Japanese/Indonesian/Korean). Both the APG and HRV technology are considered world class, and the device can be used in both pediatric and adult settings. The CSS also has two reference classes, Asian & Western descent for testing. AVACEN Medical has also kitted the device and sensor with an HP laptop and Canon printer and carry bag so your clinic or office can quickly get set up and immediately start using the device in your office practice or for patient home visits. Finally, the CSS also provides an easy-to-read two-page printed color report highlighting cardiovascular health, overall stress status, and a suggested healthcare section.

The 5-minute test is reimbursable up to 3 times per year per patient. The applicable codes are:

Source: Centers for Medicare & Medicaid Services (www.cms.gov)

Practitioners also often charge out of pocket or cash for sessions. AVACEN recommends $50 – $75 per session.

The CSS technology has been extensively clinically vetted, including more than 25,000 published clinical papers using the HRV/APG system. The device is also FDA Cleared Class II in the United States.

This is the first section of the Accelerated Photoplethysmograph Report. The Pulse Wave or the Basic Waveform is associated with a typical full contraction/dilation heart cycle. Sections of the cycle are labeled a-e. The first major peak is the systolic peak and the second is the diastolic peak. The Accelerated Pulse Wave is clinically relevant, with each section also labeled a-e, corresponding to the previous section. The waveform types can be seen in the Vascular Health Analysis section of the report.

The first reading represents a mean heart rate. The next section shows the predominant wave type that the sensor is reading during the duration of the test. That type (e.g. TYPE-1) will correspond to the Level Analysis chart at the bottom of the Accelerated Photoplethysmograph Report. This is the predominant reading that shows a level of blockage or occlusion related to estimated arteriosclerosis.

In the next section, the terms correspond to:

AE (Arterial Elasticity): Analyzes the blood circulation, the vascular elasticity and resistance of the major vessels. It detects early cardiovascular disease like atherosclerosis and peripheral circulation dysfunction.

PE (Peripheral Elasticity): Analyzes the blood circulation, the vascular elasticity and resistance of the peripheral vessels. It also detects early cardiovascular disease like atherosclerosis and peripheral circulation dysfunction.

The Level Analysis refers to a relative degree of blockage/occlusion in your vessels, supported by a visual representation. Levels 1-3 are considered healthy, Level 4 is a warning level, and Levels 5-7 are considered unhealthy. Typical readings are usually represented predominantly in 1-2 categories. If a reading is equally spread amongst several categories, a retest should be considered. The breakdown of levels can be represented below:

Level 1: Blood circulation and artery state is great!

Level 2: Blood circulation and artery state is good but a slight build up is beginning.

Levels 3-4: Blood circulation and artery state is becoming poor and build up is gaining.

Level 5: Blood circulation and artery state is bad and build up continues to increase.

Levels 6-7: Blood circulation and artery state is very bad and build up is serious.

It measures the degree of fluctuation in the length of intervals between heartbeats. For healthy people, HRV shows a fluctuation in heart rates, while unhealthy people have a simple and consistent heart rate. HRV measures the adaptability of the cardiovascular system and autonomic nervous system, which is composed of the sympathetic nervous system (SNS) and parasympathetic nervous system (PNS). Your SNS plays the role of the accelerator, also known as fight or flight. Your PNS functions as the brake, also known as rest and repair. A healthy person has a balanced autonomic nervous system.

The normal HR of an adult is 60 – 90 beats per minute.

It means a rhythm that deviates from the normal range or that an individual has an arrhythmia. It also may appear when the person moves during the test. If an Ectopic beat shows a score over 5, the test should be run again. If the user experiences palpitation, breathing difficulty or dizziness frequently, he or she should discuss symptoms with a healthcare practitioner.

It is a measurement of Autonomic Nervous System (ANS) activity.

• TP: Total Power is a combination of the 3 frequencies:
• VLF: Very Low Frequency
• LF: Low Frequency
• HF: High Frequency

Reduced TP: Decreased ANS function, decrease in regulatory competence and a decrease in the ability to cope with environmental change.

Reduced VLF: Decrease in the body’s ability to regulate body temperature and hormone levels.

Reduced LF: Loss of energy, fatigue, insufficient sleep, and lethargy.

Reduced HF: Chronic stress, aging, reduced electrical stability of the heart.

It indicates the balance between the sympathetic nervous and parasympathetic nervous system. Its normal ratio is 6:4, 5:5 or 4:6. If SNS is too high, it is in a highly nervous state. If PNS is too high, it means depression, lethargy, or lack of will. On the report, this can be seen in the ANS Balance result.

ANS Activity: Indicates the activity of Autonomic Nervous System function and its regulation competence.

Fatigue Index: Indicates the state of fatigue and loss of energy caused from stress.

Electro Cardiac Stability: Indicates the level of stability around cardiac electrical activity. For instance, chronic stress would likely lower electro cardiac stability.

Physical stress: Displays stress level in the physical state.

Mental stress: Shows stress level caused by the mental state.

Stress Resilience: This represents an individual’s ability to manage both physical and mental stress.

Unfortunately, no. Heart rate variability is only a small portion of the overall diagnostic testing solution provided by the CSS device. Outside of testing for early prediction and recorded progress of arteriosclerosis as well as blood vessel aging, the CSS device also tests for HRV, ANS electrical activity, ANS balance, and stress resiliency, all non invasively in as little as one minute.

The CSS device absolutely can be used in conjunction with AVACEN’s thermotherapy devices. Our thermotherapy devices, outside of increasing microcirculation, also activate the parasympathetic nervous system (PNS), known for “rest and digest” or stimulating relaxation. The CSS device can be used to establish a baseline PNS reading, followed by a 30-minute thermotherapy treatment with any AVACEN device, followed by another ANS (autonomic nervous system) balance test. In the majority of readings, AVACEN will increase the user’s PNS score and improve his or her ANS ratio or balance.

Health practitioners can either purchase the CSS device outright or lease it through our leasing partner, MedOne Capital. If financially qualified, health practitioners can lease the CSS device for as little as $7.33 per day, or for $11 per day in conjunction with our professional thermotherapy device, the AVACEN PRO+.

What would my revenues look like if I incorporate the CSS into my practice at an initial cost of $9,995? If your clinic or office is pursuing CPT reimbursement, the rough midpoint for the 3 applicable reimbursement codes is $67 per test, which can be applied up to 3 times per year per patient. If your facility is open 5 days a week and does at least 2 tests per day, the revenue over 5 years is $174,200, or $34,840 per year. Using the example above, if you or your facility is pursuing patient cash reimbursement, AVACEN recommends $50 – $75 per session. At the lowest fee of $50 per session test for a clinic open 5 days a week, your facility could be generating $130,000 over 5 years or $26,000 per year.

With leasing options, one professional CSS device can be leased for as little as $7.33 per day. Just one administered test per day would be profitable for your facility.