The market for home health care products and services has increased dramatically over the past five years. Health care spending growth has outpaced GDP growth over the past decade. The Carematix system of multiple devices that communicate with a single home hub attached to a PC or phone capitalizes on recent and ongoing significant changes in four key market forces pertaining to home healthcare. (in addition to the secular trend of increasing healthcare costs):

• Recent changes in managed care reimbursement policy pertaining to home health devices.


• Emerging evidence that monitoring of outcomes yields better quality of life and lowered healthcare costs.


• Increasing pressure to develop drugs and conduct clinical trials to reduce costs and time to market.


• Increased health consciousness and technology awareness among the population at large; and the aging of the population.

Users of the Carematix Wellness System

Carematix belives that various organizations including, but not limited to, disease management organizations, health insurance companies, self insured employers, pharmaceutical companies, and medical device manufactures will benefit and realize significant cost savings by using the CWS to monitor patients with chronic conditions.

According to the Journal of the American Medical Association, an estimated 100 million Americans suffer from chronic conditions such as heart disease, diabetes and lung disorders. Since the Carematix system lends itself to monitoring of various vitals, the disease states that could benefit from using the system include:

1. Hypertension
2. Obesity
3. Diabetes
4. Preeclampsia
5. CHF

Hypertension

Hypertension is defined as systolic blood pressure (SBP) of 140mm Hg or greater and diastolic blood pressure (DBP) of 90mm Hg or greater. The objective of identifying and treating high blood pressure is to reduce the risk of cardiovascular disease and associated morbidity and mortality.

High blood pressure affects about 50 million people, or one in four American adults. Of those 50 million adults, about 68 percent are aware of their condition, and only 27 percent have it under control

Hypertension, known as "the silent killer", is responsible for the deaths of more than 35,000 Americans every year. With those kinds of numbers, it's no wonder that doctors are concerned about high readings. For some people, even the most simple medical examination puts them under stress and alters their pulse. Today this is labeled "white coat hypertension." It can be difficult to distinguish true hypertension from white coat hypertension.

Uncontrolled hypertension puts an individual at risk for stroke, heart failure or kidney damage. Therefore, monitoring blood pressure, usually at home, has the potential to provide important and possibly life-saving information.

Self-measurement usually requires individuals to keep written records of their readings, and it has been questioned how accurate these records are. Self-measurement of blood pressure at home with the Carematix System helps with distinguishing "white coat hypertension", assessing response to anti-hypertensive medication, and improving patient adherence to treatment, hence potentially reducing costs and office visits.

Obesity

The Centers for Disease Control and Prevention has found that 55% of American adults are overweight. Obesity is defined as an abnormally high percentage of body fat. Overweight is defined as an increase in body weight above a standard related to height, but when sufficiently high is synonymous with obesity. Overweight and fat distribution are useful predictors of excess mortality and the risks of heart disease, hypertension, diabetes mellitus, gallbladder disease and some types of cancer, among others.

Overweight and obesity are linked to heart disease, stroke, diabetes, gallstones or gallbladder disease, Osteoarthritis (wearing away of the joints), gout (joint pain caused by excess uric acid), breathing problems, including sleep apnea (interrupted breathing during sleep), high blood cholesterol, high blood pressure. Overweight men are at greater risk for developing cancer of the colon, rectum, and prostate, and, overweight women, cancer of the gallbladder, breast, uterus, cervix, and ovaries.

Balancing physical activity with a varied diet is essential for weight management. Regular exercise will increase energy level and enhance appearance. Carematix System provides the tools for effective weight management programs.

Diabetes

The American Diabetes Association defines diabetes as a disease in which the body does not produce or properly use insulin. Insulin is needed to convert sugar, starches and other food into energy needed for daily life. Diabetes is a chronic disease that has no cure. There are two major types of diabetes. Type 1 is an autoimmune disease in which the body does not produce any insulin and occurs most often in children and young adults. These people must take insulin injections to stay alive and monitor their glucose level frequently. It accounts for about 5-10 % of diabetes. Type 2 is a metabolic disorder resulting from the body's inability to make enough, or properly use, insulin. It is the most common form of the disease. People with Type 2 may or may not take insulin, but may require frequent glucose monitoring. Insulin may not be necessary in Type 2, if the diabetes can be controlled by diet, exercise, and weight loss. It accounts for about 90-95% of diabetes. Gestational diabetes develops in 2-5% of all pregnancies, but disappears when a pregnancy is over. Women who have had gestational diabetes are at increased risk for later developing Type 2 diabetes.

Many people don't know they have diabetes until they develop these life-threatening complications, such as blindness, kidney disease, nerve disease, circulatory disease (resulting in amputations), heart disease and stroke. It is more common in African Americans, Hispanic Americans, Asian and Pacific Islanders and Native Americans. A person with diabetes should keep their disease under good control and be monitored frequently by a health care team knowledgeable in the care of diabetes. The normal range for glucose levels in a normal person without diabetes is 80-120 mg/dl. In a person with diabetes, it is slightly higher, 90-130 mg/dl, although these ranges may be individualized further depending upon a person's symptoms that accompany the readings. The patient takes a blood glucose level, usually before eating meals. The number of times a patient performs the test depends on his/her specific treatment plan. In a newly diagnosed diabetic the patient may take the test as often as 4 times a day, or someone that is more controlled might only take it 1-2 times a day.

With the Carematix system, an agency or a patient can receive daily results from the patient and intervene accordingly, rather than wait until the patient comes into the clinic once a week, month, or longer, or has to come in due to complications from poor maintenance. Other problems related to diabetes can also be detected earlier. For example, an elevated blood pressure can sometimes reveal circulatory problems, a complication of diabetes. Daily weight measurements can aid in meeting a patient's goal of weight loss/ gain. Patients don't always keep a good blood glucose log, whether they forget to write it down, or don't comply with taking their glucose levels as recommended. With the Carematix system, this data collection is all automated.

Preeclampsia

Preeclampsia is characterized by high blood pressure, swelling of the face and hands, and protein in the urine, and is diagnosed after the 20th week of pregnancy. Preeclampsia is also known as toxemia. Premature delivery may be necessary because of serious risks posed by preeclampsia to the mother and baby. Possible problems for the mother include liver damage, kidney damage, bleeding problems, or seizures. Problems for the baby include not getting enough oxygen or nutrients from the placenta. This problem can lead to growth retardation or fetal distress.

Preeclampsia is a common disorder, affecting 6 to 8 percent of all pregnancies. Eighty-five percent of all cases occur in first pregnancy. Other risk factors for the development of preeclampsia include multiples pregnancy, diabetes, chronic high blood pressure, kidney disease, and family history. It is also more common in teenagers and in women older than 35.

Usually, women have no symptoms at first. The first sign of preeclampsia may be a sudden weight gain in a week due to the abnormal retention of fluids. Swelling of the face and hands, headaches, vision problems, and pain in the upper abdomen may also occur. Protein in the urine is another sign. The patient's blood pressure is consistently elevated over a period of time. There are various degrees of severity. If the only symptom is elevated blood pressure, it is diagnosed as pregnancy-induced hypertension. Normally, the cure for preeclampsia is delivering the baby, but this may not always be possible. Possible treatments are: bed rest, twice weekly doctor visits to check blood pressure, urine and blood tests, in addition to daily blood pressures at home. A severe case would involve admission to the hospital.

Daily monitoring with the Carematix System could detect problems before they worsen, or assist with diagnosis. For the management of a patient with preeclampsia, daily blood pressures and weight measurements would considerably facilitate the treatment plan.

CHF

Congestive Heart Failure (CHF) is a rapidly growing disease estimated to affect 20 million people, 4.9 to 6 million in the United States alone. Approximately 400,000 new cases are diagnosed each year. Heart failure occurs in approximately 10 out of 100 people, and becomes more prevalent with advancing age. Due to the high prevalence and the associated costs for treatment, heart failure is now the single most costly cardiovascular illness in the United States

Heart failure, also called "congestive heart failure," is a disorder where the heart loses its ability to pump blood efficiently. The result is that the body doesn't get as much oxygen and nutrients as it needs, leading to problems like fatigue and shortness of breath. Heart failure is almost always a chronic, long-term condition that is managed with medications and lifestyle changes. The most common causes for heart failure are hypertension and coronary artery disease. A common sign of congestive heart failure is shortness of breath. Shortness of breath, caused by fluid in the lungs, can occur during exercise or when resting. Sometimes shortness of breath comes on suddenly at night. Sometimes the person will cough up pinkish, blood-tinged phlegm. Another sign of congestive heart failure is the buildup of excess fluid in the body's tissues, causing edema of the legs and sometimes of the abdomen. Weight gain can result. Other symptoms can include tiredness and weakness.

Treatments for congestive heart failure will vary with the severity and cause of the failure, but treatment is geared to the reduction of symptoms - fatigue, shortness of breath and swelling. One of the most important aspects of treatment is adherence to a low-sodium diet. This will help diminish fluid retention and will decrease the heart's work. It is extremely important that people with congestive heart failure weigh themselves every morning to assess the retention of fluid in their body. Hypertension (high blood pressure) significantly increases the risk of heart failure according to the Framingham Heart study funded by NHLBI, a component of the National Institutes of Health. The risk was found to be two times higher in men and three times higher in women than in those with normal blood pressure. The Carematix system allows for accurate, real-time monitoring of both weight and blood pressure which are key factors for managing cases of congestive heart failure.