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Applications

The Company has identified the following initial multi-billion dollar markets as those that will be commercialized, on a prioritized basis.

In addition to the markets below, the Company is working on several additional new multi-billion dollar market applications that will commercialized upon the completion of further evaluation.

For more information regarding a number of the following markets please click on the respective market of interest.

Hypertension/High Blood Pressure

This is the most commonly diagnosed condition in the United States affecting more than 74 million individuals. Over $30 billion is spent annually in the USA on the multiple prescription drugs that have been approved to treat, but not cure, high blood pressure. In addition to having side effects these drugs are not effective for a large percentage of the individuals with high blood pressure, i.e., those resistant to drug treatment. The Company’s medical device would be used to treat patients with resistant hypertension by  denervating the renal artery which has been shown in clinical studies using a radiofrequency/heat ablation approach to reduce blood pressure more than 30 points.

Atrial Fibrilation

This is second largest unmet clinical need in cardiovascular medicine today after heart failure.  Approximately 5 million adults in the United States and more than 10 million worldwide are living with AF and approximately 200,000 new cases are diagnosed in the United States each year. Atrial fibrillation, the most common type of arrhythmia, is a rapid and disorganized rhythm of the atria (upper chambers) of the heart.  The Company’s medical device represents an interventional treatment of cardiac arrhythmias with the ability to create focal, circumferential and linear transmural lesions.  

Coronary Artery Disease

Coronary artery disease (CAD) is the most common type of heart disease. It is the leading cause of death in the United States affecting more than 13 million Americans. CAD occurs when the arteries that supply blood to the heart muscle become hardened and narrowed. This is due to the buildup of cholesterol and other material, called plaque, on their inner walls. This buildup is called atherosclerosis. As it grows, less blood can flow through the arteries. As a result, the heart muscle can't get the blood or oxygen it needs. This can lead to chest pain or a heart attack. Most heart attacks happen when a blood clot suddenly stops the hearts' blood supply, causing permanent heart damage.

In most cases the blocked coronary arteries are reopened by inflating a tiny balloon inside the blockage, compressing the fatty plaque against the artery walls and widening the vessel or the use of a rotoblation device or a cutting balloon. Generally this procedure is combined with a procedure called stenting, in which a tiny tube of metal mesh, or stent, is used as a scaffold to help keep the artery open as an additional means of reducing the reclosing or restenosis of the artery. However, restenosis occurs even with traditional stents, which are made of bare medal. As a result, stents coated with a drug, referred to as drug eluting stents, are used to discourage restenosis.

As an alternative to the use of stents, independent studies have shown the ability to arrest or stop the body’s immune response from reclosing the artery or the occurrence of restenosis after being opened with an inflatable balloon, rotoblation, cutting balloon or other device by freezing the affected artery to below -70°C. The Company’s medical device represents an interventional treatment to be used in combination with any of the above artery opening approaches that will attain the cold temperature to stop the occurrence of restenosis thereby eliminating the need for stenting.  

Peripheral Vascular Disease

Peripheral vascular disease (PVD) is a condition in which the blood vessels in the lower extremities (feet, legs, or thighs) are narrowed, restricting blood flow. Peripheral vascular disease is primarily caused by atherosclerosis, the buildup of plaque in blood vessels. Approximately eight to 12 million people in the United States have peripheral vascular disease (Source: NHLBI), which translates to about 5% of people older than 50 years. Individuals with diabetes, high blood pressure, high cholesterol, or advanced age, or those who smoke or are inactive, are at risk for developing peripheral vascular disease.

In most cases the blocked arteries are reopened by inflating a tiny balloon inside the blockage, compressing the fatty plaque against the artery walls and widening the vessel or the use of a rotoblation device or a cutting balloon (angioplasty). For a percentage of PVD cases this procedure is combined with a procedure called stenting, in which a tiny tube of metal mesh, or stent, is used as a scaffold to help keep the artery open as an additional means of reducing the reclosing or restenosis of the artery. However, restenosis occurs even with traditional stents, which are made of bare medal. As a result, stents coated with a drug, referred to as drug eluting stents, are used to discourage restenosis. For a number of different clinical reasons, such as the location of the disease, the size of the artery etc., in a number of cases, stenting can’t be used which significantly increases the risk of restenosis.  In cases in which angioplasty is not successful grafting of replacement arteries is an option albeit represents a significantly more invasive and complicated procedure.

As an alternative to the use of stents or for cases in which stenting is not an option, independent studies have shown the ability to arrest or stop the body’s immune response from reclosing the artery or the occurrence of restenosis after being opened with an inflatable balloon, rotoblation, cutting balloon or other device by freezing the affected artery to below -70°C. The Company’s medical device represents an interventional treatment to be used in combination with any of the above artery opening approaches that will attain the cold temperature to stop the occurrence of restenosis thereby eliminating the need for stenting or the need for grafting.  

 

Womens Breast Tumors

It is estimated that more than half of the women in the U.S. will see a doctor about a breast abnormality sometime during their life. While the majority of these masses are non-cancerous or benign tumors, referred to as fibroadenomas, they generally cause significant anxiety for the women. Currently over 500,000 benign tumors are removed each year because of pain, the potential for continued growth and concern upon the part of the patient and/or physician regarding their future status. It is estimated that there are more than 5 million women with fibroadenomas throughout the world. Additionally, there are projected to be over 207,000 new cases of breast cancer reported in 2010 in the US. The surgical removal of breast tumors results in scarring and deformity usually requiring the women to have a second reconstructive surgical procedure. The Company’s minimally invasive procedure using a very thin needle, similar to a biopsy needle, will ablate the tumor without scarring, deformity or the need for reconstructive surgery.

Dermatology/Aesthetics  

There are a number of aesthetic/dermatological applications for the company’s cryoablation technology. As an entry point to the market, freezing of skin lesions, lipomas and keloids with ‘finesse’ and accuracy will be promoted as the introduction to market.  Also, two additional, high volume aesthetic procedures are possible with the company’s technology– a ‘botox’ like neuro/muscular weakening and adipose/fatty tissue ablation. The aesthetic market has long searched for an alternative to Botox therapy where the modality does not involve a toxin for its efficacy, where results are more predictable and the ease of application to the patient is comparable to that of Botox therapy. The current number of Botox procedures is approximately 3,000,000 a year, of which 90% pertain to facial neuromuscular areas. Additionally, the market for treatment of localized fatty tissue deposits is approximately $300 million a year and projected to increase significantly. As an alternative to Botox, a small needle, like that used to inject the toxins in a Botox procedure, would be used to partially ablate the muscle that controls frowning etc. thereby reducing and/or eliminating the condition for a three to six month period. For localized fat a needle would be used to create freezing temperatures that would ablate the excess fatty tissue which would be removed by the body’s normal immune system over time.

Barretts Esophagus/Gastroenterology

Individuals with chronic acid reflux or frequent heartburn may be at risk for a condition called Barrett’s esophagus. Barrett’s esophagus is a change in the lining of the esophagus which is the swallowing tube that carries foods and liquids from the mouth to the stomach. Left untreated, it can lead to cancer of the esophagus.  There were 86,000 new cases of Barrett's diagnosed in the U.S. last year, with an estimated potential of 3 million to 5 million Americans with undetected and/or asymptomatic Barrett's walking among us. Barrett’s can lead to esophageal cancer which is a serious worldwide problem and is the fastest growing cancer, increasing six-fold in incidence since the 1970s while other cancers have been declining. More than 16,400 new cases of esophageal cancer are expected to be diagnosed in the U.S. this year, and 14,280 people are expected to die from the disease. The goal to reduce this cancer has yet to be met. Another application would be the treatment of pancreatic cancer with an endoscope device. In 2010, an estimated 43,000 people in the US were diagnosed with pancreas cancer and almost 37,000 died from the disease. Pancreatic cancer has one of the highest fatality rates of all cancers and is the fourth-highest cause of death from cancer among both men and women worldwide. While radiofrequency heat and cryoablation are procedures currently offered by other companies for the treatment of Barrett’s Esophagus, CryoMedix’s ability to create significantly more lethal cold will result in better clinical outcomes without the need for significant pain medication. Also, the use of the company’s patent pending flexible, multitubular catheter will provide physicians a medical device that can treat pancreatic cancer.

Sleep Apnea

Over 20 million Americans, one in five adults, suffer from sleep apnea. Seventy percent of patients with sleep apnea are overweight and it seems that sleep apnea runs in families. Infants can have sleep apnea and this condition is being evaluated as a possible cause of sudden infant death syndrome. The most common form is obstructive sleep apnea, which occurs when the windpipe is blocked while sleeping. The blockage can be caused by the uvula, tonsils, tongue, throat tissue, or even by the muscles in the throat. The most common treatment, although it is a palliative therapy, is to wear a mask at night to keep the airways open. Additionally, the blockage can be surgically removed. An alternative to surgical removal is the use of the company’s minimally invasive technology to ablate the areas causing blockage to shrink the excess tissue. Additionally, for individuals with increased muscle activity in this area causing constriction of the airways, the condition can be treated by ablating and thereby reducing the muscle contractions.

Ear, Nose & Throat (ENT)

There are approximately 600,000 tonsillectomies, 250,000 adenoidectomies, multiple sinus conditions, oral lesions and other conditions treated each year in the USA. These conditions are treated by surgical removal, coblation or radiofrequency/heat ablation. The company’s minimally invasive procedure represents a clinically safer, easier and more cost effective alternative to the current medical procedures.

Pain Management

Chronic low back pain affects almost one-third of the population and represents one of the largest costs in our healthcare system. More than 11 million Americans each year receive treatment for pain. While there are a number of different types of treatments for back pain, a significant number of individuals fail to obtain relief from their pain with the proscribed treatments. One solution for chronic back pain is the use of various types of heat ablation to treat the pain. The company’s minimally invasive procedure represents a clinically safer and easy alternative to the current medical procedures.