Keeping A Close Eye On Advances In Diabetes Treatments

Diabetes is a devastating disease with enormous and expanding prevalence. Both type 1 and type 2 diabetes impose dramatic health burdens on sufferers along with difficult to manage and potentially fatal side effects. Until recently, I was unaware of the difficulty diabetes patients have in managing their disease and the number of people whose quality of life is severely impacted even after diagnosis and prescribed treatment. If managed properly, diabetes can be held in check and affected individuals can live long healthy lives. However, in many cases, current treatments make managing the disease an onerous process. A large percentage of diabetics do not properly understand how to effectively monitor their blood glucose levels so as to avoid devastating side effects. In some cases the body simply does not respond consistently or predictably to current treatments.

Recently, a small company called CellMedX (CMXC) caught my attention as it evaluates a novel approach named eBalance to better manage the disease. I was so intrigued by the early results the technology has demonstrated that I signed on as spokesperson to help to tell this developing story. The company’s technology was developed in-house to help founder and type 1 diabetic, Jean Arnett, improve her own deteriorating quality of life. Through trial and error, Jean Arnett and her partner, Bradley Hargreaves, were introduced to novel research which led them to experiment with microcurrent electrical treatments at certain frequencies; eventually arriving at settings that produced striking and consistent improvements in Jean’s condition.

The couple’s efforts culminated in a small pilot trial demonstrating that it may be possible to improve the body’s innate ability to metabolize and manage glucose. Jean, who has suffered with type 1 diabetes for 50 years, realized impressive improvements in her condition with Cell MedX eBalance microcurrent treatments, reducing her dependency on insulin. The company is now enrolling a phase 1 trial in Orange County in Southern California to determine whether results can be duplicated on a larger scale. John Sanderson M.D., the company’s Chief Medical Officer describes the upcoming trial; “The chief aim of the study is to determine whether eBalance can supplement standard treatment, as an adjunct, and thereby help persons with diabetes to better manage the disease.”

Here are some highlights of Jean Arnett’s improved condition following her ongoing use of eBalance. (While these results are not yet statistically significant, they certainly are eye opening and the basis for my intense interest in following this technology as it undertakes studies to prove itself on a broader scale):

Company Founders pre-existing Diabetic Condition

• 49 years insulin dependent type 1 diabetic. Referred to by physicians as a ‘brittle diabetic’.
• Lost one eye due to diabetic retinopathy and has nerve damage in lower legs therefore having trouble with balance. Was diagnosed with hypertension (high blood pressure) and lived on 50 mg of Cozaar for more than 15 years. Frequently experienced severe diabetic neuropathy in lower legs and toe wounds that would not heal.
• From mid-2000 when her physician changed basal rate insulin to Lantus she experienced abnormally high sugars typically 24 to 30 mmol/mol (at which stage patients are usually hospitalized) which eventually caused the nerve damage in lower legs.
• HbA1c typically measured 10.7 mmol/mol (which is often considered very high).
• High sugars caused frequent infections resulting in constant appointments with physicians for antibiotics, which did not correct the situation. At one point Jean required antibiotics six times in one year just to try to heal a toe, and even then it would not heal properly.

Founders current condition following eBalance Treatment – combined with insulin

• Hemoglobin HbA1c – went from 10.7 to Hemoglobin HbA1c – went from 10.7 to 7.5 mmol/mol (this is considered a huge improvement since it typically NEVER goes down!)
• Lantus Insulin – Long term insulin required daily (Basal rate) reduced from a high of 22 Units to today’s dosage of 10 Units.
• Humalog (short term insulin required just prior to meals) – sensitivity has increased at least 60% – meaning much less insulin required per meal.
• Completely off Cozaar – NO medication required to control blood pressure..
• No diabetic neuropathy.
• No wounds. If small ones develop from shoes etc., these heal in one or two treatments.
• Typically only sees a physician for her diabetes once per year.

The Diseaseand Related Implications

Diabetes mellitus (NYSE:DM) is a group of metabolic disorders that impair the body’s ability to metabolize carbohydrates, fat and proteins resulting in hyperglycemia (high blood sugar levels). The healthy body naturally secretes insulin, a hormone that the body requires to convert sugar, starches and other food into energy needed for daily life. In diabetics the body does not effectively produce or react to insulin. When insulin production ceases to function properly it has dramatic implications for the health of the individual.

The key measure of blood sugar is a hemoglobin A1c (HbA1c) test. Inflated levels of glycosylated hemoglobin is a consequence of hyperglycemia. For people without diabetes, the normal range for the hemoglobin A1c is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% indicate increased risk of diabetes, and levels of 6.5% or higher indicate diabetes. Because studies have repeatedly shown that high levels of glycosylated hemoglobin, an indicator of out-of-control diabetes, result in complications from the disease, the goal for people with diabetes is a hemoglobin A1c level of less than 7 to 7.5%.

Type 1 diabetes presents in early life where sufferers’ are unable to produce insulin. Type 2 diabetes is caused by both genetic and non-genetic factors that result in insulin resistance and insulin deficiency. Non-genetic factors include increasing age, high caloric intake, obesity, central adiposity, sedentary lifestyle, and low birth weight. Type 2 comprises approximately 90-95% of cases of diabetes.

Both diabetic types require some form of insulin (or sugar reducing drug) with type 1 normally taking insulin by injection or a wearable pump, while type 2 diabetics typically take an oral medication. There is some evidence that treatment requirements are changing as many type 2 patients are becoming insulin dependent, requiring injections. Of even greater concern, some type 1 patients ultimately become insulin resistant.

Side Effects

Chronic hyperglycemia leads to a variety of metabolic, hormonal, and physiological changes in the body, these then lead to a number of serious side effects that dramatically impact a diabetics quality of life. These include the risk of cardiovascular problems, such as coronary artery disease, chest pain (angina), heart attack, stroke, narrowing of arteries (atherosclerosis) and high blood pressure.

Further, high blood sugar over time can damage the walls of the tiny blood vessels required to nourish nerves. In extremities like the legs this causes tingling, numbness, burning or pain and eventually all sensation can be lost. This also contributes to nerve damage in the feet and various other foot complications. Wounds become a serious problem for diabetics as healing is impaired, potentially leading to serious infections, sometimes even requiring toe, foot or leg amputation.

The possibility of damaged blood vessels has the potential to affect all areas of the body including; the eyes where diabetic retinopathy as well as cataracts are risks, potentially leading to blindness. Diabetic hypertension is a major contributor to kidney failure or irreversible end-stage kidney disease, which often requires dialysis or a kidney transplant. Damage to nerves that control digestion can cause problems with nausea, vomiting, diarrhea or constipation. For men, erectile dysfunction may be an issue. Diabetes may leave people more susceptible to a variety of skin disorders, including bacterial and fungal infections. Type 2 diabetes may increase the risk of Alzheimer’s disease.

The objective of eBalance technology is to introduce change at the cellular level to maintain insulin’s effectiveness and keep blood sugars under control therefore mitigating complications. Cell MedX asserts that by applying a regularly scheduled proprietary treatment of microcurrent frequencies to the cells, the body is able to restore some ability to better manage insulin.

Diabetes is a Massive and Growing Epidemic

The scope of diabetes is massive. Over 387 million people worldwide suffer with diabetes and the International Diabetes Federation (IDF) expects this number to grow to close to 600 million by 2035. The alarming prevalence of the disease and its anticipated growth is placing an incredible and increasing societal and cost burden on the global population. In the United States more than 10% of all healthcare expenditures are related to diabetes and globally the total cost is estimated at $420 billion. The Centers for Disease Control and Prevention (NASDAQ:CDC) pegs healthcare cost related to diabetes above that of cancer. A recent article published in the Journal of the American Medical Association (JAMA) alarmingly concludes that currently half of all U.S. adults are diabetic or pre-diabetic. Other research suggests that 50% of diabetics are undiagnosed and large percentages of diabetics both type 1 and 2 do not monitor their glucose levels. If diabetes is undiagnosed and/or unmonitored it is certain to lead to associated side effects and increased societal cost. With so much at stake it is clearly prudent to explore all hopeful new options.

Current Treatment Options

Insulin continues to be the fundamental treatment for all forms of diabetes but it is not a cure. It is a disease management tool that requires persistent monitoring and management to be effective. Many believe that close to 50% of diabetics have trouble monitoring and managing their disease. Interestingly, for a disease of this size and scope, there has been no new treatments of significant impact since the discovery of insulin in 1920’s.

Insulin is a lifesaving drug with a minor number of side effects. One problem with insulin is that its benefits can eventually cease as the patient becomes insulin resistant.

If eBalance can be proved to be effective in a statistically significant patient pool, this technology will provide patients with an easy to use, minimally invasive device with the ability to stabilize and even improve their condition. New treatments and solutions that can be easily accessed, understood and administered have a better chance for acceptance and adoption and offer tremendous societal benefit and cost savings.

Diabetes care is a massive market, the top 10 drugs alone tallied 2013 sales of over $28 billion. Any company successfully entering this market will generate significant revenues. The impact on the shares of a company the size of Cell MedX (OTCQB:CMXC) would be astronomical.

The Top Selling Diabetes Drugs

Novo Nordisk (NYSE:NVO) and Sanofi (NYSE:SNY) are two of the largest diabetes drug developers. The combined market valuation of Novo and Sanofi is almost $300 billion.

From Fiercepharma:

On this list of the best sellers, you will find a mix of the old and new. According to data fromEvaluatePharma, one of the big dogs of big pharma data, these top 10 drugs had more than $28 billion in sales last year. All of them, even number 10, were blockbusters. KingLantusalone turned in $7.6 billion in revenue, more than the next two drugs combined and still selling strong. Revenues grew about 20% each of the last two years. Sanofi has been able to be aggressive with its pricing, particularly with the FDA decision to delay approval of potential rivalTresibapending more safety data.

1. Lantus
2. Janina
3. NovoLog/NovoRapid
4. Humalog
5. Victoza
6. Levemir
7. Human insulin and devices
8. Janumet
9. NovoMix 30
10. Humulin R

Cell MedX and eBalance

Cell MedX’s eBalance technology is designed to be a simple to use mobile tablet-sized device that can be used in a home or clinical setting. The proposed treatment regimen is 3 times a week for approximately 20 minutes. This regimen has been successful in initial examinations of the technology. In anticipation of the eventual commercialization of the technology, the company has engaged a European engineering firm to assist with the prototype’s design. Based on initial discussions and market comparisons, management believes it is realistic to introduce a device at a price point that will be desirable to insurers as a cost saving treatment.

Opportunity and Conclusions

Glucose management using insulin allows most diabetics to live a healthy life. But the use of insulin, even with modern pumps, is invasive, and some diabetics become insulin intolerant. New treatment option such as eBalance may prove to be a complementary tool contributing to an overall healthier patient. Its principle of action: managing the disease by adjusting the body’s cellular activity bioelectrically is truly novel and if proven successful; game changing. If the improvements witnessed in early tests can be duplicated in larger test groups in clinical trials, the reduction or elimination of side effects and improved overall health of patients is expected to dramatically reduce the expenses associated with the disease, and achieve reimbursement status from insurers. CellMedX is a very small company and the usual risks associated, such as cash requirements and accessibility need to be considered. At the same time the improvements Jean Arnett has demonstrated are truly remarkable. With a medically supervised trial currently recruiting, both the diabetic community and investors will want to pay attention to this evolving and compelling story.