Heart failure affects close to 5 million people in the USA and each year close to 500,000 new cases are diagnosed. More than 50% of patients seek re-admission within 6 months after treatment with an average duration of hospital stay of 6 days. The problem is only amplified when we look at the global impact of heart failure where it is estimated that 2% of the population in developing countries suffers from heart failure and that there are approximately 50 million people suffering from CHF (Congestive Heart Failure) worldwide with 2 million new cases diagnosed each year. Heart failure is the single largest economic drain on the United States Medicare system, with an annual cost of $35 billion and globally the costs that derive from heart failure exceed the costs of all forms of cancer combined. In the UK, these costs amount to 2% of the total budget of the National Health Service. While there are many drugs and treatments available, the problem is that existing treatments fail to solve the problem. Rather they offer temporary solutions or maintenance of the patient at a post-heart failure condition that does not provide a sustainable lifestyle for the patient. This is one issue that MyoStim is targeting with our technologies.
Limb & Digit amputation affects approximately 300,000 patients in the USA each year. In a study commissioned by Aldagen, the research/consulting firm Trinity Partners estimated that approximately 1.0 million people in the United States have critical limb ischemia. In a study published in the journal Cardiovascular and Hematological Disorders, researchers estimated that approximately 10% to 40% of critical limb ischemia patients are not considered candidates for surgical revascularization or endovascular procedures. Trinity Partners estimated that approximately 30% of patients with critical limb ischemia have no revascularization options.
According to the National Limb Loss Information Center, it is estimated that one out of every 200 people in the U.S. has had an amputation. Although historically most amputations are caused by Dysvascular-Related, Cancer-Related or Congenital-Related, the Trauma-Related cases are on the rise due to the multiple war efforts and the Wounded Warriors.
In order to address the above market needs, MyoStim has leveraged its patented electro-stimulation technology to bring the MyoStim products to market.
MyoStim Heart Repairing CRT/ICD – An implantable device for treating heart failure. The device is designed to grow new blood vessels and new muscle, increase contraction strength of muscle and ensure that the heart remains in rhythm reducing the risk of sudden death from arrhythmias.
The MyoStim Heart Repairing CRT/ICD – An implantable device for treating heart failure. The device is designed to grow new blood vessels and new muscle, increase contraction strength of muscle and ensure that the heart remains in rhythm reducing the risk of sudden death from arrhythmias.
The stimulator runs five (5) programs in sequence.
(1) The Kanno program stimulates angioenesis (new blood vessel growth).
(2) The Chachques-Leonhardt program recruits stem cells to injured heart tissue areas.
(3) The Leonhardt-Chachques program differentiates recruited and/or injected stem cells to beating heart muscle.
(4) The Leonhardt program senses arrhythmia's-fibrillation and delivers a low voltage pulse to restart a patient's heart back to a normal beat (replaces outdated high voltage shock ICD systems).
(5) The final program is a standard synchronization pacing program that double ensures that newly created muscle, in the previous scarred areas of the heart, beats in synchrony with the rest of the heart. The stimulation pulses also duly serve to increase the contraction twitch strength of the muscle to improve cardiac output. This product will require clinical trials of approximately 300 patients. Nearly half of the 30 to 50 million patients worldwide in heart failure are expected to be candidates for this product in the future.
MyoStim Wound Healing/ Limb Salvage Device –This Wound Healing and Blood Flow Stimulator is designed for treating wounds secondary to peripheral limb ischemia, foot ulcers and other slow healing wounds. Electrodes are placed near the affected area, and on the blood supply routes to the affected area, and stimulation is administered over a course of physician directed treatment.
Intellectual Property - MyoStim currently has three (3) Low-Intensity Electrical Current technology patents employed by its product line. The company expects that additional patents will result from the claims made in its existing patent portfolio as well as from current and future research.