Products
Premium Therapy plans on targeting this large and growing market with its innovative EMIT system. Designed to deliver ElectroMagnetic Induction Therapy (EMIT), the EMIT system consists of two components: a programmable Logic Controller (LC), which generates the required current, and an Array of Overlapping Coils (AOC) through which the current is channeled in generating the electromagnetic field. Premium Therapy's novel technology is embodied in the patented form of its AOC, which contains overlapping coils in an ergonomic, body-contoured wrap designed for the lower back, knee, shoulder, and other targeted regions of the body.
Premium Therapy's true innovation resides in its use of electromagnetic stimulation technology in a therapeutic setting along with its patented delivery device and multiple user-friendly applicators. In order to treat a wide range of diseases, Premium Therapy has developed two different models of the EMIT system, both of which are cost-effective with multiple home healthcare applications.
Product Description
The Premium Therapy EMIT system, a powerful therapeutic device created for the purpose of stimulating tissues of the human body, utilizes the revolutionary EMIT technology to deliver pulsed electromagnetic stimuli to targeted regions of the body. This patented technology is embodied in the form of ergonomic, body-contoured wraps containing a series of overlapping coils. A number of different ergonomic wraps have been developed for the lower back, knee, shoulder, and other regions targeted by the various applications of the EMIT MX and SX models. The wraps are designed to be easy to apply, with simple attachments and clear markings in order to ensure correct placement of the wrap by an untrained user. The coils housed within the ergonomic wraps, when placed over targeted areas of the human body, create stimuli powerful enough to cause muscles to contract, alter pain sensations, and/or enhance cell growth.
The EMIT system will be sold in two parts: a programmable logic controller and an array of overlapping coils.
- Programmable logic controller (LC): The logic controller is a sophisticated, but easy-to-use device designed to provide pulses of current, which create electromagnetic fields when channeled through the coils located in the various wraps. The electromagnetic field generated by the LC is capable of being adjusted in terms of amplitude and frequency in order to meet specific patient needs.
- Array of overlapping coils (AOC): The overlapping coils have technological advantages in that they effectively blanket the therapeutic area with electromagnetic stimulation, thus making therapies consistent, rapid, and easy to administer. A flexible, ergonomic wrap has been designed to position the coils over key regions targeted by each specific application. The design of the wrap will be such that markings on the material of the wrap will indicate correct alignment of the device over the intended area of the body. The wraps will also be contoured and fit to the region targeted making application even more consistent and effortless. Every design is available in multiple sizes to accommodate patients of various dimensions. Multiple wraps have been designed including knee, shoulder, pelvic, lower back, etc.
Product Applications
The EMIT MX system generates a maximal (MX) current stimulus sufficient to cause contraction in targeted muscle groups and is used in applications requiring large currents including the treatment and prevention of muscular atrophy and the treatment of neurogenic bladder and bowel. The treatment of musculoskeletal pain and arthritis, though, requires relatively lower levels of current. In order to satisfy this market, the EMIT SX model has been tailored to generate a submaximal (SX) stimulus that will not cause muscular contraction.
Emit Mx Applications
Prevention and Treatment of Muscle Atrophy: The Premium Therapy EMIT MX system addresses the unanswered need for atrophy prevention and treatment in conditions resulting in patient immobilization for greater than two weeks, such as in the case of hip, knee, and shoulder surgery; spinal cord injury; and a number of other cases. In animal models, the average muscle loss after just two weeks of immobilization was noted to be greater than 30 percent of the total pre-immobilization mass. This loss of muscle mass results in increased times to complete recovery and, with prolonged immobilization, in permanent disability. Studies have shown that inactive muscle stimulated by pulsed electromagnetism has better function and reduced loss of mass subsequent to immobilization.
Treatment of Neurogenic Bowel and Bladder: The EMIT MX system also offers a simple, noninvasive solution to the problem of neurogenic bladder and rectum causing retention of urine and bowel contents in persons with spinal cord injuries, Multiple Sclerosis, and various other disorders. Similar to the paralysis of the arms or legs in a patient with spinal cord injuries, patients with neurogenic bladder and bowel have "paralysis" of their bowel and bladder leading to difficulties with defecation and urination. The complications that can arise from neurogenic bladder and bowel are significant. In mortality studies of persons with spinal cord injuries, after a period of high mortality at the time surrounding the initial injury, neurogenic bladder has been shown to be the primary cause of death.
Invasive methods have been attempted to address this problem but without significant success and with multiple side effects. In both human and animal models, pulsed electromagnetic stimulation has been shown to increase bladder and bowel pressures, and to thereby effect evacuation. This technique is simple, safe, noninvasive, and has no known adverse effects. Using a lumbosacral wrap with coils targeting key nerves and muscles, Premium Therapy's EMIT MX system will provide effective, easy-to-use therapy for patients with neurogenic bowel and bladder.
Emit Sx Applications
Treatment of Musculoskeletal Pain: The Premium Therapy EMIT SX system offers the capability to reduce and/or eliminate pain in persons with localized musculoskeletal processes. A number of scientific studies have clearly demonstrated the power of pulsed electromagnetic coil stimulators to control pain. In one study, patients reported a 59 percent decrease in a subjective pain score after a single treatment with pulsed electromagnetic stimulation. The pain relief attained regularly persisted for several days. Additional studies have demonstrated consistent production of analgesia in subjects receiving pulsed electromagnetic stimulation, with long-lasting pain relief occurring in over half of the subjects.
Specifically in the treatment of back pain, the placement of a pulsed electromagnetic stimulator over muscles surrounding the spine consistently demonstrated a significant decrease in patient-reported scores of lower back pain. In addition to its demonstrated efficacy with lower back pain, pulsed electromagnetic stimulation has been found to be beneficial for musculoskeletal pain of all types, including neck, knee, and chronic and acute localized pain conditions.
Treatment of Arthritis: The Premium Therapy EMIT SX system also has applications in the treatment of arthritis where it has been shown that low frequency pulsed electromagnetic field stimulation results in the growth of cartilage cells. This ability to stimulate new cartilage growth creates a tremendous potential to reverse the degenerative changes of arthritis, a disease characterized by the destruction of existing cartilage in and around joint spaces.
In addition to the potential benefits of cartilage repair and growth, pulsed electromagnetic devices have also been shown to be cost-effective in reducing pain, including chronic knee pain, and improving function in osteoarthritis. Due to both its increased efficacy and lack of adverse side effects, pulsed electromagnetic stimulation may prove useful in forestalling joint replacements.
Proprietary Position
A full utility patent has been authored, filed, and is currently pending for "Method and Apparatus for Electromagnetic Stimulation of Nerve, Muscle, and/or Body Tissues." This patent takes into account both offensive and defensive postures in its claims and represents an extension of Provisional Patent No. 60/266,455. Opinions of legal counsel are confident that Premium Therapy's patent applications are enforceable and defensible. Care has been taken to file all potential claims of the invention in order to protect it from possible competition from other technologies. All patent application documents will be made available for examination by potential investors. Trademark applications are in process on the names Premium Therapy and EMIT. No conflicts or other use of these names has been found in an initial search. There are no third party claims for any interest in Premium Therapy technology, as none of the technology was developed using the facilities of any other institution and the developers were not employed by any other institution prior to the filing of their provisional patent.
Development Status
Premium Therapy's technology is currently in the bench-testing stage of development, the results of which have been highly encouraging. An Investigational Review Board (IRB) application has been filed to conduct human clinical studies and rapid approval is expected based on approval of similar studies.
Premium Therapy has contacted leading medical institutions in the U.S., many of which have expressed interest in participating in collaborative research and, given encouraging research results, purchasing the EMIT system. Investigators expressing strong interest include Dr. Henry Dillard of Harvard University, Dr. Floyd Marcus of University of California - Berkeley, Dr. Josh Williamson of the Therapeutic Institute, and Dr. Jason Martinez of the University of Arizona. It is expected that once Premium Therapy's IRB application has been approved, clinical studies will commence at each of these institutions.
Future Products
Premium Therapy anticipates future product development in profitable markets in the medical industry in the form of both the expansion of indications for the EMIT system and the development of novel technologies.
An example of a potentially profitable new indication for the EMIT system is found in the treatment of the major cause of stress urinary incontinence—a condition referred to as "idiopathic detrusor instability." Detrusor instability describes the unstable contractions of the detrusor muscle (a muscle controlling the release of urine from the bladder), which can cause sufferers to unexpectedly release urine. More than 20 million Americans are affected by this condition in which traditional therapies, such as dietary manipulation, surgical procedures, medications, and physical therapy, have been poorly tolerated and ineffective. Studies have shown that electromagnetic stimulation of sacral (an area of the lower spine) nerve roots acutely abolishes unstable contractions in patients with this condition making this a condition that will likely be treatable with the EMIT system.
In addition to researching new uses for the EMIT system, Premium Therapy will also explore novel technologies. To this end, the patent process has been initiated for a device designed to teach correct posture. This device is designed to train the user in maintenance of a healthy posture in order to treat the back and neck problems often associated with incorrect posture. In contrast to current devices that simply hold the spine in the correct position and then allow resumption of incorrect posture upon discontinuation, this device will actually train the user to maintain the correct posture by developing the musculature required for permanent correction of the problem.
While future product development is planned, Premium Therapy will concentrate, for the time being, on the ability of the EMIT system to treat muscular atrophy, neurogenic bladder and bowel, musculoskeletal pain and arthritis. Once success has been demonstrated in these markets, expansion to other markets, such as the treatment of stress incontinence, will be considered and new product development will be explored.
Strategy & Implementation Summary
