Corporate News

CURRENT EVENTS

CAPITAL RAISE

We have only just begun our 2nd and 3rd round funding efforts and have had nothing but very positive responses. In fact, so positive we decided to forego a planned private placement round to save time. Once funded and as we prepare to launch, we may re-visit this offering round to provide opportunity for our healthcare professional champions to participate and earn with us. More on this later.

INITIATIVES--PERFECT TIMING

Watching the Value-Based healthcare initiative gain traction and begin to take hold has been interesting/provocative, but should prove beneficial to the patient--we all want that. Big Data, digital media ...hopefully our healthcare system will benefit from all that has been proposed and not change for the sake of change. We have major issues ahead and the cost burden of MSDs is one for which we hope to provide solutions.

With the Value-based reimbursement model, outcomes are in the spotlight. All will soon recognize our device--with it's extended care treatment model, interrelated (clinical/at home) self-application therapy and proven TrPT efficacy--needs to be included in any MSD therapy plan to achieve the most favorable outcomes.

WHY PRESCRIPTION?

Our support of the physical therapy profession has no bounds. Back through the 1950s and 60s , PTs were considered the musculoskeletal experts and their opinions were highly regarded even by top Orthopedic surgeons. Manual TrPT was the standard treatment modality for MSDs; getting away from it has led us here.

Our device is dispensed by prescription to guarantee its effectiveness is not compromised in any way. It must be properly fit to the patients body type, size and muscle density. Multiple attachments provide customization options to configure it specifically for the patient's therapeutic requirements. It is simple to use, but there are some basic leverage fundamentals to follow and isolation methods that maximize its effectiveness; methods that are more accurate and better understood when taught by an expert.

INDUSTRY SUPPORT--PARTNERSHIP WITH APTA

Our strategic partnership with APTA is mutually beneficial. It is our intent to support the organization in every way possible. We hope to adapt our support to each member's practice. We have one collective goal; we must make a dent in this MSD cost burden and help more people avoid movement system dysfunction/disability while remaining cognizant of their overall well-being.

We designed a treatment model for our device that develops significant, active patient involvement. It incorporates a progression order conceived to ensure they recognize its importance and complete their entire course of care. Self-application techniques are taught/supervised in clinic for accurate, effective duplication at home--very important as effective TrP elimination or management requires multiple treatments, at interval, numerous times daily .

Our course curriculum for APTA's continuing education platform has been outlined and is under review. Year two following our launch, we plan to offer our in-depth TrPT courses and other promotional programs in accordance with their program.

STUDIES COMPLETE

We began observational studies with PTs and patients using our device 12 years ago. Since then we have conducted more than 30 long-term clinical studies to determine efficacy and safety. Throughout the process, we continued to develop/perfect the device by testing materials, configurations, manufacturing processes and above all we listened to our "design cooperative" of healthcare professionals. Without doubt, the result is most effective clinical and self-application device for the treatment of MSDs; a TrPT tool that is professional, easy to use, custom fits to every patient and effectively eliminates and/or manages TrPs --eliminating pain and dysfunction. It reaches every part of the body and the treatment techniques developed were proven effective with all movement system MSDs including the more complex disorders fibromyalgia, myofascial pain syndrome and muscular sclerosis. The mobility assist component was judged vital for preventive measures to avoid compensation injuries related to dysfunctional or abnormal gait resulting from injury, surgery or as part of the rehabilitation process.

FDA & USPTO

Complete

MORE ON MUSCULOSKELETAL DISORDERS:

MUSCULOSKELETAL DISORDERS

Musculoskeletal disorders are a major healthcare problem, worldwide. In the US, they are the second most common reason people see their Doctor and across the globe, they are the third most common reason in every country. Our health insurance industry spends over $120 billion annually to cover treatment costs. These are the costs we can officially quantify through health insurance industry analytics. In 2016, more than 2 million surgeries were performed relating to musculoskeletal disorders. Incredibly, more than half of our 148 million person workforce is actively being treated for a musculoskeletal disorder at any given time. Treatment procedures range from inexpensive, over-the-counter medications for pain relief to invasive surgical procedures requiring hospitalization, prescription medications and rehabilitation assistance from Physical Therapists (PTs). For example, the average total cost of back surgery is over $90,000 per patient. The dilemma for our health insurance industry is cutting costs without compromising treatment. Effective treatment is critical and directly relates to the future medical cost burden of the patient.

The most effective treatment for musculoskeletal disorders primarily involves physical therapy and almost always necessitates trigger point (TrP) therapy. TrPs are palpable nodules in a taut band of muscle that not only cause pain and muscle dysfunction but they also affect biochemical changes that make it nearly impossible for the body to fully recover without treatment. They can form in any area of any muscle or connective tissue and usually are a result of muscle overuse or acute overload, muscle trauma, microtrauma, sustained low-level muscle contractions, psychological stress and visceral disorders. Multiple modalities (methods) are used by the PT to treat TrPs but the essential procedure is manual therapy. Deactivating and eliminating TrPs manually can be a difficult process for the PT as it requires some strength and stamina on their part. To be effective, the process involves manual compression techniques followed by ice, stretching, full range of motion exercises, then moist heat. It is common for TrPs to re-form within hours of treatment, especially if all relating TrPs are not deactivated. When they re-form, dysfunction returns rather quickly. If treatment is administered again immediately, it is much more effective. The TrPs respond faster this second time around; however, fully breaking the cycle often requires repeating this treatment sequence numerous times.

Herein are the issues:

Manual therapy can be wearing on the PT physically, considering the average PT sees 20 or more patients per day. Our observations show less manual therapy is being performed by PTs due to heavy patient loads.
The most effective TrP treatment process can require repetitive treatment, often numerous times daily. Obviously, it is not feasible for a PT to schedule numerous appointments for an individual patient every day.
Muscle knots and TrPs must be rendered inactive before proper/effective stretching and strengthening can occur.
Without exception, all other musculoskeletal treatment modalities are more effective when manual or compression TrP therapy is part of treatment.
Patient involvement (PT taught/managed self-application) is critical to the process. Referred TrP pain patterns can serve as an accurate guide for the PT in identifying latent and satellite TrPs. Detecting these patterns requires informed communication with the patient. Properly coached patients can effectively treat their own condition if the appropriate means (our device) is available to them.
Less than 30% of patients referred to PTs complete their course of care. Do they see their treatment as too repetitive or feel they can do the same on their own? Regardless, the most favorable outcome has not been achieved. Will this compromise lead to re-injury or other medical issues? Most often it does. Our device will help the patient understand the value of completing their course of care with the PT and establish the importance of reaching the optimal outcome.

United States Bone and Joint Initiative.

The Burden of Musculoskeletal Disease

Release Date:
Tuesday, March 01, 2016

United States Bone and Joint Initiative Report
New report outlines the prevalence, scope, cost and projected growth of musculoskeletal disorders in the U.S.

ORLANDO, Fla.—An estimated 126.6 million Americans (one in two adults) are affected by a musculoskeletal condition—comparable to the total percentage of Americans living with a chronic lung or heart condition—costing an estimated $213 billion in annual treatment, care and lost wages, according to a new report issued today by the United States Bone and Joint Initiative (USBJI).

Musculoskeletal disorders—conditions and injuries affecting the bones, joints and muscles—can be painful and debilitating, affecting daily quality of life, activity and productivity. “The Impact of Musculoskeletal Disorders on Americans: Opportunities for Action” outlines the prevalence and projected growth of musculoskeletal disorders in the U.S., and recommends strategies for improving patient outcomes while decreasing rising health and societal costs.

“This report provides the critical data needed to understand the magnitude of the problem, and the burden, of musculoskeletal disease in our country,” said David Pisetsky, MD, USBJI president, and professor of medicine and immunology at Duke University Medical School. “The number of visits to physicians for these disorders, the cost of treating them, and the indirect costs associated with pain and loss of mobility, are proportionately much higher than the resources currently being allocated to combat these conditions and injuries.”

“As a nation, we need to establish greater funding for musculoskeletal research, improve our understanding and strategies for prevention and treatment of these injuries and conditions, and ensure that more adults and children receive appropriate treatment sooner, and on an ongoing basis, to ensure quality of life and productivity,” said Stuart L. Weinstein, MD, co-chair of the report’s Steering Committee and a professor of orthopaedics and rehabilitation at the University of Iowa Hospitals and Clinics.

Prevalence and Predictions

According to the report, the most prevalent musculoskeletal disorders are arthritis and related conditions; back and neck pain; injuries from falls, work, military service and sports; and osteoporosis, a loss of bone density increasing fracture risk, primarily in older women. An estimated 126.6 million Americans were living with a musculoskeletal disorder in 2012. More specifically:

Arthritis is the most common cause of disability, with 51.8 million—half of U.S. adults age 65 and older—suffering from the disease.
With the aging of the American population, the report projects arthritis prevalence to increase to 67 million people, or 25 percent of the adult population, by 2030. Arthritis is not just a disease for older Americans, with two-thirds of arthritis sufferers under age 65.
Back and neck pain affects nearly one in three, or 75.7 million adults. Osteoporosis affects 10 million Americans, with 19 million more (mostly women) at risk for the disease. One in two women and one in four men over the age of 50 will have an osteoporosis-related fracture, and 20 percent of hip fracture patients over age 50 will die within one year of their injury.

Cost and Health Care Impact

The burden of musculoskeletal conditions is significant in terms of treatment and care, as well as the impact upon of quality of life, mobility, and productivity, and resulting in fewer days at work and in school. In 2011, the annual U.S. cost for treatment and lost wages related to musculoskeletal disorders was $213 billion, or 1.4 percent of the country’s gross domestic product (GDP). When adding the burden of other conditions affecting persons with musculoskeletal conditions such as diabetes, heart disease and obesity, the total indirect and direct costs rose to $874 billion, or 5.7 percent of the GDP in 2015.

Other data on the costs of musculoskeletal diseases and injuries include:

Eighteen percent of all health care visits in 2010 were related to musculoskeletal conditions, including 52 million visits for low back pain, and 66 million for bone and joint injuries, including 14 million visits for childhood injuries.

Arthritis and rheumatoid conditions resulted in an estimated 6.7 million annual hospitalizations.
The average annual cost per person for treatment of a musculoskeletal condition is $7,800.

The estimated annual cost for medical care to treat all forms of arthritis and joint pain was $580.9 billion, which represented a 131 percent increase (in 2011 dollars) over 2000.

In 2012, 25.5 million people lost an average of 11.4 days of work due to back or neck pain, for a total of 290.8 million lost workdays in 2012 alone.
Among children and adolescents, musculoskeletal conditions are surpassed only by respiratory infections as a cause of missed school days.

Opportunities for Action

The report provides recommendations to curb the tremendous economic and societal costs of musculoskeletal disorders, including:

Accelerating research that compares treatment alternatives, develops new treatments and evaluates possible preventative approaches.
Improving understanding of the role of behavior change in prevention and treatment, including weight loss and self-management of conditions once they arise.
Ensuring that a higher percentage of the affected population receives access to evidence-based treatments.
Implementing proven prevention strategies for sports injuries, workplace injuries, and injuries in the military.
Ensuring that all children with chronic medical and musculoskeletal problems have access to care.
Promoting better coordination between physicians and other health care providers treating musculoskeletal disorders: primary care physicians, specialists, physical therapists, chiropractors, etc.
Ensuring that health care providers, especially primary care physicians, have the appropriate training to diagnose, and if necessary, refer patients for appropriate treatment.
Addressing data limitations, and improve systems, to improve our understanding of these conditions and how best to screen, diagnose and treat them. This includes the impact of sex and gender on musculoskeletal disorders and responses to treatment and tracking pediatric patients through adulthood to determine the lifelong burden of musculoskeletal disease.

“If we continue on our current trajectory, we are choosing to accept more prevalence and incidence of these disorders, spiraling costs, restricted access to needed services, and less success in alleviating pain and suffering – a high cost,” said Edward H. Yelin, PhD, co-chair of the report’s steering committee, and professor of medicine and health policy at the University of California, San Francisco. “The time to act to change this scenario to one with more evidence-based interventions and effective treatments, while simultaneously focusing on prevention, doing better by our society and economy, is now.”

In March of 2011, the United States Bone and Joint Initiative (USBJI), a part of the Global Alliance for Musculoskeletal Health, was created.

The goal of USBJI is to improve the quality of life for people with musculoskeletal conditions and to advance understanding and treatment of these conditions through research, prevention, and education. The cornerstone of USBJI is the burden of musculoskeletal disease, defined as the incidence and prevalence of musculoskeletal conditions; the resources used to prevent, care, and cure them; and the impact on individuals, families, and society. Direct costs of the burden of musculoskeletal disease include hospital inpatient, hospital emergency and outpatient services, physician outpatient services, other practitioner services, home health care, prescription drugs, nursing home cost, prepayment, and administration and non–health-sector costs. Indirect cost relates to morbidity and mortality, including the value of productivity losses due to disability or premature death due to a disease and the value of lifetime earnings as well as the impact on quality of life.

United States Bone and Joint Initiative
USBJI is a unique organization of organizations that brings together the spectrum of stakeholders concerned with musculoskeletal health. It is one of more than 60 national action networks of the worldwide Global Alliance for Musculoskeletal Health of the Bone and Joint Decade, endorsed by the United Nations and the World Health Organization. For more information on USBJI and its programs, visit www.usbji.org.

The American Academy of Orthopaedic Surgeons
With more than 39,000 members, the American Academy of Orthopaedic Surgeons (AAOS) is the world’s largest association of musculoskeletal specialists. The AAOS provides education programs for orthopaedic surgeons and allied health professionals, champions and advances the highest musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments, and related issues. To learn more, visit www.aaos.org.

To view the Bone and Joint Decade Report (2000-2010) visit :

http://bjdonline.org/wp-content/uploads/2012/10/BJD-10-Year-Report.pdf first decade report.