Osteogenesis Stimulated by Shock Wave Application
Approximately 25% of the North American population suffers from pathological bone and joint conditions, calcification or diseases of the tendon. The OssaTron orthopedic Lithotripter provides a non-surgical, non-invasive alternative for persons with these conditions. The OssaTron is currently operated worldwide in more than 40 centers including Germany, Austria, Japan as well as Canada and has completed over 30,000 successful cases.

Clinical studies are currently underway with the OssaTron for treatment of tennis elbow, nonunion and delayed union fractures, heel spurs and for the fixation of painful, loosened hip prostheses at several European sites.

Results of these studies have been very encouraging and pivotal studies began in early 1998. Industry analysts feel confident that FDA approval to market the OssaTron is likely to be Quarter 1, 2000.

Elbow tendonitis
Elbow tendonitis, commonly known as tennis elbow (lateral epicondylitis) or golfers elbow (medial epicondylitis) affects from 1% to 3% of the population. Symptoms range from minor pain and discomfort (in mild cases) to extreme pain and complete loss of arm mobility (in some severe instances). Common symptoms are pain and limited movement with resulting restriction in activity and function.

In Europe, this malady is commonly treated with the OssaTron in a two stage process of shockwave application at relatively low power settings. The European treatment protocol was modified slightly for the feasibility study conducted by Dr. Richard Levitt at Doctor's Hospital in Coral Gable, Florida. Each of the 20 study subjects was given an initial treatment of 1,000 shocks with the option of receiving a second treatment of 1,000 shocks after 6 weeks. Results of the initial treatment were so encouraging that only half of the patients opted to undergo the second treatment.

Subjects reported that symptoms of elbow pain had persisted for periods ranging from 6 months to 27 years prior to study enrollment. Of the 17 patients for whom 6-month follow-up data is available, all have demonstrated significant improvement in symptoms, e.g., decreased pain and resumption of normal activities. For example,

Approval has been granted by the FDA to commence a multi-centre pivotal study, and, Dr. Levitt, who will continue to be an investigator, began pivotal study treatments at Doctors Hospital in January 1998

Plantar Fasciitis - "Heel Pain Syndrome"
Each year some 40 million North Americans suffer from heel pain syndrome, sometimes called "heel spurs". Conventional treatments for this extremely painful affliction include cortisone injections, the use of orthotic devices and heel cord stretches. Despite these techniques, the pain may persist for months or years.

A single-site feasibility study was conducted by Richard Alvarez, M.D. at Memorial Hospital in Chattanooga, TN. The study commenced on February 27, 1997 and included twenty subjects who averaged 21.4 months of heel pain prior to study enrollment. In the study each subject was treated with a single OssaTron treatment of 1,000 shocks. In 90% of the cases, subjects demonstrated significant improvement in symptoms (on average, an 89% reduction in pain was experienced). Following is a case review of a patient treated in this study.

Nonunion Fractures
Over 200,000 nonunion fractures occur in North America every year. Previous treatment was limited to such conventional methods as bone grafts, internal or external fixation, electrical stimulation and casting.

The OssaTron, however, offers non-invasive, non-surgical therapy using high-energy shock waves precisely directed at the injury site. The shock waves induce micro-fractures, bleeding and osteogenesis (bone growth) around the fracture.

In Europe, the OssaTron's success rate for healing of nonunions in the tibia, humerus, metacarpal and metatarsal bones is in the range of 80%. This significant success rate has even been experienced with nonunions present for many years.

The U.S. feasibility study is being conducted at Regional Lithoptripter Services in Portland, Oregon, and to date, includes 11 patients who had sustained fractures of the tibia or humerus.

Subjects were treated under general anesthesia and received a maximum of 4,000 shocks over a period of approximately 45 minutes. Post procedure, there were several cases of bruising around the area of shock wave entry but no other side effects were recorded.

Of the 10 patients for whom 3-month follow-up data was available, 7 showed radiographic evidence of bone consolidation and experienced significant improvement in symptom scores.

For example, the following information is a case review of the first patient treated in this feasibility study.

Due to the relative scarcity of nonunion candidates in North America who meet the strict study criteria, study results may be submitted to the FDA with the modifications to conduct a multi-centre study on delayed union fractures as well as nonunions.

Fixation of Painful, Loosened Hip Prostheses
Chronic degenerative joint disease affects approximately 17 million North Americans, many of-whom require total joint replacement. Current estimates indicate that about 2.5 million people worldwide have artificial hip joints.

Short-term results of this operation are generally excellent, however, long-term results can be less satisfactory due to pain and implant loosening. The major problems with joint replacement are the fixation of an inert implant into a living bone, the long-term efficacy of the implant, and the ability of the implant to withstand the wear and tear of patient activities.

It is the hypothesis of the IDE feasibility study that treatment with the OssaTron will reduce and relieve pain and promote osseo - integration (bone ingrowth) of a loosened femoral component of an uncemented total joint replacement. In Austria and Germany; 12 patients have been successfully treated with this procedure over the past 12 months. The study began in the first quarter of 1998 with the hope of expanding into a multi-centre pivotal study- by the winter of 1998.

Institute for Sports Medicine
The institute of Sports Medicine in Toronto introduces OrthoTripsy for non invasive, non-surgical treatment of chronic bone and joint conditions.

Dr. Anthony Galea and Dr. Robert Gordon are now performing procedures with North America's first High Energy Orthopaedic Lithotripter, the OssaTron

North American patients seeking relief from non nerve related chronic heel spur or chronic tennis elbow can now benefit from extensive worldwide experience with the OssaTron. The OssaTron has been used successfully in more than 30,000 European cases, and FDA trials report very encouraging single procedure success treating Chronic Heel Pain Syndrome and Chronic Lateral Epicondylitis. Clinical studies using OrthoTripsy to treat nonunion, and delayed union fractures are producing equally exciting results. Studies in Europe support OrthoTripsy in treating partially-torn rotator cuffs and calcific tendonitis as well as loosened Orthopaedic prostheses such as hips and knees.

The OssaTron is the most powerful version of this new technology. Patients who have not responded well to conventional treatment, now have the option of OrthoTripsy to help regain the quality of life they previously enjoyed.

During treatment, the head of the OssaTron is placed on the skin, then adjusted very precisely to send the shockwaves to the specific location of the injury. Acoustic shockwaves are carried to the skin through a soft, translucent rubber bellows. The acoustic energy produced by the OssaTron is not an electrical current but is a well-proven, safe method of breaking-down calcification in the area of tendons and muscles.

The OssaTron treatment does not require surgical incisions and the healing process is internal, with no wounds, no stitches and no scars.

The effectiveness of the OssaTron treatment in healing those conditions for which it is properly indicated, is now well documented. Scientific research continues in order to better understand why it works so well and how it might be applied to help people who suffer from other bone and joint conditions.

The entire process requires approximately two hours, including check-in at the Institute for Sports Medicine, administration of anesthetic and about 30 - 40 minutes of shockwave therapy. A local anesthetic is used (with the exception of pseudarthrosis) and most patients describe the shockwave therapy sensation as unpleasant but quite bearable. All patients, except those treated for pseudarthrosis, leave directly after their treatment. Small bruises occasionally appear as a side effect.

Grant Medical, can supply information to Medical professionals about OrthoTripsy treatments, and discuss how you can also own and operate an OssaTron.

CAUTION: Investigational device limited by Federal law to investigational use.