SPARKS, Md., Nov. 15 /PRNewswire/ -- BioniCare Medical Technologies, Inc., today, announced data from a Phase IV trial of its patented pulsed electrical stimulator, the BioniCare Knee Device, that confirm the device’s safety and efficacy in managing and treating symptoms associated with osteoarthritis (OA) of the knee. Data from a previous study conducted at Johns Hopkins University demonstrated that 62% of candidates for total knee replacement were able to defer surgery at the end of four years versus only 7% of patients in a control group.
Treating Moderate-Severe to Severe Patients
“Patients in this study had OA classified radiographically as Kellgren’s II-IV severity and had not achieved sufficient success in managing their disease with other commonly prescribed OA treatments,” says Dr. Thomas Zizic, president, CEO and a cofounder of BioniCare Medical Technologies, Inc. “The overall efficacy demonstrated by the BioniCare Knee Device in this and previous clinical studies further establishes the device as a safe and effective, non-toxic, non-invasive treatment option to significantly manage the disease and improve OA patients’ quality of life.”
The prospective, open-label study, which began in November 2003, involved 288 male and female OA patients from 58 centers in the United States who had experienced an inadequate response to, or were intolerant of, therapy with nonsteroidal, anti-inflammatory medications (NSAIDs) and/or analgesics. Patients wore the BioniCare Knee Device for an average of six to 10 hours each day and were asked to report any adverse events experienced while using the device. Although patients were given the option to stay on NSAIDs and/or analgesics, they were allowed to reduce usage.
Every two to four months, patients’ outcomes were evaluated with a questionnaire based on a 5-point Likert scale measuring the effects of the BioniCare Knee Device on their assessment of OA pain in the knee, overall arthritis pain and pain experienced when walking, using stairs and lying in bed. The three primary outcome measures involved patient global evaluation of disease activity, physician global evaluation of disease severity and patient evaluation of pain in the treated knee.
Compelling Combination of Benefits: Pain Reduction, Decreased NSAID Use, No Serious Side Effects
Data showed that all patients experienced an increase in the effects of the BioniCare Knee Device on primary endpoints compared to baseline reports. Patients who reported using the device for more than 750 hours experienced 50 percent or more improvement in one or more outcome areas than those who used the device for less than 750 hours. In addition, 45.4 percent of NSAID users reduced their use by 50 percent or more and 18 percent of NSAID patients discontinued use altogether.
The patient population reported no serious adverse effects while using the BioniCare Knee Device. A rash occurred in 15.4 percent of patients due to the conducting gel used under the electrodes over the knee and proximal thigh, but only 1.4 percent of the subjects discontinued use of the device due to the rash.
Osteoarthritis: A Large and Growing Unmet Need
Twenty-one million Americans suffer from osteoarthritis. Most debilitating is osteoarthritis of the knee, which afflicts more than 10 million Americans. The incidence of the disease is increasing at a rate of 5 percent to 10 percent per year, due largely to the aging of the Baby Boomers. Although the disease affects men and women equally, women received 75 percent of the approximate 400,000 total knee replacements performed last year. In addition to an average cost of $32,000, knee replacement surgery can mean prolonged hospitalization and carries a small risk of mortality. Most recently, the lack of effective non-surgical treatments for pain and other symptoms of osteoarthritis were exacerbated by the recall of Vioxx.
The BioniCare Knee Device: A Product with an Uncommon Clinical Profile of Safety and Efficacy
The BioniCare Knee Device works through low amplitude electrical stimulation that is sub-threshold and thus undetectable to most patients. The BioniCare Knee Device is the first and only non-drug, non-invasive treatment option available for OA of the knee. In one four-year study conducted at Johns Hopkins University, 62% of candidates for total knee replacement were able to defer surgery; this was true for only 7% of patients in a control group. In addition, no patient has suffered a serious adverse event using the BioniCare Knee Device.
Its benefits include the following: -- Targeted, durable relief of pain and associated symptoms -- Substantial improvement over baseline anti-inflammatory medications -- Excellent safety profile -- High patient acceptability -- Ease of use About BioniCare Medical Technologies, Inc.
BioniCare Medical Technologies, Inc. develops and markets devices to meet the growing needs of more than 70 million Americans who suffer from the painful complications of arthritis and related musculoskeletal diseases. Through application of its patented technology, BioniCare is dedicated to the discovery of non-invasive devices for the regeneration of musculoskeletal soft tissues to significantly improve the quality of patients’ lives.
For more information about the company and the benefits of BioniCare’s non-invasive, non-drug option for treating OA, please visit http://www.bionicare.com.
BioniCare Medical Technologies, Inc.
CONTACT: Jonathan Cabral, Executive VP Sales & Marketing of BioniCareMedical Technologies, +1-410-472-1888, jcabral@bionicare.com
Web site: http://www.bionicare.com//