In 2006, the Company and the Lahey Clinic jointly announced a three-year program to study the effects of ActiPatch Therapy on a variety of soft tissue injuries and related medical conditions. The internationally renowned Lahey Clinic of Boston, whose faculty is affiliated with the Medical Schools of Harvard and Tufts, has committed to initiating a number of double-blind clinical studies on ActiPatch Therapy in the areas of plastic surgery, orthopedics and chronic wound care. Results from these clinical trials will be submitted to the United States Food and Drug Administration (the FDA) for expanded indications for the use of ActiPatch Therapy.
The company also commenced a series of double-blind clinical trials to be conducted in conjunction with leading schools of podiatry and selected clinics to document the effects of ActiPatch on treating plantar fasciitis [heel pain]. The studies in started in March 2006. The Principal Investigator for the study is Dr. William Van der Reis, a Board Certified Orthopedic Surgeon and sports medicine specialist.
The primary motivation for continued clinical trials is to obtain additional FDA approved therapeutic indications for existing and future products and to facilitate faster diffusion of the Companies medical product line by the medical community. Securing FDA approval is central to market entry and product acceptance. Below are listed currently planned clinical studies.
Ankle Sprains: This study will use Grade I and II ankle sprains (no gross instability) as the entry criteria. The patients will be randomly assigned to two treatment groups after initial biometric measurement of inversion and eversion power, (swelling around the injury) and recorded photographic documentation of the injury. Five data points, including the first visit point, will monitor the rate of recovery. The monitoring will include swelling circumferential measurements at the level of injury, photography, and repeated inversion and eversion power measurements. Digital scales will assess total weight bearing capability. The targeted claim will document an accelerated return to normal power and weight bearing capability on the actively treated ankle injury as compared to the uninjured ankle.
Heel Pain: Chief Investigator, Joel Brook, D.P.M. - The Heel Pain study is a randomized study with both a placebo and control study group. Each patient will be asked to rate morning pain prior to treatment on a severity scale of 1 to 10 (10 being intolerable and 1 being absence of pain). Patients will also be evaluated to determine weight bearing tolerance on the affected heal, and the approximate percentage of the total weight borne. The daily therapeutic treatment regime of 8 hours will be conducted on each patient during
normal sleep.
C-Sections: Chief Investigator, Chad Simmons, M.D. Dr. Simmons is chief of obstetrics and gynecology at the Methodist Hospital in Dallas. The hospital has a large residency program, which will facilitate completion of the 120 patient study within 4 months. The overall hypothesis of the study is that pulsed electromagnetic therapy will ameliorate the inflammatory effects of edema and pain without the adverse effects typically experience by standard pharmacological therapy.
Breast Augmentations: Dr. David Genecov will be the chief investigator Dr. Genecov with 11 other plastic surgical sites will each treat 10 patients with either an active or placebo device. The goal is to obtain results prior to an October meeting where Dr. Genecov is scheduled to present the results. The hypothesis of the study is the measure the comparative reduction of pain and edema between the active and placebo devices.
Blepharoplasty: This new blepharoplasty study is to test the new eye devices. The goal of the study is to compare the efficacy of the device to placebo devices in decreasing the edema, erythema, ecchymosis, and discomfort associated with the surgical recovery. The physician and the patient will evaluate efficacy in one week. The lead investigators are Dr. Jill Foster, Clinical Assistant Professor and Dr. Craig Czyz, Chief Resident at The Ohio State University Medical Center, Department of Ophthalmology.
The company also commenced a series of double-blind clinical trials to be conducted in conjunction with leading schools of podiatry and selected clinics to document the effects of ActiPatch on treating plantar fasciitis [heel pain]. The studies in started in March 2006. The Principal Investigator for the study is Dr. William Van der Reis, a Board Certified Orthopedic Surgeon and sports medicine specialist.
The primary motivation for continued clinical trials is to obtain additional FDA approved therapeutic indications for existing and future products and to facilitate faster diffusion of the Companies medical product line by the medical community. Securing FDA approval is central to market entry and product acceptance. Below are listed currently planned clinical studies.
Ankle Sprains: This study will use Grade I and II ankle sprains (no gross instability) as the entry criteria. The patients will be randomly assigned to two treatment groups after initial biometric measurement of inversion and eversion power, (swelling around the injury) and recorded photographic documentation of the injury. Five data points, including the first visit point, will monitor the rate of recovery. The monitoring will include swelling circumferential measurements at the level of injury, photography, and repeated inversion and eversion power measurements. Digital scales will assess total weight bearing capability. The targeted claim will document an accelerated return to normal power and weight bearing capability on the actively treated ankle injury as compared to the uninjured ankle.
Heel Pain: Chief Investigator, Joel Brook, D.P.M. - The Heel Pain study is a randomized study with both a placebo and control study group. Each patient will be asked to rate morning pain prior to treatment on a severity scale of 1 to 10 (10 being intolerable and 1 being absence of pain). Patients will also be evaluated to determine weight bearing tolerance on the affected heal, and the approximate percentage of the total weight borne. The daily therapeutic treatment regime of 8 hours will be conducted on each patient during
normal sleep.
C-Sections: Chief Investigator, Chad Simmons, M.D. Dr. Simmons is chief of obstetrics and gynecology at the Methodist Hospital in Dallas. The hospital has a large residency program, which will facilitate completion of the 120 patient study within 4 months. The overall hypothesis of the study is that pulsed electromagnetic therapy will ameliorate the inflammatory effects of edema and pain without the adverse effects typically experience by standard pharmacological therapy.
Breast Augmentations: Dr. David Genecov will be the chief investigator Dr. Genecov with 11 other plastic surgical sites will each treat 10 patients with either an active or placebo device. The goal is to obtain results prior to an October meeting where Dr. Genecov is scheduled to present the results. The hypothesis of the study is the measure the comparative reduction of pain and edema between the active and placebo devices.
Blepharoplasty: This new blepharoplasty study is to test the new eye devices. The goal of the study is to compare the efficacy of the device to placebo devices in decreasing the edema, erythema, ecchymosis, and discomfort associated with the surgical recovery. The physician and the patient will evaluate efficacy in one week. The lead investigators are Dr. Jill Foster, Clinical Assistant Professor and Dr. Craig Czyz, Chief Resident at The Ohio State University Medical Center, Department of Ophthalmology.
