Competitive Technologies' Pain Therapy Medical Device To Be Used In Independent Clinical Study
Fairfield, CT - Competitive Technologies, Inc. announced recently that CTT's pain therapy medical device will be used by clinical investigators at the Virginia Commonwealth University Massey Cancer Center (Massey) for a Phase II independent clinical study. The study will examine the ability of CTT's U.S. FDA-cleared device to decrease pain associated with chemotherapy-induced peripheral neuropathy (CIPN).
"We are very proud to be able to offer this breakthrough device for clinical research study at VCU Massey Cancer Center, a National Cancer Institute-designated center that helps lead our nation's cancer research agenda," said John B. Nano, CTT's Chairman, President and CEO. "The device treats pain without the harmful side effect of most drugs, including morphine. This technology brings CTT to the forefront in providing a solution to the needs of cancer patients and the improvement of palliative healthcare in the U.S. and globally. This medical device is a prime example of our strategy to connect clinical science to patient care."
Massey is the first site in the U.S. to offer a clinical study for pain in cancer patients with this device. Two international leaders in palliative care and pain management at Massey, Patrick Coyne, RN MSN, and Tom Smith, MD, the Massey Endowed Chair in Palliative Care Research, sought out CTT's device after learning of its positive results from a pilot study for patients with pain.
"CIPN can be a very debilitating side effect for some 20-30 percent of cancer patients, affecting their hands and feet with sharp pain," Dr. Smith said. "If we can minimize the opioids given to patients and reduce or eliminate pain through non-invasive procedures, we will improve quality of life for cancer patients, and create a major shift in how pain is treated in America."
Massey has received IRB approval for its study and expects to begin enrolling patients on the trial this summer. The treatment protocol calls for 15 patients with chemotherapy-induced neuropathy to be studied first.
About the Device
The medical device is a non-invasive method for rapid treatment of high-intensity oncologic and neuropathic pain, including pain resistant to morphine and other drugs. The device has U.S. FDA clearance for sales in the U.S., as well as Medical Device CE certification from the E.U. allowing sales throughout Europe and several other countries. CTT has exclusive worldwide rights to this device. The unit, with a biophysical rather than a biochemical approach, uses a multi-processor able to simultaneously treat multiple pain areas by applying surface electrodes to the skin. CTT's partner, GEOMC Co. Ltd. of Korea is manufacturing the device commercially for worldwide distribution. CTT has developed a financing unit, Competitive Technologies Financial Services (CFS), which offers customers opportunities for leasing of CTT's pain therapy medical device in the U.S. market. For more information on the device, visit http://www.CalmareTT.com.
The device has been used on over 3,000 patients in Europe, including at the Pain Management Center at Tor-Vergata University Medical Center in Rome (http://www.ptvonline.it/uo_ter_ant_ing.asp). Developed in Italy by CTT's client, Prof. Giuseppe Marineo, the technology was brought to CTT through the efforts of the Zangani Investor Community.
Aris D. Despo, CTT's Executive VP, Business Development, noted, "We are pleased to know that national leaders at Massey will be conducting the CIPN independent study with our therapy unit. Their expertise in clinical research and in relieving pain and suffering for people with cancer ensures that the study will yield scientifically valid information as we endeavor to make this therapy more readily available in the U.S."
Massey has the largest menu of clinical trials in Virginia, offering patients some of the latest treatments and technologies available. In addition, Massey is one of only six national centers designated by the Robert Woods Johnson Foundation as a Palliative Care Leadership Center, through which Dr. Smith and colleagues train other professionals from across the country in how to develop and administer palliative care programs, which include pain and symptom management.
SOURCE: Competitive Technologies, Inc.