The MC-5A, which received broad FDA 510(k) clearance in February, 2009, is a computerized medical device that applies a low amperage electric signal which transmits synthetic non-pain information through disposable surface electrodes on the skin (similar to an EKG) to surface nerve receptors of the c-fibers. Scrambler Therapy synthesizes 16 different types of nerve action potentials similar to endogenous ones, assembles them into sequences, and uses algorithms to determine patient-specific cutaneous electrostimulation to reduce and eliminate pain. ST attempts to replace the “pain” information with artificial “non-pain” information.
By providing corrective information (bioelectrical codes) through the periphery (dermatomes) to the dorsal horn of the spinal cord and central nervous system, the new code “tricks” the brain to read a discernable non-pain code as real and generated from self. When this occurs, there is an immediate “zeroing out” of the pain. Through plasticity the brain will then learn to expect, look for and prefer the non-pain code.
The MC-5A technology was developed from the research of Professor Giuseppe Marineo, a researcher and bioengineer, founder and manager of Delta Research and Development. Delta R&D is affiliated with Tor Vergata University of Rome, Italy. On February 19, 2013, The United States Patent and Trademark Office issued an International Patent for Scrambler Therapy. Scrambler Therapy is also patented in Italy. The device has CE Mark certification from the European Union.
October 2014, Starkweather, Coyne, Lyon, Elswick, Jr., An, Sturgill
October 2012, Sparadeo, D’Amato, Kaufman
Spring 2014, Sparadeo, D’Amato
January 2012, Smith, Loprinzi
June 2013, Sparadeo, D’Amato
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Dr. Frank Sparadeo received his doctoral degree from the University of Rhode Island in 1981 and completed his internship at the Boston V.A. Medical Center and his Post-Doctoral Fellowship at Brown University Medical School and Rhode Island Hospital. Dr. Sparadeo is licensed to practice clinical psychology in Rhode Island and Massachusetts
Dr. Sparadeo was an Assistant Professor of Psychiatry and Human Behavior at Brown University for 17 years. He was on the staff at Rhode Island Hospital (RIH) for 25 years. He was also on the staff at St. Joseph Hospital and The Eleanor Slater Hospital for many years. Dr. Sparadeo was the Co- Director of the Rhode Island Hospital Concussion Care Center for 5 years in the Emergency Department. He was the Coordinator of the RIH Interdisciplinary Spine Program for 15 years and he has been a consultant to several chronic pain management programs over the past 32 years. Most recently Dr. Sparadeo developed the first program in Rhode Island to focus on the dual problem of Chronic Pain and addiction. Dr. Sparadeo has trained numerous psychiatry residents and psychology fellows over the years.
Currently, Dr. Sparadeo is in private practice focusing on presurgical psychological assessments, chronic pain management, neuropsychological assessment of traumatic brain injury, dementia , ADHD and other CNS conditions. He is the past chairman of the Governor’s Permanent Advisory Commission on TLB, and has recently been a consultant to the Substance Abuse and Mental Health Services Administration (SAMHSA) in Washington, D.C. and served on the National Task Force on Substance Abuse and Disability (coordinated by SAMHSA).
Dr. Sparadeo is Calmar Pain Relief’s Director of Clinical Research.
Dr. Sparadeo was introduced to Scrambler Therapy (ST) by attending a seminar sponsored by Calmar Pain Relief in January 2010. At that time Dr. Sparadeo met with Dr. D’Amato and Robert Smith and agreed to refer two severely impaired patients to Dr. D’Amato, where ST would be applied. The results were significant and Dr. D’Amato and Bob Smith invited Dr. Sparadeo to become involved with Calmar Pain Relief by assisting with the development of Calmar and the clinical research of ST.
Since that time, Dr. Sparadeo and Dr. D’Amato have collaborated on Publications explaining the results from the successful application of ST in peer reviewed journals and articles. Dr. Sparadeo often consults clinically with Dr. D’ Amato. Dr. Sparadeo assisted Calmar Pain Relief in securing a Therapeutic Discovery Project Grant from HHS and the IRS and has assisted in the writing additional grant applications. Dr. Sparadeo and Dr. D’Amato have also collaborated on numerous presentations at professional seminars and conferences.
Mr. Smith is a founder of Calmar and has been directing its business operations and legal matters since June 2009. Mr. Smith is a highly experienced trial attorney with over 40 years of practice in civil litigation, insurance defense, medical and legal malpractice, commercial litigation, corporate matters, risk management and healthcare law in state and federal courts in Rhode Island and Massachusetts. Bob also has experience in start-up company guidance as well as executive experience with start-ups, having co-founded another start-up prior to Calmar. His forty plus years as a practicing attorney and his previous start-up experience have given him a breadth of knowledge to help Calmar navigate the pitfalls of early venture stage companies.
Mr. Smith graduated from Bryant College, magna cum laude, in 1974 and University of New Hampshire School of Law (formerly, Franklin Pierce Law Center) in 1977. He is currently a member of the Rhode Island Bar Association and admitted to practice in Rhode Island, the United States District Court for the District of Rhode Island, and the United States Circuit Court of Appeals, First Circuit.
Mr. Smith is Calmar’s Managing Member, Director of Business Operations and General Counsel.
In early 2009, Mr. Smith discovered Competitive Technologies, Inc. (CTT), a small Connecticut company, that in 2007 acquired exclusive worldwide rights to market and distribute an innovative new medical device. Mr. Smith began examining CTT’s development after it was issued broad 510(k) clearance by the FDA in February, 2009 for the MC-5A medical device. The application of this technology is called Scrambler Therapy (ST). After determining that there could be a business opportunity for the clinical application of this technology, Mr. Smith developed a business plan and contacted his longtime friend Dr. Stephen D’Amato to discuss the feasibility of opening a healthcare facility utilizing this technology to treat patients with chronic neuropathic pain. Mr. Smith arranged for CTT to demonstrate the application of this technology and treat some of Dr. D’Amato’s chronic neuropathic pain patients using ST. This very successful demonstration clearly showed the effectiveness of the MC-5A medical device. Dr. D’Amato saw the incredible potential of this new technology. Mr. Smith then presented his business plan to CTT. After an agreement with CTT was executed, Calmar Pain Relief, LLC was organized. Dr. D’Amato traveled to Rome to train under Professor Giuseppe Marineo, the Italian inventor of the technology, and Calmar opened in November 2009.
Dr. Stephen J. D’Amato is a founder of Calmar and has been directing its medical practice since November 2009. Dr. D’Amato received his medical degree from the University of Padua, Italy in 1976 and completed his residency in Emergency Medicine in 1980 at Worcester City Hospital where he was the programs first Chief Resident. He was one of the first Residency Trained Board Certified ER doctors in the US. He has been practicing medicine in Rhode Island since 1980 and served as the Medical Director and staff physician of North Providence Medical Services,Inc. (the first Free Standing Emergency Room in the country founded in 1975) from 1980 to January, 2012. Dr. D’Amato is also licensed to practice medicine in Massachusetts and Florida.
In 1999 Dr. D’Amato was appointed Clinical Assistant Professor of Emergency Medicine, Boston University School of Medicine, Roger Williams Medical Center Campus in Providence, R.I. He is on the medical staff of Roger Williams Medical Center and St. Joseph Hospital in Providence, Rhode Island.
Dr. D’Amato is Calmar’s Managing Member and Medical Director.
Dr. D’Amato was introduced to Scrambler Therapy (ST) in August 2009 by Bob Smith. After Mr. Smith presented ST technology and the business opportunity to his longtime friend, he arranged for a trial application of the MC-5A medical device on five of Dr. D’Amato’s chronic pain patients. After witnessing the amazing response of these patients, Dr. D’Amato took a sabbatical in October 2009 and was trained and certified in the science, use and application of Scrambler Therapy Technology by its inventor, Professor Giuseppe Marineo, in Rome, Italy. Calmar opened its first clinic in November 2009 in North Providence, Rhode Island.
Dr. Stephen D’Amato saw this technology as not only a business opportunity but an opportunity to help a large population of chronic neuropathic pain patients, many of whom have very limited options other than addictive drugs or invasive procedures. Dr. D’Amato has treated over thirteen hundred (1,300) chronic neuropathic pain patients with Scrambler Therapy and is the most experienced doctor in this country in the application of this technology. Dr. D’Amato is a leading authority of ST Technology.