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Reduction of Impact Forces to the Base of Skull

Date: 4/18/12

FOR IMMEDIATE RELEASE:                           

History & State of the Art Report About Protection of the Skull and Brain By Reduction of Velocity Forces to the TMJ

April 14, 2012 - Brain Pad Inc., (“BPI”) originally founded in 1995 by a Dental Surgeon in Philadelphia whose client list included professional boxers, has been protecting athletes, first in combat arts and then in helmeted sports, for over 16 years; having sold (literally) millions of Brain-Pad Jaw-Joint Protectors™ into the martial arts, boxing, and contact (i.e. helmeted) sports markets at both the amateur and professional performance levels. 

BPI will join with other organizations in being part of the solution to protect and reduce injury causing jaw-joint and base of skull impacts for athletes of all levels. In nearly two decades and three independent biomechanical studies sponsored by NFL Charities and NOCSAE in 1993[1], performed by Wayne State in 2005[2], and a study fully funded by the NFL with Biokinetics in 2011[3], the relative effectiveness of the dual arch mouth guard (more properly identified as a “jaw-joint protector” as opposed to a “mouth guard” for protecting teeth) was well established. The latest tests in 2011, using two different head forms with articulated jaws with instrumentation above the condyle and into the TMJ (i.e. Temporal Mandibular Joint) measuring linear force, validated using an impact force standard for all head-contact sports, including football helmets.   

BPI’s line of proprietary jaw joint protection devices (i.e. Brain-Pad Jaw-Joint Protector™) was first designed for a professional boxer, Jesse Ferguson, in the late 1980’s who was having symptoms of a lack of balance and nausea every time an impact was delivered to the left side of his jaw. When this intra-oral appliance (i.e. the precursor product to the Brain-Pad Jaw-Joint Protector™) was introduced to him and stabilized his lower jaw by positioning it slightly down and forward, his symptoms did not continue and he continued his career as a professional boxer for eight more years.   To reiterate: the Brain-Pad Jaw-Joint Protector™ is a dual arch mandibular orthotic that positions the jaw in a slightly down and forward position and achieves stabilization through its design, reducing and redirecting force from the impact to the jaw away from the TMJ, base of skull, and brain. The Brain-Pad appliance and the molars, which are the strongest bones in the skull, primarily absorb the impact forces. As a result of the early work done by BPI, Dr. Voight Hodgson, the technical director of NOCSAE (National Operating Committee for Standards in Athletic Equipment) and a professor at Wayne State University, became very interested in jaw interaction and the implication of impact to this region of the head looking at the mandible impacting the fossa and the transfer of force and impact to the basal skull and brain region. 

Another major concern by Dr. Hodgson was chinstrap loading and the detrimental forces affecting a number of cranial nerves that control sensory and motor functions. Brain Pad believes that its Brain-Pad Jaw Joint Protector™ addresses both of these issues.   In 2003[4] a benchmark was established by a study conducted by Biokinetics of Canada, authored by Dr Elliot Pellman that established 9.3 ± 1.9 m/sec of velocity impact as creating concussive forces. In 2005, at Wayne State University, using the head form with an articulated jaw, BPI revisited this and found similar results as in 1993 study, with impact forces being delivered directly to the facemask and also direct to the chin. Both studies found that the Brain-Pad Jaw Joint Protector™ reduced jaw-transmitted forces more than any other mouth guard or any other oral protection device.   In 2010 the Oklahoma Athletic Associations hosted the first symposium[5] on jaw-joint related concussions with leading experts in the subject matter and began to focus scientific attention on this long-neglected and vital joint (i.e. the TMJ).   Then in 2011, in a fully funded by the NFL study using a new head form with a articulated jaw at Biokinetics in Canada, it was shown that the Brain-Pad Jaw-Joint Protector was measurably superior at withstanding/reducing a 9.5 m/sec of velocity impact than other leading retail mouth guards. In fact, the study showed, when compared to wearing no mouth guard at all, those other mouth guards actually increased velocity impact forces rather than decreased velocity impact forces. BPI realizes that no one product is capable of preventing all concussions but any product, such as the Brain-Pad Jaw-Joint Protector™, that substantially reduces impact forces to the thin base of the skull can only be a benefit to the athlete.   

With brain injuries, especially head trauma, on the minds of all parents, the only acceptable result that protective sports equipment can be allowed to do is to bring about a reduction of velocity impact forces.   We have, in our scientific community, a great understanding of linear impact forces, which were greatly aided by the auto industry’s crash test programs. However, lateral, angular, and rotational forces are not understood as well. Current helmet testing protocols and equipment date from the late 1960’s and should be updated to observe more than just skull fractures.  

Brain Pad has always been the leader in advancing the science of velocity impact reduction, and as a result of that commitment, Brain Pad contacted Applied Research (“ARA”) to develop a full computational model that will be both analytical and predictive to finally understand individual tissue strain, lateral force, angular force, and rotational force.   ARA and BPI briefed the Military, NFLPA, and Congress about the potential benefit available to the US Government in both military and commercial (i.e. sports) applications. Although the briefing was well received, available funding could not be found. This study would have been the most advanced study ever done, taking advantage of the billions of dollars that have been spent trying to understand concussion mechanics to build a true digital model which could reflect, track, project, and describe potential concussion-producing forces. This research effort could lead to the establishment of realistic and effective standards for protective military and sports equipment design.  

It is time for everyone (i.e. athletes, coaches, trainers, sports medicine doctors, sports equipment manufacturers, regulating agencies, and state and federal governments) to work together to understand the potential causes and detrimental effects of concussions and to establish realistic standards of design to reduce, as much as possible, the incidence of potential brain injuries.    As an example of effective regulation, most of the international combat arts associations (i.e. International Kickboxing Federation, International Sport Combat Association, International Sport Karate and Kickboxing Association, and Kick International) take the Brain-Pad Jaw-Joint Protector’s role in reducing jaw forces to the brain very seriously with mandated use during competitions and unpaid endorsements from participants.

It is time that amateur and professional helmeted sports leagues and associations do likewise.   It is our ** responsibility to preserve the athlete’s quality of life long after the games are over.   ** athletes, coaches, trainers, sports medicine doctors, sports equipment manufacturers, regulating agencies, and state and federal governments    
 
ATTACHMENT A EXPERTS IN THE FIELD & LIST OF REFERENCES    

Experts relied upon are by Brain-Pad in supervising, performing, and evaluating the studies and tests discussed are as follows:   

A. Joseph Manzo, President, Brain-Pad, Inc. (responsible for developing or approving marketing and advertising claims, supervision of sales efforts, and evaluation of supporting tests, data, and representations). 

B. Dr. Albert Gusenbauer, Shareholder (influential maxillofacial surgeon in Canada long-involved in athlete and military safety, especially relating to concussions), Concussion Prevention in Sports – Hamilton Academy of Dentistry, January 2001, Brain Injury in Sports Related to Trauma to the Lower Jaw- Dentistry Today 2003.  Contact information: 905-928-1370; agusenbauer@cogeco.ca  

C. Dr. Robert Mongrain, R&D Joint Venture Partner (responsible for developing a customer-made version of the Brain-Pad® jaw-joint protector that can be fitted and provided by sports dentists). Contact information: 918-760-3500; rbmbike@aol.com. 

D. Timothy Walilko, Ph.D., Sr. Research Engineer, Applied Research Associates, Inc, (Biomechanical engineer long-associated with head-drop studies, helmet chin strap loading and basal skull impact injuries in sports and military). Contact information: 210-344-7644; twaliko@ara.com. 

E. Cory Schafer, League Commissioner, International Sport Kickboxing Association (became first sports league to mandate use of dual-arch mouth guards after 10 years of use, specifically the Brain-Pad® jaw-joint protector). Contact information: 352-331-0260; schafriska@aol.com. 

F. Steve Fossum, President, International Fight Sports Association (has strongly recommended and mandated use of the Brain-Pad® jaw-joint protector after 10 years of use in all competitions involving contact). Contact information: 916-663-2467; steve@fightsports.com. 

G. Dr. Edward Williams, Retired Founder of WIPSS, Inc. and inventor of the WIPSS™ jaw-joint protector re-branded as the Brain-Pad® jaw-joint protector. Contact information:215-242-3141 

H. Dr. Kem Moser, influential local maxillofacial surgeon who has been active in Prevention, Nutrition, and Oral Health for the past 30 years of his clinical practice in Kennett Square, Pa. A past president of the Penna. Craniomandibular Society, he is a Diplomat of the American Board of Dental Sleep Medicine. Dr. Moser has lectured on myofunctional therapy, sleep disorders, and dietary influences related to ideal growth and orthopedic development. He is President of the Penna. Craniomandibular Society). Contact information: 610-444-6300; 484-883-0848,kcmoser@kennett.net 

I. Dr. Steve Smith developed and tested jaw-joint protector devices on the Philadelphia Eagles in the 1979-1980 season as Director, Temporomandibular Center, and Osteopathic Medical Center of Philadelphia. Founded TMJ Clinic, 1977. Also has: Smith, S.D.: "Mouth guards in Contact Sports; Case Study/ Documentary on a TMJ Concussion Prone Patient". Essay presented May 7, 1981, Virginia Osteopathic Medical Association 75th Annual Convention, Williamsburg, VA. in Atlas of Temporomandibular Orthopedics Monograph: Dentistry in Sports Medicine, pages 77 - 100. Contact information: 610-647-2755; sdsmith@sdsmithdmd.com  

The following list of references is provided to facilitate any further inquiry that the reader may desire to pursue. Refer to the BPI web site (www.brainpads.com) to stay informed about this vital subject. 1903 The Knock- Out Blow James Gray Duncanson The British Medical Journal    1979 Sports Dentistry:Protection and Performance from Mouth Guards and Bite Splints Stephen D. Smith DMD   1993 Head and Neck reduction NOCSAE Voigt R. Hodgson Ph.D   1994 Jaw Joint Disorders in contact sports Athletes Diagnosis and Prevention Edward D. Williams DMD   1995 Concussions in sports and a preventable  Mechanism of Injury Edward D. Williams DMD   1997 ASTM Designation: F1 Standard Test Method and Performance specification for Jaw-Joint Protectors    2003 Brain Injury in Sports related to Trauma to the lower jaw Dr. Albert Gusenbauer DDS Dentistry Today   2003 Concussion in Professional Football: Reconstruction of Game Impacts and Injuries Elliot Pellman M.D   2005 Biomechanical Evaluation of Various Mouth Guards used in Contact Sports Cynthia Bir Ph.D Wayne State University    2007 Biomechanics response of the human mandible to impacts of the chin Crag, Bir, Viano and Tashman Journal of Biomechanics   2010 Jaw Joint concussion and the Preventive role of dual arch technology Tim Walilko Ph.d Oklahoma Athletic trainers  State convention    2011 Effects of Mouth Guards on Head Responses and Mandible Forces in Football Pro Biomechanics LLC and Biokinetics Annuals of Biomedical Engineering    2012 Overview of jaw joint research to be published  by Tim Walilko Ph.d Applied Research    Universal Head Protection Study Applied Research    Mandates from International Kick Boxing, International Sports Karate, Kick International, International Martial Arts Union Middle East. [1] Head-Neck Research NOCSAE January 26. 1993 [2] Biomechanical Evaluation of Mouth Guards used in contact sports Wayne State 2005 [3] Effects of Mouth Guards on Head Response and Mandible Forces on Football Helmet Impacts     Biokinetics 2011 [4] Concussion in Professional football: reconstruction of Game Impacts and Injuries. EJ Pellman Neurosurgery [5] Oklahoma Athletic Trainers Association State Convention 2010

Contact Joe Manzo for details or further information - jmanzo@brainpads.com

Brain-Pad, Inc

322 Fayette St., Conshohocken, PA 19428

Phone- 610-397-0893 -Fax- 610-397-1897                

www.brainpads.com  - info@brainpads.com 

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