FDA Issues Claim for Unequal HART Device

10/17/2017

GLEN MILLS, Pa., Oct. 17, 2017 — Unequal®, a leading manufacturer of sports protective gear, announced that the Food and Drug Administration has determined that Unequal's patented HART® CC Pad device, found in every Unequal HART chest protector, can improve safety on the playing field. This announcement follows a landmark, peer-reviewed study from Tufts Medical Center that determined Unequal to be the first ever technology proven effective in reducing the risk of sudden death from commotio cordis.

Commotio cordis is sudden death caused by a random, non-penetrating blow to the chest usually from a ball, bat, stick or hand. Millions of boys and girls ages six to 18 who play contact sports are at risk. According to Tufts Medical Center, "Largely unrecognized for years, commotio cordis is an event where a blunt, non-penetrating and innocent-appearing accidental hit to the chest causes abnormal heart rhythms and, many times, sudden death. Commotio cordis occurs most often in children, adolescents and young adults during recreational and competitive sports." According to a report by the UT Southwestern Medical Center, commotio cordis is the second most common cause of sudden death in athletes. Unequal's HART products offer the world's first heart protection technology shown to credibly safeguard at-risk athletes from this deadly killer.

Tufts Medical Center is the preeminent authority on commotio cordis, with its 20-plus years of research on the dynamics underlying the tragic medical phenomenon. Their ground-breaking, peer-reviewed, published study in the Clinical Journal of Sport Medicine, March 2016, "Development of a Chest Wall Protector Effective in Preventing Sudden Cardiac Death by Chest Wall Impact (commotio cordis)," studied and tested Unequal's patented composites. The conclusion: "It is reasonable to expect that chest protector designs incorporating these novel materials (Unequal HART) will be effective in the prevention of commotio cordis on the playing field."

Dr. Jeffrey Mandak, a board-certified cardiologist and member of the U.S. Lacrosse's Sports Science and Safety Committee, stated, "Each year young healthy athletes die unnecessarily from commotio cordis, a catastrophic injury. No parent is prepared to bury their child. At U.S. Lacrosse we have been searching for effective protection against commotio cordis for almost 20 years. At times we were not sure the goal of preventing commotio cordis would be possible, but what Unequal has accomplished is a tremendous breakthrough. It's like finding the 'Holy Grail' we have been looking for all these years. As a leader in athletic safety, U.S. Lacrosse has been poised to mandate chest protection, scientifically proven to reduce the risk of commotio cordis, not only for goalies but also field players, once such products are readily available on the market. I expect the NCAA and National Federation will soon follow suit for college and high school lacrosse, respectively. Governing bodies for other sports such as U.S, Hockey, U.S. Soccer and Little League Baseball will likely do the same."

Dr. Mark Link, a board-certified cardiac electrophysiologist, leading worldwide authority on commotio cordis and co-author of the Tufts 2016 study, has led and worked with a team of cardiac and medical professionals for decades seeking a solution. He has authored or participated in over 30 medical papers and studies on the subject. When asked about Unequal's HART, Dr. Link said, "I am excited to have played a role in discovering a technology that offers excellent protection against commotio cordis."

This is believed to be the first time a device designed to reduce risk of commotio cordis was submitted to the FDA for evaluation. Until the 2016 study using Unequal technology, Tufts had tested popular chest protectors and concluded they do not lower the risk of sudden death from commotio cordis.

The FDA indication for use (IFU) claim states: "When incorporated into a suitable garment and worn in accordance to instruction, the HART CC (commotio cordis) Pad device has been shown to reduce the mechanical impact received by the chest that may facilitate the reduction in risk of commotio cordis."

"Kids are dying from commotio cordis and they don't have to," said Rob Vito, CEO of Unequal and inventor of HART. "I have spoken with several parents who have lost loved ones to commotio cordis, and their sorrow touched my soul and motivated me to find a solution. With the Tufts study and now FDA sign-off, we are excited to be able to offer athletes of all ages serious heart protection. And you better believe my own daughter, Julia, who catches for her softball team, is fully protected. I watch the games at peace, knowing Unequal's HART is helping protect her life."

From a business unit perspective, Unequal has engaged Deutsche Bank as its financial advisor, as Unequal addresses a potential billion-dollar, undeveloped opportunity in sports protectives on a global scale.

Considering that any player on the field is at-risk, Unequal's HART products are designed for any sport, any player, any position and each contains a patented, military grade, 4-layer composite that is ergonomically placed to protect the heart area. Prices range from $89.95 to $159.95, and they are sold direct by Unequal as well as through select retail outlets. Visit http://get.unequal.com/hart for details.

About Unequal
Unequal's company mission is to protect people so they can perform at their peak level in the military, sports, work, and life. The patented fusion of a military-grade composite, made of TriDur, Accelleron, Airilon and optional ImpacShield, is engineered to protect like no other sports gear. Tens of thousands of athletes at all levels wear Unequal protectives. From national and world champion athletes to collegiate and high school teams to youth leagues across the country, Unequal protects.

This tech that protects works differently than virtually every other traditional foam and plastic of equal weight and thickness on the market. Unequal reduces acceleration and absorbs, disperses and dissipates impact energy away from the body. Unequal composites, adapted from military grade materials, are protected by 100+ worldwide patents with many more pending. Its products have been tested by independent, accredited laboratories, OEM facilities and top universities. An attendee at the White House Concussion Summit, Unequal has been recognized by: Forbes' 100 Most Promising Companies, ESPN Top-15 Best Sports Innovations, #1 Tech Innovation by Esquire.com, and was winner of the DuPont Kevlar Innovation Award. For more information, visit unequal.com.