SYRACUSE — For 10 days a year during the rutting season, bighorn sheep continually butt heads to see which ram will dominate in mating. The repeated blows don’t appear to cause any cognitive damage. The same can’t be said for human rams. Last November, St. Louis Rams quarterback Case Keenum suffered a concussion during an […]
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SYRACUSE — For 10 days a year during the rutting season, bighorn sheep continually butt heads to see which ram will dominate in mating. The repeated blows don’t appear to cause any cognitive damage.
The same can’t be said for human rams. Last November, St. Louis Rams quarterback Case Keenum suffered a concussion during an NFL football game with the Baltimore Ravens, but the Rams staff allowed him to continue playing. The criticism of this decision reflected the public’s growing awareness of the effect of repeated impact to the head that too often leads to traumatic brain injuries. Recently, a federal district court approved a settlement between hundreds of former, professional football players and the National Football League (NFL) that compensates each player up to a limit of $5 million. The federal case sends a strong signal to any sports organization that negligently handles concussions.
Concussion testing
How big a problem are sports-related concussions? “This year, between 1.6 and 3.8 million athletes will experience a sports-related concussion,” says Richard Uhlig, CEO of Motion Intelligence, Inc. “The problem is that despite growing public awareness, the standard practice used today to evaluate and treat concussions relies on self-reported symptoms and expert opinion, which provide poor reliability and sensitivity. As a result, many concussions are misdiagnosed, creating the risk of serious secondary injuries if the athlete prematurely returns to play. Physicians are clearly frustrated with the absence of credible tools to objectively assess concussion injuries before making the critical decision to allow further play. [Not surprisingly,] … parents are worried about the health of their children and the unseen consequences of … [contact sports]. But no one is more concerned than the athletes themselves about the extent of the injury and the timeline for recovery.”
The most widely used assessment tool used today is produced by ImPACT Applications, Inc. (ImPACT stands for Immediate Post-Concussion Assessment and Cognitive Testing). The Pittsburgh–based company claims that more than 10,000 medical professionals have been trained by ImPACT on concussion management. The customer base includes teams from the NFL, Major League Baseball, the National Hockey League, and World Wrestling Entertainment, Inc. ImPACT further includes more than 7,400 high schools, 1,000-plus colleges and universities, 900-plus clinics, 475-plus credentialed ImPACT consultants, and many other organizations which use its assessment product — a computerized test that takes approximately 25 minutes to complete. “ImPACT only tests for cognitive assessment of symptoms,” notes Uhlig. “Moreover, that system has been sharply criticized by many researchers and clinicians for its narrow scope and poor reliability.”
Uhlig filed his incorporation papers for Motion Intelligence in 2012 to develop a medical device for sports-related concussions. At the time, the company was headquartered in Ithaca. “Our team has been developing a product we call ClearEdge,” avers the Motion Intelligence CEO, “which is superior to any other product on the market. It’s a new standard of care that will integrate clinical best-practices with cloud-based analytics. ClearEdge offers clinicians an evolutionary, concussion-evaluation system that is comprehensive, objective, clinically reliable, cost-effective, and portable (the entire system fits in a briefcase). The apparatus, which includes a computer, a belt-fitted motion sensor, headphones, and the carrying case, is expected to be priced at $3,900 to clinicians. There is no annual fee, but there is a per-test fee. Users of ClearEdge can file for health-care reimbursement under existing CPT (current procedural terminology) codes. We are on the cusp of filing our application with the FDA (Food and Drug Administration) for clearance of our assessment system, having tested more than 1,000 people.” Uhlig notes that ImPACT does not have FDA approval. Motion Intelligence also filed for a patent on ClearEdge in 2014.
Motion Intelligence is on schedule to begin manufacturing its assessment system this summer. “The printed-circuit boards and most of the parts will be manufactured in Upstate and assembled here,” stresses David MacLean, the company’s executive director of marketing. “We have set up approximately 30 distributors around the U.S., which translates to about 150 salespeople. The sales group reaches more than 95 percent of the U.S. population. The U.S. distribution network is now in place, and we expect to set up Canada by mid-fall.”
Funding
Motion Intelligence, recently converted to a C-corporation, sought funding in 2015 through a series-A, preferred offering. (Series-A is the first round of financing sought by a new business after the seed-capital stage. The preferred stock is convertible into common stock in cases where the company is sold or it issues an IPO.) “The company set a subscription goal of $2.5 million,” states Uhlig. “The stock-offering opened on June 30, 2015, and closed on Dec. 31 when we reached the goal. Additional demand by Motion Intelligence’s distributors forced the re-opening of the subscription, at which time another $1.1 million in equity was added. The offering closed for the second time at the end of the first quarter in 2016 … The minimum subscription was $100,000.” The largest investor was Neurospine Ventures, LLC, an Arizona–based firm managed by one of the founders of K2M Group Holdings, Inc. (NASDAQ: KTWO), a global medical-device company based in Virginia. There are approximately 20 stockholders. Prior to the offering, Uhlig self-funded the venture for three years along with a $25,000 “Grants for Growth” award from New York State.
Uhlig’s interest in concussions sprang from personal experience. “I have three sons ages 14, 16, and 19, all of whom enjoy contact sports,” he notes. “They ski, ride mountain bikes, play soccer, and ice hockey. While playing hockey, one of my boys was boarded, causing me real concern for his well-being. [It was like a wake-up call.] This incident started me on a four-year odyssey to create our assessment system.”
Autism Spectrum Disorder
Uhlig developed a close relationship with SUNY Upstate Medical University and with Brian Rieger, director of the Upstate Concussion Center, and with Chris Neville, director of concussion research, both located in Upstate’s Institute for Human Performance, to test ClearEdge. Motion Intelligence was also collecting blood and saliva samples both pre- and post-injury as part of its research, which, as it turned out, overlapped with research conducted by Frank Middleton, director of the SUNY Molecular Analysis Core facility, who developed a saliva-based diagnostic for autism. With Motion Intelligence, Upstate Medical University validated this unique test that facilitates the early diagnosis of autism-spectrum disorder (ASD).
“Ongoing research has been funded by Motion Intelligence and other private-research foundations. Motion Intelligence enjoys commercialization rights for the ASD diagnostic test,” says Uhlig.
“ASD is a disorder that affects a person’s communication abilities and social skills, often causing repetitive patterns of behavior and a narrow range of interests,” explains Uhlig. “There is no known cure, but early intervention with behavioral therapies reduces the severity of the symptoms and the disabling aspects of the condition. With applied-behavioral analysis, research has shown that 47 percent of ASD children may achieve a normal IQ. The key is early diagnosis. Unfortunately, tests currently available lack the essential specificity needed for an early diagnosis of ASD … Just in the decade between 2000 and 2010, the number of children diagnosed with ASD has more than doubled to 1 in 68.”
The most common test used today for screening children for autism is the M-CHAT (Modified Checklist for Autism in Toddlers). The test, consisting of 20 questions, is a screening tool designed to identify children 16 to 30 months of age who should then receive a more thorough assessment for possible early-signs of ASD or developmental delay. The American Academy of Pediatrics recommends that all children receive autism screening at 18 and 24 months of age — in addition to broad, developmental screening at 9, 18, and 24 months — during regularly scheduled well-child visits. “In our research, we were looking for bio-markers which predict an ASD diagnostic,” Uhlig asserts. “Our screening test has been yielding impressive sensitivity and specificity numbers. We expect to have this groundbreaking technology commercially available sometime in early 2017.”
Autism Spectrum Disorder is defined by the American Psychiatric Association as a single disorder that includes autism, Asperger’s syndrome, childhood disintegrative disorder, and pervasive developmental disorder not otherwise specified. Thus ASD refers to a wide range of symptoms and severity. The rapid rise in ASD cases, as reported by the U.S. Centers for Disease Control and Prevention (CDC), has been translated by the media into an epidemic. In the 1970s and 1980s, 1 of every 2,000 children was reported with autism. According to the CDC, the U.S. prevalence of ASD in 2000 was 1 in 150; by 2010, it had risen to 1 in 68. Some of the increase comes from consolidating what was multiple diseases into one; some has come from the increase in trained diagnosticians; the willingness of parents and educators to accept the label, in part because of entitlement services, is a contributing factor; and some is derived from removing specific-age requirements in previous definitions. Whether there is an “epidemic” is debatable, but there is no debate that ASD affects 1 million to 1.2 million children under the age of 21 (according to a CDC report from 2016). The CDC report also noted that only 43 percent of the children with autism had received developmental evaluations by age three, even though autism can be reliably diagnosed as early as age two.
Motion Intelligence has been designated a START-UP NY company, which offers it the opportunity to operate tax-free for 10 years on or near the university campus. The team of 12 has established its headquarters in the SUNY Upstate Institute for Human Performance at 505 Irving Ave., a few blocks from SUNY Upstate Medical Center in Syracuse.
Uhlig was born on Long Island and grew up in Cape Vincent. He graduated from Cornell University in 1988 with a B.S. in agriculture/biology. His business career included executive stints at Merrill Lynch, Morgan Stanley, Deutsche Bank, Goldman Sachs, and Lehman Brothers. From 2003 to 2006, Uhlig taught at the Samuel Curtis Johnson Graduate School of Management at Cornell University as an executive-in-residence, and in 2009 he was head of liquidity risk at the Federal Reserve Bank of New York.
MacLean has more than 25 years of business, research, and legal experience. In his eclectic career, he was the executive producer of two award-winning independent films, founded a mixed-martial-arts company, and established a clothing company. MacLean was also the co-owner and manager of a medical-device, sales-distribution company. He holds a J.D. degree from the University at Buffalo Law School and practiced as a litigator for two, large, law firms. Cornell granted him a bachelor’s degree where he worked briefly as a research biologist for the Cornell Lab of Ornithology.
Other Motion Intelligence executives include: Dr. Randall Carpenter, executive director of clinical development; Cindy Dowd Greene, executive director of operations; and Christa MacLean, executive director of global sales.
Rieger, Ph.D. is currently an assistant professor of physical medicine and rehabilitation and the director of the SUNY Upstate Concussion Center. He earned his Ph.D. in psychology from Fordham University in 1996.
Neville, Ph.D. is currently an associate professor of clinical health practices and the director of concussion research at Upstate Medical University. He earned his Ph.D. in health practice research at the University of Rochester in 2008.
Middleton, Ph.D., is currently a professor in the department of neuroscience and physiology and the director of the SUNY Molecular Analysis Core Facility. He earned his Ph.D. in neuroscience from SUNY Upstate Medical University in 1998.
Contact Poltenson at npoltenson@cnybj.com
