BEAT PARALYSIS | together, we can get this done Jack Jablonski Foundaon
From the very start, we knew what we wanted to do: make recovery from paralysis possible. When we formed this foundaon in 2013, we did not know how we would get it done, but Jack’s determinaon to skate again inspired us. We believed a miracle was possible. Now the miracle we once hoped for has become the science we believe in. For the rst me, a medical treatment conceived and developed over decades of laboratory research is demonstrang recovery results for people living with chronic paralysis. Called spinal neuromodulaon, this treatment uses electrical smulaon of the spinal nerves to boost the natural ca-pacity of our body’s nervous system to relearn how to funcon, even aer a dev- The time for waiting is over | let’s get this done asng injury. Researchers rst reported this breakthrough in 2014, and then Mayo Clinic conrmed the validity of those recovery results in a study we funded in 2017. To keep the momentum going, the next step is to get this treatment into medical clinics as a new standard of care for the millions of people who are living with paralysis today. It is our goal to get this done. Success depends on geng regulatory approval through the FDA, but so far, no organizaon has stepped up to lead the way. Unl now. The me for waing for someone else to lead is over. Together, we can get this done. BEL13VE. Jack Jablonski Foundaon | BEAT PARALYSIS Campaign 2020 - 2022
Over 6 million people in North American live with paralysis today. Doctors told all of them that their paralysis is permanent. Medical science is changing that. We are here to help change it faster. Our Mission We created the Jack Jablonski Foundaon to advance medical research and innovave treatments that will achieve victories over paralysis. Our Vision A world where paralysis is no longer permanent. Our Goal Within the next ve years - by 2025 - everyone living with a spinal cord in-jury will have access to a new medical treatment for paralysis recovery using spinal neuromodulaon. Our Strategy - Raise money to get the science right. - Recruit a team of believers inspired to get recovery done now. Our Campaign BEAT PARALYSIS is our campaign to recruit 1,000+ new BEL13VERs and raise $1.3 million by December 2022 to fund recovery treatment for 28 pa-ents in spinal neuromodulaon research projects at Mayo Clinic and at UCLA’s Edgerton Lab.
Jack’s message | together, we will beat paralysis In December 2011, everything changed for my family and me. I was a sophomore in high school. I had just turned 16. And in a ash I was paralyzed from the chest down. It has been nearly 3,000 days since I have been able to walk, move my ngers, turn a doorknob, get out of bed without someone liing me, use a bathroom on my own, or even control my body temperature when it gets hot or cold. And aer all of this me, I sll believe in miracles. My experience is not unique. Since my injury, more than 40,000 other people in America have been injured at least as badly as I was. Not one of us ever thought we would become paralyzed. Aer our injuries, doctors told each of us our paralysis was permanent. Research is changing that. People are recovering. They are moving legs and arms again, and recovering some of those hidden body funcons we all depend on every day. We have great momentum. Now it’s me to nish this work. With your help, I know we can. Caring people from all over the world reached out to help my family and me aer my injury, and thousands more began supporng our search for recovery when we formed this foundaon. Because of that early research, the impossible is becoming possible. That is the strength of believers, together. And together, I believe we can advance this amazing treatment out of the research lab and into the clinic where it can help everyone. Together, we will beat paralysis.
“We have demonstrated that human spinal networks can be transformed years aer [a] spinal cord injury . . . to generate independent stepping and standing.” - Mayo Clinic | 2018 CONTENTS Page 2 - 3 Summary | let’s get this done This Page Jack ‘s Message |together, we will beat paralysis Page 6 - 7 Spinal Cord Injuries | paralysis is bad in so many ways Page 8 - 9 Path to Recovery | geng FDA approval for neuromodulaon Page 10 - 13 Impossible to Possible | research results are changing lives Page 14 - 15 Stepping Up | our fundraising goals 2020 – 2022: $1.3 million Page 16 -17 Join the Team | you can help me beat paralysis The Momentum & Inspiraon Funds Appendix Neuromodulaon explained Combinatorial Treatment: robocs and neuromodulaon Read the research reports Jack Jablonski Foundaon | BEAT PARALYSIS Campaign 2020 - 2022
This is killing us. A spinal cord injury is one of the worst traumas a person can experience - physi-cally, emoonally, socially, nancially. People living with paralysis can experi-ence very dierent levels of funconal loss, depending on where the injury oc-curred on the spinal cord, and on how extensive the damage to spinal nerves. The most obvious abilies lost to paral-ysis are the use of muscles for walking, sing, moving arms and legs, and even breathing when the injury is high enough on the spinal cord. Other abilies that are lost are less ob-vious, but every bit as important to health, independence, and life. Known as autonomic funcons, paralysis can lim-it or end bowel and bladder control, body temperature regulaon, sexual funcon, Paralysis is bad | in so many ways and blood pressure control. Paralysis also leads to secondary health problems like infecon, stroke, and respiratory or heart problems. Perhaps worst of all, paralysis takes away years of life expectancy from any-one living with a spinal cord injury. Sta-scally, a person living with tetraplegia will loses more than 15 years of life ex-pectancy to paralysis. This is expensive. Paralysis is a condion that comes with a high price tag. Aer the inial medical bills, an injury like Jack’s will add extra lifeme costs of $5+ million for personal care and health care costs. There are also lost wages (68% are un-employed) and other opportunity costs resulng from paralysis that the Naon-al Spinal Cord Injury (SCI) Stascal Cen-ter esmates at $77,000 per year. The cost to our country for managing the care of SCI paents exceeds $3 bil-lion each year. This is common. One in 50 Americans are living with paralysis in some form – nearly six mil-lion Americans. Every month 1,500 more Americans suer an injury to their spinal cord resulng in paralysis. Almost half of these injuries result from nothing more dangerous than riding in a car. Most of these injuries cannot be pre-dicted or prevented - they could strike anyone - but they can be repaired. Jack Jablonski Foundaon | BEAT PARALYSIS Campaign 2020 - 2022
any hope for recovery was a lost cause. Not anymore. The research we support has demon-strated that human spinal networks can be transformed years aer an injury to restore funcons once thought to be permanently lost. This can be xed. Most traumac injuries do not com-pletely sever the spinal cord. Instead, an injury is more likely to cause fractures or compression of the vertebrae, which then destroy some of the nerves that car-ry signals up and down the spinal cord. The enre medical community used to believe paralysis was permanent – that “The result of this study is that a spinal cord injury may no longer mean a lifelong sentence of complete paralysis.” Dr. Roderic Pegrew, Director Naonal Instute of Biomedical Imaging & Bioengineering (NIBIB) Naonal Instutes of Health April 4, 2014 | Fox News C4 Injury Quadriplegia/tetraplegia, results in complete paralysis below the neck T6 Injury Paraplegia, results in paralysis below the chest C6 Injury Result in paral paralysis of hands and arms as well as lower body L1 Injury Paraplegia, results in paralysis below the waist
Mayo Clinic study conrms we are close. Most paralysis recovery research focus-es on advancing medical understanding in one of these four key principles of spi-nal cord repair: Neuroprotecon: seeks to protect sur-viving cells from further damage. Regeneraon: seeks to repair dam-aged nerves and smulate regrowth. Cell Replacement: seeks to replace damaged nerve cells with new cells. Neuroplascity: seeks to restore func-on by retraining the parts of the nerv-ous system that remain undamaged. Research is underway in each of these four categories of spinal repair, and each is worthy of support; however, only one category of research has already demon-strated recovery results in humans: neuroplascity using neuromodulaon of the spinal nerve. Path to recovery | geng FDA approval for neuromodulaon While the other research pathways may deliver eventual treatments for pa-ralysis recovery, they are years away from demonstrang recovery results in human subjects, and even further away from bringing a successful treatment to paents in clinics. Neuromodulaon treatments could be widely available for use in medical clinics in as few as ve years. Paralysis is not the only condion treated with neuromodulaon. For dec-ades, loss of hearing funcon has been successfully restored through neuro-modulaon of the ear’s cochlear nerve. Where this path to recovery started. Researchers at medical centers across the country have dramacally advanced the development of neuromodulaon treatment for paralysis recovery. The treatment originated at UCLA in the mind and lab of Reggie Edgerton, then was rst tested on human subjects at the University of Louisville, and later was conrmed as legimate through a validaon study at Mayo Clinic. Although neuromodulaon alone is not expected to provide a complete re-covery from paralysis, the recovery re-sults it does produce are already making profound, posive changes in the quality and length of life for people living with paralysis. To complete this work, we need help. Most people reasonably assume that once medical discoveries are uncovered in the lab, they eventually make their way to paents in clinics. They don’t — at least not without a lot of help. The process can take decades to complete. Why? Before a new treatment can be approved by the U.S. Food & Drug Ad-ministraon (FDA) for paent use in clin-ics, a medical idea must rst successfully pass through three phases of research: (1) basic medical research, (2) applied pre-clinical research, and nally (3) clini-cal research.
Geng to the end of the path FDA approval is the only result that maers, and it is just three steps away. Basic Research. It all starts with a great idea. In 1967, Elzbieta Jankow-ska demonstrates the spinal cord controls movement, introducing the idea of the "smart" spinal cord and how it may sll funcon aer injury. Pre-Clinical Applied Research. Scienc principles are developed before moving to animal models to determine if there is potenal. In 1987, Sten Grillner proves nerve circuitry in the spinal cord controls stepping. In 1998, Dr. Reggie Edgerton proves spinal nerves can funcon inde-pendently of the brain in control of walking movement. Clinical Research. In 2011, Drs. Harkema, Edgerton (et al) demonstrate recovery in the rst human paent - Rob Summers - via electrical epidural smulaon (EES). In 2015, Dr. Edgerton demonstrates recovery using non-invasive (TES) smulaon. In 2017, Mayo Clinic becomes the rst medical center in the world to replicate and validate EES recovery results. FDA Approval. From 2020 - 22, Dr. Edgerton is compleng mulple TES trials, including one focused on upper limb recovery for 24 paents. From 2019 - 22, Mayo Clinic connues Phase 2 of its EES trial, adding TES treatment. Planned for 2023 - 25, Dr. Edgerton will complete a Phase 3 trial that will determine the rst FDA approval for a clinical treatment. Clinical Use. With FDA approval, a treatment can be provided to paents with costs covered by health insurance. Paent Impact. With broad access through clinics, a treatment can pro-vide life-changing impact for all people living with chronic paralysis. “The study we are doing now is going to provide a very solid foundaon to go to the FDA to say this needs to be available to paents.” Dr. Reggie Edgerton disnguished professor of neurosurgery, UCLA Medical School and of integrave biology and physiology, UCLA Jack Jablonski Foundaon | BEAT PARALYSIS Campaign 2020 - 2022
Recovery pioneers. Since 2010, paents at a small number of research centers around the country have been receiving experimental neuro-modulaon treatments using either epi-dural (surgically implanted) or transcuta-neous (through the skin surface) meth-ods to deliver spinal smulaon. Most of these paents have paraplegia with a focus on lower limb recovery, but a growing group with tetraplegia are dis-covering upper limb (hand) funcon re-covery. Hidden autonomic funcon re-covery is important for both groups. These paent pioneers are just the be-ginning of a treatment revoluon show-ing us how the impossible can become possible. With the momentum they have creat-ed, it is vital that we connue with the next steps on the pathway to achieve FDA approval and beat paralysis. Impossible to possible | research results are changing lives Rob, a former Oregon State pitching star, was paralyzed below the waist (C6) in 2006 from a hit-and-run accident at age 20. Aer his injury, Rob retained some ability to feel his lower limbs but could not move them. He became the rst paent in the world to receive epidur-al spinal neuromodulaon treatment four years later (2010) and was able to stand three days aer researchers turned on his implanted smulator. He now has a new smulator im-planted and is enrolled in a second study. Drew, a husband and father of a young son, was completely paralyzed from the chest down (C6/7) in 2007 aer a motorcycle accident at age 28. Four years aer his injury, and aer 21 months of therapy, he was sll not able to move his legs at all. Then, researchers implanted an epidural smulator and he regained the ability to stand and move his lower limbs when the device was on. Following two more years in the pro-gram, including extensive treatment at home, he could stand without the device on and sll move his legs voluntarily. Rob Summers | Lower | U of L | 2011 & 2014 “It has changed my life on a day-to-day basis ... I can connue to live my life as I choose and not be restricted or limited.” Andrew ‘Drew’ Meas | Lower | U of L | 2014 “It is truly like a dream come true for somebody who has been through what I have been through. This helped reclaim my life. ”
Kent, a Pro Am Motocross racer, was paralyzed from the chest down (T5/6) in 2009 when his mo-tor locked up during a race at age 21. Three years aer his injury he became the second person in the world to receive an implanted epidural smu-lator. Through neuromodulaon treatment, vol-untary movement of his lower limbs returned, as well as the ability to stand independently. In 2016, Kent was able to stand for his wedding. Jered, an avid bow hunter and father of a young son, was le paralyzed (T6) in 2013 from a snowmobile accident when he was 24. Three years aer his injury, he became the rst of two paents in our study de-signed to replicate, and if successful, validate recovery results achieved through spinal neuromodulaon treatment. The results ex-ceeded all expectaons. He is now able to stand independently and take his own steps, covering as far as 111 yards in one session. Jeremy, an accomplished pool player, was le paralyzed (T3) in 2011 aer a fall from a tree while deer hunng in Wisconsin when he was 31. Five years aer his injury, he received epi-dural spinal neuromodulaon treatment as the second paent in the Mayo Clinic validaon study and is now able stand without assistance when the smulaon device is turned on. Jered Chinnok | Lower | Mayo Clinic | 2017 “It was mind-blowing. Right away, I was able to move my toes. It was a ‘pinch me, see-if-this-is-real’ kind of thing.” Jeremy Gedatus | Lower | Mayo Clinic | 2018 “It is life changing. [This treatment] is going in places we never thought we would reach. And without the BEL13VE Foundaon, this wouldn’t be a possibility. They have made big waves and they have changed a lot of people’s lives.” Kent Stephenson | Lower | U of L | 2014 “I have seen improvement in my bowel and blad-der funcon, voluntary movement. Being able to stand on my own, it’s an amazing feeling.”
Kelly, a horse-riding enthusiast and soccer player, was le paralyzed from the waist down (T1, ASI Grade B) in 2014, aer an automobile accident when she was 18. Three years later, she started her neuromodulaon treatment us-ing an implanted epidural smulator. She can now walk a hundred yards across grass, alt-hough her balance is sll o and she needs a walker for some support. When her smulator is o, she remains completely paralyzed. More impact | and our next three steps to FDA approval Brian, who runs a coee roasng business, was le paralyzed (sensaon remained, but no ability to move his hands) from the neck down (C5) in 2011 from an accident while riding his dirt bike when he was 23. Five years aer his injury, he became one of the rst three pa-ents in the world to receive spinal neuromod-ulaon treatment targeng recovery of hand funcons in a 2016 study at UCLA Medical Cen-ter. Even without smulaon, his gripping ca-pability in his hands is up more than 300 per-cent. “There may be a limit,” he says, “but we haven’t reached it yet.” Cecilia Villarruel, a Physician Assistant, was le paralyzed from the neck down (C6/7) from an automobile accident. Thirteen years aer her injury, Cecelia and seven other paents began receiving non-invasive transcutaneous spinal neuromodulaon treatment at UCLA. Before treatment, she could not move her ngers. Aer the rst 8 treatment sessions, she could do things she had not been able to do since her inju-ry. In addion to regaining use of ngers, she and the other paents reported improved blood pressure, bladder funcon, cardiovascular func-on and the ability to sit upright without sup-port. Cecilia Villarruel | Upper | UCLA | 2018 “Small accomplishments like opening boles and doors enable independence and self-reliance that has a profound eect on people’s lives.” Brian Gomez | Upper | UCLA | 2016 “It's making a huge dierence for me . . . be-cause of the strength and dexterity I've devel-oped [in my hands and arms].” Kelly Thomas | Lower | U of L | 2019 “I took three or four steps. Something I was nev-er supposed to do ever. It was awesome. There’s no other feeling like it in the world.”
Building on the success of previous studies at UCLA (2016 and 2018), this next-step study is a larger Phase 2b clini-cal trial with twenty-four paents com-paring the results of neuromodulaon treatment delivered in two dierent sengs to acvate the spinal nerves in paents with chronic tetraplegia. The study will cover a two-year period. To prepare for the nal step needed to receive regulatory approval for paralysis recovery treatment, this new study will test treatments delivered in both clinics and at home. The treatment will be a surface (transcutaneous) method of electrical spinal smulaon. Research-ers will use upper limb (hand) gripping as well as a variety autonomic funconal recovery metrics to determine results in paents with chronic tetraplegia. This new study builds on the success of previous studies by adding an in-home treatment phase to demonstrate that this much more aordable ap-proach to treatment outside a clinic can be both eecve and easy to do. The research team seeks to improve the current medical understanding of the mechanisms of recovery, and demonstrate an aordable, eecve treatment opon. methods to deliver spinal cord smula-on (SCS). Researchers will use lower limb stepping plus a variety autonomic recovery metrics to determine results in paents with chronic paraplegia. The research team seeks to improve the current medical understanding of the mechanisms of recovery, and also the nerves in the spine for paents with chronic paraplegia. The study will cover a two-year period. To gain a beer understanding of how the treatment works, why it works and who it can help, this new study will use both EESS (smulaon coming from a device implanted in the paent) and the less invasive transcutaneous TESS (smulaon delivered through the skin) Building on the success of our inial study at Mayo Clinic (2016-2018), this next-step study is a larger Phase 2a clini-cal trial with four paents that will com-pare two dierent methods to acvate Our next three steps on the pathway to recovery: (1) a lower limb clinical trial, (2) an upper limb clinical trial, & (3) preparing the nal clinical trial for FDA approval. Phase 2a Clinical Trial - Stepping Lower Limb Recovery for Paraplegia 2019 - 2022 | Mayo Clinic | 4 paents Phase 2b Clinical Trial - Gripping Upper Limb Recovery for Tetraplegia 2020 - 2022 | Edgerton Lab | 24 paents
We want to beat paralysis. Our goal is to achieve FDA approval for clinical use of spinal neuromodulaon as a treatment for paralysis recovery in the next ve years. This will be the rst paralysis recovery treatment ever approved by the FDA. The next steps along the research path-way to achieving this goal are a Phase 2a clinical trial at Mayo Clinic and a Phase 2b clinical trial at UCLA’s Edgerton Lab. We can only complete these steps if we fund the research. And we can only fund the research with your help. More than 6 million people in North America living with paralysis are waing for us to get this done. Our BEAT PARALYSIS campaign will raise $1.3M by December 2022 with support Stepping up | our fundraising goal Together, we can get this done. How much money is needed. During 2020 – 2022: $1.3 million Phase 2a Clinical Trial—for Stepping Mayo Clinic | 4 paents | $700,000 Lower limb (stepping) recovery & auto-nomic funcon. 2+ years (2019—2022). Phase 2b Clinical Trial—for Gripping Edgerton Lab | 24 paents | $500,000 Upper limb (gripping) recovery & auto-nomic funcon. 2 years (2020 – 2022). Phase 3 Clinical Trial Design– for Victory for FDA clinical use approval | $100,000 The paent number and trial locaons will be negoated directly with the FDA using data from these two and other preceding studies. 6-month trial design period (2022). The Challenge Fund – Challenge Fund donors have already achieved 20% of our campaign goal, al-lowing us to fund project start-up grants so both research teams could begin pa-ent recruitment immediately. The Inspiraon Fund – Inspiraon Fund donors have double the impact. In addion to funding the research, Inspiraon Fund gis will cre-ate matching fund incenves we will use to inspire 1,000+ new donors to give through the Momentum Fund. The Momentum Fund – Together, over a thousand Momentum Fund donors will turn bold, innovave ideas into powerful recovery treatment opons for people living with paralysis. Momentum Fund donors can leverage the power of monthly recurring gi plans to dramacally increase giving po-tenal and accelerate greater momen-tum toward our goal. Jack Jablonski Foundaon | BEAT PARALYSIS Campaign 2020 - 2022
BEAT PARALYSIS CAMPAIGN Through a three-year fundraising eort, we will raise $1.3 million by December 2022 to advance the next two research projects along the pathway to get FDA approval for the rst clinical use of a treatment for paralysis recovery. Join us. Together, we can get this done. Why give One in 50 Americans – 6 million people – are living with paralysis. Maybe someone in your neighbor-hood, your circle of friends, or even your family is waing for recovery. Maybe you realize a paralyzing inju-ry could aect almost anyone and you want to help advance treat-ments that make recovery possible. Maybe you want to change what is possible by bringing an amazing medical innovaon to people who need it. Maybe you are inspired by Jack’s de-terminaon to get this done and you are ready to help him lead the way. Whatever your reason, your gi will help BEAT PARALAYSIS. TOTAL GOAL: $1,300,000
Building momentum. We have great momentum. Now I am asking you to help me keep that momen-tum going by funding every paent in these next two research projects. To-gether, we can get this done. Your generous support will accelerate ongoing research work that is already demonstrang results for people living with chronic paralysis, transforming lives by restoring funcons lost when a spinal cord is injured. Join me as a partner for recovery. Over the past few years, we have learned how to navigate the complex worlds of paralysis recovery research and advocacy to inspire a renewed urgency for progress. We can bundle gis from thousands of individuals to have the greatest impact on the research progress. Join the team | you can help me beat paralysis Your gi commitment will enable re-searchers at Mayo Clinic and UCLA’s Edgerton Lab to complete the tesng procedures required so that neuromod-ulaon treatment can begin giving abili-es back to millions of people who have been told paralysis is permanent. Recovery is possible. Every gi gets us closer to geng that done. 100% of your gi advances research. Every dollar you give to BEAT PARALY-SIS will be used to advance the progress of research toward FDA approval of the rst recovery treatment for chronic pa-ralysis. How can we doe this? Our foundaon covers its operang costs through events we host each year—a gala, a golf tournament, and a wine tasng. That is how every gi given for research goes 100% to research for paralysis recovery. 3 ways to pledge and give: (1) a gi by cash, check, credit card; (2) a gi of stock or other asset; (3) a matching gi from an employer. 3 pledging schedules: (1) a one-me gi paid when you are ready; (2) a schedule of regular monthly pay-ments over the 3-year period; (3) a customized schedule that works best for you. Appreciated assets. For many donors, a gi of an appreci-ated asset can be a valuable way to sup-port this research. Instead of selling an asset to make a gi, donate the asset and receive tax benets based on the full value of the asset, and save paying any taxes on gains.
Pledging opportunies to help Jack BEAT PARALYSIS # of Pledgers Gi Ranges Total Pledges 2 $100,000+ $250,000 9 $50,000 - 100,000 $550,000 18 $13,000 - 50,000 $313,000 20 $5,000 - 10,000 $100,000 50 $1,000 - 5,000 $50,000 1,000+ < $1,000 - 5,000 $27,000 1,113 < $1,000 - 5,000 $1,300,000 Pledge now to keep on pace with the research work. We do not need to raise all of the funds before we can start. In fact, we have al-ready started both projects, because the need is so urgent. But we do need your pledge now to keep the research going. Gis paid through pledge schedules will ensure funds are available to keep the re-search teams moving forward. Gis using recurring automac payments provide both consistency to the funding and convenience to you, the donor. We invite you to con-sider if a recurring monthly payment can leverage the power of your giving. Our BEL13VE team leadership John Besse, Board President US Bank, rered Robert Dollarhide, Board Vice President SG Wine & Spirits Mike Steinhauser, Treasurer 3B Group, Inc. Dr. Anne Moore, Corporate Secretary Tria Orthopedics Lance Anderson VP, Sportsengine Cheryl Besse Peter Brew Founder, Statbridge Derek Cherne Director, UBS Daniel Collins CFO, BNC Bank Chris Gausselin V3 Communicaons Michael Glover Partner, Lommen Abdo Casey Hankinson SVP, Ryan Cos Chris Heimbold Director, LITTLE Jim Horton VP, Highland Bank Kim Horton, RN Michael Jordan CEO, UNRL Ma Majka President, MN Wild Gretchen Mellies Cyber Power Systems Mindy Muenzberg Sally Oberstar US Bank, rered Alison Rosckes 3M Janice Steinhauser Travis Swan Upsher-Smith Labs Suzanne Tema MSP Public Schools
Jack Jablonski Foundaon 1820 Old Highway 8 NW, #13, New Brighton, MN 55112 www.BEL13VEfoundaon.org admin@BEL13VEfoundaon.org JJF is registered in Minnesota as a not-for-prot corporaon and designated by the IRS as a charitable organizaon under IRC secon 501(c)3. Federal TIN: 46-1604364