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Category Archives: Spinal Cord Injury Treatment
Posted: August 16, 2017 at 9:46 pm
A chemical cocktail could restore movement for people crippled after suffering spinal cord injuries, suggests new research.
Scientists say the mixture of three molecules could potentially be given therapeutically to patients to aid in their recovery after serious injury.
After spinal cord injury or stroke, axons originating in the brains cortex and along the spinal cord become damaged, disrupting motor skills.
Now, according to findings published in the journal Neuron, a team of scientists at Boston Childrens Hospital in the United States has developed a method to promote axon regrowth after injury.
They administered the therapeutic cocktail of molecules to mice with either a spinal cord injury or stroke and observed that the mice were able to recover fine motor skills.
Study senior author Doctor Zhigang He, of Boston Childrens Hospital and Harvard Medical School, said: In our lab, for the first time we have a treatment that allowed the spinal cord injury and the stroke model to regain functional recovery.
His team designed the mixture by building on earlier work from Dr. Joshua Sanes group at Harvard who focused on optical nerve injuries. Sanes observed that the combination of insulin-like growth factor 1 (IGF1) and a protein called osteopontin (OPN) promoted nerve regrowth and vision improvement in optically-injured mice.
To investigate whether the combination would influence functional recovery, the team studied a mouse model of spinal cord injury to one side of the body.
Without intervention after injury, the mice were gradually able to recover some major motor function through natural resprouting of their axons.
But big shortfalls remained in their fine motor skills, making it difficult for them to walk on ladders with irregularly spaced rungs or retrieve food pellets.
In contrast, when the mice were injected with IGF1 and OPN one day after spinal cord injury, their fine motor skills greatly improved.
By week 12, the researchers observed that the mices error rates on the irregular ladder dropped to 46 percent, performing strikingly better than the untreated control group, which still continued to make errors 70 percent of the time.
He said the improvement was caused by a boost in axon sprouting and regeneration that resulted from the therapeutic mixture.
The team wondered if adding 4- aminopyridine-3-methanol, known to improve axon conduction, into their therapeutic cocktail would further enhance the mices functional recovery.
When they gave the cocktail of three molecules, they saw that the mices error rates in the irregular ladder task fell to 30 percent only 10 per cent higher than the healthy side.
Studying a mouse model of stroke, Hes team made a surprising observation.
He said: We saw what we expected, axon sprouting in the spinal cord.
But we also found something unexpected, increased axon sprouting in the subcortical area.
By genetic manipulation Hes team ablated the sprouted axons of the CST and found that the improvement diminished. That means the functional recovery was not particularly dependent on sprouting in subcortical regions but on those in the spinal cord.
He added: The functional outcomes of such subcortical sprouting remain to be tested.
He said that his team are now in talks with rehab centres to determine the prerequisites of ultimately taking their work forward to clinical trials.
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Miracle chemical ‘cocktail’ could cure spinal cord damage – New York Post
Posted: August 15, 2017 at 1:42 pm
TAMPA, Fla., Aug. 15, 2017 /PRNewswire/ –Parents can now check their child’s spine for possible signs of scoliosis with the new app SpineScreendeveloped by Shriners Hospitals for Children. Available for free on the App Store and Google Play, SpineScreen detects curves as the cell phone is moved along a child’s back, giving parents a quick, informal way to regularly monitor their child’s spine.
Scoliosis is an abnormal curvature of the spine that can restrict movement and in some cases lead to other serious medical conditions. It is most commonly diagnosed between 10 and 15 years of age, when children grow rapidly. Some cases, however, can go undetected. At this point in a child’s life, fewer vaccinations are required, so they may see a doctor less often. Since early detection is crucial, Shriners Hospitals physicians encourage parents to download the free SpineScreen app and check kids as part of their back-to-school routine each year.
“Because there is often no known cause, monitoring for scoliosis is an important part of a child’s ongoing health care,” says Amer Samdani, M.D., chief of surgery for Shriners Hospitals for Children Philadelphia. He adds, “It is a progressive condition, so early detection is key. At Shriners Hospitals, our care ranges from routine monitoring to some of the most advanced treatments for scoliosis. The earlier we see a child, the more options we have available.”
Shriners Hospitals created the app as part of a broader initiative to highlight the importance of regular screenings and to educate parents on the signs of scoliosis and treatment options.
“With doctors and staff who are global leaders in the treatment of scoliosis care, parents turn to Shriners Hospitals for Children because they know their children will receive the best care possible,” Gary Bergenske, chairman of the Board of Directors for Shriners Hospitals for Children. “Since scoliosis usually requires ongoing medical treatment throughout childhood, our commitment to provide care regardless of the families’ ability to pay is a huge relief to parents.”
If you have immediate concerns about your child’s spine or other possible medical conditions, please consult your health care provider. For more information on scoliosis screenings, treatment options and to download the SpineScreen app, please visit shrinershospitalsforchildren.org/scoliosis.
About Shriners Hospitals for Children
Shriners Hospitals for Children is changing lives every day through innovative pediatric specialty care, world-class research and outstanding medical education. Our 22 locations in the United States, Canada and Mexico, provide advanced care for children with orthopaedic conditions, burns, spinal cord injuries, and cleft lip and palate. Learn more at shrinershospitalsforchildren.org.
Shriners Hospitals for Children is a 501(c)(3) nonprofit organization and relies on the generosity of donors. All donations are tax deductible to the fullest extent permitted by law.
Contact: Meredith ResnickEmail: rel=”nofollow”>[email protected]: 202-549-0807
View original content with multimedia:http://www.prnewswire.com/news-releases/new-spinescreen-app-helps-parents-detect-signs-of-scoliosis-in-kids-300504265.html
SOURCE Shriners Hospitals for Children
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New SpineScreen app helps parents detect signs of scoliosis in kids – Markets Insider
Posted: August 14, 2017 at 3:50 am
by Gabrielle Mays, FOX 11 News
Lucas Lindner near the dugout at Sunday, Aug. 13 Brewers game. (Photo courtesy Scott Paulus with Milwaukee Brewers Baseball Club)
MILWAUKEE (WLUK) — Sunday marked another milestone for a Fox Valley man as he threw the first pitch at Sunday’s Brewers game.
With a baseball in Lucas Lindner’s right hand, he moved his arm back and threw the ball right into the catcher’s mitt with ease.
The crowd cheered and Lindner couldn’t help but smile.
He suffered from a severe spinal cord injury after he crashed his truck last year. The crash left him paralyzed from the chest down.
Thanks to an experimental stem cell treatment called AST-OPC1, Lindner gained mobility in his arms, hands and fingers.
The procedure took place at the Medical College of Wisconsin.
FOX 11 did a story on Lindner last year.
“Throwing out the first pitch at a Major League game is not something I could have imagined a year ago. I want to show everyone that there is hope that spinal cord injury patients can regain function. I am looking forward to going back to school, pursuing my dream of working in the IT field and living independently someday,” Lindner said to Asterias Biotherapeutics.
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Man with spinal cord injury throws first pitch at Brewers game – Fox11online.com
Posted: at 3:50 am
MILWAUKEE (AP) When Milwaukee manager Craig Counsell found out the Brewers had traded for Neil Walker, he immediately wanted to know if he could get the veteran infielder into the lineup for Sundays game against Cincinnati.
After collecting just 3 hours of sleep, Walker arrived in plenty of time to collect a pair of hits in his Milwaukee debut, helping the Brewers to a 7-4 victory over the Reds.
It is easier, in my opinion, to get thrown in the fire and see how it goes, Walker said. I was happy to not be out of the lineup for two straight days.
Domingo Santana hit a three-run homer for Milwaukee, and Ryan Braun had two hits and drove in a run. The Brewers took the last two games of the weekend series after dropping six in a row.
Walker came over in a trade with the New York Mets on Saturday. He started at third base in place of the banged-up Travis Shaw and went 2-for-4 with a run scored.
He played a position that he hasnt played a ton this year and made some very nice plays, Counsell said. He handled it very professionally like hes been over there. He had quality at-bats. It was a good spot today. We needed him with Travis being out.
Brewers starter Matt Garza (6-6) allowed four runs, three earned, and five hits in 5 innings. He struck out two and walked five.
Jeremy Jeffress got two outs, Jacob Barnes tossed two scoreless innings and All-Star Corey Knebel worked the ninth for his 22nd save. Jesse Winker singled with two out, but Joey Votto flied out to left to end the game.
The Brewers jumped on Sal Romano for three runs in the first inning. Jonathan Villar drew a leadoff walk and scored on Brauns double. Walker followed with a single to right field that Winker misplayed, allowing Braun to score.
Manny Pina made it 3-0 by dropping a ball just fair down the right-field line for a ground-rule double that scored Walker.
Adam Duvalls two-run homer got Cincinnati within one in the fourth, but Eric Sogard tripled and scored on Hernan Perezs squeeze bunt in the bottom half of the inning. Santana then provided the big blow in the fifth, driving a 1-0 fastball from Romano (2-5) over the wall in right-center for a 7-2 lead.
That three-run homer to Santana really cost us, Romano said. Ive just got to be able to get that guy out in that situation.
STREAK SNAPPED: Votto went 0-for-3, ending his career-best 17-game hitting streak. He did draw a pair of walks to extend his run of reaching base at least twice to 18 games, the longest streak since Barry Bonds reached multiple times in 20 consecutive games in 2004.
SPECIAL GUEST: Lucas Lindner, an Eden, Wis., resident who regained the use of his hands and arms following a severe spinal cord injury suffered in a car accident, threw out an honorary first pitch. Lindner received treatment in a clinical trial at Froedtert Hospital in Milwaukee to the injured area of his spinal cord following the May 2016 accident.
TRAINERS ROOM: Shaw was out of the lineup after fouling a pair of pitches off his right leg Saturday. With an off day Monday, Counsell expects Shaw to be able to play Tuesday against Pittsburgh. … LHP Brent Suter was placed on the 10-day disabled list with a left rotator cuff strain. … RHP Chase Anderson (strained left oblique) allowed four runs over 4 innings in a rehab start for Triple-A Colorado Springs. … C Stephen Vogt (left knee sprain) went 1-for-4 in his third rehab game with Class A Wisconsin … RHP Anthony Swarzak was unavailable Sunday due to a stiff neck.
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Walker helps Brewers knock off Reds 7-4 – La Crosse Tribune
Posted: at 3:50 am
GREEN BAY, Wis. Brett Goode had quite an eventful week.
Returning to the Green Bay Packers was only part of it.
Last Monday morning, the veteran long snapper an unsigned free agent despite spending the past nine seasons with the Packers was still unemployed when his wife, Monica, went into labor with the couples second child.
Shortly after daughter Blakely arrived, Goode was on a plane from his home in Arkansas for a tryout with the New York Jets, one of a number of NFL teams that had called expressing interest in him.
Like, the baby was born and I left, Goode said Sunday, following his first practice with the Packers. My wife is a good wife.
Goode said he had been monitoring the Packers special teams issues kicker Mason Crosby had missed six of 11 field-goal attempts during the teams annual Family Night practice on Aug. 5 and was still hoping for a call from his old team, as hed received at the end of training camp last year.
Sure enough, the phone rang late in the week and by Saturday, Goode was on his way back to Green Bay, having signed to compete with rookie Derek Hart for his old job.
For now, Goode and Hart will compete for the job. During the Packers closed practice Sunday that was devoted to preparations for the teams Sept. 10 regular-season opener against Seattle, the long snappers both worked with holder Justin Vogel, a rookie punter, and Crosby, who has worked with Goode for virtually his entire NFL career.
It can go one of two ways. Either you bow down, or you stand up and improve and bring the best out of yourself and keep going, said Hart, whose snaps were solid during Thursday nights preseason opener. Crosby made a 39-yard field goal and three extra points in the Packers 24-9 win over Philadelphia.
Competition brings the best out of people, I think. (Goode) did it here for nine, 10 years, so I think any little thing I can pick up from him will be good, too, along the way. Were just going to keep truckin and see what happens.
Goode took over as the Packers long snapper in 2008 after veteran Rob Davis retired after 11 years on the job. Goode handled every special teams snap until suffering a season-ending knee injury in December 2015 in a game at Oakland. He then returned to the team just before last years regular-season opener and was the snapper all season. Crosby made 26 of 30 regular-season field goals and sent the Packers to the NFC championship game with a 51-yard game-winning field goal against Dallas, the longest walk-off field goal in NFL postseason history.
The Packers decided to go younger with Hart, but Goode said the Packers had indicated that they might call at the end of camp as they had last year. When Hart struggled and other teams in the league expressed an interest in Goode, the timeline changed.
I knew I was going to get a call at some point. I didnt know from whom, Goode said. Because of Mason being here and all the other guys that Ive been here with forever and obviously the coaches the way everythings run, you know how training camps run, you know the city its like home.
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Veteran Goode back for Packers long snapper competition with rookie Hart – FOXSports.com
Posted: August 12, 2017 at 10:44 pm
If you go into my attic, you will find a pair of crutches. For years, they have been used on and off for every member of the family. A broken leg, a torn ACL, a bad ankle sprain, and painful tendonitis are but a few of the injuries in the Wichtowski household.
It seemed that at least once a year, one of my kiddos had an injury, usually from a sports practice or game. As it turns out, our household is rather typical. Every year, more than 36 million children play an organized sport, and 2.6 million of those youngsters will visit the emergency department for a sport- or recreation-related injury.
Injuries vary from run of the mill scrapes and bruises to serious brain and spinal cord injuries. Most, however, fall into the musculoskeletal category.
According to the American Academy of Pediatrics, the most frequent types of sports injuries are sprains (injuries to ligaments connecting two or more bones), strains (injuries to muscles), and stress fractures (injuries to bones).
Not all these injuries will show up on an X-ray but they do cause pain and discomfort.
Many of these injuries will respond to the RICE treatment Rest, Ice, Compression and Elevation. Other treatments may include crutches, cast immobilization or physical therapy.
Get professional medical care if the injury is severe. The National Institutes of Health define severe as an obvious fracture, dislocation of a joint, prolonged swelling or prolonged and/or severe pain.
It is important for children (and their parents) to be active. The benefits of exercise far outweigh the risk for injury. Exercise reduces the chance for obesity and the risk for type 2 diabetes. In addition, it helps build social and leadership skills. Not to mention, sports are fun!
Injury prevention tips
Nonetheless, injuries happen.
With a little planning and good habits, many injuries may be avoided.
The American Academy of Pediatrics 2017 Sports Injury Prevention Tip Sheet offers the following advice:
Take time off. Plan to have at least 1 day off per week and at least one month off per year from training for a particular sport to allow the body to recover.
n Wear the right gear. Players should wear appropriate and properly fit protective equipment such as pads (neck, shoulder, elbow, chest, knee, shin), helmets, mouthpieces, face guards, protective cups and eyewear. Young athletes should not assume that protective gear will prevent all injuries while performing more dangerous or risky activities.
n Strengthen muscles. Conditioning exercises during practice strengthens muscles used in play.
n Increase flexibility. Stretching exercises after games or practices can increase flexibility. Stretching should also be incorporated into a daily fitness plan.
n Use the proper technique. This should be reinforced during the playing season.
n Take breaks. Rest periods during practices and games can reduce injuries and prevent heat illness.
n Play safe. Strict rules against headfirst sliding (baseball and softball), spearing (football) and checking (hockey) should be enforced.
n Do not play through pain. In addition, do not play when very tired, as reflexes and coordination will not be optimal.
n Avoid heat illness by drinking plenty of fluids before, during and after exercise or play. Schedule regular fluid breaks during practices and games. For example, drink 8 to 16 ounces of water, 15 to 30 minutes before exercising, 4 to 8 ounces every 20 minutes while playing, and 16 to 20 ounces after play to rehydrate. Plain water usually suffices; however, sports drinks may prove beneficial for prolonged or intense exercise or warm to hot and humid conditions. Decrease or stop practices or competitions during high heat/humidity periods; wear light clothing.
n If children are jumping on a trampoline, a responsible adult should supervise them, and only one child should be on the trampoline at a time; 75 percent of trampoline injuries occur when more than one person is jumping at a time.
Lorraine Wichtowski is a community health educator at UR Medicine Noyes Health in Dansville. For article suggestions or more information, contact Lorraine at [email protected] or (585) 335-4327.
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Got a Minute?: Keep active, but play it safe to prevent injuries – The Livingston County News
Posted: at 10:44 pm
Cervical myelopathy is a condition caused due to compression of the spinal canal in the neck region. Or, in a layman’s language, we may say it is a damage caused to the part of the spinal cord that lies in the neck. It often leads to cord dysfunction and affects patients across all age groups. There are many underlying causes for the condition, however among the common ones prevalent are due to spondylosis (called as spondylotic myelopathy) and rheumatoid arthritis.Usually cervical myelopathy shows no initial symptoms and even if it does they can be so subtle that the diagnosis may easily be missed or mislead. Also, many a times patients start experiencing neck pain only at the advanced stage which is what makes the diagnosis of the condition difficult. Other CausesApart from spondylosis and rheumatoid arthritis, cervical myelopathy may be caused due to numerous other reasons such as:*A slipped disc*Degenerated cervical discs*Tumors inside the spinal cord *Compressing on the spinal cord*Bone spurs*Fracture of the neck*Traumatic injury to the cervical spine*Autoimmune disease, such as multiple sclerosis, or neuromyelitis optica*Bone or back problems*Born with a narrow spinal canal*History of cancer that involves bonesSymptomsCommon symptoms of cervical myelopathy may depend on factors like the cause of the disease. However, some of the commonly observed symptoms include: difficulty to work with smaller objects, like buttoning up your shirt, muscle weakness and pain in shoulder and arms, changes in handwriting, and tingling or numbness in the arms, etc. Advanced cases may show symptoms like difficulty in walking, increased tripping or imbalance during walking, irregular movements, etc. And, some extreme cases of spinal cord compression may even report feeling of electric shock-like sensations below the waist or arms and problem flexing neck, etc. In the later stages of the disease, some patients usually complain of weakness in their arms/legs, as well as changes in their bowel habits. PathologyThe physical act of compression, or stenosis, may be a result of conditions such as degenerative changes of the cervical spine, known as cervical spondylotic myelopathy. Patients who are born with a smaller spinal canal diameter have a higher propensity to compress the spinalcord when degeneration occurs. Another condition that results in compression of the cord is known as ossification of the posterior longitudinal ligament (OPLL). In this condition, the ligament in the spinal canal overgrows with abnormal bone, and this in turn causes compression of the spinal cord.Diagnosis and TreatmentImaging tests required to diagnose cervical myelopathy and to evaluate the spine and surrounding structures may include:*X-ray*MRI scan*CT scans with dyeOther tests may include:*Electromyography (EMG)*Somatosensory evoked potentials*Visual evoked potential test (VEP)Treatment and Surgical OptionsTo treat cervical myelopathy it is important to treat the cause of the myelopathy. Based on that your pain can be reduced or managed. Strengthening exercises too help in reliving discomfort and pain. But, if there is any kind of structural pressure being exerted on the spinal cord, you may need an immediate surgery. This is necessary to avoid any further injury. There are different kinds of surgery and procedures recommended to stabilise the neck, such as:*Discectomy: This surgery requires removal of a part of an intervertebral disc that is exerting pressure on the spinal cord or nerve root. *Laminectomy: This surgical procedure requires removal of a portion of a vertebra, called the lamina. *Fusion of the vertebrae. Patients with instability or significant neck pain would probably best benefit form a fusion.*Cervical Fusion: During this treatment procedure screws and a plate are used to prevent the vertebrae from exerting pressure on the spinalcord. * Laminoplasty: It’s a newer treatment, in which the spinal canal is enlarged without fusion, with less risk of instability. Laminoplasty is becoming the treatment of choice for many patients with cervical spondylotic myelopathy. However, laminoplasty is not recommended for everyone. Nonsurgical Approaches and Medication: Nonsurgical approaches to relieve pain and discomfort may include:*Physical therapy*Occupational therapyAlso, your doctor may prescribe medications such as Nonsteroidal anti-inflammatory drugs among other that may help to relieve symptoms. PreventionThough it is difficult to prevent cervical myelopathy, one can follow these guidelines to prevent any accidents and strains:*Emphasise on ergonomics like learning correct lifting techniques, improving your posture, and sitting correctly especially while working on laptop, etc.*Avoid sporting activities if you have had any disc problem in the past. *Limit neck movement.*Rise slowly from a seated or laying position.Dr Satnam Singh Chhabra, Director Neuro Spine Surgery, Sir Gangaram Hospital, New Delhi
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Spinal Myelopathy: A Slow and? ?Misdiagnosed Spinal Cord Injury – Kasmir Monitor
InVivo Therapeutics Provides Business Update and Reports 2017 Second Quarter Financial Results – Business Wire (press release)
Posted: August 9, 2017 at 3:42 pm
CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today provided a general business update and reported financial results for the quarter ended June 30, 2017.
Mark Perrin, InVivos Chief Executive Officer and Chairman, said, In the second quarter, we continued to make significant progress at InVivo. During the quarter, we enrolled four more patients into INSPIRE, and we now have 16 patients in follow-up. One of these patients improved from complete AIS A SCI to motor incomplete AIS C SCI at the one-month visit. We also announced that two patients who had previously converted to AIS B had been assessed to have converted to AIS C at their 12- and 24-month visits, respectively. Of the seven total AIS grade conversions, four are AIS C conversions at this time, meaning these four patients have recovered both sensory and motor function. Given these AIS C conversions and an overall conversion rate of 54.5% (6/11) at the 6-month primary endpoint visit, we remain enthusiastic about the potential of establishing the Neuro-Spinal Scaffold as the foundation of a new standard of care for acute spinal cord injury.
Last week, we announced that the most recent patient to enroll into the INSPIRE study passed away with the cause of death deemed by the Principal Investigator at the site to be unrelated to theNeuro-Spinal Scaffold or implantation procedure. This was the third death in the INSPIRE study. Following discussions with the companys independent Data Safety Monitoring Board (DSMB), we elected to implement a temporary halt to enrollment as we engaged with the FDA to determine whether any changes to the protocol were needed. The FDA responded formally with its recommendations; we are working on assessing the recommendations and formulating a response that will include a protocol amendment. At this time, our primary focus at InVivo is re-opening enrollment in INSPIRE as quickly as possible so that we can continue to make progress toward our goal of redefining the life of the spinal cord injury patient.
For the three-month period ended June 30, 2017, the Company reported a net loss of approximately $6.3 million, or $0.20 per diluted share, compared to a net loss of $5.2 million, or $0.16 per diluted share, for the three-month period ended June 30, 2016. The results for the three-month period ended June 30, 2017 were unfavorably impacted by increases in operating expenses of $416,000 in research and development and $724,000 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $554,000 for the three-month period ended June 30, 2017 reflecting changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the three-month period ended June 30, 2017 was $6.9 million, or $0.22 per diluted share, compared to adjusted net loss of $5.8 million, or $0.18 per diluted share, for the three-month period ended June 30, 2016.
The Company ended the quarter with $21.8 million of cash, cash equivalents, and marketable securities.
For the six-month period ended June 30, 2017, the Company reported a net loss of approximately $12.7 million, or $0.40 per diluted share, compared to a net loss of $11.8 million or $0.39 per diluted share, for the six-month period ended June 30, 2016. The results for the six-month period ended June 30, 2017 were unfavorably impacted by increases in operating expenses of $1.2 million in research and development and $1.0 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $795,000 for the six-month period ended June 30, 2017 reflecting changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the six-month period ended June 30, 2017 was $13.5 million, or $0.42 per diluted share, compared to adjusted net loss of $11.4 million, or $0.37 per diluted share, for the six-month period ended June 30, 2016.
Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the impact of the derivative warrant liability. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors to better understand the Company’s operations, on a period-to-period comparable basis, with financial amounts both including and excluding the identified items.
About The INSPIRE Study
The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of theNeuro-Spinal Scaffold for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.
About the Neuro-Spinal Scaffold Implant
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural repair within and around the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Childrens Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the companys investigational Neuro-Spinal Scaffold received the 2015 Beckers Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit http://www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” designed to, potentially, and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the status of the clinical program, including the changes to the INSPIRE protocol, the timing for re-opening enrollment in the INSPIRE Study and the submission of an HDE application to the FDA. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the companys ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the expected benefits and efficacy of the companys products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the companys business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the companys Quarterly Report of the three months ended June 30, 2017, and its other filings with the SEC, including the companys Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.
June 30, 2017
Common stock, $0.00001 par value, authorized 100,000,000 shares; 32,175,179 sharesissued and outstanding at June 30, 2017; 32,044,087 shares issued and outstanding atDecember 31, 2016
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations and Comprehensive Loss
Posted: at 3:42 pm
Groups representing disabled veterans and medical researchers warned this week that legislation banning most medical experimentation on dogs at the Department of Veterans Affairs would deprive veterans of needed medical breakthroughs, and thus represents a dangerous policy change for America’s war heroes.
It’s a tricky argument for the groups, in part because it pits two worthy and popular causes against each other: animal rights, and ensuring that injured U.S. soldiers get the best medical treatment possible.
Last week, those seeking improved treatment for animals had their say. Rep. Dave Brat, R-Va., proposed an amendment to a package of four spending bills for the next fiscal year, which included VA funding.
Brat’s amendment banned any VA funding for testing or other activities that bring certain levels of pain to dogs. The amendment passed overwhelmingly, in a voice vote, after a debate in which no one spoke against it.
That easy vote took opponents of the language by surprise, but some have indicated they will work to stop or amend it. They are starting with the argument that the amendment discounts the wounded veterans who stand to benefit from research on animals.
“When House members voted on July 26, 2017 to ban all VA medical testing that causes pain to animals, specifically targeting VA’s canine research program, it was the first step toward a complete devaluation of the lives of catastrophically injured veterans,” said Sherman Gillums Jr., executive director of Paralyzed Veterans of America, in an op-ed Tuesday.
Gillums appears to be backed by the VA itself. The VA hasn’t taken a formal position on the bill, but the VA’s own website indicates strong support for continued animal testing for the sake of helping veterans.
“VA’s animal research program has saved lives in the past and will save lives in the future,” said Dr. Michael Fallon, the VA’s chief veterinary medical officer. “It’s important for people to recognize that canine research is essential to developing crucial medical advancements to help veterans and non-veterans alike.”
Fallon stressed that just 0.05 percent of its animal testing involves dogs, and he and other medical professionals say testing on dogs is often necessary at certain stages of research.
The VA’s stated position is backed by outside medical experts who say dogs are still needed in certain cases.
Cindy Buckmaster, board chairperson for Americans for Medical Progress, told the Washington Examiner that dogs have cardiovascular systems that are similar to those found in humans. She said many of the medical techniques used to help treat people for diabetes and cardiovascular disease were worked out through testing on dogs, which she said shows the value of continuing, at the VA and elsewhere.
Supporters of the research ban dismiss this line of thinking, and argue there is simply no need in the modern era to subject animals to any testing, especially tests the inflict pain. But she and Paula Clifford, executive director for Americans for Medical Progress, took issue with claims that there are other ways to research medical treatments without using animals.
“The bill based on idea that the work isn’t necessary,” Clifford said. “That’s not true, the work is necessary.”
The two sides are also feuding over what happened at the VA clinic in Richmond, Va., that prompted Brat to introduce his amendment.
During last week’s debate in the House, Brat said the VA was needlessly inflicting pain on test canines, and that a report from the VA’s Office of Research Oversight showed that dogs were being subjected to abuse.
“From what I read, the type of work they were doing was on the level of torture,” he said. “In Richmond, this included inducing heart attacks. At other labs, the VA was giving methamphetamine to narcoleptic Dobermans.”
But Buckmaster said reports of excessive cruelty are unfounded. The VA’s oversight report, released at the end of May, said officials could not “conclusively determine” signs of negligence or incompetence at the VA, even though it found a case in which a sedative was inappropriately administered to a dog.
It also found no evidence that the VA was trying to hide its use of dogs in medical research, as some charged, or that the VA kept shoddy medical records.
Given these findings, opponents of Brat’s language say it’s an extreme solution to a moderate problem, one that would eradicate most of the VA’s substantial research with dogs that is used to better the lives of veterans.
Under his amendment, all studies resulting in pain to dogs in categories D or E, as defined by the U.S. Department of Agriculture, would not be allowed. Buckmaster said category D procedures, which typically involve surgeries that cause pain that can be relieved through anesthesia or other means, are the most common performed by the VA, and said ending those procedures would essentially end most of the VA’s work.
In a statement to the Washington Examiner, Brat defended the language by saying it would prevent “only the most painful and distressing procedures” at the VA.
“Experiments that use procedures that are non-painful or slightly discomforting for dogs will continue,” he said.
The immediate goal for opponents of Brat’s amendment is to keep it out of a final spending bill for the VA, something that Congress will work on when it gets back from the August break.
Gillums of Paralyzed Veterans of America said his group will argue that the bill goes too far by banning all medical research on dogs, even when the pain can be mitigated by anesthetics.
“This would significantly limit research potential and cures for profoundly disabling conditions, in both humans and animals, for which there’s presently no relief,” he told the Washington Examiner. “It could also lead to interpretations of the bill that ban all animal research.”
He said educating lawmakers is key, and said Brat’s use of the word “torture” on the House floor “distracts from the benefits of this research.” He said the VA already has strict rules in place for this research, and that researchers should be held accountable if they actually torture animals or violate those standards in other ways.
“But banning all animal research without first gaining a full understanding of what the research community considers ‘humane,’ not politicians evoking images of helpless animals being subjected to claims of torture, is one way to ensure disabled persons who are hanging on to hope will have nothing left to hope for, if this bill passes,” he said.
Gillums said a major challenge is teaching lawmakers how the research in question can help people with spinal cord injuries, circulatory problems and other treatable diseases.
“A good place to start might be to have them visit veterans who will face these conditions for the rest of their lives,” he said. “Explain to them why a ban on certain types of animal research is necessary, even if it holds the key to potential breakthroughs that could change their lives.”
Posted: August 8, 2017 at 1:44 pm
For a veteran facing a lifetime of paralysis after suffering a spinal cord injury, hope is often the last thing to die. Yet, the recently introduced House bill, H.R. 3197, threatens to crush what little hope to which I, and the approximately 60,000 veterans living with spinal cord injury, cling. The act proposes to reduce investment in medical research, and the reason is as simple as it is controversial: animal research.
Introduced by Rep.Dave Brat (R-Va.), the Act follows reports of experimentation on dogs at the McGuire VA Medical Center in the congressmans home state. Purportedly disturbing reports revealed that animals were being given amphetamines and suffering heart attacks, among other research-based details that arent easily digestible by those outside of the scientific community. The mainstream gut reaction that followed these revelations was easy to predict. When contemplated in a vacuum, the thought of animals experiencing induced pain would bother any reasonable person. However, I do not enjoy the luxury of contemplating these thoughts in a vacuum.
When House members voted on July 26, 2017 to ban all VA medical testing that causes pain to animals, specifically targeting VAs canine research program, it was the first step toward a complete devaluation of the lives of catastrophically injured veterans. Brat declared, “From what I read, the type of work that [VA researchers] were doing was on the level of torture.”
I understand how reading a report like that would spur intense emotion and abstract horror. But if the congressman had put down the report and accompanied me to a VA hospital, he would have discovered that the price of military service is not abstract. He would have seen firsthand what it’s like to care for a paralyzed veteran with a failing heart on a VA spinal cord injury unit; or another on the polytrauma unit who needs a new pancreas, among other missing body parts that need to be replaced. After that reality check, Id have asked the congressman, to consider these facts: It was VA’s canine research that spurred the development of the cardiac pacemaker and artificial pancreas the Food and Drug Administration approved just last year, which serves to benefit both veterans and those who have never worn the uniform. Non-VA canine research has also led to the discovery of insulin, new tests and treatments for various types of cancer and has played an important role in ushering in advancements in heart surgery procedures. While that reality may be inconvenient, its like freedom and democracy; it all comes at a price. I’d rather that price involve as little human suffering as possible. It’s apparent, however, not everyone agrees.
I would like to leave the legislative debate to the congressman and his colleagues, but its the ideology behind this bill that troubles me.Those participating in the debate over the VA’s animal research program appear to fall into two camps: those who believe we should doeverythingwe can to improve the lives of seriously injured veterans, and those who refuse to stare the ugly consequences of war in the face. It is not that simple though. The U.S. military faces the ugliness for its citizens, which includes our public servants.Now that those citizens are faced with the aftermath, some are having second thoughts.
The VA has a responsibility to consistently find new and better ways of treat Americas heroes. Animal research helps the department do that. The program has helped save and improve countless lives, and it will continue to do sounless ideology, and in some cases extremism on the issue of animal rights, succeed in forcing the public’s attention away from VA waiting rooms, inpatient wards, and rehabilitation gyms across the country. This is where the price of wars across several eras can be seen almost daily, as well as where medicine and science find their ripest opportunities.
Medical and scientific experts in America, as well as across the globe, agree animal research is essential. Thats because only animal research will provide the answers needed to develop revolutionary new treatments. Whether we like it or not, canine research is especially vital to potential medical breakthroughs because of unique traits shared by humans and dogs. In fact, CNN recently highlighted in a February 2017 story how canine research is leading to better results than traditional cancer research efforts.
Despite the hyperbole used by legislators to invoke disturbing images, VA is conducting research that is vital to seriously disabled veterans.That is what cannot be forgotten or eclipsed by words hyperlinked to extreme ideologies. Canine studies address a host of medical problems afflicting them, and it advances treatments that heal them, or at the very least, mitigate their suffering and give them a better quality of life. Ive seen it for myself, as Paralyzed Veterans of America has collaborative partnerships with Yale University and New Haven VA Medical Center to further the treatment advances that make veterans sacrifices endurable.
The research conducted at these facilities includes exploring cures and treatments for fatal lung infections affecting those with spinal cord injuries, dysfunction in brain circuits that control breathing, and whether service dogs reliably reduce the symptoms of post-traumatic stress disorder. Orthopedics research conducted with animals is especially important to many VA patients, as it has been essential to the design and testing of new prosthetic devices for veterans who have lost limbs.
Much of the animal research VA is doing aims to benefit a small group of veterans with specialized needs those whove sustained serious injuries in the line of duty. As a veteran who represents tens of thousands within this group, veterans who stand to benefit from VAs animal research efforts, I am compelled to challenge those who are fighting to shut this vital program down. I ask them, instead, to take a step back and look at things from our perspective.We are veterans who live with severe disability, many still in the prime of our lives. Our lives after service will never be the same as our lives before service, but advances in research will help us experience lives with less painand more hope.
It is my sincere hope there will come a time when we dont need animals for research. Unfortunately, that time has not arrived, and because of the incredible complexity of human anatomy and our still-limited understanding of how it works, animal research will be needed for the foreseeable future. To those who remain unconvinced, Ill close with two questions:What wouldn’t you do to find a cure for spinal cord injury, cancer, chronic lung infection, orthopedic deterioration, or other serious afflictions associated with military service?Then,what would you do if it wasyourson or daughter who served and returned home profoundly broken by battle, illness or disease?
For many veterans and their families, these questions are not philosophical. Because for them, hope is indeed the last thing to die. It is now up to Congress to decide whether that hope will be put completely out of its misery.
Sherman Gillums Jr. is a retired U.S. Marine officer who suffered a spinal cord injury in 2002 while serving on active duty. His career with Paralyzed Veterans of America started in 2004 after he completed rehabilitation at the San Diego VA Spinal Cord Injury & Disease Center. He is an alum of University of San Diego and Harvard Business School.
The views expressed by this author are their own and are not the views of The Hill.