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Illinois clinic one of first places in the country to offer new device to spinal cord injury patients

Illinois clinic one of first places in the country to offer new device to spinal cord injury patients

Yahoo07-03-2025
With electrodes stuck to different parts of his back along his spine, Shane Callahan practiced walking on a recent day — with help from an exercise specialist and a harness that helped hold him upright.
Callahan has a spinal cord injury, so he wasn't supporting all of his own weight or moving his legs by himself. But something had changed. He had a little bit of sensation in his feet.
'It's pretty strange,' said Callahan, 22, of Lockport, who was injured as a passenger in a car accident 1 1/2 years ago. Since he started using the device with the electrodes, he said, he can feel his feet touching surfaces, though they still can't feel pain or temperature. 'I think there's definitely noticeable progress.'
The device, called the ARC-EX, delivers electrical pulses to his spine during his sessions at Next Steps Chicago, a neurological rehabilitation clinic in Willow Springs. The device was approved by the U.S. Food and Drug Administration in December, with some experts hailing it as a milestone in therapy for people with spinal cord injuries. Next Steps is one of the first two clinics in the country offering it.
'It's pretty miraculous,' said Mary Jones, a physical therapist and director of operations at Next Steps Chicago. 'I spent my career working toward this and to see it come to fruition is nothing short of amazing.'
Now, during Callahan's appointments at Next Steps, neuro-adaptive exercise specialist Creighton Goss attaches electrodes to the back of Callahan's neck along his cervical spine and then midway down his back, near his thoracic spine. Thin electrical cables connect the electrodes to the ARC-EX device, which delivers continuous electrical pulses throughout Callahan's appointment.
The stimulation doesn't hurt, but 'It definitely wakes you up,' Callahan said with a smile.
The ARC-EX is not the first device to deliver electrical stimulation through the skin to help people with spinal cord injuries. But unlike other commercially available devices, the ARC-EX delivers stimulation directly to the spine, rather than to other parts of the body that a person wishes to move, such as to an arm or a leg. The idea is to restore hand strength and sensation even when stimulation is no longer used.
The device is supposed to be used for up to an hour a day, alongside therapy or training, to help improve hand strength and sensation for people with incomplete spinal cord injuries. About two-thirds of people with spinal cord injuries in the U.S. have incomplete injuries, meaning that though their movement may be extremely limited, their spinal cords have not completely lost the ability to transmit messages to and from the brain.
'Some instruction from the brain gets through but not enough to create a movement, so we're providing an amplification of that signal from the brain,' said Dave Marver, CEO of Onward Medical, the company that sells the device.
Dr. Arun Jayaraman, executive director of the Technology & Innovation Hub at Chicago rehabilitation hospital Shirley Ryan AbilityLab, who is not involved with Next Steps, called the device 'an additional tool' that can be used to improve spinal cord signals to the limbs. He said it's the first device of its kind to be FDA-approved and available for everyday use by clinicians, rather than just for research purposes. The AbilityLab has an agreement to use the device for its research studies in stroke and other medical conditions later this year.
The device's FDA approval is 'huge' for the spinal cord injury community, said Marco Baptista, chief scientific officer with the Christopher and Dana Reeve Foundation, which helped support the device's development with an investment in Onward. Philanthropic venture fund SCI Ventures, which was co-founded by the foundation and other nonprofits, now holds that investment, and any revenue received from the investment will go toward supporting more research, Baptista said.
'One, this can be a device that can help people, and, two, it provides this path forward that other therapies can then follow,' Baptista said.
Next Steps Chicago, a standalone nonprofit, helped test an earlier version of the device and has always felt it's important to bring cutting-edge technologies into the community, Jones said.
'This is a catastrophic lifelong condition,' Jones said of spinal cord injuries. 'To make somebody's life a little bit easier, to give them 10% improvement, that's a big deal for someone who hasn't moved their arm or is dependent on someone else for round-the-clock care.'
The device costs clinics about $40,000, Marver said — not a small price tag, but also not the most expensive piece of equipment a clinic like Next Steps uses.
In a study funded by Onward and published in May in the peer-reviewed journal Nature Medicine, 72% of participants saw improved strength and function in their hands and arms after using the device. The FDA specifically approved the device to be used to improve hand sensation and strength.
Improving hand function is a priority for many people with spinal cord injuries, Marver said, sometimes even more so than regaining the ability to walk.
'They need their hands to get through activities of daily living, to feed themselves, to clothe themselves, to go to the bathroom,' Marver said. 'These are all things that introduce independence, dignity, quality of life.'
The device doesn't work for everyone, but so far Next Steps has seen about a dozen patients have positive results, including Callahan, Jones said. Though Callahan still has hand function, the device has helped with other areas of his body, Jones said.
Callahan said he'd been a patient at Next Steps for about a year when Jones asked him if he wanted to try the ARC-EX device.
'She was explaining the research behind it and the possible benefits of using it, and it seemed it was applicable to my injury, so I thought why not,' Callahan said.
Callahan uses a wheelchair and is paralyzed from the diaphragm down. After his accident, he spent about two months as an inpatient at AbilityLab and then another six months doing outpatient rehab with the AbilityLab.
Now, he goes to Next Steps about three times a week, for two hours at a time, where he practices movement in the treatment gym. At a recent appointment, Goss had him kneel in front of a low table, which he used to brace himself, using his arms. Goss then slowly helped Callahan move his legs back and forth, an exercise designed to help him practice shifting weight from one leg to the other.
Callahan isn't sure how much strength, movement or sensation he'll ever regain. Everyone and every injury is different. 'Nothing is guaranteed,' Callahan said, but he's trying to recover as much as he can.
'It would definitely improve my quality of life, not just for me, but for my family,' Callahan said of the prospect of regaining more function.
'We're hoping you walk in one day and say, 'Peace out, I'm done,'' Goss said. 'That would be the goal.'
'That would be the goal,' Callahan agreed.
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Aldeyra Therapeutics Receives Orphan Designation from the European Medicines Agency for ADX-2191 for the Treatment of Inherited Retinal Dystrophies including Retinitis Pigmentosa
Aldeyra Therapeutics Receives Orphan Designation from the European Medicines Agency for ADX-2191 for the Treatment of Inherited Retinal Dystrophies including Retinitis Pigmentosa

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Aldeyra Therapeutics Receives Orphan Designation from the European Medicines Agency for ADX-2191 for the Treatment of Inherited Retinal Dystrophies including Retinitis Pigmentosa

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Will psychedelics ever live up to their hype?
Will psychedelics ever live up to their hype?

National Geographic

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Will psychedelics ever live up to their hype?

Psychedelic drugs, like MDMA, have garnered promising results in treating a long list of mental health conditions. But some researchers say the studies have some key shortcomings. Photograph by Daria Kulkova, Getty Images The mind-expanding drugs may help heal many mental health conditions. But studies haven't actually proved that yet. In recent years, the conversation around psychedelic medicine has shifted from hushed discussions to headline news, with many media articles trumpeting positive scientific findings. Studies have found psychedelics effective for a wide range of mental health conditions, including depression, post-traumatic stress disorder, and substance abuse, and even physical conditions such as chronic pain. Results have been so promising that three states, Oregon, Colorado, and New Mexico, have created pathways for psychedelics to be legally administered there. 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Despite all the hype, 'we cannot conclude anything as of yet about the safety or efficacy of psychedelic therapy' for many of the conditions it's been touted to treat, says Michiel van Elk, a cognitive neuroscientist at Leiden University in the Netherlands, who coauthored an analysis in 2023 of the research's shortcomings. Some of the red flags took the spotlight last year, when the FDA rejected one of the most well-studied of the drugs, methylenedioxy-methamphetamine (MDMA), as a treatment for post-traumatic stress disorder. Even MDMA requires another large clinical trial to address lingering concerns, van Elk says. Some issues plaguing psychedelic research stem from the youthfulness of the field. Although scientists preliminarily studied the drugs during the 1950s and 60s, most of the research has happened in the past decade. But other hurdles are specific to experimenting with mind-altering substances. Here are three of the major concerns. 1. Psychedelic studies have been shockingly small. Studying these compounds is admittedly challenging. The drugs must be administered in person, generally in the presence of two trained facilitators who stay with each clinical trial participant for the six to ten hours the substance remains active. People also generally talk to therapists several times in the weeks before and after the experience. Plus, the medicine is time-consuming to get, due to restrictive government regulations. All told, running a single participant through a psychedelic study can cost tens of thousands of dollars, van Elk estimates. (Who will guide your psychedelic medicine trip?) To make studies affordable, most psychedelic research has included a small number of participants. One widely touted study finding benefits of psilocybin for major depression involved just 27 participants. Only 39 people took part a study documenting LSD's advantages for treating anxiety. Even the two studies submitted to the FDA in 2024 seeking approval for MDMA included 90 and 104 participants, respectively. By contrast, when the diabetes drug Ozempic was approved in 2017, its manufacturer submitted results in more than 4,000 people. In studies this small, a few individuals having unique experiences can skew the findings, especially if the people differ from the average to start. 'People who agree to these trials may not reflect the general population: They may be more desperate, more resistant of conventional treatments, more willing to try something wildly different from the norm,' says Frederick Barrett, a neuroscientist and director of the Center for Psychedelic and Consciousness Research at Johns Hopkins University School of Medicine. Only larger studies can confirm positive results from these small trials. 'If you want to say anything meaningful, you need to increase sample sizes by hundreds of participants,' van Elk says. One way to bring up the numbers is to pool results. Researchers did this in 2024, combining nine clinical trials on psilocybin for depression, which together found the drug twice as effective as a placebo, the inert substance used for comparison in drug trials. But even this pooled analysis, while lending support to prior results, involved just 436 total participants. 2. People are bummed when they figure out that they didn't get the drug. The most reliable studies are 'double-blind,' where neither the person giving the medicine nor the person taking it knows whether they got the drug or the placebo. This helps keep people from incorrectly attributing health improvements to the medicine. But it's nearly impossible to keep study participants from the fact that they've taken a psychedelic when the room starts singing or their hands disappear before them. 'Psychedelic studies go through the motion, but it's functionally not blinded. Everybody figures it out,' says Balázs Szigeti, a clinical data scientist in the Translational Psychedelic Research program at the University of California, San Francisco, who studies this issue. People who don't get the drug seem to especially disappointed—more so than with other medications. 'Nobody wants to be in the placebo group,' Szigeti says. 'It's a great conversation when at cocktail parties you tell your friends you're going to be in a psychedelic drug trial. But imagine months later at the same social gathering when you have to tell them nothing happened.' This letdown may skew results, causing placebo-takers in psychedelic studies to underreport improvements. In a 2024 review, researchers found that people getting placebos in clinical trials testing the antidepressant escitalopram reported greater improvements in their depression levels than comparable studies for psychedelics. The wider gap between the psychedelic and placebo group artificially makes psychedelics look better, especially when they are compared to antidepressants, Szigeti says. In reality, the two treatments may be more evenly matched. Szigeti compared results from psychedelic and antidepressant studies without a placebo group, where everyone got an active treatment, and his unpublished data suggest they actually have similar effects. Of course, that may not be a bad thing. Antidepressant pills must be taken daily and come with side effects like weight gain and sexual disfunction. In comparison, one or two psychedelic sessions, which seem to convey lasting effects, could provide an appealing alternative for some patients. But such a finding would be far from the hype 'that psychedelics can cure depression,' Barrett notes. Scientists have been unable to find a placebo that does not tip off participants. They've tried a form of vitamin B that causes tingling and flushing, a cough medicine that can make people woozy, and even low doses of the psychedelic itself. But when people are asked during the clinical trial, most know they were not given the psychedelic. A more effective approach may be to randomize people earlier in the process so the placebo group never knows they could have gotten a psychedelic, Szigeti says. Studies could also be designed with a so-called cross-over design where everyone eventually gets the psychedelic, minimizing the disappointment of those who initially do not. 3. It's unclear how addictive some substances are. One of the biggest concerns raised by the FDA advisory committee assessing MDMA was the potential for abuse should the drug become legally available. Committee members complained that the company submitting the application, Lykos Therapeutics, had not asked study participants if they experienced euphoria or elation while on the drug—a sign some might seek to later abuse it. More than two million people in the U.S. illegally use MDMA, known on the street as Ecstasy or Molly—making it the fourth most common street drug after marijuana, cocaine, and methamphetamine. (Five recent scientific findings that change what we know about cannabis.) Psilocybin and LSD are less likely to be psychologically addictive than MDMA, Barrett says. In lab studies, animals exposed to an addictive drug like cocaine seek it out to the exclusion of food and water, but 'you have to bend over backwards' to get animals to take these psychedelics, he says. Still, the potential for abuse is rarely addressed in psychedelic research, even though critics think it always should be. 'Absence of data is not evidence of absence,' van Elk says. The potential for addiction is one reason drug companies are working to produce psychedelics that convey a health benefit without inducing the hallucinations or euphoria that might entice people to seek out these substances. (Scientists are creating psychedelics without the trips.) As the field of psychedelic science matures and seeks broader acceptance, including perhaps FDA approval of one or more of the drugs, a growing number of researchers are starting to take critiques of their work to heart. 'People are becoming aware that we potentially face a credibility crisis,' van Elk says, 'and that we need to do everything we can to make sure that we do the science according to the highest standards possible.'

Pfizer Completes Licensing Agreement with 3SBio
Pfizer Completes Licensing Agreement with 3SBio

Business Wire

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Pfizer Completes Licensing Agreement with 3SBio

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'This is an important candidate that combines two key targets in a promising class of medicines, complementing our antibody-drug conjugate portfolio and further demonstrates our commitment to advancing pioneering science to deliver transformative cancer medicines and new hope to people living with cancer.' SSGJ-707 is currently undergoing several clinical trials in China for non-small cell lung cancer (NSCLC), metastatic colorectal cancer, and gynecological tumors. Positive interim Phase 2 results evaluating the safety and efficacy of SSGJ-707 as monotherapy in patients with advanced NSCLC were recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. Pfizer plans to manufacture drug substance for SSGJ-707 in Sanford, North Carolina, and drug product in McPherson, Kansas. The clinical development plan for SSGJ-707 moving forward will include trial sites across the U.S. and rest of world with priority to the Phase 3 global development plan for NSCLC and other solid tumors. The first Phase 3 global studies will initiate enrollment in the U.S. Under the terms of the agreement, 3SBio will receive a payment of $1.25 billion. Pfizer will also make a $100 million equity investment in 3SBio. Additionally, the agreement provides Pfizer the option to extend the license to include exclusive development and commercialization rights to SSGJ-707 in China. In exchange for the exclusive rights in China, Pfizer will pay 3SBio up to $150 million in option payments. For additional background on the licensing deal, please read the announcement press release here. About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world's most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients' Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Disclosure Notice: The information contained in this release is as of July 24, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about, among other topics, Pfizer Oncology, SSGJ-707, an investigational bispecific antibody targeting PD-1 and VEGF, a global, ex-China, licensing agreement between Pfizer and 3SBio, Inc. granting Pfizer exclusive rights for the development, manufacturing and commercialization of SSGJ-707, and an option to extend the license to include exclusive development and commercialization rights to SSGJ-707 in China, including their potential benefits, manufacturing plans and development plans, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks related to the ability to realize the anticipated benefits of the transaction, including the possibility that the expected benefits from the transaction will not be realized or will not be realized within the expected time period; risks related to the successful integration of the licensed asset with Pfizer's business; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of this announcement or the consummation of the transaction on the market price of Pfizer's common stock and/or operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the transaction or SSGJ-707; manufacturing capabilities or capacity; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; future exchange and interest rates; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy; changes in tax and other laws, regulations, rates and policies; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer's business and prospects, adverse developments in Pfizer's markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment, tariffs and other trade policies or economies generally; future business combinations or disposals; uncertainties regarding the commercial success of SSGJ-707 and Pfizer's commercialized and pipeline products; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications may be filed in any jurisdictions for SSGJ-707 or any of Pfizer's pipeline products for any potential indications; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether SSGJ-707 or any such other products will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of SSGJ-707 or any such other products; uncertainties regarding the impact of COVID-19; and competitive developments. 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