Health tech business ONWARD has secured its third Breakthrough Device Designation status as it continues towards its goal of commercialising its technology which could allow paralysed patients to walk again.
The venture secured Breakthrough Device Designation for its ARC-IM platform for blood pressure and trunk control in people with spinal cord injury.
It is the third such status awarded to ONWARD from the US Food and Drug Administration (FDA), following previous awards for ARC-EX for upper extremity function and ARC-IM for mobility.
ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord. The system is operated via a tablet programmer and smartwatch.
A study demonstrated the ability of this technology to enable long-paralysed people to stand and walk again with little or no assistance and a further recently-published paper showed the potential for this same therapy to normalise blood pressure in people with spinal cord injury.
ONWARD has previously spoken to NR Times about its hope that ARC-IM would be commercially available in 2024.
“Blood pressure and trunk control are two of the many challenges people with spinal cord injury must manage in order to navigate their daily lives,” says Dave Marver, chief executive officer of ONWARD.
“We are excited about this award and thankful to the FDA for recognising the potential of our technology to improve the quality of life for those with spinal cord injury.”
The FDA endorsement comes as the latest breakthrough for ONWARD, following the backing of $32million earlier this year through a fundraising round to help it continue with its journey.
Previously, Dave Marver told NR Times about how its ARC EX device is expected to be commercially available in late 2023, with its Up-LIFT trial underway in the UK – at the Queen Elizabeth University Hospital in Glasgow – United States, Canada and the Netherlands.
The trial began in January with plans to enrol 65 people at up to 15 centres worldwide.
An external, non-invasive platform, the ARC EX is set to deliver movement and strength in the hands and upper body of people with spinal cord injury, compared to rehabilitation training alone.
And in one of the most keenly-awaited health tech breakthroughs of recent years, its ARC IM technology is set to go into trials mid next year, with its commercial launch anticipated in 2024.
Both platforms are designed to deliver targeted, programmed stimulation of the spinal cord to restore movement, independence, and health in people with spinal cord injury, ultimately improving their quality of life.
Breakthrough Device Designation is an FDA program designed to help patients and their physicians receive timely access to technologies that have the potential to provide more effective treatment or diagnosis for debilitating conditions of great unmet need, such as spinal cord injury.
As part of this designation, the FDA will provide ONWARD with priority review and the opportunity to interact with FDA’s experts throughout the premarket review phase as the technology moves toward eventual commercialisation.
Scarring study could pave way for new MS treatment avenues
New research investigates links between inflammation, scarring and progressive disabilities.
Brain and spinal cord scars in people with multiple sclerosis (MS) may reveal why they develop progressive disabilities, research suggests.
A new study explores whether inflammation leads to permanent scarring in three diseases. Researchers examined multiple Sclerosis (MS), Aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (AQP4-NMOSD) and Myelin oligodendrocyte glycoprotein antibody-associated disorder (MOGAD).
They also assessed if the scarring offers a reason for the absence of slow progressive disability in AQP4-NMOSD and MOGAD.
Damage and repair
The body’s immune system targets the myelin, the insulation around the nerves in all three conditions. This causes inflammation and leads to the removal of the myelin within the brain and spinal cord. Areas of demyelination appear as white spots on an MRI.
This could lead to symptoms such as visual problems, numbness, weakness, bowel or bladder dysfunction.
The repair mechanisms within the body try to reinstate the nerves and repair the lesions but this can be incomplete. It could result in a scar that remains visible on MRIs and leaves nerve fibres vulnerable to further damage over time.
Multiple sclerosis study
The researchers revealed that with MS, areas of inflammation reduced only modestly in size which led to a moderately sized scar. If the scar is in a region of the brain and spinal cord that controls arm or leg muscles then nerve fibres can degenerate and cause slow worsening of the disability in the secondary progressive course of MS.
Research and results
Eoin Flanagan, a Mayo Clinic neurologist and senior author of the study said: “The differences in scarring that we found will help physicians distinguish these three diseases more easily to aid in diagnosis.
“More importantly, our findings improve our understanding of the mechanisms of nerve damage in these three diseases and may suggest an important role of such scars in the development of long-term disability in MS.”
AQP4-NMOSD and MOGAD do not share the same slow progression of disability that MS does.
With AQP4-NMOSD, large areas of inflammation occur during attacks causing severe symptoms. Scarring is common but smaller than and in less important locations than MS. This leads to fewer long-term problems.
Researchers found that with MODGAD, despite the large areas of inflammation that occur during an attack, the lesions tend to disappear completely over time.
With MOGAD, despite having large areas of inflammation during an attack, the researchers found lesions tended to disappear completely over time and not leave any scar. This fits well with the excellent recovery from episodes and overall good long-term prognosis without the slow worsening disability seen in MS.
While the reasons for the recovery are not known, it could mean an enhanced ability to put the covering back onto nerves.
Dr Flanagan concluded: “We hope that the improved understanding on the ways MOGAD repairs its lesions so well may lead to novel treatment avenues to prevent scar formation in MS.”
Watch the webinar: Understanding and managing suicidal risk
Suicidal risk and understanding how best to respond was the subject of a recent webinar for professionals working with brain and spinal injured clients.
Assessments including how to assess the different levels of risk, including looking out for red flags, primary drivers and secondary drivers, were all addressed to empower people to deal with what is a hugely difficult topic.
The ‘Understanding Suicidal Risk – A Guide for Professionals’ event, held by Sphere Memory and Rehabilitation Team with donations going to brain injury recovery charity SameYou, came in response to rising levels of case managers and other professionals reporting clients experiencing difficulties and displaying risk factors.
Life-changing brain, spinal cord and complex injuries can be significant factors in increasing suicidal risk, as a result of the huge spectrum of difficult emotions a person faces in dealing with their new reality, with this only being amplified by the ongoing impact of the pandemic.
And for the professionals dealing with clients going through such trauma, suicidal thoughts and acts can cause great distress to them and it can be difficult to know how to react and what action to take.
Dr Katherine Dawson, director and consultant clinical neuropsychologist at Sphere, says: “People hear ‘suicide’ and can panic. There is understandable fear associated with it, and often those around the individual may inadvertently respond in quite a reactive way, wanting to try and fix the issue. We recognise that this can cause significant distress and anxiety and it can be hard to know what to do in the face of suicidal risk.
“Hopelessness is the most immediate risk factor for suicide so instilling hope is essential. The assessments we will consider in the webinar outline how to assess the different levels of risk including looking out for red flags, primary drivers and secondary drivers.
“We focus on how to complete a suicide interview collaboratively, leading to a clear plan of risk escalation and services to involve at specific times.
“Through putting the spotlight on a suicide intervention management plan, we can look at this in a thoughtful and containing way, reducing the risk of reactivity and decreasing anxiety.”
Watch the webinar here:
Rediscovering independence with live-in care
How Agincare supports people with acquired brain injuries, acquired spinal cord injuries and more diverse neurological needs.
If injury or illness means living life your way isn’t easy, live-in care can provide support. Agincare is experienced in supporting people with acquired brain injuries, acquired spinal cord injuries and more diverse neurological needs.
As a family owned and run business and one of England’s largest care groups, we’re proud to have been delivering skilled and professional care with a smile for 35 years.
If you’re looking for round-the-clock support without compromising on your choice, lifestyle, or independence, live-in care is designed for you.
To discover the difference that live-in care can make, we’d like you to meet Callum.
Callum is no less an adrenaline junkie today than he was as a teenager. Unfortunately, at age 16, while having fun with friends, Callum fell 30 feet. He sustained trauma to his head, memory loss and an acquired spinal cord injury.
Callum spent the next two years in hospital. With his mobility declining and behavior becoming challenging, Callum’s social worker decided to research live-in care.
Hope was nearly lost when it became clear many companies weren’t able to support his needs. Thankfully, Callum found hope again.
Agincare was assessed to be the best suited to support Callum. With great care, we matched him with Pawel, his new live-in care worker, who immediately began tailored training and getting to know Callum.
Soon, Callum was ready to move back home. The move was emotional, and Callum sometimes has difficulties processing feelings, but Pawel was there for him; patient, flexible and understanding. With Pawel’s support, Callum began a new chapter.
How it works
What we offered Callum was an affordable alternative to traditional care homes or home care visits, with the goal of independence at its core. Live-in care means that you have round-the-clock support, from the comfort of your home, where you can live your way.
With live-in care you welcome a care worker into your home, and from then on they’re always at hand. We understand that this can be a big step, which is why our matching process is done with great consideration, and it’s a process done by a person, not a computer.
We look for care workers with a special blend of compassion, reliability and a great sense of humour; all of whom are English-speaking and enhanced DBS (police) checked.
Our service is special because we fully manage it. Other live-in care services offer less protection and fewer guarantees for the same price.
Because Agincare employ and pay the care workers, it means we have the duty of care. So for example, if your care worker is ill, it’s our job, not yours, to find someone to replace them.
We are also fully regulated by the Care Quality Commission for a higher level of protection, and your peace of mind. In addition to this, we’re always at the end of a phone if you need support.
Whether you would like support attending your job or university, you want a helping hand around the house, you need assistance with medications or mobility, or you’re seeking real companionship with someone who’s fully trained to support you – live-in care can help you live your life to the fullest.
The person-first approach you see in Callum’s story comes from us working with you, your medical requirements, and your specific needs, every single step of the way. Our care workers take the time to understand you as an individual.
Because of this, what matters to you matters to us. Ultimately, our aim is to empower you to live as full, active, and independent a life as possible.
Looking to the future
What happened next? We’re proud to say that with Pawel advocating for Callum, he’s gone from strength to strength. Callum now has triumphs under his belt including developing his speech, recovering memories and putting his pen to poetry and art again.
Callum now can socialise, connect with his community and have friends visit with pizza and a few beers. He can rest assured knowing his care worker is always there for his encouragement.
Callum is also able to see his young daughter often, and his mother, who wanted an active role in his support, now has exactly that. With live-in care the possibilities are endless.
“I have my life back to the best it can be, I can see my friends when I want and my family. I am so happy and want others in my position to have the same level of care I have, and most importantly… hope.” – Callum
If you’d like to find out more about what live-in care can do for you, speak to our friendly team today.
Contact Agincare: 0808 271 9860.
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