SpineX Announces Successful in-Human Results to Treat Adults with Cerebral Palsy

First in-human study using its proprietary non-surgical and non-invasive SCiP device to treat adults with Cerebral Palsy shows marked patient improvement after just eight weeks

SpineX

SpineX Inc. today announced groundbreaking results in its first in-human study treating an adult with Cerebral Palsy (CP). The study, published in the esteemed medical journal BioElectronic Medicine, demonstrates significant functional improvements in an adult with CP after treatment with the company’s proprietary non-surgical SCiP™ therapy.

Led by Rahul Sachdeva, PhD and Kristin Girshin, PT, DPT

This study affirms how after just eight weeks of SCiP therapy treatment, a 60-year-old woman living with CP is able to perform daily living activities with minimal external assistance. “This is an absolute game changer for the CP community,” says the patient, who has lived with CP her entire life. Despite living with this severely debilitating condition, she has managed her symptoms with current standard of care therapies. However, she consistently encountered limited mobility and spent a great deal of energy completing routine tasks.

“After eight weeks of SCiP therapy, my balance was better, I was more confident in walking and climbing stairs with minimal assistance and was able to get dressed in less than half my usual time,” she says. “Over the years, I’ve tried every possible therapy available, but none of them had the impact that SCiP had, and in such a short period of time.”

Breakthrough Device Designation

SpineX has Breakthrough Device Designation (BDD) from the US FDA for SCiP and its proposed treatment of CP. SpineX has also engaged with the FDA to align on a proposed clinical trial to be conducted later this year, with the results expected to lead to FDA clearance of the SCiP device for the treatment of CP. “SCiP is a key missing piece in the puzzle for the treatment of CP,” says Dr. Girshin, lead therapist for the study and a key opinion leader within the CP community. “I am excited by the potential impact that SCiP could have on the CP population for both adults and children.”

About SpineX Inc.

SpineX Inc. is a clinical stage bioelectric MedTech company developing noninvasive spinal cord neuromodulation devices as a platform technology. SCONE™ and SCiP™ are two FDA-designated Breakthrough Devices being developed by SpineX for the treatment of adults with Neurogenic Bladder and Children with Cerebral Palsy respectively. SCONE™ and SCiP™ are investigational devices and are limited by Federal (USA) law to investigational use only. FDA has not yet reviewed the safety and effectiveness of SCONE™ and SCiP™.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.
AppliedVR Co-founder and President Josh Sackman, "We're committed to developing a significant body of scientific evidence that demonstrates how our RelieVRx program, which is rooted in self-regulation, cognitive behavioral therapy skills and mindfulness, engages the brain and can impact the experience of pain. While we know there can be a strong placebo effect, this feasibility study showed that only the active RelieVRx treatment created changes at a physiological and brain activity level, creating a strong foundation for future research."
Researchers and clinicians from Emory Winship Cancer Institute collaborated to test their prostate cancer population notes Prevencio.
First patients treated with H-Guard at the National Institute for Health and Care Research Manchester Clinical Research Facility. MHRA approves continuation of Invizius's first-in-human clinical study following a prearranged two-patient safety and performance review. Study is investigating safety and tolerability of H-Guard®, a second generation complement regulator, to address serious immune system-driven complications of dialysis.

By using this website you agree to accept Medical Device News Magazine Privacy Policy