Therapeutic Areas: NeuroModulation

Pioneering brain-changing breakthroughs

The field of neuromodulation is growing rapidly, with emerging applications incorporating a range of electromagnetic stimuli,
from magnetic fields to electric currents.

We know that working in an ever-evolving arena can be nerve-wracking.

Relax. We’ve got you and your neuromodulation device covered.

Proxima’s agile management approach allows our therapeutically-aligned team to adapt to your needs, while maintaining tight timelines and strategically managing the success of your device.

INDUSTRY VETERANS IN MEDTECH

Our team has extensive global experience in the MedTech industry, including specific expertise in neuromodulation clinical trial research and management.
Our MedTech industry veterans have worked clinical studies for a wide range of neuro devices, including those that supported the PMA approval for the first neuromodulation device marketed in the US.

Our success in neuromodulation is rooted in providing you with what you need most—experience, transparency and reliability.

Deep Brain & NEuromodulation Experience

We use proven, effective solutions to manage your trial from start to finish.
At Proxima Clinical, we understand the complexities that come with conducting successful clinical trials. Our clinical and regulatory management strategy focuses on agility, efficiency, speed and a deep understanding of neuromodulation.

We work with class II and class III devices, whether they support a 510(k), PMA, post approval, or observational assessment.
Therapeutic indications:
Epilepsy and Lennox-Gastaut Syndrome (LGS)
Stroke Rehabilitation
Depression, Anxiety, and PTSD
Tinnitus
Weight Loss
Snoring, Sleep Apnea
Parkinson’s Disease
Neurostimulation and Electrophysiology
Essential Tremor
Migraine
Attention Deficit Disorder
Spinal Cord Injuries
Post-traumatic Stress Disorder
Urinary Incontinence
OAB
Team experience:
Vagus Nerve Stimulation (VNS)
Transcutaneous Stimulation
Deep Brain Stimulation (DBS)
Transcranial Magnetic Stimulation (TMS)
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium that includes Baylor College of Medicine, Texas Children's Hospital, Texas A&M University, Rice University, University of Houston, and Fannin Innovation Studio. SWPDC is supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.
Physician
Chester J. Koh, MD
“Proxima has been such a wonderful help every step of the way. Everyone is truly great to work with.”
Junior Project Engineer
Karen Wells

Frequently Asked Question

Are IRBs Inspected by FDA?
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Glossary

Special Control
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Latest INsight

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Latest Video

What Are The 3 Types of FDA Pre-Market Submissions?
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Need a faster, leaner CRO that provides accurate results, too?
Our experts understand the changing landscape of neuromodulation.
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