ONWARD Medical Receives FDA Approval for Pivotal Study Launch

ONWARD Medical Takes a Significant Step with FDA IDE Approval

ONWARD Medical N.V., a leading force in neurotechnology and a pioneer in developing therapies for movement restoration, has achieved a vital milestone. The company recently received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence the Empower BP pivotal study. This innovative study aims to evaluate the safety and efficacy of the ARC-IM System, a novel neurostimulation technology specifically designed to address blood pressure instability following spinal cord injuries (SCI).

The Importance of Blood Pressure Management after SCI

Managing blood pressure instability is a critical unmet need among those who have experienced SCI. This issue profoundly impacts cardiovascular health and overall quality of life, placing a considerable burden on both patients and healthcare providers. More than half of individuals with SCI encounter blood pressure fluctuations, affecting an estimated 350,000 people across the US and Europe. Symptoms like dizziness, blurred vision, and fatigue can severely hinder daily functioning.

Understanding the ARC-IM System

The ARC-IM System developed by ONWARD is an implantable spinal stimulation technology that aims to provide targeted and personalized management of blood pressure irregularities. The pivotal Empower BP study represents the first comprehensive evaluation of this advanced system, and the involvement of approximately 20 leading neurorehabilitation and neurosurgical research centers across the US, Canada, and Europe underscores the global significance of this initiative.

About the Empower BP Study

Scheduled to begin before the year's end, the Empower BP study will be a randomized, double-blinded, sham-controlled trial, focusing on participants with spinal cord injuries at specific levels (C2-T6) and varying injury severities (AIS A-D). Observing blood pressure instability characterized by chronic orthostatic hypotension and episodes of autonomic dysreflexia will be central to this study's objectives.

The Perspectives of ONWARD’s Leadership

Dave Marver, CEO of ONWARD Medical, expressed excitement regarding this achievement, stating, "This is an important milestone for ONWARD and the SCI community. Our ARC-IM System is designed to address several unmet needs, including blood pressure instability, a significant recovery target after spinal cord injury. This IDE approval propels us forward in our mission to restore autonomic functions and enhance independence for those affected by SCI and related movement disabilities.”

The Clinical Significance of ARC-IM System

Past feasibility studies have demonstrated encouraging top-line interim results, indicating improved blood pressure regulation and greater hemodynamic stability among participants. Remarkably, individuals previously reliant on anti-hypotension medications reported substantial reductions or the complete discontinuation of these drugs, alongside noticeable enhancements in their overall well-being and energy levels.

Recognition from the FDA

The FDA's designation of the ARC-IM System as a Breakthrough Device reflects ONWARD's commitment to addressing critical healthcare needs. This recognition is allotted to pioneering therapies offering significant benefits in treating unmet medical conditions, granting the company regulatory advantages as they advance through the development phase.

About ONWARD Medical

ONWARD Medical is dedicated to transforming the landscape of neurotherapy through groundbreaking research and innovative treatments aimed at reinstating movement and functional independence for individuals facing spinal cord injuries and other disabilities. The company boasts over a decade of rigorous scientific exploration and clinical trials facilitated by partnerships with leading hospitals and research institutions. With multiple Breakthrough Device designations granted, ONWARD's commitment to innovation is evident in every aspect of its work.

Headquarters and Operations

Headquartered in the Netherlands, ONWARD Medical maintains a Science and Engineering Center in Switzerland, along with a US operations office located in Boston, Massachusetts. Traded on Euronext Paris, Brussels, and Amsterdam under ticker ONWD, the company's US ADRs are available through OTCQX as ONWRY. ONWARD's vision is to continually push the boundaries of neurotechnology, enhancing the quality of life for countless patients worldwide.

Frequently Asked Questions

What is the Empower BP pivotal study?

The Empower BP pivotal study is designed to assess the safety and efficacy of the ARC-IM System in managing blood pressure instability following spinal cord injuries.

What does the acronym ARC-IM stand for?

ARC-IM refers to the Advanced Rehabilitation Control - Implantable Model, the innovative neurostimulation technology developed by ONWARD Medical.

How does the ARC-IM System work?

The ARC-IM System delivers targeted spinal cord stimulation to help regulate blood pressure, aiming to improve the quality of life for individuals experiencing instability post-injury.

Who is participating in the Empower BP study?

Approximately 20 top neurorehabilitation and neurosurgical centers from the US, Canada, and Europe will participate in this significant research initiative.

Why is addressing blood pressure instability critical after SCI?

Addressing blood pressure instability is crucial because it can affect neurological recovery and lead to severe health issues like cardiovascular disease, significantly impacting patients' lives.

About The Author

Hello Kelly Martin here, a financial and publicly traded company specialist committed to writing with clarity and sage advice. Having a wealth of experience and a thorough grasp of corporate dynamics and the financial environment, my main goal in writing blog posts and articles is to provide insightful analysis together with useful guidance. My objective is to arm readers with the information they need to comprehend the complexities of publicly traded companies and make wise financial decisions.

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