ANEUVO Achieves Major Milestones with ExaStim® Success

ANEUVO Marks a Significant Achievement in Healthcare

ANEUVO, renowned for its groundbreaking work in non-invasive therapies, is on the brink of expanding its reach by hitting two critical milestones. The company has successfully achieved ISO 13485 compliance and secured CE Mark certification for its pioneering device, the ExaStim Stimulation System. These achievements reinforce ANEUVO's unwavering commitment to safety and quality, opening doors for the ExaStim device in the European healthcare market.

Understanding the CE Mark Certification

The CE Mark is essential as it certifies that the ExaStim device meets the European Union's rigorous health and safety standards established under the Medical Devices Regulation. This certification enables ANEUVO to market and sell ExaStim across Europe, thus giving clinicians and patients access to a revolutionary, non-invasive therapy specifically designed for enhancing motor function in those suffering from chronic spinal cord injuries (SCI).

The Importance of Non-Invasiveness

The non-invasive nature of the ExaStim device is a game changer. It offers a safe alternative to traditional treatments that may require surgical intervention. By delivering spinal cord stimulation without the need for incisions, ExaStim presents a new horizon for treatment options aiming to restore functionality in patients who have endured the challenges of spinal injuries.

ANEUVO's Vision for the Future

Dr. Yi-Kai Lo, co-founder and CEO of ANEUVO, highlights the significance of receiving the CE Mark. He describes it as a transformative moment for the company and emphasizes its potential to provide crucial therapies for those in need. This accomplishment not only signifies regulatory approval but also represents a leap towards real-world clinical applications that can change lives.

ISO 13485 Compliance: A Mark of Quality

Achieving ISO 13485 compliance is no small feat. This internationally recognized standard for quality management in medical devices reflects ANEUVO's dedication to global safety and reliability. It ensures that the company adheres to the highest quality control measures, which is essential in the highly regulated medical field.

Expanding Horizons in the European Market

The introduction of the ExaStim device in Europe is a vital step in ANEUVO's plan for global expansion. As Europe is known for its leadership in medical innovation, launching ExaStim here could significantly impact the treatment landscape for patients suffering from chronic conditions. With these certifications firmly in place, ANEUVO is poised to scale operations and deliver transformative technologies worldwide.

Inside the ExaStim Stimulation System

The ExaStim Stimulation System represents an innovative advance in bioelectronic medicine. It uses targeted and selective spinal cord stimulation to restore vital connections within the nervous system. This portable neurostimulation device operates through multi-electrode pads that deliver electrical pulses directly to affected nerves. The convenience of controlling this system via standard mobile devices adds to its appeal, making it accessible and user-friendly.

About ANEUVO: Pioneering Bioelectronic Medicine

ANEUVO is at the forefront of developing bioelectronic solutions aimed at enhancing the quality of life for individuals facing disabling diseases. With its cutting-edge biotechnology platform, ANEUVO is dedicated to overcoming significant healthcare challenges, striving to deliver effective solutions to underserved patients globally. The company's mission reflects a commitment to creating a healthier and more equitable world.

Contact Information

For U.S. Media Inquiries:

Diane Mulligan

President

M&C Communications

Email: dmulligan@mandccommunications.com

Phone: +1 720 273-0927

For EU Media Inquiries:

Akampion

Dr. Ludger Wess / Ines-Regina Buth

Email: info@akampion.com

Phone: +49 40 88 16 59 64 / +49 30 23 63 27 68

Frequently Asked Questions

What is the ExaStim Stimulation System?

The ExaStim Stimulation System is a portable neurostimulation device that non-invasively delivers spinal cord stimulation to aid recovery from chronic spinal cord injuries.

What does the CE Mark certification signify?

The CE Mark certification indicates that the ExaStim device complies with European health and safety regulations, allowing it to be marketed in Europe.

How does the ExaStim device work?

ExaStim uses electrical pulses delivered through a multi-electrode pad to stimulate spinal cord nerves, enhancing motor function in patients.

What is ISO 13485 compliance?

ISO 13485 compliance certifies that ANEUVO follows stringent quality management standards essential for medical devices, ensuring safety and reliability.

What are ANEUVO's future plans?

ANEUVO aims to expand its reach by introducing ExaStim to key markets, enhancing treatment options for individuals with chronic conditions.

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