NeurAxis, Inc. Looks Ahead: A Bright Future for Patients

NeurAxis Inc. Shares Its Vision with Shareholders

NeurAxis, Inc. (NYSE American: NRXS), a rising star in medical technology, is dedicated to developing neuromodulation therapies that tackle chronic health issues affecting both children and adults. Recently, CEO Brian Carrico reached out to shareholders through a heartfelt letter, marking the company's achievements from the past year and shedding light on its ambitions for the future.

Celebrating a Year of Remarkable Achievements

As we reflect on the strides NeurAxis made in the previous year, we are excited to showcase the significant milestones that have propelled the company forward. In particular, NeurAxis has concentrated on enhancing its innovative IB-Stim technology, designed to manage pediatric irritable bowel syndrome (IBS). This pioneering approach underlines the company's commitment to addressing critical healthcare challenges faced by younger patients.

Focus on Growth and Innovation

NeurAxis is committed to sustaining remarkable growth while embracing innovation. This upcoming year, the company plans to submit applications to the FDA for broader indications, intending to expand its reach to adult IBS and pediatric functional dyspepsia cases. This progression reflects a strategic vision aimed at positioning NeurAxis as a leader within the gastroenterology arena.

IB-Stim Technology: Transforming Patient Care

In 2024, IB-Stim emerged as the first FDA-indicated therapeutic solution tailored specifically for pediatric IBS. This groundbreaking leap has enabled NeurAxis to offer treatment to around 1,000 young IBS patients. By employing advanced technology, the company is not only providing essential support to these children but also reaffirming its role as a vital contributor to improving quality of life.

Insurance Coverage Expansion

With robust, peer-reviewed data, NeurAxis has successfully expanded insurance coverage for its innovations. Previously covering just four million lives, the coverage now extends to a remarkable 51 million individuals, significantly bolstering the potential for sustainable growth and revenue.

Regulatory Advancements: Paving the Way for Success

The company marked a crucial breakthrough in November by receiving FDA 510(k) clearance to extend IB-Stim’s age indication. The new approval now embraces patients aged 8 to 21 years, widening its addressable market substantially. This important development indicates NeurAxis's intent on building stronger connections within the healthcare community and ensuring that its therapies reach those who need them most.

New CPT Code Approval

Another notable achievement includes the approval of a new Current Procedural Terminology (CPT) Category I code for PENFS procedures, effective January 1, 2026. This milestone allows for enhanced patient access and represents a fundamental step towards adapting the treatment for future procedures involving NeurAxis's innovative technologies.

Research and Development: A Commitment to Evidence

NeurAxis's commitment to scientific research is evident, with extensive peer-reviewed studies conducted in collaboration with leading children's hospitals. The rigorous academic scrutiny of its technology has paved the way for greater acceptance and adoption, reinforcing its position as a credible and innovative force in the healthcare field.

Strong Market Potential

The anticipated publication of clinical practice guidelines later this year holds particular promise for NeurAxis. These guidelines will be based on a thorough review of pediatric IBS literature and are expected to enhance insurance policy coverage across the nation, heralding a new era of accessibility for patients.

Looking Ahead: Prospects for 2025 and Beyond

NeurAxis is set to make waves with the commercial launch of its Rectal Expulsion Device (RED), recently granted 510(k) clearance by the FDA. The positive policy coverage by Medicare and many commercial insurers positions the company for an exciting start in 2025, offering screening tools for chronic constipation and pelvic floor dysfunction.

Aiming for Financial Stability

Underpinned by strong sales growth and disciplined cost management, NeurAxis is targeting cash flow breakeven by 2026. The recent backing from life science-focused investment funds enhances the company’s balance sheet, providing a robust foundation for realizing its objectives.

Gratitude and Inspiration

In conclusion, NeurAxis expresses heartfelt appreciation to its shareholders for their unwavering support. The company also acknowledges the hard work and dedication from its employees, partners, and board members which has fueled its journey of success. Together, they are shaping a future full of promise and innovation in healthcare.

Brian Carrico

President and Chief Executive Officer

Frequently Asked Questions

What is NeurAxis, Inc. focused on?

NeurAxis is dedicated to advancing neuromodulation therapies aimed at chronic conditions, particularly in children and adults.

What achievements did NeurAxis have in 2024?

In 2024, NeurAxis launched IB-Stim for pediatric IBS and achieved significant insurance coverage expansions.

What future plans does NeurAxis have for 2025?

NeurAxis plans to submit for expanded FDA indications and commercialize new devices like RED for chronic constipation.

How has peer-reviewed data impacted NeurAxis?

Peer-reviewed studies have expanded insurance coverage and validated NeurAxis's innovative treatment technologies.

Who can benefit from NeurAxis's treatments?

NeurAxis's treatments primarily benefit children and young adults suffering from IBS and related gastrointestinal conditions.

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