Unveiling a New Era: ALACHUA, Fla. and TAMPA, Fla., Aug. 21, 2023. Amid a symphony of innovation and commitment, Axogen, Inc. (NASDAQ: AXGN), a trailblazer on the global stage of pioneering surgical solutions for peripheral nerve injuries, proudly heralds the resounding success of Avance Nerve Graft’s inaugural week at the majestic Axogen Processing Center (APC) in Dayton, Ohio.
Basking in the glow of this monumental achievement, Karen Zaderej, the visionary force behind Axogen’s journey as Chairman, CEO, and President, exclaims, ‘A new dawn breaks as Avance Nerve Graft takes its first steps within the hallowed halls of our state-of-the-art APC. This center is not just bricks and mortar; it’s the embodiment of our aspirations, propelling us towards the horizon of the first half of 2024, where our Biologics License Application (BLA) submission awaits. A tribute to progress, our BLA will etch our name in the annals of nerve-related solutions, amplifying the quality of life for countless patients.’
With each heartbeat of progress, the APC unravels its story, a tale woven with the threads of biologics validation. An expansive canvas spanning 107,000 square feet unfolds, adorned with the grace of ISO14644 clean rooms, inner sanctums of quality labs, a training haven for surgeons and tissue advocates, and the pulsating heart of cutting-edge support systems – a symphony of elements that orchestrate the ballet of high-quality, biologic processes. Here, potential knows no bounds; the APC’s prowess triples the existing processing capacity, and its architecture anticipates the contours of future growth.
Todd Puckett, the maestro of manufacturing, praises, ‘Dayton’s local artisans have conjured magic in constructing this center of excellence. A battalion of nearly 100 passionate souls, driven by reverence for the gift of tissue donation, forms our tapestry. As the science of nerve repair undergoes a renaissance, Ohio’s embrace, along with the collaboration of the City of Vandalia and the Dayton Development Coalition, stands as our cornerstone.’
In this narrative of innovation, the curtain rises on a new chapter, a tale of dedication and transformation that reverberates beyond boundaries. Axogen’s saga continues to resonate, echoing the promise of tomorrows sculpted by healing hands and compassionate hearts
About Axogen
Stepping into the Realm of Nerve Marvels: Enter Axogen (AXGN), a trailblazer standing at the forefront of a transformative journey dedicated to unraveling the secrets of peripheral nerve regeneration and repair. With a symphony of scientific ingenuity, Axogen has harnessed the power of innovation to breathe life back into the intricate pathways of peripheral nerves, rekindling hope for those whose lives have been touched by physical damage or trauma.
Passion courses through the veins of Axogen’s dedicated workforce, a group of visionaries united by a common goal: to reignite peripheral nerve function and quality of life. Their canvas is one of resilience, woven with threads of innovative solutions that bridge the gap between injury and healing. Each breakthrough resonates with the promise of renewed possibilities, shaping destinies once marred by the loss of muscle control, sensory perception, or the cruel grip of pain.
At the heart of Axogen’s endeavor lies a comprehensive arsenal of marvels – a treasure trove of cutting-edge products meticulously crafted to mend the fractured pathways of the nervous system. Two realms, each with its own tale to tell, unfold under the spotlight. Scheduled procedures, akin to a harmonious ballet, grant respite to those grappling with nerve defects or the aftermath of surgery. Whether it’s restoring sensation after a mastectomy, reconstructing nerves following the removal of painful neuromas, or rejuvenating the realm of oral and maxillofacial procedures, Axogen’s innovations serve as a beacon of healing light.
In contrast, emergent procedures paint a portrait of urgency, sprung from traumatic injuries that thrust patients into the realm of ERs. In these moments of vulnerability, Axogen’s offerings shine as beacons of hope, guiding specialists through the maze of recovery. The company’s dedication extends beyond the laboratory, as it responds swiftly to the call of those whose nerves are in dire need of rescue.
Enter the cast of heroes that grace Axogen’s stage – Avance® Nerve Graft, a phoenix reborn from processed human nerve allografts, ready to bridge severed nerves without the shadow of a second surgical site. Axoguard Nerve Connector®, a virtuoso in tensionless repair, dances elegantly to rejoin severed nerves. Axoguard Nerve Protector® dons the mantle of guardian, enfolding and shielding damaged nerves while weaving a tapestry of reconstruction. And then, the future beckons with Axoguard HA+ Nerve Protector™, a trailblazing fusion of science and art, a gel-coated guardian promising both short- and long-term protection.
This symphony of innovation is not confined by borders. Axogen’s resonance reaches across oceans, blessing the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and beyond. As the curtain rises on a world forever transformed by the magic of nerve repair, Axogen stands as a testament to human potential, orchestrating the melody of healing, one nerve at a time.
Cautionary Statements Concerning Forward-Looking Statements
Embarking on a Visionary Journey: Within the tapestry of this press release, a glimpse into the future emerges, woven with threads of possibilities and ambitions. Imagine a symphony of words that leap from the pages, carrying the essence of hope, innovation, and anticipation. As we delve into the realm of tomorrow, we encounter forward-looking statements that paint a vivid picture of what lies ahead.
In this kaleidoscope of insight, words like ‘expects,’ ‘anticipates,’ and ‘plans’ serve as beacons guiding us through the labyrinth of what’s to come. The canvas is vast and diverse, spanning timetables for Biologics License Application (BLA) submissions, the pivotal role of the Axogen Processing Center (APC) in this journey, and the promise of expansion and growth. At the heart of it all lies the backdrop of markets, trends, and economic factors, blending seamlessly with the tapestry of business plans and estimations.
Yet, this is no crystal ball; uncertainties linger, lending an air of realism to the narrative. The specter of COVID-19, global supply chains, and geopolitical shifts cast their shadows, reminding us that even the most carefully woven tapestries can be influenced by unexpected gusts of wind. The story encompasses hospital staffing challenges, the dance of product development and potential, the intricate steps of regulatory processes, and the art of financial performance and sales growth.
As we navigate this panorama of possibilities, we realize that these words are not cast in stone; they are brushstrokes on the canvas of time. The forward-looking statements are both a testament to ambition and a humble acknowledgment of the unpredictability of the future. And so, within the pages of this press release, we find a mosaic of aspirations, dreams, and the determination to chart a course toward tomorrow’s horizon. As these words echo through time, they remind us that the journey is just as important as the destination, and the pursuit of progress is a melody that continues to resonate.