Axogen Processing Center (APC) Celebrates its Opening with Ohio Leaders in Vandalia
Axogen, a leader in peripheral nerve injury solutions, announced the opening of its Axogen Processing Center (APC) in Vandalia, Ohio. The state-of-the-art facility will process Avance Nerve Graft®, designed to treat peripheral nerve deficits. The 107,000 sq. ft. center features ISO14644 clean rooms, quality labs, and training facilities, providing three times the previous processing capacity. With plans for expansion, the center employs nearly 100 professionals, addressing FDA regulatory transitions from section 361 tissue product to section 351 biologic. The opening ceremony on June 12, 2024, will include remarks from company leaders and tours of the new facility.
- Opening of a 107,000 sq. ft. Axogen Processing Center (APC) with advanced facilities.
- APC provides three times the previous processing capacity, enabling future growth.
- The facility supports the regulatory transition of Avance Nerve Graft from FDA section 361 to section 351 biologic.
- APC includes ISO14644 clean rooms, internal quality labs, and training labs.
- Located in Vandalia, Ohio, an area with a strong talent pool of engineers and technicians.
- Currently employs nearly 100 professionals with plans to expand.
- No direct mention of immediate financial improvements or revenue increase.
- Potential delay risks associated with the regulatory transition process.
- Initial costs and investments for setting up the new facility may impact short-term financials.
Showcasing Axogen’s Dedication to Fueling Ohio’s Biotechnology Sector Growth
ALACHUA, Fla. and TAMPA, Fla., May 28, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that it will celebrate the opening of its Axogen Processing Center (APC) with leaders of the Ohio community on June 12, 2024. APC is designed to process Avance Nerve Graft®, a regenerative peripheral nerve scaffold indicated for the treatment of peripheral nerve functional deficit and used by surgeons across the U.S. and internationally to surgically repair injured nerves. The facility is located at 913 Industrial Park Dr. in Vandalia, Ohio.
“The development and validation of our Axogen Processing Center is a significant accomplishment for Axogen,” said Chairman, CEO and President Karen Zaderej. “This facility will meet the stringent standards needed for processing our industry-leading Avance Nerve Graft as a biologic and position us for significant future expansion and growth. We are pleased to have selected and constructed the facility in the Vandalia and the broader Dayton Ohio area where we have a strong team of talented engineers, quality professionals and technicians, dedicated to supporting patients with peripheral nerve injuries.”
APC is a world-class biologic processing center designed to provide expanded capacity and support the regulatory transition of Avance from a U.S Food and Drug Administration section 361 tissue product to a section 351 biologic. The 107,000 sq. ft. facility includes ISO14644 clean rooms, internal quality labs, a surgeon and tissue agency training lab, and state-of-the-art support systems and redundancies required for high-quality biologic processes. APC provides approximately three times the previous processing capacity and was designed for future growth and expansion. The facility currently employs nearly 100 professionals with plans to increase this number as production scales up.
The event will include:
- Opening ceremony featuring remarks from Karen Zaderej, Chairman, Chief Executive Officer and President of Axogen Inc., Todd Puckett Vice President of Operations of Axogen, Inc. and Eddie Pauline, President and Chief Executive Officer at Ohio Life Sciences.
- Tours of the facility including laboratory areas and community spaces.
About Axogen
Axogen (AXGN) is the leading Company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven, and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.
Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products used across various applications and surgical specialties, including traumatic injuries, oral and maxillofacial surgery, breast reconstruction, and the surgical treatment of pain. These applications encompass both scheduled and emergent procedures. Specifically, scheduled procedures are often pursued by patients seeking relief from conditions caused by a nerve defect or previous surgical interventions. Such procedures include providing sensation for women undergoing breast reconstruction following a mastectomy, nerve reconstruction after the surgical removal of painful neuromas, and oral and maxillofacial procedures, as well as nerve decompression. Conversely, emergent procedures typically arise from injuries that initially present in an emergency room, with specialists intervening either immediately or within a few days following the initial injury. This broad range of applications underscores Axogen’s vital role in addressing diverse patient needs in peripheral nerve repair.
Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance Nerve Graft®, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector®, a porcine submucosa extracellular matrix (ECM) coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector®, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; Avive+ Soft Tissue MatrixTM, a multi-layer amniotic membrane allograft used to protect and separate tissues in the surgical bed during the critical phase of tissue repair; and Axoguard Nerve Cap®, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma. The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, South Korea, and several other European and international markets.
For more information, visit www.axogeninc.com.
Cautionary Statements Concerning Forward-Looking Statements
This press release contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations or predictions of future conditions, events, or results based on various assumptions and management's estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements include the Company’s statements of its expectations and estimates regarding completion of the rolling BLA submission in the third quarter of 2024, statements of its plan to provide the remaining Clinical and Chemistry, Manufacturing and Controls components of the BLA to the FDA in the coming months, statements of the estimated time of potential BLA approval in mid-2025, and statements of optimism regarding priority review. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, global supply chain issues, hospital staffing issues, product development, product potential, clinical outcomes, regulatory process and potential approvals, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, recent geopolitical conflicts in the Middle East, potential disruptions due to management transitions, as well as those risk factors described under Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements.
Company Contact:
Axogen, Inc.
Harold D. Tamayo, Vice President of Finance
htamayo@axogeninc.com
FAQ
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