Axogen, Inc Announces Full Launch of Avive+ Soft Tissue Matrix™
Axogen has launched Avive+ Soft Tissue Matrix™, a new product designed to serve as a soft tissue barrier, aiding in peripheral nerve healing.
This resorbable, multi-layer amniotic membrane allograft conforms to FDA requirements for Human Cellular and Tissue-based Products (HCT/P). It provides temporary protection and tissue separation during the critical healing phase.
Company leadership highlighted Avive+'s role in addressing the $800 million nerve protection market composed of various injuries such as carpal and cubital tunnel syndromes and crush injuries.
Avive+ complements Axogen’s existing products like Axoguard Nerve Protector® and Axoguard HA+ Nerve Protector™. Clinical feedback suggests the product enhances patient outcomes in acute traumatic injury cases.
- Launch of Avive+ Soft Tissue Matrix™ expands Axogen's product portfolio.
- Targets the $800 million nerve protection market.
- Conforms to FDA requirements for Human Cellular and Tissue-based Products.
- None.
Insights
The launch of Avive+ Soft Tissue Matrix™ by Axogen, Inc. signifies a notable advancement in the realm of peripheral nerve injury treatment. The product's multi-layer amniotic membrane design can potentially revolutionize how soft tissue barriers are used during nerve healing. Nerve protection and healing are critical stages in trauma recovery and the introduction of this innovative product is timely and relevant to current medical needs. This launch also aligns well with Axogen's existing portfolio, enhancing the company’s comprehensive offerings.
For retail investors, it's important to note that the market for nerve protection, valued at
This product launch follows FDA regulations for Human Cellular and Tissue-based Products, which underscores its compliance and could enhance trust among healthcare professionals. Investors should monitor upcoming earnings reports to see how this product contributes to revenue growth.
From a market positioning perspective, Avive+ Soft Tissue Matrix™ enhances Axogen's competitive edge in a niche but essential segment of the healthcare industry. Addressing various nerve injuries such as carpal and cubital tunnel syndromes, as well as crush injuries, this product has the potential to broaden Axogen's market share significantly. Given the mentioned $800 million market size, capturing even a small percentage would be beneficial.
However, the launch’s success will depend on several factors including market penetration strategies, pricing and competition. Investors should look at how Axogen plans to market this product, including partnerships with medical institutions, training for healthcare providers and patient outcomes data to build credibility and trust in the product.
It's also worth considering the broader implications of this launch on Axogen's brand as an innovator in surgical solutions. Successful adoption could lead to increased attention and investment in their other products.
ALACHUA, Fla. and TAMPA, Fla., June 24, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announces the launch of its newest product, Avive+ Soft Tissue Matrix™. Avive+™ is intended for use as a soft tissue barrier and is a resorbable, multi-layer amniotic membrane allograft that provides temporary protection and tissue separation during the critical phase of peripheral nerve healing. Avive+ is processed and distributed in accordance with U.S. Food and Drug Administration (FDA) requirements for Human Cellular and Tissue-based Products (HCT/P) under 21 CFR Part 1271 regulations, U.S. State regulations as a 361 human tissue product.
“Product innovation is integral to our mission at Axogen," stated Karen Zaderej, Chairman, CEO, and President. "With the introduction of Avive+ Soft Tissue Matrix, we are excited to enhance our comprehensive solutions for nerve protection and address a significant need for patients with compression or non-transected nerve injuries.”
Nerve protection represents approximately
"As a hand surgeon, I've seen the positive impact of using Avive+ Soft Tissue Matrix,” stated Sunishka Wimalawansa, MD, Associate Professor of Orthopedic and Plastic Surgery at Wright State University in Dayton, OH. "The multi-layer design provides ideal handling, a robust barrier that retains the inherent properties of an amniotic membrane, and most importantly, the opportunity to improve patient outcomes after acute traumatic injury."
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 Matrix™, 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 countries.
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 Ms. Zaderej’s statement that Avive+ Soft Tissue Matrix will address a significant need for patients with compression or non-transected nerve injuries, as well as statements relating to the estimated size of the nerve protection market. 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 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.
Contact:
Axogen, Inc.
Harold D. Tamayo, Vice President of Finance, and Investor Relations
htamayo@axogeninc.com
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