Axogen, Inc.

Company focus

• Advances peripheral nerve regeneration and repair through development and commercialization of regenerative medicine technologies.
• Aims to restore nerve function and improve quality of life for patients with peripheral nerve injuries.
• Provides clinically proven, cost-effective repair solutions for surgeons and healthcare providers.

Core product portfolio

• Avance Nerve Graft
  • Biologically active, off-the-shelf processed human nerve allograft for bridging severed peripheral nerves.
  • Decellularized and sterile; preserves a three-dimensional laminin-lined tubular bioscaffold, epineurium, and microvasculature.
  • Available in lengths up to 70 mm and diameters up to 5 mm; flexible and can be trimmed to fit.
  • No immunosuppression required; shelf life ~3 years; stored sterile and thawed in under 10 minutes.
  • More than 17 years of clinical evidence and over 120,000 implants since launch.
• Avance product line
  • The Avance Nerve Graft and related products together constitute the Avance line.
• Axoguard Nerve Connector
  • Porcine ECM coaptation aid for tensionless repair of transected nerves; tubular design with open ends for nerve ends.
  • Typically used for gaps ≤5 mm; available in seven diameters and two lengths; room-temperature storage; single-use.
• Axoguard Nerve Protector
  • Porcine submucosa ECM wrap to protect and reinforce nerve reconstructions and minimize soft tissue attachments.
  • Offered in five widths and two lengths; room-temperature storage; 24-month shelf life.
• Axoguard HA+ Nerve Protector
  • Similar to Axoguard Protector with a sodium hyaluronate/sodium alginate gel coating to reduce friction and improve nerve gliding.
  • Five sizes up to 4 cm x 8 cm; room-temperature storage; 24-month shelf life.
• Axoguard Nerve Cap
  • Porcine ECM device to protect nerve ends and reduce symptomatic neuroma formation.
  • Six sizes; room-temperature storage; 18-month shelf life.
• Avive+ Soft Tissue Matrix
  • Multi-layer amniotic membrane allograft to protect and separate tissues during healing.
  • Designed to remain present for at least 16 weeks during the critical healing window; multi-layer design with epithelial cells on both sides; can be sutured or secured in place.
  • Launched June 24, 2024; regulated as a Section 361 HCT/P product under 21 CFR Part 1271.

Regulatory status and product transitions

• December 3, 2025: FDA approved the Biologics License Application (BLA) for Avance as an acellular nerve scaffold for adults and pediatric patients (one month or older) with sensory nerve discontinuities ≤25 mm.
• Accelerated approval for sensory nerve discontinuities >25 mm and for mixed/motor discontinuities is contingent on confirmatory data.
• Post-marketing requirements include a comparative study versus nerve autograft:
  • Protocol due February 5, 2026.
  • Study completion by December 5, 2030.
  • Final report due June 5, 2031.
  • Ongoing 180-day progress reports starting May 31, 2026.
• Transition plan: Avance products will move from regulation as 361 HCT/P tissue products to licensed biologics under the 351 Public Health Service Act. Products manufactured before BLA approval may remain in the supply chain under 361 requirements until expiration.
• Commercial availability of Avance under BLA standards expected early in Q2 2026.

Manufacturing, processing, and facilities

• Avance Method
  • Proprietary, multi-step processing of donated human peripheral nerve tissue, including recovery, testing, donor review, debridement, processing, packaging, and sterilization.
  • Preserves extracellular matrix microarchitecture while removing cells and debris; includes removal of chondroitin sulfate proteoglycan to enhance regeneration.
• Production and facility footprint
  • Avance tissue processing and packaging moved in 2023 to the Axogen Processing Center (APC) Facility.
  • APC Facility: 107,000 sq ft on approximately 8.5 acres in Vandalia, Ohio; registered with the FDA as a biologics manufacturing facility and supports anticipated sales growth and capacity expansion.
• Recovery and processing network
  • Partners with FDA-registered tissue establishments and AATB-accredited recovery agencies.
  • Uses a combination of internal staff and subcontractors for recovery, storage, testing, processing, and sterilization.
  • Employs independent GLP/cGMP laboratories for confirmatory testing and product release.

Market scope and opportunity

• Geographic availability: United States, Canada, Germany, United Kingdom, Spain, and several other countries.
• Total addressable market (TAM) estimates by segment:
  • Extremities (traumatic peripheral nerve injury): ~ $2.9 billion/year.
  • Oral maxillofacial & head and neck (OMF): ~ $1.2 billion/year.
  • Breast reconstruction neurotization: ~ $677 million/year (including potential from Resensation technology for implant-based reconstructions).
  • Urology (nerve repair in prostate cancer surgeries and related procedures): ~ $754 million/year.
• Estimated total TAM: at least $5.6 billion/year based on literature, procedure databases, and company unit pricing assumptions.

Revenue, customers, and clinical footprint

• U.S. distribution of Avance Nerve Graft, Axoguard Nerve Connector, Axoguard Nerve Protector, Axoguard HA+ Nerve Protector, Axoguard Nerve Cap, and Avive+ Soft Tissue Matrix is the primary contributor to reported sales.
• Avance has more than 17 years of clinical evidence and over 120,000 implants since launch.

Other details

• Avive+ Soft Tissue Matrix serves as a barrier to soft tissue attachment to help reduce nerve tethering and is designed to remain in place through the critical healing window.
• Resensation: initiative launched in 2023 to enhance sensation in breast reconstruction, with a focus on implant-based procedures.
• Economic development incentives: grants totaling up to $2.7 million (including $1.3 million in cash grants) were obtained to support the APC Facility; clawback potential of up to approximately $950,000 as of December 31, 2025 if milestones are not met.
• Device handling: several products have 18–24 month shelf lives depending on configuration; room-temperature storage; sterile packaging; single-use.

Bottom line

Axogen develops and commercializes regenerative medicine technologies for peripheral nerve repair, offering a portfolio of biologic and ECM-based implants to bridge nerve gaps, protect and guide regeneration, and prevent neuromas and tethering. The company integrates tissue recovery and proprietary processing (the Avance Method) with an expanded U.S. manufacturing facility, has secured BLA approval for Avance with a transition plan to 351 biologic status, and markets its products across multiple countries with a TAM estimated at $5.6 billion or more.