FDA-filed SPL labeling · retrieved through openFDA

Processed Nerve Allograft

Processed nerve allograft (Avance Nerve Graft) is a surgically implanted nerve scaffold used to treat sensory, mixed, and motor nerve discontinuity — gaps in damaged nerves — in adults and children as young as one month old.

Brand name Avance Nerve Graft
Rx Form 1 Route Soft Tissue
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJan 23, 2026
AvailabilityRx
Earliest approval/marketing year 2026
FDA-listed product records 32
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 21, 2026
Processed Nerve Allograft at a glance The quick version — the full detail is in the Patient Information Guide below.
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HelloPharmacist Editorial Team Bottom Line
Avance Nerve Graft is a surgically implanted scaffold that bridges gaps in damaged nerves, guiding the body's own nerve fibers to regenerate across the defect. It is used for sensory, mixed, and motor nerve discontinuity in patients from one month of age onward. As with any surgical procedure involving donor tissue, there are procedural and infection-related risks your surgeon will discuss with you.

📖 Processed Nerve Allograft: Patient Information Guide

A plain-language walkthrough of Processed Nerve Allograft — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Avance Nerve Graft is a processed nerve scaffold implanted surgically to repair gaps in damaged nerves. It is approved for use in adults and children as young as one month old.

  • Avance Nerve Graft: Sensory nerve discontinuity with gaps of 25 mm or shorter
  • Avance Nerve Graft: Sensory nerve discontinuity with gaps longer than 25 mm — approved under accelerated approval; continued approval may depend on confirmatory trials
  • Avance Nerve Graft: Mixed and motor nerve discontinuity — approved under accelerated approval; continued approval may depend on confirmatory trials
⚙️How it works

Avance Nerve Graft works as a bridge across a damaged nerve gap. Its preserved internal structure — tiny channels called endoneurial tubes — gives growing nerve fibers a physical path to follow. The inner walls of these channels are lined with proteins (including laminin, collagen, and fibronectin) that send biological signals encouraging nerve cell migration, nerve fiber growth cone interaction, and new nerve fiber extension (neurite outgrowth). The exact mechanism is not fully known, but the bioactive laminin in particular appears important for supporting nerve regeneration.

💊How it's taken

Avance Nerve Graft is surgically implanted — it is not taken by mouth or applied at home. The number and size of grafts used depend on the size and number of nerve gaps being repaired, as determined by the surgeon. Each graft is a one-time implant for a single patient.

  • The graft is thawed in sterile saline or Lactated Ringer's solution for about 6 minutes just before implantation — never heated
  • Once thawed, the graft must be implanted or discarded within 12 hours
  • The graft may be trimmed to fit the nerve defect precisely
🤒Side effects — in detail

The most common side effects reported with Avance Nerve Graft in clinical studies were mild to moderate and related to the surgical procedure.

  • Procedural pain (reported in 4% of patients)
  • Hyperesthesia — heightened or uncomfortable skin sensitivity — at the implant site (3%)
  • Infection at the implant site
  • Swelling at the implant site
  • Adhesions (internal scar tissue bands)
  • Hypertrophic (thickened, raised) scarring
  • Impaired motor or sensory function
  • Neuroma formation (an overgrowth of nerve tissue)

One serious adverse reaction (wound dehiscence — the surgical wound reopening) occurred in a clinical trial. Contact your surgical team right away if your wound opens, you develop signs of infection, or you notice worsening pain or loss of sensation or movement.

⚠️Warnings & precautions
  • Risk of infectious disease transmission: Avance Nerve Graft is made from human donor tissue. Although donors are screened and tested for HIV, hepatitis B and C, syphilis, HTLV-1, and HTLV-2, and screened for CJD, no screening process eliminates all risk. No confirmed cases of viral disease or CJD transmission from Avance have ever been reported. Any suspected infection should be reported to Axogen Corporation at 1-888-296-4361.
  • Procedural complications: Surgery to implant the graft carries risks including pain, heightened sensitivity, infection, swelling, internal scarring, thickened scars, bleeding, impaired nerve function, and neuroma formation. Anesthesia-related risks also apply. Your surgical team will monitor for these and manage them if they occur.
📋Before taking it
  • Pregnancy: There is no safety data for Avance Nerve Graft use during pregnancy. No animal reproductive studies have been done. Discuss the risks and benefits with your doctor.
  • Breastfeeding: There is no data on effects on breast milk, the nursing infant, or milk production. Talk to your doctor before proceeding.
  • Children: Avance Nerve Graft is approved for pediatric patients aged one month and older. Pediatric use is based on extrapolation from adult clinical data.
  • Older adults (65+): Only a small number of patients 65 and older participated in clinical studies. It is not known whether they respond differently from younger patients.
  • Because the graft is derived from human donor tissue, patients should be aware of the small but real risk of infectious disease transmission before consenting to surgery.
📦How to store it

Store AVANCE at ≤-40°C (≤-40°F) and keep frozen until use.

📄 Written from Processed Nerve Allograft’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Processed Nerve Allograft — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Avance Nerve Graft, and where does it come from?
Avance Nerve Graft is a processed scaffold made from donated human nerve tissue. The donor cells are removed, but the internal structure — tiny tubes that guide nerve fiber regrowth — is kept intact along with key proteins that help nerves regenerate. It's a one-time surgical implant, not a medication you take at home.
What kinds of nerve injuries is it used for?
Avance is used to bridge gaps in damaged peripheral nerves — the nerves outside the brain and spinal cord. That includes sensory nerves (which carry feeling), as well as mixed and motor nerves (which also control muscle movement). It can be used in both adults and children as young as one month old.
What side effects should I watch for after the procedure?
The most commonly reported side effects were post-surgical pain and heightened skin sensitivity at the site. Other things to watch for include signs of infection (redness, warmth, discharge, fever), wound reopening, swelling, or changes in feeling or movement in the affected area. Call your surgeon right away if any of those happen — don't wait for your next appointment.
Is there any risk from the graft being made from human tissue?
There is a small, theoretical risk of infectious disease transmission since the graft comes from donated human tissue. Donors are carefully screened and tested for infections like HIV and hepatitis, but no screening is 100% perfect. That said, no case of viral disease or CJD transmission from Avance has ever been confirmed. Your surgeon will go over this risk with you before the procedure.
Can Avance Nerve Graft be used if I'm pregnant or breastfeeding?
There's currently no safety data on using Avance Nerve Graft during pregnancy or while breastfeeding. This doesn't mean it's definitely unsafe, but it does mean you and your doctor need to weigh the risks and benefits carefully before going ahead. Make sure your surgeon knows your situation.
How will I know if the nerve graft is working?
Nerve regeneration is a slow process — recovery of sensation or movement can take months. In clinical studies, improvement was measured using a test called static two-point discrimination, which checks how well you can feel two close points of touch. Your surgical team will monitor your progress over time. Follow all your scheduled follow-up appointments so they can track how well your nerve is healing.
Is Processed Nerve Allograft available over the counter?
Processed Nerve Allograft is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Processed Nerve Allograft first available?
Processed Nerve Allograft has been available in the United States since at least 2026, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Processed Nerve Allograft?
Processed Nerve Allograft is supplied by 2 manufacturers listed in the FDA NDC Directory, including Axogen Corporation, Isomedix Operations Inc.

💬 Answers drafted from Processed Nerve Allograft’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Processed Nerve Allograft comes

Processed Nerve Allograft is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Insert or device

By mouth · Soft Tissue
Brands Avance Nerve Graft
How this form is used
What it may be used for
  • Avance Nerve Graft is used to repair sensory nerve gaps of 25 mm or shorter in adults and children aged one month and older
  • Avance Nerve Graft is used to repair sensory nerve gaps longer than 25 mm in adults and children aged one month and older (accelerated approval)
  • Avance Nerve Graft is used to repair mixed and motor nerve discontinuity in adults and children aged one month and older (accelerated approval)
Important instructions
  • Avance Nerve Graft is thawed in sterile normal saline or Lactated Ringer's solution for approximately 6 minutes immediately before surgical use — it must not be heated
  • Avance Nerve Graft must be implanted or discarded within 12 hours of thawing
  • Avance Nerve Graft is available in 16 size combinations; the surgeon selects the length and diameter that best matches the nerve gap to be repaired
  • Avance Nerve Graft may be trimmed to fit the defect, and each graft is intended for a single patient only
Available strengths 16 strengths
Show 10 more strengths Show fewer strengths
32 FDA-listed product records

📊 Processed Nerve Allograft across the U.S. market

How Processed Nerve Allograft appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
2
Manufacturers
1
Brand names
32
FDA-listed product records
2026
First marketed
Axogen Corporation50%
Isomedix Operations Inc50%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

🔍 Compare Processed Nerve Allograft products

A representative set of FDA-listed product records for Processed Nerve Allograft — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 32 of 32 products — FDA National Drug Code Directory. See every product, package size and price: browse all 32 Processed Nerve Allograft NDCs →

🏷️ Sold under these brand names

Avance Nerve Graft

🏭 Manufacturers & labelers

Axogen Corporation 16 Isomedix Operations Inc 16

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 23, 2026
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Processed Nerve Allograft.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Processed Nerve Allograft after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
32
Distinct labelers/manufacturers represented
2
Linked representative label
Axogen Corporation
Linked label effective
Jan 23, 2026
Composite sections available
20
Linked SPL Set ID
e50d90fa-83ef-4d1b-9691-2b9c7bbdc2ae
Linked SPL Document ID
5c0c36c2-0dcf-4762-8653-31805880f668
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Axogen Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.