allay™ Nerve Cap Receives FDA De Novo Classification
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Introducing

The first and only fully absorbable in situ forming technology designed to protect transected nerves, prevent axonal escape, and reduce the risk of neuroma formation.
Unmet Clinical Need

Neuroma prevention

76% of patients who undergo amputation will experience chronic pain.¹

Treatment Challenge

Advanced surgical methods have shown promise, but fail to consistently prevent neuroma formation

When peripheral nerves are cut during amputation, they attempt to regenerate. However, without a distal nerve to regenerate onto, they often develop neuromas that can cause phantom and residual limb pain for amputees. 

Successful treatment requires:

  • Protecting transected nerves
  • Preventing axonal escape
  • Reducing the risk of neuroma formation

Solution

Optimize recovery with allay™ Nerve Cap

Conforms & Cushions

Non-compressive & protective, matches mechanical properties of nerve and accommodates post-op swelling

Optimizes Recovery

Permits exchange of nutrients & O₂ to maintain nerve health
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allay™ Nerve Cap is designed to

Optimize recovery & reduce the risk of neuroma formation

Proven Results

No neuroma formation across six preclinical studies (n>200)²

DEMONSTRATED NEUROMA PREVENTION

No neuroma formation across
six preclinical studies (n>200)²

Fast & intuitive procedure

Direct visualization

Transparent hydrogel enables direct visualization to ensure procedural success. 

Fast-acting

Activates upon delivery to ensure procedural confidence.

Entirely sutureless

Without the need for sutures, procedural time is reduced, and nerve stitch granulomas are eliminated.

Two kits. All treatment options covered.

The allay™ Nerve Cap system is provided in a sterile non-pyrogenic Small Nerve Set or Large Nerve Set for single use only.

Small Nerve Set
Nerve Sizes: 1, 2, 3 and 4 mm
Model # TL-5515-1

Large Nerve Set
 Nerve Sizes: 5, 6, and 7 mm
Model # TL-5515-2

Additional Delivery Tips | Model # TL-7627 – One box includes 6 packages, each containing one small and large delivery tip.

The allay™ Nerve Cap is indicated for use in adults aged 22 years or older as a physical barrier to separate the peripheral nerve end from the surrounding environment to reduce the risk of the development of a symptomatic neuroma.

The allay™ Nerve Cap is not designed, sold, or intended for use except as described in the indication for use and is contraindicated for use in:

  • Areas of active surgical site infection.
  • Areas of active blood flow.
  • Areas of excessive movement or over a jointⁱⁱ.
  • Patients with a known allergy to poly(ethylene glycol) (PEG) or the color additives FD&C Yellow No. 5 Dye (tartrazine) or FD&C Blue No. 1 Dye (Brilliant Blue FCF).
  • Only physicians who have adequate surgical training should use the allay™ Nerve Cap.
  • The allay™ Nerve Cap system is provided sterile. Do not use if the packaging is open or damaged. Do not use if the Powder in the Powder Vial is not free flowing.
  • The allay™ Nerve Cap is not intended for patients under 22 years of age.
  • The safety and effectiveness of the allay™ Nerve Cap was based on non-clinical performance testing only.
  • For single use only. The allay™ Nerve Cap is designed to be used as a single-use device.
  • Discard open used and unused portions of the allay™ Nerve Cap system including any unused mixing tips and Cap Forms after the procedure. Do not re-sterilize or reuse as in situ formation will be adversely affected.
  • Use within 30 minutes of preparation of the Applicator. Discard entire system if not used within 30 minutes.
  • Store at room temperature.
  • The allay™ Nerve Cap polymerizes rapidly so the injection should proceed uninterrupted without stopping. Stopping during injection may result in the tip clogging. A replacement tip is provided, should this occur.
  • This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity [CFR 21 Part 201.20].

Potential complications that may be associated with any peripheral nerve surgery may include pain, infection, decrease or increase in nerve sensitivity, and complications associated with the use of anesthesia. Minor discomfort in the surgical site may occur for several days.

  1. Mioton LM, et al. Targeted Muscle Reinnervation Improves Residual Limb Pain, Phantom Limb Pain, and Limb Function: A Prospective Study of 33 Major Limb Amputees. Clin Orthop Relat Res. 2020 Sep;478(9):2161-2167.
  2. Data on File at Tulavi Therapeutics.