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

Preventing neuromas to reduce pain

Neuromas are the leading cause of pain in amputees.¹ While some surgical techniques reduce pain, they require microsurgery, are time consuming, and are a net loss for hospitals.¹⁻²

No current treatment reduces operative time and risk of neuroma formation and is sutureless and fully resorbable.

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 but inhibits cell migration to promote healing.

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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)³

DEMONSTRATED NEUROMA PREVENTION

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

Fast & intuitive procedure instills procedural confidence

Directly visualized

Transparent contrasting gel enables direct visualization to ensure procedural success.

Fast-acting

Activates upon delivery to ensure procedural confidence.

Entirely sutureless

Without sutures, procedural time is reduced, operative consistency is improved, and foreign body response is minimized.

Two sets: treat multiple nerves and sizes

A single allay™ Nerve Cap set enables surgeons to efficiently treat multiple nerves across a broad range of sizes.

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. Mackinnon, The Role of the Peripheral Nerve Surgeon in the Treatment of Pain, Neurotherapeutics, Volume 16, Issue 1, 2019, Pages 9-25.
  3. Data on File at Tulavi Therapeutics.