Nerve Protection that Changes the Game

Tulavi is redefining peripheral nerve surgery with proven hydrogel technology designed to optimize nerve recovery.

Nerve Injury Often Leads to Painful Neuromas¹
When a peripheral nerve is severed, regenerating axons may grow erratically, resulting in the development of a painful neuroma.What is a Neuroma? A neuroma is a non-cancerous growth of nerve tissue that commonly arises after a nerve has been injured or disrupted.

The fully-absorbable allay™ Hydrogel Cap is designed to protect the transected nerve, optimizing recovery and reducing the risk of neuroma formation.

allay™ remains in place for 8 months, protecting the nerve throughout the critical period of neuroma formation.²,³

Backed by science. Trusted in practice.

Built on the Adaptive Hydrogel Technology, which has been used in over 5 million patients worldwide⁴, the fully absorbable allay™ Hydrogel Cap is designed to:

PROTECT
Transected Nerves

Creates a non-compressive, hydrophillic, and flexible hydrogel cap that conforms to nerve ends

BLOCK
Axonal Escape

Provides a mechanical barrier, preventing escape of disorganized axons

REDUCE
Neuroma Formation

No neuroma formation demonstrated across 6 preclinical studies, n>170

"The allay Hydrogel Cap helped to provide this patient with relief she had not seen in many years... Life Changed."
Saphenous Nerve Neuroma Excision
Orthopedic Surgeon, North Carolina
"This saved me over two hours in the OR on a patient who would not have done well under extended anesthesia"
Below Knee Amputation
Plastic Surgeon, California
"Patient had painful neuromas from 3 fingers amputated, feels great now. I wouldn’t have even offered him the surgery without this great option."
Revision Digital Amputation
Orthopedic Surgeon, Florida

Fast & Intuitive Procedure

The allay™ Hydrogel Cap rapidly forms in situ to create a conformable and protective cushion.

Entirely Sutureless Application

Hydrogel Cap Forms in Seconds

Conforms & Cushions Transected Nerve

Full Absorption in 8 Months

Through the process of hydrolysis, the allay™ Hydrogel Cap is fully absorbed in approximately 8 months, remaining in place throughout the critical period of neuroma formation.²,³

Single Solution. Treat Multiple Nerves & Sizes

A single allay™ Hydrogel 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
One box includes 6 packages
Each package contains one single use delivery tip
Model # TL-7627

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. Yang H, Dong Y, Wang Z, Lai J, Yao C, Zhou H, Alhaskawi A, Hasan Abdullah Ezzi S, Kota VG, Hasan Abdulla Hasan Abdulla M, Lu H. Traumatic neuromas of peripheral nerves: Diagnosis, management and future perspectives. Front Neurol. 2023 Jan 11;13:1039529. doi: 10.3389/fneur.2022.1039529. PMID: 36712443; PMCID: PMC9875025.
  2. Data on File at Tulavi Therapeutics
  3. Oliveira KMC, et al. Time course of traumatic neuroma development. PLoS One. 2018 Jul 16;13(7):e0200548.
  4. Based on product volumes from four hydrogel companies across multiple specialties, developed by Incept LLC.