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WE CAN’T GET ANY COOLER.

Revolutionizing the treatment of pain with a cryoneurolysis nerve block
  • FDA cleared to block pain
  • long-lasting1, immediate nerve block
  • non-systemic, non-narcotic
  • portable, handheld delivery system

THE TECHNOLOGY BEHIND THE TREATMENT

The iovera° treatment is powered by the Focused Cold Therapy® delivery system, a convenient handheld device which harnesses the unique properties of cryotherapy to target peripheral nerves and immediately block pain. Highly pressurized liquid nitrous oxide (N2O) travels through the handpiece to the closed end needles of the Smart Tip, where it undergoes a phase change and becomes very cold. This phase change forms a precise cold zone in the tissue, causing a temporary nerve block.

Backed by a growing portfolio of over 88 patents and with over 12,000 patient treatments to date*, iovera° represents a widely growing option for physicians to manage their patients’ pain.

*As of March 2018


1

TREATMENT

The temperature of the treatment area is lowered by drawing in heat energy from the surrounding tissue to form a precise cold zone below -20°C, resulting in 2nd degree (Axonotmesis) nerve injury

Sunderland, Nerves and Nerve Injuries, 1968, p.68.; Zhou, et al. Cryobiology. 2003 46:26–32.


2

DEGENERATION

The cold zone causes degeneration of the axon & myelin sheath without harming surrounding tissues

Pre-clinical results from MYO-0448



3

REGENERATION & REINNERVATION

Axon regenerates at the rate of about 1mm per day*; axon and myelin sheath fully regenerate and nerve signaling is restored

Hsu and Stevenson. J. Neural Transm. 2014 121:15-20.
*Evans, et al. Br J Anaesth. 1981 53(11):1121-7.


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BEYOND DRUGS.   BEYOND BLOCKS.

Seeking to expand pain management treatment options beyond drugs (and their side effects) or existing nerve block therapies, the iovera° system uses the body’s natural response to cold for immediate pain relief.

The platform iovera° system enables the use of Smart Tips to reach both deep and shallow peripheral nerves. Each Smart Tip is sterile and single patient use.

Listed below are examples of nerves that have been treated with the
iovera° system in clinical practice:

  • Anterior Femoral Cutaneous Nerve
  • Genicular Nerve
  • Genitofemoral Nerve
  • Iliohypogastric Nerve
  • Ilioinguinal Nerve
  • Infrapatellar Saphenous Nerve
  • Intercostal Nerves
  • Lateral Femoral Cutaneous Nerve
  • Lower Occipital Nerve
  • Occipital Nerve
  • Posterior Tibial Nerve
  • Pudendal Nerve
  • Sacroiliac Joint Nerves
  • Supraorbital Nerve
  • Suprascapular Nerve
  • Trigeminal Nerve

CLINICAL DATA

Results from a multicenter, randomized, sham-controlled, double-blind trial demonstrate that patients who received the iovera° treatment experienced relief from osteoarthritis symptoms1:

1 Reference: Radnovich, R. et al. “Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial.” Osteoarthritis and Cartilage (2017) p1-10.


Clinical results comparing 50 patients who were treated with iovera° 5 days prior to TKA surgery vs 50 patients who were not, have shown that the iovera° treated group demonstrated1:

1 Reference: Dasa, V. et al. “Percutaneous freezing of sensory nerves prior to total knee arthroplasty.” The Knee (2016) p523-528.


Results from a multi-center, prospective, sham-controlled, double-blind study demonstrate that patients who received the iovera° treatment one week prior to TKA surgery reduced opioid consumption post-TKA1

1 Reference: Vinod Dasa, MD, Richard D. Berkowitz, MD, Antonia Chen, MD, Carlos Higuera, MD, Brian M. Ilfeld, MD, Martin Roche, MD, Juan C. Suarez, MD, Philip A. Stull, MD, Cryoneurolysis Prior to TKA for Post-Surgical Pain. Louisiana Orthopedics Association (LOA) Annual Meeting, Feb 2018.

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