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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 75 patents and with over 3,000 patient treatments to date*, iovera° represents a widely growing option for physicians to manage their patients’ pain.

*As of Jan 2016


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

KNEE PAIN REDUCTION

In a single-arm, post-market clinical study of knee pain, 33 subjects received iovera° treatment on one or both knees to the Infrapatellar branch of the Saphenous Nerve (ISN).

Data on file per myoscience report MYO-0867

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POST-SURGICAL PAIN MANAGEMENT

In a retrospective chart review of 48 patients, clinical results show patients treated with iovera° prior to TKA
(vs those who were not):1
requested less opioids2
(12-week post period)
reported less stiffness3
(6 & 12 weeks post)
reported less knee pain3
(6 & 12 weeks post)

1 V. Dasa et al. Cryoneurolysis Nerve Block for Total Knee Arthroplasty. Myoscience Clinical Reports. 2016; 1(1):1-4.

2 iovera° patients requested 1933.75mg ave. morphine equivalents (MME) compared to 3751.25 mg for non-iovera° patients (p=0.0006).

3 Compared to a control group, iovera° patients had higher KOOS Pain Scores (difference of 11.2 & 13.4) and KOOS Symptom Scores (difference of 12 & 13.4) at 6 & 12 weeks post-surgery, respectively

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