Iovera

iovera° Interview Support

Talking Points - iovera°

• iovera° treatment uses the body’s natural response to cold to immediately relieve pain without the use of drugs or surgery.
• The iovera° system can be used to treat pain transmitted via peripheral nerves that can be safely accessed without risk of damage to adjacent sensitive structures.
• The iovera° system is used to treat chronic pain and perioperative pain.
• The iovera°treatment directs a controlled dose of cold via closed-end needles to specific peripheral nerves for precise, predictable and immediate pain relief.
• Peripheral nerves treated with the iovera° system stop signalling pain for a period of time, followed by a restoration of function. Clinical studies have found that the iovera° treatment results are safe, effective and temporary.

Supporting Points

• Pain affects more Americans (100 million) than diabetes (25.8 million), heart disease (23.3 million) and cancer (11.9 million) combined.Further, pain exacts a tremendous impact on healthcare costs, rehabilitation, lost productivity, in addition to the emotional and financial burdens it places on patients and their families. 
• Frequent knee pain affects approximately 25% of adults, limits function and mobility, and impairs quality of life.
• As of 2016, over 875,000 total knee replacements were being performed annually in the United Stateswith that number expected to grow by 36% annually.³

1. The American Academy of Pain Medicine “Facts and Figures on Pain” http://www.painmed.org/patientcenter/facts-on-pain/#incidence June 5, 2014.
2. Nguyen, Uyen-Sa D.T., DSc, et al. “Increasing Prevalence of Knee Pain and Symptomatic Knee Osteoarthritis,” Ann Intern Med. (2011 December 6); 155(11): 725–732.
3. Definitive Healthcare in-patient nationwide database 2016.

Q&A

How does the iovera° treatment work?

The iovera° treatment uses the body’s natural response to cold to immediately block a sensory nerve from sending pain signals. Using a small probe (also referred to as Smart Tip), a precise code zone is formed under the skin – cold enough to temporarily stop the nerve from signaling, providing pain relief until the nerve regenerates.

The iovera° treatment utilizes a patented delivery system. This convenient and powerful handheld system employs specially designed Smart Tips for various pain treatments. Highly pressurized liquid nitrous oxide (N₂O) travels from the handpiece to the closed-end needles of the Smart Tip, where it undergoes a phase change and becomes very cold. This phase change draws in heat energy from the surrounding tissue forming a precise zone of cold. The gaseous nitrous oxide is expelled out of the handpiece, leaving nothing behind in the body.  

The precise application of cold to specific sensory nerves immediately relieves pain.

What is the iovera° treatment like?

Once the area to be treated has been cleansed, the area is marked for treatment and a local anesthetic is administered for comfort. The Smart Tip is inserted into the treatment region and a treatment cycle is performed. When the treatment cycle is finished, The Smart Tip is removed and inserted into the next site in the treatment region. Results are immediate so the patient will feel a reduction in pain right away.

Does the  iovera° treatment hurt?

Local anesthetic is administered before treatment. While the treatment should not be painful, it is normal to experience pressure, a sensation of cold, warmth, tingling and/or tapping during treatment. This altered sensation during treatment is an indication that the treatment is working.

How does the iovera° treatment for pain compare to other treatments?

The iovera° treatment is precise, immediate, and predictable. Nothing is injected into the body so there are no systemic side effects. Full results are typically felt before the appointment is over. The treatment is a minimally invasive, outpatient treatment and only requires local anesthetic – there is no sedation, general anesthetic or hospital stay (unless otherwise indicated by the treating physician).

The iovera° treatment is distinct from other therapies that use cold to target nerves in that it operates between -20° C (-4° F) and -88° C (-126.4° F). This is the temperature range where peripheral nerve function can be blocked temporarily without damage to surrounding tissues and regeneration of the nerve occurs.

How much does the iovera° treatment cost? Is it covered by insurance?

The price of an iovera° treatment is determined by the doctor. The iovera° treatment may be covered by insurance with varying reimbursement amounts. Patients are encouraged to ask their physician or insurance provider for more information regarding their individual insurance reimbursement and payment options.

Is the iovera° system cleared by the FDA? What are its indications?

Yes, the iovera° system has the following FDA clearance in the United States:

The Myoscience iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue.

The iovera° system’s “1x90” Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

Who is the ideal patient?

• Patients 22 years or older.
• Patients with identifiable localized focal pain innervated by accessible peripheral nerves.
  • Accessible by an iovera° Smart Tip
  • Not adjacent to any sensitive structures (e.g. motor nerves)
• Normal nerve anatomy within treatment location.
• Able to tolerate treatment.
  • Appropriate patient positioning
  • Tolerance for treatment duration (~15-30 minutes)

What other nerves/body areas can be treated?

The iovera° system can be used to treat pain transmitted via peripheral nerves that can be safely accessed without risk of damage to adjacent sensitive structures.

Can the iovera° treatment replace the need for surgery or other therapies?

The iovera° treatment effect is temporary. It does not change the underlying condition for which a physician has recommended surgery or certain therapies. However, iovera° treatment prior to surgery can help improve pain scores, function and overall symptoms.^{1, 2}

Backgrounder

About Myoscience, Inc.

Fremont, California-based Myoscience is a privately-held medical device company committed to making its platform technology, the iovera° system, the standard of care for managing pain without the need for opioids.

About iovera°

The iovera° system is a small, hand-held device that uses disposable tips to penetrate the skin in order to target the source nerve. The iovera° treatment provides immediate, long-lasting pain relief by blocking the nerve’s ability to signal pain. The iovera° system is cleared by US FDA for the blocking of pain.  It is also cleared for relieving pain and symptoms associated with osteoarthritis of the knee for up to 90 days.

The iovera° treatment

The iovera° treatment is typically performed by trained physicians, for example: orthopaedic surgeons, anaesthesiologists, rheumatologists, and pain management specialists. The treatment area is first cleaned and then marked. The iovera° Smart Tips are then used to deliver the treatment to the targeted area. While the treatment should not be painful, it is normal to experience pressure, a sensation of cold, warmth, tingling and/or tapping during treatment. The treatment can take as little as 8 minutes and may be comprised of multiple treatment cycles for each area, depending on patient anatomy. Results are immediate, so the patient and physician will know when the iovera treatment has achieved the desired result. Duration of the pain relief varies (see the “Effectiveness and safety” section below for additional information).

The iovera° treatment is reimbursed by Medicare and several private insurers. Patients are encouraged to ask their physician or insurance provider for more information regarding their individual insurance reimbursement and payment options.

How it works

The iovera° system is a convenient and powerful handheld device that employs specially designed Smart Tips for various treatments. The iovera° system creates a precisely controlled, sub-dermal cold zone that allows doctors to selectively treat specific nerves for accurate and predictable results.

iovera° treatments provide immediate pain relief by drawing on the body’s natural response to cold to temporarily disrupt pain signaling by peripheral nerves for a period of time. This signal disruption is followed by a restoration of function as the treated area regenerates in predictable fashion. The results are safe and effective.  

The iovera° system uses liquid nitrous oxide (N₂O) that is contained within the handpiece. This highly pressurized liquid travels from the handpiece to the closed-end needles of the Smart Tips, where it undergoes a phase change and becomes very cold (below -20C). This phase change draws in heat energy from the surrounding tissue forming a precise zone of cold. The nitrous oxide is then expelled out of the handpiece as gas, leaving nothing behind the body.

This precise application of cold creates a temporary nerve block based on a process called Wallerian degeneration (2^nd degree nerve injury). This degeneration affects the axon and myelin sheath, leaving the surrounding nerve components intact. When sensory nerves (nerves that pass impulses from receptors toward or to the central nervous system) are treated, their ability to signal is interrupted, which immediately blocks pain signals. Post-treatment, the axon slowly regenerates until in reconnects (reinnervates) to the sensory receptor for a predictable restoration of nerve function.

Effectiveness & safety

The iovera° system has the following FDA clearance and indications in the United States:

The Myoscience iovera° system is used to destroy tissue during surgical procedures by applying freezing cold.  It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. . It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue.

The iovera° system’s “1x90” Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

Clinical Results:

• Compared to the sham group, patients who received iovera° treatment had a statistically significant greater change from baseline in the WOMAC pain subscale score at Day 30 (p=0.0004), Day 60 (p=0.0176), and Day 90 (p=0.0061). Patients deemed WOMAC pain responders at Day 120 continued to experience a statistically significant treatment effect at Day 150.
• 94% of patients who received iovera° treatment prior to surgery had a hospital stay of less than two days compared to only 33% in the control group.²
• 50% of patients who received ioveraº treatment were discharged on the day of surgery compared to only 14% in the control group.
• Over 80% of subjects reported ≥2 point improvement in pain score at 30 days.
• An average of 70% improvement in WOMAC functionality subscale at 7 days.
• 70% of subjects reported a treatment effect at 56 days.¹
• No serious adverse events were reported related to the iovera° treatment.

Because the iovera° system uses Nitrous Oxide, it is incapable of reaching a temperature that would cause permanent nerve injury. As with any medical treatment, a doctor should always be consulted.

As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to:

• Bruising (ecchymosis)
• Swelling (edema)
• Inflammation and/or redness (erythema)
• Pain and/or tenderness, including headache
• Altered sensation (localized dysesthesia)  

Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

Use of the iovera° treatment for post-surgical pain management

The iovera° treatment can pave the way for knee surgery recovery, when used as a pre-surgical treatment for post-surgical pain. In a clinical study², patients treated with iovera° prior to TKA surgery reported less knee pain and stiffness than patients not treated. In the same study, it was discovered that the iovera° treated patients requested only half the opioids as patients not treated, while reporting similar function and pain scores.

• Knee pain after surgery: iovera° patients reported KOOS Pain Scores that were statistically significantly higher (p<0.05) with a difference of 11.2 (6 weeks post) and 13.4 (12 weeks post) over non-iovera° patients
• Stiffness after surgery: iovera° patients reported KOOS Symptom Scores that were statistically significantly higher (p<0.05) with a difference of 12 (6 weeks post) and 13.4 (12 weeks post) over non-iovera° patients
• Opioid use: iovera° patients requested 1933.75mg average morphine equivalents (MME) compared to 3751.25 mg for non-iovera° patients (p=0.0006) over the 12 week post-surgical period