Clinical Need

A drug-free treatment for the millions of chronic pain patients, one 20-minute visit at a time

Executive Summary

Chronic pain affects more than 52 million U.S. adults (prevalence). With an incidence of almost 13 million new chronic pain patients yearly, there is a constant roll-over of about one-quarter of all patients. A typical pain practitioner sees about 100 patients per week with an average time per patient around 15 to 20 minutes. The “bread and butter” of pain clinics are drug injections for diagnostic purposes and to provide therapy or needle-based nerve ablations. Repeat drug injections, 2-3 months apart, are the norm depending on drug class. These and prescriptions dominate at about 80 to 105 per practitioner per week. Opioids are THE primary drug class used to treat chronic pain, accounting for more than a quarter (27%!) of the total pain management market.

In order for a drug-free therapy to be successful, it must fit into this 20-minute patient visit window to allow the clinic to stay financially proficient. While very efficacious, neuromodulation treatments generally require longer physician interactions than drug injections to allow for the surgery of the device placement, as well as multiple visits to implant the trial and the permanent systems. As a result, only about 100,000 out of millions of potential patients are treated with neuromodulation (~80k patients via SCS or DRG, ~10k permanent PNS, ~10k short-term PNS) today. There is a clinical need for a better solution.

What is chronic pain and why does it matter?

Chronic pain, as defined by Johns Hopkins Medicine, is pain that persists beyond the expected time for healing and commonly occurs with chronic conditions like arthritis. This pain might be continuous or intermittent and can hinder physical activities, mental health, social relationships, sleep quality, work, and quality of life. It is a significant medical issue that needs frequent treatment. Chronic pain is also an expensive health problem in the United States. It is a source of significant financial strain due to high medical costs for ongoing treatment, medication, and healthcare services, as well as the potential loss of productivity from reduced work capacity or disability.

The prevalence of chronic pain in the US is high

In 2021, the CDC reported that 21% of U.S. adults (about 52 million individuals) had experienced chronic pain, with 7% (17 million) experiencing high-impact chronic pain with significant restrictions in activities of daily living. The US Institute of Medicine reports that chronic pain results in costs ranging from 560 to 635 billion US dollars to the healthcare system annually.

High-impact chronic pain lasts over 3 months and significantly limits activities, like working, attending school, or doing household chores. Individuals with this type of pain often experience intense pain, mental health issues, cognitive difficulties, more self-care challenges, and higher healthcare usage compared to those with less restrictive chronic pain. Approximately 83% of those with high-impact chronic pain cannot work, and a third struggle with basic self-care. [source]

A 2020 National Health Interview Survey of more than 10,000 adults, published in JAMA, revealed that the annual incidence rates of chronic pain and high-impact chronic pain are 5.2% and 1.2%, respectively. This translates to around 13 million new chronic pain cases and 3 million new high-impact chronic pain cases each year among the 247 million U.S. adults.

The number of new cases of chronic pain patients each year is greater than new diagnoses of cancer, heart disease, stroke, and hypertension combined (figure 1). While not a leading cause of death in the US, chronic pain is a major burden on the individual suffering from it, their supporting family and friends as well as society as a whole.

13 million: The annual incidence of new chronic pain patients in the U.S.

Figure 1: Chronic pain affects millions of new patients every year (incidence; all numbers U.S.)

Interventional Pain Management: Trends, Treatments, and Market Dynamics

Conventional pain treatments often depend on medications, especially opioids. The global market for pain management drugs and devices is estimated to be between $80 billion and $100 billion annually in 2023 [source] . Factors influencing a physician's treatment choice include the severity and duration of the patient's pain, previous treatments tried, and specific requirements set by CMS and private insurers.

Pain therapy typically involves drugs, then nerve ablation and neuromodulation. The main method for administering pain management drugs is oral, over-the-counter (OTC), and prescription, followed by drug injections. Chronic pain interventional treatments include drug injections (like epidural steroid, facet blocks, and others), drug infusion via an implanted pump similar to a neurostimulator, radiofrequency ablation of nerves, and neuromodulation techniques such as spinal cord and peripheral nerve stimulation.

The Opioid Epidemic

Opioids, also called narcotics, are prescribed by doctors to treat severe pain. Opioids are especially used by patients with chronic headaches and backaches, recovering from surgery, or experiencing acute pain associated with cancer, sports injuries, accidents, or other incidents. Opioids include codeine, fentanyl, oxycodone, and morphine, often sold under brand names such as OxyContin, Percocet, Palladone, and Vicodin [source]. Prolonged use and overuse of opioids are factors encouraging addiction. According to CDC data in 2021, 220 people died each day from an opioid overdose.

Source: https://www.cdc.gov/opioids/basics/epidemic.html

The typical time for a patient visit with a pain physician is 15 to 20 minutes

A typical pain practitioner sees about 100 patients per week and fills about 80-105 prescriptions [source]. Many pain practices have an injection day or two, as well as an ablation day to be able to handle the large number of patients. A common interventional pain clinic visit duration is 15 to 20 minutes handshake-in to handshake-out. This time allows for an assessment of the patient status, any updates to an earlier diagnosis, as well as time to apply new treatments as applicable either via needle-based drug injection or needle-based radiofrequency ablation. Given the number of patients that can be treated with injections and ablations, the two form the “bread and butter” of many interventional pain clinics. In order to stay financially viable, clinics must strive to maximize the number of patients per week, resulting in an average of 3 to 4 per hour.

What Neuromodulation can do for chronic pain and why it matters

Neuromodulation for chronic pain involves using electrical pulses on nerve tissues in either the peripheral or central nervous systems, such as with spinal cord or dorsal root ganglion stimulation. The widely accepted Gate Control Theory of pain explains this process: electrical stimulation of larger, faster nerve fibers reduces pain signal processing, decreasing pain perception. This is because these larger fibers transmit sensory information more rapidly than smaller fibers responsible for pain and temperature. Therefore, correctly applied electrical stimulation can alter pain perception, especially when other treatments have failed. However, the effectiveness of neuromodulation decreases if treatment is delayed; it's more beneficial when applied earlier in the treatment process.

Ref: Kumar K, et al; Impact of Wait Times on Spinal Cord Stimulation Therapy Outcomes; Pain Pract. 2014;14: 709-720o

If Neuromodulation is so effective, why isn't it used more?

Neuromodulation, despite being a reliable pain treatment, isn't widely used because it's more expensive than many drug treatments or nerve ablation. Insurance companies usually require a patient to have unsuccessful back surgery before approving spinal cord stimulation (SCS), which costs about $40,000 per patient. This is compared to the $8,000 annual cost for conventional pain management, taking insurers five years to break even.

Most neuromodulation treatments require more than one clinic visit to (1) first verify the treatment location by surgically placing trial leads for 7 to 14 days into the patient, with part of the the trial leads exiting the patient’s skin and the outside portion of the wires being draped to the patient’s skin, followed by (2) a second visit to remove the trial leads and document the success of the pain suppression. Typically, if the patient’s pain perception reduced by at least half, then a (3) third visit follows to place the permanent system that includes fully implanted leads. These three procedural visits combine for a total of 60 to 120 minutes for that one patient, effectively blocking multiple 15-20 minute windows that could be allocated to treat other patients from the clinic’s point of view. Thus, to increase provider acceptance, neuromodulation solutions need to reduce the procedural time and number of procedures to reach the chronic implant stage.

The neuromodulation market size is growing at 19% CAGR

Regardless, the neuromodulation market is strong ($7.7 billion in 2022) and growing. Today’s pain treatment market is divided into spinal cord stimulation (SCS) or dorsal root ganglion (DRG) stimulation and peripheral nerve stimulation (PNS). The global market for neurostimulation devices reached about $8.2 billion in 2023 and is expected to grow to $11.7 billion by 2028, with a 7.4% growth rate [source].

Lots of room to grow: <1% of yearly new chronic pain patients receive neuromodulation

One of the major challenges to larger market penetration are high expenditures for current chronic SCS/DRG/PNS therapies, leading to stringent prior authorization requirements by insurance providers. Following payer/insurance approval, about 80,000 patients receive SCS or DRG stimulation annually. Additionally, around 20,000 patients receive short-term or chronic PNS treatments, totaling 100,000 patients treated with neuromodulation for chronic pain each year. While 100,000 patients benefit from neuromodulation annually, this number is small compared to the 12.9 million new chronic pain patients each year (0.77%). To increase its reach and societal impact, neuromodulation treatments need to be simpler to become more widely accessible, as well as more resource efficient, requiring less clinician and operating room time, and thus resulting in lower cost to insurers who are thereby enticed to approve this drug-free treatment for chronic patient patients earlier.