Introduction: ARC-EX therapy
ARC-EX therapy is an innovative treatment developed by Onward Medical that has shown promising results in a pivotal trial for spinal cord injury recovery. It’s a non-invasive therapy that delivers targeted, programmed spinal cord stimulation to improve strength, function, and sensation in patients with chronic tetraplegia due to cervical spinal cord injury.
The therapy uses electrodes placed along the spine near the site of injury to promote nerve activity and growth during physical therapy exercises. The goal is not only to increase motor function while the device is attached and operating but also to enhance the long-term effectiveness of rehabilitation drills.
In the Up-LIFT trial, after an average of 25 stimulation sessions, 72% of the participants showed improvement in both strength and function. The treatment led to meaningful changes in the daily lives of patients, with no serious adverse events reported, indicating the primary endpoints for safety and effectiveness were met.
Onward Medical has submitted a De Novo application to the US Food and Drug Administration (FDA) in April 2024, and they plan to follow with a marketing application in Europe. This could potentially make the ARC-EX therapy available for clinical use in the near future.
Because the device is non invasive, it's a simple addition to physical rehabilitation programs- a sort of pilates for the fingers.
ARC-EX therapy refers to a noninvasive therapeutic device produced by Onward Medical, which is designed to aid in the functional recovery after spinal cord injuries (SCI). The device, known as ARC-EX (“EX” indicating “external”), uses electrodes placed along the spine near the site of injury to promote nerve activity and growth during physical therapy exercises.
Here are some key points about ARC-EX therapy:
- Noninvasive: Unlike some other spinal stimulation devices, ARC-EX does not require surgical implantation of electrodes.
- High-Frequency Waveform: It uses a 10-kilohertz carrier frequency overlay, which may numb the skin beneath the electrode, allowing patients to tolerate a higher amperage.
- Personalized Treatment: The current amplitude is personalized to each patient, and sometimes even to individual exercises.
- Clinical Trial Success: Results from a pivotal trial showed significant improvements in recovery from spinal injuries, with over 70% of patients showing an increase in at least one measurement of both strength and function.
- Quality of Life: 87% of study participants noted some improvement in quality of life in a follow-up questionnaire.
The therapy has been highlighted for its potential to improve hand and arm functions, which can be life-changing for individuals with tetraplegia or quadriplegia. Onward Medical has also submitted a De Novo application to the US Food and Drug Administration (FDA) in April 2024, indicating that the technology could soon be available in the US market.
How does ARC-EX therapy work?
ARC-EX therapy works by delivering targeted, programmed spinal cord stimulation non-invasively through electrodes placed along the spine near the site of injury. Here’s a detailed explanation of how it functions:
Electrode Placement: The therapy uses noninvasive electrodes that are placed along the spine, specifically in the area of the neck for quadriplegic patients. These electrodes are crucial for the stimulation process.
Nerve Activity and Growth: The electrodes promote nerve activity and growth during physical therapy exercises. This is essential for enhancing motor function and the long-term effectiveness of rehabilitation drills.
High-Frequency Waveform: One of the innovations of ARC-EX is the use of a very high-frequency waveform. The device uses a 10-kilohertz carrier frequency overlay, which may numb the skin beneath the electrode, allowing patients to tolerate a higher amperage of electrical stimulation without discomfort.
Personalized Treatment: While aspects of the treatment like electrode placement are standardized, the current amplitude is personalized to each patient and sometimes even to individual exercises. This customization ensures that the stimulation is effective and comfortable for the patient.
Improvement in Function: The therapy has shown to lead to improvements in upper limb strength, function, and sensation in patients with chronic tetraplegia due to cervical spinal cord injury. Over 70% of patients in the study showed an increase in at least one measurement of both strength and function between standard therapy and ARC-EX therapy.
The goal of ARC-EX therapy is not only to increase motor function while the device is attached and operating but also to have a lasting impact on the effectiveness of rehabilitation exercises, potentially leading to meaningful changes in the daily lives of patients.
What are the risks of ARC-EX therapy?
ARC-EX therapy, like any medical treatment, may have potential risks. However, according to the latest data from a pivotal trial, no serious adverse events related to ARC-EX therapy were reported. This suggests that the primary endpoints for safety and effectiveness were met during the trial.
While the therapy has been found to be safe in clinical trials, it’s important to note that all medical treatments can carry some level of risk. These might include:
- Discomfort or Skin Irritation: Due to the electrical stimulation, there might be a risk of discomfort or skin irritation under the electrode placement areas.
- Placebo Effect: There is a possibility of a placebo effect, where participants might perceive an improvement in their condition due to the belief that they are receiving treatment rather than the treatment itself.
- Individual Variability: Individual responses to therapy can vary, and not all patients may experience the same level of benefit.
It’s also worth mentioning that the therapy is still relatively new, and long-term risks and benefits are continuing to be evaluated. Patients considering ARC-EX therapy should discuss it thoroughly with their healthcare provider to understand all potential risks and benefits in the context of their specific medical condition.
What is the cost of ARC-EX therapy?
The cost of ARC-EX therapy is not explicitly stated in the available information. However, it is mentioned that the price to insurers or patients for a commercial version of ARC-EX therapy is still subject to negotiation. This indicates that the cost will likely be determined based on negotiations between the manufacturer, insurance companies, and healthcare providers.
For context, spinal cord injuries (SCI) can be quite costly over a lifetime. For example, the average lifetime cost for a paraplegic is estimated at $2.5 million and $5 million for a tetraplegic. These figures include healthcare costs, living expenses, and indirect costs such as loss of income.
It’s important for patients interested in ARC-EX therapy to consult with their healthcare providers and insurance companies to get the most accurate and up-to-date information regarding the cost of the therapy and coverage options.
Is ARC-EX covered by insurance?
The coverage of ARC-EX therapy by insurance is a crucial aspect for patients considering this treatment. As of the information available, the price to insurers or patients of a commercial version of ARC-EX therapy is still subject to negotiation. This suggests that discussions are ongoing and the therapy may not yet be widely covered by insurance plans.
Since insurance policies vary greatly, and the therapy is relatively new, it would be best for patients to check with their specific insurance provider for the most accurate and up-to-date information regarding coverage. Additionally, as the therapy gains regulatory approval and becomes more established, insurance coverage may become more standardized.
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