We first became aware of ActiPatch last year and the product has been on our radar since then. However, a recent article in mHealth Intelligence Magazine really roused our interest.
ActiPatch has been approved by the National Health Service (NHS), meaning UK physicians will be able to prescribe the product to their patients to manage chronic pain and the NHS will cover the cost.
We got chance to put a few questions to Dr. Sree N. Koneru, VP of Product Development at BioElectronics Corporation, the manufacturer of ActiPatch.
Q: Please explain in one sentence what ActiPatch is?
ActiPatch is a wearable medical device that uses electromagnetic fields to regulate irregular nerve activity and relieve chronic pain.
Q: How long did it take to develop ActiPatch and what did this process entail?
The ActiPatch is an evolving product, as we are constantly increasing our research and development efforts. The current version of ActiPatch took 17 years to develop.
The bulk of this time was spent on utilizing developments in microelectronics to miniaturize our device, conform to health, safety and quality standards, establishing reliable supply chains, perform exhaustive clinical studies and finally, to obtain regulatory approvals to market the device.
The current version of ActiPatch took 17 years to develop.
Q: ActiPatch utilizes Electromagnetic Pulse Therapy (often referred to as PEMFT or PEMF). In basic terms, how does Electromagnetic Pulse Therapy work?
When electrical energy is used to provide therapeutic benefits, it is known as electrotherapy.
Electromagnetic Pulse Therapy, commonly referred to as PEMFT, PEMF, PRFE or PSWT is one form of electrotherapy and works by pulsing high-frequency (1000 times a second), low-energy (< 200 times a typical cell phone) electromagnetic signals into the nerves in the target tissue where pain is present.
Physicians agree that the level of chronic pain is poorly related to the level of underlying tissue damage. An example is knee osteoarthritis, where pain levels are often unrelated to the level of degeneration (as measured by radiological imaging).
The new understanding of chronic pain is that nerves essentially “learn” the pain over time and become hypersensitive. This is the reason why NSAID’s and other pain relief drugs work poorly, since they do not target the underlying problem.
Electromagnetic Pulse Therapy reduces nerve hypersensitivity through its signals, which results in pain relief. The following analogy may be helpful:
“An agitated child can be hard to pacify, and tends to hyper-reactive. But if a safe alternative that engage the child, such as a toy is provided, then the hyper-reactive nature tends to decrease and agitation disappears over time. Hypersensitive nerves are like an agitated child, and Electromagnetic Pulse Therapy is like a safe toy that engages the agitated nerves, helping calm them.”
Q: Our readers are very familiar with TENS units. Could you explain the differences and where there are any similarities between how ActiPatch and Transcutaneous Electrical Nerve Stimulation work?
While ActiPatch and TENS units are both electrotherapy modalities, that is where their similarities end.
TENS units send current signals directly across the skin to regulate nerve activity, and this leads to the characteristic tingling sensation during use. While TENS units have their place in medicine, they have some limitations:
- Prolonged TENS use is not possible, since sending electricity across the skin continuously can damage it. As such, treatment sessions are typically limited to 20 minutes
- TENS requires skin contact to work, so it cannot be used by individuals with sensitive or bandaged skin
- Individuals report discomfort from the tingling sensation during use
- TENS requires electrodes and gel to work effectively, so constant reapplication of gel may be necessary, making it cumbersome to use
ActiPatch provides the benefits of TENS and some more, while eliminating all the limitations:
- ActiPatch can be used 24/7, since there is no skin contact needed
- ActiPatch does not require skin contact to work, so it can be used on bandages or taped directly over clothing
- There is no sensation when using an ActiPatch, so users can wear it for an extended period
- There are no electrodes or application of gel, so ActiPatch is an ideal wearable electrotherapy device for pain relief
Electromagnetic Pulse Therapy reduces nerve hypersensitivity through its signals, which results in pain relief.
Q: What makes ActiPatch unique, how does it differ to other products on the market?
We have already seen how ActiPatch is different from TENS. ActiPatch can work better than non-prescription pain drugs or ointments for some individuals because it targets the underlying condition: nerve hypersensitivity.
There are other electromagnetic pulse therapy products on the market, but they come in big, bulky versions and often require a trained clinical to obtain therapy. ActiPatch is lightweight, discreet and affordable and costs only a few pence per hour of therapy.
ActiPatch is the only non-prescription electromagnetic pulse therapy product of its type on the market.
Q: We saw that officials from BioElectronics (the company that manufactures ActiPatch) said the NHS approval was linked to a study that investigated how using ActiPatch as a pain therapy would affect overall healthcare costs in the UK. Could you tell us about the key findings from this study?
The NHS study is indeed very exciting for us, since it indicates that ActiPatch users will experience pain relief and improve quality of life.
Most important, the study demonstrates that employing ActiPatch as a standard line of therapy for chronic pain can save overall healthcare costs by 42%. Some of the key findings are:
- Pain was reduced by an average of 36%
- Quality of life was improved by an average of 27%
- Costs associated with physician visits (calculated by reduced visits) was reduced by 58.5%
- Costs associated with prescription medication use (indicative of reduced medication use) was reduced by 35%
Q: While the objective of ActiPatch is to provide drug-free pain relief, can it and has it been used alongside pain medications?
We understand that pain management and treatment is very complex. As such, a multi-modal treatment therapy is often the best approach to providing effective pain relief.
While we envision a future of drug-free therapy for pain relief, ActiPatch is designed to be used both as an adjunct with other pain therapies, or as a standalone therapy.
For instance, most subjects who participate in clinical trials involving ActiPatch commonly use other pain therapies as well. However, they find that ActiPatch use can mitigate the need to use pain medication.
ActiPatch is the only non-prescription electromagnetic pulse therapy product of its type on the market.
Q: One of the most interesting things we see with the product, unlike TENS is that it can be used by people who have implanted electronic devices, i.e. pacemakers, defibrillators. Can you explain how ActiPatch is safe to use with implanted electronic devices?
The ActiPatch produces a peak spatial power of about 73µW/cm2, and has an effective penetration depth of about 6cm before losing therapeutic power.
At these power levels, electromagnetic fields are incapable of heating tissue, or in this instance, implanted electronic devices. Moreover, implantable electronic devices are designed and built to be shielded from external electromagnetic interference, such as from Wi-Fi routers, cell phones and other electronic devices.
TENS devices and hand-held radios produce energy levels that are orders of magnitude higher than the ActiPatch, and hence should not be brought in proximity to implanted electronic devices.
Q: We read that ActiPatch should not be submerged in water, e.g. showering, bathing, swimming, etc. Is it suitable for sports where you would perspire heavily?
The ActiPatch is built to be water resistant, and can withstand basic activities such as taking a shower or getting wet in the rain. However, it is not water-proof and should not be worn when taking a bath or swimming.
It is suitable for sports that involve heavy perspiration, but unlike any wearable, care must be taken to regularly clean skin.
Additionally, it is recommended to clean the area where the ActiPatch is going to be used, to prevent any moisturizer or other cosmetics from being trapped underneath the device for an extended period.
Q: Which territories is ActiPatch currently available in?
ActiPatch is currently available in over 25 countries. As an example, popular ActiPatch markets are the United Kingdom, Vietnam, Australia, Italy and the United States.
Q: What’s next for ActiPatch, are you working on new products or continuing to develop the existing ones?
The body is as electrical as it is chemical in nature. As humans continue to live longer, we are likely to experience degenerative health conditions during a lifetime.
At team ActiPatch, we believe that electrotherapies will play a significant role in treating 21st century maladies. We envision developing a range of affordable, safe, easy-to-use medical products that can treat major chronic healthcare conditions.
To that end, we are developing products for other diseases that are being linked to hypersensitive nerves, such as migraine, overactive bladder, primary dysmenorrhea and restless leg syndrome.
For example, our migraine research project investigates if regulating the activity of ophthalmic nerves in the forehead can reduce the intensity and frequency of migraine attacks.
We’d like to thank Dr. Koneru for taking part in this Q&A session and we’re excited to see future products from ActiPatch. You can learn more about ActiPatch at: www.actipatch.com
This is the first in a series of question and answer sessions with individuals and companies who are working in the field of pain management that will appear on TheGoodBody.com.
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