January 31, 2024 | The field of noninvasive neuromodulation has witnessed significant growth in recent years, with hundreds of companies targeting various disorders such as pain, vestibular disorders, tinnitus, Alzheimer’s, and various wellness conditions. While the majority of these companies utilize electrical stimulation, other modalities, including magnetic, ultrasound, and optical, have also been explored.
More recently, there has been an emergence of companies focused on noninvasive vibratory or mechanical stimulation, a modality currently underrepresented in the marketplace as well as at neuromodulation conferences. However, Neurotech Reports anticipates that this approach to neuromodulation will gain traction, given its potential advantages compared to other noninvasive methods. In this article, we highlight how vibratory/mechanical stimulation works to reduce pain and showcase several promising commercial companies and developing initiatives based on this approach to neuromodulation.
History
Research on the effects of vibratory stimulation dates back to as early as 1960, examining tactile stimulation within the dorsal horn in cats. Notable contributions include Patrick David Wall’s work, who, five years later, published the gate theory of pain with Ronald Melzack. Publications in the 1970s and 1980s, such as Lundeberg’s studies in 1983 and 1984, demonstrated the inhibitory effects of vibratory stimulation on pain, lasting up to days compared to non-invasive neuromodulation (e.g., TENS). Salter’s extensive work in the 1980s and early 1990s highlighted the role of Pacinian proprioception corpuscles in pain neuromodulation. A study by Marovino and Baxter compared mechanical vs. electrical stimulation for pain treatment, revealing that mechanical stimulation was two- to three times more effective in reducing pain than TENS.
While extensively studied for pain treatment, vibratory/mechanical stimulation has also been explored for various conditions, including tinnitus, vestibular disorders, RA, sleep apnea, dry eyes, bleeding, wound healing, headaches, erectile dysfunction, restless leg syndrome, GI disorders, stress management, and opioid reduction, among others.
Companies
There is a growing number of companies with products based on vibratory/mechanical stimulation. Some notable examples include:
Otolith Labs, Inc., under the leadership of Sam Owen, founder/CEO, is at the forefront of developing what the company claims to be the first medical wearable designed for the treatment of chronic vertigo. The head-worn device, positioned above the ear, has undergone validation through multiple clinical studies. In September 2022, the company successfully secured $20 million in a Series A funding round, with support from backers such as vestibular patient and billionaire Mark Cuban.
Neosensory, Inc. has developed and is marketing the Duo device for the treatment of tinnitus. The device is an over-the-counter product priced at $999 and is based on research conducted in 2018 by Marks KL et al. This innovative device employs bimodal stimulation, utilizing sounds via a smart phone app and a vibrotactile wrist-worn vibratory stimulator. The company reports that 91% of users experience some degree of relief from tinnitus. Neosensory has garnered $14.2 million in funding, with the most recent injection of $11.8 million in a Series A round in January 2019.
Vibrant Gastro, Inc., led by CEO John Schellhorn, has innovated a prescription vibratory pill designed to be swallowed for the relief of chronic idiopathic constipation. The capsule administers vibrations to mechanically stimulate the colon, causing contractions that propel its contents. According to Crunchbase, they have raised $15 million.
Harmonic Pain Solutions, part of Pain Care Labs and founded by Amy Baxter, a pioneer in early commercial noninvasive neuromodulation devices like the Buzzy device (launched in 2006), has developed and is seeking FDA clearance for its DuoTherm device for the treatment of back pain. This prescription device, priced at $1,500, combines thermal and mechanical stimulation.
Olympic Ophthalmics, established in 2017 by CEO and inventor Michael Gertner, has developed the iTEAR 100, FDA 510(k) cleared in 2020. This prescription device utilizes mechanical stimulation to enhance tear production through the external nasal nerve, emitting vibrations that stimulate the tear glands to increase tear production.
Discussion
Commercial devices using mechanical/vibratory stimulation to treat pain and other disorders have been available for nearly two decades. However, these devices have only recently gained attention within the neuromodulation community. The lack of distribution/awareness is primarily due to the absence of reimbursement for noninvasive neuromodulation in general, the absence of major players bringing such devices to market, the affordability of alternative reimbursed solutions (e.g., opioids for pain), and the lack of financial incentives for professional communities to embrace these devices compared to implantable devices requiring surgical procedures.
Over time, Neurotech Reports expects greater applications of mechanical/vibratory stimulation, partly due to eventual reimbursement and the advantages of vibratory over electrical stimulation as outlined above.
