Neurent Medical, a medtech company based in Galway, Ireland, has developed the NEUROMARK system to treat chronic rhinitis via a simple in-office procedure which targets the nerves responsible for many common symptoms. Chronic rhinitis affects a huge number of people and has been estimated to affect 1 in 4 people in the U.S.
Symptoms are consistent with chronic inflammation of the mucosal membrane in the nose, leading to a variety of issues including sneezing, postnasal drip, congestion, and itching. Conventional therapies involve long-term pharmacological interventions which meet with mixed success and require patients to administer medications repeatedly.
An alternative involves targeting the nerves that drive some of the key symptoms of chronic rhinitis, such as congestion. However, these nerves are hard to reach, and need to be targeted carefully so that nearby tissue is not damaged. Neurent Medical reports that the NEUROMARK system can do just that. The system is designed to be used in a simple procedure in a clinician’s office involving local anesthesia.
See a video about the system below:
Medgadget had the opportunity to talk with Brian Shields, Neurent Medical CEO and co-founder, about the technology.
Conn Hastings, Medgadget: Please give us an overview of chronic rhinitis – what is it and who does it affect?
Brian Shields, Neurent Medical: Chronic rhinitis is inflammation and swelling of the mucosal membrane in the nose that results in persistent symptoms such as congestion, runny nose, sneezing and nasal itching. In the U.S. alone, it affects one in four individuals and is known to significantly decrease quality of life by having an adverse effect on a patient’s sleep quality, mood, and daily activities. It’s also known to decrease productivity at work, school and during sports, leading to three and a half million lost workdays and two million lost school days per year. Simply put, millions of people are living with symptoms of chronic rhinitis on a day-to-day basis, and the traditional rhinitis patient journey is often full of frustration and dissatisfaction due to temporary and limited treatment options. That’s why we’re focused on delivering an innovative in-office treatment option for these patients.
Medgadget: How is the condition currently treated, and what are the limitations of such treatment approaches?
Brian Shields: There is always the option of allergen avoidance and pharmacotherapy which can be relatively effective for certain patients; however, medications are chronic and offer suboptimal efficacy for many patients. Many people with persistent symptoms are treated using a cocktail of prescribed medications including steroidal sprays, decongestant sprays, and oral or nasal antihistamines and symptom relief ends if medication compliance stops. In addition to the significant expense, excessive steroid use can cause damage to nasal and bodily tissues and decongestant spray dependency can exacerbate symptoms.
Surgical interventions are a last-resort option and are primarily directed at addressing nasal obstruction, one of the key symptoms. Typically, these procedures involve the volumetric reduction of inflamed soft tissue using thermal/electrosurgical energy or microdebriders. While these procedures may provide partial and short-term relief, they are associated with the risks and complications of surgery. Recent in-office treatments using cryotherapy and radio frequency (RF) probes create lesions on the mucosal surface with the aim of impacting nerves that drive rhinitis symptoms. However, these devices rely on surgeon skill to effectively impact underlying nerves in varied anatomy. They also present the risk of intra- and post-procedure complications and patient discomfort caused by trauma to adjacent tissue and blood vessels.
Medgadget: What inspired the company to design the NEUROMARK System, and how did it come about?
Brian Shields: The concept of NEUROMARK and Rhinitis Neurolysis Therapy (RNT) was born when my co-founder, David Townley, and I were working alongside ENT surgeons and patients during an innovation fellowship program. We spent over 1,000 hours shadowing surgeons to determine what the greatest unmet or under-met clinical needs in ENT were. What stood out as a glaring need for innovation was a safe and effective non-drug therapy for treating rhinitis. On exploring this further, with some of those surgeons, we started to consider surgical treatments which have fallen out of favor given the time, cost and patient risk burdens associated with them. One such treatment was the vidian neurectomy procedure (first performed in 1958 in the UK). Based on our research on this treatment and a greater understanding of the nasal anatomy, we realized we could have a true impact on symptom relief by targeting nerves that cause underlying inflammation in the nasal cavity, specifically the parasympathetic nerves. We had the large market opportunity, and we had proof of concept for a proprietary approach, and we ran with it. We now have an approach with multiple rigorous pre-clinical and clinical studies that have shown our Rhinitis Neurolysis Therapy can adequately target nerve tissues while maintaining vascular integrity.
Medgadget: Please give us an overview of the NEUROMARK System, and how it works.
Brian Shields: NEUROMARK RNT is an innovative in-office treatment option for chronic allergic and non-allergic rhinitis. It’s designed to disrupt hard-to-reach, hyperactive parasympathetic nerves that drive the core symptoms of congestion and rhinorrhea, while maintaining the integrity of adjacent nasal tissue.
Its unique design allows physicians to target and treat multiple nerve segments in a single procedure, while utilizing algorithms that determine when enough therapy has been delivered. The therapy is automatically tailored to each individual patient, reducing risk of tissue damage and increasing confidence that the symptom-causing nerve has been altered. We’ve learned a one-size-fits-all approach doesn’t work, so we created a product that safely impacts specific nerves and accounts for patient-to-patient anatomical variability.
The therapy is conveniently administered in a single procedure in the ENT physician’s office using just a topical anesthetic, offering an immediate return to normal activity.
Medgadget: How does the system ensure precision and safety?
Brian Shields: RNT’s algorithms and biofeedback monitoring are core components of the technology’s ability to safely and precisely disrupt nerves that cause underlying inflammation. Our algorithms monitor tissue parameters and control the location and duration of energy delivered. This prevents over treatment and tissue damage, and it also prevents under treatment that leads to unaltered symptom-causing nerves.
The unique therapy wand comprises of a super-elastic leaflet design that conforms to highly varying anatomy and disrupts multiple primary and accessory parasympathetic nerve branches with a single placement. The smart console guides optimal placement of the leaflets and provides visual cues on the treatment status. The therapy leaflets simultaneously deliver numerous micro-lesions to disrupt multiple nerve segments with a single placement. Our approach differs from other devices that create relatively large lesions on the mucosal surface with a limited depth of tissue destruction, and without any meaningful feedback to the physician on the effect on underlying nerves. NEUROMARK was designed to consistently disrupt neural supply by precisely applying a safe level of energy. We believe that’s how you enable effective and positive patient care.
Medgadget: Is there a steep learning curve for users adopting the therapy?
Brian Shields: We designed NEUROMARK with the end user in mind, and ease of integrating into the office workflow was one of the key attributes we focused on. Further, the system takes the guesswork out of a procedure by guiding the optimal placement and extent of therapy delivered . Our smart console and therapy wand work together to show the clinician where therapy is being delivered and for how long, and thanks to the leaflet design, multiple nerves can simultaneously receive therapy with a single placement. Patients could receive the in-office treatment on their lunch break and return to work afterwards without experiencing any discomfort. All around, the treatment is designed to efficiently provide symptom relief and a positive patient experience, and that starts with ease of use for the provider.
Medgadget: Has the system been trialed clinically? When do you envisage that it might be available?
Brian Shields: Multiple rigorous pre-clinical and clinical studies have shown Rhinitis Neurolysis Therapy can adequately disrupt nerve tissues with proprietary RF delivery while maintaining vascular integrity. Early clinical evidence points to a significant reduction in key symptoms of rhinorrhea and congestion, while being comfortable and safe for patients. Data from our RELIEVE study will be used to demonstrate safety and efficacy to the FDA. We are expecting FDA clearance of NEUROMARK this year, followed by U.S. commercialization in select markets.
We’ve received extremely positive feedback from surgeons and patients so far. There is a large unmet need in the treatment of chronic rhinitis and we’re confident our therapy will help clinicians provide a gentle, effective treatment option for their patients.