Ken Londoner, CEO and founder of BioSig Technologies, which develops sensing and stimulation technologies for physiological and neurological disorders, spoke to Med-Tech Innovation News about its NeuroClear range and its plans going forward.
Tell us about NeuroClear’s technology. How does it help develop solutions to treat physiological and neurological disorders?
At NeuroClear, we focus on improving current neurostimulation therapies' safety and efficacy and developing novel solutions to diagnose and treat a range of critical neurological disorders. Through our novel proprietary hardware and software architecture, we aim to address technological deficiencies that prevent physicians from delivering optimal treatments, such as assessing the completeness of the procedures and optimising the energy delivery based on the physiological response.
What is behind the sensing and stimulation technology? Including the physical technological aspects as well as the research.
We have started working on the neurostimulation initiative in 2019, after several years of research. We initially became aware of the additional clinical applications that may benefit from the core competencies we have already demonstrated at BioSIg (acquisition and analysis of low amplitude, high-frequency signals) almost three years before that. At that time, we were running preclinical studies with our flagship electrophysiology product, the PURE EPÔ System at Mayo Clinic. Through that collaboration, we decided to bring our products into other areas of healthcare, starting with neurology.
Our internal R&D team is highly skilled at identifying clinical applications and developing technologies in both electrophysiology and neuromodulation. Our technology development is led by Barry D. Keenan. A former executive at Medtronic and Alfred Mann Foundation for Scientific Research, he brought to us over 20 years of deep industry expertise in several sectors, including neuromodulation, deep brain stimulation, sensing, imaging, and cardiac pacing. Having developed and brought to market the world’s first artificial pancreas (Medtronic’s MiniMedTM 670G), he is ideally positioned to lead this important initiative.
What conditions have you developed solutions for so far?
We have identified resistant hypertension as our first area of focus. Renal denervation has proven to be effective in reducing hypertension, but clinical endpoints remain suboptimal. Hypertension is one of the most common reasons for clinical visits and prescriptions in the US, and the number of people who suffer from hypertension keeps rising. Over half of all diagnosed patients are not responding to their medical therapy within a year of initiating the treatment.
Our flagship nerve mapping technology N-SENSEÔ will aim to deliver a more significant reduction in ambulatory blood pressure by introducing a feedback loop for optimal ablation outcomes.
Chronic pain is another area of our research interest. In the US alone, approximately 20% of adults (that’s every fifth person!) suffer from chronic pain. This debilitating condition leads to significant dependency on opioids, affects mental health, and exacerbates other chronic diseases. Chronic pain is also associated with a reduced ability to work and difficulty performing everyday activities, so the impact on society is very significant. Our research indicates that our technology may contribute to the better acceptance and improved success of closed-loop ablations for chronic pain. Closed-loop ablations have many benefits compared to traditional drug therapies, including reduced side effects and dependency on opioids.
What “gaps” does N-Sense fill when it comes to electroneurogram systems?
We are looking to establish nerve activity before, during, and after the ablation, which can help a physician establish consistent feedback between the tissue and the device. That feedback loop allows for more precise therapy delivery, meaning the right amount of energy is delivered during the procedure – no more and no less. This is a critical component of a successful procedure that can lead to more successful clinical outcomes, decreased procedure times, and fewer re-do procedures.
Tell us more about your plans.
We have recently started working with the University of Minnesota. The institution is known for its significant contributions to autonomic nervous system disease, particularly hypertension, and we are thrilled to work with their research team.
In parallel, we have recently been allowed a first patent that we exclusively licensed from the Mayo Foundation for Medical Education and Research. That intellectual property focuses on electroporation - an emerging technique that has demonstrated efficacy in treatments for several critical conditions, most notably cancer, and is currently being evaluated for the treatments of autonomic nervous disorders. We will be incorporating this technique into our studies to assess its impact on hypertension treatments.
We feel that with world-class research and clinical leadership, a highly skilled engineering team, and a strong manufacturing partnership, we can advance one of the fastest-growing sectors in the medical device market.
Anything else you’d like to add?
As with our flagship electrophysiology device, we hope to elevate the standards of care for some of the most critical diseases.
Elevated blood pressure is a challenging condition. While its effects are not immediately apparent to patients, hypertension significantly increases the risks of heart failure, ventricular arrhythmia, heart attacks, stroke, and chronic kidney disease. We hope that our technology can help reduce hospitalisation rates, healthcare spending and, ultimately, improve patient health. We have a strong team of leading engineering and research talent, and we feel that this collaboration can lead to substantial discoveries.
