Panelists Discuss Policy Shifts at Bioelectronic Medicine Forum

by Sharena Rice, contributing editor

April 2025 issue, Neurotech Business Report

Neurotech Reports’ 2025 Bioelectronic Medicine Forum at the New York Academy of Medicine convened industry pioneers, investors, and innovators to explore the evolving landscape of bioelectronic medicine. The event illuminated both the challenges and transformative opportunities shaping this dynamic field, offering a blend of cautious optimism, regulatory insights, and groundbreaking technological advancements.

Investors highlighted a shifting financial environment marked by increasing complexity. Mir Imran of InCube Ventures pointed to rising operational costs and prolonged regulatory approval timelines, reflecting tighter liquidity in the medtech and biotech sectors. Jeff Chu of Features Capital echoed this sentiment, noting that liquidity challenges have forced several companies to scale back operations despite earlier optimism. Jeff Cohen of Ladenburg Thalmann & Co added that disruptions in presubmission meetings with regulatory bodies are creating additional hurdles, underscoring the need for strategic adaptability in a constrained funding landscape. These insights emphasized the importance of disciplined capital allocation and robust planning to navigate the industry’s financial realities.

Though an FDA official originally slated to speak at the conference was not allowed to participate, two former FDA employees involved with neurological devices added some context to the current situation in Washington. The discussions focused on the need for early and proactive strategies to overcome bottlenecks. Carlos Peña, drawing on his extensive FDA experience with neuro and vascular devices, stressed the value of early feasibility studies to streamline the approval process. He cautioned that pre-submission meetings remain a significant choke point for many companies. Tim Marjenin, now with MCRA, identified biocompatibility as the primary obstacle to device approvals, urging developers to prioritize rigorous testing. Victor Pikov of Medipace highlighted the critical role of reimbursement, citing the bankruptcy of Pear Therapeutics—despite its $1.6 billion valuation—as a sobering example of how reimbursement challenges can derail even the most promising ventures. These discussions underscored the necessity of aligning innovation with regulatory and reimbursement frameworks to ensure commercial viability.

The forum showcased a wave of cutting-edge technologies poised to redefine bioelectronic medicine. During the entrepreneur and sleep and respiratory disorders panels, Ahmet Tezel of LivaNova praised closed-loop stimulation systems for sleep apnea, pointing to Inspire Medical’s success with responsive, patient-centric therapies. Karl Stoklosa of Precisis GmbH discussed minimally invasive treatments for drug-resistant epilepsy, with promising European results paving the way for a planned U.S. launch in 2028. Charles Nolet of Synergia Medical introduced an innovative optoelectronic approach to vagus nerve stimulation for epilepsy, leveraging light-based technology for precision without needing to use any metal components. By removing metal components, Synergia’s devices are less prone to electromagnetic interference that may cause device malfunctions.

Jay Sanguinetti of Sanmai explored the potential of focused ultrasound neuromodulation, which offers deep and precise brain stimulation, opening new possibilities for treating the nervous system. Daniel Powell of Spark Biomedcial unveiled OhmBody, a direct-to-consumer product designed to alleviate menstrual symptoms, tapping into an underserved market with a user-friendly solution. In the realm of neurodevelopmental disorders, Colin Kealey of NeuroSigma highlighted trigeminal nerve stimulation’s promise for autism and ADHD, emphasizing the need for effective side-effect management to improve therapy adherence.

Marom Bikson of Wearable Medicine presented a novel approach to user-friendly, disposable electrotherapies that resemble topical treatments, addressing adoption barriers by simplifying interfaces and eliminating complex electronics. Yi-Kai Lo of ANEUVO shared progress on spinal cord injury stimulation, which earned a CE mark, while Frederik Ceyssens of ReVision Implant discussed high-resolution neural interfaces aimed at restoring functional vision, surpassing the capabilities of earlier systems.

In a compelling fireside chat with Jeremy Koff, Ray Cohen, whose leadership at Axonics culminated in a record-breaking acquisition by Boston Scientific, offered pragmatic advice. Skeptical of the effort required to create new market categories, Cohen advocated focusing on established markets with clear reimbursement pathways. He emphasized understanding patient experiences before engaging physicians and, despite his admitted aversion to lawyers, urged early-stage firms to invest in top-tier licensing attorneys to navigate intellectual property complexities. His insights highlighted the importance of strategic focus and practical execution in achieving commercial success.

During the conference, investors agreed that understanding mechanisms of action through detailed cell biology experiments is critical for de-risking ventures. Such scientific rigor not only builds confidence among stakeholders but also lays a robust foundation for long-term development and scalability.

The Bioelectronic Medicine Forum painted a picture of an industry at a crossroads, balancing regulatory complexities, financial constraints, and reimbursement challenges with bold innovation. By prioritizing patient-centric solutions, strategic regulatory engagement, and scientific precision, bioelectronic medicine may drive sustainable growth and redefine therapeutic possibilities for patients worldwide.

Biogen Exec Discusses Biopharma/BioElectRx Interaction

by Sharena Rice, contributing editor

April 2025 issue, BioElectRx Business Report

Since the advent of bioelectronic medicine in the last decade, startup firms in the space have sought to attract attention from the biotech and pharmaceutical industries. Perhaps more than any other sector of the medical device industry, bioelectronic medicine offers numerous opportunities for partnership with and investment from drug manufacturers. While there have been a handful of examples of cooperation between device and pharma firms on combination products such as implantable pumps, until the field of bioelectronic medicine emerged, there had not been a high degree of interest from biopharma firms in partnership with device firms.

At the 2025 Bioelectronic Medicine Forum at the New York Academy of Medicine earlier this month, Lisa Shafer, a vice president of biotech firm Biogen, offered a valuable assessment of the historical reasons for this device, and also the opportunities for bridging the chasm. Shafer has held leadership positions at device firms Medtronic and Cerebral Therapeutics as well as pharma companies Teva and Upsher-Smith before joining Biogen so she’s in a unique position to understand the distinct cultures of both industries. She also serves as an advisor to BioElectRx startup firm Neuraworx.

Speaking on her own behalf, Shafer delivered a compelling keynote outlining what could be considered a strategic roadmap for bioelectronic medicine. Her address explored the transformative potential of implantable bioelectronic technologies, the structural challenges impeding progress, and the critical need for aligned incentives to drive industry-wide disruption. For executives, investors, and dealmakers, Shafer’s insights provide a call to strategically connect the dots for better outcomes on this emerging frontier.

Shafer opened by framing bioelectronic medicine within the legacies of two industry pioneers: Phil Sharp, whose founding of Biogen established a cornerstone of U.S. biotechnology, and Earl Bakken, whose vision at Medtronic catalyzed decades of innovation in bioelectronic medicine. These examples underscore the power of integrating biotechnology and medical device expertise—a synergy Shafer deems essential for advancing bioelectronic therapies. She emphasized that strategic collaboration across these domains is not merely aspirational but a prerequisite for delivering next-generation solutions.

Drawing on her leadership at both device and biopharma firms, Shafer highlighted a persistent industry challenge: the siloed mentalities separating pharmaceutical and medical device sectors. She noted the absence of vagus nerve stimulation from competitive analyses in pharmaceuticals, a gap she attributed to entrenched sectoral divides. For bioelectronics to fulfill its promise of site-specific, targeted therapies, Shafer advocated for robust cross-industry dialogue. Such collaboration is critical to overcoming historical barriers and unlocking the full potential of implantable technologies.

Shafer addressed a common critique, the perceived invasiveness of implants, with a nuanced perspective. She argued that systemic pharmaceuticals, with their off-target effects and variable efficacy, are also invasive. Furthermore, the psychological burden of daily medication regimens serves as constant reminders to patients of their chronic illness. Yet compliance is an issue with medications: many drug failures can be traced to the lack of patient adherence. While autoinjectors represent a path to progress, Shafer championed implantable bioelectronics for their ability to deliver sustained, precise interventions, minimizing patient burden and enhancing therapeutic consistency.

Bioelectronic implants ensure consistent delivery, mitigating risks associated with patient non-compliance. She pointed to emerging closed-loop therapies, exemplified by Tim Denison’s work, which leverage neural sensing to detect disease-specific bioelectronic signatures and optimize treatment in real time. Strategic partnerships that integrate these sensing capabilities, Shafer argued, could yield significant returns by improving efficacy, enhancing patient outcomes, and reducing healthcare costs.

A pivotal challenge Shafer identified lies not in scientific complexity but in misaligned economic incentives. Traditional healthcare models, heavily reliant on pharmaceutical sales, often resist the adoption of disruptive bioelectronic solutions. This presents both a challenge and an opportunity to improve patient outcomes. She mentioned gene therapy’s economic hurdles, with per-patient costs of $2 to 3 million and persistent challenges with AAV vectors, which underscore the need for cost-effective, scalable alternatives.

To fully realize bioelectronic medicine’s potential, Shafer emphasized the need for rigorous economic modeling in clinical studies and innovative financing to address upfront costs. For executives, this could mean prioritizing partnerships that bridge biotech and device expertise. For investors, this can look like funding scalable, disruptive technologies with clear economic advantages. For dealmakers, it involves structuring agreements that incentivize long-term value over short-term gains.

Shafer’s vision is a strategic imperative: bioelectronic medicine stands at a pivotal juncture, poised to redefine precision medicine. By fostering collaboration, embracing sensing-driven innovations, and aligning incentives between bioelectronic medicine and pharmaceuticals, stakeholders can transform patient care and capture significant market opportunities.

OSA Neuromodulation Players Discuss the Market in NYC

by James Cavuoto, editor

April 2025 issue, BioElectRx Business Report

Representatives from the three largest players in the neuromodulation market for treating obstructive sleep apnea took the stage last month in a session at the 8th annual Bioelectronic Medicine Forum in New York City. In a session moderated by BBR contributing editor Victor Pikov, John Rondoni, chief product and innovation officer at Inspire Medical Systems, Ahmet Tezel, chief innovation officer at LivaNova, and Jeyakumar Subbaroyan, chief clinical officer at Nyxoah, offered their insights on their technologies and the market dynamics surrounding sleep apnea treatments.

Rondoni discussed the prevalence of OSA in the U.S. and the importance of effective treatment options. Inspire’s device focuses on ensuring patient compliance, which is critical for long-term success. Their data shows that Inspire users average 5.7 hours of use per night, significantly higher than CPAP users. “If I had to pick one area of medicine where I think we have the biggest opportunity to make an impact on everyday health, for most people it’s by getting a better night of sleep,” he said.

Inspire emphasizes four key elements for an ideal OSA treatment solution: long-term reduction in disease burden, supported by data from the STAR trial; patient compliance; a safe surgical procedure; and favorable comparison to other implantable devices. Rondoni said that 93% of patients who receive Inspire therapy would recommend it to others.

Sensing is a key aspect of the company’s therapy. “Inspire has always focused on using sensors to improve our therapy,” he said. The next version of the product will put the sensors inside the device to make the surgical procedure easier. Also on the horizon are features like posture detection, and sleep detection.

Subbaroyan presented Nyxoah’s vision of “making sleep simple” using the company’s Genio therapy, which uses a patient-centric bilateral hypoglossal nerve stimulation system. The system has shown promising safety and efficacy in clinical studies, including the Dream IDE study which is currently under peer review. Nyxoah has been on the market in Europe for about five years and hopes to have FDA approval later this year.

The Genio system includes an implantable stimulator with a lead-free, battery-free device that can be implanted with minimal incision and is MRI compatible. It also incorporates an external activation chip that patients wear to power the device, and a patient app that enables self-titration and therapy progress tracking, emphasizing a patient-centric approach.

The Dream clinical study involved 115 patients and demonstrated significant improvements in apnea-hypopnea index and oxygen desaturation index, with a reduction of about 70%. The study also reported a low device-related serious adverse event rate of 2.6%, comparable to other studies. Comparing Nyxoah’s study to previous studies, including Inspire’s, Subbaroyan pointed out that the Dream study included a more difficult-to-treat population and also required participants to sleep a minimum of 55 minutes in a supine position. Future generations of the Genio system will feature embedded sensors, cloud connectivity and data analysis, and smarter implant electronics, he said.

Tezel shared insight into LivaNova’s recent entry into the sleep apnea field, leveraging their experience in VNS for epilepsy and depression. LivaNova aims to provide innovative solutions and plans to release pivotal trial results soon. “We believe that it’s our job to offer more options to both the physicians and the patients,” he said. “This is a high growth market. It can sustain more than one player, and we’re excited that we’re gonna get into it.

The discussion touched on the potential for AI and machine learning to enhance treatment personalization and efficacy. As the market evolves, the need for robust clinical evidence and patient-reported outcomes will increase, especially in light of changing reimbursement landscapes. Each of the panelists expressed optimism about future developments and the potential for collaboration to improve patient outcomes in sleep apnea management.

In a later entrepreneur panel discussion at the conference, Bryan McLaughlin from startup firm LunOSA described his firm’s injectable approach to hypoglossal nerve stimulation.