NeuroGyn Reaches Critical Milestone: PosStim™ Neurostimulator Ready for Clinical Evaluation

Zurich, October 2025 – NeuroGyn AG proudly announces a decisive advancement in the development of its proprietary pelvic neurostimulator PosStim™, designed for Genital Nerve Stimulation (GNS). The project has successfully reached design freeze (July 2025) — a key step marking the transition from research and development to the clinical validation phase. This milestone paves the way for the first human clinical studies, expected to begin in 2026.

From Concept to Clinical Readiness

Since its foundation, NeuroGyn has pursued a clear vision: to transform the treatment of complex pelvic disorders through Genital Nerve Stimulation (GNS-procedureÒ – NeuroGyn AG – CH), a novel therapeutic approach rooted in the emerging discipline of Neuropelveology. Unlike traditional sacral neuromodulation or drug-based therapies, GNS directly targets genital nerves via a minimally invasive genital approach in outpatient setting, offering the potential for higher efficacy, reduced complications and costs, and broader applicability across multiple disease areas.

The development of PosStim™ was guided by three core design principles:

  1. Clinical simplicity – a device tailored to the unique anatomical and physiological requirements of genital neuromodulation.
  2. Patient accessibility – robust technology with a lean, cost-efficient design to enable global availability, not only in high-income markets.
  3. Therapeutic versatility – a system adaptable to a spectrum of chronic conditions, from overactive bladder and chronic pelvic pain to hypertension, osteoporosis, depression, erectile dysfunction, and more….

Why Design Freeze Matters

Achieving design freeze is a pivotal milestone in the MedTech development pathway. It means that PosStim™’s hardware and software architecture are now finalized, validated, and the design transfer stage – the bridge between prototype and large-scale manufacturing – has already begun.

For patients, this marks the beginning of a new era: the transition from a promising surgical therapy to a standardized, regulated medical technology. For investors and partners, design freeze demonstrates that NeuroGyn’s technology is de-risked at the engineering level and is now on a clear trajectory towards regulatory approval and commercialization.

Preparing for First-in-Human Clinical Study

NeuroGyn is preparing a multicenter clinical program, with leading university hospitals in four different continents already engaged as study sites. The first pilot/pivotal studies will focus on patients suffering from therapy-refractory overactive bladder, a condition with limited treatment options and high unmet medical need.

Subsequent trials are planned to explore the wider therapeutic potential of GNS. These studies will not only validate the safety and efficacy of PosStim™, but also provide the first large-scale evidence for Neuropelveology as a clinical discipline (www.theison.org).

Global Readiness and Medical Leadership

Beyond its technological innovation, NeuroGyn’s progress is already supported by a growing international network of gynecologists who have been formally trained and certified in both the LION and GNS procedures (Certification ISON Level 2) through the International School of Neuropelveology (https://neurogyn.com/professional-training/). These specialists are already familiar with the PosStim™ concept and are eagerly awaiting its market availability to begin implementation in their own practices. This global base of trained experts ensures immediate clinical adoption once regulatory clearance is achieved.

As a result, the clinical and educational infrastructure for the PosStim™ system is already in place. NeuroGyn has not only created a technology but has already built the professional ecosystem and demand required to bring it rapidly to market.

This strong position reflects the vision and leadership of Prof. Marc Possover, Founder and CEO of NeuroGyn AG, internationally recognized as the founder of Neuropelveology. As a gynecologist and surgeon, member of the French National Academy of Surgery, and recipient of the Médaille de la Légion d’Honneur, Prof. Possover has spent decades pioneering minimally invasive pelvic nerve surgery and establishing Neuropelveology as a medical discipline. His scientific authority and global network have positioned NeuroGyn at the forefront of bioelectronic medicine for women’s health.

A New Chapter in Bioelectronic Medicine

The PosStim™ project reflects NeuroGyn’s pioneering role at the intersection of minimally invasive surgery, neuropelveology, and bioelectronic medicine. By focusing on the pelvic nervous system – an area largely overlooked by mainstream neuromodulation companies – NeuroGyn is creating a new therapeutic frontier with profound implications for millions of patients worldwide.

“Design freeze is more than an engineering milestone; it marks our readiness to bring the GNS therapy into clinical reality. With NeuroGyn and PosStim™, we are not only addressing pelvic disorders but expanding the therapeutic reach of neuromodulation to conditions throughout the human body – both in therapeutic and preventive medicine. In doing so, we are redefining the indications for neuromodulation and introducing these possibilities into a specialty where they have so far been virtually nonexistent: Gynecology. This marks a decisive step forward in bringing the most advanced neuromodulation science and technology to women’s health worldwide” says Prof. Marc Possover, Founder & CEO of NeuroGyn AG. “Our first human study will be the gateway to establishing Genital Nerve Stimulation as a new standard of care, while expanding the horizons of bioelectronic medicine.”

Outlook

With design freeze now completed, NeuroGyn will advance into:

  • Design transfer and preparation of the first manufacturing series.
  • Regulatory engagement with European and U.S. authorities to ensure alignment with safety and clinical standards.
  • Pilot clinical study initiation, followed by pivotal trials in 2026 to support CE marking and FDA approval.

By reaching this stage, NeuroGyn demonstrates its ability to translate a visionary scientific concept into a tangible medical technology, backed by robust engineering and clinical strategy.

About NeuroGyn AG

NeuroGyn AG, headquartered in Kanton Zug, Switzerland, is a medical technology company pioneering the field of Neuropelveology. Founded by Prof. Marc Possover, Chairman of the International Society of Neuropelveology, NeuroGyn develops novel neurostimulation systems for the treatment of chronic pelvic and systemic disorders.

Its flagship product, PosStim™, is the world’s first implantable neurostimulator designed specifically for Genital Nerve Stimulation (GNS).

For further information: www.neurogyn.com