In a significant stride towards revolutionizing the field of pelvic neuromodulation, Neurogyn AG, the leading medical technology company in the field of neuropelveology, has announced the acquisition of two pivotal US patents. These patents, aimed at refining the surgical methodology of implantation and addressing corresponding indications, are poised to tap into an extremely lucrative market potential.
The Genital Nerves Stimulation - GNS, a therapeutic approach involving the modulation of genital nerves in front of the pubic bone, holds immense promise in treating a variety of conditions “all together” such as urinary and fecal incontinence, pelvic pain, overactive bladder and for the first time in pelvic neuromodulation, erectile dysfunctions. However, the efficacy of traditional methods has been hampered by surgical complexities and limitations in indication specificity.
US-patent 11,464,986 – October 2022
The first patent secured by Neurogyn focuses on streamlining the surgical GNS implantation process, aiming to enhance precision and minimize invasiveness. By leveraging advanced techniques and innovative device designs, Neurogyn aims to make genital neuromodulation accessible to patients while ensuring superior clinical outcomes, but also accessible for all pelvic physicians, urologist, coloproctologist and much more relevant all gynecologists (only 0.35% of gynmecologists are trained in competitor methgods such as SNM and PN, while the GNS bases on a surgical technique of implantation similar to the classical TVT, a surgical techhnique used for mesh implantation for treatment for urinary incontinence – a surgical method in which all gynecologist around the world are trained with.
The patent also targets the identification and refinement of indications for genital neuromodulation, with a particular emphasis on addressing underserved medical needs. Through meticulous research and clinical validation, Neurogyn aims to expand the scope of pelvic neuromodulation to encompass a broader range of conditions with especially one groundbreaking indication, erectile dysfunctions with around 250 million patients suffering from this condition around the world, unlocking untapped market potential and improving patient care.
US-patent 10,232,175 - March 2019
The second patent targets the retropubic location of the pacemaker, that enables a well protection of the pacemaker again migration and external traumas.
Comparing with classical technique of sacral or pudendal neuromodulation, Genital Neuromodulation presents following major advantages:
1. For the patients:
- No need for an invasive surgical test phase. Because the genital nerves are located superficially in front of the pubic bone, test stimulation can easy be achived using adgesive skin electrode and a simple TENS device. Patients can test as long as necessary and in normal conditions of private/work life (in surgical test phase, test periode is limited in time because of risk for infection).
- Easy recharge of the NeuroGyn patented “PossoverTM Pacemaker” in front of the pubic area by simply using a bell, without compromising patient’s activity (as in SNM where patient cannot either seat or walk for hours).
- Cosmetic advantages: because of the specific form of the PossoverTM Pacemaker”, implantation of the patient required only a “bikini incision >>2cm in length, while the pacemaker is located in well protection of the pubic bone.
2. For the Insurance: the 'non-necessity' of a surgical test phase in the GNS therapy allows for a considerable reduction in therapeutic costs (>60%), especially considering that 30% of patients who undergo such a test phase will not pass this initial phase. Thus, these “negative-test” patients undergo two surgical interventions under general anesthesia, the first for the implantation of test electrodes, the second for their explantation - and this without any therapeutic benefit for these patients
3. For physicians – especially for gynecologists, the GNS implantation is a procedure performed in ambulatory sector, in local anesthesia and in <15min.
Prof. mult. Dr. med. Marc Possover, Founder and Chief Scientific Officer at Neurogyn AG, expressed optimism about the transformative impact of these patents on the field of pelvic neuromodulation. "These patents represent a significant milestone in our mission to advance medical technology and improve patient outcomes suffering from pelvic organs disfunctions and pain. By harnessing innovation and scientific rigor, we are poised to redefine the standard of care in pelvic neuromodulation."
The acquisition of these patents’ underscores Neurogyn's commitment to innovation and incoming leadership in the field of medical technology. With a focus on addressing unmet clinical needs and enhancing patient care, Neurogyn AG continues to push the boundaries of possibility in pelvic neuromodulation.
Literature:
Possover M. “GNS-Double-Down”: A New Minimally Invasive Surgical Access technique for Electrical Genital Nerve Stimulation to treat Pelvic Organs Dysfunctions – An anatomical study on human cadavers. J Minim Invasive Gynecol. 2023 Jun;30(6):480-485
Possover M. Neuropelveology: an emerging discipline for the management of pelvic neuropathies and bladder dysfunctions through to spinal cord injury, anti-ageing and the Mars Mission. J Clin Med 2020;9:3285
Possover M. Principles of Neuropelveology – Ostergard’s Urogynecology“ – Edition 2021