[Lieyun Network (WeChat:ilieyun
) Beijing] Reported on December 27
NeuSpera Medical, Inc. recently announced that it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), marking the initiation of its first long-term clinical study for the company’s ultra-miniaturized implantable neuromodulation platform. This MRI-compatible, ultra-small neuromodulation device employs wireless energy to power a microscopic implanted electrode, delivering neurostimulation therapy for urgency urinary incontinence (UUI), a subtype of overactive bladder.
(Ultra-small implantable electrodes with a diameter of 2 mm)
(Wireless external energy transmitter and control system connected to a mobile phone)
(Comparison of the size of an ultra-small implantable neuromodulator with a coin)
NeuSpera Medical, Inc. (San Jose, California) is a clinical-stage neuromodulation device company dedicated to developing implantable medical device technologies that improve the lives of patients suffering from chronic diseases or functional disorders. Leveraging its fourth-generation mid-range wireless power transmission technology, NeuSpera Medical, Inc. has significantly miniaturized its devices, enabling implantation into deeper anatomical sites and delivering more reliable therapeutic outcomes compared to other miniaturized neuromodulation technologies. This technology platform aims to provide patients and physicians with novel, earlier treatment options, while the minimally invasive nature of the therapy enhances its broader applicability. To date, the company has completed a Series B financing round, raising over $30 million from several multinational medical device companies and prominent venture capital firms.
NeuSpera Platform Leverages Proprietary Mid-Range Wireless Power Transfer to Miniaturize Implantable Devices (Sometimes Referred to as Bioelectronic Medicine). One of the Greatest Advantages of NeuSpera’s Products Is That Its Hermetically Sealed Implantable Module Is Over 100 Times Smaller Than Traditional Neuromodulation Devices, Promising to Reduce the Complexity of the Implantation Procedure and Alleviate Postoperative Pain and Complications for Patients. Traditional Neuromodulation Devices Are Bulkier Due to the Need for Implanted Batteries and Require More Complex and Invasive Surgical Methods for Implantation into the Patient’s Body.
“The NeuSpera team will continue this meaningful research, applying its novel technology platform to patients struggling with symptoms of urgency urinary incontinence,” said Ye Weigang, Founder and Managing Partner of DT Capital Partners, the lead investor in NeuSpera Medical, Inc. “The FDA’s approval of this Investigational Device Exemption (IDE) application marks a significant milestone in the company’s lifecycle and demonstrates the maturity of its medical device technology platform. We look forward to seeing the company’s revolutionary technology bring more therapeutic applications to patients in the future.”
Dr. Milton M. Morris, President and Chief Executive Officer of NeuSpera, stated, “Urgency urinary incontinence leaves patients unable to control or predict their condition on a daily basis, imposing a significant burden.” “The approval of this clinical trial is critically important for patients who have not received timely treatment, aligning with our ultimate goal of helping them improve and manage their disease symptoms.”
