Neuspera Medical Receives Investigational Device Exemption for Its Ultra-Miniaturized Implantable Device
Regulatory Approval to Start Phase I of its Pivotal Trial
SAN JOSE, Calif., Dec. 10, 2019 /PRNewswire/ — Neuspera Medical Inc., a clinical stage, private, venture capital backed neuromodulation company, announced the receipt of an Investigational Device Exemption (IDE) from the FDA – enabling the company to conduct the first long-term clinical trial of its ultra-miniaturized neuromodulation platform. An MRI Conditional version of Neuspera’s wirelessly powered implant designed for use as a sacral nerve stimulator will be studied for treatment of Urinary Urge Incontinence (UUI) – a prevalent form of Over Active Bladder.
“The Neuspera team continues to take meaningful steps to bringing their novel technology platform to patients battling the symptoms of UUI,” said Adam Fine, Founder & Managing Partner of Windham Venture Partners – a major investor in Neuspera Medical. “The Investigational Device Exemption marks a key milestone in the company’s lifecycle and speaks to the maturity of the medical device platform. We look forward to more applications in the future.”
The Neuspera platform leverages proprietary power transfer methods that enable miniaturization of implantable devices – sometimes referred to as bioelectronic medicines. Neuspera’s hermetically sealed implantable modules are more than 100 times smaller than traditional neuromodulation devices and is expected to reduce implant procedure complexity, patient post-surgical pain and complication. Traditional neuromodulation devices require an implanted battery power source and are therefore larger and require more complex and invasive implantation procedures.
“Urinary Urge Incontinence can be a significant burden for patients who struggle daily with the perceived loss of control and the unpredictable nature of the condition,” said Milton M. Morris, Ph.D., President & CEO of Neuspera. “The approval to conduct our clinical trial in this important and underserved population of patients is a key step toward our goal of improving their care and outcome.”
About Neuspera
Neuspera Medical, Inc. (San Jose, CA) is committed to developing implantable medical device technology that will improve the lives of patients battling with chronic illness or dysfunction. The company is leveraging its Fourth Generation Mid-Field Powering Technology, which allows for devices that are significantly smaller, that may be implanted deeper, and may be more reliable than other miniaturized neuromodulation technologies. This technology platform is designed to provide patients and physicians new, and potentially earlier treatment options that are less invasive and more adaptable.
Investor Relations: www.Neuspera.com
About Windham Venture Partners
Founded in 2006, Windham Venture Partners is a New York City based venture capital firm focused on healthcare, with a particular emphasis on medical technology (devices and diagnostics) and healthcare IT / digital health. Windham partners with visionary founders and entrepreneurs commercializing game-changing technologies to serve unmet needs in order to improve the lives of large numbers of patients and yield robust returns for its investors.
Learn More about Windham Venture Partners: www.windhamvp.com
SOURCE Neuspera Medical Inc.