Submits De Novo 510(k) for Protect PNS for Treatment of OAB Symptoms
Submits De Novo 510(k) for Protect PNS for Treatment of OAB Symptoms
BOCA RATON, Fla., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Micron Medical, a privately-held medical device company engaged in the development, manufacture and commercialization of innovative wireless, minimally invasive, electroceutical device solutions for urological conditions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MOVENTIS PNS, a percutaneous implantable pulse generator (pIPG) nerve stimulator system to treat chronic peripheral nerve pain that has therapeutic effects for common urological conditions involving pelvic pain. The Company has already commenced a limited U.S. commercial launch of the product. In addition, Micron has submitted a De Novo 510(k) application for PROTECT PNS in the significant market indication of overactive bladder (OAB).
The Micron device, at only 7 cm long, is smaller than any PNS implant currently available on the market today, at a volume of only 0.10 cc. Moreover, it provides power levels up to 23.3 mA, which is also more powerful than any other currently available PNS device. The small size and significant power is designed for the rugged tissue impedance needs of peripheral tissue mediums to ensure that long-lasting and continuous therapy will be delivered.
“The FDA’s 510(k) clearance of Moventis PNS, along with the PROTECT PNS De Novo submission application, provide the potential for Micron to offer an unmatched neuromodulation product offering to the urology community in 2021. We are delighted to be able to bring a new, minimally invasive treatment option to patients who suffer from debilitating peripheral origin pelvic pain as a result of common, yet significant, urological conditions,” said Laura Perryman, co-Founder and President of Micron Medical. “In addition, our submission of the De Novo application for PROTECT PNS, a wireless, minimally invasive, electroceutical device solution for the treatment of OAB, a condition that affects over 37 million Americans1 and represents a multi-billion dollar market opportunity, is a key regulatory milestone for Micron.”
“The MOVENTIS PNS FDA clearance allows Micron to evolve from a development-stage medical device company to a commercial organization with a significant opportunity to treat thousands of patients each year who suffer from pelvic pain,” said Matt Kemp, Chief Commercial Officer of Micron Medical. “We have already begun a limited commercial rollout of this exciting product and expect that it will be well-received by the urologic market. In OAB, if our PROTECT PNS receives FDA classification, we will be targeting a large market with established reimbursement with device-specific coding granted by the American Medical Association.”
Additional Recent Key Achievements
Clinical Highlights
- PROTECT RCT Study – PROTECT PNS vs. InterStim (sacral neuromodulation standard of care)
- Ongoing pivotal, non-inferiority head-to-head trial of PROTECT PNS vs. InterStim to support Centers for Medicare & Medicaid Services (CMS) category I C-Code status review
- 1:1 randomization of up to 150 patients at 17 sites across U.S. and EU
- Outcomes are over 75.5% reduction in urinary incontinence episodes from primary endpoint at 3 months sustaining out to 12 months
- Study expected to be completed by end of 2020
- GUARDIAN RCT Study (Prospective 2nd RCT of Micron for treatment of symptoms of OAB)
- Recently received FDA investigational device exemption approval
- Proposed prospective study evaluating the PROTECT PNS in office implant versus medical management alone for 36 months in a total of 160 patients
- Will be utilized for CMS category I C-Code status review
Intellectual Property
- Acquired method of use patent for tibial insertion
- Filed eight additional new patents for PROTECT PNS; three issued to date in 2020
- Acquired exclusive license from StimGuard LLC, providing access to 4 patents for OAB
About Micron Medical
Micron Medical is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with convenient, safe, minimally invasive, and highly cost-effective urological solutions that are easily incorporated into their daily lives. Micron’s goal is to evolve its patented, cutting-edge platform for neuromodulation to standard of care, increasing the accessibility for patients worldwide while lowering the economic impact of urology care management. www.micronmed.com.
Contacts
Gil Bao
Micron Medical Corporation
info@micronmed.com
888.691.0585
Jeremy Feffer
LifeSci Advisors
jeremy@lifesciadvisors.com
(212) 915-2568
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1 Irwin_DE, Kopp_ZS, Agatep_B, Milsom_I, Abrams_P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU International 2011;108(7):1132-8.
