Clinical study data to evaluate the safety and
efficacy of the Neuspera System for the treatment of urinary urge
incontinence (UUI) will support the FDA submission for regulatory
approval
SAN
JOSE, Calif., July 23,
2024 /PRNewswire/ -- Neuspera Medical, Inc., a
neuromodulation company pioneering the Neuspera Implantable Sacral
Neuromodulation (SNM) System, announced it has reached a
significant milestone: All implanted patients have completed the
6-month primary endpoint visit in the SANS-UUI pivotal trial of the
Neuspera System. The Neuspera System is a discreet, minimally
invasive, ultra-miniaturized implant designed to provide patients
personal control and relief from urinary urge incontinence (UUI), a
symptom of overactive bladder (OAB). The clinical data will support
the U.S. Food and Drug Administration (FDA) submission for
regulatory approval of the Neuspera System to treat OAB
symptoms.
![Neuspera Medical, Inc., is committed to developing implantable medical devices that will improve the lives of patients battling chronic illnesses. The Neuspera platform is designed to provide patients and physicians with new, and potentially earlier, treatment options that are less invasive and more adaptable. These therapeutic alternatives aim to help patients restore their health and well-being for a better quality of life. For more information, please visit www.neuspera.com. (PRNewsfoto/Neuspera Medical, Inc.) Neuspera Medical, Inc., is committed to developing implantable medical devices that will improve the lives of patients battling chronic illnesses. The Neuspera platform is designed to provide patients and physicians with new, and potentially earlier, treatment options that are less invasive and more adaptable. These therapeutic alternatives aim to help patients restore their health and well-being for a better quality of life. For more information, please visit www.neuspera.com. (PRNewsfoto/Neuspera Medical, Inc.)](https://mma.prnewswire.com/media/2276288/Neuspera_Medical_Logo.jpg)
"We're grateful to every physician and patient who participated
in the clinical trial, and we're excited that our uniquely
differentiated technology will help millions of patients when it is
FDA-approved for treatment of OAB symptoms," said Steffen Hovard, CEO of Neuspera Medical. "The
fact that the market is only 5% penetrated at this time is a clear
indication that patients are looking for something different than
what's available today. The Neuspera System delivers true
innovation."
OAB is a common medical disorder affecting roughly one in six
adults. OAB symptoms include a sudden, uncontrolled need or urge to
urinate, urine leakage, and/or the need to pass urine many times
during the night and day. These symptoms can make it difficult to
work, socialize, exercise and lead a normal, active life which can
lead to depression, self-esteem and social stigma issues.
This milestone comes on the heels of the American Urological
Association (AUA) and Society for Urodynamics, Female Pelvic
Medicine and Urogenital Reconstruction's (SUFU) recently published
2024 Guideline on the Diagnosis and Treatment of Idiopathic
Overactive Bladder. The guideline promotes a shared decision-making
process between the patient and physician that weighs the patient's
comorbidities along with expressed values, preferences, and
treatment goals in order to help them make an informed decision
regarding treatment. This new guideline will facilitate OAB patient
access to the therapy that best meets their particular needs and
goals without requiring a lengthy stepwise approach through
multiple levels of therapy. SNM is recognized as the "gold
standard" neuromodulation therapy for OAB. With a dramatically
smaller implant and incision size than anything else on the market,
and efficacy comparable to the best SNM data[1], Neuspera is
expected to benefit greatly from the new guideline's consultative
approach providing accelerated patient access to minimally invasive
therapies that were previously considered "third line."
The SANS-UUI multi-center, single-arm clinical study was
designed to demonstrate the safety and efficacy of the Neuspera
System and gain FDA approval in the U.S. Patients were screened and
implanted with the device at 26 centers across the U.S. and
Europe. Patients who participated
in the Phase One clinical trial – and who have been finding relief
using the Neuspera System to successfully control their UUI
symptoms for up to 3.5 years – have called the Neuspera System
"life-changing," "the miracle," and "easy to do."
"I love that there is no battery implant compared to traditional
devices and that it's outside of my body and I'm in charge of it,"
said one patient who participated in the Phase One clinical
trial.
"It's improved my life so much that I tell everybody about it,"
another patient said.
"Reaching the final patient's primary endpoint visit for the
clinical trial is an important milestone in Neuspera's journey
towards revolutionizing the way physicians utilize SNM therapy,"
said Dr. Steve Siegel, chief medical
officer of Neuspera Medical. "This will be a great solution for
patients who want a high degree of symptom control with the
smallest implantable neurostimulator available, designed to empower
patients and provide ultimate discreetness putting control of
life-altering symptoms in patients' hands."
"As the coordinating investigator for the SANS-UUI clinical
trial, based on my experience with the Neuspera System and how
patients are responding, I'm excited to soon be able to offer an
OAB treatment option that truly gives patients control of their
bladders in the least invasive way with the ability to
self-administer their therapy when it's convenient for them, and
nobody else can see or feel it," said Dr. Osvaldo Padron with Florida Urology
Partners.
The Neuspera System has FDA clearance for treating chronic pain
of peripheral nerve origin and is currently an investigational
device for treating UUI, a symptom associated with OAB.
About Neuspera Medical
Neuspera Medical, Inc. is
committed to developing implantable medical devices that will
improve the lives of patients battling chronic illnesses. The
Neuspera platform is designed to provide patients and physicians
with new, and potentially earlier, treatment options that are less
invasive and more adaptable. These therapeutic alternatives aim to
help patients restore their health and well-being for a better
quality of life. For more information, please visit
www.neuspera.com.
The Neuspera System is the least invasive sacral neuromodulation
device and includes an ultra-miniaturized pulse generator attached
to an electrode array. It is designed to be discreet and fit within
the protected space of the sacral foramen, so patients typically
don't feel any lump or bulge and the tiny 4-5 mm scar from the
implant procedure is usually barely perceptible, even if you know
where to look. This design eliminates the need for more invasive
tunneling and a separate pocket for an implanted battery, avoiding
issues that negatively affect patient satisfaction with traditional
SNM systems while empowering patients to regain control of their
OAB symptoms and life.
1 Based on outcomes of the SANS-UUI Phase I clinical
data; Padron et al. (2021). TREATMENT OF URINARY URGENCY
INCONTINENCE (UUI) WITH AN ULTRA-MINIATURIZED SACRAL NERVE
MODULATION (SNM) SYSTEM: PRELIMINARY OUTCOMES OF THE SANS-UUI
STUDY. Journal of Urology. 2021 Sep 1;206(Supplement
3):e1158.
Media Contact:
Shelli Lissick
Bellmont Partners
651-276-6922
shelli@bellmontpartners.com
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SOURCE Neuspera Medical, Inc.