Nine Continents Medical, Inc.

ITNS™ therapy

Overactive bladder (OAB) affects approximately 40 million U.S. adults, or nearly one in six, and impacts men and women equally. OAB is a clinical diagnosis with symptoms of urgency, frequency, nocturia, and urgency incontinence. Those suffering from lack of bladder control may be anxious or unwilling to find themselves in environments where access to a bathroom may be difficult, thus profoundly impacting their quality of life by restricting everyday activities and social interactions, and even occupational activities.

First-line therapies for OAB include behavioral therapies (e.g., bladder training, bladder control strategies, pelvic floor muscle training, and fluid management). Second-line therapy uses medications such as oral antimuscarinics or oral β3-adrenoceptor agonists. Unfortunately, first-line therapies fail in at least half of OAB patients, and second-line therapies are discontinued by 80% of patients within six months. Thus, an estimated 16 million Americans with OAB would benefit from safe and effective third-line therapy.

ITNS™ (Implantable Tibial Nerve Stimulator) is an innovative third-line therapy that provides neurostimulation for the treatment of OAB.

The ITNS is percutaneously implanted in the leg and automatically stimulates the tibial nerve, with no patient activation or recharging.

Press release: ITNS-01

-PRESS RELEASE-

Pacific Urology to Conduct Overactive Bladder Clinical Feasibility Study

SAN RAMON, CA, May 8, 2019 – Under the direction of Parminder Sethi, MD, Pacific Urology, a large private urology practice, will begin a clinical feasibility study of a novel medical device for patients with drug-resistant overactive bladder (“OAB”).

The device is an implantable tibial nerve stimulator (“ITNS™”), a miniature, self-powered unit placed in the lower leg under local anesthesia. The ITNS has a projected battery life between 7 and 10 years, and requires no patient activation or recharging.

Nine Continents Medical, Inc., a privately-held medical device company, recently received Investigational Device Exemption (“IDE”) from the U.S. Food and Drug Administration (“FDA”) for this first human study of the ITNS. The ITNS is not approved for commercial distribution, and is limited to investigational use.

According to the American Urological Association, OAB affects approximately 40 million U.S. adults, or nearly one in six, and impacts men and women equally. Those suffering from lack of bladder control may be anxious or unwilling to find themselves in environments where access to a bathroom may be difficult, thus profoundly impacting their quality of life by restricting everyday activities and social interactions, and even occupational activities. An estimated 16 million Americans with OAB have no effective treatment.

Parminder Sethi, M.D. is a diplomate of the American Board of Urology since 2000. He is currently a fellow of the Royal College of Surgeons. He completed his urology residency at Ohio State University and trained at the University of Iowa Hospitals and Clinics. Dr. Sethi is one of a few urologists who specialize in the use of advanced technology to treat incontinence and overactive bladder, and was instrumental in developing Pacific Urology’s Continence Center. His specialties include treatment for incontinence, enlarged prostate and erectile dysfunction, as well as minimally invasive kidney stone surgeries and bladder reconstructive surgery. Dr. Sethi, who will lead the clinical investigation, stated, “The ITNS is an exciting new development for treating OAB. This technology has potential to help many of my patients who need a new approach. I look forward to evaluating its performance.”

About Pacific Urology:

With clinics in Concord, Walnut Creek, Brentwood, San Ramon and Livermore, Pacific Urology is one of the San Francisco Bay Area’s largest urology practices. Pacific Urology restores urologic health for men, women and children, and treats numerous health issues including overactive bladder, prostate cancer, kidney stones, bladder and kidney cancer, erectile dysfunction, incontinence, infertility and more, while also performing vasectomy and vasectomy reversal. www.PacificUrology.com

About Nine Continents Medical:

This San Francisco Bay Area company’s technology has potential for helping patients with a variety of diseases, and its scientists and engineers are focusing its first clinical product on OAB. For additional information, contact Alan Ostroff, COO, at alan@9cmed.com. Find Nine Continents Medical on LinkedIn. www.9cmed.com

Leadership

Peter Jacobson

CEO

With 40+ years’ experience in active implantable devices, Peter has held executive leadership positions at ELA Medical, Sorin, and Nanostim and has been granted more than 25 patents. Peter was a co-founder of Nanostim and Nine Continents Medical.

Alan Ostroff

COO

With 35+ years’ experience in active implantable devices. Alan has held executive leadership positions at Cameron Health and Nanostim and has been granted more than 75 patents. Alan was a co-founder of Nanostim and Nine Continents Medical.

Wade Keller

Engineering Director

With 25+ years’ experience in medical devices, Wade has been responsible for the design and transfer to manufacturing of numerous medical devices. He previously held engineering positions at Cameron Health and Nanostim and has been granted more than 30 patents.