URO-1 to Launch New Botox-Injection System for Treating Overactive Bladder
URO-1, a medical device startup company in Winston-Salem, has received approval from the U.S. Food and Drug Administration to begin marketing its first product, a new system using existing endoscopes for injecting Botox into the bladder to treat overactive bladder.
The instrument, called the Repris Bladder Injection System, is intended to make Botox injections easier for doctors and more comfortable for patients while improving treatment outcomes, said Ted Belleza, URO-1’s president and chief executive officer.
“It’s a win-win-win,” he said.
URO-1 will introduce Repris at the annual meeting of the American Urological Association in San Francisco this month, then make instruments available to doctors in the Southeast for use in procedures for several months “to confirm market assumptions and develop sales tactics,” Belleza said.
URO-1 recently received a $250,000 Small Business Research Loan from the North Carolina Biotechnology Center to help commercialize the device.
“The progress of URO-1 contributes greatly to supporting the growing cluster of early stage medical device companies in the Piedmont Triad,” said Nancy Johnston, executive director of the Biotech Center’s Piedmont Triad Office. “It also shows the value of experienced medical device entrepreneurs, medical expertise and product development know-how.”
URO-1 will use the loan to tool up product manufacturing and defray the costs of market launch, Belleza said.
Precision delivery of Botox
The idea for the Repris Bladder injection System came from John J. Smith III, M.D., a Winston-Salem urologist.
Repris is intended to replace current endoscopic instruments used by urologists to inject Botox into the bladder wall via the urethra. Those devices use a metal alloy sheath as a conduit for three lumens, or thin tubes, that allow an endoscope lens, a needle and fluids access to the bladder.
Repris uses a disposable polymer sheath that is much less expensive. It also contains a polymer-based, needle-tipped cannula that reverts to its preformed curve when extended into the bladder. The curve of the retractable “memory cannula” gives doctors better control of the instrument and easier access to a broader area of the bladder for precise delivery of Botox, Belleza said.
Repris also helps them repeatedly inject the precise amount of Botox with confidence, he said. The instrument includes a no-look metered syringe that produces an audible click and a tactile cue when a precise volume of medicine is injected, removing the guesswork.
“Among the (assisting) nurses, that’s a hit,” Belleza said. “I love simple solutions, and that one’s so simple.”
Repris allows physicians to follow specific procedural steps that have been shown to reduce urinary retention, a complication of Botox injections in which patients can’t release urine. The condition requires patients to self-catheterize their bladders, an uncomfortable procedure. That prospect that can inhibit many patients from undergoing Botox treatment and deter many first-time patients from seeking follow-up treatments.
Overactive bladder a common condition
Overactive bladder, also called urge incontinence, is a frequent and acute need to urinate, followed by the involuntary leakage of urine. It is caused by bladder muscle spasms. Botox injections relax those muscles.
Botox, a bacterial neurotoxin that temporarily paralyzes muscles, has been a blockbuster cosmetic drug for smoothing frown lines and facial wrinkles for nearly two decades before being used more recently to treat overactive bladder and even migraine headaches.
The FDA estimates that 43 million Americans have overactive bladder and that as many as 30 percent of men and 40 percent of women experience symptoms.
Belleza estimates that from 300,000 to 500,000 Botox injections for overactive bladder are performed annually – “a fairly impressive number,” he said.
Because most patients who seek treatment are women, URO-1 will target that market first with Repris, he said.
The company will rely on Novex Innovations, a contract development and manufacturing organization in Winston-Salem, to scale up production of Repris, Belleza said. URO-1, currently located in the Richard Dean Anderson Biomedical Research Building in the Wake Forest Innovation Quarter, will soon move across the street into the same building that Novex occupies in the technology park.
Planning to increase staff later this year
URO-1 was established in late 2016 by four co-founders – two of them physicians. It is backed by $1.36 million in series A financing led by the venture capital firm Acorn Campus Taiwan with participation by several angel investors including four doctors. Acorn, with U.S. operations in Santa Clara, Calif., invested in Belleza’s most recent venture, EndoSee Corp., of Los Altos, Calif.
URO-1 has three employees – Belleza, Chief Technical and Operating Officer Jack Snoke and Vice President of R&D Philip Allred. It will likely add one or two more later this year, Belleza said.
URO-1 has conceptualized other potential urology products including one for treating ureteral and kidney stones and another undisclosed one that is halfway through the development process. Belleza said the cannula invention used in the Repris system could become a platform technology with multiple medical applications.
Belleza is a California-based entrepreneur and business development executive with three decades of experience at several successful medical device companies. In late 2010 he co-founded EndoSee, maker of a hand-held disposable office hysteroscope -- a thin, lighted tube that is inserted into the vagina to examine the cervix and inside of the uterus. The company was acquired by Cooper Surgical in 2014.
Belleza came out of an 18-month retirement in 2017 to lead URO-1. The company is preparing to launch its website in conjunction with its participation in the upcoming American Urological Association meeting.