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| The Nuro System--Courtesy of Avanced Uro-Solutions |
Medtronic ($MDT) has just disclosed that it bought Advanced Uro-Solutions in December 2014 for an undisclosed amount. In August 2013, the FDA cleared the startup's neurostimulation device, the Nuro System, to treat overactive bladder (OAB) and its associated symptoms of urinary urgency, urinary frequency and urge incontinence.
Medtronic is planning to launch the device within the next 12 months in the U.S. through its Neuromodulation division within the Restorative Therapies Group.
Until now, the Elizabethton, TN-based company has flown largely under the radar. It was founded in 2009 by Dr. Brent Laing and Dr. John Green.
"The acquisition of Advanced Uro-Solutions expands Medtronic's portfolio of treatment options for those suffering from chronic symptoms of overactive bladder," Linnea Burman, VP and GM of gastro/urology therapies at Medtronic, said in a statement.
"Medtronic continues to invest in fully implantable bladder control and bowel control therapies, and the addition of the Nuro system to our existing portfolio of products will introduce more people suffering from bladder control issues to the benefits of neuromodulation," she added.
Medtronic already markets bladder control therapy that uses sacral neuromodulation; the InterStim system that was approved by FDA in 1997 for urge incontinence and in 1999 for urinary retention and significant symptoms of urgency-frequency.
The 510(k) clearance cited the Urgent PC Neuromodulation System from Uroplasty as the predicate product for the Nuro System.
The system works via tibial nerve stimulation to directly target bladder dysfunction. It's not an implant, but works by placing a 34-gauge needle near the ankle that's positioned along the path of the nerve. Use of the Nuro system for 30 minutes weekly is intended to resolve symptoms after 12 weeks. Some patients may need ongoing therapy every three to four weeks to sustain bladder function improvement.
Roughly one in six U.S. adults suffers from OAB, with an anticipated worldwide population of 546 million OAB patients globally by 2018 as the world's population ages, according to the company.
"Studies show that roughly 80% of patients prescribed oral medications to treat their OAB symptoms have stopped taking them at 12 months," Dr. John Green, former chairman and CEO of Advanced Uro-Solutions, said in a statement.
Medtronic's Neuromodulation unit includes implantable neurostimulation and targeted drug delivery systems for the management of chronic pain, common movement disorders, spasticity and urologic and gastrointestinal disorders.
In the most recent quarter Medtronic's neuromodulation revenues grew by mid-single digits with the larger Restorative Therapies Group adding 5% on a constant currency basis to hit $1.65 billion compared to the same quarter a year prior. That's a bit slower growth than for overall revenues, which were up 8% in constant currency to $43 billion during the quarter.
- here is the Medtronic release
- and the FDA letter clearing the Nuro System (PDF)