Blog Tag: Neuromodulation
NeuroTronik Closes $23.1 million Series B Round
NeuroTronik, a North Carolina based subsidiary of NeuroTronik LTD of Dublin, announced that it recently closed a $23.1 million Series B funding round. The press release noted that the round was led by contributions from Boston Scientific, Synergy Life Science Partners, and several venture capital firms. NeuroTronik was quoted in the release as aiming to improve patient outcomes, shorten hospital stays, and reduce hospital recidivism rates.
According to NeuroTronik, the therapy, known as CANS Therapy, utilizes a neuromodulation device designed to stimulate the cardiac autonomic nerve via a catheter. NeuroTronik describes the device as less invasive than currently used implantable defibrillators, providing an alternative to drug-based treatments. According to the company, NeuroCatheterTM is temporarily placed in a vein just above the heart and is controlled via an external NeuroModulatorTM that can be positioned bedside.
“Physicians need better therapy tools to treat Acute Heart Failure in the hospital. With the achievement of our Series A milestones and through subsequent work, our team has demonstrated that NeuroTronik CANS Therapy™ holds considerable promise to be a unique and valuable tool for physicians for use in this clinical setting,” said Fred McCoy, CEO and Director, NeuroTronik LTD in a prepared statement.
NeuroTronik stated that it plans to use the Series B funding to obtain regulatory approval to market its CANS Therapy device in Europe. After obtaining European approval, NeuroTronik plans to bring the treatment to the United States.
Previous news sources state that NeuroTronik closed a $13.1 million Series A round in May of 2013, and was spun out of a medical technology incubator called Synecor in 2012.
Stimwave’s Wireless Pain Relief SCS System Receives FDA Clearance
Fort Lauderdale-based company Stimwave Technologies announced today that its eight-electrode wireless, micro-technology neuromodulation device for relief of chronic back and leg pain received FDA 510(k) clearance. The Company plans to begin full nationwide commercialization January 1, 2016.
According to Stimwave, its Freedom-8A Spinal Cord Stimulation (SCS) System is the world’s first fully-programmable wireless SCS neuromodulation device that eliminates the need for painful tunneling and internal battery placement within the body. Stimwave states that its device features a compact 0.4 cc profile and eight electrodes placed near nerve fibers around the dorsal aspect of the spinal column. The device is said to deliver selected pulses of energy to the electrodes to alter the transmission of pain signals to the brain. Additionally, Stimwave notes that its device is implanted in an outpatient setting through a standard needle, eliminating the need for general anesthesia or a large surgical incision.
Dr. David Kloth, M.D., medical director of the Connecticut Pain Care Center and author of Pain Wise, stated:
“Patients’ needs in pain management are complex and unique. The Freedom-8A SCS System is a first-of-its-kind product and offers a wide variety of advanced programming features, polarity selection options for up to eight separate electrodes per device, in the body in the least invasive fashion ever offered. This advancement will provide clinicians with a multitude of options and allow patients the most amount of freedom over their pain management.”
According to the press release, Stimwave is currently investigating the safety and efficacy of even wider programmability options, such as high-frequency programming up to 10,000 Hz, in an FDA approved clinical trial.
Medtronic Continues Expansion After Covidien Acquisition
Medtronic PLC recently announced its acquisition of Advanced Uro-Solutions, a Tennessee-based privately-held developer of neurostimulation products for treatment of bladder control issues. According to the Star Tribune, the terms of the acquisition, which closed in December 2014, were not disclosed.
Medtronic describes itself as a leader in the field of neuromodulation, the targeted and regulated delivery of electrical impulses and pharmaceuticals to specific sites in the nervous system. Medtronic states that its current portfolio includes implantable neurostimulation and targeted drug delivery systems for management of chronic pain, common movement disorders, spasticity, and urologic and gastrointestinal disorders.
Advanced Uro-Solutions manufactures a percutaneous tibial nerve stimulation system called the NURO™. The NURO is promoted for use in therapy that involves a small external stimulator and a single, reusable lead. It is described as providing temporary stimulation to the tibial nerve and treatment to patients with overactive bladder (OAB) and other urinary irregularities. According to the FDA’s 510(k) Premarket Notification Database, the NURO device was cleared by the FDA for the treatment of OAB as being substantially equivalent to a predicate device, the Urgent PC Stimulator (manufactured by Uroplasty, Inc.).
The USPTO Assignment database includes records for three patents and patent applications that have been assigned to Advanced Uro-Solutions LLC, including: U.S. Pat. Pub. No. 2014/0288613, U.S. Pat. No. 8,818,520, and U.S. Pat. No. 8,660,646. Each of these is entitled “Percutaneous Tibial Nerve Stimulator.” FIG. 2 of the ‘646 patent is shown to the left.
Medtronic states that it plans to implement the NURO system in the U.S. within the next 12 months, adding to its portfolio of urinary and bowel control therapies. Medtronic’s acquisition of Advanced Uro-Solutions follows shortly after its recent $49 Billion acquisition of Covidien.