PARIS – Two months after successfully listing on Euronext Brussels and Euronext Amsterdam stock exchanges, raising nearly $100 million, Onward Medical NV reported completion of enrollment in its Up-LIFT study on its noninvasive electrical spinal cord stimulation, called Arc therapy.
Medtronic plc snagged FDA premarket approval for its recharge-free implantable neurostimulator (INS), Vanta, for patients with intractable pain. The spinal cord stimulator offers up to 11 years of device life, with optimal programming. That represents a 10% improvement on the Dublin-based company’s previous longest-lasting INS, Primeadvanced, and a near doubling of device life compared to Abbott Laboratories’ Proclaim and Boston Scientific Corp.’s Wavewriter Alpha, using the settings recommended in the clinician manuals.
LONDON – Wise Srl has received CE marking for its cortical strip electrode, validating the underlying flexible electronics technology and opening the door to the development of implantable devices for long-term neurostimulation.
Medtronic plc has launched Careguidepro, its first patient-focused digital tool for spinal cord stimulation. The mobile app and online portal enables providers to better manage patients’ pain relief with real-time feedback and data.
Onward NV secured $32 million in a new financing round led by Invest-NL and Olympic Investments. All the company’s existing investors also participated in the round, including medical technology investors LSP, Inkef Capital, Gimv, and Wellington Partners. The new funds will support Eindhoven, Netherlands-based Onward's development and commercialization of its Arc-Im and Arc-Ex spinal cord systems, designed to provide targeted spinal cord stimulation to help people with spinal cord injuries regain movement and independence.
Nevro Corp.'s spinal cord stimulation system cut diabetic neuropathy pain in half or more in 85% of patients in a study published on April 5 in JAMA Neurology. Patients receiving the stimulation treatment delivered by the Senza system experienced an average reduction in pain of 76% at six months in the largest clinical largest trial to date to evaluate the use of spinal cord stimulation (SCS) in painful diabetic neuropathy (PDN).
Medtronic plc is looking to increase market share in pain stimulation with its differential target multiplexed (DTM) therapy, a recharge-free device and its next big disrupter, evoked compound action potential (ECAP). The company is currently developing a closed-loop SCS system for chronic pain following failed back surgery based on ECAP and DTM algorithms.
Nevro Corp. has submitted a premarket approval supplement to the U.S. FDA seeking a green light for its Senza system to treat chronic pain associated with painful diabetic neuropathy (PDN). This submission is expected to allow the company to gain approval and kick off U.S. launch activities for this indication in the second half of next year. Nevro would be tapping into a big market, as diabetes affects roughly 1 in 10 adults in the U.S. and can damage peripheral nerves, resulting in severe pain and numbness in the extremities.
Medtronic plc reported 12-month data from a large, multicenter, randomized controlled clinical trial affirming the superiority of differential target multiplexed spinal cord stimulation (DTM SCS) in relieving chronic back pain, vs. traditional SCS therapy, using its Intellis platform.
SAN FRANCISCO – After slowing growth starting in mid-2018 and a court battle with Boston Scientific Corp. that ended in a favorable resolution, 2019 was a much better year for pain neurostimulation player Nevro Corp., as it launched a major new product. So far, 2020 is looking up too. Its shares (NYSE:NVRO) gained 5% following a presentation at the J.P. Morgan (JPM) Healthcare Conference, where it preannounced 2019 revenues and offered 2020 guidance.
