Helius Medical said today it signed a $7 million strategic agreement with A&B Company Limited to develop and commercialize Helius’ Portable Neuromodulation Stimulator in China, Hong Kong, Macao, Taiwan and Singapore. With the agreement, A&B will provide Helius with a $7 million credit facility, with $2 million drawn down and convertible promissory notes issued, the company […]
Neuromodulation/Neurostimulation
FDA clears Medtronic’s Tyrx envelope for DBS devices
Medtronic (NYSE:MDT) said today that it’s launching its Tyrx surgical envelope in the U.S. for use with deep-brain stimulation devices, after it won 510(k) clearance from the FDA for use of the infection-fighting envelope with implantable neurostimulators. Fridley, Minn.-based Medtronic said it’s planning to make the Tyrx device, acquired for $160 million in January 2014, available for […]
Medtronic wins expanded FDA PMA for Verify system
Medtronic (NYSE:MDT) said yesterday it won an expanded FDA premarket approval for its Verify system for testing patients for use with its Interstim bladder or bowel control sacral neuromodulation device during basic evaluations. The Verify allows patients with overactive bladder, non-obstructive urinary retention or bowel incontinence to test Interstim system for 3-7 days before making a long-term commitment, the Fridley, […]
Neuromod raises $6.2m in Series A
Neuromod said today it raised $6.2 million (EU€5.5 million) in a Series A round of financing, with fund slated to support its mutebutton bi-modal neuromodulation device for patients with chronic tinnitus. Funds from the round came from venture capital firm Fountain Healthcare Partners, the Dublin-based company said. “Neuromod is delighted to announce this investment, which […]
How Valencia Technologies got its anti-hypertension implant to trial for less than $11m
Jeff Greiner would be the 1st to tell you that developing a neurostimulation implant is an expensive process. It took $100 million for Advanced Bionics to develop a cochlear implant, Greiner told MassDevice.com, and another $50 million for its neurostim device. CVRx has raised more than $250 million for its neurostim implant for treating cardiovascular conditions, he noted. That’s why […]
St. Jude Medical wins CE Mark for Infinity DBS device
St. Jude Medical (NYSE:STJ) said today that it won CE Mark approval in the European Union for its Infinity deep-brain stimulation device and directional lead for treating movement disorders. Little Canada, Minn.-based St. Jude said the Infinity system is designed so that Apple (NSDQ:AAPL) mobile devices can be used as wireless controllers, via a Bluetooth connection. It’s […]
Great Lakes NeuroTech wins $1.9m NIH grant for Parkinson’s DBS research
Great Lakes NeuroTech said it won $1.9 million from the National Institute of Health to fund development and commercialization of a deep brain stimulation device for patients with Parkinsons disease. The device platform will combine wearable motor symptom sensing abilities and a DBS system into an integrated unit, as well as intelligent algorithms for searching […]
Tal Medical launches study of MR-based depression device
Tal Medical said today it launched a dose optimization trial of its low field magnetic stimulation device designed to treat depression and other neuropsychiatric disorders. The company said it enrolled the 1st patient in the randomized, placebo-controlled 120-patient study, with data from the trial expected in early 2017. “Initiating the dose optimization study represents a significant […]
Analyst: Nevro could have the upper hand in patent spat with Boston Scientific
Nevro Corp. (NYSE:NVRO) appears to have the upper hand in a patent challenge from Boston Scientific (NYSE:BSX) over its Senza chronic pain device, according to patent attorneys interviewed by Leerink Partners analyst Danielle Antalffy. Nevro’s Senza device, which won premarket approval from the FDA, is designed to deliver up to 10,000Hz to the spinal cord, allowing it to […]
Mainstay: ReActiv8 data may be enough for CE Mark, announces earnings
Mainstay Medical (EPA:MSTY) said that data from a trial of its ReActiv8 neurostim may be enough to win it CE Mark approval in the European Union and released its 6-month earnings today. The company’s multi-center, prospective ReActiv8-A clinical trial examined patients with chronic lower back pain treated with the company’s implantable ReActiv8 neurostimulation device. Of the […]
Mainstay Medical raises $15m
Mainstay Medical (EPA:MSTY) said yesterday it raised $15 million in a debt financing round to help fund its ReActiv8 implantable device for individuals with chronic low back pain. The debt facility came from IPF Partners, according to Dublin, Ireland-based Mainstay. “We are pleased to have secured this $15 million debt facility. These funds strengthen our financial […]