Targeted drug delivery and conventional medical management have shown to have a reduction in healthcare use and costs for cancer patients in comparison to conventional medical management alone, according to a new study from Medtronic. The study found that there were significant cost savings to payers and fewer inpatient visits with shorter inpatient stays. It […]
Neuromodulation/Neurostimulation
Brainsway sets terms for $30m IPO
Brainsway this week set the terms on its forthcoming initial public offering in the U.S., saying it hopes to raise nearly $30 million. The Jerusalem-based company, which developed a transcranial magnetic stimulation device to treat psychological disorders, said it plans to float 2.5 million American Depository shares at roughly $11.94 apiece. Each ADS is slated […]
Avanos Medical wins FDA nod for ON-Q Bolus pump
Avanos Medical (NYSE: AVNS), which rebranded from Halyard Health last June, said today that it won FDA 510(k) clearance for its ON-Q* with Bolus pump drug infusion device. The Alpharetta, Ga.-based company said that the new ON-Q* with Bolus system features improvements to improve ease of use and reduce postoperative opioid use for pain management. Read the whole story […]
FDA panel: Neuronix Alzheimer’s therapy fails to prove efficacy
An FDA advisory panel has unanimously agreed that the benefits of Neuronix’s NeuroAD system, intended to slow the progress of Alzheimer’s disease, do not outweigh the risks to patient health. Yoqneam, Israel-based Neuonix had applied for de novo clearance of the system. NeuroAD is approved for use in Europe, Australia and Israel, but the FDA panel found […]
Dyve Bioscience touts proof-of-concept study for transdermal painkiller
Dyve Bioscience this week touted data from a human proof-of-concept pilot study of its transdermal sodium bicarbonate therapy for pain reduction in people with acute gout flare. The study enrolled 24 people with a history of gout. Those in the active treatment group were given lotion containing sodium bicarbonate and menthol, while those in the […]
Theranica raises $35m Series B for neuromod migraine patch
Theranica Bio-Electronics said yesterday that it raised a $35 million Series B round for the Nerivio Migra neurostim patch it’s developing to treat migraine headache. Netanya, Israel-based Theranica said VC shop aMoon led the round, joined by all of its existing backers, Lightspeed Venture Partners, LionBird, Corundum Open Innovation and Takoa. The company raised an […]
Cala Health licenses MGH-developed neuromod tech
Cala Health said this week it inked a deal to license technology from Partners Healthcare and its affiliate Massachusetts General Hospital intended to improve the company’s non-invasive neuromodulation platform for investigating and treating chronic diseases. The licensed technology was developed from research on transcutaneous vagus nerve stimulation and respiratory-gated vagal afferent nerve stimulation at a […]
FDA issues ‘leap-frog’ guidance on brain/computer interfaces
FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch. FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used […]
Axonics Modulation Technologies slides on misses Q4, 2018 earnings
Axonics Modulation Technologies (NSDQ:AXNX) took a hit after it posted fourth-quarter and 2018 losses that exceeded the consensus forecast on Wall Street. The company is developing a sacral nerve stimulation device to treat incontinence. Irvine, Calif.-based Axonics said yesterday that its losses grew 95.6% to -$9.6 million, or -50¢ per share, on sales of $494,000 […]
Pacira to acquire Myoscience in $220m deal
Pacira Pharmaceuticals (NSDQ:PCRX) said today that it has signed a deal to acquire Myoscience and its pain relief device for up to $220 million. Myoscience’s iovera system is designed to safely freeze nerves while protecting surrounding tissue. As part of the deal that is slated to close by early April, Pacira plans to incorporate the iovera system into […]
Inspire Medical wins more Blue Cross Blue Shield coverage
Five more Blue Cross Blue Shield health plans have extended coverage to Inspire Medical Systems’ (NYSE:INSP) sleep apnea therapy, the company said today. These plans and the effective dates of their coverage are: Independence Blue Cross, in Pennsylvania, March 4, 2019; Blue Cross Blue Shield of Louisiana, Feb. 20, 2019; Wellmark, in Iowa and South […]