A neurostimulation device developed to treat focal epilepsy has received breakthrough device designation from the FDA. Precisis AG’s Easee [Epicranial Application of Stimulation Electrodes] minimally invasive system is designed to deliver individualized brain stimulation without neurosurgery. The electrode is placed subcutaneously on the cranium and a current is applied to the affected brain area to prevent or mitigate seizures.
A sense of normalcy is returning to the U.K., at least from a regulatory perspective. The U.K.’s Medicines and Healthcare Products Regulatory Agency will continue to support COVID-19 clinical trials with ongoing regulatory and scientific input, but all further applications and meeting requests for COVID-19 products will be considered according to usual timelines rather than on an emergency basis, the agency said Feb. 23.
PARIS – Companion Spine SAS has raised $55 million to help develop its noninvasive diagnostic and interventional implant solutions for the treatment of degenerative disc disease and lumbar spinal stenosis. This series A round was led by Viscogliosi Brothers LLC, a New York-based investment company specializing in financing disruptive technology in spine treatment.
LONDON – Oxford University spinout Oxdx Ltd. has raised £2.6 million (US$3.6 million) in pre-seed funding to advance development of a technology for directly identifying infectious pathogens without the need to purify, culture or amplify samples first. The instant testing method uses a mixture of a single universal reagent, high resolution microscopy and machine learning, to identify specific species and strains of bacteria, viruses and other pathogens within minutes.
Paving the way for wider dissemination of up-to-date information on drugs approved in the EU, the European Medicines Regulatory Network adopted a common standard for the electronic product information (EPI), which includes the package leaflet for patients and the summary of product characteristics for health care professionals.
U.K. startup Tympahealth Technologies Ltd. has received $8 million in seed financing for commercialization of its point-of-care hearing health assessment system. The Tympa system is a CE marked and FDA-registered device for high-resolution ear drum visualization, ear wax removal and hearing screening assessments. Health care entrepreneurs Maurice Ferre and Arjun Desai led the financing round.
Mindmaze SA continued to add significant funds to its coffers with $105 million as part of a series B financing round, following a $125 million debt financing in October. The new money brings total funding to more than $300 million for the company’s virtual reality-based digital neurotherapeutics platform. Its successful fundraising has pushed the company into unicorn status, making it the first Swiss firm to be valued at more than $1 billion.
LONDON – Two years into the pandemic and the number of new drugs approved by the EMA fell from 97 approvals in 2020 to 92 in 2021. But both years are still well up on pre-COVID-19 times in 2019 when 66 products got the nod, according to the EMA’s annual human medicines report.
In the latest chapter in an ongoing contract dispute between AOP Orphan Pharmaceuticals GmbH and Pharmaessentia Corp., the German Federal Court of Justice this week set aside the €143 million (US$162.8 million) in damages awarded to AOP, citing procedural flaws in quantifying the product supply and damages.
Swiss spinal surgery company Neo Medical SA has closed a $20.6 million financing round led by Swisscom Ventures. The funds will be used for U.S. commercialization of the company’s Advise augmented reality (AR) platform for spinal surgery. The platform is due to launch this year and will complement Neo Medical’s existing implant and instrument solutions. “The funds will be used for recruitment of sales direct sales force, training and education activities in the U.S. as well as U.S. scientific and clinical activities,” Neo Medical CEO Vincent Lefauconnier told BioWorld. “In 2022, we will see some key scientific and clinical work being published showing the massive benefit for patient of the use of our unique combination of technologies.”
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