Dariohealth Corp. and Sanofi U.S., a subsidiary of Paris-based Sanofi SA, inked a strategic agreement that provides Dario with $30 million to speed commercial adoption of the company’s integrated digital therapeutics platform. The company simultaneously announced definitive agreements with institutional investors to purchase approximately 5,342,013 shares of its common stock at $7.49 per share, a deal that will generate about $40 million for the company.

PARIS – One year after inception, Lauxera Capital Partners SAS reported final closing of its Lauxera Growth I fund at nearly $300 million, making it the leading European fund devoted to financing health-tech businesses. Lauxera Capital’s objectives involve supporting fast-growing European firms and ramping their international business development.

Germany passed a law in 2019 that provides for a combined premarket review and coverage mechanism for lower-risk devices that provides a staged path for rate-setting with the help of real-world evidence (RWE). That model has caught the attention of other European Union member states, such as France, but may be useful in the U.S. as well, given the FDA’s policy moves for RWE and digital health over the past few years.

Med-tech deals are showing a 136% increase in value, partially due to rising interest in digital health technologies, and despite decreasing activity focused on the COVID-19 pandemic. While deal values are up, the opposite is true for M&A values. They have fallen by 15% in comparison with the same time frame last year.

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.

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.”

PERTH, Australia – Impedimed Ltd.’s L-Dex bioimpedance technology could quickly become the standard of care for measuring cancer-related lymphedema following clinical trial results that showed a 59% relative reduction in progression compared to the standard of care, Impedimed CEO Rick Carreon told BioWorld.

Blue Note Therapeutics Inc. took a new approach to expanding its pipeline of prescription digital therapeutics (PDT) with an exclusive licensing agreement with the University of Sydney for Conquerfear, a metacognitive intervention that helps cancer survivors cope with the fear of disease recurrence. Blue Note has developed its PDTs internally to date but hopes to convert Conquerfear’s elements, which are typically delivered face-to-face, into a PDT for the U.S. and Canada. As a digital therapy, the program could potentially reach many more patients.

As attention turns to new drugs that can address the growing burden of Alzheimer’s disease (AD) in an aging global population, Retispec Inc. has developed a noninvasive test that may be able to detect early signs of the neurodegenerative disease decades before clinical symptoms appear – and when therapies appear to be most helpful in slowing or reversing Alzheimer’s. By using “off-the-shelf” ophthalmic equipment, the Toronto-based company’s solution enables assessment by optometrists or other eye professionals during a standard eye exam.

Developers of apps for digital health have struggled to obtain Medicare coverage in the U.S. for their products, an impasse that seems unlikely to resolve anytime soon. Jason Bennett of CMS said on a Feb. 9 webinar that while the durable medical equipment (DME) benefit category seems like a natural fit for digital health products, there are some statutory and definitional roadblocks, including that digital health products might not be durable enough to qualify.