With a round of conference presentations and a new marketing program launched this week, Sight Sciences Inc. kicked off a focused effort to increase awareness of its Omni surgical system’s FDA clearance for glaucoma procedures performed independently of cataract surgery. The coordinated push aims to further boost revenues, which saw an estimated 65% increase compared to 2020 and 12% increase quarter-on-quarter, based on preliminary fourth quarter and fiscal year 2021 results.
It’s no mystery why Scipher Medicine Corp. successfully raised $110 million in a series D financing round to further develop the company’s precision medicine platform. The company aims to address one of most modern medicine’s most challenging enigmas: how to eliminate the cost and adverse effects associated with the prescription of expensive medications that provide life-changing outcomes for some and no benefit for others. The new funds boost Scipher’s total funding to $227 million, of which $192 million has come into the Waltham, Mass.-based company’s coffers in the last 12 months.
Noninvasix Inc. received a breakthrough device designation from the FDA for its noninvasive Livox central venous oxygenation monitor, which allows real-time monitoring of central venous oxygen saturation (ScvO2) in patients at risk of septic shock. The Noninvasix optoacoustic platform consists of a disposable patient interface with a reusable probe, data display and hardware.
Several recent studies highlight the rapidly expanding applications for neuromodulation using bioelectronic devices. A pair of articles in the Journal of the American Heart Association and Journal of the American College of Cardiology focused on the benefits to patients with heart failure and those at risk of post-operative atrial fibrillation, respectively. A study published in Brain Stimulation found that 85% of tinnitus patients experienced resolution of their symptoms when using a neuromodulation device.
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.
With an ambitious goal of bringing 24/7 electroencephalogram (EEG) capabilities to hospitals across the country, Epitel Inc. closed a $12.5 million series A financing round that it plans to use to fund the initial pilot for commercialization of its wearable, wireless EEG platform. The Epilog platform received FDA clearance for use in hospital emergency departments and critical care units last year.
In a move that stunned and dismayed analysts and investors, Masimo Corp. announced a definitive agreement to acquire Sound United LLC Tuesday evening for $1.025 billion. Masimo’s stock (NASDAQ:MASI) plunged on the news of its intended purchase of the high-performance consumer audio products company, plummeting 39% from $228.84 at Tuesday’s close to $139.60 at Wednesday’s opening bell. Volatility led the Nasdaq to suspend trading in the stock for four minutes before 10 am. The stock recovered slightly during the day to close Wednesday at $147.00.
With an FDA 510(k) clearance now in hand, Cloudcath Inc. is planning a phased launch of its remote monitoring platform for peritoneal dialysis (PD) patients. The company will make the system available on a limited basis in second half of 2022 “with broad U.S. availability increasing throughout 2023 and 2024,” Cloudcath CEO Aly ElBadry told BioWorld. The Cloudcath system continuously analyzes the dialysate fluid used in PD to detect early signs that a patient needs evaluation or intervention and then alerts both patients and clinicians.
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.
At long last, the FDA granted premarket approval to Senseonics Holdings Inc.’s fully implantable Eversense E3 continuous glucose monitoring (CGM), an implantable device that provides accurate glucose readings for six months. The CGM will be available in the U.S. through Senseonics’ commercial partner, Ascensia Diabetes Care Holdings AG, starting in the second quarter. In Europe, the previous generation Eversense XL is available today and the company plans to launch the E3 in the third quarter of 2022.
