Brainaurora Medical Technology Ltd. has filed for an initial public offering (IPO) in Hong Kong to develop its digital therapeutics for the treatment of cognitive impairment diseases. The company claims to be the first in China to launch a digital therapeutics (DTx) product for cognitive impairment, as well as the largest company in China in terms of revenue from the commercialization of cognitive impairment DTx products in 2022.
Luminopia Inc. reeled in $16 million in an oversubscribed series A financing led by U.S. Venture Partners. The funds will support full commercial launch of the company’s U.S. FDA-cleared digital therapeutic for the treatment of children ages 4-7 with amblyopia. “We are thrilled to announce the successful close of our oversubscribed series A round, which will allow us to advance our mission of pioneering a new class of treatments for the 15 million Americans who suffer from neuro-visual disorders,” said Scott Xiao, Luminopia’s co-founder and CEO.
Cardiorenal SAS reported it has been granted a breakthrough device designation by the U.S. FDA for its Tenor at-home blood potassium measuring device. The Tenor smart device combines multiple technologies, app and cloud capabilities to assist patients with chronic kidney disease in measuring their blood potassium levels from home, obtaining results in under five minutes.
There is a growing body of evidence showing prescription digital therapeutics (DTx) are effective, but slow progress in agreeing reimbursement and integrating them into care pathways is limiting access for patients and holding back commercial development in Europe.
Pear Therapeutics Inc. filed for bankruptcy protection under chapter 11 to buy time to sell its assets. The company was the first-to-market for prescription digital therapies, with three PDTs gaining regulatory nods from the FDA: Reset for substance use disorder, Reset-O for opioid use disorder and Somryst for insomnia. Reset-A received breakthrough device designation in 2021. The Reset therapies are approved for use in conjunction with medication therapy or other outpatient therapy for substance use.
Visionhealth GmbH will use the €3 million (US$3.2 million) it recently raised in a pre-series A financing to conduct a clinical trial on its digital health app designed to provide more accurate dosing of treatments for chronic obstructive pulmonary disease (COPD) and asthma.
Wangli Technology, a subsidiary of Adai Technology (Beijing) Co. Ltd., has raised ¥100 million (US$14 million) to continue developing digital therapeutics aimed at mental health indications.
Vicore Pharma Holding AB and its partner Alex Therapeutics AB reported positive results from the U.S. pilot phase of a study assessing the effects of digitally delivered cognitive behavioral therapy (CBT) in treating anxiety in patients with idiopathic pulmonary fibrosis (IPF). The four-week study in 10 patients found the digital therapeutic, called Almee, functioned properly, was safe and the user experience was favorable.
Millions of patients with fibromyalgia have battled widespread pain with few effective treatment options for decades. The U.S. FDA has offered reason for hope and better health with four recent decisions. On Oct. 4, Solon, Ohio-based Multi Radiance Medical Inc. (MRM) received clearance for its Fibrolux therapy laser for the condition, following Neurometrix Inc.’s de novo authorization for its transcutaneous electrical nerve stimulation device, Quell, in May. Remedee Labs SA received breakthrough device designation (BDD) for its endorphin stimulation system in May and Swing Therapeutics Inc. was granted BDD for its digital therapy in Aug. 2021.
In May, Sidekick Health AB revealed an expanded partnership with New York-based Pfizer Inc. for autoimmune-related conditions. Now, it has joined forces with Eli Lilly and Co. to help patients battling breast cancer with its gamified platform. The companies plan to introduce the integrated digital therapeutic starting in July with the roll out beginning in Germany.
