Software Machines and Adaptive Implants in Orthopedics (SMAIO) SA raised $10 million on the Paris Euronext Growth market. The offer price was set at $6.66 a share. “Thanks to this IPO, we will now be able to ramp commercial development of our I-Kontrol arthrodesis platform in Europe and secure a foothold in the United States,” Philippe Roussouly, CEO of SMAIO SA, told BioWorld.
A brainwave biomarker licensed by digital therapeutic startup Empower Therapeutics Inc. showed potential to identify patients with high sensitivity to pain. In a new study carried out by researchers at the University of Birmingham, U.K., the biomarker predicted which patients had a pain score of seven out of 10 or higher (severe pain) following lung surgery.
A 2,000-patient U.K. study has been set up to generate real-world evidence of the value of using AI technology to detect bowel polyps (adenomas) during colonoscopy procedures. The aim is to show whether Medtronic plc’s GI Genius system improves the detection of polyps when deployed in both expert centers and non-specialist units, in the routine diagnostic screening of patients referred from primary care or through the national fecal immunochemical testing program.
Cardiorenal is advancing a digital solution for chronic kidney disease (CKD) patients with a new seed investment. The Grenoble, France-based startup’s product Tenor attracted $3.7 million from investors to secure regulatory clearance in the U.S. and Europe.
Bringing a new medical device or diagnostic to market has never been a small feat for small companies, and regulatory review is still one of the largest hurdles facing device makers. However, a new report by Boston Consulting Group (BCG) and the UCLA Biodesign program shows that the twin issues of coverage and reimbursement still combine to present the most difficult hurdle to overcome for med-tech companies.
Carthera SA reported results from a pilot clinical trial to evaluate the safety and efficacy of its Sonocloud technology in patients with mild Alzheimer’s disease (AD). The results, published in Alzheimer’s Research and Therapy, show early promise of the treatment in reducing the amyloid load of AD and potentially other neurological conditions as well as to stimulate neurogenesis and improve cognitive performance.
With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues. For now, sponsors should apply the approaches and flexibilities used during the COVID-19 pandemic to the current situation, the groups said March 30.
The U.K. National Institute for Health and Care Excellence said its review of the Prontosan line of wound care products by B. Braun Medical AG of Melsungen, Germany, may be a cost saver for the National Health System compared to saline flush for chronic wounds. However, the agency also noted that most of the evidence of the effectiveness is of “not good quality,” suggesting that the company conduct more clinical trials to cover the evidence gap.
Leading clinicians in the U.K. have set out a blueprint for integrating pharmacogenomic testing into prescribing in all cases where there is a known association between a gene variant and how an individual will respond – or not – to a particular drug.
LONDON – A U.K. trial has shown it is possible to seamlessly insert point-of-care genotype testing for a rare genetic variant that causes hearing loss into the current care pathway in neonatal treatment for sepsis.
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