In a pivotal milestone for Memed Ltd., the U.S. FDA cleared its Memed BV test on whole blood samples, which will help health care providers distinguish between bacterial and viral infections. The test, which yields results in as little as 15 minutes, can reduce the risk of unnecessary prescriptions which is a key driver of antibiotic resistance.
Organox Ltd. raised £25 million (US$33 million) in a funding round that will allow the company to expand its operations in the U.S. on the back of significantly increasing demand from transplant centers, Oern Stuge, executive chairman, at Organox told BioWorld. The Oxford, U.K.-based company which makes systems to preserve and transport livers for transplant is also preparing for its eventual listing on Nasdaq, he added.
Caristo Diagnostics Ltd. is deploying its medical imaging technology, Cari-Heart, at several NHS hospitals in a pilot project that will help identify patients at risk of heart attack years before it occurs. Cari-Heart detects signs of inflammation around coronary arteries. “No other company is doing this,” Frank Cheng, CEO of Caristo told BioWorld. “No one is using CT to quantify and visualize coronary inflammation” to predict the risk of a heart attack years in advance.
Inovedis GmbH received clearance from the U.S. FDA for its Sinefix implant system, which can be used to repair rotator cuff tears. Sinefix allows surgeons to refix the rotator cuff tendon to the bone using a simplified surgical technique that aims to significantly reduce the time and cost of the procedure.
Sonio SAS closed its series A fundraising round raising $14 million that will go some way in helping the company deliver on its mission to improve access to quality pregnancy monitoring for women everywhere through its software-as-a-service (SaaS) platform. Sonio has developed an artificial intelligence (AI) prenatal screening solution that automates ultrasound reporting while providing image quality control and detection of potential anomalies. The capital raise was led by Cross-Border Impact Ventures, a North American impact fund dedicated to the health of women and children.
The European Commission (EC) fined Illumina Inc. a record €432 million (US$476 million) for closing the acquisition of Grail Inc. before receiving regulatory approval. It is the highest fine ever imposed on a company by the EC for completing a deal without its consent. Grail was fined €1,000. The companies were found to be in breach of EU merger control rules.
Coloplast A/S agreed to acquire wound care company Kerecis Ehf for up to $1.3 billion in a bid to strengthen its presence in the high-growth, U.S.-centric biologics segment. Kerecis has developed a technology which uses intact fish skin from Atlantic cod to treat chronic wounds. It has around 5% share of the U.S. biologics market.
Parasym Ltd.’s neuromodulation technology significantly decreased postural tachycardia syndrome (POTS) and has the potential to be a safe and effective treatment for individuals living with the condition, according to a recent study. The result from the trial represents a substantial breakthrough for people with POTS, as there are no U.S. FDA approved treatments for the condition, Nathan Dundovic, co-founder at Parasym, told BioWorld.
Electromedical Products International Inc. (EPI) Alpha-Stim AID technology is finally being made available by the NHS in the U.K. to treat patients with anxiety some two years after the National Institute for Health and Care Excellence (NICE) said there was not enough good-quality evidence to support the case for routine adoption.
The €5.5 million (US$6 million) Escala Medical Ltd. recently received from the European Innovation Council will help the company expand its operations as it looks to officially launch its Apyx device in the U.S. later this year, CEO and founder Edit Goldberg told BioWorld. Already FDA-cleared, Apyx offers incision-free pelvic organ prolapse (POP) treatment to the women suffering from the often painful and debilitating condition.
