Uromems SAS raised $47 million in a series C financing round for its Uroactive system, the first smart automated artificial urinary sphincter device to treat stress urinary incontinence. With the funds the company will be able to “tackle the last stage of our clinical trials before commercial launch,” Hamid Lamraoui, CEO and co-founder of Uromems, told BioWorld.
Femasys Inc. received CE mark for four women’s health products – Femaseed, Femvue, Femcerv and Femcath – after obtaining certification under the EU Medical Device Regulation. This allows the company to expand its market reach and it will now focus on delivering its innovative solutions for women’s reproductive health within the EU.
The problems with devices for low-volume conditions are well known, and regulatory agencies such as the European Union’s Medical Device Coordination Group are working to ease the regulatory hurdles for these products.
The industry is again raising concerns that new EU health technology assessment rules coming into force on Jan. 12, 2025, will have the opposite of the desired effect and slow down access to innovative therapies.
France’s Théa Open Innovation, a subsidiary of Laboratoires Théa SAS, terminated its licensing agreement with South Korea’s Olix Pharmaceuticals Inc., and returned global rights of Olix’s ocular small interfering RNA (siRNA) biologic agents, OLX-301D and OLX-301A.
Cureosity GmbH has raised €3.8 million (US$4.1 million) in growth financing to expand the use of its virtual reality therapy which promotes the sensorimotor and cognitive rehabilitation in patients who have suffered a stroke or with neurodegenerative diseases. The funding came from existing and new investors including Techvision Fonds and Nomainvest, a Belgian family office.
France’s Théa Open Innovation, a subsidiary of Laboratoires Théa SAS, terminated its licensing agreement with South Korea’s Olix Pharmaceuticals Inc., and returned global rights of Olix’s ocular small interfering RNA (siRNA) biologic agents, OLX-301D and OLX-301A.
A team of researchers have developed a blood test which uses artificial intelligence to predict Parkinson’s disease in patients up to seven years before symptoms appear. The test, based on the identification of eight biomarkers in the blood, will be able to identify patients who can be treated earlier with therapies to slow down the progression of the disease or even prevent it from occurring.
Newco Yellowstone Biosciences Ltd. has been formed to develop soluble bispecific T-cell receptors against a novel class of tumor-specific antigens it has discovered in leukemia patients who were cured by a donor stem cell transplant. The company has proprietary access to a biobank of over 10,000 samples from more than 3,000 acute myeloid leukemia (AML) patients. A small number of these patients were cured by an allogeneic bone marrow transplant, whilst unusually, having no sign of graft-vs.-host disease.
Scientists spread across Europe and the U.S. filed for protection of an implantable electrode array including a plurality of microneedles, which may be implanted into the auditory nerve bundle and stimulate the auditory nerve in response to receiving electrical signals representative of observed sounds.