Andera Partners and Novo Holdings A/S led a financing round which raised $25 million for Fire1 Ltd. and will accelerate the development of the company’s remote monitoring technology that improves outcomes for heart failure patients. Andera and Novo are new investors in Fire1 and were joined in the fundraising round by existing investors Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic plc, New Enterprise Associates and Seventure Partners.
Woven Orthopedic Technologies LLC, received U.S. FDA 510(k) clearance for its Ogmend implant enhancement system for use in spine surgery. Ogmend is expected to give surgeons more confidence in using surgical screws when operating in compromised fixation scenarios.
Vivasure Medical Ltd. received a €30 million (US$32 million) strategic investment from Haemonetics Corp. to help develop its Perqseal closure device system which manages bleeding complications associated with large-bore arterial vessel closure. Haemonetics has an option to buy Vivasure upon the completion of the company achieving certain milestones.
Biotechnology startup Reveal Genomics SL said that a study, published in Nature Communication, found its machine learning-based technology applied to circulating tumor DNA (ctDNA) is able to predict drug response and survival outcome in patients with metastatic breast cancer treated with endocrine therapy and CDK4/6 inhibitors.
Startup Metsystem ApS received €500,000 (US$529,080) from Denmark’s Bioinnovation Institute (BII) that will allow the company to conduct trials to validate its personalized prognosis platform for cancer metastasis. An organ-specific assessment of the metastasis potential of a patient’s primary tumor would enable clinicians to better balance the trade-off between providing the potentially life-extending benefit of preventative chemotherapy to those at higher risk and avoiding the adverse effects from chemotherapy in those who are unlikely to need it.
The U.S. FDA granted Sooma Oy breakthrough device designation for its patient-administered neuromodulation device to treat depression. Sooma Depression Therapy uses a mild electrical current to stimulate targeted brain areas, resulting in a significant improvement in depressive symptoms.
Methinks Software SL (dba Methinks.AI), a digital health company, is working on the U.S. FDA submission for its artificial intelligence (AI)-based stroke triage software, which will aid in the detection of acute stroke, after recently receiving CE mark certification.
Feops NV hopes to raise €10 million (US$10.67 million) in a series C fundraising round that will allow the company to scale up its operations worldwide. This follows the release of a study in JACC: Cardiovascular Interventions which revealed that its cloud-based platform, Feops Heartguide, significantly improved efficiency and outcomes of left atrial appendage closure (LAAC) procedures.
CN Bio Ltd. launched the Physiomimix single-organ higher throughput system commercially in hopes it will foster the adoption of microphysiological systems which increase productivity, improve data quality and offer cost-effective solutions for drug discovery.
