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.
The fundraising environment for startups in med tech is expected to continue to be challenging for at least another year as public markets remain closed and private investors favor companies that have already de-risked their products. One of the major issues in the U.K. and Europe is that the IPO markets are “pretty much shut” and “our public markets aren’t working”, therefore companies are having to rely on private funding, with venture capital being one of those sources, said Robert Tansley, partner, at venture capital fund Cambridge Innovation Capital (CIC).
As companies increasingly use artificial intelligence (AI) in medical devices and applications to help treat and diagnose patients, innovators must be careful of excluding large sections of the population in their algorithms and in their data gathering process, delegates heard at the Medtech Futures conference in Cambridge, U.K.