Tensive Srl's Regenera, a bio-absorbable breast implant, promises to help the millions of women who undergo breast cancer surgery every year, to feel whole again. “While surgery will save many lives, it comes at the cost of losing something very personal, which is the sense of a woman's wholeness. I think that's what has been a major challenge,” Sanjay Kakkar, CEO told BioWorld.
Regulatory and reimbursement challenges in Europe are leading an ever-increasing number of med tech companies to prioritize the U.S. market for the launch of their devices. However, certain technologies can reach European patients more quickly, presenting valuable opportunities with the EU, delegates heard at the LSI Europe ’25 conference in London this week.
Safeheal SAS secured a further €10 million (US$11.72 million) in a series C extension funding round, adding to the €35 million it raised earlier in the year. The funds will go towards Colovac, its temporary endoluminal bypass device designed as an alternative to stoma for colorectal cancer patients undergoing surgery.
The financing environment remains difficult for solutions addressing women’s health, Lara Zibners, co-founder and chair of Calla Lily Clinical Care Ltd., told BioWorld. “Until I entered this space, I've never spoken to an investor in any other area who said, ‘I need to go home and ask my wife’,” she said on the sidelines of the LSI conference in London.
Companies developing AI-based health care solutions need to ensure they have quality data, a solution that can easily integrate into clinical workflow systems and teams with evolving skills, to attract investment, delegates heard at the LSI Europe ’25 conference in London.
IMU Biosciences Ltd. is working to transform society’s understanding of the immune system. The company’s platform maps the immune system at molecular, cellular and system levels, to unlock new insights into immune-related health and diseases, paving the way for clinical applications that could improve patient outcomes.
IMU Biosciences Ltd. is working to transform society’s understanding of the immune system. The company’s platform maps the immune system at molecular, cellular and system levels, to unlock new insights into immune-related health and diseases, paving the way for clinical applications that could improve patient outcomes.
Quantum Surgical SAS has secured CE marking for the expanded use of its Epione robotic platform to treat bone tumors and metastases. The regulatory green light allows surgeons to use Epione to treat inoperable tumors which are difficult to reach due to their size or location at an early stage, in a simple and effective way.
Vicentra BV’s insulin patch pump, Kaleido, will soon reach more patients with diabetes after it raised $85 million in a series D funding round. The company said the Kaleido is among the smallest, lightest, and most precise insulin patch pumps available.
Cyted Health Ltd. raised $44 million in a series B financing round to expand the reach of Endosign, its capsule sponge technology, in the U.S. Endosign is a minimally invasive device used to collect cell samples from the esophagus for the early detection of esophageal diseases, offering the potential to transform early cancer detection and improve health outcomes.
