Diagnostics innovator Renalytix AI plc and dialysis giant Davita Inc. partnered to develop a program to identify individuals with early-stage kidney disease and improve outcomes for the 37 million Americans with chronic kidney disease (CKD). The companies plan to launch the collaborative effort in three cities in 2021 to build a diverse, real-world evidence dataset as a base for moving forward.

While the first quarter may be a little slow as the winter COVID-19 surge continues to disrupt business, expect high capital reserves in med tech and life sciences to make 2021 a year for brisk deal activity, according to the 2021 Ernst & Young (EY) M&A Firepower report. In 2020, industry M&A activity fell to the lowest levels since 2014, but the multinational audit and consulting firm found that the industry now has record levels of deal capacity that it is poised to use to accelerate growth coming out of the pandemic.

Cognitoss, a resorbable bone graft in development by Locate Bio Ltd., received U.S. FDA breakthrough device designation for treating chronic osteomyelitis, a progressive, inflammatory bone infection. The graft uses a new class of composite collagen product combined with a dual-phasic release of antibiotics to prevent reinfection.

Ultromics Ltd. received U.S. FDA 510(k) clearance for its artificial intelligence-driven decision support tool for the diagnosis of coronary artery disease (CAD). Used in conjunction with a clinician's assessment, Echogo Pro's algorithms improve disease prediction and support more accurate diagnosis. Echogo Pro is a stress-Echo module in the Oxford, U.K.-based company's Echogo suite for CAD diagnosis.

Nextgen Biomed Ltd. has begun a clinical trial of a breath test to monitor antibody levels in individuals vaccinated against COVID-19. Be'er Ya'akov, Israel-based Shamir Medical Center authorized the trial for test developer Scent Medical Technologies Ltd. (Scentech Medical), which is in the midst of merging with Nextgen. The merged company will be called Scentech Medical.

New investors think Brainsgate Ltd. has some valuable new ideas, including its novel treatment for ischemic stroke, so they headed up the latest investment round. BNP Joint Capital led the $14 million round as a first-time investor along with Spero and previous investors Elron, Medtronic, Agate, Pitango, and Cipio.

A new $23 million in funds gives Brainbox Solutions Inc. a head start as it begins enrollment in the pivotal clinical trial of its mild traumatic brain injury (TBI) diagnostic and prognostic test. Bioventures Investors took the lead in the series A financing. The Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, and Astia Angels participated in the fundraising round along with qualified investors including the Cleveland Cavaliers' Kevin Love, a mental health advocate.

Flowonix Medical Inc. and Swk Holdings Corp. closed a $33 million financing that included $10 million in debt facility from Swk in addition to $23 million in a series B round led by returning investor Farallon Capital Management with support from several new investors. The financing will replace approximately $7.5 million in prior venture debt from Hercules Capital. It will also fund development of new products, entry into new disease markets, production expansion, and partnerships with pharmaceutical companies.

Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.

Coagulo Medical Technologies Inc. raised $6.5 million in financing to accelerate delivery of its precision-medicine coagulation diagnostics platform. 20/20 Healthcare Partners led the investment with participation from Sands Capital, Good Growth Capital, IAG Capital Partners, and private investors. The company also received funding through a Small Business Innovation Research (SBIR) grant from the National Science Foundation to develop a COVID-19-related coagulation test.