Bellaseno GmbH began recruiting patients in Australia for two clinical trials of its resorbable breast scaffold products on Aug. 4. The company expects to enroll 10 patients with pectus excavatum, a structural deformity of the chest in which the breastbone presses inwards.
Bio-Rad Laboratories Inc. signed a $170 million deal to acquire all the outstanding shares of molecular diagnostics subsidiary Curiosity Diagnostics SpZoo from Scope Fluidics SA. The deal consists of approximately $100 million in cash and up to $70 million in future milestone payments. The pre-commercial platform company is the developer of a CE-marked 15-minute point-of-care (POC) rapid PCR system which tests for SARS-CoV-2 virus and methicillin-resistant or-sensitive Staphylococcus aureus bacteria (MRSA/MSSA).
Conmed Corp. is acquiring soft tissue augmentation company Biorez Inc. for $85 million and up to an additional $165 million in growth-based earnout payments over a four-year period. The New Haven, Conn.-based company develops Biobrace, a bioinductive implant which promotes soft tissue healing in tendon and ligament injuries. The implant is cleared for use by the U.S. FDA in two product sizes.
Think Surgical Inc. is deepening ties with South Korean company Curexo Inc. through a new development and distribution deal. Under the terms of the agreement, Think will have exclusive rights to distribute Curexo’s Cuvis-Joint robotic platform, including any additional technology, in the U.S. and other countries. The orthopedic robot is currently used by surgeons in Korea and India for pre-planning surgery.
The U.S. FDA has granted 510(k) clearance to a blood-based biomarker assay for disease monitoring of patients with metastatic breast cancer (MBC). The Divitum Tka assay, developed by Uppsala, Sweden-based Biovica International AB, measures the activity of the enzyme thymidine kinase-1 (TK1) which is highly associated with cell proliferation and a predictive marker of tumor aggressiveness. It is the first liquid cancer cell proliferation biomarker assay to be approved by the FDA for use in monitoring metastatic breast cancer.
The U.K.’s National Institute for Health and Care Excellence (NICE) has added two placental growth factor (PIGF)-based tests developed by Perkinelmer Inc. to guidance on diagnosing suspected preterm preeclampsia. The Waltham, Mass.-based company’s kit and Delfia Xpress soluble fms-like tyrosine kinase 1 (sFlt-1) kit are recommended to screen levels of PIGF and Sflt-1, both key biomarkers in the pathophysiology of preeclampsia. The guidance means health care providers across the U.K. will be able to use the test, along with a standard clinical assessment, to confirm suspected preterm preeclampsia in women from 20 weeks of pregnancy onwards.
The U.K. NHS is implementing the use of Oxford, U.K.-based Genincode plc’s predictive genetic test for patients suffering with hypercholesterolemia and familial hypercholesterolemia (FH). The Academic Health Science Network for the North East and North Cumbria (AHSN NENC) is adopting the Lipid Incode test in Darlington following a successful pilot study which demonstrated the test can detect and diagnose people with high cholesterol, a known risk factor for the development of cardiovascular disease (CVD). It is the first commercial polygenic test for CVD to be implemented by the NHS.
3M Co. reported a planned spinoff of its health care business by 2023, during the company’s second quarter earnings. The health care company will operate as a separate public company focused on wound care, health care IT, oral care and biopharma filtration. 3M said the health care business is expected to be spun off with net leverage of approximately 3.0x to 3.5x EBITDA and the ‘New 3M’ company will retain a stake of 19.9% in health care, which will be monetized over time.
Shares in Royal Philips NV fell by almost 10% on July 25 after the company stated that its second quarter Q2 sales deteriorated amid supply shortages and prolonged lockdowns in China. Group sales for Philips amounted to €4.2 billion (US$4.29 billion) in the second quarter of 2022, representing a 7% year on year decline. Management reduced its 2022 outlook to 1%-3% organic sales growth from a previously estimated 3% to 5% growth and said it expects growth of between 6% and 9% for the second half of 2022.
Ophthalmic and microsurgery device maker Carl Zeiss Meditec AG is investing in regenerative medicine startup Precise Bio Ltd. to jointly develop 4D bio-fabricated corneal transplants for diseases that require endothelial keratoplasty and natural lenticule transplants. Under the terms of the agreement, Carl Zeiss Meditec will lead a series B financing round in Precise Bio and fund development of two cornea transplant products.
