Pediatric orthopedics company Orthopediatrics Corp. has signed a $33 million deal to buy competitor Pega Medical Inc. As part of the deal, Orthopediatrics will acquire Pega’s Fassier-Duval telescopic intramedullary system. The implant is designed to treat bone deformities in children with osteogenesis imperfecta. Orthopediatrics will pay a $31 million upfront cash payment plus $2 million in stock – which includes certain restrictions for three years.
The U.S. FDA has granted clearance for Earlitec Diagnostics Inc.’s Earlipoint evaluation tool for the diagnosis and assessment of autism spectrum disorder (ASD) in children aged 16-30 months. The eye-tracking technology utilizes Dynamic Quantification of Social-Visual Engagement (DQSVE), which captures a child’s moment-by-moment looking behavior. The clearance was based on positive results from two studies in which more than 500 children were enrolled.
With top line results from its major phase III RECON study in hand, Axogen Inc. is hoping to expand adoption of its allograft nerve repair product Avance. RECON was designed as a non-inferiority study comparing Avance to nerve cuffs (manufactured conduits) which are commercially available. The study met its primary endpoint for the return of sensory function as measured by static two-point discrimination, and the safety profile was consistent with previously published data.
Oncologica Ltd. is expanding its testing service to include an at-home molecular immunoglobulin E (IgE) antibody allergy test. The Cambridge, U.K.-based precision medicine company said the new Allergyfocus test can detect 99% of globally known allergens from a finger prick blood sample. The IgE test provides a personalized antibody profile of allergy triggers such as different foods, pollen, mould or animals.
Tel Aviv-based startup Scopio Labs Ltd. has received U.S. FDA 510(k) clearance for its artificial intelligence (AI) powered cell morphology platform, X100HT. The laboratory device is designed to locate and display images of white cells, red cells and platelets acquired from fixed and stained peripheral blood smears. Analysis of the images is then provided using AI technology.
Penumbra Inc. presented new data at the LINC Symposium in Leipzig, Germany, evaluating its Indigo aspiration system for submassive pulmonary embolism (PE). The subgroup analysis evaluated performance outcomes of patients with main pulmonary artery (PA) emboli vs. discrete unilateral or bilateral PA emboli without main PA involvement. Data from the study suggests the system can be used effectively for both proximal and distal aspiration thrombectomy in the pulmonary arteries.
Sophia Genetics SA shared preliminary findings from its multimodal Deep-Lung-IV clinical study at the 2022 American Society of Clinical Oncology annual meeting. The study is utilizing Sophia’s cloud-based, artificial intelligence diagnostic platform to identify multimodal predictive signatures of response to immunotherapy for patients with advanced lung cancer.
Grail LLC reported a new study with the U.K.’s NHS to assess the clinical utility of its Galleri multi-cancer early detection test (MCED) for reducing late-stage cancer diagnoses. Menlo Park, Calif.-headquartered Grail presented the study design during the American Society of Clinical Oncology (ASCO) meeting in Chicago. The randomized controlled trial will enroll 140,000 asymptomatic participants aged 50-77 living across England to determine if Galleri can find cancers at an early stage when they are less advanced.
University of Edinburgh spinoff Biocaptiva Ltd. has raised an additional $2.6 million (£2.1 million) in seed financing for its cell free DNA (cfDNA) capture device, Biocaptis. Business angel syndicate Archangels led the round, with participation from Scottish Enterprise and Cancer Research Horizon, the innovation engine of Cancer Research UK.
A start-up rival to Illumina Inc. has emerged from stealth mode, debuting a new low-cost gene sequencing platform, the UG 100. Ultima Genomics Inc. has raised approximately $600 million from investors including General Atlantic, Andreessen Horowitz, D1 Capital and Khosla Ventures to scale development of the whole-genome sequencing, single-cell sequencing technology. Initial data using the platform to sequence more than 200 human genomes will be presented at the upcoming Advances in Genome Biology and Technology (AGBT) conference.
