Private equity health care company Archimed, of Lyon, France, acquired a majority stake in Namsa, the only full continuum contract research organization focused exclusively on medical devices. Namsa’s president and CEO, John Gorski, the Gorski family and senior managers will hold stakes in the company, amounting to a significant double-digit percentage. The price of the deal was not disclosed.
Wetherby, U.K.-based Avacta Group plc has entered an agreement with Abingdon Health Ltd., of York, U.K., for the production of Avacta’s saliva-based rapid SARS-CoV-2 antigen test as part of its ongoing expansion of manufacturing capacity.
Baylis Medical Co., of Mississauga, Ontario, reported the first clinical use of its Versacross Steerable Access Solution, performed at the University of California, San Francisco. The newest addition to the Versacross transseptal platform combines the Versacross RF wire with a steerable sheath, for an all-in-one solution to enable radiofrequency ablation procedures.
Ness Ziona, Israel-based Biomx Inc. is collaborating with Boehringer Ingelheim GmbH, of Ingelheim am Rhein, Germany, to utilize the Biomx Xmarker microbiome-based biomarker discovery platform to potentially identify biomarkers for inflammatory bowel disease (IBD). As part of the collaboration, Biomx will generate metagenomic data of gut microbiome samples obtained from IBD patients, with the aim of identifying biomarkers using the Xmarker platform.
Bionano Genomics Inc., of San Diego, said a study published in Nature Communications used its genome imaging technology to increase understanding of the genome structures that make tumors like glioblastoma multiforme, lung cancer and chronic myeloid leukemia so aggressive. By combining Bionano’s Saphyr data with sequencing data using custom developed software, a team led by the University of California San Diego was able to reconstruct circular pieces of genetic material in cancer cells that allow the tumor to grow much more rapidly. The increased understanding of these circular DNA fragments can help in the development of targeted therapies and contribute to a more efficient use of existing drugs.
Bioreference Laboratories Inc., an Opko Health company based in Elmwood Park, N.J., began testing principals, teachers and other staff for COVID-19, across New York's five boroughs, in preparation for a safer back-to-school environment.
Bioventrix Inc., of San Ramon, Calif., has resumed cases in the pivotal ALIVE trial after it was paused due to the COVID-19 pandemic. The study is evaluating less-invasive ventricular enhancement, or LIVE, therapy using the company’s Revivent Tc transcatheter ventricular enhancement system. The new cases took place at St. Luke’s Medical Center in St. Louis and the Cardiovascular Institute of the South in Houma, La.
San Diego-based Clarify Medical Inc. said its Clarify Medical Home Phototherapy system for psoriasis, eczema and vitiligo is available to Multiplan Phcs and Multiplan Network members, effective immediately.
Tampa-based Concept Medical Inc. reported the first patient enrolled in its TRANSFORM-1 European, randomized, controlled trial using the Magictouch sirolimus-coated balloon for small coronary vessels. The patient was enrolled at Maria Cecilia Hospital in Cotignola, Italy, and underwent successful percutaneous coronary intervention performed by Antonio Colombo.
Diagnostic Centers of America, of West Palm Beach, Fla., and Boca Radiology Group, of Boca Raton, have teamed up with Nijmegan, Netherlands-based Screenpoint Medical to improve the early detection and treatment of breast cancer using the Screenpoint’s artificial intelligence-based solution, Transpara, in mammography.
Endologix Inc., of Irvine, Calif., reported the first implant of its recently approved Alto endograft outside the U.S., completed by Andrew Holden and Andrew Hill of Auckland City Hospital in New Zealand.
Hamburg, Germany-based Evotec SE is partnering with the University of Oxford regarding access to biospecimens from the Quality in Organ Donation (QUOD) biobank. Under terms of the agreement, Evotec will investigate samples from 1,000 donors of the biobank using a comprehensive multiomics analysis to generate greater understanding of disease mechanism in liver, kidney and cardiovascular disease.
Tokyo-based Fujitsu Ltd. and Shinagawa Hospital have launched a joint research and development project for artificial intelligence technology to support diagnostic imaging via chest CT for early detection of COVID-19 pneumonia.
Medtronic plc, of Dublin, said it is implementing a new operating model, with an eye toward enhancing the customer experience, driving revenue growth and winning market share. The company plans to reorganize its current groups to create operating units, each formed from Medtronic’s existing businesses and organized around specific therapy areas. The company will transition to this new model beginning in its fiscal third quarter and will be fully effective at the start of its fourth quarter of fiscal year 2021. With the changes, the company is initiating a Simplification Restructuring Program, which is expected to incur total pre-tax costs of approximately $400 million to $450 million, the majority to be recognized by the end of fiscal year 2022. The program is expected to result in cost savings starting this fiscal year, with annualized ongoing cost savings of approximately $450 million to $475 million realized by fiscal year 2023. Management plans to discuss its new operating model at its upcoming investor day, to be held virtually Oct. 14.
Oncimmune Holdings plc, of Nottingham, U.K., signed an autoantibody profiling collaboration with a biopharmaceutical company with experience in developing immune checkpoint inhibitors (CPIs). The program, which is scheduled to complete in the second quarter of 2021, will evaluate the autoantibody profiles from patient samples collected in a clinical trial of a CPI. Under the agreement, Oncimmune will use its proprietary biomarker discovery engine, Serotag, to identify tumor-associated antibody markers that are predictive of response and immune-related adverse events.
Pinnacle IVD, of Nashville, Tenn., reported the addition of the CovID Rapid Antigen Detection Test (RAD) to its existing diagnostic test product line. Pinnacle has notified the U.S. FDA through pre-EUA format that it intends to submit an emergency use authorization (EUA) within 10 days.
To help those fighting COVID-19, Madison, Wis.-based Promega Corp. has released Xpressamp Direct Amplification Reagents that facilitate RNA extraction-free sample preparation that is automation-friendly.
Radioisotope Life Sciences, of Tampa, Fla., has purchased General Electric’s U.S. radiopharmacy network. Capitor, a boutique global financial advisory firm, structured and brought the deal to investors. Financial terms were not disclosed.
San Diego-based Sorrento Therapeutics Inc. and Smartpharm Therapeutics Inc., of Cambridge, Mass., said the former has completed the acquisition of Smartpharm, a gene-encoded protein therapeutics company developing nonviral DNA and RNA gene delivery platforms for COVID-19 and rare diseases. The merger was completed Sept. 1, with Smartpharm becoming a wholly owned subsidiary of Sorrento. The total value of the consideration payable to the holders of capital stock of Smartpharm in the merger was $19.4 million, subject to certain adjustments for net working capital, indebtedness, transaction expenses and cash. Upon completion of the merger, Smartpharm stockholders became entitled to receive an aggregate of about 1.76 million shares of Sorrento common stock based on a price per share equal to $10.60.
Rancho Cordova, Calif.-based Thermogenesis Holdings Inc. and its joint venture, Immunecyte Inc. reported plans to roll out a comprehensive diagnostic and therapeutic product line to fight the global COVID-19 pandemic.
Todos Medical Ltd., of Rehovot, Israel, has entered a COVID-19 testing and contract partnership with Pangea, based in Israel. Under the terms of the agreement, Todos will be the preferred supplier of COVID-19 testing products for Pangea’s suite of offerings aimed at securely delivering contact tracing and COVID testing passport services in Israel and certain African countries, whereas Todos will be able to integrate and tailor Pangea’s technology offering into its services package in the U.S., Canada and Mexico to create ‘COVID bubbles’ for employers, schools, sports leagues and other clients to deliver a full solution for COVID testing and contact tracing in a HIPAA compliant, ‘opt-in’ privacy tailored fashion.
Vibrent Health, of Fairfax, Va., said that the NIH has awarded the company a new funding award to continue as the Participant Technology Systems Center of the All of Us Research Program. With the award, Vibrent Health will continue to provide the digital health platform that is the participant technology backbone of NIH’s All of Us Research Program, paving the way for the next phase of the initiative. Initial funding for the first year of the award is $39 million. The project is expected to be five years.
Vivalnk, a Campbell, Calif.-based provider of connected health care solutions, has partnered with San Francisco-based Mazzetti, a provider of health care building systems engineering solutions, to deploy rapid response patient monitoring solutions for COVID-19 in the U.S.