Aural Analytics Inc., of Scottsdale, Ariz., reported the kickoff of a multiproduct pivotal study to demonstrate the safety and efficacy of its speech-based tools for measuring pulmonary function and speech motor function in amyotrophic lateral sclerosis. The company anticipates submitting the results of this multisite, multilanguage, 280-participant, prospective, blinded study to the U.S. FDA in late 2021.
Cytosorbents Inc. Corp., of Monmouth Junction, N.J., said it has closed on the third amendment of its amended loan and security agreement with Bridge Bank. Under the terms of the amendment, the company repaid the outstanding principal balance of its existing $15 million term loans and simultaneously received a commitment from Bridge Bank to provide a new term loan of $15 million if needed.
Alajuela, Costa Rica-based Establishment Labs Holdings Inc. said it recently received institutional review board approval to initiate a patient series in Costa Rica to study its Motiva Mia system for minimally invasive augmentation, which includes the Motiva Ergonomix2 Diamond breast implant, and has completed the procedure in the first 21 patients in the study.
Everheart Systems, a Webster, Texas-based developer of fully implanted mechanical circulatory support devices, said that it has changed its corporate name to Corvion Inc.
First Nation Group, of Niceville, Fla., reported a new partnership with Nightware Inc., the Minneapolis-based creators of the Nightware therapeutic platform, to deliver care to those diagnosed and struggling with severe nightmares associated with post-traumatic stress disorder or nightmare disorder.
Audubon, Pa.-based Globus Medical Inc. won a group purchasing agreement with Premier. The agreement covers Globus’ Trauma Platform, which includes Anthem Plating, Autobahn Nailing, Arbor External Fixation, and Captivate Screw Platforms.
Haliodx SAS, of Marseille, France, said that it has signed an exclusive distribution agreement with São Paulo-based Diagnosticos da America SA for Immunoscore commercialization in Brazil.
Stockholm-based Irras AB reported an exclusive distribution agreement with Anade SA, a distributor of neurosurgical medical devices and technologies in Latin America. The company said its Irraflow product line has received regulatory clearance in Costa Rica and Argentina, and regulatory clearance is being pursued in five additional markets Latin American markets.
Palo Alto, Calif.-based molecular diagnostics company Lucence Inc. reported that its Palo Alto laboratory received certification from the U.S. Department of Health and Human Services’ Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. With this accreditation, Lucence will rapidly scale U.S.-based testing capacity for its liquid biopsy blood test, Liquidhallmark.
Paris-based Microport Cardio Rhythm Management SA (CRM) reported the first enrollment in the Astral-4LV clinical trial to evaluate the safety and efficiency of Axone, a quadripolar left ventricular lead. Axone is designed for use in heart failure patients with cardiac resynchronization therapy (CRT) indications that require the implantation of a CRT pacemaker (CRT-P) or CRT implantable defibrillator (CRT-D). The Axone lead has a diameter of 0.4 mm, which is about four times smaller than the diameter of a standard LV lead, and has been designed to better navigate in narrow and tortuous coronary veins. Astral-4LV is a prospective, single arm, multicenter clinical trial that will enroll 152 patients at 20 centers in France, Germany, Italy, Netherlands, Portugal, Spain and Austria.
St. Helier, Jersey-based Novocure Ltd. reported that the first patient has been enrolled in its global phase 3 TRIDENT trial, a randomized study in newly diagnosed glioblastoma (GBM) testing the potential survival benefit of initiating Optune concurrent with radiation therapy. Trident will enroll 950 newly diagnosed GBM patients who, after surgery or biopsy, are candidates for radiation therapy and temozolomide. The experimental group will receive Optune concurrent with radiation therapy and temozolomide for six weeks, followed by Optune and temozolomide. The control group will receive radiation therapy and temozolomide for six weeks, followed by Optune and temozolomide. Patients will continue on Optune for 24 months or until second tumor progression, whichever occurs first.
Yokneam Ilit, Israel-based Rewalk Robotics Ltd. entered a contract with a German private health insurance company to allow all eligible beneficiaries with spinal cord injury (SCIs) to apply for the procurement of a Rewalk 6.0 exoskeleton system. It is the first such agreement with a private health insurer and follows a series of contracts with several statutory health insurance companies in Germany that Rewalk signed earlier this year. Under the terms of this contract, eligible individuals can receive a Rewalk Personal 6.0 exoskeleton for everyday use after successful training, which can enable individuals with SCIs to stand and walk again.
Linkoping, Sweden-based Sectra AB secured an enterprise imaging contract from the South-Eastern Norway Regional Health Authority. The contract comprises a radiology module and a region-wide multimedia solution to store medical images and multimedia across all medical specialties. South-Eastern Norway Regional Health Authority is the largest of the four health care regions in Norway and provides health care to approximately 3 million people. Initially, the radiology module will be implemented at Oslo University Hospital and the intention is for the other health care providers in the region to follow.
Ann Arbor, Mich.-based Strata Oncology Inc. said it has completed a major renovation and expansion of its high-throughput cancer sequencing facility, resulting in a doubling of its previous laboratory capacity.
Thermo Fisher Scientific Inc., of Waltham, Mass., reported the availability of a new direct from saliva polymerase chain reaction (PCR) test for COVID-19, to enable high-frequency surveillance testing at colleges and universities. The Taqcheck SARS-CoV-2 Fast PCR assay, by Carlsbad, Calif.-based Applied Biosystems Inc. uses raw saliva samples and simplifies workflow using instruments that are widely available to deliver data quickly.
Philadelphia-based Tridiuum Inc. said it has been selected for a behavioral health pilot with Fresenius Medical Care North America, of Waltham, Mass. The pilot, which will begin with dialysis centers in the North Georgia area, will integrate the Tridiuum One platform into the company's clinical workflow for early identification of patients' behavioral health issues.
Twist Bioscience Corp., of South San Francisco, has expanded its gene product line with the launch of Clonal-Ready Gene Fragments. The new offering can be used, with and without adaptors, to build constructs and minimize the time and cost of screening for perfect clones.
Englewood, Colo.-based Viveve Medical Inc. said the U.S. FDA has approved amendments to its pivotal PURSUIT trial. The multicenter, randomized, double-blinded, sham-controlled IDE study is assessing the Viveve system for improvement of stress urinary incontinence in women.
Richland, Wash.-based Vivos Inc. said it has completed surrogate lymph node testing using mouse spleen injections of hydrogel, demonstrating uniform perfusion and stability. The tests were designed and conducted in collaboration with Mayo Clinic.