The Advanced Medical Technology Association (Advamed) and Startx reported a new partnership designed to provide med-tech entrepreneurs within the Palo Alto, Calif.-based Startx network exclusive access to Advamed’s resources and expertise to develop and commercialize the latest health care innovations. Startx’s medical community consists of more than 450+ entrepreneurs, managing more than 180 active companies developing medical devices, diagnostic tests, patient monitoring systems, devices to support cancer care and drug-device combinations.
San Diego-based Biocept Inc. reported that Pittsburgh-based Highmark, America's fourth largest Blue Cross Blue Shield affiliate, has made a positive coverage determination that Biocept's Target Selector liquid biopsy assay has been accepted for medical coverage for use in the diagnosis and treatment of patients with non-small-cell lung cancer (NSCLC). The coverage determination follows two years of evaluation performed by the Allegheny Health Network Cancer Institute of Biocept's liquid biopsy assay to more rapidly assess the molecular status of patients with NSCLC, enabling oncologists to select the most appropriate therapy while also reducing the overall cost of care.
Marlborough, Mass.-based Boston Scientific Corp. signed an investment agreement with an exclusive option to acquire Menlo Park, Calif.-based Farapulse Inc., a privately held company developing a pulsed field ablation (PFA) system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. This PFA system – comprising a sheath, generator and catheters – is intended to ablate heart tissue via the creation of a therapeutic electric field instead of using thermal energy sources such as radiofrequency ablation or cryoablation. Farapulse is pursuing regulatory approval in the U.S. and received FDA breakthrough designation for its endocardial ablation system in May 2019. The company intends to initiate a pivotal IDE trial in the U.S. and is pursuing CE mark approval in Europe.
New York-based Dariohealth Corp. and Jupiter, Fla.-based Hmc Healthworks, reported that the companies have entered into a sales and distribution partnership pursuant to which Hmc will incorporate Dariohealth's digital therapeutics solution into its comprehensive care management programs. Hmc will offer Dariohealth's platform on both a stand-alone basis as well as incorporated into Hmc's comprehensive care management solutions.
Los Angeles-based Decision Diagnostics Corp. reported it is finalizing its COVID-19 Saliva Swift Kits for international use, along with its recommended pricing for the global market. The kit, which is expected to launch Sept. 26, 2020, will be wholesale at $8.95 with a suggested retail price of $12.95.
Exagen Inc., of San Diego, reported the launch of Avise Vasculitis AAV, a new testing panel of individual analytes designed to provide physicians with rapid and reliable results in the assessment and monitoring of ANCA-associated vasculitis (AAV). ANCA (anti-neutrophil cytoplasmic antibody)-associated vasculitis is a group of autoimmune diseases characterized by vascular inflammation and damage. Early signs and symptoms vary greatly and are not always indicative of the severity of the disease. Rapid and accurate testing is essential to prevent death and long-term disability. It is intended for use in patients suspected of ANCA-associated vasculitis, otherwise recognized as small vessel diseases: granulomatosis with polyangiitis, microscopic polyangiitis and eosinophilic granulomatosis with polyangiitis.
Hancock Jaffe Laboratories Inc., of Irvine, Calif., said it has received a positive determination from the Nasdaq Hearings Panel for continued listing on The Nasdaq Capital Market, pursuant to an extension through Dec. 28, 2020, to evidence compliance with the minimum $1 bid price requirement.
Nashua, N.H.-based Icad Inc. said it is disappointed with CMS’ decision to exclude its intraoperative radiation therapy (IORT) as part of the new bundled payment system for cancer care. Icad cited recently published, peer-reviewed data on the long-term efficacy of IORT vs. external beam radiation therapy and said it will submit additional IORT-related data to CMS to support a petition for reconsideration.
Mimedx Group Inc., of Marietta, Ga., has completed enrollment in its phase IIB study of its micronized injectable amniotic tissue product in patients with knee osteoarthritis (KOA). The prospective, double-blind, randomized controlled trial is assessing micronized dehydrated human amnion chorion membrane injection in comparison with saline placebo injection in the treatment of KOA.
Misonix Inc., of Farmingdale, N.Y., has entered an exclusive supply and distribution agreement with Gunze Ltd., of Osaka, Japan, to bring Gunze’s Theragenesis Bilayer Wound Matrix to the U.S. market. The arrangement expands Misonix’s current tissue regeneration wound portfolio of Theraskin and Sonicone with a entry into the xenograft skin substitute segment.
Ortho Clinical Diagnostics, of Raritan, N.J., has been awarded $12.9 million by the Biomedical Advanced Research and Development Authority, part of HHS’ Office of the Assistant Secretary for Preparedness and Response, to support development of its SARS-CoV-2 antigen test and continued regulatory support of its total and IgG antibody tests. The two antibody tests were granted emergency use authorization by the U.S. FDA in April.
Polarityte Inc., of Salt Lake City, was awarded a Phase I Small Business Innovation Research grant from the NIH for an application titled “Fluid Management System for Point of Care Device for Novel Regenerative Treatment for Chronic Wounds.” The grant, which totals approximately $245,000, is funded over a six-month period and will support research to apply for a subsequent larger phase II grant.
Joelton, Tenn.-based Radiation Business Solutions (RBS) reported it has reached an agreement to purchase Radmax Inc., a radiation oncology medical billing company headquartered in Tyler, Texas, effective Aug. 31. Financial terms were not disclosed. RBS also said it is developing a new radiation oncology network, Vidacore.
Royal Philips NV, of Amsterdam, launched Azurion Lung Edition, a 3D imaging and navigation platform to accelerate the diagnosis and treatment of lung cancer, in the U.S. The suite combines CT-like 3D images acquired at the tableside (Cone Beam CT) with live X-ray guidance.
Erlangen, Germany-based Siemens Healthineers AG reported a master collaboration agreement with Basel, Switzerland-based Novartis Pharma AG to develop diagnostic tests for therapeutic products across Novartis’ therapeutic pipeline. The initial program will focus on developing a serum neurofilament light chain immunoassay for patients with multiple sclerosis and other neurological diseases.
Titan Medical Inc., of Toronto, reported the launch of a new name and brand identity for its robotic surgical system under development, the Enos robotic single access surgical system.