3M Co. Chairman and CEO Mike Roman sent a letter to U.S. Attorney General William Barr, Maryland Governor Larry Hogan, who also chairs the National Governors Association, and Tim Fox, attorney general of Montana and president of the National Association of Attorneys General, highlighting the company’s actions to curb counterfeiting and price gouging of personal protective equipment during the COVID-19 pandemic. The company also pledged support for efforts against those who are exploiting the crisis by marketing counterfeit products or gouging the public.
Bioiq, of Atlanta, reported the availability of a national COVID-19 response program solution. Specifically, its COVID-19 solution enables health plans, employers and government agencies to provide access to information and testing resources to at-risk individuals, including frontline responders, health care providers and people working in critical infrastructure.
Biotelemetry Inc., of Malvern, Pa., reported the activation of an expanded service using its Mobile Cardiac Outpatient Telemetry to monitor QT prolongation in COVID-19 patients.
New lab results from Bluewave Technologies Inc., of Orange City, Fla., indicate that when used as directed, its device can effectively kill the nonenveloped virus, MS2 Bacteriophage, and methicillin-resistant Staphylococcus aureus.
Bruker Corp., of Billerica, Mass., reported a distribution agreement with U.K.-based Primer Design Ltd., a subsidiary of Vélizy-Villacoublay, France-based Novacyt SA, for Bruker-Hain Diagnostics to distribute the CE-IVD-labeled Genesig real-time PCR coronavirus (COVID-2019) assay, effective immediately. Nehren, Germany-based Bruker-Hain Diagnostics has a portfolio of DNA/RNA extraction and preparation systems and kits.
Foldax, of Salt Lake City, completed initial enrollment in its early feasibility study for the Tria Lifepolymer heart valve. Fifteen patients have been enrolled in four sites.
Kyoto, Japan-based Kyocera Corp. entered a share transfer agreement with NEC Corp. to acquire all of the latter’s shares in Showa Optronics Co. Ltd., a Japanese optical components manufacturer. After the share transfer is completed, Kyocera will own 93.53% of Showa Optronics’ shares. That company will begin operating as a subsidiary of Kyocera June 1, under the name Kyocera Showa Optronics Co. Ltd.
Westport, Conn.-based Lumendi LLC said its randomized trial of the Dilumen endolumenal interventional platform (EIP) successfully met the primary endpoint of a 200-patient prospective study. The study is evaluating Dilumen’s effect on endoscopic procedure time for precancerous colorectal complex polypectomies. The results from an early interim analysis of data collected with 140 recruited patients demonstrates a statistically significant reduction in procedure time with Dilumen EIP against the control group, supporting successful early completion of study enrollment. There were no reportable serious adverse events during enrollment.
Obalon Therapeutics Inc., of Carlsbad, Calif., a vertically integrated weight loss solutions company commercializing an FDA-approved swallowable, gas-filled intragastric balloon system to treat obesity, reported that it has engaged Canaccord Genuity LLC to explore potential financial and strategic options, in response to the COVID-19 pandemic. The company has halted manufacturing operations and believes it has enough balloons for patients currently in treatment, but will likely not be able to ship new orders for the U.S. and foreign markets in second quarter of 2020.
Pasadena, Calif.-based Omnipathology Medical Solutions Corp. reported the release of its COVID-19 laboratory-developed test in the Greater Los Angeles area. The company plans to submit for FDA emergency use authorization within the next two weeks.
PRA Health Sciences Inc., of Raleigh, N.C., said it is expanding its Mobile Health Platform for remote clinical monitoring, adding new capabilities that address sponsor needs for virtual study support during the COVID-19 crisis. The new features include the ability to transition existing paper-based studies into more decentralized, siteless studies so that patient care and evaluation can continue during critical study time frames.
Vancouver, B.C.-based Precision Nanosystems Inc. is partnering with Fujifilm Corp., of Tokyo, to adopt PNI’s Nanoassemblr technology and portfolio of instruments for Fujifilm’s manufacturing facility, compatible with U.S., European and Japanese good manufacturing practice regulations. Under the agreement, Fujifilm also has the rights to offer contract manufacturing services using PNI’s technology and to use PNI technology to develop and market its internal drug products.
Salt Lake City-based Predictive Technology Group reported that its wholly owned subsidiary, Predictive Laboratories, has notified the U.S. FDA of its intent to immediately distribute its Assurance AB COVID-19 IgM/IgG rapid antibody test for point-of-care diagnosis. The fingerstick test displays results in 15 minutes.
Spok Holdings Inc., of Springfield, Va., reported its board of directors unanimously rejected an unsolicited proposal from B. Riley Financial Inc. to acquire Spok for $12 per share in cash, saying the offer substantially undervalues the company.
Stemcell Technologies Inc., of Vancouver, British Columbia., said that human tissue culture systems developed by the company were used by researchers at China’s Centre for Disease Control to grow lung airway cells that could propagate the COVID-19 coronavirus. The researchers were then able to isolate the virus, obtain the viral gene sequence and make the data available to scientists around the world.
T2 Biosystems Inc., headquartered in Lexington, Mass., has obtained a license for a rapid COVID-19 test developed by Hackensack Meridian Health’s Center of Discovery and Innovation. The licensed assay has been used within the health system under FDA emergency use authorization. T2 Biosystems will adapt it to run on its T2Dx instrument.
South San Francisco-based Twist Bioscience Corp. reported that its synthetic SARS-CoV-2 RNA Controls have been added to the U.S. FDA website as reference materials for development, verification and validation of SARS-CoV-2 tests.
Tampa-based Vycellix Inc. and Avectas Ltd., of Dublin, are teaming up to develop next-generation approaches for cell and gene therapies. The companies will collaborate on the delivery of Vycellix’s RNA immunomodulator, VY-M, using Avectas’ cell engineering platform, Solupore, and explore ways to optimize the manufacturing process of cell-based immunotherapeutic products.