As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering severe respiratory effects from the novel coronavirus. To that end, Beyond Air Inc., of Garden City, N.Y., and Rehovot, Israel, has applied to the U.S. FDA to conduct an IDE trial of its inhaled nitric oxide (NO) system, Lungfit Bro, in COVID-19 patients.
Endologix Inc., of Irvine, Calif., has won approval from the U.S. FDA for its Alto abdominal stent graft system, the company’s next-generation Ovation system for polymer endovascular aneurysm repair (EVAR). The company plans to begin rolling out Alto initially to high-volume customers of its Ovation iX system, who are already skilled at using Ovation stent grafts.
Hayward, Calif.-based Reflexion Medical Inc. has received the green light from the U.S. FDA to market its Reflexion X1 system for standard radiation therapy treatments. The company, which also is breaking new ground with the development of biology-guided radiotherapy (BgRT), aims to eventually bring multi-tumor precision radiotherapy to all stages of cancer treatment. The FDA cleared the Reflexion X1 for stereotactic body radiotherapy, stereotactic radiosurgery and intensity modulated radiotherapy. The clearance allows physicians to treat a single tumor with precise beam shaping and radiation dose delivery.
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As the COVID-19 strain of coronavirus continues to spread around the globe, companies are scrambling to develop effective diagnostics and vaccines to contain the outbreak and reduce future threats. Among those is Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., which has been awarded a $5 million grant from the Bill & Melinda Gates Foundation to speed testing and scale of smart delivery device for its COVID-19 vaccine candidate.
San Francisco-based Invitae Corp. is putting pedal to the metal in its quest to bring comprehensive genetic testing into mainstream clinical practice, reporting the acquisition of three companies – Diploid, Youscript Inc. and Genelex Labs LLC – following Tuesday’s market close. The total bill for the three deals comes to $195 million, $57 million of which is in cash.
Tirat Carmel, Israel-based Insightec Ltd. has inked a deal for a series F financing of up to $150 million led by Koch Disruptive Technologies (KDT), a subsidiary of Koch Industries. The round, which has a post-money valuation of $1.3 billion, is earmarked for continued study of the company’s low-intensity, focused ultrasound technology in treating certain movement disorders.
Neuronetics Inc., of Malvern, Pa., has won U.S. FDA breakthrough device designation for its Neurostar transcranial magnetic stimulation (TMS) device for the treatment of patients with drug-resistant bipolar depression. The news comes as the company reported a strong fourth quarter for 2019, with revenue up 11% year-over-year to $17.4 million.
Campbell, Calif.-based startup Supira Medical Inc. scooped up $35 million in a series B financing led by Cormorant Asset Management. Also participating in the round were The Capital Partnership, 415 Capital, Amed Ventures and Shifamed Angels. The new capital is earmarked to advance the development and clinical evaluation of the company’s next-generation percutaneous ventricular assist device.
Keeping you up to date on recent developments in diagnostics, including: Question of COVID-19 contagion window; A paper-based, portable coronavirus test; Finding the next pandemic threat early on; Anatomy study reveals schizophrenia subtypes.
