Breaks Categories: News

WednesdayMar 10, 2021 9:59 am

BioMedNewsBreaks – XPhyto Therapeutics Corp. (CSE: XPHY) (OTCQB: XPHYF) (FSE: 4XT) Announced Partner Has Received ISO Certification for Rapid COVID-19 Test

XPhyto Therapeutics (CSE: XPHY) (OTCQB: XPHYF) (FSE: 4XT), a bioscience accelerator focused on next-generation drug delivery, diagnostic and new active pharmaceutical ingredient investment opportunities, has announced that 3a-diagnostics GmbH ("3a") has received EN ISO 13485 certification for its rapid point-of-care, SARS-CoV-2 RT-PCR Test System ("Covid-ID Lab"). 3a-diagnostics is XPhyto’s exclusive German diagnostics development partner. In addition the company expects CE-IVD approval for the product this month. These two approvals will allow  3a-diagnostics GmbH to distribute the Covid-ID Lab. The EN ISO approval is the internationally recognized European standard for quality control and management systems in the category of design and manufacture of…

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WednesdayMar 10, 2021 9:01 am

BioMedNewsBreaks – Vivos Therapeutics Inc. (NASDAQ: VVOS) Announces FDA 510(k) Application for Exclusive Oral Appliance

Vivos Therapeutics (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative treatments for patients suffering from sleep-disordered breathing including obstructive sleep apnea (“OSA”), recently submitted an application to the U.S. Food and Drug Administration (“FDA”) for its mmRNA (“mmRNA”) oral appliance(TM). The 510(k) Class II application focuses on the oral appliance as a treatment for mild-to-moderate OSA, sleep-disordered breathing and snoring in adults. The company’s oral appliance is an updated version of the company’s existing mRNA appliance(R), which previously received FDA clearance as a Class II oral appliance. The company noted that once it received approval for the…

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TuesdayMar 09, 2021 12:46 pm

BioMedNewsBreaks – Healthy Extracts Inc. (HYEX) Releases FY 2020 Revenue Results, Year-End Accomplishments

Healthy Extracts (OTCQB: HYEX), a leading developer and manufacturer of heart health, brain health and supplementary technologies, has announced its year-end financial numbers and business updates for the 12-month period ending Dec. 31, 2020. Financial highlights of the report include revenue increases of 71% to $1,276,559 compared to 2019 revenues of $748,377 and a net shareholder equity increase of $3.7 million. In addition, the company eliminated all convertible debt. The report attributes the increases to Healthy Extracts transition to its new business of selling health-nutrition products. Business highlights for the year include a company name change, full reporting and upgrade to…

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TuesdayMar 09, 2021 11:54 am

BioMedNewsBreaks – DarioHealth Corp. (NASDAQ: DRIO) Reports Q4, FY 2020 Numbers, Business Highlights

DarioHealth (NASDAQ: DRIO), a pioneer in the global digital therapeutics market, has released its financial and business update report for the fourth quarter and full year 2020. The company reports significant progress across all aspects of its long-term strategic operating plan, including securing several accounts in the B2B (“B2B”) channel that are generating revenue and enrolling members and completing financing that provides capital to move forward on growth initiatives. In addition, DRIO’s acquisition of Upright allows the company to expand its digital therapeutics offering to include musculoskeletal. Other highlights included DRIO’s agreement to provide its digital therapeutics solution to eligible…

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TuesdayMar 09, 2021 11:00 am

BioMedNewsBreaks – Brain Scientific Inc. (BRSF) Secures FDA Clearance for Next-Gen NeuroCap(TM)

Brain Scientific (OTCQB: BRSF), a neurology focused medical device and software company, today announced its receipt of U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its next-generation NeuroCap(TM) device. NeuroCap is an advanced electroencephalogram (“EEG”) electrode array used to obtain rapid EEGs in routine clinical and research settings where recording of STAT EEGs is desired. “We are constantly working on new products for the EEG market. In the new version of NeuroCap, we added velcro strips for better adhesion. We also expanded the size range by adding an XS (extra small) size,” said Irina Nazarova, marketing director at Brain…

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MondayMar 08, 2021 2:38 pm

BioMedNewsBreaks – 180 Life Sciences Corp. (NASDAQ: ATNF) to Present at Inaugural Emerging Growth Virtual Conference

180 Life Sciences (NASDAQ: ATNF), a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain, today announced that it will present at the Inaugural Emerging Growth Virtual Conference, hosted by M Vest LLC and Maxim Group LLC. The conference is slated to take place from 9:00 a.m.-5:00 p.m. ET on March 17 – 19, 2021, and will feature roundtable discussions with C-suite executives moderated by Maxim Research analysts, fireside chats with live Q&A, as well as presentations from hundreds of domestic and international issuers. According to the update, 180…

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MondayMar 08, 2021 1:54 pm

BioMedNewsBreaks – GT Biopharma Inc. (NASDAQ: GTBP) Releases Preclinical Results for Prostate Cancer Treatment

GT Biopharma (NASDAQ: GTBP), a clinical-stage biopharmaceutical company focused on disruptive, target-directed natural killer (“NK”) cell engager immunotherapy technologies, has announced preclinical results for its ROR1 (“ROR1”) TriKE(TM) (“TriKE”) product candidate, which is being evaluated as a prospective therapy for the treatment of prostate cancer. The treatment is based on the fact that tyrosine kinase transmembrane receptor ROR1 has been shown to be overexpressed on certain cancer cells and to play a functional role in influencing the metastatic potential of various solid tumor cancers. Through its TriKE treatment, GT Biopharma targets ROR1 on cancer cells, redirecting NK cells to attack…

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MondayMar 08, 2021 1:25 pm

BioMedNewsBreaks – Vivos Therapeutics Inc. (NASDAQ: VVOS) Opens First-Ever Pneusomnia Clinic, Unveils New Tech to Test for Sleep Apnea at Home

Vivos Therapeutics (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative treatments for patients suffering from sleep-disordered breathing including obstructive sleep apnea (“OSA”), has opened the first Pneusomnia clinic, a clinician-owned, integrated medical-dental sleep center. The center will feature the Vivos System through its Medical Integration Division. Located in Del Mar, California, the clinic is owned and operated by local physicians, including Dr. Mimi Guarneri, a cardiologist, founder and president of the Academy of Integrative Health and Medicine; she will lead the center. Vivos created its Medical Integration Division last year with the objective of fostering an environment where medical…

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MondayMar 08, 2021 12:24 pm

BioMedNewsBreaks – Predictive Oncology Inc. (NASDAQ: POAI) Announces Development of Newly Designed System for Direct-to-Drain Fluid Waste Management

Predictive Oncology (NASDAQ: POAI), a knowledge-driven company focused on applying artificial intelligence (“AI”) to personalized medicine and drug discovery, today announced that its Skyline Medical Division is renewing the development of a new Generation 3 STREAMWAY(R) System for direct-to-drain fluid waste management. According to the update the new device will see no change to its intended use and will not require a separate 501(k) submission with the Food and Drug Administration. In addition, the new design will include key changes to the product that will be smaller, lighter and easier to install with the goal of improving operator reliability, reducing…

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MondayMar 08, 2021 11:16 am

BioMedNewsBreaks – AzurRx BioPharma Inc. (NASDAQ: AZRX) Announces Plans to Participate in 33rd Annual ROTH Conference, $10M Registered Direct Offering

AzurRx BioPharma (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (“GI”) diseases, today announced that its CEO and Chairman, James Sapirstein, will participate in a panel discussion during the ROTH Conference slated to be held virtually from March 15-17, 2021. According to the update, the panel, “Therapeutics Against SARS-CoV-2 – Viral Variants Will Not Fade Away: A discussion of various developmental therapeutics for SARS-CoV-2 infection,” is scheduled to begin at 12:00 p.m. ET on March 15, 2021. During the panel, Sapirstein will discuss the need for drug therapies to address issues related to COVID-19, including…

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