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| Magnolia Medical Launches New Steripath Gen2 With Integrated Syringe Posted: 08 Jul 2020 10:15 AM PDT SEATTLE, July 8, 2020 /PRNewswire/ -- Magnolia Medical announced today the launch of the new Steripath ® Gen2 Initial Specimen Diversion Device ® with integrated syringe. The trusted solution for reducing blood culture contamination is now optimized for 'hard stick' patients and syringe collection protocols. The Steripath Gen2 with integrated syringe is designed to address the difficult intravenous access (DIVA) or 'hard stick' patient population. This innovative device provides healthcare workers the precise control to carefully collect blood samples from patients with compromised vasculature. The DIVA population represents a large percentage of all patients, 17-59% 1,2,3, that present symptomatic for sepsis and require blood cultures. Steripath Gen2 with integrated syringe additionally benefits hospitals that require syringe collection as part of their blood culture protocol. "We are pleased to introduce the first FDA-cleared initial specimen diversion device with integrated syringe," said Greg Bullington, CEO of Magnolia Medical. "This new product introduction represents an important step forward for the Steripath product family as we expand the tools available to help nurses, phlebotomists and healthcare workers address unique needs for specific patient circumstances." The patented Steripath® Gen2 ISDD ® product portfolio, including both direct-to-media and syringe configurations, are the only FDA 510(k)-cleared devices indicated to reduce blood culture contamination. 4 This exclusive indication was cleared by the FDA based on peer-reviewed published controlled clinical studies demonstrating Steripath's ability to reduce blood culture contamination by 83% 5 and 88% 6. The Steripath Gen2 platform integrates user-controlled negative pressure to divert and sequester the initial 1.5 to 2.0 mL of blood collected for culture, the portion known to most likely contain contaminants. 7 The device has been demonstrated effective for use with blood cultures drawn via both venipuncture and peripheral IV starts. 5,6 Steripath is a clinically proven solution to address a significant hidden problem in healthcare: the misdiagnosis of sepsis. 5,6 Improving the accuracy of diagnostic test results for sepsis reduces unnecessary antibiotic treatment. This helps to address the growing threat of antibiotic-resistance, decreases hospital length of stay and associated healthcare-acquired infections while significantly reducing avoidable hospital costs. 8,9 Magnolia Medical Technologies develops, manufactures and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency and predictability of critical laboratory tests. Magnolia Medical invented and patented the Initial Specimen Diversion Technique (ISDT™) and Device (ISDD ®) for blood culture collection and contamination prevention. The company has amassed an intellectual property portfolio including more than 70 issued method, apparatus and design patents with more than 50 additional patent applications pending. For more information, visit www.magnolia-medical.com.
View original content to download multimedia: http://www.prnewswire.com/news-releases/magnolia-medical-launches-new-steripath-gen2-with-integrated-syringe-301090252.html SOURCE Magnolia Medical Technologies |
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| Posted: 08 Jul 2020 10:12 AM PDT Westport, CT, July 08, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the "Company") and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it is partnering with Albany Molecular Research Inc. , (AMRI), a leading global contract research, development and manufacturing organization (CDMO), for support in undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a standalone treatment or in combination with other anti-viral agents or immune modulators. "As part of our ongoing development and commercialization strategy we are delighted to be working with AMRI as our second US-based active pharmaceutical ingredient (API) supplier. The rapid transfer, scale up and validation of merimepodib API manufacture is key to our future supply chain and commercialization strategy," commented Steve King, Chief Operating Officer, ViralClear. He continued, "ViralClear is committed to using US-based CDMOs for the development and commercialization of merimepodib." "AMRI is proud to partner with ViralClear in this vital effort of seeking a potential treatment for COVID-19," said Christopher Conway, President, AMRI. "Our team is committed to applying the expertise and experience we're renowned for to help combat this complex global health challenge." About BioSig Technologies BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals ( www.biosig.com ). The Company's first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. About Viral Clear Pharmaceuticals, Inc. and Merimepodib (MMPD) BioSig Technologies, Inc.'s (Nasdaq: BSGM) subsidiary, ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed. A manuscript titled, "The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue Remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro", was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. ("ViralClear") as a corresponding author. This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch. About AMRI AMRI , a contract research development and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. AMRI's team combines scientific expertise and market-leading technology to provide a complete suite of solutions in discovery, development, analytical services, and API and drug product manufacturing. www.amriglobal.com Forward-looking Statements This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Andrew BallouBioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floorWestport, CT 06880aballou@biosigtech.com203-409-5444, x133AMRI Kerry HutchingsKerry.hutchings@amriglobal.com |
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