Vasodilation

Imara Announces Interim Analysis Data From Forte Phase 2b Clinical Trial Of Tovinontrine (Imr-687) In Transfusion-Dependent Subjects With Beta-Thalassemia

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Monday, November 22, 2021

Interim data from the Forte study demonstrated tovinontrine was well-tolerated, with the most frequent adverse events (>=10% of subjects in pooled tovinontrine dose groups) being nausea, headache and dizziness.

Key Points: 
  • Interim data from the Forte study demonstrated tovinontrine was well-tolerated, with the most frequent adverse events (>=10% of subjects in pooled tovinontrine dose groups) being nausea, headache and dizziness.
  • The Forte study is a 9-month, global, randomized, double-blind, placebo-controlled, multicenter Phase 2b clinical trial evaluating the safety and tolerability of tovinontrine (IMR-687) in approximately 120 adult subjects with beta-thalassemia.
  • For TDT subjects, the clinical trial is evaluating the effect of tovinontrine versus placebo in reducing transfusion burden.
  • For NTDT subjects, the clinical trial is evaluating the effect of tovinontrine versus placebo on fetal hemoglobin as well as total hemoglobin.

Imara Announces Primary Endpoint Change in the Ardent Phase 2b Clinical Trial of Tovinontrine (IMR-687) in Sickle Cell Disease

Retrieved on: 
Monday, November 22, 2021

BOSTON, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced a change to the primary endpoint for the Ardent clinical trial, a Phase 2b study of tovinontrine (IMR-687) in patients with sickle cell disease (SCD), based on the recommendation of the U.S. Food and Drug Administration (FDA).

Key Points: 
  • In reviewing the Ardent draft SAP and prior to any database lock for analysis, the FDA recommended that Imara change the primary endpoint to be annualized rate of VOCs.
  • The endpoint revisions do not affect the conduct of the trial or operational aspects of the study.
  • The Ardent Phase 2b clinical trial is a fully-enrolled, global, randomized, double-blind, placebo-controlled, multicenter study with approximately 115 adult patients with sickle cell disease (SCD) enrolled.
  • Sickle cell disease (SCD), a hemoglobinopathy, is a rare inherited red blood cell disorder.

Imara Announces Interim Analysis Data from Forte Phase 2b Clinical Trial of Tovinontrine (IMR-687) in Transfusion-Dependent Subjects with Beta-thalassemia

Retrieved on: 
Tuesday, November 16, 2021

BOSTON, Nov. 16, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat subjects suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced data from a pre-specified interim analysis from its ongoing Forte Phase 2b clinical trial of tovinontrine (IMR-687) in transfusion-dependent subjects (TDT) with beta-thalassemia.

Key Points: 
  • Safety data through week 24 from higher and lower dose groups were pooled for this interim analysis to prevent unblinding of the study.
  • Interim data from the Forte study demonstrated tovinontrine was well-tolerated, with the most frequent adverse events (10% of subjects in pooled tovinontrine dose groups) being nausea, headache and dizziness.
  • The Forte study is a 9-month, global, randomized, double-blind, placebo-controlled, multicenter Phase 2b clinical trial evaluating the safety and tolerability of tovinontrine (IMR-687) in approximately 120 adult subjects with beta-thalassemia.
  • For TDT subjects, the clinical trial is evaluating the effect of tovinontrine versus placebo in reducing transfusion burden.

Zylö’s Erectile Dysfunction Product Concept Wins Best Abstract Award

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Wednesday, November 10, 2021

GREENVILLE, SC, Nov. 10, 2021 (GLOBE NEWSWIRE) -- A novel nitric-oxide-releasing product concept developed by Zylö Therapeutics was awarded Best Abstract - Basic Science at the annual scientific meeting of the North American Sexual Medicine Society of North America (SMSNA), held October 21-24 in Scottsdale. The abstract, titled “Synergy Between Sildenafil and Topically Delivered Nitric-Oxide in Eliciting an Erectile Response in a Rat Model of Radical Prostatectomy” was presented by Moses Tar M.D. of Albert Einstein College of Medicine and was co-authored by Andrew Draganski Ph.D., Zylö’s director of product development, and Kelvin Davies Ph.D., professor of urology and professor of physiology and biophysics at Einstein College.

Key Points: 
  • The abstract, titled Synergy Between Sildenafil and Topically Delivered Nitric-Oxide in Eliciting an Erectile Response in a Rat Model of Radical Prostatectomy was presented by Moses Tar M.D.
  • of Albert Einstein College of Medicine and was co-authored by Andrew Draganski Ph.D., Zyls director of product development, and Kelvin Davies Ph.D., professor of urology and professor of physiology and biophysics at Einstein College.
  • This work, funded by a $225,000 NIH STTR grant award, demonstrated compelling results in a radical prostatectomy rat model of ED.
  • In addition, Zyls Z-pod technology has the ability to effectively deliver nitric oxide, a powerful molecule that is critical for maintenance of human health.

Vibrato Medical Appoints Paul A. LaViolette to its Board of Directors

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Thursday, November 4, 2021

Vibrato Medical, an innovator in the treatment of peripheral arterial disease (PAD), announced today that Paul A. LaViolette has been appointed to its board of directors.

Key Points: 
  • Vibrato Medical, an innovator in the treatment of peripheral arterial disease (PAD), announced today that Paul A. LaViolette has been appointed to its board of directors.
  • The contributions he has made to the medical technology industry have left a profound impact, said Juliana Elstad, CEO of Vibrato Medical.
  • Im so pleased to be joining the Vibrato board and to support development of this disruptive, noninvasive therapy for advanced peripheral arterial disease, said LaViolette.
  • LaViolette will join current Vibrato board members Bobby Azamian, MD, PhD, Juliana Elstad, Babak Nazer, MD, and Jason Tester.

Loop Medical Closes $6.4 Million Series A Financing

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Thursday, October 14, 2021

Loop Medical , a healthcare company reinventing blood collection, today announced it has completed a $6.4 million Series A financing round led by SARSTEDT Group and Casdin Capital .

Key Points: 
  • Loop Medical , a healthcare company reinventing blood collection, today announced it has completed a $6.4 million Series A financing round led by SARSTEDT Group and Casdin Capital .
  • In connection with the financing, Rainer Schuster, board member sales/marketing/R&D, SARSTEDT Group, and Shaun Rodriguez, director of life science research, Casdin Capital, will join the Loop Medical board of directors.
  • Loop Medical has raised more than $10 million in investment and grants to date, including $3.6 million from the Bill & Melinda Gates Foundation.
  • Loop Medical is based in EPFL Innovation Park (Lausanne, Switzerland) and was established in 2016.

Vibrato Medical Closes $4M Series A Funding Round and Receives $1.5M NIH Grant

Retrieved on: 
Tuesday, September 14, 2021

Our goal is to become the preferred therapeutic system for patients with reduced tissue perfusion, such as those with PAD and CLI.

Key Points: 
  • Our goal is to become the preferred therapeutic system for patients with reduced tissue perfusion, such as those with PAD and CLI.
  • Our recent funding puts us on the path towards that vision, said Juliana Elstad, CEO at Vibrato.
  • We are excited to partner with Vibrato Medical on the development of a truly novel technology to treat this terrible condition.
  • The company plans to use Series A funding and its $1.5M NIH grant for its pilot clinical study, to design and build its second-generation device, and advance its intellectual property.

Aerami Therapeutics Announces Orphan Drug Designation for Imatinib for the Treatment of Pulmonary Arterial Hypertension

Retrieved on: 
Wednesday, August 25, 2021

Food and Drug Administration(FDA) has granted the company orphan drug designation for imatinib for treatment of patients with pulmonary arterial hypertension (PAH).

Key Points: 
  • Food and Drug Administration(FDA) has granted the company orphan drug designation for imatinib for treatment of patients with pulmonary arterial hypertension (PAH).
  • AER 901, Aeramis drug-device combination product candidate for inhaled imatinib for the treatment of PAH is currently in a Phase 1 trial with completion targeted for the end of 2021.
  • The Fox achieves deep lung deposition by administering drug only during inhalation and controlling the flow rate and volume during inspiration.
  • Aerami undertakes no obligation to update any forward-looking statements for any reason.

Lawrence Berkeley National Laboratory Introduces New Method to Monitor Endothelial Function, Aiding Prevention, Treatment of Heart Disease

Retrieved on: 
Wednesday, March 31, 2021

Lawrence Berkeley National Laboratory (Berkeley Lab) has announced a new non-invasive method employing cuff-based measurement of flow-mediated dilation to detect preclinical cardiovascular disease.

Key Points: 
  • Lawrence Berkeley National Laboratory (Berkeley Lab) has announced a new non-invasive method employing cuff-based measurement of flow-mediated dilation to detect preclinical cardiovascular disease.
  • The new method will enable the accurate, inexpensive, and routine detection and monitoring of preclinical cardiovascular disease via both endothelial function and endothelium-independent vasodilation.
  • The novel method is the only noninvasive vasorelaxation assessment technique to achieve the previously unprecedented accuracy of invasive methods such as ultrasonic imaging.
  • Berkeley Lab is a multiprogram national laboratory, managed by the University of California for the U.S. Department of Energys Office of Science.

Worldwide Industry for Isosorbide to 2025 - by Product, Application, End-use and Region

Retrieved on: 
Monday, December 21, 2020

The derivatives of isosorbide, namely isosorbide dinitrate and isosorbide mononitrate, find extensive applications across various end use industries across the globe.

Key Points: 
  • The derivatives of isosorbide, namely isosorbide dinitrate and isosorbide mononitrate, find extensive applications across various end use industries across the globe.
  • Amongst these, isosorbide dinitrate is a solid, colorless crystal that is widely used as a vasodilator agent in the treatment of angina pectoris.
  • Apart from this, manufacturers operating in the industry are adopting waste recycling strategies for minimizing waste emission during the production of isosorbide.
  • What is the structure of the global isosorbide market and who are the key players?