Regression dilution

MRM Health Completes Patient Recruitment in Ulcerative Colitis Study, Secures Financing and Provides Outlook for 2023

Retrieved on: 
Tuesday, March 7, 2023
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“2023 also started very promising as we reached a major milestone by completing early January patient recruitment in the Phase 2a study with MH002 in Ulcerative Colitis, while patient recruitment in our phase 2 study in Acute Pouchitis continues to progress.

Key Points: 
  • “2023 also started very promising as we reached a major milestone by completing early January patient recruitment in the Phase 2a study with MH002 in Ulcerative Colitis, while patient recruitment in our phase 2 study in Acute Pouchitis continues to progress.
  • MRM Health has now enrolled all 45 mild-to-moderate UC patients.
  • MRM Health has an ongoing corporate partnership with IFF since 2020, aiming to tackle a range of metabolic diseases.
  • As part of its ongoing program in T2D, MRM Health recently reached a next milestone upon successfully achieving preclinical development targets.

Longeveron Announces Completion of Enrollment in Phase 2a Trial of Lomecel-B™ for the Treatment of Alzheimer’s Disease

Retrieved on: 
Thursday, November 10, 2022
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MIAMI, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced the completion of enrollment in its Phase 2a trial of Lomecel-BTM in patients with mild Alzheimers Disease (AD).

Key Points: 
  • MIAMI, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced the completion of enrollment in its Phase 2a trial of Lomecel-BTM in patients with mild Alzheimers Disease (AD).
  • We are pleased to have completed enrollment in our Phase 2a study of Lomecel-BTM for Alzheimers Disease.
  • The Phase 2a trial follows the previously announced positive results of Longeverons Phase 1b clinical trial of Lomecel-BTM for AD.
  • Longeveron is advancing Lomecel-B through clinical trials in three indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimers Disease, and Aging Frailty.

Longeveron Names Jerome Bailey Vice President of Business Operations

Retrieved on: 
Thursday, September 15, 2022
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MIAMI, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN),a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced it has named Jerome Bailey as the companys new vice president of business operations.

Key Points: 
  • MIAMI, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN),a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced it has named Jerome Bailey as the companys new vice president of business operations.
  • I am excited to join the Longeveron team, said Mr. Bailey.
  • I look forward to working with the exceptional team at Longeveron to continue to advance the companys robust pipeline through upcoming clinical milestones.
  • Longeveron is advancing Lomecel-B through clinical trials in three indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimers Disease, and Aging Frailty.

U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Longeveron’s Lomecel-B™ Product for Treatment of Hypoplastic Left Heart Syndrome (HLHS) in Infants

Retrieved on: 
Wednesday, August 31, 2022
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Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently in a Phase 2a trial for HLHS.

Key Points: 
  • Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently in a Phase 2a trial for HLHS.
  • The Fast Track Designation must continue to be met or FDA can withdraw the designation.
  • The FDA previously granted Longeverons Lomecel-B Orphan Drug and Rare Pediatric Disease designations in November of 2021 for HLHS.
  • Fast Track Designation represents a significant milestone in our efforts to develop Lomecel-B as a treatment for infants with HLHS, said Chris Min, M.D., Ph.D., Longeverons Interim Chief Executive Officer and Chief Medical Officer.

Longeveron Receives Intent to Grant Notice from the European Patent Office for Methods to Monitor Efficacy of Lomecel-B™ Cell Therapy Through Levels of Vascular Biomarker

Retrieved on: 
Thursday, August 25, 2022
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15861319.0) related to methods to treat endothelial dysfunction and monitor the efficacy of allogeneic mesenchymal cell therapies, also known as medicinal signaling cells (MSCs).

Key Points: 
  • 15861319.0) related to methods to treat endothelial dysfunction and monitor the efficacy of allogeneic mesenchymal cell therapies, also known as medicinal signaling cells (MSCs).
  • We are extremely pleased to receive this notice from the European patent office, said Chris Min, M.D., Ph.D., Interim Chief Executive Officer and Chief Medical Officer at Longeveron.
  • This patent will bolster our robust intellectual property portfolio and support our goal of delivering effective cell therapies for a range of aging-related and life-threatening conditions.
  • The patent is titled Methods for Monitoring Efficacy of Allogeneic Mesenchymal Stem Cell Therapy in a Subject.

NeuroOne® Announces $3.5 Million Accelerated Milestone Payment from Zimmer Biomet for Evo® sEEG Electrode

Retrieved on: 
Wednesday, August 3, 2022
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EDEN PRAIRIE, Minn., Aug. 3, 2022 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the Company entered into an amendment to its Exclusive Development and Distribution Agreement with Zimmer Biomet, Inc. ("Zimmer") that will provide the Company with a $3.5 million accelerated payment within 10 business days which relates to certain milestone payments.  In addition, Zimmer Biomet will receive a Warrant to purchase 350,000 shares of the Company's common stock, with an exercise price of $3.00 per share.

Key Points: 
  • In addition, Zimmer Biomet will receive a Warrant to purchase 350,000 shares of the Company's common stock, with an exercise price of $3.00 per share.
  • Dave Rosa, Chief Executive Officer of NeuroOne, states, "I want to thank Zimmer for all their support to date and their confidence in our business, technology and future endeavors.
  • Under the Exclusive Development and Distribution Agreement signed by both parties in July 2020, Zimmer Biomet has exclusive global distribution rights to distribute the Company's Cortical and sEEG diagnostic electrode technology.
  • Forwardlooking statements may include statements regarding the future of NeuroOne's partnership with Zimmer, NeuroOne's receipt of the $3.5 million payment, and NeuroOne's need for short-term financing.

InspireMD Provides Highlights from Recent Presentations and Live Case Transmission at LINC 2022

Retrieved on: 
Thursday, June 9, 2022
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TEL AVIV, Israel, June 09, 2022 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke, today provided the following highlights from multiple presentations and live case transmission, all featuring its CGuard Embolic Prevention Stent System, from LINC 2022, which was held June 6-9.

Key Points: 
  • TEL AVIV, Israel, June 09, 2022 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke, today provided the following highlights from multiple presentations and live case transmission, all featuring its CGuard Embolic Prevention Stent System, from LINC 2022, which was held June 6-9.
  • Of particular note, CGuard was featured in a very successful live case that clearly demonstrated the advantages of optimal vessel conformability with sustainable MicroNet mesh protection for best patient outcomes.
  • The patient was a 62 year old asymptomatic male with progressive and calcified internal carotid critical stenosis.
  • The procedure was successfully performed with the 10mm x 30mm CGuard EPS, obtaining an excellent angiographic result.

Xanadu Mines Ltd Scoping Study - Kharmagtai Copper-Gold Project

Retrieved on: 
Wednesday, April 6, 2022
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TORONTO, April 06, 2022 (GLOBE NEWSWIRE) -- Xanadu Mines Ltd (ASX: XAM, TSX: XAM) (Xanadu, XAM or the Company) is pleased to announce the release of the Scoping Study (Study) for its flagship Kharmagtai Copper-Gold Project, based on an updated 2021 Mineral Resource Estimate, located in the South Gobi region of Mongolia.

Key Points: 
  • TORONTO, April 06, 2022 (GLOBE NEWSWIRE) -- Xanadu Mines Ltd (ASX: XAM, TSX: XAM) (Xanadu, XAM or the Company) is pleased to announce the release of the Scoping Study (Study) for its flagship Kharmagtai Copper-Gold Project, based on an updated 2021 Mineral Resource Estimate, located in the South Gobi region of Mongolia.
  • This Study confirms the potential of Kharmagtai as a globally significant, long life, low cost, low risk future copper-gold mine.
  • It is a preliminary technical and economic study of the potential viability of the Kharmagtai Project.
  • The Study is based on the material assumptions set out in the attached Scoping Study.

InspireMD Announces the Inclusion of its CGuard Carotid Stent in CREST-2 Trial Following FDA Approval of the Investigational Device Exemption Supplement Application

Retrieved on: 
Monday, February 28, 2022
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TEL AVIV, Israel, Feb. 28, 2022 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, today announced its CGuard Carotid Stent, utilizing its proprietary MicroNet mesh, will be included as a device option for stenting in the CREST-2 Trial. Following the approval of the Carotid Revascularization Endarterectomy or Stenting Trial (CREST-2) Investigational Device Exemption (IDE) supplement application from the U.S. Food and Drug Administration (FDA) last week, InspireMD will be evaluating strategic sites to enable expediated access.

Key Points: 
  • Following the approval of the Carotid Revascularization Endarterectomy or Stenting Trial (CREST-2) Investigational Device Exemption (IDE) supplement application from the U.S. Food and Drug Administration (FDA) last week, InspireMD will be evaluating strategic sites to enable expediated access.
  • The CREST-2 Trial is widely acknowledged as the most significant ongoing trial to scientifically investigate the optimal course of treatment to prevent stokes for asymptomatic patients with significant carotid disease.
  • The trial will enroll an estimated 2,480 participants which will remain in the study for 4 years following the start of intervention.
  • Investors and security holders are urged to read these documents free of charge on the SECs web site at http://www.sec.gov.

NanoVibronix Announces Encouraging Interim Results in Real World Patient Study of UroShield

Retrieved on: 
Tuesday, December 7, 2021
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Elmsford, NY, Dec. 07, 2021 (GLOBE NEWSWIRE) -- NanoVibronix, Inc ., (NASDAQ: NAOV), a healthcare device company that produces the UroShield and PainShield Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced positive interim results from an independent, real world patient study of its UroShield at Southampton University Health Sciences.

Key Points: 
  • Elmsford, NY, Dec. 07, 2021 (GLOBE NEWSWIRE) -- NanoVibronix, Inc ., (NASDAQ: NAOV), a healthcare device company that produces the UroShield and PainShield Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced positive interim results from an independent, real world patient study of its UroShield at Southampton University Health Sciences.
  • Brian Murphy, CEO of Nanovibronix, stated, Interim results and observations from both the patient qualitative work and laboratory analysis are highly encouraging and represent another important step towards full commercialization of UroShield.
  • The study consists of both laboratory and patient studies and is nearing completion.
  • Full results of the study are expected to be published in the second quarter of 2022.