Obstruction

Legacy Sponge-on-a-String Esophageal Cell Collection Device Subject of Class II FDA Recall

Retrieved on: 
Donnerstag, Mai 9, 2024

NEW YORK, May 9, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), announced that the legacy EsophaCap sponge-on-a-string (SOS) esophageal cell collection device, which it briefly supplied to third-party institutions for their own research studies, has been subjected to a Class II FDA recall due to two serious device failures reported in a recent publication of one of these studies. EsophaCap is not a commercial Lucid product.

Key Points: 
  • In addition, troubling reports of serious device failures have plagued SOS devices for many years, leading to multiple Class II FDA recalls similar to this one.
  • Dr. Aklog added, "In stark contrast, Lucid's EsoCheck® Esophageal Cell Collection Device , with its patent-protected Collect+Protect™ technology, is a modern groundbreaking technology.
  • These detachments were similar to previously-reported detachments of the Cytosponge Cell Collection Device, an SOS manufactured by Medtronic, which led to two Class II FDA recalls, including a June 2023 open global recall , which remains in effect.
  • As the manufacturer of record, Lucid proactively informed the FDA of the reported device failures and concluded that a Class II recall of the EsophaCap SOS was necessary and was made effective as of April 25, 2024.

Cytokinetics Reports First Quarter 2024 Financial Results

Retrieved on: 
Mittwoch, Mai 8, 2024

SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2024. Net loss for the first quarter was $135.6 million, or $1.33 per share, compared to net loss for the first quarter of 2023 of $131.3 million, or $1.38 per share. Cash, cash equivalents and investments totaled $634.3 million at March 31, 2024.

Key Points: 
  • Announced Topline Data from the Phase 1 Study of CK-586;
    SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2024.
  • Announced the appointment of Sung Lee to serve as the Company’s Executive Vice President, Chief Financial Officer effective as of May 8, 2024.
  • Revenues for the first quarter 2024 were $0.8 million compared to $4.6 million for the corresponding period in 2023.
  • Members of Cytokinetics’ senior management team will review the company’s first quarter 2024 results on a conference call today at 4:30 PM Eastern Time.

Cytokinetics Announces Start of CEDAR-HCM, a Clinical Trial of Aficamten in a Pediatric Population With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Retrieved on: 
Mittwoch, Mai 8, 2024

SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (HCM), is open to enrollment.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (HCM), is open to enrollment.
  • Aficamten is a next-in-class cardiac myosin inhibitor in development for the potential treatment of HCM.
  • HCM can present similarly in adolescents and children as it does in adults and may negatively impact overall quality of life.
  • Patients will be randomized on a 2:1 basis to receive aficamten or placebo, and those receiving aficamten will begin with 5 mg dosed once daily.

New Real-World Study on Retrograde Instillation of JELMYTO® for Treatment of Low-Grade Upper Tract Urothelial Cancer Reports Similar Complete Response Rate and Lower Stricture Rate Compared to OLYMPUS Pivotal Trial

Retrieved on: 
Samstag, Mai 4, 2024

The study includes a stepwise approach to retrograde administration of JELMYTO and reports that retrograde administration of JELMYTO in the clinic (n=20) produced a 60% complete response rate in patients and ureteral stents were placed in 25% of patients, which is lower than the rate reported in the pivotal OLYMPUS study.

Key Points: 
  • The study includes a stepwise approach to retrograde administration of JELMYTO and reports that retrograde administration of JELMYTO in the clinic (n=20) produced a 60% complete response rate in patients and ureteral stents were placed in 25% of patients, which is lower than the rate reported in the pivotal OLYMPUS study.
  • In the OLYMPUS study 58% (n=41) of patients achieved a complete response, defined as the absence of tumor lesions 3 months after initiation of JELMYTO treatment assessed by urine cytology and ureteroscopy.
  • For additional information about the retrograde administration of JELMYTO, consult the JELMYTO Instructions for Administration accompanying the Full Prescribing Information.
  • Three patients who were unable to tolerate the retrograde approach had antegrade administration of JELMYTO via a nephrostomy tube.

Incannex Healthcare Inc. Quarterly Update, Q1 2024

Retrieved on: 
Dienstag, April 16, 2024

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Inc. (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is pleased to provide quarterly activities update and for the quarter ended 31 March 2024.

Key Points: 
  • MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Inc. (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is pleased to provide quarterly activities update and for the quarter ended 31 March 2024.
  • Incannex is undertaking various U.S. Food and Drug Administration (‘FDA’) research and development (‘R&D’) programs for cannabinoid pharmaceutical products and psychedelic medicine therapies.
  • During the quarter, Incannex released top line results from the PsiGAD1 clinical trial conducted at Monash University, based in Melbourne, Australia.
  • This announcement has been approved for release to NASDAQ by the Incannex Board of Directors.

Cytokinetics Announces Three Late Breaking Clinical Trial Presentations Relating to SEQUOIA-HCM at the European Society of Cardiology Heart Failure 2024 Congress

Retrieved on: 
Mittwoch, April 10, 2024

SOUTH SAN FRANCISCO, Calif., April 10, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced three Late Breaking Clinical Trial presentations relating to SEQUOIA-HCM, (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), at Heart Failure 2024, an International Congress of the European Society of Cardiology, taking place in Lisbon, Portugal from May 11, 2024 – May 14, 2024.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., April 10, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced three Late Breaking Clinical Trial presentations relating to SEQUOIA-HCM, (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), at Heart Failure 2024, an International Congress of the European Society of Cardiology, taking place in Lisbon, Portugal from May 11, 2024 – May 14, 2024.
  • Title: Aficamten for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy: SEQUOIA-HCM an International Multicenter Phase 3 Trial
    Title: Enhancing Exercise Response in Obstructive HCM: Insights from Aficamten's Impact on Patients with Obstructive Hypertrophic Cardiomyopathy in SEQUOIA-HCM
    Presenter: Gregory Lewis, M.D., Jeffrey and Mary Ellen Jay Chair and Section Head, Heart Failure Medical Director, Cardiopulmonary Exercise Testing Laboratory, Professor of Medicine, Harvard Medical School
    Title: Dosing and Safety Profile of Aficamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy: Results from SEQUOIA-HCM
    Presenter: Caroline Coats, M.D., Ph.D., Lead Clinician, West of Scotland Inherited Cardiac Conditions Service, Honorary Senior Lecturer, School of Cardiovascular and Metabolic Health, University of Glasgow

Nothing Introduces Ear and Ear (a) along with new ChatGPT Integrations

Retrieved on: 
Donnerstag, April 18, 2024

LONDON, April 18, 2024 /PRNewswire/ -- Nothing today announced during its Q1 Community Update, live from Tokyo, Japan that it will be establishing a new foundation of its audio product suite with two new wireless earbuds, Nothing Ear and Nothing Ear (a). Simultaneously, Nothing announced it will enhance its overall user experience with industry-first ChatGPT integrations in its audio and smartphone products.

Key Points: 
  • Simultaneously, Nothing announced it will enhance its overall user experience with industry-first ChatGPT integrations in its audio and smartphone products.
  • A refinement of Ear (2), Ear preserves and evolves Nothing's iconic transparent earbud design to deliver the company's best-ever audio experience, delivering richer sound without compromising on performance.
  • Ear supports the LHDC 5.0 and LDAC codec for high-resolution streaming over Bluetooth, resulting in powerfully pure audio.
  • In the UK, customers can walk away with Ear and Ear (a) at the Nothing Store Soho celebration on 20 April.

Nothing Introduces Ear and Ear (a) along with new ChatGPT Integrations

Retrieved on: 
Donnerstag, April 18, 2024

LONDON, April 18, 2024 /PRNewswire/ -- Nothing today announced during its Q1 Community Update, live from Tokyo, Japan that it will be establishing a new foundation of its audio product suite with two new wireless earbuds, Nothing Ear and Nothing Ear (a). Simultaneously, Nothing announced it will enhance its overall user experience with industry-first ChatGPT integrations in its audio and smartphone products.

Key Points: 
  • Simultaneously, Nothing announced it will enhance its overall user experience with industry-first ChatGPT integrations in its audio and smartphone products.
  • A refinement of Ear (2), Ear preserves and evolves Nothing's iconic transparent earbud design to deliver the company's best-ever audio experience, delivering richer sound without compromising on performance.
  • Ear supports the LHDC 5.0 and LDAC codec for high-resolution streaming over Bluetooth, resulting in powerfully pure audio.
  • In the UK, customers can walk away with Ear and Ear (a) at the Nothing Store Soho celebration on 20 April.

5 years after the Mueller report into Russian meddling in the 2016 US election on behalf of Trump: 4 essential reads

Retrieved on: 
Donnerstag, April 18, 2024

But the nearly two-year investigation into alleged Russian interference in the 2016 U.S. presidential election dominated headlines – and revealed what has become Trump’s trademark denial of any wrongdoing.

Key Points: 
  • But the nearly two-year investigation into alleged Russian interference in the 2016 U.S. presidential election dominated headlines – and revealed what has become Trump’s trademark denial of any wrongdoing.
  • For Trump, the Russia investigation was the first “ridiculous hoax” and “witch hunt.” Mueller didn’t help matters.
  • “While this report does not conclude that the president committed a crime, it also does not exonerate him,” the special counsel stated.

1. Obstruction of justice

  • But Orentlicher wrote that obstruction of justice is “a complicated matter.” According to federal law, obstruction occurs when a person tries to impede or influence a trial, investigation or other official proceeding with threats or corrupt intent.
  • But in a March 24, 2019, letter to Congress summarizing Mueller’s findings, then-Attorney General William Barr said he saw insufficient evidence to prove that Trump had obstructed justice.


So it was up to Congress to further a case against Trump on obstruction charges, but then-Speaker of the House Nancy Pelosi declined, arguing that it would be too divisive for the nation and Trump “just wasn’t worth it.”

Read more:
Trump and obstruction of justice: An explainer

2. Why didn’t the full report become public?

  • Charles Tiefer is a professor of law at the University of Baltimore and expected that Trump and Barr would do “everything in their power to keep secret the full report and, equally important, the materials underlying the report.” Tiefer was right.
  • To keep Mueller’s report private, Barr invoked grand jury secrecy – the rule that attorneys, jurors and others “must not disclose a matter occurring before the grand jury.”


Trump and Barr also claimed executive privilege to further prevent the release of the report. Though it cannot be used to shield evidence of a crime, Tiefer explained, “that’s where Barr’s exoneration of Trump really helped the White House.”

Read more:
How Trump and Barr could stretch claims of executive privilege and grand jury secrecy

3. Alternative facts

  • Perhaps the most disappointing finding, they argued, is that there are no known fixes to this problem.
  • They found that fact-checking has little impact on changing individual beliefs, and more education only sharpens the divisions.
  • And with that, they wrote, “the U.S. continues to inch ever closer to a public square in which consensus perceptions are unavailable and facts are irrelevant.”

    Read more:
    From 'Total exoneration!'

4. Trump’s demand for loyalty

  • What sets Trump apart, Ouyang wrote, is his “exceptional emphasis on loyalty.” Trump expects personal loyalty from his staff – especially from his attorney general.
  • “Trump values loyalty over other critical qualities like competence and honesty.
  • Read more:
    Why does a president demand loyalty from people who work for him?

Safer roads in Ireland with Connected Vehicles milestone

Retrieved on: 
Mittwoch, April 10, 2024

Vienna/Dublin, March 19, 2024 – Ireland's NIMS (Network Intelligence and Management System) initiative is launching a C-ITS pilot project to increase traffic safety.

Key Points: 
  • Vienna/Dublin, March 19, 2024 – Ireland's NIMS (Network Intelligence and Management System) initiative is launching a C-ITS pilot project to increase traffic safety.
  • Since January 2024, C-ITS is fully integrated into the operational Traffic Management solution NIMS providing information to roadusers in realtime.
  • C-ITS allows the exchange of data between vehicles, infrastructure and authorities.
  • The NIMS project, of which Kapsch TrafficCom is a part since 2020, has a financial scope in the low double-digit million range.