CMR

Oncternal Therapeutics Provides Business Update and Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 7, 2024

Our grant revenue was $0.3 million for the fourth quarter ended December 31, 2023 and was $0.8 million for the full year 2023.

Key Points: 
  • Our grant revenue was $0.3 million for the fourth quarter ended December 31, 2023 and was $0.8 million for the full year 2023.
  • Our total operating expenses for the fourth quarter ended December 31, 2023 were $9.9 million, including $2.2 million in non-cash stock-based compensation expense.
  • Research and development expenses for the quarter totaled $6.7 million, and general and administrative expenses for the quarter totaled $3.3 million.
  • We believe these funds will be sufficient to fund our operations into the first quarter of 2025.

CMR Surgical hires industry leader to drive operations across Asia Pacific, the Middle East and Africa

Retrieved on: 
Monday, February 19, 2024

CMR Surgical hires industry leader to drive operations across Asia Pacific, the Middle East and Africa

Key Points: 
  • CMR Surgical hires industry leader to drive operations across Asia Pacific, the Middle East and Africa
    Sushobhan Dasgupta joins as President and Chief Commercial Officer for Asia Pacific, the Middle East and Africa
    CAMBRIDGE, UK – 19 February 2024, 07:00 (GMT).
  • CMR Surgical (CMR or ‘the Company’), the global surgical robotics business, today announces that Sushobhan Dasgupta has joined the Company as President and Chief Commercial Officer for Asia Pacific, the Middle East and Africa.
  • Sushobhan brings over 30 years of global healthcare experience across diverse MedTech markets worldwide, including three decades with Johnson & Johnson (J&J).
  • Supratim Bose, Chief Executive Officer of CMR Surgical, commented: “Asia Pacific, the Middle East and Africa are some of the fastest growing markets in the world for surgical robotics and so we are pleased to welcome Sushobhan to CMR to oversee our commercial operations across these regions.

CMR Surgical hires industry leader to drive operations across Asia Pacific, the Middle East and Africa

Retrieved on: 
Monday, February 19, 2024

CMR Surgical hires industry leader to drive operations across Asia Pacific, the Middle East and Africa

Key Points: 
  • CMR Surgical hires industry leader to drive operations across Asia Pacific, the Middle East and Africa
    Sushobhan Dasgupta joins as President and Chief Commercial Officer for Asia Pacific, the Middle East and Africa
    CAMBRIDGE, UK – 19 February 2024, 07:00 (GMT).
  • CMR Surgical (CMR or ‘the Company’), the global surgical robotics business, today announces that Sushobhan Dasgupta has joined the Company as President and Chief Commercial Officer for Asia Pacific, the Middle East and Africa.
  • Sushobhan brings over 30 years of global healthcare experience across diverse MedTech markets worldwide, including three decades with Johnson & Johnson (J&J).
  • Supratim Bose, Chief Executive Officer of CMR Surgical, commented: “Asia Pacific, the Middle East and Africa are some of the fastest growing markets in the world for surgical robotics and so we are pleased to welcome Sushobhan to CMR to oversee our commercial operations across these regions.

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on: 
Tuesday, March 12, 2024

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Key Points: 
    • 16

      Guideline on allergen products development for
      immunotherapy and allergy diagnosis in moderate to lowsized study populations

      17

      Table of contents

      18

      Executive summary ..................................................................................... 3

      19

      1.

    • Specific effects ................................................................................................. 17

      14
      15

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 2/18

      53

      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

      66

      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

    • 71

      Recommendations are made on the clinical development, potential study designs and safety

      72

      considerations for allergen products within the scope of the guideline.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 3/18

      88

      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

      89

      there is no such treatment available for type IV allergies.

    • 93

      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

      94

      quality and clinical development according to the current knowledge.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 4/18

      127

      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

      128

      conditions will require separate clinical trials (see Section 6).

    • 129

      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

      130

      DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

      131

      substantially to the allergen products as discussed above.

    • 1

      156

      ?

      Guideline on the clinical development of products for specific immunotherapy for the treatment

      157
      158

      of allergic diseases - CHMP/EWP/18504/2006
      ?

      159
      160
      161

      Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

      ?

      Guideline on process validation for finished products - information and data to be provided in
      regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 5/18

      162

      ?

      Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

      163

      4.

    • In any

      199

      case, a reduced validation should include all relevant manufacturing process steps that are considered
      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 6/18

      200

      product specific.

    • 290

      Diagnostic allergen products (Type I allergy)

      291

      A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

      292

      intracutaneous or provocation testing.

    • 298

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 9/18

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      306

      7.1.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 11/18

      377

      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

      378

      In general, the clinical development should be performed according to current guidelines.

    • In such single trial, the suitability as a test allergen as well as the

      376

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 12/18

      415

      dose finding for the therapeutic allergen could be investigated.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 13/18

      454
      455

      8.2.1.

    • 493

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 15/18

      527

      In general, sensitivity and specificity of the product should be determined.

    • 540

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 16/18

      561

      10.2.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      595

      4.

    • Allergol Immunopathol, 1989;

      602

      17(2):53-65

      603

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 18/18

MNA: Hospital Accrediting Agency (Joint Commission) Issues Findings Supporting St. Vincent Hospital Nurses' Complaints about Unsafe Patient Care, Stating that SVH was Found to Be Non-Compliant with Applicable Patient Care Conditions for Medicaid and Medic

Retrieved on: 
Wednesday, March 6, 2024

WORCESTER, Mass., March 6, 2024 /PRNewswire/ -- Nurses at St. Vincent Hospital, who have filed a number of official complaints and gone public with their serious concerns about patient care conditions that are harming patients at the Worcester-based facility, have had their claims validated by The Joint Commission, which conducted an investigation into the nurses complaints and found the hospital to be "non-compliant with applicable Centers for Medicaid and Medicare Services (CMS) Conditions."

Key Points: 
  • Your report was used to assist our team to better understand the organization's systems of providing care.
  • During the onsite review, the organization was found to be non-compliant with applicable Centers for Medicaid and Medicare Services (CMS) Conditions.
  • The complaints detailed a serious and ongoing degradation of care, which were based on more than 600 official reports filed by nurses over the last six months.
  • Founded in 1903, the Massachusetts Nurses Association is the largest union of registered nurses in the Commonwealth of Massachusetts.

A clearer vision for surgical robotics: CMR Surgical announces significant update to Versius

Retrieved on: 
Thursday, February 8, 2024

CMR Surgical (CMR) – the global surgical robotics business – has today announced the launch of vLimeLite – an integrated fluorescence imaging system to visualise ICG (Indocyanine green), which will give surgeons enhanced visualisation, where indicated.

Key Points: 
  • CMR Surgical (CMR) – the global surgical robotics business – has today announced the launch of vLimeLite – an integrated fluorescence imaging system to visualise ICG (Indocyanine green), which will give surgeons enhanced visualisation, where indicated.
  • Supratim Bose, Chief Executive Officer of CMR Surgical, commented: “With 3D HD visualisation, surgeons already have a fantastic view of their operating field at our Versius console.
  • As long-term partners of CMR, we were delighted to be the first to get our hands on its ICG system.
  • Through the Versius Connect app, Versius Trainer and CMR clinical registry, Versius unleashes a wealth of insights to ultimately improve surgical care.

A clearer vision for surgical robotics: CMR Surgical announces significant update to Versius

Retrieved on: 
Thursday, February 8, 2024

CMR Surgical (CMR) – the global surgical robotics business – has today announced the launch of vLimeLite – an integrated fluorescence imaging system to visualise ICG (Indocyanine green), which will give surgeons enhanced visualisation, where indicated.

Key Points: 
  • CMR Surgical (CMR) – the global surgical robotics business – has today announced the launch of vLimeLite – an integrated fluorescence imaging system to visualise ICG (Indocyanine green), which will give surgeons enhanced visualisation, where indicated.
  • Supratim Bose, Chief Executive Officer of CMR Surgical, commented: “With 3D HD visualisation, surgeons already have a fantastic view of their operating field at our Versius console.
  • As long-term partners of CMR, we were delighted to be the first to get our hands on its ICG system.
  • Through the Versius Connect app, Versius Trainer and CMR clinical registry, Versius unleashes a wealth of insights to ultimately improve surgical care.

St. Vincent Nurses File Complaints with State and Federal Agencies Citing Dangerous Conditions that Jeopardize the Safety of Patients Admitted to the Hospital - Call For Immediate Intervention to Protect Patients & End Suffering

Retrieved on: 
Tuesday, January 30, 2024

WORCESTER, Mass., Jan. 30, 2024 /PRNewswire/ -- The nurses of St. Vincent Hospital, who are represented by the Massachusetts Nurses Association (MNA) have filed a number of official complaints with the Department of Public Health Division of Healthcare Quality, Joint Commission (which accredits acute care hospitals), the Center for Medicare and Medicaid Services and the Mass. Board of Registration in Nursing in response to a growing and dire crisis in the safety of care for patients admitted to the Worcester-based facility. Reporters who wish to receive copies of the complaints can email David Schildmeier at [email protected].

Key Points: 
  • Board of Registration in Nursing in response to a growing and dire crisis in the safety of care for patients admitted to the Worcester-based facility.
  • Nurses continue to witness the violation of the hospital's handbook on Patient Rights and Responsibilities, but their concerns have gone unanswered.
  • The hospital rarely staffs intensive care units with enough staff to provide this level of care to the most critically ill patients.
  • Founded in 1903, the Massachusetts Nurses Association is the largest union of registered nurses in the Commonwealth of Massachusetts.

Cytokinetics Presents New Data at CMR 2024 From FOREST-HCM, the Open Label Extension Clinical Trial of Aficamten

Retrieved on: 
Thursday, January 25, 2024

SOUTH SAN FRANCISCO, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data at CMR 2024 demonstrating favorable effects on cardiac structure, function and fibrosis related to treatment with aficamten in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM).

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data at CMR 2024 demonstrating favorable effects on cardiac structure, function and fibrosis related to treatment with aficamten in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM).
  • At the time of this analysis, 16 patients in FOREST-HCM had completed a CMR at baseline and at Week 48.
  • Baseline characteristics of the CMR cohort were comparable to the overall patient population in FOREST-HCM.
  • We look forward to expanding on these data in the future.”

Cytokinetics Announces New Data From FOREST-HCM to be Presented at CMR 2024

Retrieved on: 
Thursday, January 18, 2024

SOUTH SAN FRANCISCO, Calif., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced an upcoming presentation at CMR 2024 taking place online and in person in London, UK from January 25-27, 2024.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced an upcoming presentation at CMR 2024 taking place online and in person in London, UK from January 25-27, 2024.
  • Title: Effect of Aficamten on Structure and Function in Patients with Obstructive Hypertrophic Cardiomyopathy: The FOREST-HCM CMR Sub-study