Medical Devices

DoseMe Enables Precision Dosing at Independence Health System

Retrieved on: 
Thursday, May 2, 2024

DoseMe , a leading provider of model-informed precision dosing (MIPD) software, has announced its collaboration with Excela Health, now part of Independence Health System .

Key Points: 
  • DoseMe , a leading provider of model-informed precision dosing (MIPD) software, has announced its collaboration with Excela Health, now part of Independence Health System .
  • This alliance will advance therapeutic drug monitoring and optimize pharmacogenetics integration into pharmacokinetic/pharmacodynamic (PK/PD) models as part of IHS’s precision dosing strategy and initiatives.
  • With five hospitals, nearly 1,000 healthcare providers and more than 7,000 employees, Independence Health System serves a ten county region and is the largest employer in Butler and Westmoreland counties.
  • For more information on precision dosing models offered by DoseMe, visit https://doseme-rx.com/why-dosemerx/drug-packages

ATEC to Present at Upcoming Conferences

Retrieved on: 
Thursday, May 2, 2024

Alphatec Holdings, Inc. (Nasdaq: ATEC), a provider of innovative solutions dedicated to revolutionizing the approach to spine surgery, announced today that management will participate in the following investor conferences:

Key Points: 
  • Alphatec Holdings, Inc. (Nasdaq: ATEC), a provider of innovative solutions dedicated to revolutionizing the approach to spine surgery, announced today that management will participate in the following investor conferences:
    The Bank of America Healthcare Conference at the Encore Hotel in Las Vegas, NV, on May 15, 2024, at 1:40pm PT
    The Barclays MedTech West Coast Bus Tour at the Fairmont Grand in Del Mar, CA, on May 20, 2024, at 8:00am PT
    The Wells Fargo West Coast MedTech Tour at the Lodge at Torrey Pines in La Jolla, CA, on May 30, 2024, at 11:40am PT
    The Jefferies Health Care Conference in New York, NY, on June 5, 2024, at 4:00pm ET
    As an inducement material to accepting employment with the Company, and in accordance with Nasdaq Listing Rule 5635(c)(4), ATEC today announced that the independent Compensation Committee of the Board of Directors has approved aggregate grants to 14 new employees (who are not executive officers) of, collectively, 14,024 restricted stock units (“RSUs”) under the Company’s 2016 Employment Inducement Award Plan.
  • The RSUs will vest in equal annual installments on each of the first four anniversaries of the grant date, provided that the recipient remains continuously employed by ATEC as of such vesting date.
  • In addition, the RSUs will vest fully upon a change of control of ATEC.

Bruker Reports First Quarter 2024 Financial Results

Retrieved on: 
Thursday, May 2, 2024

Bruker Corporation (Nasdaq: BRKR) today announced financial results for its first quarter ended March 31, 2024.

Key Points: 
  • Bruker Corporation (Nasdaq: BRKR) today announced financial results for its first quarter ended March 31, 2024.
  • First quarter 2024 Bruker Scientific Instruments (BSI) segment revenues of $651.1 million increased 3.9% yoy, with organic revenue flat.
  • First quarter 2024 Bruker Energy & Supercon Technologies (BEST) segment revenues of $73.1 million increased 17.5% yoy, with organic revenue growth, net of intercompany eliminations, of 18.9%.
  • Bruker will host a conference call and webcast to discuss its financial results, business outlook, and related corporate and financial matters today, May 2, 2024, at 8:30 am Eastern Standard Time.

bioAffinity Technologies News Update

Retrieved on: 
Thursday, May 2, 2024

bioAffinity Technologies , Inc. (Nasdaq: BIAF; BIAFW) shares recent Company news.

Key Points: 
  • bioAffinity Technologies , Inc. (Nasdaq: BIAF; BIAFW) shares recent Company news.
  • Physicians outside of Texas are also signing up with our wholly owned subsidiary, Precision Pathology Laboratory Services, to order CyPath® Lung for their patients.
  • bioAffinity Technologies’ National Sales Director Dallas Coleman announced that Jackie Kennedy has joined the Company as Pulmonary Sales Executive for CyPath® Lung in the San Antonio/Austin market.
  • “Patients have told us how much they appreciate having a Patient Coach who can walk them through the collection process,” bioAffinity Technologies President and CEO Maria Zannes said.

New Study Published in JACC: Heart Failure Reveals that Despite Significant Efforts to Improve Acute Heart Failure Treatment Over the Past 20 Years, Management Remains Unchanged

Retrieved on: 
Thursday, May 2, 2024

Decongestion remains a central goal of inpatient management, but contemporary decongestion practices and associated weight loss are not well described.

Key Points: 
  • Decongestion remains a central goal of inpatient management, but contemporary decongestion practices and associated weight loss are not well described.
  • In the TREAT-AHF study, the distribution of inpatient body weight change was similar to those reported from ADHERE nearly two decades ago.
  • Reprieve is partnering with industry-leading heart failure researchers and Truveta to understand and advance acute heart failure patient outcomes.
  • The clinical evidence from the TREAT-HF study demonstrates that heart failure decongestion management has not substantially changed in 20 years,” said Mark Pacyna, chief executive officer of Reprieve Cardiovascular.

Charles River Launches Viral Vector Reference Materials to Streamline the Transition to GMP

Retrieved on: 
Thursday, May 2, 2024

Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of its reference materials for adeno associated virus (AAV) and lentiviral vector (LVV) portfolio, designed to streamline Cell and Gene Therapy (CGT) research and development as it scales to Good Manufacturing Practice- (GMP) quality.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of its reference materials for adeno associated virus (AAV) and lentiviral vector (LVV) portfolio, designed to streamline Cell and Gene Therapy (CGT) research and development as it scales to Good Manufacturing Practice- (GMP) quality.
  • Moving towards a gold standard for reference materials, Charles River is introducing six AAV reference material serotypes, offering superior empty and full capsid ratios and high vector genome concentration (GC/mL), plus five LVV reference material products, available with different combinations of promoters and reporter genes.
  • Charles River will officially launch its AAV and LVV reference materials with supporting case study data during the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, May 7 – 11, 2024, in Baltimore, MD.
  • We look forward to showcasing our robust portfolio and supporting data during the ASGCT Annual Meeting.” – Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services, Charles River

Thermo Fisher Scientific Launches New CXCL10 Testing Service

Retrieved on: 
Thursday, May 2, 2024

Thermo Fisher Scientific One Lambda Laboratories, a CLIA facility in Fishers, Ind., has introduced a new CXCL10 testing service, which allows for non-invasive urine sample collection and testing, with results available in as little as 24 hours, providing valuable information faster than currently used tests.

Key Points: 
  • Thermo Fisher Scientific One Lambda Laboratories, a CLIA facility in Fishers, Ind., has introduced a new CXCL10 testing service, which allows for non-invasive urine sample collection and testing, with results available in as little as 24 hours, providing valuable information faster than currently used tests.
  • In keeping with our commitment to health equity, we believe this lower-cost, non-invasive testing option can expand access to care and improve patient adherence, since the sample can be collected at any local clinic,” says Chris McCloskey, director, Transplant Services, Thermo Fisher Scientific.
  • Thermo Fisher’s CXCL10 testing service may supplement current standards of care that may lack specificity or sensitivity, which may lead to unnecessary and invasive biopsies, or produce results too late to influence care, making treating rejection more difficult.
  • The Thermo Fisher One Lambda Laboratories CXCL10 assay was developed and validated by One Lambda Laboratories.

Outset Medical to Present at Upcoming Investor Conferences

Retrieved on: 
Wednesday, May 1, 2024

Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced that members of management will participate at the BofA Securities Health Care conference on Tuesday, May 14, 2024 at 2:20 p.m. Eastern time/11:20 a.m. Pacific time, and at the RBC Capital Markets Global Health Care conference on Wednesday, May 15, 2024 at 1:35 p.m. Eastern time/10:35 a.m. Pacific time.

Key Points: 
  • Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced that members of management will participate at the BofA Securities Health Care conference on Tuesday, May 14, 2024 at 2:20 p.m. Eastern time/11:20 a.m. Pacific time, and at the RBC Capital Markets Global Health Care conference on Wednesday, May 15, 2024 at 1:35 p.m. Eastern time/10:35 a.m. Pacific time.

Glaukos Announces First Quarter 2024 Financial Results

Retrieved on: 
Wednesday, May 1, 2024

Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced financial results for the first quarter ended March 31, 2024.

Key Points: 
  • Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced financial results for the first quarter ended March 31, 2024.
  • “Our record first quarter results reflect successful global execution of our key strategic plans,” said Thomas Burns, Glaukos chairman and chief executive officer.
  • Loss from operations in the first quarter of 2024 was $39.1 million, compared to operating loss of $33.0 million in the first quarter of 2023.
  • Non-GAAP loss from operations in the first quarter of 2024 was $32.8 million, compared to non-GAAP operating loss of $26.8 million in the first quarter of 2023.

SecondWave Systems Demonstrates Reduction in Disease Activity in Clinical Study Evaluating Novel Ultrasound-Based Anti-Inflammatory Therapy in Rheumatoid Arthritis

Retrieved on: 
Wednesday, May 1, 2024

SecondWave Systems, Inc. , a pioneer in the emerging field of bio-ultrasonic medicine, today announced completion of a pilot clinical study evaluating its novel noninvasive ultrasound stimulation technology in the treatment of patients with rheumatoid arthritis (RA).

Key Points: 
  • SecondWave Systems, Inc. , a pioneer in the emerging field of bio-ultrasonic medicine, today announced completion of a pilot clinical study evaluating its novel noninvasive ultrasound stimulation technology in the treatment of patients with rheumatoid arthritis (RA).
  • This study involved splenic ultrasound treatment of 13 participants, and showed significant improvement in disease activity, with 10 of 13 participants experiencing benefit during the treatment period.
  • The purpose of the pilot clinical study (clinicaltrials.gov: NCT05417854) was to assess safety and initial efficacy of the investigational device in the treatment of rheumatoid arthritis.
  • “In this clinical trial, most study participants started with moderate or high rheumatoid arthritis disease activity.