Medical Devices

Ephicacy Consulting Group Completes Acquisition of Advance Research Associates

Retrieved on: 
Thursday, May 2, 2024
Technology, Medical Devices, Consulting, Clinical Trials, Professional Services, Biometrics, Biotechnology, Pharmaceutical, Health, Data Management, Contract research organization, ARA, Biostatistics, Patient, Acquisition, Associate, Data management, Pharmaceutical industry

Ephicacy Consulting Group, Inc. (“Ephicacy”), a leading biometrics Contract Research Organization (“CRO”), today announced that it has acquired Advance Research Associates (“ARA”), a provider of data management and biostatistical consulting services for clinical trials.

Key Points: 
  • Ephicacy Consulting Group, Inc. (“Ephicacy”), a leading biometrics Contract Research Organization (“CRO”), today announced that it has acquired Advance Research Associates (“ARA”), a provider of data management and biostatistical consulting services for clinical trials.
  • Since its founding in 2005, Ephicacy has grown into a leading biometrics Contract Research Organization (“CRO”) leveraging its global talent pool to deliver clinical analytics services.
  • “It is ARA’s mission to consistently provide the highest quality customized data management and biostatistical consulting services to our clients.
  • Joining forces with Ephicacy represents a natural evolution of that mission,” said Peter Shabe, ARA Founder and Ephicacy’s incoming Global Head of Biostatistics Consulting.

Asahi Kasei Bioprocess to Unveil THESYS™ ACS ERGO Synthesis Column at TIDES USA

Retrieved on: 
Thursday, May 2, 2024
Biotechnology, Technology, Health, General Health, Pharmaceutical, Other Science, Other Technology, Medical Devices, Research, Genetics, Science, Safety, AKBA, EVP, RNA, Hynes Convention Center, DNA, ACS, Therapy, Booth, Nucleotide, Multimedia, AKB, Fine chemical

This new synthesis column offers drastically reduced changeover time between batches while maintaining user safety and product quality.

Key Points: 
  • This new synthesis column offers drastically reduced changeover time between batches while maintaining user safety and product quality.
  • View the full release here: https://www.businesswire.com/news/home/20240502639431/en/
    Concept image of the THESYS™ ACS ERGO synthesis column.
  • (Photo: Business Wire)
    Following the success of AKB’s DAC ERGO™, a liquid chromatography column, the company has continued advancing column technology with the THESYS™ ACS ERGO.
  • The THESYS ACS ERGO is designed for oligonucleotide synthesis and includes an operator-friendly design to facilitate a smooth and safe changeover between runs.

Tandem Diabetes Care Announces First Quarter 2024 Financial Results and Updates Full Year 2024 Financial Guidance

Retrieved on: 
Thursday, May 2, 2024
Diabetes, Health, Medical Devices, Sale, Tandem Diabetes Care, Economics, Depreciation, Webcast, Event, Adjustment, GAAP, Bank

Non-GAAP operating loss(1) totaled $40.5 million, or negative 21 percent of sales, compared to $44.4 million or negative 26 percent of sales.

Key Points: 
  • Non-GAAP operating loss(1) totaled $40.5 million, or negative 21 percent of sales, compared to $44.4 million or negative 26 percent of sales.
  • (1) A reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures and additional information can be found in Table E “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release.
  • The Company’s non-GAAP guidance for the fiscal year ending December 31, 2024 is set forth below.
  • A reconciliation of each of the historical GAAP financial measures to the most directly comparable historical non-GAAP financial measures has been provided in Table E “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release.

Paragon 28 to Present at the Bank of America Securities 2024 Healthcare Conference

Retrieved on: 
Thursday, May 2, 2024
General Health, Health, Medical Devices, Paragon, Ankle, Foot, Interim management, Interim, Bank, Conference, FNA

Paragon 28, Inc. (NYSE: FNA), a leading medical device company exclusively focused on the foot and ankle orthopedic market, today announced that Albert DaCosta, Chairman and CEO, and Krissy Wright, Interim CFO, will participate in a fireside chat at the Bank of America Securities 2024 Healthcare Conference on Tuesday, May 14, 2024, at 5:00 p.m. Pacific Time / 6:00 p.m. Mountain Time.

Key Points: 
  • Paragon 28, Inc. (NYSE: FNA), a leading medical device company exclusively focused on the foot and ankle orthopedic market, today announced that Albert DaCosta, Chairman and CEO, and Krissy Wright, Interim CFO, will participate in a fireside chat at the Bank of America Securities 2024 Healthcare Conference on Tuesday, May 14, 2024, at 5:00 p.m. Pacific Time / 6:00 p.m. Mountain Time.
  • A live webcast, as well as the archived recording, will be available on the investor relations section of the Company’s website at ir.paragon28.com.

KARL STORZ and Well Lead Medical Announce Exclusive Agreement for Distribution of ClearPetra Stone-Removal System in the U.S.

Retrieved on: 
Thursday, May 2, 2024
Health Technology, Health, Medical Devices, Well, MIT Tech Talk, Urology, Kidney, American Urological Association, Marketing, Cleveland Clinic, MD, PCNL, Gynaecology, FRCSC, Stone, Booth, Master of Science, AUA, KARL, Research institute, Pharmaceutical industry

KARL STORZ United States announces an exclusive agreement with Well Lead Medical to offer the ClearPetra suction-evacuation ureteral access sheath in conjunction with KARL STORZ endoscopic visualization devices for comprehensive urinary stone management.

Key Points: 
  • KARL STORZ United States announces an exclusive agreement with Well Lead Medical to offer the ClearPetra suction-evacuation ureteral access sheath in conjunction with KARL STORZ endoscopic visualization devices for comprehensive urinary stone management.
  • “Our strategic collaboration with Well Lead Medical on ClearPetra represents a major step forward in stone management.
  • “The collaboration between Well Lead Medical and KARL STORZ represents a significant milestone in our commitment to advancing endourology.
  • During the show, KARL STORZ will be sponsoring a Tech Talk on May 4, 10:00–10:25 a.m., at Booth #1733.

Varex Announces Financial Results for Second Quarter Fiscal Year 2024

Retrieved on: 
Thursday, May 2, 2024
Radiology, Health, Medical Devices, Webcast, Access, VREX, Compact disc, GAAP, EPS, Ratio, Bank

Varex Imaging Corporation (Nasdaq: VREX) today announced its unaudited financial results for the second quarter of fiscal year 2024.

Key Points: 
  • Varex Imaging Corporation (Nasdaq: VREX) today announced its unaudited financial results for the second quarter of fiscal year 2024.
  • Non-GAAP gross margin was 33% in the quarter compared to 33% in the second quarter of fiscal year 2023 and non-GAAP EPS decreased to $0.16 from $0.26 in the second quarter of fiscal year 2023.
  • Cash flow from operations was $3 million in the second quarter of fiscal year 2024.
  • Varex will conduct its earnings conference call for the second quarter of fiscal year 2024 today at 3:00 p.m. Mountain Time.

Cerus Corporation Announces First Quarter 2024 Financial Results

Retrieved on: 
Thursday, May 2, 2024
Medical Supplies, Health, Medical Devices, Hospitals, Health Technology, General Health, Biotechnology, FDA, Red blood cell, Investment, AUC, Cerus Corporation, Research, Canadian Blood Services, LED, Patient, Platelet, Government, GAAP, Growth, Pharmaceutical industry

The Company expects to report GAAP net loss attributable to Cerus Corporation for the full-year 2024 while also remains committed to adjusted EBITDA breakeven for the full-year 2024.

Key Points: 
  • The Company expects to report GAAP net loss attributable to Cerus Corporation for the full-year 2024 while also remains committed to adjusted EBITDA breakeven for the full-year 2024.
  • R&D expenses for the first quarter of 2024 were $14.5 million, compared to $17.4 million for the first quarter of 2023.
  • Net loss attributable to Cerus Corporation for the first quarter of 2024 was $9.7 million, or $0.05 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $15.6 million, or $0.09 per basic and diluted share, for the first quarter of 2023.
  • As discussed during prior quarters, the Company expects full-year 2024 non-GAAP adjusted EBITDA breakeven, though over the near term, results may not be consistent quarter by quarter.

InfuSystem to Report First Quarter 2024 Financial Results on May 9, 2024

Retrieved on: 
Thursday, May 2, 2024
Other Manufacturing, Medical Devices, Medical Supplies, Hospitals, Health Technology, Manufacturing, Managed Care, Health, Oncology

InfuSystem Holdings, Inc. (NYSE American: INFU) (“InfuSystem” or the “Company”), a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers, announced today it will issue first quarter 2024 financial results on Thursday, May 9, 2024, before the market opens.

Key Points: 
  • InfuSystem Holdings, Inc. (NYSE American: INFU) (“InfuSystem” or the “Company”), a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers, announced today it will issue first quarter 2024 financial results on Thursday, May 9, 2024, before the market opens.
  • The Company will also conduct a conference call for all interested parties on Thursday, May 9, 2024 at 9:00 a.m. Eastern Time to discuss its financial results.
  • To participate in this call, please dial (800) 285-6670 or (713) 481-1320, or listen via a live webcast, which is available in the Investors section of the Company’s website at https://ir.infusystem.com/ .
  • A replay of the call will be available by visiting https://ir.infusystem.com/ for the next 90 days or by calling (888) 556-3470, replay access code 159874 through Thursday, May 16, 2024.

Hologic Announces Financial Results for Second Quarter of Fiscal 2024

Retrieved on: 
Thursday, May 2, 2024
Women, Biotechnology, Surgery, Oncology, Health, COVID-19, Medical Devices, Consumer, Sale, Table, Xi, Investment, Depreciation, Tax, SSI, Acquisition, Vii, EPS, European, Bank statement, GAAP, Bank

Organic revenue for the fiscal second quarter of 2024 excludes the divested Blood Screening and SSI ultrasound imaging businesses.

Key Points: 
  • Organic revenue for the fiscal second quarter of 2024 excludes the divested Blood Screening and SSI ultrasound imaging businesses.
  • These non-GAAP financial measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP.
  • The Company generally uses these non-GAAP financial measures to facilitate management's financial and operational decision-making, including evaluation of Hologic's historical operating results, comparison to competitors' operating results and determination of management incentive compensation.
  • ET today to discuss its financial results for the second quarter of fiscal 2024.

Epredia and NovaScan Announce Intent to Enter U.S. Distribution Agreement for MarginScan™ Device for Non-Melanoma Skin Cancer Detection

Retrieved on: 
Friday, May 3, 2024
Biotechnology, Health, General Health, Pharmaceutical, Oncology, Other Science, Medical Devices, Research, Hospitals, Surgery, Science, MMS, Sale, Cancer, Partnership, Skin cancer, NMSC, Patient, Physician, Multimedia, Marketing, Neoplasm, Letter, Medical imaging

View the full release here: https://www.businesswire.com/news/home/20240502185446/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240502185446/en/
    MarginScan™ Device for Non-Melanoma Skin Cancer Detection (Photo: Business Wire)
    Skin cancer is the most common group of cancers diagnosed worldwide1, and it is estimated that one in five Americans will develop skin cancer in their lifetime2.
  • Non-melanoma skin cancers (NMSC) are the most common cancers in the United States, affecting more than 3 million Americans a year3.
  • Most surgeries for NMSC are simple excisions, which may result in removal of substantial healthy tissue around the suspected cancer.
  • With this planned agreement, Epredia will serve as the primary distribution partner of MarginScan™ and will have exclusive distribution rights in the United States.