Category 1

Profound Medical Announces First Quarter 2024 Financial Results and Issues Full-Year 2024 Revenue Guidance

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星期四, 五月 9, 2024
Sale, FDA, CMS, International, Urology, PIN, Food, Travel, Software, TSX, Insurance, S&D, Research, Category 1, Level 1, Consultant, Intelligence, Prostate cancer, Webcast, Prostate, International Financial Reporting Standards, OPPS, GG5, Patient, GG1, Medicare, MRI, G&A, Marketing, Veterans' affairs, Telephone, Food and Drug Administration, Growth, BPH

TORONTO, May 09, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today reported financial results for the first quarter ended March 31, 2024 and provided full-year 2024 revenue guidance.

Key Points: 
  • TORONTO, May 09, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today reported financial results for the first quarter ended March 31, 2024 and provided full-year 2024 revenue guidance.
  • Earlier this week, Profound announced that 25 TULSA-related scientific research presentations have already been delivered at major medical meetings around the world thus far in 2024.
  • First quarter 2024 revenue increased approximately 3% from $1.86 million in the same three-month period a year ago.
  • First quarter 2024 S&D expenses increased by 15% to approximately $2.4 million, compared with $2.1 million in the first quarter of 2023.

Gyre Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

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星期二, 三月 26, 2024
Hepatitis, KPMG, GNI, Cirrhosis, Patient, Chronic obstructive pulmonary disease, Sale, Coagulopathy, Ernst & Young, Idiopathic pulmonary fibrosis, Fibrosis, Therapy, COPD, Marketing, Partnership, Arthur Andersen, Audit committee, SAN, Safety, CVR, CHB, Fatty liver disease, Prevalence, Pharmacy, Hospital, Research, Acquisition, TGF, Pirfenidone, GAAP, Toxicity, Inflammation, Accounting, Entecavir, Loss, Orthostatic hypertension, IPF, Partner, NASH, Category 1, Pharmaceutical industry

Mr. Nussbaum brings nearly four decades of experience in accounting and financial reporting in the U.S. and Asia Pacific Region.

Key Points: 
  • Mr. Nussbaum brings nearly four decades of experience in accounting and financial reporting in the U.S. and Asia Pacific Region.
  • In October 2023, Gyre (formerly known as Catalyst Biosciences, Inc. (“Catalyst”)) completed the previously announced business combination with GNI Group Ltd. (“GNI”) and related entities.
  • In October 2023, Gyre Pharmaceuticals completed enrollment of its Phase 3 trial in patients with CHB-associated liver fibrosis in the PRC.
  • Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
    Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”).

Profound Medical Announces Fourth Quarter and Full Year 2023 Financial Results

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星期四, 三月 7, 2024
International, Doctor of Philosophy, PIN, Prostate cancer, Research, Intelligence, Telephone, Marketing, Webcast, TSX, Food, GG5, Sale, Annual report, Travel, BPH, S&D, Consultant, Prostate, Level 1, Food and Drug Administration, Patient, News, Clinical trial, Insurance, G&A, Siemens Healthineers, International Financial Reporting Standards, MRI, Software, GG1, Category 1, Cryptocurrency

TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Fourth quarter 2023 revenue increased 60% from approximately $1.3 million in the same three-month period a year ago.
  • G&A expenses for the 2023 fourth quarter increased by 41% to approximately $3.0 million, compared with approximately $2.1 million in the same period in 2022.
  • Fourth quarter 2023 S&D expenses increased by 74% to approximately $2.9 million, compared with $1.7 million in the fourth quarter of 2022.

Profound Medical Announces Preliminary Unaudited Fourth Quarter and Full Year 2023 Revenues

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星期三, 一月 3, 2024
Category 1, Conference, Cleveland Clinic, Hospital, Sale, Johns Hopkins Hospital, Cone Health Women's Hospital, Prostate cancer, Level 1, Monroe Dunaway Anderson, Investment, TSX, News, Prostate, Pharmaceutical industry

Profound anticipates total revenues for the fourth quarter of 2023 to be in the approximate range of $1.9 million to $2.0 million, with the full amount coming from recurring revenue, which consists of the sale of TULSA-PRO® consumables, lease of medical devices, procedures and services associated with extended warranties.

Key Points: 
  • Profound anticipates total revenues for the fourth quarter of 2023 to be in the approximate range of $1.9 million to $2.0 million, with the full amount coming from recurring revenue, which consists of the sale of TULSA-PRO® consumables, lease of medical devices, procedures and services associated with extended warranties.
  • This represents recurring revenue growth of between 51% and 59% year-over-year, and between 10% and 16% sequentially over the 2023 third quarter.
  • For the full year 2023, Profound anticipates total revenues to be in the approximate range of $7.1 million to $7.2 million.
  • These figures are preliminary and unaudited, and actual revenues may differ.

Gynesonics Announces New Category 1 CPT Code for its Sonata Transcervical RF Ablation Procedure Used to Treat Uterine Fibroids

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星期二, 一月 2, 2024
Category 1, Constipation, Commercial, Hysterectomy, Woman, Uterine fibroid, Language, Place of birth, Literature, ACOG, Sonata, American Medical Association, Medicare, Obstetrics, Fibroid, American College, Uterus, Current Procedural Terminology, CPT, Patient, Pressure

The new code is effective January 1, 2024, and is defined as CPT 58580 Transcervical ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency.

Key Points: 
  • The new code is effective January 1, 2024, and is defined as CPT 58580 Transcervical ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency.
  • Commenting on the new CPT code, Skip Baldino, President and Chief Executive Officer of Gynesonics said, “We are very pleased that the AMA has established a new Category I code that applies to our Sonata® Procedure for the treatment of uterine fibroids.
  • The code is a critical milestone for the broader adoption of the technology to treat uterine fibroids in the United States.
  • Fibroids are treated from inside the uterus, so the Sonata Procedure requires no incisions, no tissue is surgically removed, and the uterus is preserved.

Volaris Reports November 2023 Traffic Results: 90% Load Factor

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星期二, 十二月 5, 2023
Category 1, P&W, ASMS, Volaris, Pratt & Whitney, ULCC, Yoy, VLRS, Revolutions per minute, CITY, BMV, ASM, GTF, Airline

MEXICO CITY, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Controladora Vuela Compañía de Aviación, S.A.B.

Key Points: 
  • MEXICO CITY, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Controladora Vuela Compañía de Aviación, S.A.B.
  • de C.V. (NYSE: VLRS and BMV: VOLAR) ("Volaris" or "the Company"), the ultra-low-cost carrier (ULCC) serving Mexico, the United States, Central, and South America, reports its November 2023 preliminary traffic results.
  • In November 2023, Volaris' ASM capacity decreased by 2.2% year-over-year, while RPMs decreased by 0.2%; the result was a load factor increase of 1.8 pp YoY to 89.8%.
  • Volaris transported 2.7 million passengers during the month, a 0.9% decrease compared to November 2022.

Volaris Reports October 2023 Traffic Results: 2% YoY Demand Growth with an 89% Load Factor

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星期一, 十一月 6, 2023
Yoy, MEXICO, NYSE, Volaris, Category 1, CITY, BMV, VLRS, ULCC, Aircraft, Airline, ASMS

de C.V. (NYSE: VLRS and BMV: VOLAR) (“Volaris” or “the Company”), the ultra-low-cost carrier (ULCC) serving Mexico, the United States, Central, and South America, reports its October 2023 preliminary traffic results.

Key Points: 
  • de C.V. (NYSE: VLRS and BMV: VOLAR) (“Volaris” or “the Company”), the ultra-low-cost carrier (ULCC) serving Mexico, the United States, Central, and South America, reports its October 2023 preliminary traffic results.
  • In October 2023, Volaris’ capacity (measured in ASMs) increased by 2.4% year-over-year, while demand (measured in RPMs) increased by 2.2%; the result was a load factor decrease of 0.2 pp YoY to 89.5%.
  • Demand (measured in RPMs) in the Mexican domestic market decreased by 5.2%, while demand increased by 20.1% in the international market.
  • Demand remains strong in both domestic and international markets, driving the domestic load factor to a new October record high.

Profound Medical Announces CMS Extension of Temporary ‘Code’ for TULSA to ASC Setting

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星期五, 十一月 3, 2023
ASC, HCPCS, Medicare, United States Army Medical Corps, Abdominal ultrasonography, American Medical Association, Category 1, Elective surgery, Wilford Hall Ambulatory Surgical Center, TSX, OPPS, Hospital, Prostate, Patient, Centers for Medicare & Medicaid Services, CMS

The ASC extension will go into effect on January 1, 2024.

Key Points: 
  • The ASC extension will go into effect on January 1, 2024.
  • C9734 was one of 11 HCPCS C codes that were added to the ASC Covered Procedure List, out of the 235 procedure recommendations CMS received.
  • CMS determined that these 11 codes correspond to procedures that are frequently performed in outpatient settings and increasingly show lower risks of serious complications and inpatient admissions.
  • In the meantime, we are pleased that both U.S. hospitals and ASCs performing the TULSA procedure on Medicare patients will now be able to utilize the temporary C code, C9734.”

Profound Medical Announces Second Quarter 2023 Financial Results

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星期三, 八月 9, 2023
Workforce, Insurance, Prostate, American Medical Association, Interim, Travel, International, International Accounting Standards Board, Marketing, S&D, Bank statement, Telephone, Clinical trial, G&A, Research, Category, Sale, Category 1, PIN, International Financial Reporting Standards, United States Army Medical Corps, TSX, Video game, Pharmaceutical industry, Cryptocurrency

TORONTO, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • TORONTO, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today reported financial results for the second quarter ended June 30, 2023.
  • Total operating expenses, which consist of research and development (“R&D”), general and administrative (“G&A”), and selling and distribution (“S&D”) expenses, were approximately $7.5 million in the second quarter of 2023, a 14% decrease from approximately $8.7 million in the second quarter of 2022.
  • Second quarter 2023 S&D expenses decreased by 6% to approximately $2.3 million, compared with $2.4 million in the second quarter of 2022.
  • For complete financial results, please see Profound’s filings at www.sedar.com , www.sec.gov and on the Company’s website at www.profoundmedical.com under “Financial” in the Investors section.

Global TROP2 Antibody Market Research Report 2023: Drug Sales & Clinical Trials Outlook 2028 - Approx 20 in Clinical Trials with 2 Expected to be Available in the Market in the Next 5 Years - ResearchAndMarkets.com

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星期一, 三月 13, 2023
Health, Pharmaceutical, Attention, AstraZeneca, Category 1, Breast cancer, Breast, TACSTD2, Indication, Name, Merck, Progression-free survival, Cancer, US FDA, Daiichi Sankyo, Patient, Clinical trial, Therapy, Lung, Neoplasm, Drug development, Science, Lung cancer, III, Vaccine, Pharmaceutical industry, Sacituzumab govitecan, Pembrolizumab

The "Global TROP2 Antibody Market, Drug Sales & Clinical Trials Outlook 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global TROP2 Antibody Market, Drug Sales & Clinical Trials Outlook 2028" report has been added to ResearchAndMarkets.com's offering.
  • Even though TROP-2 has garnered curiosity among researchers, there remains just one approved and commercially available antibody against it, Trodelvy.
  • Even though Gilead is leading the current TROP-2 targeted therapy market segment, it is not the only market player.
  • Global TROP2 Antibody Sales Opportunity: > USD 3 Billion
    Approved TROP2 Antibody In Market: 1 Drug (Trodelvy in 2020)
    TROP2 Antibody Clinical Pipeline By Company, Indication & Phase