IVL

Johnson & Johnson to Acquire Shockwave Medical

Retrieved on: 
Friday, April 5, 2024
Research, Medical Devices, Health Technology, Cardiology, Biotechnology, Other Health, Health, Pharmaceutical, Science, Cardiovascular disease, Worldwide, Growth, Peripheral artery disease, Coronary artery disease, Johnson & Johnson, Patient, PAD, JNJ, Perella Weinberg Partners, Acquisition, Electrophysiology, Death, IVL, Medtech, Ventricular fibrillation, European, PCI, Artery, Laminar, Stenosis, Hand, Physician, Percutaneous coronary intervention, CAD, Pharmaceutical industry

Johnson & Johnson (NYSE: JNJ) and Shockwave Medical, Inc. (Nasdaq: SWAV) (“Shockwave”) today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired.

Key Points: 
  • Johnson & Johnson (NYSE: JNJ) and Shockwave Medical, Inc. (Nasdaq: SWAV) (“Shockwave”) today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired.
  • The transaction is expected to accelerate revenue growth for both Johnson & Johnson and Johnson & Johnson MedTech.
  • Delivers immediate operational accretion: The transaction will be accretive to operating margin for both Johnson & Johnson and Johnson & Johnson MedTech.
  • Under the terms of the agreement, Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash through a merger of Shockwave with a wholly owned Johnson & Johnson subsidiary.

FastWave Earns Third Utility Patent for Next-Generation IVL Technology

Retrieved on: 
Wednesday, March 6, 2024
IVL, Stenosis, Physician, Patent, Hospital, Disease, Associate, Health, Patient, Artery, Massachusetts General Hospital, Harvard Medical School, Mortality, Pharmaceutical industry

MINNEAPOLIS, March 6, 2024 /PRNewswire-PRWeb/ -- FastWave Medical, a clinical-stage medical device company developing differentiated intravascular lithotripsy (IVL) technology, announced the issuance of its third utility patent by the United States Patent and Trademark Office (USPTO). This latest patent – granted just three years from the company's inception – underscores FastWave's ambitious commitment to transforming the treatment of calcific artery disease.

Key Points: 
  • MINNEAPOLIS, March 6, 2024 /PRNewswire-PRWeb/ -- FastWave Medical, a clinical-stage medical device company developing differentiated intravascular lithotripsy (IVL) technology, announced the issuance of its third utility patent by the United States Patent and Trademark Office (USPTO).
  • "The issuance of FastWave's third utility patent is a testament to the phenomenal work being done by their experienced team.
  • By developing advanced lithotripsy platforms, FastWave aims to solve the gaps with existing IVL technology while improving ease of use and patient safety by reducing procedural complications.
  • Co-founder and CEO of FastWave Medical, Scott Nelson, emphasized the company's commitment to advancing IVL technology, stating, "We are thrilled to receive our third utility patent, which further validates the ingenuity of our IVL systems.

Shockwave Medical Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 15, 2024
Acquisition, IVL, Investment, Physician, Cardiovascular disease, Growth, Adjustment, CPT, Piping and plumbing fitting, Patient, Remuneration, Video game

Gross profit for the fourth quarter of 2023 was $177.7 million compared to $126.5 million for the corresponding prior year period.

Key Points: 
  • Gross profit for the fourth quarter of 2023 was $177.7 million compared to $126.5 million for the corresponding prior year period.
  • Gross margin for the fourth quarter of 2023 was 88%, consistent with 88% for the corresponding prior year period.
  • Adjusted EBITDA was $68.2 million in the fourth quarter of 2023, a 20% increase compared to adjusted EBITDA of $56.6 million in the fourth quarter of 2022.
  • Shockwave Medical will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on Thursday, February 15, 2024, to discuss its fourth quarter and full year 2023 financial results.

AVS Appoints Elizabeth Galle as Vice President of Clinical Affairs

Retrieved on: 
Tuesday, February 6, 2024
General Health, Health, Cardiology, Medical Devices, Growth, Research, IVL, Safety, Publication, FDA, Food, Artery, Medicine, Boston Scientific, Pharmaceutical industry

AVS (Amplitude Vascular Systems, Inc), an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease with its PIVL™ therapy, announced the appointment of Elizabeth Galle as the company’s new Vice President of Clinical Affairs.

Key Points: 
  • AVS (Amplitude Vascular Systems, Inc), an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease with its PIVL™ therapy, announced the appointment of Elizabeth Galle as the company’s new Vice President of Clinical Affairs.
  • She comes to AVS with more than two decades of leadership experience in the device space, most recently serving as the Vice President of Global Clinical Research at CVRx.
  • Prior to CVRx, Galle was the Senior Clinical Manager of clinical scientists and biostatisticians at Boston Scientific Corporation, where she supported the design and execution of a large portfolio of cardiovascular clinical studies.
  • “AVS has emerged as a pioneer in an exciting and novel area in medicine, intravascular lithotripsy,” Galle said.

FastWave Medical Announces Appointment of World-Renowned Medical Advisors to Accelerate its Intravascular Lithotripsy Programs

Retrieved on: 
Thursday, February 1, 2024
Calcium, Cardiovascular disease, IVL, Patient, Physician, Pharmaceutical industry

MINNEAPOLIS, Feb. 1, 2024 /PRNewswire-PRWeb/ -- FastWave Medical Inc., a pioneering medical device company focused on differentiated approaches to addressing calcified cardiovascular disease through advanced intravascular lithotripsy (IVL), today announced the appointments of eight medical advisors.

Key Points: 
  • MINNEAPOLIS, Feb. 1, 2024 /PRNewswire-PRWeb/ -- FastWave Medical Inc., a pioneering medical device company focused on differentiated approaches to addressing calcified cardiovascular disease through advanced intravascular lithotripsy (IVL), today announced the appointments of eight medical advisors.
  • The newly appointed medical advisors include some of the world's most prominent interventional cardiologists and vascular surgeons, underscoring FastWave Medical's commitment to rapidly advancing its next-generation IVL therapies.
  • These key advisors will be pivotal in moving FastWave Medical's coronary and peripheral IVL systems through the stages of product development and clinical trials.
  • Scott Nelson, CEO of FastWave Medical, commented, "On behalf of our entire group at FastWave Medical, we are honored to welcome such an impressive group of physicians to be extended team members to accelerate our IVL platforms.

Shockwave Medical Appoints Renee Gaeta as Chief Financial Officer

Retrieved on: 
Monday, January 29, 2024
Patient, Therapy, Health, CFO, Certified Public Accountant, IVL, Loyola Marymount University, Bachelor of Science, Cardiovascular disease, Growth, Management

SANTA CLARA, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, announced today the appointment of Renee Gaeta as Chief Financial Officer (CFO), effective February 5, 2024.

Key Points: 
  • SANTA CLARA, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, announced today the appointment of Renee Gaeta as Chief Financial Officer (CFO), effective February 5, 2024.
  • Renee succeeds Dan Puckett, CFO at Shockwave since 2016, who previously announced his decision to retire.
  • “Renee is a highly skilled and accomplished executive with a proven track record in the medical device and healthcare industries,” said Doug Godshall, Chief Executive Officer at Shockwave.
  • “I am thrilled to welcome Renee to Shockwave and look forward to partnering with her through our next phase of growth and profitability.

New Shockwave Coronary IVL Publication Shows Similar Outcomes in Women And Men

Retrieved on: 
Thursday, November 9, 2023
Yale School of Medicine, CAD, IV, Treatment, Coronary artery disease, Dissection, Doctor of Philosophy, IVL, Journal, St. Francis Hospital, TLF, MACE, HR, Perforation, CT, Woman, Safety, Society, USE, Hospital, Reflow soldering, EMPOWER, Cardiovascular disease, Pharmaceutical industry, Birth control, MD, Cardiology

The one-year results from Disrupt CAD III and IV trials were recently published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) .

Key Points: 
  • The one-year results from Disrupt CAD III and IV trials were recently published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) .
  • In the patient-level pooled analysis, titled “Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes,” use of IVL for lesion preparation of severely calcified lesions had similar safety and effectiveness in women and men at a one-year follow-up.
  • At one-year, major adverse cardiovascular event (MACE) rates were not different between women and men (12.3% vs 13.2%, p=0.52) and there was no difference between women and men in target lesion failure (TLF, 10.4% vs. 11.2% p=0.43).
  • The European lead is Nieves Gonzalo, MD, PhD, Consultant Interventional Cardiologist at Hospital Clinico San Carlos in Madrid, Spain.

Shockwave Medical Reports Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 6, 2023
Medicare, Physician, RVU protocol, EBITDA, PFS, Shock wave, IVL, United, Remuneration, Centers for Medicare & Medicaid Services, Growth, Investment, Patient, CMS, Cardiovascular disease, Video game, Pharmaceutical industry

SANTA CLARA, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, today reported financial results for the three months ended September 30, 2023.

Key Points: 
  • SANTA CLARA, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, today reported financial results for the three months ended September 30, 2023.
  • Gross profit for the third quarter of 2023 was $161.5 million compared to $113.5 million for the third quarter of 2022.
  • Total operating expenses for the third quarter of 2023 were $117.9 million, a 54% increase from $76.7 million in the third quarter of 2022.
  • Shockwave Medical will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on Monday, November 6, 2023, to discuss its third quarter 2023 financial results.

Centers for Medicare & Medicaid Services Establishes New Category I CPT® Add-On Code for Coronary IVL

Retrieved on: 
Friday, November 3, 2023
Senior, Physician, American Medical Association, PFS, IVL, Marketing, MAC, CMS, RVU protocol, Cardiology, Health insurance

Providers should contact their local Medicare Administrative Contractor (MAC) or CMS for specific information as payment rates vary by region.

Key Points: 
  • Providers should contact their local Medicare Administrative Contractor (MAC) or CMS for specific information as payment rates vary by region.
  • Prior to the establishment of CPT® code +92972, there were no additional RVUs or fees for physicians who performed coronary IVL.
  • CMS first proposed the new CPT® add-on code via the FY2024 Proposed PFS which, following a 60-day public comment period, has now been finalized.
  • It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered.

Shockwave Medical Introduces Enhanced Coronary IVL Catheter in the United States

Retrieved on: 
Friday, October 20, 2023
Food, C2, MD, Shock wave, IVL, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Level 2, St. Francis Hospital, Workflow, TCT, Calcium, Cardiovascular disease, Medical imaging

SANTA CLARA, Calif., Oct. 20, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, announced today the planned U.S. introduction of the Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) catheter following approval by the U.S. Food and Drug Administration. The Shockwave C2+ catheter provides 50 percent more pulses per catheter than the Shockwave C2 catheter that was approved in the U.S. in 2021. The enhanced C2+ catheter will make its U.S. debut at the 35th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation, with the full commercial launch planned for the beginning of November.

Key Points: 
  • SANTA CLARA, Calif., Oct. 20, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, announced today the planned U.S. introduction of the Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) catheter following approval by the U.S. Food and Drug Administration.
  • The Shockwave C2+ catheter provides 50 percent more pulses per catheter than the Shockwave C2 catheter that was approved in the U.S. in 2021.
  • The enhanced C2+ catheter will make its U.S. debut at the 35th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation, with the full commercial launch planned for the beginning of November.
  • “The enhancements of Shockwave C2+ will be an added benefit of IVL for optimally treating complex calcium, including more diffuse disease, as well as nodular and thick, eccentric calcium,” said Richard Shlofmitz, MD, Chairman, Department of Cardiology, St. Francis Hospital in Roslyn, New York, who performed the first U.S. commercial case with Shockwave C2+.