National coverage determination

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Silk Road Medical, Inc. - SILK

Retrieved on: 
Lunedì, Novembre 13, 2023

NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Silk Road Medical, Inc. (“Silk Road” or the “Company”) (NASDAQ: SILK).

Key Points: 
  • NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Silk Road Medical, Inc. (“Silk Road” or the “Company”) (NASDAQ: SILK).
  • The investigation concerns whether Silk Road and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • On October 10, 2023, Silk Road announced that its second quarter 2023 revenues were expected to be below its first quarter revenues and significantly reduced its expected full year 2023 revenues.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

InspireMD Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Lunedì, Novembre 6, 2023

TEL AVIV, Israel and MIAMI, Nov. 06, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for treatment of carotid artery disease and prevention of stroke today announced financial results and business updates for the third quarter ended September 30, 2023.

Key Points: 
  • Generated CGuard revenue for the third quarter 2023 of $1,556,072, an 8.8 % increase over the same period in 2022.
  • Sold 2,734 CGuard EPS stent systems in the third quarter of 2023, as compared to 2,624 in the third quarter of 2022, an increase of 4.2 %.
  • Total financial income for the third quarter of 2023 was $461,000, an increase of $380,000 or 469% compared to $81,000 for the third quarter of 2022.
  • Management will host a conference call today, Monday, November 6th, at 8:30 AM ET, to review financial results and provide an update on corporate developments.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Silk Road Medical, Inc. - SILK

Retrieved on: 
Domenica, Novembre 5, 2023

NEW YORK, Nov. 05, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Silk Road Medical, Inc. (“Silk Road” or the “Company”) (NASDAQ: SILK).

Key Points: 
  • NEW YORK, Nov. 05, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Silk Road Medical, Inc. (“Silk Road” or the “Company”) (NASDAQ: SILK).
  • The investigation concerns whether Silk Road and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • On October 10, 2023, Silk Road announced that its second quarter 2023 revenues were expected to be below its first quarter revenues and significantly reduced its expected full year 2023 revenues.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Silk Road Medical, Inc. - SILK

Retrieved on: 
Venerdì, Ottobre 27, 2023

NEW YORK, Oct. 27, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Silk Road Medical, Inc. (“Silk Road” or the “Company”) (NASDAQ: SILK).

Key Points: 
  • NEW YORK, Oct. 27, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Silk Road Medical, Inc. (“Silk Road” or the “Company”) (NASDAQ: SILK).
  • The investigation concerns whether Silk Road and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • On October 10, 2023, Silk Road announced that its second quarter 2023 revenues were expected to be below its first quarter revenues and significantly reduced its expected full year 2023 revenues.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Silk Road Medical, Inc. - SILK

Retrieved on: 
Giovedì, Ottobre 19, 2023

NEW YORK, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Silk Road Medical, Inc. (“Silk Road” or the “Company”) (NASDAQ: SILK).

Key Points: 
  • NEW YORK, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Silk Road Medical, Inc. (“Silk Road” or the “Company”) (NASDAQ: SILK).
  • The investigation concerns whether Silk Road and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • On October 10, 2023, Silk Road announced that its second quarter 2023 revenues were expected to be below its first quarter revenues and significantly reduced its expected full year 2023 revenues.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

InspireMD Supports CMS’ Final National Coverage Determination (NCD) Expanding Coverage of Carotid Stenting (CAS) to Include Both Asymptomatic and Standard Risk Patients

Retrieved on: 
Giovedì, Ottobre 12, 2023

TEL AVIV, Israel and MIAMI, Oct. 12, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced its support for the Centers for Medicare and Medicaid Services (CMS) final National Coverage Determination (NCD) which expands coverage of carotid artery stenting (CAS) and transcarotid artery revascularization (TCAR) to include both asymptomatic and standard risk patients.

Key Points: 
  • Provides additional treatment options for patients and treating physicians; likely expands CAS addressable market
    InspireMD advancing both CAS and TCAR stent delivery platforms along U.S. and E.U.
  • Marvin Slosman, Chief Executive Officer of InspireMD, stated, “We support CMS’s final decision on the expansion of coverage of CAS to include both symptomatic and asymptomatic carotid artery disease patients considered to be either standard or high risk for surgery.
  • The company anticipates filing for Premarket Approval (PMA) in the second half of 2024 when one-year follow up has been completed.
  • InspireMD will provide further updates on this and other recent developments during its regularly scheduled third quarter 2023 conference call in November.

RedDress Launches ActiGraft PRO with G-Code Reimbursement Status for the US Wound Care Market

Retrieved on: 
Martedì, Luglio 18, 2023

TEL AVIV, Israel and JACKSONVILLE, Fla., July 18, 2023 /PRNewswire/ -- RedDress, a personalized and autologous wound care solution created from patients own whole blood, today announced that its ActiGraft PRO product is now commercially available throughout the US and is eligible for reimbursement nationally from Medicare and Medicare Advantage via NCD 270.3 and G-0465 & G-0460 codes. ActiGraft PRO is the most advanced whole-blood wound care solution on the market, offering a quick procedure time while eliminating the need for a centrifuge or a needle for blood transfer. Reimbursement for the procedure through Medicare and Medicare Advantage is $1726 per application for up to 20 applications in hospital outpatient facilities and wound care centers.

Key Points: 
  • ActiGraft PRO is the most advanced whole-blood wound care solution on the market, offering a quick procedure time while eliminating the need for a centrifuge or a needle for blood transfer.
  • Reimbursement for the procedure through Medicare and Medicare Advantage is $1726 per application for up to 20 applications in hospital outpatient facilities and wound care centers.
  • "Launching ActiGraft PRO, our most advanced wound care product, along with Medicare reimbursement status for patients across the US, is a significant milestone for us as a company and for the national wound care market as a whole", said Alon Kushnir, CEO and co-founder of RedDress.
  • The ActiGraft PRO system is an autologous, point-of-care wound management solution created from patient's whole blood.

Alzheimer's Association Welcomes Announcement of CMS Coverage for FDA-approved Treatments

Retrieved on: 
Venerdì, Luglio 7, 2023

It is clear that CMS leaders have listened to experts, advocates, people living with Alzheimer's and families.

Key Points: 
  • It is clear that CMS leaders have listened to experts, advocates, people living with Alzheimer's and families.
  • It is reflected in their plan for delivering coverage of traditionally approved treatments proven to deliver meaningful benefit," said Joanne Pike, DrPH, Alzheimer's Association president and CEO.
  • Today's announcement by CMS to open up Medicare coverage comes following extensive efforts by the Alzheimer's Association, bipartisan members of Congress , state attorneys general , clinicians, and, most importantly, advocates from communities all across the country.
  • "We were disappointed, however, that CMS did not take this opportunity to initiate the formal process to reconsider their National Coverage Determination policy .

Reapplix Receives Innovative Technology Contract from Vizient for the 3C Patch® Wound Management System

Retrieved on: 
Lunedì, Maggio 22, 2023

SOUTHLAKE, Texas, May 22, 2023 /PRNewswire-PRWeb/ -- Reapplix announced its 3C Patch® Wound Management System has received an Innovative Technology contract from Vizient, Inc. the nation's largest member-driven healthcare performance improvement company. The contract was awarded based on the recommendation of 3C Patch by hospital experts who serve on one of Vizient's member-led councils, and it signifies to Vizient members unique qualities that potentially bring improvement to the healthcare industry.

Key Points: 
  • SOUTHLAKE, Texas, May 22, 2023 /PRNewswire-PRWeb/ -- Reapplix announced its 3C Patch® Wound Management System has received an Innovative Technology contract from Vizient, Inc. the nation's largest member-driven healthcare performance improvement company.
  • Innovative Technology contracts are recommended after review and interaction with products submitted through Vizient's Innovative Technology Program.
  • The patented 3CPatch® System is an innovative, evidence-based biological wound therapy made entirely from the patient's own blood – nothing else.
  • "We are proud of this Vizient Innovative Technology contract and what it means for clinicians and their patients with chronic wounds.

Alzheimer's Association Statement on Donanemab Phase 3 Topline Data Release

Retrieved on: 
Mercoledì, Maggio 3, 2023

CHICAGO, May 3, 2023 /PRNewswire/ --  On behalf of the millions of Americans impacted by the devastation of Alzheimer's disease, the Alzheimer's Association enthusiastically welcomes the robustly positive topline data reported today by Eli Lilly on the TRAILBLAZER-ALZ2 Phase 3 clinical trial of donanemab for the treatment of early symptomatic Alzheimer's disease.

Key Points: 
  • "These are the strongest phase 3 data for an Alzheimer's treatment to date.
  • For people in the earliest stages of Alzheimer's, these results suggest donanemab will significantly change the course of the disease.
  • Today's topline data is further evidence that this class of treatments can provide a meaningful benefit to people living with early Alzheimer's.
  • "We look forward to additional data from the TRAILBLAZER-ALZ2 trial at the Alzheimer's Association International Conference (AAIC) in July, including data on participant safety and representation.