RFD | Jotup

MIMEDX Provides Update on AXIOFILL® Request for Designation (“RFD”) from FDA

Retrieved on:

Wednesday, March 27, 2024

Annual report, Letter, Risk, Environment, District court, Stem cell, Research, Classification, RFD, Acquisition, Security (finance), Marketing, FDA, Health, Food

MARIETTA, Ga., March 27, 2024 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has issued a determination letter in connection with the RFD process related to AXIOFILL, a human-derived particulate wound dressing. In the letter, FDA reaffirmed its position that AXIOFILL does not meet the regulatory classification requirements of a Human Cell, Tissue or Cellular or Tissue-based Product (“HCT/P”) under Section 361 of the Public Health Service Act (“PHSA”).

Key Points:

Since the FDA has issued a final agency decision, we are taking steps to assert our position in court."
Today, there are at least three nearly identical products, including AXIOFILL, that are treated differently by FDA.
The first of these products received an RFD designation classifying it as a 361 product, consistent with other HCT/Ps.
Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

BEK TV Debuts 'Special Cowboy Moments' Capturing the Essence of Cowboy Life and Legacy

Retrieved on:

Tuesday, February 27, 2024

Century, RFD, Heart, RFD TV, 20th century, The Cowboy Channel, Woman, BEK

The program premieres on BEK TV on Wednesday, February 28th, at 5pm CT. For more information on the show and how to watch, log onto BEK Buzz .

Key Points:

The program premieres on BEK TV on Wednesday, February 28th, at 5pm CT. For more information on the show and how to watch, log onto BEK Buzz .
Hear the stories of 20th Century rodeo legends, up-and-comers, and fourth generation ranchers with Special Cowboy Moments!
"We want to bring these stories to as many people as possible, and BEK TV enables us to do that."
Don't miss BEK TV's debuts of Special Cowboy Moments on Wednesday, February 28, at 5pm CT on BEK TV!

Allegiant Announces Ten New Routes with One-Way Fares as Low as $45*

Retrieved on:

Monday, February 12, 2024

LAS VEGAS, Feb. 12, 2024 /PRNewswire/ -- Allegiant Travel Company (NASDAQ: ALGT) today announced 10 new nonstop routes to 14 cities around the country. To celebrate, the company is offering one-way fares on the new routes as low as $45.*

Key Points:

To celebrate, the company is offering one-way fares on the new routes as low as $45.
The new routes to Los Angeles International Airport (LAX) in California include:
Laredo, Texas via Laredo International Airport (LRD) – beginning June 12, 2024 with one-way fares as low as $69.
*
Rockford, Illinois via Chicago Rockford International Airport (RFD) – beginning June 12, 2024 with one-way fares as low as $79.
*
Rapid City, South Dakota via Rapid City Regional Airport (RAP) – beginning June 14, 2024 with one-way fares as low as $69.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of MiMedx Group, Inc. - MDXG

Retrieved on:

Saturday, January 6, 2024

LLP, FDA, Letter, News, Pomerantz, MiMedx, RFD

NEW YORK, Jan. 6, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of MiMedx Group, Inc. ("MiMedx" or the "Company") (NASDAQ: MDXG).

Key Points:

NEW YORK, Jan. 6, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of MiMedx Group, Inc. ("MiMedx" or the "Company") (NASDAQ: MDXG).
The investigation concerns whether MiMedx and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
However, on December 21, 2023, MIMEDX received a Warning Letter from FDA reiterating the agency's position on AXIOFILL."
Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

MIMEDX Provides AXIOFILL® Update & Reiterates 2023 Full Year Net Sales and Fourth Quarter Adjusted EBITDA Margin Outlook

Retrieved on:

Friday, December 29, 2023

Classification, Physician, ECM, FDA, Letter, Public Health Service Act, Stem cell, RFD, Growth, Safety, Patient

MARIETTA, Ga., Dec. 29, 2023 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today provided the following update regarding AXIOFILL and reiterated its outlook for 2023 full year net sales growth and fourth quarter adjusted EBITDA margin.

Key Points:

Receipt of FDA Warning Letter for AXIOFILL Classification; Not Related to Safety
MARIETTA, Ga., Dec. 29, 2023 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today provided the following update regarding AXIOFILL and reiterated its outlook for 2023 full year net sales growth and fourth quarter adjusted EBITDA margin.
However, on December 21, 2023, MIMEDX received a Warning Letter from FDA reiterating the agency’s position on AXIOFILL.
MIMEDX plans to provide commentary about this matter during its upcoming fourth quarter and year end 2023 conference call in late-February.
As such, we are also reiterating our expectations for full year 2023 net sales in the high-teens and fourth quarter adjusted EBITDA margin above 20%.

SP Plus Corporation Launches its AeroParker Online Booking Reservation System at Airports in Illinois, Kentucky, South Dakota, and Texas

Retrieved on:

Tuesday, October 17, 2023

Chicago Rockford International Airport, RFD, Jackass Aeropark, SP, Software as a service, CVG, Airport, Marketing, Tablet, FSD, Aviation, Sioux Falls Regional Airport, El Paso International Airport, Cincinnati/Northern Kentucky International Airport, ELP, Airline, Online shopping

In Texas, SP+ launched AeroParker at the Park Air Express Valet Parking operation, at El Paso International Airport (ELP).

Key Points:

In Texas, SP+ launched AeroParker at the Park Air Express Valet Parking operation, at El Paso International Airport (ELP).
These four new wins by AeroParker demonstrate SP+’s success in cross-selling AeroParker to existing clients where SP+ provides operational services.
"Through the launch of our AeroParker reservation system at these regional airports, which collectively handle millions of passengers each year, we are proud to enable them with a user-friendly, online pre-booking reservation system," said Alan Daring, VP Business Development, AeroParker.
"SP+ also provides operational services at these airports, and now with the addition of AeroParker technology, SP+ is instrumental in providing passengers an enhanced and efficient experience at the airport.

REFUND (RFD), Announces Its Launch, Unleashing the Cryptocurrency Revolution

Retrieved on:

Tuesday, May 23, 2023

Uncertainty, Blockchain, Brace, Hope, RFD, News, Movement, Sensation, Lip, Cryptocurrency, Online shopping

Now, with REFUND, Blurr.eth is poised to leave an mark on the cryptocurrency sphere.

Key Points:

Now, with REFUND, Blurr.eth is poised to leave an mark on the cryptocurrency sphere.
Enveloped in secrecy, Blurr.eth conceived REFUND as a daring game theory experiment, a gesture to give back to the community that nurtured its success.
In a cryptocurrency landscape dominated by influencers and contrived marketing, REFUND stands tall, showcasing the remarkable power of unity.
Join the REFUND community today and witness the birth of a revolution that will resonate throughout time.

OM1 Launches Analytics to Deliver Mental Health & Immunology Insights on Prescriber Trends and Therapy Effectiveness

Retrieved on:

Wednesday, May 24, 2023

Science, Research, Pharmaceutical, Health, Mental Health, Artificial Intelligence, Health Technology, Technology, Cloud, RFD, Analytic, OM1, Prescription, Geography, Doctor of Science, MD, Patient, Drug development, Nursing

OM1 , a leading real-world data, outcomes, and technology company with a focus on chronic conditions, today announced the launch of two new Real-World Analytics products – Prescriber Trends and Comparative Outcomes – to provide standardized, ready-to-access analyses of trends in treatment and outcomes in immunology and mental health condition areas.

Key Points:

OM1 , a leading real-world data, outcomes, and technology company with a focus on chronic conditions, today announced the launch of two new Real-World Analytics products – Prescriber Trends and Comparative Outcomes – to provide standardized, ready-to-access analyses of trends in treatment and outcomes in immunology and mental health condition areas.
A combination of market trends – an emphasis on personalized medicine, the rise of new modalities and treatment options, and regulatory challenges – means that pharmaceutical companies are constantly amending commercial strategies to keep up.
The healthcare landscape continues to evolve, but one thing remains constant – the need for deep, actionable, and data-backed insights.
Comparative Outcomes: leverages extensive patient outcomes data extracted from unstructured clinical notes to provide information on the effectiveness and comparative effectiveness of medications across various outcomes over time.

FreeCast Special Offer Brings Even More Value to Value Channels

Retrieved on:

Tuesday, April 11, 2023

ORLANDO, Fla., April 11, 2023 /PRNewswire/ -- FreeCast is announcing special pricing on its Value Channels subscription package. For a limited time, Value Channels will be available for $30 a year. Those who purchase a one-year subscription will pay the equivalent of $2.50 per month, a more than 60% savings over the normal $6.99 per month pricing, with the discount locked in for an entire year.

Key Points:

ORLANDO, Fla., April 11, 2023 /PRNewswire/ -- FreeCast is announcing special pricing on its Value Channels subscription package.
For a limited time, Value Channels will be available for $30 a year.
Value Channels is FreeCast's virtual pay-TV package, bringing a selection of family pay channels and unlimited cloud DVR together for an attractive low price.
Subscriptions to Value Channels also include the base FreeCast service, formerly known as SelectTV.

OM1 Launches Analytic Reports Uncovering Causes of Medication Discontinuation in Immunology Patients

Retrieved on:

Thursday, February 2, 2023

OM1 a leading real-world data, outcomes and technology company with a focus on chronic diseases, today announced the launch of its Reasons for Discontinuation (RfD) Analytic Reports.

Key Points:

OM1 a leading real-world data, outcomes and technology company with a focus on chronic diseases, today announced the launch of its Reasons for Discontinuation (RfD) Analytic Reports.
Leveraging the OM1 Real-World Data CloudTM , Immunology Real-World Data Network, and proprietary artificial intelligence (AI) technology, the RfD reports contain highly valuable, difficult-to-obtain medication discontinuation trends for bDMARDs, cDMARDs, and tsDMARDs in primary dermatologic and rheumatologic conditions.
Understanding discontinuation patterns in patients is critical so that pharmaceutical companies can act on insights related to tolerability, costs, and emerging contraindications to improve the patient experience.
To learn more about the Reasons for Discontinuation (RfD) Reports and other custom analyses available, please email [email protected] .