Author: Michelle Dryden

Categories
Art & Life Business Lifestyle Programs & Events

Miranda Lambert’s MuttNation & Tractor Supply award over $250,000 in grants to 52 animal shelters

Mutts Across America program makes surprise donation in every state

 

NASHVILLE, Tenn. — (BUSINESS WIRE) — #4H — Three-time GRAMMY Award-winning Country superstar Miranda Lambert’s MuttNation Foundation and Tractor Supply Company (NASDAQ: TSCO), the largest rural lifestyle retailer in the United States, teamed up for the third consecutive year to donate more than $250,000 to animal shelters across the nation.

 

Through MuttNation’s Mutts Across America program, one outstanding shelter or foster-based rescue in every state – plus Washington, D.C. and a “Wildcard” pick – are being honored with a surprise $5,000 grant.

 

“Finding deserving shelters and rescue groups across the country is easy,” said Bev Lambert, Miranda’s mother and co-founder of MuttNation, who also conceived Mutts Across America. “It’s narrowing it down to just one in each state that’s really tough.”

 

“Mutts Across America is MuttNation’s cornerstone – it was our first signature program,” added Miranda. “These grants give us the chance to show our appreciation and spotlight shelters across the country for their hard work, year-round, to improve the lives of shelter pets. We’re so proud to partner with Tractor Supply on this and other programs, allowing us to elevate our goals and increase the number of animals’ lives we can change.”

 

Since the initiative’s origin nine years ago, MuttNation’s Mutts Across America has supported more than 450 shelters with over $1.75 million in grants. Tractor Supply began partnering with MuttNation in 2021.

 

“Shelter pets have our hearts at Tractor Supply,” stated Kimberley Gardiner, chief marketing officer at Tractor Supply. “Miranda’s passion for this cause and the work she has done through MuttNation truly inspire us and supporting their work is a privilege and joy. These shelters are saving the lives of animals and pets and providing the care they need as they wait for their future owners.”

 

Each year, MuttNation conducts extensive research to carefully choose the organizations that will be honored with the annual grants and, this year, is specifically recognizing some of the outstanding shelters that help seniors, special needs dogs, large dogs and pit mixes; the “Love Harder” dogs that are easy to love but hardest to get adopted. There is no application process for Mutts Across America, and the recipients are given no advance notice before receiving the award.

 

In addition to the Mutts Across America partnership, MuttNation and Tractor Supply started the Relief For Rescues Fund earlier this year to help shelters and shelter pets recover from natural disasters. To date, the fund has generated over $357,000 to support shelter animals affected by disasters such as floods, fires, hurricanes and tornadoes, with funding already dispersed to organizations responding to shelter pets impacted by severe flooding in California’s Central Valley, a violent EF4 tornado in Mississippi and more.

 

Tractor Supply is the exclusive retailer of MuttNation pet products, with a percentage of all sales going to the MuttNation Foundation to promote and facilitate its mission.

 

The 2023 Mutts Across America grant recipients are:

Shelter Name State
Aide for Animals Sanctuary Alabama
Juneau Animal Rescue Alaska
Unconditional Love Pet Rescue (ULPR) Arkansas
NAGI Foundation Arizona
Animal Compassion Team of California California
Soul Dog Rescue Colorado
Army’s Legacy Animal Rescue and Sanctuary Connecticut
Rural Dog Rescue DC
Humane Animal Partners Deleware
UFAR Animal Parnters Florida
Homeward Bound Pet Rescue Georgia
The Hawaii SPCA Maili Waianae Hawaii
Heart of Idaho Animal Sanctuary Idaho
Second City Canine Rescue Illinois
Grateful Rescue and Sanctuary (Grateful Rescue) Indiana
Dogs Forever of Iowa (Dogs Forever) Iowa
Clay County Animal Rescue & Education Center Kansas
LIFE House for Animals Kentucky
4 Paws Rescue Inc. Louisiana
Underhound Railroad, Inc. Maine
Senior Dog Sanctuary Maryland
Cape Ann Animal Aid Christopher Cutler Rich Animal Shelter Massachusetts
K9 Stray Rescue League Michigan
Great River Rescue Minnesota
HoofBeats and PawPrints Rescue Mississippi
Columbia Second Chance Missouri
The Dedman Foundation Montana
FurEver Home, Inc. Nebraska
Hearts Alive Village Nevada
Second Chance Ranch Rescue NH New Hampshire
Marty’s Place Senior Dog Sanctuary, INC New Jersey
Pet-A-Bulls, Inc. New Mexico
Paws Crossed Animal Rescue New York
Lake Norman Humane North Carolina
Prairie Paws Rescue North Dakota
Multiple Breed Rescue Ohio
Oklahoma Alliance for Animals Oklahoma
Southern Oregon Humane Society Oregon
Speranza Animal Rescue Pennsylvania
Anchor Paws Rescue Rhode Island
Pet Helpers Adoption Shelter and Spay/Neuter Clinic South Carolina
B-Squad Dog Rescue South Dakota
New Leash on Life Tennessee
Dog Ranch Rescue Texas
Hearts 4 Paws Rescue Utah
Homeward Bound , Addison County’s Humane Society Vermont
Wolf Trap Animal Rescue Virginia
Old Dog Haven Washington
Humane Society of Harrison County- WV West Virginia
Bob’s House for Dogs Wisconsin
Laramie Peak Humane Society Wyoming
Bonaparte’s Retreat Dog Rescue *WILDCARD*

Tennessee

 

About MuttNation Foundation

Founded by Miranda and her mom, Bev Lambert, in 2009, MuttNation is a donation-supported 501c(3) nonprofit organization with a mission to promote the adoption of shelter pets, advance spay & neuter and educate the public about the benefits of these actions. MuttNation provides financial support and works with transport partners to assist and relocate animals during times of natural disaster. MuttNation Fueled by Miranda Lambert, a pet line of toys and supplies that benefits the Foundation, is available exclusively at Tractor Supply Company stores throughout the US. www.muttnation.com

 

About Miranda Lambert:

Already a decorated songwriter, Academy of Country Music Entertainer of the Year, passionate shelter animal advocate, restaurateur and business woman, superstar Miranda Lambert adds New York Times best-selling author to her impressive list of titles with the arrival of her debut book, “Y’all Eat Yet?,” available everywhere now.

 

Palomino, her eighth solo album, arrived in 2022 as the largest female Country album debut of the year and earned a GRAMMY nomination for Best Country Album. Named among the best of the year by the New York Times, TIME, Rolling Stone, Billboard, Stereogum, People and many more, it marks the latest installment in a storied career that has spanned seven previous No. 1 solo albums, 11 No. 1 hit radio singles, more than 70 prestigious awards and countless sales certifications, earning the most-awarded artist in ACM history praise from NPR as “the most riveting country star of her generation.”

 

With her headlining Velvet Rodeo Las Vegas residency extended through late 2023 at Planet Hollywood Resort & Casino’s Bakkt Theater, the top streaming female Country artist of 2022 was also named to the TIME100 list honoring the world’s most influential people, with Pitchfork declaring that she “manages the hat-trick of both timelessness and timely activism.” Whether challenging conventional gender notions in her recent Top 10 hit “If I Was A Cowboy” or using her voice to write and record the inclusive “Y’All Means All” anthem for Netflix’s “Queer Eye,” the Texas native continues to expand the tent of the Country genre via her music, including with her latest release, the cross-genre collaboration “If You Were Mine” with Leon Bridges.

 

Idyllwind, her clothing and cowboy boot collection, is an exclusive brand sold at all Boot Barn stores nationwide, while her home goods collection, Wanda June Home, is available exclusively at Walmart. She is also the first female artist to have her own venue on Broadway in Nashville with her Casa Rosa Tex-Mex cantina. An avid animal lover, Lambert’s MuttNation pet product line is available exclusively at Tractor Supply Co. with proceeds benefitting her MuttNation Foundation, a 501c3 nonprofit that has raised over $8 million since its inception in 2009. The Foundation’s mission is to promote the adoption of rescue pets, support animal shelters across the country, advance spay & neuter and assist with the transport of animals during times of natural disaster.

MirandaLambert.com | Facebook | Twitter | Instagram | TikTok | YouTube

 

About Tractor Supply

For 85 years, Tractor Supply Company (NASDAQ: TSCO) has been passionate about serving the needs of recreational farmers, ranchers, homeowners, gardeners, pet enthusiasts and all those who enjoy living Life Out Here. Tractor Supply is the largest rural lifestyle retailer in the U.S., ranking 291 on the 2023 Fortune 500. The company’s more than 52,000 Team Members are known for delivering legendary service and helping customers pursue their passions, whether that means being closer to the land, taking care of animals or living a hands-on, DIY lifestyle. In store and online, Tractor Supply provides what customers need – anytime, anywhere, any way they choose at the low prices they deserve.

 

As of April 1, 2023, the Company operated 2,164 Tractor Supply stores in 49 states, including 81 stores acquired from Orscheln Farm and Home in 2022 that will be rebranded to Tractor Supply by the end of 2023. For more information on Tractor Supply, visit www.tractorsupply.com.

 

Tractor Supply Company also owns and operates Petsense by Tractor Supply, a small-box pet specialty supply retailer providing products and services for pet owners. As of April 1, 2023, the Company operated 189 Petsense by Tractor Supply stores in 23 states. For more information on Petsense by Tractor Supply, visit www.Petsense.com.

 

Contacts

Media Contact for Tractor Supply Company:
Mary Winn Pilkington (615) 440-4212

Tricia Whittemore (615) 440-4410

corporatecommunications@tractorsupply.com

Media Contacts for Miranda Lambert:
Ebie McFarland | Janet Buck

Essential Broadcast Media

(615) 327-3259

ebie@ebmediapr.com | janet@ebmediapr.com

For MuttNation:
Nina Miller

nmiller@muttnation.com

Categories
Business Healthcare Lifestyle Science

Blue Earth Diagnostics announces results of post-hoc analysis assessing impact of urinary activity on interpretation of POSLUMA® (Flotufolastat F 18) injection PET/CT in prostate cancer

− Based on data from prospective Phase 3 LIGHTHOUSE and SPOTLIGHT studies in newly diagnosed and recurrent prostate cancer –

 

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced results of a post-hoc analysis assessing the impact of urinary activity on the interpretation of POSLUMA® (flotufolastat F 18) injection (formerly known as 18F-rhPSMA-7.3) PET/CT in prostate cancer.

 

The analysis was based on data from Blue Earth Diagnostics’ prospective Phase 3 LIGHTHOUSE and SPOTLIGHT studies that evaluated the diagnostic performance and safety of POSLUMA in newly diagnosed and recurrent prostate cancer. The majority read results from 3 blinded readers assessing 712 evaluable POSLUMA scans showed that urinary activity did not influence disease assessment for the majority (96%, 682/712) of patients and that halo artifacts, that can potentially inhibit image assessment, occurred very rarely (0.3%, 2/712). The results as reported expanded on the initial data from a single reader that were detailed in the abstract. Recently approved by the U.S. FDA, POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. The results were reported at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, held June 24 – 27, in Chicago, Ill.

 

“The ability to gather actionable information from PSMA PET scans is important for physicians to make informed decisions about patient management for men with prostate cancer,” Phillip Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering. “Activity in the urinary bladder area is a common feature of PSMA-PET radiopharmaceuticals. It can potentially obscure tumors and lymph nodes in the prostate region, which is the most common site of recurrence, and interfere with accurate image interpretation. The data presented here build on early clinical experience and suggest that, among this large dataset from two Phase 3 prospective trials, POSLUMA urinary activity is relatively low and rarely impacts disease assessment.”

 

“We are pleased to share these results about our new FDA-approved product, POSLUMA, with the imaging community at SNMMI,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “POSLUMA represents a new class of PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology. It is engineered to advance clinical decision-making by providing beneficial information for treatment planning in men with prostate cancer, which can lead to changes in patient management. In preclinical and Phase 1 studies, POSLUMA demonstrated a high binding affinity for PSMA, with low urinary bladder activity, thus providing the potential for enhanced image evaluation in the prostate and regions near the ureters for patients with prostate cancer. We conducted this post-hoc analysis of PET scans from the Phase 3 LIGHTHOUSE and SPOTLIGHT studies to further investigate these earlier findings. We believe that POSLUMA’s diagnostic performance, high-affinity PSMA binding and low urinary activity characteristics make it a valuable diagnostic tool that is radiolabeled with 18F for high image quality and readily available patient access.”

 

Results presented at SNMMI were based on 712 evaluable POSLUMA scans (348 newly diagnosed patients and 364 patients with recurrent prostate cancer from LIGHTHOUSE and SPOTLIGHT, respectively). Of the 718 eligible scans, 6 were excluded on the basis of cystectomy, renal failure or presence of a urinary catheter. Findings included quantitative analyses of activity in the urinary bladder, based on maximum and mean standardized uptake values (SUVmax and SUVmean, respectively). Qualitative analyses conducted by 3 blinded, independent PET readers examined the impact of any urinary activity on the ability to assess the prostate/prostate bed and pelvic/retroperitoneal lymph nodes using a 3-point scale.

 

The median bladder SUVmax and SUVmean for POSLUMA were 17.1 and 12.5, respectively. For the qualitative metrics, by majority read, it was possible to distinguish urinary activity from disease uptake in 96% (82/712) of patients. Halo artifacts impacting assessment around the ureters and bladder were only observed in 0.3% (2/712) of patients.

 

There were several limitations to the study, including that it was not designed as a head-to-head comparison with other PSMA-PET radiopharmaceuticals and that any comparisons with data from other radiopharmaceuticals reported in the literature should be made with caution. Another limitation was that reader agreement was not formally tested. It should also be noted that, per the Important Safety Information for POSLUMA, the interpretation of POSLUMA PET in patients with suspected prostate cancer recurrence may differ depending on imaging readers, particularly in the prostate/prostate bed region.

 

Results of the presentation, “Post-hoc analysis of the LIGHTHOUSE and SPOTLIGHT studies to assess the impact of urinary activity on interpretation of 18F-rhPSMA-7.3,” were presented at SNMMI on June 27, 2023, by Phillip Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz. Full session details and the abstract are available in the SNMMI 2023 online program here.

 

Blue Earth Diagnostics’ LIGHTHOUSE Phase 3 clinical trial (NC04186819) was a prospective, Phase 3, multi-center, single-arm, imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of POSLUMA PET in men with newly diagnosed prostate cancer. Results have been presented at the 23rd Annual Scientific Meeting in Urologic Oncology (SUO) in December 20221 and at ASCO GU in February 2023.2 The SPOTLIGHT trial (NCT04186845) was a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of POSLUMA PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Results from the SPOTLIGHT study were published online on April 26, 2023 in the Journal of Urology: DOI: 10.1097/JU.0000000000003493.3

 

About POSLUMA® (flotufolastat F 18)

POSLUMA® (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3) is an optimized, targeted radiohybrid diagnostic imaging agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Precision PET imaging with POSLUMA can help identify the location and extent of prostate cancer, providing clinically valuable information to guide patient management. POSLUMA represents a new class of high-affinity PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology and is labeled with the radioisotope 18F to provide readily available patient access and leverage the high image quality of 18F-labeled PSMA PET imaging to facilitate effective detection of disease. POSLUMA was approved by the U.S. Food and Drug Administration in May 2023.

 

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics received U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023. rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval.

 

Indication and Important Safety Information About POSLUMA

INDICATION

POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

  • with suspected metastasis who are candidates for initial definitive therapy
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

 

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
  • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
  • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
  • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

 

To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

 

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

 

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com.

 

References

1 Chapin BF, LIGHTHOUSE Study Group. 134: Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in patients with newly diagnosed prostate cancer: Results from a phase 3, prospective, multicenter study (LIGHTHOUSE). SUO Annual Meeting. Orlando, FL: https://suo-abstracts.secure-platform.com/a/gallery/rounds/15/details/2390, 2022.

 

2 Chapin BF on behalf of Koontz B, LIGHTHOUSE Study Group. “Detection of true positive M1 lesions by 18F-rhPSMA-7.3 PET in newly diagnosed prostate cancer: Results from the phase 3 prospective LIGHTHOUSE study,” 2023 ASCO Genitourinary Cancers Symposium (ASCO GU), ASCO GU 2023. San Francisco, Calif.: https://meetings.asco.org/abstracts-presentations/217100, 2023.

 

3 Jani AB, Ravizzini GC, Gartrell BA, et al. Diagnostic Performance and Safety of 18F-rhPSMA-7.3 PET in Men with Suspected Prostate Cancer Recurrence: Results from a Phase 3, Prospective, Multicenter Study (SPOTLIGHT), The Journal of Urology® (2023), doi:10.1097/JU.0000000000003493.

Contacts

For Blue Earth Diagnostics (U.S.)

Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)

Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0) 7917 536939

clare.gidley@blueearthdx.com

Media

Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business Lifestyle Programs & Events Regulations & Security

AM Best to host briefing on the medical stop-loss market

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best will host a webinar discussing the recent trends and developments in the growing stop-loss market on July 13, 2023, at 2 p.m. (EDT).

Medical stop-loss insurance premium has grown substantially in the past several years, as employer groups look for more efficient solutions for health care coverage. The one-hour briefing, titled, “AM Best’s Briefing – Stop-Loss Market: Seeing Growth Potential While Facing New Challenges and Risks,” will cover the following topics:

  • Drivers of stop-loss growth;
  • Rising volume of high-cost claims;
  • Impacts of new gene and cell therapies;
  • Medical and prescription drug cost-containment strategies; and
  • AM Best’s view of the stop-loss market.

 

The panel will consist of the following senior AM Best analytical staff and industry leaders:

  • Stephanie Whalen, president, Union Labor Life Insurance Company;
  • Andy Folsom, vice president, Companion Life;
  • Sally Rosen, senior director, AM Best; and
  • Doniella Pliss, director, AM Best.

 

Attendees can submit questions during registration or by emailing conferenceinformation@ambest.com. The event will be streamed in video and audio formats, and playback will be available shortly after the event.

 

To find out more about the briefing or to register, please visit https://www3.ambest.com/conferences/events/eventregister.aspx?event_id=CME922.

 

Additionally, please visit http://www3.ambest.com/bestweek/purchase.asp?record_code=331037 to see AM Best’s recent report on the stop-loss insurance market segment.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318

al.slavin@ambest.com

Categories
Art & Life Business Culture Lifestyle Sports & Gaming

Great Clips® unveils inaugural class of the first-ever, Hockey Hair Hall of Fame

Grand prize winner and other inductees to be spotlighted during NHL Awards Broadcast on TNT

 

MINNEAPOLIS — (BUSINESS WIRE) — Great Clips, the Official Hair Salon of the NHL and the NHLPA, today announced the inaugural six member class of the first-ever, virtual Hockey Hair Hall of Fame as part of the #ShowYourFlow campaign.

 

From April 17 through May 7, Great Clips received nearly 4,000 photo and video submissions from hockey fans throughout U.S. and Canada on social media and through www.GreatClips.com/HockeyHair.

The six inductees enshrined include: Conor Busler from Lynnfield, MA (Age 3), Nigel McDonald from Dallas, TX (Age 15), Kate Boysen from Lee’s Summit, MO (Age 36), Micah Kim from La Prairie, Manitoba (Age 4), Everly Bain from Port Coquitlam, British Columbia (Age 9) and Grady Duden from Sioux Center, IA (Age 20). To view the first-ever class of the Hockey Hair Hall of Fame, visit www.GreatClips.com/HockeyHair.

 

All inductees received free haircuts for a year and signed Show Your Flow prizing from NHL All-Star Jack Hughes and will be featured on Great Clips social and online channels.

 

With the highest score by judges, Conor Busler, a Boston Bruins fan, also received a Grand Prize package that included a trip to Nashville to attend the 2023 NHL Awards™. The prize package included tickets to the NHL Awards, roundtrip airfare, hotel accommodations and $300 for food and local transportation.

 

In collaboration with the NHL, Conor Busler and the other five inductees will be celebrated and featured in a segment during the NHL Awards broadcast on TNT this evening. Before the NHL Awards, Conor will also meet with NHL All-Stars Jack Hughes (New Jersey Devils) and Cale Makar (Colorado Avalanche®) who appeared in Great Clips television commercials during the 2023 Stanley Cup® Playoffs.

 

“We’d like to thank all of the hockey fans that participated in our #ShowYourFlow campaign and showed us their amazing hockey hair flows,” said Lisa Hake, vice president of marketing and communications at Great Clips, Inc. “Hockey hair comes in all shapes, sizes and styles and that was definitely put on display over the last several weeks. We’re excited to memorialize and reward these six fans for their hockey hair passion and hockey fandom.”

 

Submissions were scored by a judging panel based on their creativity and originality, their passion for hockey and hockey hair, and the overall quality and appeal of their content. Members of the all-star judging panel included two-time NHL All-Star and New Jersey Devils Center Jack Hughes, Canadian women’s hockey star Sarah Nurse, national talent show finalists and TV stars The Cline Twins, and hockey fan and influencer Jesse Pollock.

 

About Great Clips, Inc.

Great Clips, Inc. was established in 1982 in Minneapolis, Minnesota. Today, there are over 4,400 independently owned Great Clips® salons throughout the United States and Canada, making it the world’s largest salon brand. Great Clips is 100 percent franchised, and salons are owned locally by more than 700 franchisees across the U.S. and Canada. Great Clips® franchisees employ more than 25,000 stylists. Great Clips® franchised salons provide value-priced, high-quality haircare for men, women and children. Getting a great haircut at a Great Clips® salon is more convenient than ever with Online Check-In, ReadyNext® text alerts and Clip Notes®. To check in online, visit GreatClips.com or download the free app. For more information about Great Clips, Inc. or to find a salon location near you, visit GreatClips.com.

 

About the NHL

The National Hockey League (NHL®), founded in 1917, consists of 32 Member Clubs. Each team roster reflects the League’s international makeup with players from more than 20 countries represented, all vying for the most cherished and historic trophy in professional sports – the Stanley Cup®. Every year, the NHL entertains more than 670 million fans in-arena and through its partners on national television and radio; more than 191 million followers – league, team and player accounts combined – across Facebook, Twitter, Instagram, Snapchat, TikTok, and YouTube; and more than 100 million fans online at NHL.com. The League broadcasts games in more than 160 countries and territories through its rightsholders including ESPN, WBD Sports and NHL Network in the U.S.; Sportsnet and TVA Sports in Canada; Viaplay in the Nordics, Baltics, and Poland; YLE in Finland; Nova in Czech Republic and Slovakia; Sky Sports and ProSieben in Germany; MySports in Switzerland; and CCTV5+ in China; and reaches fans worldwide with games available to stream in every country. Fans are engaged across the League’s digital assets on mobile devices via the free NHL® App; across nine social media platforms; on SiriusXM NHL Network Radio™; and on NHL.com, available in eight languages and featuring unprecedented access to player and team statistics as well as every regular-season and playoff game box score dating back to the League’s inception, powered by SAP. NHL Original Productions and NHL Studios produce compelling original programming featuring unprecedented access to players, coaches and League and team personnel for distribution across the NHL’s social and digital platforms.

 

The NHL is committed to building healthy and vibrant communities using the sport of hockey to celebrate fans of every race, color, religion, national origin, gender identity, age, sexual orientation, and socio-economic status. The NHL’s Hockey Is For Everyone™ initiative reinforces that the official policy of the sport is one of inclusion on the ice, in locker rooms, boardrooms and stands. The NHL is expanding access and opportunity for people of all backgrounds and abilities to play hockey, fostering more inclusive environments and growing the game through a greater diversity of participants. To date, the NHL has invested more than $100 million in youth hockey and grassroots programs, with a commitment to invest an additional $5 million for diversity and inclusion programs over the next year.

 

NHL and the NHL Shield are registered trademarks of the National Hockey League. NHL and NHL team marks are the property of the NHL and its teams. © NHL 2023. All Rights Reserved.

 

About the National Hockey League Players’ Association

The National Hockey League Players’ Association, established in 1967, is a labour organization whose members are the players in the National Hockey League. The NHLPA works on behalf of the players in varied disciplines such as labour relations, product licensing, marketing, international hockey and community relations, all in furtherance of its efforts to promote its members and the game of hockey. In 1999, the NHLPA Goals & Dreams fund was launched as a way for the players to give something back to the game they love. Over the past 23 years, more than 80,000 deserving children in 34 countries have benefited from the players’ donations of hockey equipment. NHLPA Goals & Dreams has donated more than $25 million to grassroots hockey programs, making it the largest program of its kind. For more information on the NHLPA, please visit www.nhlpa.com.

 

NHLPA, National Hockey League Players’ Association and the NHLPA logo are registered trademarks of the NHLPA and are used under license. © NHLPA. All Rights Reserved.

Contacts

Media Contact:
Heather Leiferman

952.746.6562

Heather.Leiferman@greatclips.com

Categories
Business Lifestyle Regulations & Security

AM Best removes from under review with developing implications and affirms credit ratings of Reserve National Insurance Company

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has removed from under review with developing implications and affirmed the Financial Strength Rating of A- (Excellent) and the Long-Term Issuer Credit Rating of “a-” (Excellent) of Reserve National Insurance Company (RNI) (Chicago, IL). The outlook assigned to these Credit Ratings (ratings) is stable.

 

The ratings reflect RNI’s balance sheet strength, which AM Best assesses as very strong, as well as its adequate operating performance, limited business profile and appropriate enterprise risk management. The ratings further reflect RNI’s integration with its new parent company, Medical Mutual of Ohio (MMO), after its acquisition effective Dec. 1, 2022. AM Best expects that the acquisition will provide strategic alignment between companies in the form of diversified product offerings and geographic expansion. AM Best notes that on a standalone basis, RNI has limited financial flexibility. However, the company’s excess capital along with its relationship with MMO provides added capacity to support business objectives going forward.

 

RNI is a specialty accident and health (A&H) insurer headquartered in Oklahoma City, Oklahoma that provides coverage throughout the United States. RNI is licensed currently in 49 states and the District of Columbia. MMO is a mutual health insurer domiciled in Ohio. MMO and its subsidiaries provide commercial, Medicare Advantage and Medicare Supplement, A&H, life, and disability insurance plans to both individual groups, health benefits administration to large group employers that maintain uninsured A&H plans, provides compliance expertise, technology, and administrative support services for wellness and related incentive plans and administers employee assistance programs. MMO serves approximately 1.2 million health members, primarily Ohio.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Cristian Sieira
Financial Analyst

+1 908 882 2315
cristian.sieira@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Alan Murray
Associate Director
+1 908 882 2195
alan.murray@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

Categories
Business Culture Healthcare Lifestyle Regulations & Security Science

Members vote yes for first contract in UFCW Local 152’s cannabis division

EGG HARBOR TOWNSHIP, N.J. — (BUSINESS WIRE) — UFCW Local 152 members at The Botanist dispensaries in Egg Harbor and Atlantic City, N.J. voted overwhelmingly on June 21 to ratify a bargaining agreement with their employer, making it the first of its kind for cannabis workers at the local union.

 

The three-year agreement calls for raises as well as ratification bonuses and improved health benefits. The base salary for new hires is increased and all members at both Botanist locations have access to the grievance process through their union.

 

“This strong first contract is the culmination of months of hard bargaining on behalf of our members,” Local 152 President Brian String said. “The unity displayed by these workers was crucial to our success and sets a strong foundation for continued achievements.”

 

UFCW Local 152 represents more than 60 workers at The Botanist across the two locations. Members grow, harvest and process cannabis and sell it in several forms at their retail spaces. Customers can seek assistance from the experts at either location to find the products that meet their medical needs.

 

For more than a decade, Local 152 has been at the forefront of organizing the cannabis industry in New Jersey. Earlier this year, workers at another cannabis cultivation site owned by MPX NJ group voted to join the union and are in negotiations to determine their first contract.

 

“Our expertise in bargaining across many diverse, challenging industries makes Local 152 a powerful ally for cannabis workers,” String said.

 

“No one has to go it alone. With a union, we’re all in this together.”

Contacts

Brian String, President

UFCW Local 152

(609) 704-3900

Categories
Business Lifestyle Regulations & Security

AM Best removes from under review with developing implications and affirms credit ratings of Trinidad & Tobago Insurance Limited

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has removed from under review with developing implications and affirmed the Financial Strength Rating of A- (Excellent) and the Long-Term Issuer Credit Rating of “a-” (Excellent) of Trinidad & Tobago Insurance Limited (TATIL) (Trinidad and Tobago). The outlook assigned to these Credit Ratings (ratings) is stable.

 

The ratings reflect TATIL’s balance sheet strength, which AM Best assesses as strongest, as well as its strong operating performance, limited business profile and appropriate enterprise risk management.

 

TATIL’s balance sheet strength is supported by its risk-adjusted capitalization being at the strongest level, as measured by Best’s Capital Adequacy Ratio (BCAR). TATIL’s surplus growth and level of risk-adjusted capitalization continues to be supported by profitable overall earnings, favorable liquidity measures, steady operating cash flows, as well as an effective reinsurance program that mitigates catastrophic loss.

 

TATIL has generally produced favorable underwriting results, and absent the recent market turmoil, this has been augmented by stable levels of investment and rental income, resulting in historically profitable overall operating performance. These factors are somewhat offset by the geographic concentration of TATIL’s operations, its continuing challenge to maintain earnings and market share in extremely competitive markets and its inherent exposure to catastrophe events.

 

The company recently completed the acquisition of Colonial Fire and General Insurance Company Limited (Colfire), consolidating its position as one of the top two dominant property/casualty insurers in the Trinidad and Tobago market. TATIL and Colfire will operate as separate entities in the short to medium term; however, integration efforts will concentrate on extracting business synergies and achieving economies of scale where possible.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Ricardo Longchallon
Senior Financial Analyst
+1 908 882 2019
ricardo.longchallon@ambest.com

Sharon Marks
Director
+1 908 882 2092
sharon.marks@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

Categories
Business Government Healthcare International & World Lifestyle Science

FDA approves Bayer’s Ultravist® (iopromide) injection for contrast-enhanced mammography

  • Ultravist™-300, -370 is now the only contrast agent in the U.S. indicated to visualize known or suspected lesions of the breast in adults, as an adjunct to mammography and/or ultrasound
  • Contrast-enhanced mammography (CEM) is an emerging modality combining digital mammography with the administration of a contrast agent1
  • Strategically expands Bayer’s portfolio in breast imaging, including contrast agents and injectors

 

WHIPPANY, N.J. — (BUSINESS WIRE) — Bayer announced today that Ultravist® (iopromide)-300, -370, its iodine-based contrast agent, has been approved by the U.S. Food and Drug Administration (FDA) for contrast-enhanced mammography (CEM) – making it the only contrast agent approved for this indication. The product can be used to visualize known or suspected lesions of the breast in adults, as an adjunct to mammography and/or ultrasound. CEM is an emerging modality that combines digital mammography with the administration of a contrast agent, such as Ultravist, to help identify breast lesions.1

 

The new FDA approved indication aligns with the recent increased focus on supplemental imaging needs for women at a higher risk for breast cancer, which may include the 40-50% of U.S. women older than 40 with dense breasts.2

 

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, Head of Radiology Research and Development, Bayer. “We are pleased to be able to offer additional options for breast imaging to healthcare professionals, as we aim to support them in their role of providing clear answers from diagnosis to care for patients.”

 

The approval expands upon Bayer’s focus on breast imaging, with a portfolio that also includes Gadavist® (gadobutrol) injection, a gadolinium-based contrast agent approved for use with MRI (Magnetic Resonance Imaging) to assess the presence and extent of malignant breast disease in adult patients. In 2019, the MEDRAD® Stellant FLEX Computed Tomography (CT) Injection System with Certegra® Workstation was also cleared in the U.S. for use in CEM. Through the use of iodine-based x-ray contrast agents, CEM can allow for better visualization of abnormalities in breast tissue that may not be visible with standard mammography.3

 

About breast cancer and contrast-enhanced mammography

In 2020, there were 2.3 million women diagnosed with breast cancer globally, according to the World Health Organization (WHO).4 Contrast-enhanced mammography (CEM) has been demonstrated to help with visualization of lesions in breast tissue and is a relatively low-cost breast imaging examination. CEM is easy to perform in everyday clinical practice and can be used in various clinical settings, such as when routine imaging produces inconclusive findings. It can also be a helpful tool when breast MRI is unavailable or contraindicated.5

 

About Ultravist

INDICATIONS and IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

Intra‐arterial Procedures*: Ultravist® is indicated for: • Cerebral arteriography and peripheral arteriography in adults; • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults; • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older.

 

Intravenous Procedures*: Ultravist® is indicated for: • Excretory urography in adults and pediatric patients aged 2 years and older; • Contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older; • Contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound.

 

*Specific concentrations and presentations of Ultravist® are recommended for each type of imaging procedure [see Dosage and Administration (2.2, 2.3, 2.4)] in the Full Prescribing Information]

 

IMPORTANT SAFETY INFORMATION

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE

Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use.

 

Risks Associated with Intrathecal Use: Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Ultravist® is for intra-arterial or intravenous use only. Ultravist® is not approved for intrathecal use.

 

Hypersensitivity Reactions: Ultravist® can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can also occur. There is increased risk of hypersensitivity reactions in patients with a history of previous reaction to a contrast agent and known allergic disorders, or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and have emergency resuscitation equipment and trained personnel available prior to Ultravist® administration. Monitor all patients for hypersensitivity reactions.

 

Acute Kidney Injury: Acute kidney injury, including renal failure, may occur after administration. Risk factors include: pre-existing renal insufficiency, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma or other paraproteinemia, and repetitive and/or large doses of Ultravist® . Use the lowest necessary dose of Ultravist® in patients with renal impairment. Hydrate patients prior to and following Ultravist® administration. Do not use laxatives, diuretics, or preparatory dehydration prior to Ultravist® administration.

 

Cardiovascular Adverse Reactions: In patients with cardiac and / or renal disease, hemodynamic disturbances including shock and cardiac arrest may occur during or shortly after administration of Ultravist®. Hypotensive collapse and shock have occurred. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography. Use the lowest necessary dose of ULTRAVIST in patients with congestive heart failure. Always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions.

 

Thromboembolic Events: Serious, in some cases fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiography procedures. During these procedures, increased thrombosis and activation of the complement system can occur. Risk of thromboembolic events can be influenced by: length of procedure, catheter and syringe material, underlying disease state, and concomitant medications. To decrease thromboembolic events, use meticulous angiographic techniques and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases the risk of clotting. Avoid angiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism.

 

Extravasation and Injection Site Reactions: Extravasation can occur, particularly in patients with severe arterial or venous disease. In addition, injection site reactions such as pain and swelling at the injection site can also occur. Ensure intravascular placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms.

 

Thyroid Storm in Patients with Hyperthyroidism: Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of Ultravist®.

 

Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media (ICM) in pediatric patients 0 to 3 years of age. Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. After exposure to ICM, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates. The safety and effectiveness of Ultravist® in pediatric patients younger than 2 years of age have not been established, and Ultravist® is not approved for use in pediatric patients younger than 2 years of age.

 

Hypertensive Crisis in Patients with Pheochromocytoma: Hypertensive crisis in patients with pheochromocytoma has occurred with iodinated contrast agents. Closely monitor patients when administering Ultravist® if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of Ultravist® necessary and have measures for treatment of a hypertensive crisis readily available.

 

Sickle Cell Crisis in Patients with Sickle Cell Disease: Iodinated contrast agents may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following administration and use only if the necessary imaging information cannot be obtained with alternative imaging modalities.

Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering Ultravist® to patients with a history of a severe cutaneous adverse reaction to Ultravist®.

 

Interference with Laboratory Tests: Ultravist® can interfere with protein-bound iodine test.

Common Adverse Reactions: Common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision.

 

Please see Full Prescribing Information for Ultravist®.

About Gadavist

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):

  • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates.
  • To assess the presence and extent of malignant breast disease in adult patients.
  • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

 

Gadavist® is indicated for use in magnetic resonance angiography (MRA):

  • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.

 

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • The risk of NSF appears highest among patients with:
    • Chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or
    • Acute kidney injury
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended GADAVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

 

Contraindication and Important Information about Hypersensitivity Reactions: Gadavist® is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist®. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist® administration. Before Gadavist® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Gadavist®.

 

Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible.

 

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.

 

Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Gadavist®. Extravasation into tissues during Gadavist® administration may result in moderate irritation.

 

Overestimation of Extent of Malignant Disease in MRI of the Breast: Gadavist® MRI of the breast overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.

 

Low Sensitivity for Significant Arterial Stenosis: The performance of Gadavist® MRA for detecting arterial segments with significant stenosis (>50% renal, >70% supra-aortic) has not been shown to exceed 55%. Therefore, a negative MRA study alone should not be used to rule out significant stenosis.

 

Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Gadavist® in clinical studies were headache (1.7%), nausea (1.2%) and dizziness (0.5%).

 

Please see Full Prescribing Information for Gadavist® (Vials and Syringes).
Please see Full Prescribing Information for Gadavist® (Imaging Bulk Package).

 

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on Twitter: @BayerPharma

 

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

PP-ULT-US-0096-1 June 2023

______________________

1 Kimeya F. Ghaderi, Jordana Phillips, Hannah Perry, Parisa Lotfi, and Tejas S. Mehta. Contrast-enhanced Mammography: Current Applications and Future Directions. RadioGraphics 2019 39:7, 1907-1920.

2 Susan G. Koman. Breast Density on a Mammogram. Updated April 4, 2023. Retrieved June 12, 2023 from: https://www.komen.org/breast-cancer/risk-factor/breast-tissue-density/.

3 Contrast-enhanced Mammography: How Does It Work? William F. Sensakovic, et al. RadioGraphics 2021 41:3, 829-839.

4 World Health Organization. Breast Cancer Fact Sheet. Updated March 26, 2021. Retrieved May 26, 2023 from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.

5 Maxine S. Jochelson, Marc B. I. Lobbes. Contrast-enhanced Mammography: State of the Art. Radiology 2021; 299:36–48.

Contacts

Contact for media inquiries:
Jennifer May, 412-656-8192
Email: jennifer.may@bayer.com

Categories
Business International & World Lifestyle Science Technology

CloudBees announces DevOps World 2023

DevOps World to inspire growth and innovation through five events with sessions from industry experts.

 

SAN JOSE, Calif. — (BUSINESS WIRE) — CloudBees, the leading software delivery platform for enterprises, today announces the return of DevOps World 2023. The five-event series of events will take place September through November 2023.

 

At the largest global gathering of DevOps practitioners, CloudBees invites developers, managers, executives, and community members to explore the ever-evolving DevOps landscape in an event series that will span the United States, United Kingdom, and Asia. Registration is open now at devopsworld.com.

This year, DevOps World will be a series of events to reach more community members, IT executives, software developers, and continuous delivery practitioners around the world. With expert-led sessions, panels, and workshops, DevOps World will provide unparalleled insights that drive innovation in the DevOps community. The conference and expo will explore modern software delivery, DevSecOps, and open source topics.

 

CloudBees has assembled an inspiring lineup of speakers, industry thought leaders, and experts for this year’s event, with each featuring a keynote from the contributing authors of “Investments Unlimited: A Novel About DevOps, Security, Audit Compliance, and Thriving in the Digital Age.” Speakers include:

  • John Willis, Founder, Botchagalupe Technologies
  • Andrés Vega, Vice President of Operations, North America, ControlPlane
  • Helen Beal, Chief Ambassador, DevOps Institute
  • John Rzeszotarski, VP of Platform Engineering, Dexcom
  • Tapabrata “Topo” Pal, Vice President, Architecture, Fidelity Investments
  • Bill Bensing, Field CTO, Kosli

 

In addition to the keynotes, attendees will hear from industry experts Autodesk, Veeam Software, vFunction, and more. Speakers will provide instruction and share insights on security and risk management, AI risks to the marketplace, managing cloud native applications, and much more. Each event will include use-case examples for DevOps in the financial, manufacturing and Industry 4.0, and software and technology industries, with key session topics including “AI Risks to the Marketplace,” “Managing Cloud Native Applications,” “Accelerating Digital Transformation in Finance,” “Moving ahead with Industry 4.0;” and more.

 

“With more than a decade of successful DevOps World events, CloudBees recognized the need to expand and accommodate global demand. We’re delivering local expert-led presentations, workshops, and sessions for community members to advance their skills and get ahead of the competition,” said CloudBees Chief Product Officer Shawn Ahmed. “In addition, CloudBees looks forward to introducing exciting innovations at this year’s conference that will expand on our current offerings to improve software delivery.”

 

DevOps World 2023 will include a tour in New York, Chicago, Silicon Valley, London, and Singapore beginning in September, with tour dates and locations as follows:

  • New York/New Jersey area: September 13-14 at the Hyatt Regency Jersey City
  • Chicago: September 27 at the Museum of Science and Industry
  • Silicon Valley: October 18-19 at the Hyatt Regency Santa Clara
  • Singapore: October 26 at Fairmont Singapore & SWISSÔTEL The Stamford, Singapore
  • London: November 29 at etc.Venues St Pauls

 

In addition to in-person events, select DevOps World sessions will be available online for virtual attendance. Register for DevOps World 2023 here.

 

To learn more about CloudBees visit www.cloudbees.com.

 

About CloudBees

CloudBees provides the leading software delivery platform for enterprises, enabling them to continuously innovate in a world powered by the digital experience. CloudBees enables organizations with highly-complex environments to deliver scalable, compliant, governed, and secure software from the code a developer writes to the people who use it. The platform connects with other best of breed tools, improves the developer experience, and enables organizations to bring digital innovation to life continuously to unlock business outcomes that create market leaders and disruptors.

Contacts

CloudBees PR
Laura Shubel

BIGfish PR for CloudBees

cloudbees@bigfishpr.com

Categories
Business Environment Lifestyle Regulations & Security Technology

Knightscope client further expands emergency communication system order

Shopping center security robot client renews contract for third year

 

MOUNTAIN VIEW, Calif. — (BUSINESS WIRE) — $KSCP #SecurityRobot—Knightscope, Inc. [Nasdaq: KSCP] “(Knightscope” or the “Company),” a leading developer of autonomous security robots and blue light emergency communication systems, today announced that a University in New Jersey signed a purchase order for two additional K1 Blue Light Towers adding to the $1.25 million order announced earlier this year.


Universities are among Knightscope’s top priorities as the Company strives to protect all places people live, work, study and visit. Protecting the nation’s children and educators is essential to securing our future, and there are many steps that can be taken now to further enhance school safety as outlined in Knightscope’s blog here. New and existing users of Knightscope technologies that follow these recommendations, broaden their use of such enhanced safety measures, and continually renew service agreements further validate the Company’s efficacy and value.

 

Knightscope Authorized Partner Extends Shopping Mall Contract

Transcend Security Solutions – one of Arizona’s largest, premier contract security providers – extended its K5 Autonomous Security Robot (ASR) contract at a popular Arizona shopping mall for the third year. The K5 patrols the courtyard of the mall and much of the outer perimeter of the buildings that make up this mixed office and retail space. The mall prides itself on the property’s focus on technology, innovation and design, which makes Knightscope’s ASR right at home and a premium addition to their security staff.

 

To learn more about Knightscope’s Autonomous Security Robots and Blue Light Emergency Communication Systems, book a discovery call or demonstration now at www.knightscope.com/discover.

 

About Knightscope

Knightscope is an advanced public safety technology company that builds fully autonomous security robots and blue light emergency communications systems that help protect the places people live, work, study and visit. Knightscope’s long-term ambition is to make the United States of America the safest country in the world. Learn more about us at www.knightscope.com. Follow Knightscope on Facebook, Twitter, LinkedIn and Instagram.

 

Forward-Looking Statements

This press release may contain “forward-looking statements” about Knightscope’s future expectations, plans, outlook, projections and prospects. Such forward-looking statements can be identified by the use of words such as “should,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” “proposes” and similar expressions. Forward-looking statements contained in this press release include, but are not limited to, statements about the Company’s path to profitability, the Company’s targeted annualized revenue run rate, the Company’s plans for top-line growth, the Company’s ability to deliver on its backlog of new orders, the benefits of the Company’s planned streamlining of its operations and rightsizing of its combined workforce and the Company’s ability to achieve improved margins. Although Knightscope believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. These risks and uncertainties include, among other things, the risk that the restructuring costs and charges may be greater than anticipated; the risk that the Company’s restructuring efforts may adversely affect the Company’s internal programs and the Company’s ability to recruit and retain skilled and motivated personnel, and may be distracting to employees and management; the risk that the Company’s restructuring efforts may negatively impact the Company’s business operations and reputation with or ability to serve customers; the risk that the Company’s restructuring efforts may not generate their intended benefits to the extent or as quickly as anticipated. Readers are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” in Knightscope’s Annual Report on Form 10-K for the year ended December 31, 2022. Forward-looking statements speak only as of the date of the document in which they are contained, and Knightscope does not undertake any duty to update any forward-looking statements, except as may be required by law.

Contacts

Public Relations:
Stacy Stephens
Knightscope, Inc.
(650) 924-1025

Corporate Communications:

IBN (InvestorBrandNetwork)

Los Angeles, California

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