Rollcage Stage II

U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Longeveron’s Lomecel-B™ Product for Treatment of Hypoplastic Left Heart Syndrome (HLHS) in Infants

Retrieved on: 
Wednesday, August 31, 2022

Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently in a Phase 2a trial for HLHS.

Key Points: 
  • Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently in a Phase 2a trial for HLHS.
  • The Fast Track Designation must continue to be met or FDA can withdraw the designation.
  • The FDA previously granted Longeverons Lomecel-B Orphan Drug and Rare Pediatric Disease designations in November of 2021 for HLHS.
  • Fast Track Designation represents a significant milestone in our efforts to develop Lomecel-B as a treatment for infants with HLHS, said Chris Min, M.D., Ph.D., Longeverons Interim Chief Executive Officer and Chief Medical Officer.

Guardant Health Expands Use of Guardant Reveal™ Liquid Biopsy Test for Residual Disease Detection and Recurrence Monitoring to Include Early-Stage Breast and Lung Cancers

Retrieved on: 
Monday, August 15, 2022

The Guardant Reveal test may be initiated as soon as three weeks after surgery.

Key Points: 
  • The Guardant Reveal test may be initiated as soon as three weeks after surgery.
  • Guardant Reveal is the first blood-only test that detects residual and recurrent disease in patients with Stage II and III CRC, breast or lung cancer without the need for a tissue biopsy.
  • Guardant Health has commercially launched Guardant360, Guardant360 CDx, Guardant360 TissueNext, Guardant360 Response, and GuardantOMNI tests for advanced stage cancer patients, and Guardant Reveal for early-stage cancer patients.
  • The Guardant Health screening portfolio, including the Shield test, aims to address the needs of individuals eligible for cancer screening.

Net Health Expands Predictive Analytics Resources for Wound Care Providers

Retrieved on: 
Thursday, July 7, 2022

PITTSBURGH, July 7, 2022 /PRNewswire/ -- Further expanding its analytics capabilities and leadership position within the wound care marketplace, Net Health, a provider of specialty electronic health systems and advanced healthcare analytics, today announced the addition of two new predictive analytics resources to improve clinical and operational outcomes for wound care providers.

Key Points: 
  • PITTSBURGH, July 7, 2022 /PRNewswire/ -- Further expanding its analytics capabilities and leadership position within the wound care marketplace, Net Health, a provider of specialty electronic health systems and advanced healthcare analytics, today announced the addition of two new predictive analytics resources to improve clinical and operational outcomes for wound care providers.
  • The Missed Visit Prediction indicator is available in Net Health Wound Care, one of the nation's most widely used electronic health record (EHR) platforms for wound care.
  • Both features are embedded in automated workflow processes and alert providers when risk is detected, enabling providers to intervene in real-time.
  • "Predictive analytics is transforming every aspect of healthcare and establishing new industry benchmarks for better outcomes, cost savings and other efficiencies every day," said Josh Pickus, CEO of Net Health.

Harley-Davidson 2022 Investor Day Update: Hardwire Stage II

Retrieved on: 
Tuesday, May 10, 2022

MILWAUKEE, May 10, 2022 /PRNewswire/ -- Harley-Davidson, Inc. ("Harley-Davidson") (NYSE:HOG) will host its 2022 Investor Day at the Harley-Davidson Museum in Milwaukee, WI today.

Key Points: 
  • MILWAUKEE, May 10, 2022 /PRNewswire/ -- Harley-Davidson, Inc. ("Harley-Davidson") (NYSE:HOG) will host its 2022 Investor Day at the Harley-Davidson Museum in Milwaukee, WI today.
  • "In motorcycling, when you want to get more out of an engine, you upgrade it by adding a Stage II kit, that is what we are doing with our Hardwire strategy, tuning the engine of our business for improved acceleration and increased performance."
  • This press release relates to the company's strategic plan, The Hardwire, including Hardwire Stage II.
  • Therefore, investors should construe these statements regarding The Hardwire and Hardwire Stage II only as goals, aims, and objectives rather than promises of future performance or absolute statements.

Longeveron Announces Fourth Quarter and Full Year 2021 Financial Results and Operational Progress

Retrieved on: 
Friday, March 11, 2022

For Longeveron, 2021 was a year defined by effective execution, successful financings, and significant progress across our robust Lomecel-B pipeline of clinical trials, said Geoff Green, Chief Executive Officer at Longeveron.

Key Points: 
  • For Longeveron, 2021 was a year defined by effective execution, successful financings, and significant progress across our robust Lomecel-B pipeline of clinical trials, said Geoff Green, Chief Executive Officer at Longeveron.
  • In fourth quarter 2021, the U.S. FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation to Lomecel-B for the treatment of infants with HLHS.
  • Net Loss: Net loss was $4.1 million in the fourth quarter of 2021 compared to $1.4 million for the same period in 2020.
  • Management will host a conference call today at 8:30 a.m. Eastern Time to discuss the Companys fourth quarter and year end 2021 financial results and provide a business update.

MP Materials Awarded Department of Defense Heavy Rare Earth Processing Contract

Retrieved on: 
Tuesday, February 22, 2022

MP Materials Corp. (NYSE: MP) today announced it has been awarded a $35 million contract through the U.S. Department of Defense (DoD) Industrial Base Analysis and Sustainment Program to support the construction of a commercial scale processing facility for heavy rare earth elements (HREE) at Mountain Pass.

Key Points: 
  • MP Materials Corp. (NYSE: MP) today announced it has been awarded a $35 million contract through the U.S. Department of Defense (DoD) Industrial Base Analysis and Sustainment Program to support the construction of a commercial scale processing facility for heavy rare earth elements (HREE) at Mountain Pass.
  • In a separate contract awarded in December 2020, the DoD committed $9.6 million to MP Materials Stage II optimization, a project underway to restore LREE processing capabilities to Mountain Pass.
  • MP Materials Corp. (NYSE: MP) is the largest producer of rare earth materials in the Western Hemisphere.
  • The Company owns and operates the Mountain Pass Rare Earth Mine and Processing Facility in California, North Americas only active and scaled rare earth production site.

Smart Meter's Cellular iBloodPressureTM Reduces Hypertension in 71 percent of Patients

Retrieved on: 
Thursday, February 17, 2022

The data showed that 71 percent of the patients with elevated levels of hypertension saw a reduction after only 3- months of using the iBloodPressure.

Key Points: 
  • The data showed that 71 percent of the patients with elevated levels of hypertension saw a reduction after only 3- months of using the iBloodPressure.
  • The iBloodPressure is a cellular-connected blood pressure monitoring system that automatically transmit blood pressure data to a remote patient monitoring system or electronic health record (EHR) system (including PointClickCare).
  • This provides more accurate tracking of blood pressure data and saves staff time in healthcare facilities by not having to manually write down or input results.
  • "The health care professionals we serve appreciate the simplicity and reliability of this cellular blood pressure device from Smart Meter."

Endometriosis Epidemiology Forecast Report 2021-2030 - Focus on US, France, Germany, Italy, Spain, UK, and Japan - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 15, 2022

The report includes a 10-year epidemiology forecast for the diagnosed prevalent cases of endometriosis.

Key Points: 
  • The report includes a 10-year epidemiology forecast for the diagnosed prevalent cases of endometriosis.
  • The diagnosed prevalent cases of endometriosis are segmented by age (12-54 years) and laparoscopy confirmation status (whether suspected or confirmed endometriosis).
  • The report includes a 10-year epidemiology forecast for the diagnosed prevalent cases of endometriosis.
  • The diagnosed prevalent cases of endometriosis are segmented by age (12-54 years) and laparoscopy confirmation status (whether suspected or confirmed endometriosis).

Stage, A New Marketplace and Community, Launches to Support Breast Cancer Patients, Fighters, Survivors and Supporters

Retrieved on: 
Tuesday, February 1, 2022

LOS ANGELES, Feb. 1, 2022 /PRNewswire/ -- Stage , a mission-driven marketplace and community for women with breast cancer and their supporters, launches today.

Key Points: 
  • LOS ANGELES, Feb. 1, 2022 /PRNewswire/ -- Stage , a mission-driven marketplace and community for women with breast cancer and their supporters, launches today.
  • Powered by survivors and experts, Stage was created by women who have been through the breast cancer journey.
  • In the U.S., 1 in 8 women will battle breast cancer in their lives.
  • Their three-pillar annual giving program supports organizations offering financial assistance, fertility preservation and integrative therapies and support to breast and ovarian cancer patients.

Guardant Health to Present Data Highlighting the Clinical Utility of Its Liquid Biopsy Tests in Gastrointestinal Cancers at ASCO GI Cancers Symposium

Retrieved on: 
Wednesday, January 19, 2022

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced it will present data highlighting the clinical utility of its liquid biopsy tests in the treatment and management of early- to late-stage gastrointestinal cancers, including colorectal cancer, at the 2022 ASCO Gastrointestinal Cancers Symposium being held January 20-22, 2022.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced it will present data highlighting the clinical utility of its liquid biopsy tests in the treatment and management of early- to late-stage gastrointestinal cancers, including colorectal cancer, at the 2022 ASCO Gastrointestinal Cancers Symposium being held January 20-22, 2022.
  • (Abstract 168)
    Additionally, clinical utility data will demonstrate that the Guardant360 liquid biopsy test detects microsatellite instability-high (MSI-H) status in patients with advanced gastrointestinal cancers at a similar frequency to tissue-based testing1,2.
  • Tissue biopsies can be difficult to obtain, time-consuming, and lead to complications, all of which can delay a patients treatment.
  • Guardant Health has commercially launched Guardant360, Guardant360 CDx, Guardant360 TissueNext, Guardant360 Response, and GuardantOMNI tests for advanced stage cancer patients, and Guardant Reveal for early-stage cancer patients.