Umbilical cord

Celularity Announces Commercial Biomaterial Products Receive Saudi Food and Drug Authority (SFDA) Product Classification

Retrieved on: 
Wednesday, October 18, 2023

FLORHAM PARK, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies and advanced biomaterial products, today announced that its Halal Certified biomaterial products have been classified by the Saudi Food and Drug Authority (SFDA) as “Minimally Manipulated Biological Products” for importation license purposes in the Kingdom of Saudi Arabia. The SFDA independently reviewed and issued classifications for each of the following Celularity Halal Certified biomaterial products:

Key Points: 
  • FLORHAM PARK, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies and advanced biomaterial products, today announced that its Halal Certified biomaterial products have been classified by the Saudi Food and Drug Authority (SFDA) as “Minimally Manipulated Biological Products” for importation license purposes in the Kingdom of Saudi Arabia.
  • The SFDA independently reviewed and issued classifications for each of the following Celularity Halal Certified biomaterial products:
    Biovance®, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy.
  • Biovance® is an intact, extracellular matrix structure that provides a natural scaffold to support the body’s wound-healing process.
  • “The SFDA’s Minimally Manipulated Biological Product classification establishes a clear regulatory pathway for the importation of our Halal Certified biomaterial products into Saudi Arabia,” said Robert J. Hariri, M.D., Ph.D., Chairman, CEO, and Founder of Celularity.

Anthem Blue Cross and Blue Shield Foundation and Count the Kicks Partner to Expand Stillbirth Prevention Program Throughout Virginia

Retrieved on: 
Monday, October 9, 2023

Anthem Blue Cross and Blue Shield Foundation is partnering with Count the Kicks, an evidence-based stillbirth prevention program, to educate expectant parents in Virginia about the importance of getting to know their baby’s movement in the third trimester of pregnancy.

Key Points: 
  • Anthem Blue Cross and Blue Shield Foundation is partnering with Count the Kicks, an evidence-based stillbirth prevention program, to educate expectant parents in Virginia about the importance of getting to know their baby’s movement in the third trimester of pregnancy.
  • She was using the Count the Kicks app every day in the third trimester of her pregnancy.
  • “We are excited to partner with Count the Kicks to improve maternal and infant health outcomes here in Virginia,” said Jennie Reynolds, Anthem HealthKeepers Plus President in Virginia.
  • The results have led researchers to call for urgent action to address the stillbirth crisis in the U.S. and to study Count the Kicks on a national level.

REGENATIVE LABS, TOGETHER WITH THE PAIN AND SLEEP THERAPY CENTER, ANNOUNCE NEW CARE ADVANCEMENTS USING WHARTON'S JELLY ALLOGRAFTS IN TEMPOROMANDIBULAR JOINT DEFECTS

Retrieved on: 
Tuesday, October 3, 2023

PENSACOLA, Fla., Oct. 3, 2023 /PRNewswire/ -- Regenative Labs (Regenative), a leading HCT/P manufacturer, announces a retrospective case series demonstrating new care advancements using its Wharton's Jelly allografts in the supplementation of Temporomandibular Joint (TMJ) defects.

Key Points: 
  • PENSACOLA, Fla., Oct. 3, 2023 /PRNewswire/ -- Regenative Labs (Regenative), a leading HCT/P manufacturer, announces a retrospective case series demonstrating new care advancements using its Wharton's Jelly allografts in the supplementation of Temporomandibular Joint (TMJ) defects.
  • Standard treatment includes simply resting the jaw muscles and avoiding use, massage, physical therapy, medication management, and, when all else fails, surgery.
  • After one application of Regenative's Wharton's Jelly allograft, the patient's pain improved by an average of 75% after 90 days.
  • "A few years ago, we started using PRF (platelet-rich fibrin) therapy in the jaw joint, and we thought that was revolutionary.

GaiaGift Triples Physician Network to Ethically Collect Increasing Volumes of Birth Tissues Needed for the Rapidly Burgeoning Development of Cell and Gene Therapies

Retrieved on: 
Thursday, September 7, 2023

Birth tissues, including umbilical cord blood, placental tissue, and umbilical cord tissue, are a key resource for the development of regenerative medicines.

Key Points: 
  • Birth tissues, including umbilical cord blood, placental tissue, and umbilical cord tissue, are a key resource for the development of regenerative medicines.
  • Through GaiaGift's focused approach to physician and patient education on emergent cell therapies, GaiaGift is making these valuable birth tissue resources available to scientists and developers of next-generation therapeutics.
  • To learn more about GaiaGift's birth tissue donation program and the expanded physician network, visit https://www.gaiagift.com or contact [email protected] .
  • GaiaGift, LLC is dedicated to transforming medical research by expanding access to birth tissues and cells derived from birth tissues to the scientific community.

Cell Genesis Launches CEXCI Cord Protein Banking: A Revolutionary Advancement in Stem Cell Science

Retrieved on: 
Friday, July 7, 2023

This innovative approach harnesses the power of umbilical cord stem cells protein to unlock a world of possibilities for improved health outcomes and transformative medical treatments.

Key Points: 
  • This innovative approach harnesses the power of umbilical cord stem cells protein to unlock a world of possibilities for improved health outcomes and transformative medical treatments.
  • One of the key advantages of Cord Protein Banking is its compatibility with existing cord blood banking services.
  • Cell Genesis is committed to driving scientific advancements and pioneering research in the field of cord protein applications.
  • To learn more about CEXCI Cord Protein Banking and how it can empower the future of personalized medicine, please visit our website CEXCI .

Global Data Center Infrastructure Management (DCIM) Strategic Analysis Report 2023: Why Datacenters are Becoming Increasingly Complex & How Do We Manage Datacenter Complexity?

Retrieved on: 
Tuesday, July 4, 2023

With Focus Shed on Harnessing Digital Transformation in the COVID-19 Era, Datacenters Storm into the Spotlight

Key Points: 
  • With Focus Shed on Harnessing Digital Transformation in the COVID-19 Era, Datacenters Storm into the Spotlight
    Over 60% of Companies in North America, Europe & Asia Expect to Witness Higher Velocity of Change in Digital Transformation During the Years 2020 through 2023
    Companies Make an Abrupt, Immediate & Epic Shift Towards Remote Working Mandated Due to COVID-19, Exerting Double Pressure on Datacenters: WFM Employees as a % of the Total Workforce
    As the Umbilical Cord to the Outside World, The Internet Rises in Importance Amid the Pandemic
    With Enterprises Moving to the Cloud Amid the Pandemic, Its Time for Cloud Datacenters to Upgrade Their Infrastructure to Meet Increased Demand for Public Cloud Services: Global Public Cloud Services Market (In US$ Billion)
    Increasing Workloads in the Cloud & Spending on Datacenter Gear Move in Parallel: Global Market for Blade Servers (In US$ Million) for Years 2020, 2022, 2024 & 2027
    As Data Reservoirs, Datacenters Have Become Information Powerhouses for Modern Day Organizations: Global Datacenter IP Traffic (In Petabytes Per Month) for Years 2017 Through 2022
    So What's Driving Growth in Global IP Traffic.
  • These Interesting Statistical Facts Provide the Answer
    Bandwidth Continues to Explode Even in a Simple Smart Home: Application Requirements of Smart Home/Consumer Apps (In Mbps) by 2023
    Growth in Public Wi-Fi Hotpots Means Any Anytime, Anywhere Data Consumption: Global Number of Public Wi-Fi Hotspots (In Million) for Years 2018 Through 2023
    M2M & IoT is Bathed With Big Data: Global M2M/IoT Connections (In Billion) for Years 2019, 2021, 2023
    Who is Generating the Biggest Data Volume in the IoT Ecosystem?
  • % Share of IoT Connections by Vertical for the Year 2020
    Are Datacenters Prepared for this Onslaught of Data Flood?
  • Here's How Data Center Infrastructure Management (DCIM) Can Help

New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Retrieved on: 
Monday, June 26, 2023

SPRING HOUSE, Pa., June 26, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) hemolytic disease of the fetus and newborn (HDFN).1 A statistically significant (54 percent [n=7/13]) proportion of participants who received nipocalimab achieved the primary endpoint of a live birth at or after gestational age of 32 weeks without intrauterine transfusions (IUTs)1,a compared to the historic reference point of 10 percent, which was derived from published and unpublished data.2-5,b Among the seven participants who achieved the primary endpoint, the median gestational age at delivery was 37 and 1/7 weeks.6 This study demonstrates the potential for nipocalimab to help address the underlying disease mechanism of EOS HDFN.1 If approved, nipocalimab would be the first anti-neonatal Fc receptor (FcRn) treatment and the first approved non-surgical intervention for pregnancies at high risk of HDFN in the U.S.7 These data will be presented for the first time at the Fetal Medicine Foundation World Congress in Valencia, Spain on June 26, 2023.1 Janssen is planning a pivotal Phase 3 trial for nipocalimab in pregnancies at risk for severe HDFN.

Key Points: 
  • "There is a significant unmet need to help address the serious and life-threatening health consequences of HDFN.
  • "These Phase 2 UNITY data in high-risk pregnancies demonstrated the important role that nipocalimab, an FcRn blocking antibody, may play in preventing the transfer of maternal alloantibodies through the placenta, thereby offering a potential treatment option for this devastating disease."
  • A conservative benchmark of 10 percent of patients not requiring an IUT was chosen to account for uncertainties in the accuracy and representation of the underlying data.2
    d.  Dr. Kenneth Moise is a paid consultant for Janssen.
  • He has not been compensated for any media work.

Therapeutic Solutions International Files for Orphan Drug Designation Using JadiCell Adult Universal Donor Stem Cells for Treatment of Acute Respiratory Distress Syndrome

Retrieved on: 
Monday, June 26, 2023

Therapeutic Solutions International (TSOI) announced today filing with the FDA for Orphan Drug Designation for its JadiCell Adult Stem Cell Product for treatment of Acute Respiratory Distress Syndrome (ARDS).

Key Points: 
  • Therapeutic Solutions International (TSOI) announced today filing with the FDA for Orphan Drug Designation for its JadiCell Adult Stem Cell Product for treatment of Acute Respiratory Distress Syndrome (ARDS).
  • The Company has been advancing clinical use of this novel umbilical cord derived mesenchymal stem cell in the area of neurology and pulmonology with an FDA cleared clinical trial for COVID-19 associated ARDS.
  • Granting of Orphan Drug Designation would qualify JadiCells for certain benefits and incentives, including seven years of marketing exclusivity, tax credits for clinical trials, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application fees.
  • “We are thankful for the positive feedback we have been receiving from Key Opinion Leaders in the area of regenerative medicine and pulmonology which prompted us to pursue the Orphan Drug Designation for specific aspects of ARDS,” said Timothy Dixon, President, and CEO of the Company.

Bloomage Biotech Pioneers the Bio-Health Industry with the Launch of the World Hyaluronic Acid Valley

Retrieved on: 
Thursday, June 8, 2023

Parsippany, New Jersey, USA, June 08, 2023 (GLOBE NEWSWIRE) -- On June 3rd, Bloomage Biotech marked its presence at the distinguished Hyaluronic Acid Industry Conference in Jinan, China.

Key Points: 
  • Parsippany, New Jersey, USA, June 08, 2023 (GLOBE NEWSWIRE) -- On June 3rd, Bloomage Biotech marked its presence at the distinguished Hyaluronic Acid Industry Conference in Jinan, China.
  • The discourse aims to transcend the horizons of the hyaluronic acid industry and explore its potential as a major player in the broader bio-pharmaceutical and health sectors, initiating a dialogue about the future of high-quality development in the hyaluronic acid industry.
  • Ms. Zhao Yan, Chairperson and CEO of Bloomage Biotech, applauded the "World Hyaluronic Acid Valley" project for its substantial resource and industry strengths.
  • She envisions the future of the "World Hyaluronic Acid Valley" not merely as a hyaluronic acid industry cluster but as a trailblazer in technological innovation, industry expansion, health product consumer experience, and market application within the hyaluronic acid sector.

StemInov Will Bioproduct the First Cell Therapy Drug to Treat Inflammatory Diseases

Retrieved on: 
Monday, June 5, 2023

StemInov, a biotechnology company developing an innovative biomedicine based on stem cells from umbilical cords to treat inflammatory diseases, septic shock and acute respiratory distress syndrome (ARDS), will bioproduct the first cell therapy drug from umbilical cord stem.

Key Points: 
  • StemInov, a biotechnology company developing an innovative biomedicine based on stem cells from umbilical cords to treat inflammatory diseases, septic shock and acute respiratory distress syndrome (ARDS), will bioproduct the first cell therapy drug from umbilical cord stem.
  • WhartSep, the drug bioproduced by a specific process developed by StemInov, is made of mesenchymal stem cells derived from the umbilical cord (Wharton Jelly WJ-MSC), which have very interesting properties for the treatment of inflammatory diseases.
  • Once manufactured, the biomedicine is frozen in vials that are directly injectable after thawing to patients in intensive care.
  • on June 7th at 2 pm" said Julie Hutin, CEO of StemInov.