Regenerative medicine

EQS-News: HepaRegeniX publishes data for its first-in-class MKK4 inhibitor HRX-215 for the treatment of acute and chronic liver diseases in Cell

Retrieved on: 
Wednesday, April 10, 2024
Liver, Liver failure, DOI, Cell death, Regeneration, Clinical professor, Colorectal cancer, Transplant, Hepatectomy, Risk, Patient, MKK4, Mayo Clinic, Manuscript, Liver transplantation, Teaching hospital, Human, MAP, Liver regeneration, Hepatocyte, PHLF, Regenerative medicine, Safety, Hepatology, Liver disease, Dietary supplement

HRX-215 is a small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4).

Key Points: 
  • HRX-215 is a small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4).
  • "The positive results in terms of safety and tolerability confirm our intention to soon offer a drug that has the potential to revolutionize the treatment of severe liver diseases.
  • The data pave the way for further Phase II studies evaluating the efficacy of HRX-215 in humans," emphasizes Dr. Wolfgang Albrecht, COO of HepaRegeniX.
  • Further, HRX-215 was also able to protect hepatocytes from cell death in a model for acute liver injury.

Longeveron Issues Letter to Shareholders Highlighting Corporate Strategy, Clinical Pipeline and 2024 Key Priorities and Goals

Retrieved on: 
Monday, April 8, 2024
SOC, CDMO, Orphan drug, Letter, Cell, Science, Bone marrow, Disease, Partnership, Caregiver, Hypoplastic left heart syndrome, Patient, Fast Track, Research, Microsoft Exchange Server, Standard of care, Security (finance), CLEAR, Surgeon, Regenerative medicine, FDA, BLA, Development, Pharmaceutical industry

MIAMI, April 08, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders.

Key Points: 
  • MIAMI, April 08, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders.
  • Today, I am excited to update you on our overall strategy, business objectives, approach to capital allocation, and 2024 key priorities and goals.
  • Our focus remains steadfast on raising the funds necessary to continue our operations and delivering transformative solutions to patients and creating sustainable value for our shareholders.
  • In 2024, we are focusing our efforts on two of our most promising programs: Hypoplastic Left Heart Syndrome (HLHS); and Alzheimer’s Disease.

Organogenesis Announces Favorable Court Ruling Dismissing Securities Fraud Case

Retrieved on: 
Wednesday, April 3, 2024
Organogenesis, District court, Surgery, Regenerative medicine, Court, Prejudice

CANTON, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (NASDAQ: ORGO) a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today announced that on March 29, 2024, the United States District Court for the Eastern District of New York granted, with prejudice, the Company’s motion to dismiss all claims asserted.

Key Points: 
  • CANTON, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (NASDAQ: ORGO) a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today announced that on March 29, 2024, the United States District Court for the Eastern District of New York granted, with prejudice, the Company’s motion to dismiss all claims asserted.
  • “We are very pleased with the Court's decision,” said Lori Freedman, Chief Administrative and Legal Officer for Organogenesis.
  • “We are happy to have this behind us so we can continue to focus on our mission to substantially improve patient outcomes while lowering the overall cost of care.”

Sientra Announces Completion and Winning Bidders of its Section 363 Sales Auction

Retrieved on: 
Tuesday, April 2, 2024
Stifel, Tiger, Sale, Berkeley Research Group, Acquisition, Blank Rome, United States bankruptcy court, Bankruptcy, Breast, Regenerative medicine, Hearing, Kirkland & Ellis, Kirkland, Insurance

IRVINE, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Sientra, Inc. (“Sientra” or the “Company”) announced that, following the completion of its Section 363 sales auction, Tiger Aesthetics Medical, LLC (“Tiger”) has been declared the successful bidder for certain of the assets of Sientra used in its breast reconstruction and augmentation business. As consideration for the acquisition, Tiger will pay a cash consideration of $42.5 million as well as assume certain liabilities of the Company, including up to $7 million in cure costs for certain assumed contracts, all the Company’s warranties for breast implants sold prior to the closing date, and all of the Company’s customer contracts.

Key Points: 
  • IRVINE, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Sientra, Inc. (“Sientra” or the “Company”) announced that, following the completion of its Section 363 sales auction, Tiger Aesthetics Medical, LLC (“Tiger”) has been declared the successful bidder for certain of the assets of Sientra used in its breast reconstruction and augmentation business.
  • Sientra also announced that it has entered into a definitive agreement with Nuance Intermediary, LLC (“Nuance”), pursuant to which Nuance will acquire substantially all the assets of Sientra used in its BIOCORNEUM business.
  • Tiger Aesthetics Medical, LLC is represented by Blank Rome LLP as legal counsel and H.C. Wainwright & Co. as investment banker.
  • Nuance Intermediary, LLC, an investment of Nuance Holdings LLC, as well as the owner of Nuance Medical, is represented by Ferguson Braswell Fraser Kubasta PC as legal counsel.

NurExone Reports Fourth Quarter and Year Ended December 31, 2023 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, April 2, 2024
ODD, Research, Growth, Drug discovery, Exercise, NRX, CFO, RNA, Laboratory, Contract research organization, Regenerative medicine, Investigational New Drug, Safety, Spinal cord injury, Intellectual property, Plasma protein binding, Small RNA, FDA, Food, Cryptocurrency

TORONTO and HAIFA, Israel, April 02, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, developing regenerative medicine therapies, today provided a business update and reported financial results for the fourth quarter and financial year ended December 31, 2023.

Key Points: 
  • TORONTO and HAIFA, Israel, April 02, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, developing regenerative medicine therapies, today provided a business update and reported financial results for the fourth quarter and financial year ended December 31, 2023.
  • For the fourth quarter of 2023, expenses were US$0.31 million, compared to US$0.39 million in the previous year.
  • For the fourth quarter of 2023, expenses were US$0.40 million, compared to US$0.46 million in the previous year.
  • For the fourth quarter of 2023, expenses were US$0.02 million, compared to US$0.17 million in the previous year.

BioStem Technologies to Present at the 14th Annual LD Micro Invitational Conference

Retrieved on: 
Tuesday, April 2, 2024
Sofitel New York Hotel, OTC, Conference, Regenerative medicine

POMPANO BEACH, Fla., April 02, 2024 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics for advanced wound care, today announced that it will present at the 14th Annual LD Micro Invitational Conference at the Sofitel New York on April 8-9, 2024.

Key Points: 
  • POMPANO BEACH, Fla., April 02, 2024 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics for advanced wound care, today announced that it will present at the 14th Annual LD Micro Invitational Conference at the Sofitel New York on April 8-9, 2024.
  • This year’s LD Micro Invitational is expected to feature presentations from 80 companies, with the opportunity for private one-on-one meetings.
  • BioStem’s presentation will be available to view here: https://ldinv14.sequireevents.com/ .
  • To request a meeting with Mr. Matuszewski, please contact PCG Advisory at 646-863-6893 or Dean Summers at [email protected] .

SOHM, Inc. and Coastar Therapeutics Sign MoU and Announce Collaboration to Revolutionize Genome Editing Using Red Blood Cell Membrane Derived Carriers

Retrieved on: 
Monday, April 1, 2024
Gene editing, Cell, IBN, Partnership, Tissue, Genetics, Medicine, Regenerative medicine, OTC, Cas9, Immune system, Therapy, Vaccine

Genome editing, particularly through the use of CRISPR-Cas9 technology, has emerged as a groundbreaking approach in the field of genetic research and therapeutics.

Key Points: 
  • Genome editing, particularly through the use of CRISPR-Cas9 technology, has emerged as a groundbreaking approach in the field of genetic research and therapeutics.
  • Coastar's red blood cell membrane derived carriers have shown immense potential in efficiently delivering therapeutic cargo into cells.
  • These carriers, derived from the natural membrane of red blood cells, possess several advantages, including biocompatibility, stability, and the ability to evade the immune system.
  • The integration of Coastar's red blood cell membrane derived carriers with SOHM's ABBIE protein-based system holds great promise for both in vitro and in vivo applications.

Celularity Receives Healthcare Common Procedure Coding System (HCPCS) Q Code Approval from the U.S. Centers for Medicare & Medicaid Services for Biovance® 3L

Retrieved on: 
Tuesday, March 26, 2024
CELU, HCPCS, Growth, Regenerative medicine, Medicare, CMS

The designated HCPCS Q code is Q4283 and is available starting April 1, 2024.

Key Points: 
  • The designated HCPCS Q code is Q4283 and is available starting April 1, 2024.
  • "The HCPCS Q code approval by CMS further recognizes Biovance® 3L as an important therapeutic option for the treatment of wounds,” said Dr. Robert J. Hariri, M.D., Ph.D., Celularity CEO, chairman and founder.
  • “The medical community has been rapidly adopting this product, and the HCPCS Q code approval paves the way for Biovance® 3L to realize additional growth, enabling the potential to impact more lives.
  • We will continue to innovate in this important part of our business and look forward to providing future updates.”
    The Healthcare Common Procedure Coding System (HCPCS) is produced by the Centers for Medicare and Medicaid Services (CMS).

In Preparation for Expected Human Clinical Trials, NurExone Signs Agreement for Large Scale Preclinical Testing for Its Spinal Cord Injury Therapy, ExoPTEN

Retrieved on: 
Friday, March 22, 2024
Drug discovery, Rat, NRX, PTEN, Patient, Contract research organization, IND, Regenerative medicine, Behavior, Spinal cord, Spinal cord injury, SCI, Pharmaceutical industry

This large-scale animal testing represents a significant step towards filing an Investigational New Drug (IND) application in the US for NurExone’s ExoPTEN therapy for spinal cord injury (SCI).

Key Points: 
  • This large-scale animal testing represents a significant step towards filing an Investigational New Drug (IND) application in the US for NurExone’s ExoPTEN therapy for spinal cord injury (SCI).
  • Under the terms of the agreement, Vivox will provide Contract Research Organization (CRO) services to NurExone, as a prerequisite to commencing Human Trials under the planned IND.
  • The testing will encompass mobility, behavior, motor and sensory recovery of rats following Spinal Cord Injury and treatment with ExoPTEN," said Dr. Lior Shaltiel, CEO of NurExone.
  • By collaborating with Vivox, NurExone aims to accelerate the development and regulatory path of ExoPTEN, to bring this potentially transformative treatment to patients in need.

Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update

Retrieved on: 
Friday, March 22, 2024
Diagnosis, Research, U.S. FDA, Peripheral artery disease, Infection, Patent, Buddha's hand, Evaluation, PAD, Journal, Sale, University, Doctor of Philosophy, Efficacy, Priority review, Regenerative medicine, Clinical trial, Trial of the century, Vascular surgery, HAV, Hospital, Injury, Nationwide Children's Hospital, HUMA, FACS, Amputation, Food, FDA, Defense, BLA, PDUFA, Pharmaceutical industry

DURHAM, N.C., March 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the investigational Human Acellular Vessel (HAV) closer to planned U.S. market launch.

Key Points: 
  • There was no revenue for either the fourth quarter of 2023 or the fourth quarter of 2022, and there was no revenue for the year ended December 31, 2023.
  • Research and development expenses were $20.2 million for the fourth quarter of 2023, compared to $15.0 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023, compared to $63.3 million for the year ended December 31, 2022.
  • General and administrative expenses were $6.0 million for the fourth quarter of 2023, compared to $5.8 million for the fourth quarter of 2022, and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022.
  • The 2023 increases in net loss resulted from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above.