DiscGenics Announces US FDA Approval to Proceed with Phase III Clinical Evaluation of Allogeneic, Injectable Disc Progenitor Cell Therapy for Symptomatic Lumbar Degenerative Disc Disease
DiscGenics, Inc., a privately held, late-stage clinical, biopharmaceutical company developing allogeneic, cell-based, regenerative therapies for musculoskeletal degeneration, today announced it has gained acceptance from the U.S. Food and Drug Administration (FDA) for the clinical protocols and Chemistry, Manufacturing, and Controls…
TETROUS ANNOUNCES FIRST SURGICAL PROCEDURES USING ENFIX TAC™ DEMINERALIZED BONE FIBER IMPLANTS TO ENHANCE ENTHESIS HEALING IN ROTATOR CUFF REPAIR
TETROUS, INC., a leading regenerative medicine company today announced that it has completed the first surgical cases using EnFix TAC™, its latest product that expands its line of EnFix™ implants to cover every surgical technique for rotator cuff repair. The…
Xylyx Bio announces exclusive license agreement with Vanderbilt University for donor organ rehabilitation asset
Xylyx Bio, a regenerative medicine company developing innovative solutions for tissue and organ repair, today announced entry into an exclusive license agreement with Vanderbilt University for the rights to a xenogeneic cross-circulation platform that restores damaged donor organs to transplant condition. The…
X-Therma Announces XT-Thrive® Drug Master File (DMF) Accepted by U.S. Food and Drug Administration (FDA)
X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, announces that the Food and Drug Administration (FDA) accepted a Drug Master File (DMF) covering its product, XT-Thrive®. This DMF covers the Chemistry, Manufacturing and…
LyGenesis Announces First Patient Dosed in its Phase 2a Clinical Trial of a First-in-Class Regenerative Cell Therapy for Patients with End-Stage Liver Disease
LyGenesis, a clinical-stage biotechnology company developing cell therapies for large unmet medical needs, announced today that the first patient has been dosed in their Phase 2a clinical trial evaluating their first-in-class allogenic regenerative cell therapy transplanted into patients’ lymph nodes…
Ajinomoto Co., Inc. Enhances StemFit iPS Cell Expansion Medium
Today, Ajinomoto Co., Inc. (“Ajinomoto Co.”) (TSE: 2802) launched a new version of its StemFit™ iPSC expansion medium. The enhanced version of its widely used StemFit™ products is designed to improve the growth and pluripotency of induced pluripotent stem cells (iPSC)…
Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA)…
REGENATIVE LABS, TOGETHER WITH THE PAIN AND SLEEP THERAPY CENTER, PUBLISHES CASE STUDY DEMONSTRATING NEW CARE ADVANCEMENTS USING WHARTON’S JELLY ALLOGRAFTS IN TEMPOROMANDIBULAR JOINT DEFECTS
Regenative Labs (Regenative), a leading HCT/P manufacturer, announces the publication of a case study demonstrating new care advancements using its Wharton’s Jelly allografts in the supplementation of Temporomandibular Joint (TMJ) defects. The case study titled “Single-Center Retrospective Study of Flowable Umbilical…
