AmnioFix (dehydrated human amnion/chorion membrane micronized) / MiMedx - LARVOL DELTA

CLINICAL OUTCOMES UTILIZING A DEHYDRATED HUMAN AMNION/CHORION MEMBRANE (DHACM) ALLOGRAFT AS A PROTECTIVE BARRIER AGAINST COLORECTAL ANASTOMOTIC LEAKS IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) (CCCongress 2025) - "DiscussionThis study examines the potential benefit of adding DHACM as a risk-mitigation strategy to prevent anastomotic leaks in IBD patients undergoing a colectomy. Data from this cohort is consistent with other reports of low AL rates in patients receiving DHACM for colorectal anastomoses in a general population.6,7 Larger multi-centered studies are warranted to confirm these findings and the overall applicability of DHACM in colorectal surgery.ReferencesHammond J. J Gastrointest Surg, 2014; 18:1176.Turrentine F. J Am Coll Surg, 2015; 220:195.AMNIOFIX® Human Amniotic Membrane Allograft Instructions for Use.2022.Koob T. Int Wound J, 2013; 10:493.Uludag M. Int J Colorectal Dis, 2009; 24:809.Ortega F. J Am Coll Surg, 2017; 225:e6.Jrebi N. Am J Gastroenterol, 2024; S(2)."

Clinical • Clinical data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Human amniotic membrane graft removal and histopathologic evaluation following closure of a full thickness macular hole. (PubMed, Am J Ophthalmol Case Rep) - "Three months after the second surgery, we performed the third surgery with placement of dehydrated human amniotic/chorionic membrane (DHACM AMNIOFIX) over the macular hole and SO tamponade...OCT imaging, prior to hAM removal, noted the hAM integration into the inner retina. In addition, we show that the graft can be removed after 6 months without obvious damage to the retina."

Journal • Retinal Disorders

AmnioFix: The Role of Amnion Membrane Allografts in Nipple Preservation (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Stanford University | Initiation date: Oct 2023 ➔ Jun 2024

Trial initiation date

Dehydrated human amnion/chorion membrane use in emergent craniectomies shows minimal dural adhesions. (PubMed, J Wound Care) - "Dehydrated human amnion/chorion membrane (DHACM) allografts (AMNIOFIX, MIMEDX Group Inc., US) have been shown to reduce the rate of dural scar tissue formation in re-exploration of posterior lumbar interbody fusion operations which require entry into the epidural space...Placement of DHACM below and on top of the dura resulted in negligible adhesion being found during the defect exposure, and there were no intraoperative complications during cranioplasties. Reported estimated blood loss across the seven patients averaged 64.2ml, total operative time averaged 79.2 minutes, and time dedicated to exposing defect for bone flap placement was <3 minutes."

Journal • CNS Disorders • Fibrosis • Immunology • Vascular Neurology

AmnioFix: The Role of Amnion Membrane Allografts in Nipple Preservation (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Stanford University

New trial

Nerve spare robot assisted laparoscopic prostatectomy with amniotic membranes: medium term outcomes. (PubMed, J Robot Surg) - "Once the retrograde release of the NVB is performed then 599 patients underwent placement of dHACM graft (AmnioFix by MiMedx, Marietta, GA, USA)...Our findings indicate that dHACM allowed for an even faster period for continence recovery which was independent of grade of NS. Future comparative studies may further assess the impact of new amniotic membrane types on the functional and oncological outcomes after RALP."

Journal • Benign Prostatic Hyperplasia • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

Two New Studies Demonstrate in vitro Bioactivity Potential of Micronized Dehydrated Human Amnion Chorion Membrane (mdHACM) to Prevent Pathological Processes Underlying Osteoarthritis (OA) and Tendinopathy (GlobeNewswire) - "MiMedx Group, Inc...announced two peer-reviewed studies investigating the use of micronized dehydrated human amnion chorion membrane (mdHACM) for the treatment of debilitating conditions involving degeneration of connective tissue: osteoarthritis (OA) and tendinopathy. The first study, published in Osteoarthritis and Cartilage Open, identified a novel mechanism of action by which PURION® Processed mdHACM regulates degradative processes in human articular chondrocytes....These results further support mdHACM as an investigational new drug (IND) candidate for the treatment of OA and highlight potential disease modifying activities. The second study, published in the Journal of Biomedical Materials Research, Part B, examined chronicity and poor outcomes following tendon injury attributable to prolonged inflammation and hypervascularity..."

Preclinical • Osteoarthritis • Pain

MIMEDX Reports Top-Line Data From Two Late-Stage Musculoskeletal Trials With Proprietary Amniotic Tissue Technology (GlobeNewswire) - P2b, N=446; "MiMedx Group...announced top-line results from two late-stage musculoskeletal clinical trials of the Company’s micronized dehydrated Human Amnion Chorion Membrane (mdHACM): a Phase 2B clinical trial for the treatment of Knee Osteoarthritis (KOA)....An interim review of the 446 patients enrolled in the clinical trial showed that the study did not meet its two primary efficacy endpoints of a statistically significant change in the Visual Analog Scale (VAS) for Pain or in the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index...the Company now believes that two Phase 3 studies in KOA will be required to file a BLA and intends to provide an update for the timing of the filing, previously tentatively planned for late-2024 or early-2025, following review and discussion with the FDA."

BLA • P2b data • CNS Disorders • Musculoskeletal Pain • Osteoarthritis • Pain

MiMedx Announces Last Patients Last Visits in Three Late-Stage Musculoskeletal Trials with Proprietary Tissue Technology (GlobeNewswire) - "MiMedx Group...today announced that the last patients have completed their last clinical visits in two late-stage Investigational New Drug (IND) trials...Phase 3 studies of AmnioFix® Injectable...as a potential treatment for Plantar Fasciitis and Achilles Tendonitis. In addition, all clinical effectiveness endpoint visits have been completed in a Phase 2B study of mdHACM as a potential treatment for Knee Osteoarthritis....We anticipate announcing top-line results of all three trials this summer, have commenced planning efforts to initiate our Phase 3 clinical trial for Knee Osteoarthritis, and plan to file a Biologics License Application (BLA) for Plantar Fasciitis in the first half of 2022....The blinded efficacy visits for this study are complete, with the 12-month safety visit follow up as requested by FDA scheduled to compete in October 2021. The Company intends to initiate a Phase 3 study of mdHACM injection in the treatment of Knee Osteoarthritis in Q3 2021,..."

BLA • New P3 trial • P3 data: top line • Trial completion • CNS Disorders • Osteoarthritis • Pain

MiMedx Announces Fourth Quarter and Full Year 2020 Financial and Operating Results (GlobeNewswire) - "We are aggressively pursuing FDA approval for our novel therapeutic biologic, AmnioFix® Injectable, to reduce pain and improve function in patients suffering from plantar fasciitis and knee osteoarthritis."

Clinical • CNS Disorders • Osteoarthritis • Pain

Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy (clinicaltrials.gov) - P=N/A; N=8; Terminated; Sponsor: MiMedx Group, Inc.; N=80 ➔ 8; Enrolling by invitation ➔ Terminated; Slow enrollment

Clinical • Enrollment change • Trial termination • Head and Neck Cancer • Laryngeal Cancer • Oncology • Otorhinolaryngology • Solid Tumor

MiMedx Concludes Enrollment for Phase 2B Study of Osteoarthritis (OA) of the Knee (GlobeNewswire) - "The OA Clinical Trial is the first randomized clinical study of a micronized dehydrated Human Amnion/Chorion Membrane (mdHACM) Injection in the Treatment of KOA....'We have enrolled the planned number of patients needed to assess the statistical significance of response to treatment in this Phase 2B trial, ahead of our enrollment schedule, despite the access restrictions from the COVID-19 pandemic.'"

Enrollment closed • CNS Disorders • Osteoarthritis • Pain

MiMedx Concludes Enrollment for Phase 3 Plantar Fasciitis Trial (GlobeNewswire) - "MiMedx Group, Inc....today announced the conclusion of enrollment for a Phase 3 study of plantar fasciitis, an inflammation of the fibrous tissue along the bottom of the foot that results in intense pain. This key clinical trial explores how placental science may address and treat musculoskeletal pain and function disorders. The study has met its timelines....'We look forward to sharing the results of this trial in 2021.'"

Enrollment status • P3 data • CNS Disorders • Musculoskeletal Pain • Pain

Phase update (GlobeNewswire) - P2➔P3, Pain

Phase shift • Pain

Up-To-Date Role of The Dehydrated Human Amnion/Chorion Membrane (AMNIOFIX) for Wound Healing. (PubMed, Expert Opin Biol Ther) - "Amniofix and other dHACM (dehydrated human amniotic/chorionic membrane) therapies reported faster and complete healing with lower complication rates, when compared to other similar products. These features encourage the use of Amniofix in Diabetic foot ulcers and Venous Leg Ulcers, besides other conditions such as plantar fasciitis."

Journal • Diabetes • Venous Ulcer

Placenta to the Rescue: Limb Salvage Using Dehydrated Human Amnion/Chorion Membrane. (PubMed, J Burn Care Res) - "A clinical case is presented describing an experience with dehydrated human amnion/chorion membrane (dHACM, EpiFix®/AmnioFix®, MiMedx Group, Marietta, GA) graft to obtain granulation over an open fracture with desiccated bone...The authors suspect that the dHACM applications contributed to successful granulation coverage to the affected bones that were otherwise not amendable to other coverage options. This contributed to limb salvage and a successful outcome."

Journal

Micronized dHACM Injectable for the Treatment of Plantar Fasciitis (clinicaltrials.gov) - P2/3; N=147; Completed; Sponsor: MiMedx Group, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Dec 2018 ➔ Aug 2018

Clinical • Trial completion • Trial completion date

Robot-Assisted Laparoscopic Transvaginal Repair of Ileal Conduit Fistula to Vagina (AUA 2019) - "Transvaginal robot-assisted laparoscopic repair of an enterovaginal fistula from an ileal conduit to the vagina is technically feasible and can provide a reach advantage compared to traditional transvaginal surgery. Interposition can be achieved with an alternative allogfraft material such as Amniofix (MiMedx). This robotic approach can be successful as demonstrated in this moderate-term follow up."