Stratatech Corp.

DUBLIN, Feb. 19, 2024 /PRNewswire/ -- The '3D Cell Cultures: Technologies and Global Markets' report has been added to ResearchAndMarkets.com's offering. 3D cell culture technologies are a powerful tool for studying cell biology, disease mechanisms and drug discovery. 3D cell culture models mimic the 3D structure and cell-cell interactions that are found in real tissues, making them more accurate and predictive than traditional 2D cell culture models. There are a variety of 3D cell culture technologies available, including: Scaffold-based 3D cell culture: This approach uses a scaffold to provide a 3D support structure for cells to grow on. Scaffolds can be made from a variety of materials, including natural polymers, synthetic polymers and hydrogels. Scaffold-free 3D cell culture: This approach does not use a scaffold. Instead, cells are grown in a suspension of culture medium and gel-forming agents, such as collagen or Matrigel. Bioprinting: This approach uses a 3D printer to deposit cells and biomaterials layer-by-layer to create complex 3D cell culture models. 3D cell culture technologies have a wide range of applications, including: Drug discovery: 3D cell culture models can be used to screen new drug candidates for safety and efficacy before they are tested in clinical trials. 3D cell culture models can also be used to study the mechanisms of drug resistance and to develop new strategies to overcome drug resistance. Disease modeling: 3D cell culture models can be used to study the biology of diseases and to develop new treatments. For example, 3D cancer models can be used to study tumor growth and metastasis, and 3D neurodegenerative disease models can be used to study the progression of neurodegenerative diseases. Regenerative medicine: 3D cell culture models can be used to develop new cell-based therapies for a variety of diseases. For example, 3D skin models can be used to grow new skin for patients with burns or other skin injuries, and 3D liver models can be used to grow new liver tissue for patients with liver disease. This report aims to provide a comprehensive study of the global 3D cell culture technologies market. It provides a detailed description of the different types of healthcare interoperability solutions and their current and historical market revenues. The scope of the report encompasses the major types of 3D cell culture which are being used by industry, academic researchers, government labs, and independent research groups. This includes the main inputs such as cell lines, media, sera, reagents, software, and instrumentation. It analyzes the current market status, examines future market drivers and presents forecasts of growth over the next five years. The market structure has been reorganized for this edition. Also, more research was done on base case data for different product areas. The greater emphasis is on the different products used for 3D cell culture, but the report also investigates the market in terms of types of applications, end users and geographic regions. The Report Includes 17 data tables and 105 additional tables An overview of the global market landscape related to the 3D cell cultures technologies In-depth analysis of global market trends, featuring historical revenue data for 2020-2022, estimated figures for 2023, as well as forecasts for 2028. This analysis includes projections of Compound Annual Growth Rates (CAGRs) spanning through 2028 Evaluation of the current market size and revenue growth prospects specific to 3D cell cultures technologies, accompanied by a comprehensive market share analysis categorized by type, end user, and geographical region Information on analytical systems used in tissue and cell culture, cellomics, and human cancer model initiative (HCMI) Details about assay development for mesenchymal stem cells, In Vitro testing of adventitious agents and description of assays and assay kits A look at the main classes of models for researching cancer and other diseases, benefits of 3D models to cancer research and description of 3D engineered scaffolds Analysis of the market's dynamics, specifically growth drivers, restraints, and opportunities and discussion on the impact of COVID-19 on the world of cell culture Insights into U.S. regulatory status of bioprinted products; basic guidance for the regulation of biologics, regenerative medicine and xenotransplants Relevant patent analysis, including recent activity and a list of key patents Detailed profiles of leading market participants, providing a descriptive overview of their respective businesses, including Abcam PLC, Agilent Technologies Inc., Corning Inc., Merck KGAA, Beckman Coulter, and Synvivo Inc. Key Topics Covered: Chapter 1 Introduction Chapter 2 Summary and Highlights Chapter 3 Market Overview Chapter 4 Market, by Type Chapter 5 Assays, Imaging and Analysis Chapter 6 Regulation and Standardization Chapter 7 3D Models for Cancer Chapter 8 Landscape for Toxicology and Drug Safety Testing Chapter 9 Market Breakdown by Region Chapter 10 Stem Cell Landscape Chapter 11 Regenerative Medicine: Organ Transplants and Skin Substitutes Chapter 12 Company Profiles 3D Bioprinting Solutions 3D Biotek 4D Technology Abcam Akron Biotech Agilent Technologies Alpco Amsbio Beckman Coulter Bioinspired Solutions Biotime Biovision Cell Applications Cellink Corning Cyprotex Cytiva Cytoo EMD Millipore / Merck Emulate Envisiontec Epithelix Eurofins Greiner Bio-One International Hamilton Robotics Hub Organoids Hurel Corp. Insphero Invitrocue Kiyatec Inc. Lifenet Health Lorem Vascular / Cytori Therapeutics Mattek Mimetas Organovo Holdings Perkinelmer Plasticell Pluristem Therapeutics Poietis Promega Corp. Seahorse Bioscience Stemcell Technologies Stratatech Corp. Synvivo Tap Biosystems Tecan Trading Zen-Bio For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Burn patients with the most serious wounds require an autograft: the harvesting of that person’s own healthy skin, which is then transplanted to the burn site. There is now a regenerative medicine alternative. The FDA has approved an engineered skin product that’s placed on the wound, serving as a scaffold for a patient’s skin cells to grow. The regulatory decision for the product, called StrataGraft, covers the treatment of adults whose burn injury still leaves some of the deep skin layers intact. Developed by Dublin, Ireland-based Mallinckrodt Pharmaceuticals, StrataGraft is intended to reduce the need for autograft, a procedure that can introduce additional complications and also leaves a patient with another site that requires healing. The FDA based its approval on the results of two clinical trials enrolling a total of 101 adults with deep partial-thickness thermal burns, the kind of burns caused by a heat source such as fire, hot surfaces, or scalding water. In both studies, each patient served as a test subject and as a control. Two burn wounds of comparable area and depth were identified on each patient. Those wounds were randomly selected to receive treatment with StrataGraft or autograft—each patient received both treatments. The study’s main goal was to measure the percentage of StrataGraft treatment sites that achieved complete wound closure, decreasing the need for additional treatment with an autograft. In results from one of the studies that was recently published in the journal Burns, treatment with StrataGraft eliminated the need to harvest tissue for an autograft in all but three of 71 patients. After three months, 92% of the StrataGraft-treated wounds had closed. StrataGraft is made from two kinds of human skin cells, keratinocytes and dermal fibroblasts. These cells are grown together to make a bi-layered construct, or scaffold. The product, which is 100 square centimeters in size, is for topical use only. The size of the StrataGraft applied should be equal to the surface area of the wound, according to the prescribing information. The constructs may be trimmed to fit the wound size. Because StrataGraft is made from cells collected from human donors, as well as some animal-derived materials, the FDA cautions that the product does introduce some risk of transmission of infectious diseases or agents. No such problems were reported in clinical trials. The immune systems of patients did not reject StrataGraft as foreign, nor was any infection reported. The most common treatment-related side effect was itching, which was reported in 11 patients. Other side effects included blisters, scarring, and slower healing at the treatment site. StrataGraft was initially developed by Stratatech, a Madison, Wisconsin-based startup whose science stemmed from research at the University of Wisconsin. Mallinckrodt acquired Stratatech in 2017 for about $76 million up front and another $121 million tied to milestone payments. StrataGraft is among the first products to win FDA approval under the agency’s regenerative medicine advanced therapy (RMAT) designation, a part of the 21st Century Cures Act intended to encourage the development of novel regenerative medicine therapies. The first RMAT approval was awarded to Bristol Myers Squibb in February for its cancer cell therapy Breyanzi. Stratatech’s research received support from the U.S. Biomedical Advanced Research and Development Authority, which is interested in the product as a tool for a mass casualty event that requires treatment of burns. Patients who have conventional burns will benefit, too, said Mallinckrodt Chief Scientific Officer Steven Romano, speaking on a company video accompanying the company’s announcement of the regulatory decision. “The approval of StrataGraft marks a significant milestone for the burn care community,” Romano said. “In the last two to three decades, there have been few advances in the treatment of the type of burns for which StrataGraft is indicated. Burn surgeons now have a new treatment to help reduce the need for autografting.” Photo by Mallinckrodt Pharmaceuticals

Mallinckrodt‘s (NYSE: MNK) Stratatech today received FDA approval for its StrataGraft for treating adult patients with thermal burns. The Bedminister, N.J.-based company designed StrataGraft to treat thermal burns that have intact dermal elements, or remaining deep skin layers, for which surgical intervention is clinically indicated. “Serious burns can be an incredibly difficult injury to treat and can adversely affect more than just the skin. The goal of burn management is to help the patient return to the highest level of functionality and independence possible while improving the overall quality of life,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a news release. “This approval provides health care professionals a novel way to treat burn wounds.” The gold standard treatment for many deep burns involves removing damaged, burned skin and replacing it with a skin graft. Skin grafts are often taken from the patient’s own body and moved to the burned area to heal it. However, the procedure leaves a new wound where the healthy skin was removed. StrataGraft has two kinds of human skin cells called keratinocytes and dermal fibroblasts. The skin cells are grown together to make a bi-layered constructed called a cellularized scaffold. The skin graft is made for topical application. It is placed onto a burn site by a healthcare provider and a patient’s skin cells will grow to replace the skin cells that were lost from the burn. Stratatech suggests that StrataGraft could help avoid or decrease the amount of healthy skin needed for a skin graft. Stratatech received $86 million to develop the skin graft. The U.S. Biomedical Advanced Research and Development Authority awarded Mallinckrodt’s Stratatech $26 million in late 2018 under Project BioShield.