Biotech Life Sciences Initiates New Study of Anti-aging Formulas in Helping Covid-19 Post-viral Fatigue and Chronic Fatigue Syndrome

BioTech Life Sciences | August 06, 2020

BioTech Life Sciences (BioTech – https://btl.science) recently announced it was studying the effects of its proprietary formulas on long-term patient symptoms related to COVID-19 Post-Viral Fatigue (long-haulers) and chronic fatigue syndrome (C.F.S.). The findings will be a part of a larger research study undertaken by the company, and is currently calling for voluntary participants; especially those who suffer from myalgic encephalomyelitis (M.E.), chronic fatigue syndrome, or Post-Viral Fatigue. BioTech specializes in anti-aging, stem cell production and neuroscience, and has discovered a clear link between COVID-19 long-haulers, C.F.S., and the therapeutic benefits of certain anti-aging compounds. According to the Cleveland Clinic and a recent Atlantic article, patients who survive COVID-19 typically recover in roughly two weeks' time. But there are a growing number of patients – as many as 20% – who inexplicably suffer with the disease for months, with longer lasting complications. These so called long-haulers report symptoms including fevers, chest pain, shortness of breath and debilitating fatigue.

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CELL AND GENE THERAPY

Dyadic Announces a NIIMBL Coronavirus Grant Under the White House’s American Rescue Plan

Dyadic International, Inc. | December 23, 2021

Dyadic International, Inc. a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve access to biologic vaccines and drugs at flexible commercial scales, announced it is the recipient of one of thirty-two project grants awarded by the National Institute for Innovation in Manufacturing Biopharmaceuticals funded through the White House’s American Rescue Plan. Under the NIIMBL grant, Dyadic will receive up to $690,000 in funding to engineer the Company’s proprietary and patented C1 thermophilic fungal protein production platform to produce two different antibodies. “We are honored to have been selected by NIIMBL to receive this grant and to further leverage Dyadic’s C1-cell protein production platform to help the nation prevent, prepare for, and respond to coronavirus and other public health threats. The grant provides us with the opportunity, among other attributes, to further demonstrate to academia, industry, and governmental agencies the rapid speed at which we can develop stable C1 expressing cell lines to produce antibodies as compared to traditional cell lines, such as Chinese Hamster Ovary cells. We look forward to moving this project forward in the new year,” Mark Emalfarb, Dyadic’s President and Chief Executive Officer NIIMBL members include large and small companies, academic institutions, non-profits, and federal agency partners who are well-equipped to significantly strengthen the nation’s preparedness and response to public health crises. Through the ARP funding, NIIMBL has selected projects that will Provide testbeds for process development, for next generation manufacturing approaches, and for drug product manufacturing approaches that provide access to industrially relevant equipment and facilities for pre-competitive manufacturing innovation Support the development of significantly improved methods for vaccine production, quality, and distribution, including mRNA and other vaccine platforms Demonstrate rapid scaling for production of coronavirus antigens and medical countermeasures for variants of concern Train a diverse biopharmaceutical manufacturing workforce Demonstrate the concept of mobile Good Manufacturing Practices capabilities to support mRNA vaccine and gene therapy production Dyadic’s project grant is intended to benchmark the speed that the C1 manufacturing platform will have when compared to current state of the art methods, which could lead to a rapid ability to produce medical countermeasures and vaccines in response to future pandemics. About NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology in the U.S. Department of Commerce with significant additional support from its members. Visit NIIMBL.org to view a summary of these projects and to learn more about NIIMBL. About Dyadic International, Inc. Dyadic International, Inc. is a global biotechnology company that is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica, named C1. The C1 microorganism, which enables the development and large-scale manufacture of low-cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales.

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MEDICAL

Emmaus Life Sciences Announces Launch of Full-Service Telehealth Solution

Emmaus Life Sciences, Inc. | April 12, 2022

Emmaus Life Sciences, Inc. (OTQXC: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced the launch of an innovative full-service telehealth solution with its strategic partners, including Asembia LLC, US Bioservices Corporation and UpScriptHealth. The telehealth program capitalizes on the expansion of telemedicine in the U.S. to afford patients and providers on-line access to Endari®, the company's prescription-grade L-glutamine oral powder, for the treatment of sickle cell disease. The launch of our full-service telehealth solution reflects our stated commitment to make Endari accessible to sickle cell patients in need and we are excited to be launching the program, Our solution will allow patients to see a doctor without leaving home, thereby eliminating unnecessary travel time and expense and the risk of infection that can occur with hospital visits. Eligible patients will be able to receive a same-day physician authorization and prescription for Endari and to have the prescription delivered to their homes within just a few days. As the telehealth solution grows, we are optimistic that it will help us to reach new patients and add meaningful revenue for Emmaus." Yutaka Niihara, M.D., M.P.H., Emmaus' Chairman and Chief Executive Officer. According to a December 3, 2021 report from the U.S. Department of Health & Human Services (HHS), available at the HHS website at https://www.hhs.gov, the share of Medicare visits conducted through telehealth in 2020 increased 63-fold, from approximately 840,000 in 2019 to 52.7 million. The report noted that telehealth was particularly helpful in offsetting potential foregone behavioral health care and that states with the highest use of telehealth in 2020 included Massachusetts, Vermont, Rhode Island, New Hampshire, and Connecticut. Other industry sources suggest that the trend toward telehealth accelerated in 2021 and is likely to be sustained. We believe that affording patients and telehealth prescribers access to Endari in a quick and convenient way will improve their experience and potentially increase adherence rates, We look forward to working with our strategic partners on this important project." George Sekulich, Senior Vice President of Global Commercialization of Emmaus. About Emmaus Life Sciences Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease. The company currently markets U.S. Food and Drug Administration approved Endari® (L-glutamine oral powder) indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older. The company is also engaged in the discovery and development of innovative treatments and therapies for certain rare and orphan diseases as well as those affecting larger populations, such as diverticulosis. About Sickle Cell Disease There are approximately 100,000 people living with sickle cell disease (SCD) in the United States and millions more globally. The sickle gene is found in every ethnic group, not just among those of African descent; and in the United States an estimated 1-in-365 African Americans and 1-in-16,300 Hispanic Americans are born with SCD.1 The genetic mutation responsible for SCD causes an individual's red blood cells to distort into a "C" or a sickle shape, reducing their ability to transport oxygen throughout the body. These sickled red blood cells break down rapidly, become very sticky, and develop a propensity to clump together, which causes them to become stuck and cause damage within blood vessels. The result is reduced blood flow to distal organs, which leads to physical symptoms of incapacitating pain, tissue and organ damage, and early death

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MEDICAL

Cardea Bio completes planned launch of CRISPR QC

Cardea Bio | April 06, 2022

Today, Cardea Bio, Inc. - the world's only mass producer of biocompatible semiconductors - announced a significant milestone with the launch of CRISPR QC Inc. as a separate business using Cardea's CRISPR-chip™ technology for a range of quality control services for CRISPR gene editing. This milestone is an important move for Cardea Bio on its mission to realizing real-world applications of their BPU™ (Biosignal Processing Unit) Platform. After recently establishing dedicated lab facilities and office spaces, as well as completing the initial investor funding, CRISPR QC is now ready to offer analysis services for R&D groups in therapeutics, animal breeding, plant biology, and academics in need of advanced insights to their CRISPR efforts. One of the challenges for successful CRISPR gene editing is a lack of understanding and standardization of processes around predicting and optimizing CRISPR assay outcomes. At CRISPR QC, we work with scientists to improve the quality of life for all. That's why we're excited to work with the Chief Scientific Officer of Cardea Bio, Dr. Kiana Aran, who recently received NIH funding to help set some of the US quality control standards for CRISPR therapies, In addition to this, CRISPR QC provides previously unavailable data and insight into the CRISPR editing process, resulting in significant time-savings and first to market application opportunities for our customers, including CRISPR/Cas technology-driven solutions which are commercially available as of now." Ross Bundy, President of CRISPR QC. With CRISPR QC going into business with valuable first-of-a-kind services in the growing CRISPR space, we can now showcase a distinct example of what our BPU Platform can enable our partners to do - products and applications otherwise not possible. That in turn drives growth opportunities and revenue for Cardea Bio, unlocking significant value for both CRISPR QC's and Cardea's stakeholders, I'm anticipating that CRISPR QC will get a number of near-term opportunities to help its customers bring transformative gene-editing insights and solutions to scientists and researchers working on CRISPR therapies, as well as other market changing applications." Michael Heltzen, CEO at Cardea Bio. About CRISPR QC Inc. CRISPR QC is a biotechnology company dedicated to improving the capabilities of scientists and researchers to improve their CRISPR assay designs through technological innovation. Using market-leading solutions, we can identify CRISPR activity in amplicons and genomic DNA and model results of the CRISPR process In vivo vs. In vitro. Our service is available to therapeutic companies and academic researchers to help them accelerate the development of their CRISPR-based therapies and to animal breeding and plant biology scientists who seek to improve the food chain for humankind. About Cardea Bio Cardea Bio is the world's only mass producer of a biocompatible semiconductor, the BPU™ (Biosignal Processing Unit). The BPU is the first and only semiconductor capable of translating real-time streams of multiomics signals into digital information. Through the BPU™ platform, Cardea's long-term vision is to democratize access to the biosignals and insights behind the most advanced technology on our planet: Nature and biology. The Internet of Biology is that way becoming possible. Cardea is headquartered in San Diego and has additional activity in Los Angeles. Cardea is a 100% American developed and built biocompatible semiconductor technology for applications across a variety of sectors including human health, agriculture, molecular diagnostics, biotechnology, environmental monitoring, and animal health.

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INDUSTRIAL IMPACT

Amnio Technology Launches Two New Dual-Layer Allografts, FDA Recognizes Products as Minimally Manipulated, Homologous Use HCT/Ps

Amnio Technology | February 15, 2022

Amnio Technology, a global leader in the development of and distribution of amniotic tissue allografts is announcing the launch of two new PalinGen® membrane products, PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane. The new allografts, like the entire family of PalinGen® membrane products, are minimally manipulated, homologous use and chorion-free. The dual-layered nature of the allografts allow for unidirectional application with two outward facing epithelial sides. The proprietary Advantek® process used to manufacture PalinGen® membranes preserves the extracellular matrix components and regulatory proteins present in amniotic tissues. Preserving the characteristics of the natural tissue aids in wound management. PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are indicated for patients suffering from non-healing acute and chronic wounds as well as complex and/or open surgical wounds and burns. Senior Director of New Product Development, Robert Diller, PhD, shared his insight into the motivation for developing a multilayered amniotic product, "The PalinGen® Dual layer membranes have increased durability and slower resorption, which makes them ideal for use in robotic and other surgical applications" "With the application of single-layer PalinGen® membrane products, patients already experience improved clinical outcomes compared to treatment with standard of care. Cytokines, growth factors, and extracellular matrix proteins have been identified in amnion membranes and contribute to the complex wound healing process. Compared to single layer allografts, PalinGen® Dual Layer membranes deliver twice as many of these components to the wound area," lead Research Scientist on the development project, Sarah West The FDA recognized PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane as being minimally manipulated, homologous use human cell, tissue, and cellular and tissue-based products or HCT/Ps. In letters received from the Tissue Reference Group (TRG) within the Office of Tissues and Advanced Therapies (OTAT) on September 30, 2021, and February 8, 2022, respectively, FDA confirmed that PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane would be regulated solely under section 361 of the PHS Act and the regulations in 21 CFR 1271. Amnio Technology has a long history of Good Tissue Practices (GTP) experience and compliance. In recent years, the FDA has issued final guidance on its Framework for the Regulation of Regenerative Medicine Products, making the confirmation of the regulatory status of amniotic products critical for business continuity in the amniotic tissue space. William Brown, Managing Director of Operations at Amnio Technology, recognized the efforts of the entire Amnio Technology Team, "We continue to be successful in the development and launch of new Products in our pipeline, which meet the Regulatory framework of the FDA and other Agencies. With a Team dedicated to compliance from the first step, we continue to expedite new product availability to clinicians for implementation into their practice and, ultimately, the ability to improve quality of life for the patient." Both PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are available in a variety of sizes suited for the patient's needs. About Amnio Technology Amnio Technology is a clinical stage biotechnology company dedicated to advancing the science of regenerative medicine. Established in 2013, Amnio Technology has developed core competencies in Good Tissue Practice and HCT/P Safety becoming a global leader in the development and distribution of amniotic tissue allografts. The Company has a robust pipeline of products and its liquid allograft for the treatment of chronic ulcers, PalinGen® Flow, is currently in a Phase 2 clinical trial.

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