List of Biologics Companies in Florida - 54

Adolore Biotherapeutics, Inc., is a biotechnology company focused on developing novel therapies for the treatment of chronic pain and other pain and nervous system conditions or disorders. Our best-in-class lead programs are long-acting locally acting gene-therapies that are opioid-free Disease Modifying Anti-Pain therapies (DMAPs) for the treatment of a variety of chronic pain indications. The Company’s two current CA8* gene therapy programs are in preclinical development for treatment of patients suffering from erythromelalgia, a life-long heritable chronic pain condition representing an orphan drug disease with no approved therapy, and chronic osteoarthritis knee pain, affecting a large number of patients that is often treated with opioids due to the lack of alternatives, thus contributing to the ongoing opioid crisis.

AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases, with an initial focus in ophthalmology. AGTC's lead product candidates are designed to treat inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. AGTC's product pipeline includes six named ophthalmology development programs across five targets (X-linked retinoschisis (XLRS), X-linked retinitis pigmentosa (XLRP), achromatopsia, wet age-related macular degeneration and blue cone monochromacy), two non-ophthalmology programs (alpha-1 antitrypsin deficiency and adrenoleukodystrophy) and AGTC is continuing to develop early research studies in additional indications. The company is also exploring genetic defects in cells in the inner ear that lead to deafness and expects to advance several product candidates into development within the next few years. AGTC employs a highly targeted approach to selecting and designing its product candidates, choosing to develop therapies for indications having high unmet medical need, clinical feasibility and commercial potential. AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as, expertise in the formulation, manufacture and physical delivery of gene therapy products Find AGTC on YouTube at goo.gl/sMdJqX.

AIM ImmunoTech Inc., an immuno-pharma company headquartered in Ocala, Florida, is focused on the research and development of therapeutics to treat multiple types of cancers, as well as immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases. AIM ImmunoTech’s flagship products include Ampligen® (Rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® (Interferon Alfa-N3). Ampligen® represents an RNA being developed for globally important cancers, viral diseases, and disorders of the immune system. Ampligen® is also being evaluated for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Alferon N Injection® is approved for a category of STD infection and patients that are intolerant to recombinant interferon in Argentina. Alferon is the only natural-source, multi-species alpha interferon currently approved for sale in the U.S. for the intralesional treatment of refractory (resistant to other treatment) or recurring external Condylomata Acuminata/genital warts (GW) in patients 18 years of age or older. We operate a 30,000-square-foot facility in New Brunswick, NJ to produce Ampligen® and Alferon®. We are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed to commercialize the many potential therapeutic aspects of Ampligen® and our FDA-approved drug Alferon® N.

Ambulero is a cell and gene therapy spin-out of the University of Miami focused on advancing new therapies to fight vascular disease. We are a platform company that can deliver the adhesion molecule E-selectin using different cell and synthetic vector technologies. We work on rare vascular diseases as well as more common indications effecting large patient populations.

Axogen is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. We are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or discontinuity to peripheral nerves by providing innovative, clinically proven and economically effective repair solutions for surgeons and health care providers. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain. Axogen’s comprehensive portfolio of products focuses on helping patients touch, run, feel, kiss, smile and hug—some of the many things healthy peripheral nerves allow us to do.

Beacon Therapeutics is an ophthalmic gene therapy company founded in 2023 to restore and improve the vision of patients with a range of prevalent and rare retinal diseases that result in blindness. The Company has an established scientific foundation that combines a late-stage development candidate to treat X-linked retinitis pigmentosa (XLRP), as well as two preclinical programs, one targeting dry age-related macular degeneration (AMD) and another in-licensed from the University of Oxford targeting cone-rod dystrophy (CRD), an inherited retinal disease. Lead development candidate AGTC-501, is a gene therapy program in Phase II clinical trials for the treatment of XLRP, an inherited monogenic recessive disorder that causes progressive vision loss in boys and young men. XLRP is predominantly caused by mutations in the retinitis pigmentosa GTPase regulator (RPGR) gene. AGTC-501 expresses the full length RPGR protein, thereby addressing the full complement of photoreceptor damage caused by XLRP, including both rod and cone loss. Beacon Therapeutics also has access to a target generation technology platform that will identify, screen, and search secreted proteins in the ophthalmology space. The Company is supported by funds from Syncona and additional investors including Oxford Science Enterprises.

BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioRetain processing method. BioRetain has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies' quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks ("AATB"). These systems and procedures are established per current Good Tissue Practices ("cGTP") and current Good Manufacturing Processes ("cGMP"). Our portfolio of quality brands includes VENDAJE, VENDAJE AC, and VENDAJE OPTIC. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida.

BioTissue is the leader in innovative applications of human birth tissues for regenerative wound healing, aiming to improve patient outcomes. The company is committed to promoting regenerative healing through its birth tissue products.

Optimize Product Recovery and Scalability - Since 2009, CARR Biosystems has been providing single-use separation systems to biopharma companies seeking low-shear separation, high-recovery performance, and fast processing time. Avoid the expense and waste of CIP/SIP stainless steel centrifuges and step up to the scalable, industry-leader. Our wide range of separation equipment accelerates the production of high-quality biological products and medicines, for seamless scaling up, down, or out.

Cognigenics develops innovative RNA-based gene therapies targeting memory loss, cognitive decline, anxiety associated with mild cognitive impairment and other neurocognitive and neuropsychiatric disorders. Our intranasal delivery platform targets neuronal receptors in the brain involved in CNS disorders including anxiety, and Mild Cognitive Impairment.

CTM is dedicated to developing surgical implants to help physicians treat post-operative biologic issues that are beyond their control.

We Focus on Identifying, Acquiring and Developing Disease-Modifying Therapeutic Drug Candidates with Rare Disease Indications

Cytonics is a research and development company dedicated to discovering and developing therapeutics based on the protease inhibitor Alpha2 Macroglobulin (A2M). Theyhave discovered a unique “bio-marker” that can assist physicians in improving patient outcomes by pinpointing the source of orthopedic pain. We are also developing a range of therapeutic products for the treatment of painful osteoarthritis, back, and joint pain.

Cytovia Therapeutics aims to accelerate patient access to transformational cell therapies and immunotherapies, addressing several of the most challenging unmet medical needs in cancer. Cytovia focuses on harnessing the innate immune system by developing complementary and disruptive Flex-NK™ bispecific antibody and iPSC-derived, TALEN® gene-edited NK-cell platforms. FLEX-NK™ bispecific antibodies are built on a quadrivalent multifunctional antibody platform designed to engage natural killer cells by targeting NKp46 using Cytovia's proprietary Flex-NK™ technology. The company is also developing three types of iPSC-derived NK (or iNK) cells: unedited iNK cells, TALEN® gene-edited iNK cells with improved function and persistence, and TALEN® gene-edited iNK cells with chimeric antigen receptors (CAR-iNKs) to improve tumor-specific targeting. ​ These two technology platforms are being used to develop treatment of patients with solid tumors such as hepatocellular carcinoma (HCC) and glioblastoma as well as hematological malignancies such as relapsed multiple myeloma. Clinical studies are expected to initiate in 2023.

Dyadic International, Inc. (Nasdaq: DYAI) - We are a global biotechnology company focused on further improving and leveraging the patented and proprietary C1 expression system to help bring biologic vaccines and drugs to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers to improve access and cost to patients and the healthcare system - but most importantly to save lives.

Emmune, Inc. is a start-up biotechnology company that has a novel approach for treating and preventing HIV infection. We engineered a synthetic antibody from the receptors that HIV uses to infect T cells, CD4 and CCR5. Because this synthetic antibody, known as “eCD4-Ig,” is built from the viral receptor and co-receptor, it recognizes 100% of HIV-1 isolates. A single intramuscular inoculation with an AAV vector expressing eCD4-Ig protected monkeys from multiple intravenous challenges with live virus.

Enalare Therapeutics Inc. is a clinical stage biopharmaceutical company dedicated to developing and commercializing novel therapies for patients suffering from life threatening acute respiratory and critical care conditions, including respiratory depression caused by drug overdose, post-surgery, and other conditions. The Company is planning to initiate pivotal studies for its lead compound ENA-001 in the near term.

EXUMA Biotech is a clinical-stage biotechnology company committed to bringing to market cell & gene therapies for the treatment of cancer. Founded in 2015, The company has rapidly built its core technologies and a growing global presence with operations in China (Shanghai and Shenzhen), Grand Cayman, and headquarters in West Palm Beach, FL.

Florida International University is a higher education institution that provides academic programs and conducts research.

Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has seven marketed prescription pharmaceutical products and over 20 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital and Sentynl.

Gift of Life Marrow Registry facilitates blood stem cell and marrow transplants for children and adults battling life-threatening diseases, including leukemia, lymphoma, sickle cell and other genetic disorders. Gift of Life is a leading national bone marrow and stem cell registry that serves patients all over the world seeking donors for transplants. It was founded during the grass roots efforts to save the life of New Jersey leukemia patient Jay Feinberg, and has grown to become a leading global registry. Gift of Life is accredited by the World Marrow Donor Association, and is an affiliate donor registry of the National Marrow Donor Program and participant in the international Bone Marrow Donors Worldwide registry. Gift of Life added an in-house apheresis center in 2019 and cellular therapy laboratory in 2020, ensuring its commitment to quality and consistency every step of the way.

HCW Biologics Inc., a preclinical stage biopharmaceutical company, focuses on discovering and developing novel immunotherapies for chronic, low-grade inflammation, and age-related diseases. The company’s lead product include HCW9218, which is an injectable immunotherapeutic for patients with pancreatic, ovarian, breast, prostate, and colorectal cancers, as well as pulmonary fibrosis; and HCW9302 for auto-immune diseases, such as alopecia areata and metabolic diseases. It also develops HCW9201, a cell-based therapy that is in Phase II clinical trials for the treatment of patients with relapsed/refractory acute myeloid leukemia; and HCW9206 for the treatment of acute myeloid leukemia. The company was incorporated in 2018 and is headquartered in Miramar, Florida.

ILiAD Biotechnologies is utilizing its B-Tech vector platform to develop next generation vaccines to eradicate infectious diseases and improve lives. Its lead candidate, BPZE1, which has completed Phase 2 clinical trials, is the most advanced next generation vaccine for the prevention of whooping cough, a serious illness caused by Bordetella pertussis.

ImmunSYS is a clinical stage biopharmaceutical company focused on the development of innovative cancer immunotherapy products to improve the lives of patients with late-stage metastatic prostate cancer and other metastatic solid tumor cancers. ImmunSYS is at the forefront of an entirely new approach to treating cancer. Our platform therapy has been shown to be effective in some metastatic cancers and may have wide applications as a cancer treatment for several solid tumor cancers, with the potential for cure in some patients. The company’s revolutionary therapy, YourVaccx™ utilizes a novel combination of controlled cell lysis and a triple-component immunotherapeutic drug. This new immunotherapy focused therapy is designed to empower the immune system to recognize and selectively attack cancer cells throughout the body. The company is initially developing the new cancer therapy for the treatment of metastatic prostate cancer, with a pipeline of additional development programs for other solid tumor cancers. Our proprietary therapy was conceived by the focal prostate cancer therapy pioneer and inventor of the male lumpectomy, Gary Onik, M.D. He is not only the inventor, but also a patient. Dr. Onik developed aggressive metastatic prostate cancer in 2018 and received his own therapy. He had a complete response and remains disease-free to date. ImmunSYS is committed to bringing life-changing treatments to cancer patients by bringing the tumor to the immune system to fight cancer in a new way. We believe our new YourVaccx™ therapy has the potential to offer cancer patients substantial benefits over the existing standard of care, including the potential for cure in some patients.

INmune Bio Inc. is a clinical stage immuno-oncology company focused on harnessing the patient’s immune system to treat cancer. INKmune, the company’s lead product, primes patient’s NK cells (natural killer cells) to kill cancer. INmune is targeting residual disease, the cancer cells that survive initial treatments that return to cause the cancer relapse. By controlling residual disease, patients may live longer. Using a novel mechanism of action and a precision medicine approach, INKmune therapy should enhance NK cells’ ability to eliminate residual disease. Media coverage provided for informational purposes only and third party links provided as a resource. INmune Bio does not control the content of third parties. XPro1595, Quellor, LIVNate, INB03, INKmune and other drug candidates, have not yet been shown to be safe or effective, and has not been approved by any regulatory body.

iTolerance is a privately held regenerative medicine company enabling tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging our proprietary technology platform, iTOL-100, we are advancing a pipeline of programs using both allogenic pancreatic islets and stem-cells that have the potential to cure diseases. Our lead program, iTOL-101 is being developed for Type 1 Diabetes and in a preclinical non-human primate study, pancreatic islet cells co-implanted with iTOL-101 exhibited long-term function with control of blood glucose levels and restoration of insulin secretion without the use of chronic immune suppression. Our follow-on candidate, iTOL-102 is leveraging significant advancements in stem cells, which allows a potentially inexhaustible supply of insulin-producing cells for use in Type 1 Diabetes. Additionally, the Company is developing iTOL-201 for liver failure and iTOL-301 as a potential regenerative protein and cell therapy that leverages stem cell sources to produce proteins or hormones in the body in conditions of high unmet need.

LifeSouth is a 501(c)(3) non-profit community blood supplier for more than 125 hospitals in Alabama, Florida and Georgia.

We are a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions. Our lead investigational product is Lomecel-B™, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions associated with aging. We are currently conducting Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS), which is the current exception to our focus on aging. Our mission is to advance Lomecel-B™ and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Our philosophy is that healthy aging can be improved through regenerative medicine approaches. Life expectancy has substantially increased over the past century as a result of medical and public health advancements. However, this increase in longevity has not been paralleled by the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging – a period known as healthspan. As we age, we experience a profound decline, in both number and function, in our own MSCs, a decrease in immune system function, decline in blood vessel functioning, chronic inflammation and other issues. Our clinical data suggest that Lomecel-B™ addresses these conditions through multiple mechanisms of action, or MOAs, that simultaneously target key aging-related processes.

Be at the heart of exceptional care. Team MHS Florida is an award-winning group of friends and colleagues at one of the largest not-for-profit health systems in the nation. We're 16,000 strong, advancing towards a brighter future together. We're passionate about the work we do, delivering deep, personalized care for patients and their families. That’s what we call the Memorial Experience. Memorial Healthcare System is proud to be an equal opportunity employer committed to workplace diversity. Memorial Healthcare System recruits, hires and promotes qualified candidates for employment opportunities without regard to race, color, age, religion, gender, gender identity or expression, sexual orientation, national origin, veteran status, disability, genetic information, or any factor prohibited by law. We are proud to offer Veteran’s Preference to former military, reservists and military spouses (including widows and widowers). You must indicate your status on your application to take advantage of this program. Employment is subject to post offer, pre-placement assessment, including drug testing.

NAYA Biosciences is building a group of companies leveraging the next generation of biotechnologies to increase patient access to life-transforming treatments in oncology, fertility, and regenerative medicine. Our unique capabilities in biology, cell and gene therapy, and artificial intelligence provide a synergistic platform for the accelerated clinical development and commercialization of these breakthrough treatments.

Neobiosis, LLC is a privately owned, clinical stage, biomedical contract development and manufacturing organization (CDMO) with two production facilities in downtown Gainesville and a Research & Development laboratory located within the Sid Martin UF Innovate biotechnology Institute in Alachua, FL. The focus of Neobiosis is the isolation of tissues, cells and extracellular vesicles (EVs), with medicinal potential, from donated perinatal (birth) tissues, including umbilical cord, umbilical cord blood and amniotic fluid. The name Neobiosis ("new life") is derived from a series of experiments called Parabiosis ("living together") where it was discovered that tissues, cells and EVs from a young donor could be used to promote the healing of older individuals. Neobiosis produces innovative products from healthy, full-term births, for client organizations who wish to take biomedical products though FDA-approved clinical trials for commercialization in a global market. Neobiosis is also committed to advancing an in-house pipeline of intellectual property and biologicals for use in anti-aging and regenerative medicine.

Oncogenuity is a biopharmaceutical company committed to developing and commercializing new treatments for genetically driven diseases. Our lead asset targets the KRAS mutation G12D, which plays a significant role in pancreatic and colorectal cancers, as well as other “untreatable” cancers of considerable unmet need. Our core technology focuses on the delivery of PNA’s (peptide nucleic acids). The PNA acts as a targeting sequence for gene-silencing. These targeting sequences are interchangeable, and we plan to aggressively pursue both oncology and non-oncology genetic mutations where gene silencing can be effective. We are a partner of Fortress Biotech, and we have an exclusive licensing agreement with Columbia University to develop oligomers (ONCOlogues) that attack genetically driven diseases at the DNA level.

OPKO Health, Inc., a healthcare company, engages in the diagnostics and pharmaceuticals businesses in the United States, Ireland, Chile, Spain, Israel, Mexico, and internationally. The company's Diagnostics segment operates BioReference Laboratories, a clinical laboratory that offers laboratory testing services. The Bio-Reference Laboratories also provides core genetic testing and leverage products, such as the 4Kscore prostate cancer test. The company's Pharmaceutical segment offers Rayaldee for treatment for secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease, and vitamin D insufficiency; OPK88004, a selective androgen receptor modulator; and OPK88003, a once or twice weekly oxyntomodulin that is in Phase IIb trials for type 2 diabetes and obesity. It is also developing hGH-CTP, a once-weekly human growth hormone injection that completed Phase III clinical trial in partnership with Pfizer, Inc.; VARUBI for chemotherapy-induced nausea and vomiting; and Factor VIIa drug for hemophilia. In addition, this segment develops and produces specialty active pharmaceutical ingredients; and discovers drugs for the treatment of cancer, heart disease, metabolic disorders, and a range of genetic anomalies. Further, it develops, manufactures, markets, and sells pharmaceutical, nutraceutical, and veterinary products; commercializes food supplements and over the counter products; manufactures and sells products primarily in the generics market; and imports, markets, distributes, and sells pharmaceutical products in a range of indications, including cardiovascular products, vaccines, antibiotics, gastro-intestinal products, hormones, and others. Additionally, the company operates pharmaceutical platforms in Ireland, Chile, Spain, and Mexico. OPKO Health, Inc. was incorporated in 1991 and is headquartered in Miami, Florida.

Oragenics, Inc. is a development-stage company dedicated to fighting infectious diseases, including those caused by coronaviruses and multidrug-resistant organisms. Its lead product is NT-CoV2-1, an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the NIH and the NRC with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. Its lantibiotics program features a novel class of antibiotics against bacteria that have developed resistance to commercial antibiotics.

OrganaBio was founded in 2018 with the mission to become the hub for tissue sourcing, clinical sample processing and contract manufacturing services to support cell and gene therapy developers around the globe. At our core, we continually apply a data-driven approach with meaningful insights across our strategically located facilities to provide solutions to our clients where they need it most. Headquartered in Miami, Florida, OrganaBio delivers products and services that span the full development lifecycle – from proprietary tissue supply chains and cellular starting materials to expert development, testing, and other support services that expedite the path to clinical translation.

Pasithea Therapeutics is a biotechnology company primarily focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders. We leverage our expertise in the fields of neuroscience, medicinal chemistry, and translational medicine to develop new molecular entities that target the pathophysiology underlying such diseases with the goal of bringing life-changing therapies to patients.

Ponce Therapeutics is developing a state-of-the-art biotechnology platform to restore the youthful balance of aged or “senescent” and young cells in your skin, targeting the senescent cells for elimination. This provides a “reboot” of your genetic program to turn the clock on your skin back to its youthful exuberance.

Regenative Labs strives to process the highest quality human tissue allografts available in accordance with FDA and AATB requirements. Regenerative Medicine is a discipline that uses nature’s chemistry and biology to help the body repair itself.

Resolve Therapeutics is a biotechnology company developing an exciting new biologic compound for the treatment of lupus that inhibits a key upstream step in the interferon cascade. The company is based on technology and compounds exclusively licensed from the University of Washington. The company will develop these compounds through early clinical testing and partner with a pharmaceutical company for late stage clinical development and commercialization.

Ridgeback Biotherapeutics is a biotechnology company focused on developing treatments and diagnostics for underserved patient populations primarily in pediatric orphan and emerging infectious diseases. The team at Ridgeback is dedicated to working toward finding life-saving and life changing solutions for patients and diseases that need champions. Headquartered in Miami, Florida, Ridgeback Biotherapeutics is a privately held, majority woman-owned biotechnology company; all funding for Ridgeback Biotherapeutics has originated from Wayne and Wendy Holman; two science driven individuals who invest in technologies that they believe will make the world a better place.

San Rocco Therapeutics is a biotechnology company with its primary focus on curative gene therapies for Sickle Cell Disease and Thalassemia

Singh Biotechnology (SBT) is a biotechnology organization that is in the business of discovering and developing unique and propriety therapeutic agents for the treatment of a variety of diseases (cancers, autoimmune, and ophthalmologic diseases) by leveraging our novel technology platform. At Singh Biotechnology we use our novel proprietary disruptive technology single domain antibody (sdAb) platform to create miniature antibodies that comprise solely of the variable region and therefore the sdAb is devoid of light chains. Using our proprietary technology we have engineered our sdAbs to be specific & bi-specific, with the ability to cross the cell membrane as well as the blood brain barrier (BBB) to specifically & selectively target intracellular proteins which play an important role in the pathogenesis of a variety of diseases. The United States Food and Drug Administration (FDA) granted orphan drug designation to Singh Biotechnology for its novel anti-STAT3 B VHH13 single domain antibody (sdAb) SBT-100: -For the treatment of pancreatic cancer on August 29th, 2016. -For the treatment of osteosarcoma on September 27th, 2017.

Stuart Therapeutics (Stuart) is a clinical stage biopharmaceutical company focused on the development of a unique tissue reparative platform for eye diseases called PolyColTM (PolyCol). PolyCol is a family of synthesized polypeptide sequences that are specifically designed to repair damaged extracellular matrix (ECM) helical collagen. Helical collagen structures play an important role in healthy tissues and they are damaged in chronic and acute/traumatic disease processes and injuries. Stuart was founded in 2018 to champion a new approach to the treatment of chronic diseases. Each of our founders has been affected directly or indirectly by chronic eye disease, and we have a passion for the pursuit of new and effective solutions for these indications. Stuart’s areas of interest are Dry Eye Disease, Glaucoma, and Dry Age-Related Macular Degeneration.

We are a team of dedicated professionals with expertise in delivering medicines to the body through the inhaled route. The Leadership Team combined has over 100 years of experience in developing inhaled medicines and bringing these medicines to the U.S. and European markets. Our purpose at Transpire Bio is framed by two core elements: Access and Innovation. For common diseases where adequate therapies exist, we seek to expand access to these complex inhaled medicines globally by developing and commercializing lower-cost generic alternatives. For diseases with few treatment options, we seek to innovate by harnessing existing known mechanisms of action, and dramatically improve the risk-benefit profile of selected molecules by developing these as inhaled therapeutics. Our understanding of the complexities of inhaled drug-device products will allow us to advance these therapies and improve the health of people around the globe.

Tregeutix (pronounced ti·rəˈgyoo·tiks or trəˈgyoo·tiks) is advancing unique, first-in-kind antigen-specific immunotherapeutic approaches by addressing how microbiota derived antigen cross-reactivity maintains full and complete repertoire of Foxp3+ regulatory T cells (Tregs) essential for health. Touted as a 'holy grail'​ for curing diseases such as allergy, autoimmunity and tumors since their 2001 discovery, thymus-derived Foxp3+ Tregs have yet to yield predictable therapeutic benefits in human trials. Much of this translational gap stems from a fundamental failure to recognize that Tregs rely on commensal microbiota derived antigen cross-reactivity to simultaneously coordinate both antigen-specific tolerance and effective immune response. At Tregeutix we are developing a novel discovery framework dubbed SPIRAL that predicts each and every Treg, regardless of its perceived antigen specificity, is maintained by microbiota derived cross-reactive antigens. Healthy microbiota is necessary for a healthy immune system. However, prevailing efforts to harness its therapeutic potential to treat inflammatory disorders are largely based on empirical correlations that lack predictability. In contrast, the novel discovery framework developed by Tregeutix, which relies on antigenic similarity (cross-reactivity), is uniquely positioned to identify specific microbiota necessary for individualized antigen-specific immunotherapy. By simplifying and removing unpredictability from antigen-specific immunotherapies, SPIRAL allows systematic and non-random discovery of novel class of Treg-based disease-modifying immunotherapeutics that we refer to as tregeutics, specific members of microbiota that maintain antigen-specific Tregs involved in protection against allergies and autoimmune diseases as well as in determining effectiveness of vaccines to natural infections and tumors.

U.S. Stem Cell, Inc. is a leader in regenerative medicine and is committed to providing autologous cell therapies for the treatment of degenerative conditions. The company specializes in the development of proprietary, physician-based stem cell therapies; novel regenerative solutions, including its lead product AdipoCell™; physician training and certification; veterinary applications; stem cell banking; as well as creating and managing new stem cell clinics. In the past 20 years, to the company’s knowledge, U.S. Stem Cell, Inc. has completed more clinical treatments than any other regenerative care provider in the world. With more than 700 physicians trained and certified with the company, U.S. Stem Cell, Inc. boasts the largest network of physicians working together to continue its mission of harnessing the body’s own ability to heal from within to treat a wide variety of conditions and to improve quality of life.

U.S. Stem Cell, Inc. is a leader in regenerative medicine and is committed to providing autologous cell therapies for the treatment of degenerative conditions. The company specializes in the development of proprietary, physician-based stem cell therapies; novel regenerative solutions, including its lead product AdipoCell™; physician training and certification; veterinary applications; stem cell banking; as well as creating and managing new stem cell clinics. In the past 20 years, to the company’s knowledge, U.S. Stem Cell, Inc. has completed more clinical treatments than any other regenerative care provider in the world. With more than 700 physicians trained and certified with the company, U.S. Stem Cell, Inc. boasts the largest network of physicians working together to continue its mission of harnessing the body’s own ability to heal from within to treat a wide variety of conditions and to improve quality of life.

We are the regenerative medicine company that develops and delivers innovative allograft solutions designed to support the body’s healing and regenerative potential, ultimately improving patient outcomes and quality of life. The underpinnings of our regenerative medicine solutions technology date back 50 years to the founding of The University of Miami Tissue Bank in 1970. We experienced multiple firsts in clinical and scientific achievement leading up to 2014, when VIVEX acquired the University of Miami Tissue Bank. This acquisition streamlined our strategic plan to focus on new regenerative medicine solutions, research and development, expansion of manufacturing capabilities, and sales and marketing efforts.

Based in South Florida, ZEO ScientifiX™ is a publicly traded biotechnology company committed to the research, development and manufacture of new biologic medicine, with a focus on current and potential regenerative therapeutics. ZEO ScientifiX™ is the leading, fully integrated Biologic Medicine Company. Our mission is to transform regenerative medicine through the development of novel nano-technologies and to become the health care incubator for the next generation of biologic medicines.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging two licensed proprietary product platforms to develop pharmaceutical products that address unmet medical needs in the areas of renal and inflammatory diseases. Lead renal candidate, Phase 2a-ready VAR 200, mediates removal of excess intracellular lipids in the kidney’s filtration system that contribute to kidney damage leading to end-stage kidney disease. Lead anti-inflammatory drug candidate, inflammasome ASC inhibitor (IC 100), blocks initiation and perpetuation of damaging inflammation that’s pathogenic in a multitude of inflammatory diseases.