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Avobis Bio was founded to advance the development of implantable cell therapies to treat debilitating conditions without a cure. By combining the world class capabilities of the Mayo Clinic and W. L. Gore & Associates, bringing breakthrough solutions to patients, physicians and health care systems around the world is closer than ever. In a tribute to the patients we serve and the power of their own mesenchymal stem cells, Avobis Bio draws its name from the Latin a vobis, meaning “from you” or “by you”. Avobis Bio will explore the use of these mesenchymal stem cells combined with enabling bioabsorbable scaffolds with the goal of enhancing the effectiveness of the cells in stimulating the body to heal. Avobis Bio was formed as a joint venture between Mayo Clinic and W. L. Gore & Associates. Mayo Clinic brings a depth of clinical experience and infrastructure to the team, as well as scientific research and development related to cell therapy. This complements Gore’s experience applying material science expertise in developing and commercializing products in the biopharmaceutical and medical device industries. Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body.

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Avobis Bio draws its name from the Latin a vobis, meaning “from you” or “by you.”

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Copyright © 2020 Avobis Bio, LLC. All rights reserved. Mayo and Mayo Clinic are trademarks of Mayo Foundation for Medical Education and Research. GORE and designs are trademarks of W. L. Gore & Associates. © 2020 W. L. Gore & Associates, Inc.

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Avobis Bio’s advanced investigational therapies are based on the unique synergistic combination of living cells and bioabsorbable materials. By leveraging biological and physical cues, we intend to develop a therapeutic effect capable of overcoming some of the most challenging conditions. Mesenchymal stem cells are multi-potent stem cells that have capacity to differentiate into a limited number of cell types under specific conditions in the laboratory. Recently, mesenchymal stem cells have demonstrated an ability to regulate the immune system in a multi stage process. The potentially broad impact mesenchymal stem cells can have on local tissues has led to their investigation in numerous medical conditions. IMPACT (IMmune Progenitor And Cell Therapeutics) is the cGMP development, translational, and manufacturing cGMP facility at Mayo Clinic Rochester and has been working to develop cells as drugs for 20 years. Members and collaborators of IMPACT at Mayo Clinic have published significant contributions in the understanding and potential therapeutic use of mesenchymal stem cells. The lab has completed and published results from several early clinical trials investigating the safety, feasibility and potential efficacy of mesenchymal stem cells in a variety of pathologies. IMPACT’s commitment to exceptional quality standards is reflected in their accreditation by AABB and the Foundation for the Accreditation of Cellular Therapy (FACT). Bioabsorbable materials provide a temporary structure for cell adherence and localization in the tissue then safely and predictably degrade in the body. Gore’s bioabsorbable web technology is a uniquely designed web of biocompatible synthetic polymers that is gradually absorbed by the body. Its 3D matrix of open, highly interconnected pores facilitates cell infiltration and tissue generation, leaving no permanent material behind. Gore bioabsorbable technology is proven and trusted. It is backed by more than 20 years of research and clinical use, with a record of reliability in numerous parts of the body. Avobis Bio is investigating how Gore’s bioabsorbable web technology in combination with investigational mesenchymal stem cells may be developed into new treatment options for patients.

Mesenchymal stem cells (blue nuclei) adherent to bioabsorbable web fibers (red).

Porous web of bioabsorbable fibers.

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1. Naji A, Eitoku M, Favier B, Deschaseaux F, Rouas-Freiss N, Suganuma N. Biological functions of mesenchymal stem cells and clinical implications. Cell Mol Life Sci. 2019 Sep;76(17):3323-3348.

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Information regarding the current U.S. clinical trial can be found here.

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The initial focus of Avobis Bio is on developing an investigational regenerative approach to treat perianal fistulas, a debilitating condition that afflicts patients with Crohn's disease. Perianal fistulas are painful tunneling wounds connecting the rectum or anus to the skin. Few healing options exist, and patients endure multiple surgeries and ongoing risk of life-threatening complications. The investigational treatment involves harvesting and processing a patient's own mesenchymal stem cells, which are populated on a bioabsorbable polymer scaffold and surgically implanted in the fistula. Interim results of a Phase I trial were published in the journal Gastroenterology and we plan to explore this therapy in additional research to determine if these promising results can be replicated. Dietz AB, Dozois EJ, Fletcher JG, et al. Autologous mesenchymal stem cells, applied in a bioabsorbable matrix, for treatment of perianal fistulas in patients with crohn's disease. Gastroenterology 2017;153(1):59-62.e2.

1. Lightner AL, Faubion WA, Fletcher JG. Interdisciplinary management of perianal crohn's disease. Gastroenterol Clin North Am 2017; Sep:46(3):547-562.

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Avobis Bio was founded to develop implantable cell therapies to treat debilitating conditions without a cure and is currently conducting a clinical trial to assess the safety and efficacy of an investigational cell therapy for perianal fistulas. In some circumstances, patients with serious or life-threatening diseases or conditions who do not have access to clinical trials may seek special access to investigational therapies outside of a clinical trial setting. These situations are often referred to as early access, expanded access, or compassionate use. We share the urgency of patients seeking new treatments, and we understand some patients may be interested in accessing investigational therapies before approval by the Food & Drug Administration (“FDA”) when such patients do not have access to, or are not eligible for, clinical trials. Making Avobis Bio’s investigational therapy available through early access, expanded access, or compassionate use (an “Expanded Access Program”) is a complex matter that we have carefully considered. For detailed information regarding any Avobis Bio Expanded Access Programs that may be currently available (and corresponding instructions on submitting any requests) please refer to the Reagan-Udall Foundation’s website and find “Avobis Bio” in the company directory (https://navigator.reaganudall.org/company-directory).

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Effective Date: [6/1/2020] Thank you for using this website, which is owned by Avobis Bio (“Avobis,” “we,” “us,” or “our”). This privacy policy (this “Policy”) applies only to information collected through our website (our “Site”). Please take a few minutes to review this Policy. Some of the information we collect through the Site may be “Personal Information” - information that identifies you personally, alone or in combination with other information available to us. Other information may be non-personally identifiable, such as information collected by IP addresses. Your Consent This Policy is part of the Terms of Use that governs your use of the Site. A link to our Terms of Use is provided at the bottom of each page of the Site. This Policy is Part of Our Terms of Use This Policy is part of the Terms of Use that govern your use of the Site. Types of Personal Information We Collect Information You Manually Provide. Avobis collects the Personal Information you manually provide when you use our Site. For example, we collect information when you create an account, sign up for email updates, ask us a question, create a post, or otherwise interact with our Site. Some of the information you manually provide may be Personal Information. We may also collect any Personal Information you submit on or through our Site when you provide feedback, comment on an article or picture, or contact us with questions. Information Sent to Us by Your Web Browser. We collect information that is sent to us automatically by your web browser. This information typically includes your IP address, the identity of your Internet service provider, the name and version of your operating system, the name and version of your browser, the date and time of your visit, and the pages you visit. Please check your browser if you want to learn what information your browser sends or how to change your settings. 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