Stacy Arnold

Stacy Arnold

Greater Tampa Bay Area
27K followers 500+ connections

About

With nearly 20 years of experience in the biotech industry, I am a seasoned executive and…

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Experience

  • axogen Graphic
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    Macon, Georgia Area

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    Tampa, Florida, United States

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    Tampa, Florida, United States

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    Gainesville, Florida Area

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    Greater Atlanta Area

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    Greater Atlanta Area

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    Greater Atlanta Area

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    Greater Atlanta Area

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    Savannah, Georgia Area

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    Cocoa Beach, Florida, United States

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    Macon, Georgia Area

Education

Licenses & Certifications

Volunteer Experience

Publications

  • Optimizing tissue cryopreservation techniques for cryopreservation solution modifications

    CryoBiology

    The purpose of this study was to observe how minor changes to cryopreservation solutions affect the success of cryopreservation controlled-rate freeze cycles.

    Other authors
    See publication
  • Functional Performance and Biomechanics of Decellularized Human Aortic Valves

    QScience

    Allograft decellularization based on detergents and/or enzymes to reduce antigenicity has been reported to damage tissue structure.

    Other authors
    See publication
  • CryoValve® SG Human Aortic Valve: The Next Generation Allograft Heart Valve

    AATB American Association of Tissue Banks

    A combination of in vitro bench data, in vivo animal data and human clinical data demonstrate the benefits of SynerGraft technology when applied to allograft aortic heart valves. SynerGraft technology was developed to decellularize allograft tissue without negatively impacting the structural integrity of the tissue. The CryoValve SG Human Aortic Valve (CryoValve SGAV) has received a Humanitarian Use Device designation from the US FDA. Review for a Humanitarian Device Exemption by FDA is…

    A combination of in vitro bench data, in vivo animal data and human clinical data demonstrate the benefits of SynerGraft technology when applied to allograft aortic heart valves. SynerGraft technology was developed to decellularize allograft tissue without negatively impacting the structural integrity of the tissue. The CryoValve SG Human Aortic Valve (CryoValve SGAV) has received a Humanitarian Use Device designation from the US FDA. Review for a Humanitarian Device Exemption by FDA is pending

    Other authors
    See publication
  • Long-Term Cryogenic Storage Impact on Heart Valve Performance

    AATB American Association of Tissue Banks

    Cryogenic preservation is the recommended technique for long-term storage of allograft heart valves. Analyses of the probability of tissue degradation during cryopreservation and predictions of long-term tissue stability using theoretical models have shown that ultra-low temperatures in cryogenic storage cause the movement of the molecular tissue constituents to be arrested and cease deleterious chemical reactions. A theoretical examination of worst case phenomenon such as water partitioning…

    Cryogenic preservation is the recommended technique for long-term storage of allograft heart valves. Analyses of the probability of tissue degradation during cryopreservation and predictions of long-term tissue stability using theoretical models have shown that ultra-low temperatures in cryogenic storage cause the movement of the molecular tissue constituents to be arrested and cease deleterious chemical reactions. A theoretical examination of worst case phenomenon such as water partitioning and temperature excursions show that below -165oC, valves remain sufficiently far below their glass transition temperature preventing any storage degradation (Karlsson, 2009). The present study evaluates and compares the performance of human heart valves held in long-term liquid nitrogen storage (liquid phase) to valves stored less than one year. This study provided experimental data that long-term cryogenic storage does not impact heart valve performance and durability confirming the aforementioned theoretical models.

    Other authors
    See publication

Patents

  • Vascular Access System With a Reinforcement Member

    Filed US 15/035,626

    A system for providing a continuous flow of blood between two locations in a cardiovascular system of a patient is provided. The system includes a blood conduit having a proximal portion configured to be attached to an artery. The system also includes a distal portion configured to be inserted into a blood vessel at an insertion site and to be advanced there through to a location spaced apart from the insertion site. Moreover, the system includes a reinforcement member positioned at least…

    A system for providing a continuous flow of blood between two locations in a cardiovascular system of a patient is provided. The system includes a blood conduit having a proximal portion configured to be attached to an artery. The system also includes a distal portion configured to be inserted into a blood vessel at an insertion site and to be advanced there through to a location spaced apart from the insertion site. Moreover, the system includes a reinforcement member positioned at least partially about the blood conduit in at least one of the distal portion, the proximal portion, or a combination thereof.

    See patent
  • Tissue implants for implantation and methods for preparing the same

    Issued US 8,475,827

    Other inventors
  • Vascular Access System With Connector

    Filed US 20150025437

    Other inventors
    See patent

Projects

  • Tampa Headquarters Construction Project

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    Executive Sponsor for this multi-million dollar construction initiative to build Axogen's Tampa Headquarters.

    See project
  • JOTEC Integration

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    Leading the global integration of JOTEC into CryoLife, Inc including systems, processing, and cross-functional structure.

    Included in this effort is collaborating with and overseeing executive leadership in the execution of integration-related tasks to ensure on time completion of critical integration milestones.

  • JOTEC Due Diligence & Acquisition

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    CryoLife, Inc. ("CryoLife"; NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has entered into a definitive agreement to acquire JOTEC AG ("JOTEC"). JOTEC is a German-based, privately-held developer of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair. The combination of CryoLife and JOTEC will create a Company with a broad and highly…

    CryoLife, Inc. ("CryoLife"; NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has entered into a definitive agreement to acquire JOTEC AG ("JOTEC"). JOTEC is a German-based, privately-held developer of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair. The combination of CryoLife and JOTEC will create a Company with a broad and highly competitive product portfolio focused on aortic surgery, and will position CryoLife to compete strongly in the important and growing endovascular surgical markets.

    My role in this effort was leading the CryoLife executive team in the planning, execution, and completion of due diligence for the $250+ million acquisition of JOTEC. The result was the successful completion of the due diligence and the signing of a definitive agreement.

  • Mergers & Acquisitions - PhotoFix

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    In 2016, CryoLife acquired the PhotoFix asset from GBI. My role was leading corporate due diligence for the purchase, leading integration of the asset into the CryoLife systems, and leading the manufacturing transfer from GBI (Denver, Colorado) to CryoLife (Kennesaw, GA).

    • Establish project governance in accordance with CryoLife NPD procedures
    • Manage and track the project team with resource and delivery plans
    • Track and control project costs in accordance with the agreed…

    In 2016, CryoLife acquired the PhotoFix asset from GBI. My role was leading corporate due diligence for the purchase, leading integration of the asset into the CryoLife systems, and leading the manufacturing transfer from GBI (Denver, Colorado) to CryoLife (Kennesaw, GA).

    • Establish project governance in accordance with CryoLife NPD procedures
    • Manage and track the project team with resource and delivery plans
    • Track and control project costs in accordance with the agreed budget
    • Track and control project timeline in accordance with agreed timeline
    • Ensure on-going risks and issues are recognised, resolved and communicated
    • Management and motivation of internal project team and 3rd party stakeholder contracted to the project to ensure a professional and successful delivery
    • Responsible for risk planning and issue identification working with the Project Sponsors, Stakeholders, and Business Leaders
    • Manage the SharePoint site for the project/work stream.

  • New Product Development - NeoPatch DFU

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    Project description:

    In 2015, R&D completed concept and feasibility of a new product development technology, NeoPatch DFU (human chorioamniotic membrane). My role as project lead was to manage new product development design transfer processes according to FDA design controls. In April 2016, the final stage of Design Control (Design Transfer) was completed and this product launched into commercial production to support the now completed 50 patient clinical trial.

    • Establish…

    Project description:

    In 2015, R&D completed concept and feasibility of a new product development technology, NeoPatch DFU (human chorioamniotic membrane). My role as project lead was to manage new product development design transfer processes according to FDA design controls. In April 2016, the final stage of Design Control (Design Transfer) was completed and this product launched into commercial production to support the now completed 50 patient clinical trial.

    • Establish project governance in accordance with FDA Design Control and CryoLife procedures
    • Manage and track the project team with resource and delivery plans
    • Track and control project costs in accordance with the agreed budget
    • Track and control project timeline in accordance with the agreed timeline
    • Responsible for issue identification working with the Project Sponsors, Stakeholders, Business Leaders, and project team

Honors & Awards

  • Top 40 Under 40 Award

    Tampa Bay Business Journal

    These 40 business people have achieved success in their industries and demonstrate a commitment to bettering Tampa Bay.

Languages

  • German

    Limited working proficiency

  • French

    Limited working proficiency

  • Dutch

    Elementary proficiency

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