Jonathan Elsner, Phd, Mba Email & Phone Number

Frederick, Md, Us

Burlington, Massachusetts, Us

• In my role as Vice President of Clinical Affairs, I established and managed the U.S. office, overseeing all operational activities. I• directed clinical and marketing initiatives surrounding the company’s pivotal IDE multi-center trial for a device utilized in oncological robotic surgery. • Recruited KOLs and activated 15 of the top U.S. hospitals within less than two years from IDE approval.• Despite industry-wide challenges posed by COVID-19 and stringent eligibility criteria, I successfully recruited Key Opinion Leaders and activated 15 top U.S. hospitals within a year post-IDE approval.• My strategic marketing initiatives resulted in a significant increase in patient enrollment, achieving a fourfold increase year-over-year. • Led a diverse team, managed budgeting and contract negotiations, and maintained client relationships.

• Spearheaded a multinational clinical team overseeing the company’s pivotal IDE multi-center trial for the revolutionary cartilage regeneration device, GelrinC®, across 24 sites spanning the U.S., Europe, and Israel.• I orchestrated day-to-day clinical operations, managing vendors including Contract Research Organizations (CROs), labs, and Electronic Data Capture (EDC) systems, ensuring impeccable subject retention and data acquisition.• Through the implementation of an innovative marketing strategy, I achieved a remarkable threefold increase in patient enrollment year-over-year • Led strategic communication with CMS, resulting in a crucial coverage decision for the GelrinC® clinical trial. • Oversaw the development of essential study documents, including protocols, amendments, Investigator’s Brochures (IB), Data Management Plans (DMP), Statistical Analysis Plans (SAP), Informed Consent Forms (ICF), and Case Report Forms (CRFs), while managing supply logistics for surgical procedures.• Guided the development of Standard Operating Procedures (SOPs), and ensured compliance with regulatory standards and quality controls, including oversight of Data Safety Monitoring Board (DSMB) committee meetings and FDA reporting requirements. • Fostered collaborative relationships with Global Key Opinion Leaders through activities such as Medical Advisory Boards.• Prepared and monitored the annual department budget. • Analyzed data and interpreted findings for effective presentation to a variety of audiences, e.g. the Board of Directors, scientific meetings, external regulatory agencies, and partners.

Memphis, Usca, Us

• Throughout my tenure, I pioneered groundbreaking advancements in healthcare technology, notably inventing the NUsurface® Meniscus Implant—a revolutionary solution addressing the primary cause of knee osteoarthritis and pain by restoring meniscal biomechanical function. Achieving CE approval in Europe in 2008 and FDA breakthrough device designation in 2019 underscored its significance.• At the helm of the NUsurface Implant's pivotal trials in the U.S., I orchestrated the technological sections of the PMA application, securing IDE and De-Novo FDA trial approvals. Steering IDE multi-center clinical trials, I oversaw all facets, from KOL identification to site selection, IRB approval, and contract negotiations, establishing 22 study sites and ensuring the successful completion with 243 subjects.• Implementing lean management practices, I optimized trial processes, ensuring predictable patient enrollment and surpassing targets with a 4x increase through innovative marketing strategies recognized by the PR Society of America with a Prism Award.• My leadership extended beyond clinical trials, encompassing comprehensive research and development projects in biomaterials, biomechanics, computational modeling, and animal studies, resulting in prolific scholarly contributions, patents, and conference presentations. I fostered strategic collaborations with esteemed institutions like the Cleveland Clinic and Duke University, advancing technological alliances and supporting market access plans through clinical outcomes and health economics projects.• Guiding the transition from R&D to commercialization, I oversaw the launch of the NUsurface® System in the European market, directing programs for surgical instruments, user training, and accompanying materials. Additionally, I developed robust risk management plans in collaboration with regulatory and R&D teams, ensuring the product's safety and efficacy throughout its lifecycle.

Tel Aviv, Il

Master Of Business Administration (Mba), Entrepreneurship/Entrepreneurial Studies

Phd, Biomedical Engineering

B.Sc., Biomedical Engineering