Inquis is a medical device incubator in search of good ideas. The company is backed by several venture capital investors.

• Developed & Commercialized ClariFix Cryoablation Device for the treatment of Chronic Rhinitis• Co-authored FDA 510(k) & CE Mark technical files that led to clearance and approval of a Class II/IIa device• Interfaced with outside counsel to create intellectual property, establish FTO, and manage patent portfolio • Interfaced with KOLs and scientific advisory board to develop the ClariFix procedure• Proctored US clinical trial cases & trained initial commercial users • Oversaw creation & establishment of FDA 21 CFR compliant and ISO13485 certified quality system• Interfaced with FDA and Notified Bodies during submission reviews & audits• Setup in-house cleanroom (CER) production facility & oversaw initial manufacturing • Co-developed company budget, product pipeline, and clinical & regulatory strategy with executive team • Directed cross-functional team including consultants and internal employees to achieve company milestones• Assisted in fundraising and strategic diligence

• Built company budget, product pipeline, and regulatory & clinical strategy with executive team • Developed Intellectual Property Portfolio with General Counsel and design team • Led the creation, development & manufacturing activities for the CE marked & FDA cleared Vent-Os Sinus Dilation System on a $6MM budget• Directed cross-functional team including consultants and internal employees to achieve company milestones• Proctored OUS & US clinical trial cases• Led of all future product development activities, budget, & timeline• Setup company quality system using outside consultant to comply with ISO13485 & FDA QSR requirements• Setup & oversaw manufacturing via contract manufacturing• Assisted in regulatory submissions, FDA and Notified Bodies interactions• Assisted in fund raising activities

• Led delivery system development of the CE marked Nellix AAA device• Proctored OUS clinical trial cases• Reviewed patient CTs & consulted with physicians to identify patients & treatment plans• Assisted in creation and execution of biocompatibility & animal study testing • Optimized balloon expandable catheter-based delivery system to ensure balloon performance and safe implant delivery for endovascular aneurysm repair• Created, Executed and Oversaw design verification testing for IDE filing and OUS Clinical Trials• Revised test methods to comply with ISO standards and to achieve required confidence and reliability• Managed integration of Nellix design into Endologix quality system• Authored design verification & validation protocols

• Developed a Phase 3 electronic device for sublingual delivery of an opioid for acute pain management• Led the design and development of the electro-mechanical locking system for diversion prevention• Supported EE group in board layout of Phase 3 device by providing mechanical constraints drawings and manufacturability requirements• Optimized mechanical drivetrain to ensure accurate delivery of medication• Designed components of device for moldability• Generated device user needs/requirements from 3rd party interviews with healthcare personnel • Managed all device logistics between contract manufacturer and clinical sites for Phase 2 clinical trial • Designed and developed dip molded cap for device protection and sanitation• Created and executed design verification testing for Phase 2 clinical trial

• Led development of an intramyocardial (IM) steerable needle delivery system for the treatment of heart failure using stem cells • Designed a one-piece needle that had ability to extend and retract to reduce amount of injectate lost during procedure• Developed a self-expanding delivery system to treat atherosclerosis in the coronary arteries• Led development & implementation of laser equipment and processes for cutting, welding, and marking of polymers and metals (CoCr, NiTi, Mg) throughout Guidant’s US & OUS facilities• Responsible for early stage laser processing feasibility work across all divisions of Guidant

• Developed and validated the balloons for FDA cleared AGILTRAC .035 peripheral dilation catheter (Balloon family – Diameter: 4-14mm & Length: 20-100mm)• Trained and supervised 10 operators for product transfer to manufacturing