Jim Kasic

There is an immediate and growing need for a device to inject therapeutic agents in very small volumes directly into the heart and other organs under endoscopic guidance. High-value, low volume injectates derived from processed autologous stem cells, microRNA, hydrogel compounds and exosomes all present exciting potential. They typically need to be administered into an organ in a pattern of injections of around 100 microliters each over a pre-determined time, such as 5 seconds for each injection, and injected into the organ at a specific needle penetration depth (e.g., 3-5 mm). Micro-injection Systems has invented and applied for patent protection for a novel device to address this important need – initially supplying devices to researchers, followed by clinical trials and widespread application in human use.

Boulder iQ and Boulder Sterilization offers a true One Stop Shop for medical device companies including all four pillars needed for success: Regulatory Affairs, Design & Development, Manufacturing AND Sterilization, all under one roof. I founded this company to satisfy all these needs that I’ve experienced in my 30+ year career in medical devices, from large companies to multiple startups. Please let Boulder iQ and Boulder Sterilization support your success. www.boulderiq.com. • Regulatory Affairs: A great team of specialists for regulatory strategy, quality management systems, FDA regulatory meetings (Q-Subs) and applications for class I, II or III products (e.g., 510(k)), full authorship & follow-up of submissions, remediation of MDRs, 483s, warning letters, full EU regulatory coordination, audits and training. • Design and Development: Concept, human factors/usability engineering, FDA QSR & EU Design Control compliant product engineering & development, Verification and Validation and ongoing sustaining engineering. • Manufacturing of Class I, II and III products including mechanical and electromechanical devices, disposables and implantables in our ISO class 7 clean room • Sterilization including fast turnaround small batch sterilization use Ethylene Oxide and larger batch sterilization using Chlorine Dioxide

Mr. Kasic preforms makes Angel Investments, Raises Capital and does Medical Device Consulting as well as Design, Development, Marketing and Sales of innovative Class I, II and III medical devices. Through Boulder BioMed Mr. Kasic served and CEO of Sophono, Inc- sold to Medtronic and US President OrthoWin, Inc - sold to BioMed Currently through Boulder BioMed, Jim serves as CEO of Boulder IQ and Boulder Sterilization where he is the founder and owner. He also serves as CEO of EndoShape, Inc. Formerly through Boulder BioMed, Jim recapitalized OtoMag (a German hearing implant manufacturer) as a significant equity partner and served as the President and CEO of the resulting company “Sophono” a manufacturer and distributor of implantable hearing devices. He oversaw the strategic management and operational oversight of the company’s global business development, operations, and sales. Jim raised over $14M in investments and helped build the company from start-up to more than $5M in revenue with 35+employees in less than two years. Jim’s knowledge of EU and US regulation helped secure their success by acquiring both the CE Marking and FDA Clearance. The company’s flagship product reached more than 4000 patients in more than 45 countries, held four patents with 20 more pending, received recognition from multiple outlets, and was the first company to receive CID4 competitive funding. The company was sold to Medtronic as part of a successful exit strategy in 2013. Board Seats (Current); Gelsana Colorado BioScience Association Flourish Medical Board Seats (Past) Sophono, Inc Meadows Swim and Tennis Club Solo-Dex AQ BioMed Cirrus MD DNP BioMed 7L, LLC

*** Sold Sophono to Medtronic **** President and CEO - Secretary of the Board Through Boulder BioMed - as Co-founder and CEO responsible for all global operations, manufacturing and building the business in all markets. As CEO raised over $12M of investment into the company and built the company in 2 years to over $10M in sales by achieving up growth, clinical use and adoption in over 45 countries. Mr. Kasic co-founded Sophono through Boulder BioMed, which acquired the core technology from Prof Dr. Ralf Siegert and Otomag GmbH in 2010. Under his leadership as President/CEO Sophono completed the following: • CE Mark and ISO 13485 in 2010 • FDA Clearance in 2011 • Several patents issued and pending • First company to receive CID4 competitive funding (www.cid4.com) • IRS Therapeutic Discovery Grant • 2012 Colorado Company to Watch Winner • 2012 Colorado Bio Science Association Rising Star Award Winner • 2013 Colorado BIZ Top Manufacturing Company

Patented novel obesity treatment medical device

Innovative surgical instrument for removing the ceramic lining from hip joints during revision surgery.

Resurrected an IDE submission stagnant over 18 months, completing two years of clinical site monitoring and increasing clinical trial site enrollment and IRB approval. Manage a group of eight scientists and engineers in the US and EU in addition to 20 clinical trial sites consisting of over 100 investigators. Managed budget to run 2 IDE Clinical Trials. Accountable for FDA submissions and clinical trials.

Managed all aspects of worldwide sales and marketing including hiring and training international sales, marketing and operational staff headquartered in US and France. Built and managed Direct-to-Consumer product launch and marketing campaigns with call centers. Established 70+ international implanting centers of excellence, wrote clinical trial protocols and directed international clinical trials. Full budget accountability.

Managed engineering teams of 10 engineers for the design and implementation of catheter delivery systems. Designed and implemented the reduction in delivery system size from 12F to 7F (43% diameter decrease) allowing for percutaneous axial vein insertion rather than femoral artery cut down thus reducing procedure time and morbidity.

Designed, built production line, and validated a one-size fits all tapered vascular graph which replaced the proposed 10 new products in less than 18 months. Built a cohesive team of 30+ engineers, manufacturing operators, quality, regulator and marketing staff to cut product development time in half. Promoted to Product Manager to launch business segment around lower limb disease. Developed business plans.