Executive Insights Series: Essentials for Building an Investable Life Sciences Company

12:00 pm - 2:00 pm PST
Keynote Speaker

Michael Hite

CEO, Ayuda Medical, Ex-CEO, Impel NeuroPharma

Michael is a serial healthcare technology entrepreneur and innovator. He’s a graduate of UW Foster Business School, and was the founding CEO of Impel Pharmaceuticals, which was launched at the UW Business Plan Competition in 2008 and later had an IPO on NASDAQ.  Prior to Impel he was on the founding team of SCOLR Pharma. Michael helped develop the technology platforms and commercialize products at Impel and SCOLR, and he shares inventorship on more than 13 patents in pharmaceuticals and medical devices.

Before coming to Seattle, Michael grew up in West Virginia, one of the states hit hardest by the opioid epidemic.  After Impel, he co-founded Ayuda Medical with the goal of preventing fatal opioid overdoses. Ayuda is developing the first wearable device to detect overdoses and call for help, the ARMband.  Ayuda has been awarded over $3M in NIH/National Institute of Drug Abuse Small Business Investigational Research grants, and they are now preparing for pivotal clinical studies and FDA submission.

Speakers

Xavier Gonzales, MD

Former VP & CSO at Spiration/Olympus Medical
Speaker

Xavier's entrepreneurial journey began in 1994 with the development of the Class III InControl “Metrix” implantable pacemaker/defibrillator for diagnosing and treating supraventricular arrhythmias in the field of interventional cardiology. The company and technology were acquired by Guidant Corporation (now part of Boston Scientific) in 1988.

Following his consultancy for Guidant and various local start-ups, Xavier and other entrepreneurs founded Spiration Inc. in 1999 in Redmond, WA to develop minimally invasive bronchoscopic and surgical methods and devices for treating lung diseases. Spiration was built from the ground up, requiring multiple rounds of investment to support hiring personnel, research and development, intellectual property, engineering, bench, preclinical and clinical trials, regulatory affairs, quality, manufacturing, marketing, and eventually a sales team. In 2010, Spiration was acquired by Olympus Medical Corporation, and Xavier continued as Vice President and Chief Scientific Officer, supporting R&D and clinical projects for Spiration and the Olympus Respiratory Division. At the Spiration/Olympus Redmond facility, he developed additional products for lung cancer diagnostics, interventional bronchoscopy, interventional GI endoscopy, and surgery. The Spiration Valve System received FDA approval in 2018. Xavier was a member of multiple Olympus executive teams and provided technological assessments for Olympus partnerships and acquisitions. He retired from Olympus in December 2021.

Since 2022, Xavier has been working as an independent consultant, focusing on strategy for medical device projects and start-up companies. In the same year, he joined the Washington Innovation Network (WIN) program as a pro bono mentor, assisting entrepreneurs and early-stage MedTech companies. Currently, Xavier supports 13 companies in the WIN program and serves as the lead mentor for four of them. He also provides support to the University of Washington innovation programs.

Kat Duncan

Partner - Corporate Law at Fenwick
Speaker

Kat is a trusted legal and business advisor to technology-focused companies ranging from early-stage startups to mature, publicly traded corporations. Known for her hands-on approach, Kat provides tailored strategic guidance to her clients, helping them address both immediate challenges and long-term goals.

With extensive experience navigating the full corporate lifecycle, Kat advises clients on all aspects of general corporate and securities law, from formation to seed and venture capital financings through M&A and IPOs. Kat also represents venture capital firms and strategic investors that invest in these companies.

Kat is also active in the broader startup community, serving on the startup advisory board to the Washington Technology Industry Association and contributes to the venture capital data report, the Venture Beacon, in collaboration with Aumni, a J.P. Morgan company.

Kat has been selected in Super Lawyers as a “Rising Star” for nine consecutive years (2013 – 2022).

Hayan Yoon, PhD

Partner - Intellectual Property at Fenwick
Speaker

Hayan provides comprehensive patent guidance to her clients, specializing in advising emerging growth and publicly traded life science companies and venture capital firms on various aspects of strategic intellectual property and patent counseling.

Hayan has an in-depth grasp of the life sciences industry and corporate goals. She leverages her significant scientific and legal experience in life sciences to counsel clients related to U.S. and foreign patent prosecution and management, patent strategy, IP diligence pre-litigation assessment, post-issuance proceeding, and validity and infringement opinions. She has extensive experience in assessing competitive IP landscapes and complex IP assets and advising strategies for improving IP assets while mitigating risks.

Before her legal career, Hayan was a postdoctoral fellow at UC Berkeley and the Damon Runyon Cancer Research Foundation, and a researcher at a gene therapy company. She maintains her passion for life sciences while providing counsel to her clients in the life science industry.