F Randall Grimes Email and Phone Number

Cofounded and built Beacon Biomedical based on my analysis, which suggested that patient friendly screening alternatives could completely transform the colorectal cancer screening market, bring 24 million Americans (TAM) into a state of compliance and deliver outsized clinical and economic benefits. In-licensed technology, developed the product, obtained partners, built channels, and began sales.• Directed venture funding preparation; written business plan, pitch decks & scripts. Obtained >$1 million in equity funding from industry insiders and physicians• Established partnerships with oncology KOLs and leading research centers for colorectal, breast and lung cancer Dx studies, including Fred Hutchinson, Huntsman Cancer Center, Mayo Clinic, Banner-MD Anderson, Howard University, Boston University and Duke Medical. • Secured strategic partnership with largest laboratory in AZ providing access to 480 draw sites.• Designed and budgeted pivotal study in support of FDA 510(k) DeNovo and obtained regulatory approval for 900 subject multicenter population enriched study of advanced neoplasia detection.• Obtained CLIA approval to launch for BeScreened-CRC, by designing non-clinical verification and clinical validation protocols, conducting data analysis, and reporting results.• Designed and implemented a CLIA compliant QC system, Certified in 2018 AZDH audit.• Winner: AZBio Fast Track Award, Arizona Innovation Challenge, Venture Madness final four, & Molecular Tri-Con “Swimming” finalist. Secured $1.5 million in equity and non-dilutive funding

Led partnering, research planning and funding efforts for pre-clinical drug development• Partnered with diagnostic/therapeutic KOLs, developed collaborations with UC Davis, VA Tech, Edward Via College of Medicine and University of Washington for NIH and NFL sponsored projects • Revamped program for the preclinical discovery of novel neurotrophic factors as disease modifying agents in Parkinson’s disease, expanded diagnostic portfolio into traumatic brain injury and chronic traumatic encephalopathy, leading teams of up to five PhD

• Managed product planning, R&D and funding efforts for breast cancer and Alzheimer’s products. Breast cancer assets were acquired 2012, Alzheimer’s assets were spun off and acquired in 2013.• Built and Launched Companion Diagnostic and personalized medicine co-development service.• Prepared submissions and led Pre-IDE discussion with FDA’s hematology panel regarding product classifications and PMA study designs for Alzheimer’s diagnostics approvals.• Planned, obtained clinical partners and ran diagnostic studies of 375 and 460 subjects.• Obtained $2.75 million in NIA funding for Alzheimer’s Dx.• Lead economic, clinical and competitive analysis for product placement, reimbursement pricing.• Launched Breast Cancer Test (dtectDx Breast) as a Laboratory Developed Test (LDT).• Evaluation of in-licensing opportunities; technical, regulatory, market and reimbursement merit. • Authored and submitted patents and publication manuscripts for IVD Algorithms, Novel Imaging Agents and epigenetic Test for Alzheimer’s disease. Managed US and International IP Portfolio.

• Secured over 20 projects each valued over 6 figures with clients across US. • Submitted $25 million in competitive grant proposals for biomarker diagnostics, radiological equipment, and remote patient monitoring. 40% award success rate from NIH and DoD.

• Developed business plans for micromachined microfluidic & medical devices and overall corporate plans. • Conducted primary market research and collected secondary research, worked with practitioners, scientific staff and vendors to translate needs into product specifications.• Raised $10 million in research grants and investments for advanced ventriculo-peritoneal shunts, cardiac transvalvular catheters, and other medical devices.

Lead product development of electrochromic mirrors - now common on higher end vehicles.Conucted orgainic and electrochemical research on projects including electrochomics, thin film ionic conductors, and organofunctional silanes.Awarded three patents.

Commanded one squad of fourteen men during operation Desert StormCompleted six years of duty, honorably discharged as Sergeant.