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University of Utah Technology Startups

University of Utah Technology Startups. Transforming Two Medical Device Industries. Andy Raguskus. 2 Industry Transformations. Hearing Aids : 1995 – 2014 World’s first DIGITAL canal hearing a ids U of Utah, BYU, Cal Tech professors Utah seed round investors + VC funding

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University of Utah Technology Startups

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  1. University of UtahTechnology Startups

    Transforming Two Medical Device Industries Andy Raguskus
  2. 2 Industry Transformations HearingAids: 1995 – 2014 World’s first DIGITAL canal hearing aids U of Utah, BYU, Cal Tech professors Utah seed round investors + VC funding Sonic Innovations, Inc. Hypodermic Needles & Syringes: 2014 World’s first ANTI-INFECTIOUS hypodermic needles U of Utah professor & Moran Eye Center CEO Utah seed round investors XEnd Medical Systems
  3. Map of Human Hearing 120 100 80 60 40 20 0 Upper Comfort Level Loudness (dB) Threshold of Hearing 250 500 1k 2k 4k 8k 16k Frequency (Hz)
  4. Map of Human Hearing 120 100 80 60 40 20 0 Upper Comfort Level Loudness (dB) Vowels Consonants Threshold of Hearing 250 500 1k 2k 4k 8k 16k Frequency (Hz)
  5. Typical Hearing Loss 120 100 80 60 40 20 0 Upper Comfort Level Loudness (dB) Vowels Threshold of Hearing Consonants 250 500 1k 2k 4k 8k 16k Frequency (Hz)
  6. Hearing Aids - 1995 Poor sound quality Unappealing Uncomfortable Unreliable Expensive Low battery life Analog technology
  7. Disruptive Technologies Tom Stockham, Doug Chabries, Carver Mead Proprietary digital algorithms Superior sound quality Speech understanding Tiny DSP chip In-the-canal size Computer programmed
  8. Building a Business Raised $44 MM in 5 Rounds IPO in May 2000 $440 MM valuation Goldman Sachs 700 jobs in 14 countries, 150 in Utah 17th Largest Utah company 6th Largest global hearing company
  9. Sonic Innovations Revenues
  10. Hearing Industry Transformation 1995 2014 Analog technology Screwdriver control Technician – designed Poor performance 39% Satisfaction $2 BN Worldwide sales Digital technology Software control Scientists & Engineers Better performance 72% Satisfaction $9 BN Worldwide sales
  11. The Next Transformation Reduce the incidence of infections caused by hypodermic needles. Eye infections cost >$100 Million Blood contaminations cost >$5 Billion Litigation costs >$1.5 Billion Patient quality of care
  12. Clinical Need: Eye Injections 7.2 Million injections in USA in 2013 Growing 20% /yr. 1 in 2000 Infections from needle 3,600 Infected eyes $12k Per infected eye $43 MM treatment cost $1.5 BN Litigation cost Patient quality of life
  13. Clinical Need: Eye Injections Conjunctiva is a mucousmembrane Antiseptic cannot kill all surface bacteria Needle carries bacteria into center of eye Vitreous - no defense against invaders Single bacterium can cause infection
  14. Clinical Need: Blood Cultures Journal of Emergency Medicine (Vol 35; 2008) 3,901 Cultures, 5% False positives False pos. cost extra 4.5 hospital days = $4,385 U.S. ≈22 MM cultures 1.1 MM contaminations 5 MM hospital days $4.8 BN cost in 2001 Patient consequences
  15. How Sterile Needles Cause Infection Antiseptics kill < 100% Less on mucous tissue Pathogens on needle Always a few in needle
  16. How Sterile Needles Cause Infection Antiseptics kill < 100% Less on mucous tissue Pathogens on needle Always a few in needle
  17. Anti-Infective Needle & Syringe Anti-infective film Vicryl, PLGA, PTFE Channel insert Inject meds or draw blood 30 GA, 1/2” needle 20 GA, 1” needle Multiple design iterations
  18. “Bench to Bedside” - Grand Prize April 2014
  19. Market & Competition $6 BN Market worldwide ≈ 200 Manufacturers Thousands of models None claim anti-infection capability No “prior art” found in patent search No internet hits
  20. Market Entry Eye needles = $86 MM with 20% growth Blood culture needles = $360 MM with 5% growth Reduced U.S. medical costs $43 MM treatment for infected eyes $1.5 BN litigation for infected eyes $5 BN for reduced blood culture false positives Better patient outcomes
  21. Milestones Done: Next Steps: XEnd Medical formed Patents pending Exclusive license to IP Contract manufacturer Clinical protocols Access to eye bank Access to cadavers Seed round funding Build prototypes Conduct 2 clinical trials Prove efficacy – 4Q 2014 Raise “A” round $4-5 MM 510(k) and CE Mark Launch in 3Q 2015
  22. Team Randy Olson, MD - Chairman & CMO CEO, Moran Eye Center (50 faculty, 500 employees) Prof. and Chair of Ophthalmology at U. of Utah Active eye surgeon & worldwide lecturer in ophthalmology Published > 200 peer-reviewed papers + several books Consultant to Allergan, Abbott Medical, Becton Dickenson Inventor & sole patent holder of AHNS Andy Raguskus, EE - President & CEO Serial entrepreneur - 5th med-tech startup Chairman & CEO: Sonic Innovations, 1996-2008 $0 to $125 MM Revenue; Goldman Sachs IPO Utah “Entrepreneur of the Year, 2001” Sun Microsystems, GE Medical, USAF
  23. Transformative ?? Potential to become “standard of care” Eye injections Blood cultures Joint injections Spinal injections Immunosuppressed patients Infants
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