Tom Hedman, PhD Founder. Snoring: 48% of men, 34% of women & growing (obesity, allergies, aging)...

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The NEXT Treatment for Snoring and Obstructive Sleep Apnea Tom Hedman, PhD Founder

Transcript of Tom Hedman, PhD Founder. Snoring: 48% of men, 34% of women & growing (obesity, allergies, aging)...

  • Slide 1

Tom Hedman, PhD Founder Slide 2 Snoring: 48% of men, 34% of women & growing (obesity, allergies, aging) Sleep deprivation snorer; sleep cycle disruption, stress family Can lead to OSA Obstructive Sleep Apnea: Breathing interrupted during sleep by obstruction of the airway US: 4.2% age 16 & older, ~10 million adults & growing Over age 65: 28% of men, 24% of women Slide 3 Injectable Collagen Crosslinking Immediate effect Permanent covalent bonds Low cost high profit margin NEXT NEXT NEXT - Nonsurgical EXogenous Crosslink Therapy genipin Slide 4 Equine Soft Palate Collagen Mapping Slide 5 Wind Tunnel Video: Experiments with untreated (brown) and treated (dark blue) equine soft palates Slide 6 69% Reduction in Maximum Transient Deformation Slide 7 51% Reduction in Steady State Vibration Amplitude Virtual Elimination of Low Frequency High Energy Vibration Slide 8 Competitive Advantage: Primary competition: Primary competition: Existing surgical treatments Existing surgical treatments Oral appliances that alter geometry of pharynx/ upper airway (incl. CPAP) Oral appliances that alter geometry of pharynx/ upper airway (incl. CPAP) Minimally invasive stiffening procedures Minimally invasive stiffening procedures Competition: inconsistent, limited or temporary effectiveness; invasive (surgery), inconvenient or uncomfortable (oral appliances, CPAP); Competition: inconsistent, limited or temporary effectiveness; invasive (surgery), inconvenient or uncomfortable (oral appliances, CPAP); Existing and emerging minimally invasive procedures rely on formation of scar tissue which is inherently disorganized, weak, easily degraded Existing and emerging minimally invasive procedures rely on formation of scar tissue which is inherently disorganized, weak, easily degraded NEXT Effective! Preserves matrix integrity, strengthens tissue NEXT Effective! Preserves matrix integrity, strengthens tissue Slide 9 Patent Portfolio 10 US and 7 international patents issued or in condition for allowance Snoring Obstructive Sleep Apnea specific patent pending Additional 20+ US and international patents pending Issued Patents USForeign 10/230,671 Found in condition for allowance Australia 2002335683 7,435,722Canada 2,458,821 8,153,600Australia 2004268628 8,022,101Japan 2006-524909 8,119,599Canada 2,536,415 8,198,248Korea 8,211,938Australia 2010266306 Claims found allowable 8,283,322 8,450,276 12/966,812 Found in condition for allowance Slide 10 Over 10 years experience with new business development; successful in funding and market launch of a host of consumer, commercial, and medical/chemical products Formerly VP-Product Management & Marketing for Landmark Earth Solutions (newly formed and wholly owned subsidiary of Leggett & Platt); held senior positions with Robert Bosch, The Coleman Company, Vermont American, and Char-Broil MBA - Bellarmine University, BS - Florida State Univ., adjunct faculty - Indiana Wesleyan Univ. Lyle T. Hawkins CEO/President Founder of 7 biotech companies, 25+ years in biomechanics research, led 1 st North American artificial disc design/ development team Graduate of MIT, & Ph.D. in Bioengineering from Strathclyde University Currently Associate Professor at University of Kentucky Tom Hedman, PhD Founder, CSO 20+ years in medical device regulatory, clinical, and quality functions Successful in bringing a crosslinking technology through FDA as Class III Med. Dev. Worked at Baxter, Cordis J&J, CryoLife (Dir), Percutaneous Valve Technologies (Sr. Dir. Head RA/CA), and AtriCure (VP) with successful FDA approval track record Maintains her RAPS Regulatory Affairs Certification Elsa Abruzzo VP Reg./Clinical Affairs Ind.& Manuf. Engineering Management Team Slide 11 Funding required for 2014-2015: $250k ($1.25M initial valuation) Patent prosecution and annuity costs Gap funding R&D between NIH SBIR Phase I and Phase II grants Partial support for CEO/President business plan development, market research Contact Tom Hedman for more information: [email protected]