Published on March 3, 2014
Tom Hedman, PhD Founder
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
NEXT NEXT - Nonsurgical EXogenous Crosslink Therapy • • • • Injectable Collagen Crosslinking Immediate effect Permanent covalent bonds Low cost – high profit margin genipin
Equine Soft Palate Collagen Content (hyp, nmol/mg) Achilles Tendon Skin Annulus Fibrosus Aorta Soft Palate Spleen Kidney Liver 0.0 Collagen Mapping 200.0 400.0 600.0 800.0 1000.0
Wind Tunnel Video: Experiments with untreated (brown) and treated (dark blue) equine soft palates
Transient Comparison Time(sec) vs Displacement (cm) 0.45 0.4 Displacement (cm) 0.35 0.3 69% Reduction in Maximum Transient Deformation 0.25 0.2 Control Treated 0.15 0.1 0.05 0 0 1 2 3 Time (seconds) 4 5 6
51% Reduction in Steady State Vibration Amplitude 0.05 0.04 Virtual Elimination of Low Frequency – High Energy Vibration Treated 0.03 Displacement (cm) Control 0.02 0.01 0 -0.01 0 0.1 0.2 0.3 0.4 0.5 -0.02 -0.03 -0.04 Time (seconds) 0.6 0.7 0.8 0.9 1
Competitive Advantage: Primary competition: Existing surgical treatments Oral appliances that alter geometry of pharynx/ upper airway (incl. CPAP) Minimally invasive “stiffening” procedures 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 NEXT – Effective! Preserves matrix integrity, strengthens tissue
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 US Foreign 10/230,671 Found in condition for allowance Australia 2002335683 7,435,722 Canada 2,458,821 8,153,600 Australia 2004268628 8,022,101 Japan 2006-524909 8,119,599 Canada 2,536,415 8,198,248 Korea 8,211,938 Australia 2010266306 Claims found allowable 8,283,322 8,450,276 12/966,812 Found in condition for allowance
Management Team Lyle T. Hawkins CEO/President Tom Hedman, PhD Founder, CSO Elsa Abruzzo VP Reg./Clinical Affairs Ind.& Manuf. Engineering • 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. • Founder of 7 biotech companies, 25+ years in biomechanics research, led 1st North American artificial disc design/ development team • Graduate of MIT, & Ph.D. in Bioengineering from Strathclyde University • Currently Associate Professor at University of Kentucky • 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
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@example.com
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