410 likes | 419 Views
Building a Global Life Science Company in NZ. Unlocking Regenerative Healing. Regenerative Tissue Substitutes. US Soft Tissue Repair. Millennium US Markets for Soft Tissue Repair, 2008. Platform. Dura. CMF. Dental & Oral. Cardiovascular. Abdominal Wall. Breast. Pelvic Floor.
E N D
Regenerative Tissue Substitutes
US Soft Tissue Repair Millennium US Markets for Soft Tissue Repair, 2008
Platform Dura CMF Dental & Oral Cardiovascular Abdominal Wall Breast Pelvic Floor Gastrointestinal Joint Nerve Tendon/Ligament Extremities
Endoform & Cell cross-talk Lun, S et al. (2010). Biomaterials31(16): 4517-29. Schultz GS et al Wound Repair Regen 2011 Mar-Apr;19(2):134-148
>Angiogenesis Irvine et al (2011) In press.
Remodeled Endoform™ 4 x High magnification Day 7 Day 14 Day 42
Endoform™ D T • partial and full thickness wounds • pressure ulcers • venous ulcers • chronic vascular ulcers • diabetic ulcers • tunnelled undermined wounds • traumatic wounds • surgical wounds
Clinical • Dr Jeremy Simcock (NZ) pilot study • 12 patients DFU’s and VU’s • Increased vascularity and granulation tissue formation • Dr Brock Liden (USA) • 19 participants with 24 wounds (DFU and VU) • Mean decrease in wound area at 12 weeks was 73.4%. • Mean time to complete closure was 6.8 weeks. • 50% closed at 12 weeks • Increased vascularity and granulation tissue formation • Dr Jeremy Simcock (NZ) • 5 patient tumor resection with single-stage split-thickness graft onto Endoform
Endoform™ R T • Soft Tissue Reconstruction Floden et al. Journal of Biomedical Materials Research Part B: Applied Biomaterials 2011;96B(1):67-75.
Endoform™2.0 • Infection Control
Competitive Advantage 1.0 rapid vascular in-growth, stimulates cell proliferation , completely remodeled & safe†
Competitive Advantage 1.0 Strong in thin formats, laminated for load bearing & persistence rapid vascular in-growth, stimulates cell proliferation , completely remodeled & safe†
Competitive Advantage 1.0 Simple and quick to use Strong in thin formats, laminated for load bearing & persistence rapid vascular in-growth, stimulates cell proliferation , completely remodeled & safe†
Competitive Advantage 1.0 Low COGs Simple and quick to use Strong in thin formats, laminated for load bearing & persistence rapid vascular in-growth, stimulates cell proliferation , completely remodeled & safe†
Competitive Advantage 1.5 Low COGs Ease to Use Robust Biology
Business Model Exceptional returns +/- Partners Product Format Orthopaedic Cardiovascular $$$$$ + Stem/Progenitor cells Strong positive cashflows - Partnered + Bioactives Soft Tissue Reconstruction $$$ development & clinical complexity + Layers Single Active Wound Care $
Business Model • Start simple, validate the opportunity, learn & iterate • Develop (r&D) and manufacture to produce strong positive cash flow • Partner with proven companies for sales and marketing • Pursue more complex applications for exceptional returns
NZ Factors
??? Ingenuity
RegenMed Will lead to therapies that will fundamentally change current therapies and complement the use of pharmaceuticals, biologicals & medical devices because offers the opportunity to restore function and cure chronic conditions1 1. Mason C., Brindley, D.A., Culme-Seymour E.J. and Davie N.L. (2011).Cell therapy industry: billion dollar global business with unlimited potential. Regenerative Medicine, May 2011, Vol. 6(3), 265-272.
RegenMed • Devices/Therapeutics/Combinations • Mixed regulatory paths • Mixed business models • No dominant players • Interest from Big device & pharma • High growth and pricing potential
Summary • Strong platform, multiple products, unmet clinical need & large fast-growing markets • Attained no. of value accretive milestones & external validation • Revenue and cash-flow – WIP • Many challenges ahead - no set formula or prescription…