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1. Pdf to keynote version 1.04 a drivers#
2. Pdf to keynote version 1.04 a trial#
3. Pdf to keynote version 1.04 a license#
4. Pdf to keynote version 1.04 a iso#

We decided it best to focus on one market – We chose the Hernia Mesh Marketġ Safety study Stage 2 Effectiveness trial $3-5MM US 510(k) $2-3MM US IDE 1-2YR 30 patients $5-8MM 2-4YR 1-2YR Regulatory Pathways (Class III) Stage 1 Stage 2 Stage 3 Preclinical study Pilot trial Pivotal trial $3-5MM $15-22MM US PMA $2-3MM US IDE 30 patients 150 patients $20-30MM 1-2YR 4-7YR 1-2YR 2-3YR.We thought, “Focus on the total SSI Market” – We spoke with clinicians and industry experts and ran the numbers.This was confirmed but other markets proposed – So we move forward.We thought that SSIs were a big problem – We asked several the customers.Solution= Affinity Therapeutics’ Antimicrobial formulation – Formulated to be used with the stronger synthetic meshes – antimicrobial activity for ~30 days.Biological Mesh – Antimicrobial mesh sold by Gore – Protection that lasts 7-21 days Needs= prevention of SSI – Synthetic Mesh vs.TAM=$1.1B Hernia Mesh repair SAM = $650M Ventral Hernias TM ≤ $650M Frost and Sullivan - Surgical Site Infections Pose Serious Threat and Increase Demand for Advanced Infection Control Technologies 2. New CDC standards on prevention and regulation.Surgical Infection Prevention project (2002) – Reduce SSIs by 90%2.Reduction of SSI incidence ratios by 25% by 20142 – Market Dynamics.Prevention of infection and prevention of readmission (40%) 2.

Pdf to keynote version 1.04 a drivers#

SSIs account for16% of hospital-acquired infections2 – Market Drivers.$10 billion in annual U.S healthcare expenditures1.SSIs occur in 1.5 million surgeries annually1.Co.) developers of technology Cost Structure Revenue Streams CRO’s, CMO’s, Regulatory, Strategic Licensing, Royalties, Co-Development Marketing, Education and Branding Milestone payments, Strategic Partnerships Collaborations “Market-driven indication) Regulatory studies” Support of KP’s marketing plan Key Channels Resources Infrastructure of IP Strategic Partners Access to (as Med. Partners Activities Propositions Relationships Segments CROs Key Partner Cost Reduction Personal and Medical Device Medical Device Pre-Clinical Study Prophylaxis of Technical Companies Companies Fund Raising Hernia Mesh Assistance

Pdf to keynote version 1.04 a iso#

Or “Big Pharma” Cost Structure Revenue Streams ISO 10993 analysis SBIR Clinical Trials Licensing Manufacturing Co-Development Strategic PartnershipsĪ medical device company focusing on at least 5 different indications – Our customer was the physicians or surgeons – Gain device approval from the FDA – Manufacture the product (open our own plant) – Distribute the product (customer acquisition) – Sale the product (huge sales team) – Get reimbursement from both Medicare and private insuranceĭevice Consulting Associate Director Research Scientist 10 10 Other companies Program Manager Associate Director Director, R&D Director, R&D Marketing Manager 80 Bioavailable and Specialists Large Animal Models Manufacturers Unmodified Hospitals Pre-Clinical Studies Infection Reduction Non-Dilutive Funding Cost Reduction Clinical Increase “Quality of Collaborations Life” Regulatory Path IDE Submission Key Resources Channels Intellectual Property Infrastructure of Access to developers Strategic Partners of technology Such as Medical Device cos. Key Value Customer Customer Partners Activities Studies Propositions Relationships Segments Formulation Cyclodextrin supplier Extended local Personal Assistance Surgeons In vitro analysis Clinical Collaborators Drug delivery Technical Assistance Wound Therapy In Vivo analysis Medical Device Cos.

Pdf to keynote version 1.04 a license#