4. No patentability No or weak patent Non-provisional(s) filed Strong, issued patents 2 IP Position or applications and pending (Lab 1) Freedom to operate or or Provisionals only Issued patents, but weak 5. Physics would have to be Will require large Some challenges but will Simple and straight 2 Technical bent investments/research, be overcome with time forward design with known Feasibility Development will be cost and within a reasonable materials and methods prohibitive cost (Lab 2) 6. Unclear regulatory PMA 510k - clinical data needed 510k - no clinical data 1 Regulatory pathway or needed Pathway De Novo Exempt 7. Clinical success unlikely Clinical success is unclear. Clinical success is likely but Clear path to clinical 2 Clinical Others have tried and Large patient volumes or will require special success feasibility failed long time-frame trials expertise and/or research Others have been clearly required successful (Lab 2) 8. Reimbursement unlikely New application to CMS Reimbursement could fall Reimbursement readily 1 no cash paying incentives necessary prior to any under an existing code but accepted or patients are Reimbursement payments being issued a new code will eventually very incentivized to pay need to be filed cash 48 TOTAL (product)
2 4. IP Position (Lab 1) No patentability or Freedom to operate No or weak patent applications or Provisionals only Non-provisional(s) filed and pending or Issued patents, but weak Strong, issued patents 2 5. Technical Feasibility (Lab 2) Physics would have to be bent Will require large investments/research, Development will be cost prohibitive Some challenges but will be overcome with time and within a reasonable cost Simple and straight forward design with known materials and methods 1 6. Regulatory Pathway Unclear regulatory pathway PMA 510k - clinical data needed or De Novo 510k - no clinical data needed Exempt 2 7. Clinical feasibility (Lab 2) Clinical success unlikely Others have tried and failed Clinical success is unclear. Large patient volumes or long time-frame trials required Clinical success is likely but will require special expertise and/or research Clear path to clinical success Others have been clearly successful 1 8. Reimbursement Reimbursement unlikely no cash paying incentives New application to CMS necessary prior to any payments being issued Reimbursement could fall under an existing code but a new code will eventually need to be filed Reimbursement readily accepted or patients are very incentivized to pay cash 48 TOTAL (product)