Jaya over AtheroSclerosis
Beyond Balloon, Stents and By-pass
The ELAN (Epiarterial Laser ANgioplasty) Procedure
The path to commercialization is quite different for every technology.
This module addresses the stage, development risk and cost, and the size of the market for the ELAN Laser Medical System.

Total market size --
•  12 to 15 thousand devices world-wide over 5 years + Consumable

Annual market --
•  Consumable driven
•  Consumable cost - same as Drug Eluting Stent
•  Consumable usage - same as balloons and stents

Market structure -
•  Device to be bought by Hospitals
•  Specialised Surgery Device
•  Significant Outcome advantages
•  Significant Cost Advantages
•  Minimally Invasive Procedure (Thoracoscopic / Endoscopic)
•  Demand generated by patients, physicians and insurance because:
             i) No medications post-op
             ii) Rare failures / blockage recurrence post-op
             iii) Capable of Preventing Heart Attack and Brain Stroke (market expansion)
             iv) Ability to treat patients considered untreatable (market expansion)

Competition -
Coronaries:
       Bypass Surgery
              •  Procedure simpler than bypass surgery
              •  Less Invasive (Thoracoscopic), shorter hospitalisation.
              •  Similar / better outcome
              •  No drugs post op
              •  Elimination of disease process, no fear of recurrence / repeat procedure
         Stents
              •  Procedure marginally more complex than stenting
              •  Better outcome
              •  Elimination of disease process, no fear of recurrence / repeat procedure
              •  No drugs post op

Carotids:
          Carotid Endarterectomy and Stents:
              •  Procedure simpler than Carotid Endarterectomy
              •  Better Outcome, little risk of post-op stroke
              •  No drugs post op
              •  Elimination of disease process, no fear of recurrence / repeat procedure

Peripheral Arteries:
          Reversed Vein / Prosthetic Graft Surgery and Stents
              •  Simpler procedure
              •  Hybrid approach possible (Endoscopic Minimally Invasive or Open or Combined)
              •  No risk of post-op thrombosis
              •  No drugs post op
              •  Elimination of disease process, no fear of recurrence / repeat procedure

Regulatory pathway -
United States:
              •  IDE and PMA

European Union, Canada, Australia:
              •  CE certification or similar before Clinical Trial

Erstwhile Eastern Bloc of Europe:
              •  Romania, Albania etc. - Clinical Trial possible without CE certification

India:
              •  Clinical Trial immediately after animal trial completion

Clinical trial design -
              •  Controlled Clinical Trial
              •  Time - 2 years
              •  Expense - USD 10 to 20 Million
              •  Ability to recruit patients - No difficulty
              •  End Point - Demonstration of absence of atherosclerosis in treated portion of arterial tree
                                      at 12 months post-op. IVUS and OCT for Coronaries and
                                      USG, CT or MRI for Carotid and Peripheral arteries.

Strength of intellectual property -
              •  Strong - covers US, Eurasia, Canada, Australia, India and Japan till 2031.

Reimbursement pathway -
              •  Similar to existing treatments in US, EU, Canada and Australia.
              •  In India - Patient pays

Potential adoption curve -
              •  Steep curve. Patient, physician and insurance driven.
              •  Quick adoption driven by significant Cost and Outcome advantages over existing treatments.
              •  Ability to prevent Heart Attacks and Brain Strokes.

Degree of unmet medical need -
              •  Significant.
              •  Treatment for Vulnerable Plaque not available.
              •  Treatment to prevent Heart Attacks and Brain Strokes not available.
              •  Elimination of Atherosclerotic disease process not possible with existing treatments.

Stage of development of the technology -
              •  Full function first generation prototype in use in trials at University of Texas Health Science Center at Houston, Texas.
              •  FDA compliant hardware documentation.
              •  Complete software documentation.
Key considerations - ELAN Laser Device for Elimination of Atherosclerosis: