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Reinventing the Injection Sequence

Medtech Automation is an Accelerating Theme

  • 23-27% of Orthopedic Surgeons have required time of from work due to injury or illness
  • 8% of Orthopedic Surgeons required longer than 3 weeks off because of injury.
  • 36% of injured surgeons reported pain from an occupational injury “at least “minimally impacted” their performance
  • 43% of injured surgeons were forced to take a break from work.

The VeloJect Concept of Injection Technology is Designed To:

  • Deliver pharmaceutical compounds to the targeted tissue locations.
  • Facilitate convenient and comfortable application of fluids in precisely prescribed dosages.
  • Improve visualization and access to deeper tissue with increasing confidence and less obscuration.
  • Reduce the fatigue and fine-muscle strain associated with manual manipulation of plunger devices.
  • Potentially enable a faster surgical procedure with less physical effort.

Pain Management: Opinions, Friction & Uncertainties Abound

  • Skepticism among HCPs and hospital buyers persists around the clinical efficacy and reproducibility of Exparel®
  • Selected community observations suggest that ~60% of the time, Exparel® works approximately 36 hours.
  • Surgeons often rely on a larger 20-gauge needle due to time constraints and physical fatigue concerns.
  • Many physicians accept the clinical uncertainties because pain control is so important for their patients and their paying institutions.
  • But many more do not.

Software Controlled, High-Pressure Positive Displacement Pump

Veloject High-Pressure Positive Displacement Pump

Intellectual Property & Know-How

Veloject IP

  • US Patent No. 11,229,750
  • Track 1 continuation filings: 17/575,601 and 17/575,604
  • US Provisional Patents (63/006,056; 63/252,607)
  • Additional OUS filings imminent
  • Veloject Advantage img

Modeling the Opportunity & Business Environment

A Customer Base Increasingly Hungry for Effective Solutions

  • Veloject Orthopaedic Physicians Graph
  • Veloject Surical Practice Graph Older Orthopaedist Graph
  • Veloject
  • The average orthopedic physician age &
    practice size are increasing.

    Demographic factors mean the suitability & attractiveness
    of the VeloJect technology will increase
    & improve over time.
  • High volume physicians demand
    user-centered solutions.

    Surgeons are increasingly older, less patient, and fatigued by
    cumbersome & non-optimized technologies.

Sources:

  • Cherf, John MD. A Snapshot of U.S. Orthopaedic Surgeons: Results from the 2018 OPUS Survey (via AAOS Now). September 1, 2019.
  • American Academy of Orthopaedic Surgeons. www.aaos.org.

Strong Value Proposition with Overlapping Customers

  • Our focus categories represent 90% of the company’s estimated addressable market.
  • Many of these procedures are performed by the same specialist surgeon (therefore, cross-category, the VeloJect customer is the same).
  • Providing training to surgeons on the safe and effective use of VeloJect is more readily attainable with greater applicability to more procedures.
  • Physicians performing orthopedic procedures are already very familiar with the action and the potential benefit of intraop pain control.
  • The ongoing move to an outpatient setting for these elective procedures means patient satisfaction and efficient post-op management are high priorities.

Risk-Adjusted Unit & Revenue Potential is Extraordinary

Veloject Risk-Adjusted Unit

VeloJect in its Present Embodiment is a 510(k) Device

  • VeloJect has identified multiple predicate devices and obtained expert regulatory opinion that FDA is likely to accept the product in its current embodiment via the 510(k) clearance process.
  • VeloJect is presently running all design & development activities through an enterprise level QMS (Quality Management System)
  • VeloJect employs experienced engineering experts (mechanical, electrical and software) in order to maintain an attractive timeline for the 1st generation device’s DHF completion.

VeloJect Clinical Advisory Board (CAB)

  • VeloJect believes that involving high-profile, high-credibility physicians through its Clinical Advisory Board is important for all aspects of product development and commercialization.
  • Onboarding additional Clinical Advisory Board members will pave the way for a more technologically advanced and increasingly commercially accepted VeloJect product portfolio.

VeloJect’s Next-Generation Technology Platform

  • VeloJect is pursuing several highly attractive fundamental improvement opportunities in the design and feature set of the injection technology.
  • Following the initial 510(k) clearance, VeloJect intends to focus on these new innovations through our 2nd generation product development program
  • The next generation product holds great potential for exciting new applications and enhancements.

VeloJect: Business & Product Summary

  • VeloJect has completed its initial funding round and achieved its major milestones relating to the working prototype, IP filings, written legal & regulatory opinions, and contract manufacturer selection
  • VeloJect is on the path to obtaining 510(k) clearance and entering the US marketplace.
  • VeloJect has the potential to revolutionize fluid injections, particularly in light of ongoing questions and challenges relating to efficacy of the injection sequence.