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
Intellectual Property & Know-How
- 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
Modeling the Opportunity & Business Environment
A Customer Base Increasingly Hungry for Effective Solutions
The average orthopedic physician age &
Demographic factors mean the suitability & attractiveness
practice size are increasing.
of the VeloJect technology will increase
& improve over time.High volume physicians demand
Surgeons are increasingly older, less patient, and fatigued by
user-centered solutions.
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 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.