Regulatory and Intellectual Property Overview
Our strategic approach to regulatory compliance and intellectual property safeguards our innovations and supports our market entry efforts.
Regulatory Strategy
FDA and CPT Strategy
- U.S. FDA: We are navigating the FDA 510(k) regulatory pathway effectively.
- Current Status: Pre-submission preparations are ongoing.
- Bench Studies: Safety and effectiveness bench studies have been completed.
- ANSI Study: An ANSI study has been initiated to further validate our claims.
AMA
- Device-Specific CPT Code 0198T:
- Successfully prevented the termination of the CPT code.
- Accepted by leading managed care (LMC) organizations and insurers.
- Two clinical studies are required to support ongoing reimbursement efforts.
Intellectual Property and Market Entry
Ownership and Patents
- Intellectual Property: All intellectual property rights are exclusively owned by OculoPULSE.
- Patent Applications: Two patent applications have been filed and globalized.
- Patents Issued: Two patents have been granted and globalized.
- Upcoming Application: A third patent application is currently in preparation.
- Freedom to Operate: Completed a freedom-to-operate analysis by Wilson Sonsini Goodrich & Rosati (WSGR).
Market Entry Strategies
United States
- Adoption: Identified 1,800 early adopters to facilitate initial market penetration.
- Sales Team: Will engage 12 regional sales representatives to expand reach and support.
Japan
- Market Insights: Established connections with opinion leaders and distributors to navigate local conditions.
European Union
- Market Insights: Built relationships with opinion leaders and distributors in the EU market.
India
- Clinical Studies: Conducting clinical studies and overseeing the production of out-of-U.S. (OUS) tip manufacturing.
This comprehensive regulatory and intellectual property strategy positions us well for successful market entry and sustainable growth in the ocular health sector.