Wire-First Philosophy
Fully compatible with standard 0.014” coronary guidewires, preserving operator familiarity and existing workflow.
Next-Generation CTO Intervention
Precision Re-Entry for
Complex Coronary Occlusions
The SAFER-Device is a low-profile, dual-lumen, wire-based support catheter designed to standardize antegrade dissection and re-entry in chronic total occlusion PCI.
Device/Design Patent Granted · PCT WO 2023/17066 A1 · Method Patent PCT Filed 2024
The Clinical Challenge
Chronic Total Occlusions — the most demanding lesion in PCI
14.7–52%
of coronary angiography patients present with CTO
4 Million+
coronary angiograms performed annually in the US & Europe (NIH)
3rd Gen
Prototype — refined through iterative engineering and clinical input
About Haty-Tech & SAFER-Device
Engineered to simplify one of cardiology's hardest problems
Haty Technology is a Texas-registered company commercializing the SAFER — Subintimal Antegrade FEnestration Re-entry — technology, a next-generation solution for CTO percutaneous coronary intervention.
The foundational SAFER technique was introduced by Carlino et al. in Catheterization & Cardiovascular Interventions (2023) as a controlled antegrade dissection-and-re-entry method using small, targeted contrast injections to modify plaque compliance and facilitate safe guidewire passage.
Building on that clinical insight, the SAFER-Device was engineered to further simplify and standardize execution of the technique — expanding its reach beyond high-volume CTO centers to a broader operator community.
Core Technology
Four principles of the SAFER-Device
Every design decision is grounded in a clear engineering philosophy — preserving operator familiarity while enabling procedures previously out of reach.
Controlled Micro-Dissection
Enables small, targeted hydraulic or mechanical expansion of the subintimal space — avoiding the uncontrolled hydraulic propagation of earlier techniques.
Guided Re-Entry
Provides stability and directional control to orient the re-entry wire toward the true lumen. The inflated balloon maintains micro-channel patency during re-entry.
Minimal Learning Curve
Functions like a standard support catheter, lowering the barrier for non-CTO operators to safely perform antegrade dissection and re-entry.
Clinical Benefits
Designed for every level of operator
SAFER-Device complements current strategies for experienced CTO operators while opening new procedural avenues for the broader interventional cardiology community.
Expert CTO Operator
Seamless integration right after antegrade wire escalation to facilitate treatment
Non-exclusive — does not preclude switching to more aggressive (e.g. STAR) or complementary approaches such as retrograde or epicardial techniques
Additional tool in the expert's armamentarium for challenging anatomies
Non-CTO Operator
Expands capability beyond intraluminal-only strategies like antegrade wire escalation
Codifies procedural steps with standardized training for safe subintimal access and true lumen re-entry
Safe hand-off pathway — if the device does not achieve re-entry, the patient can be referred to a CTO expert with minimal additional risk
Enables more complete first-attempt cases at lower-volume centers
Market Opportunity
A large and growing addressable market
CTO PCI represents one of the last frontiers of interventional cardiology, with significant unmet clinical need across coronary and peripheral vascular applications.
4M+
Coronary angiograms performed annually across the US and Europe (NIH estimate)
~15–52%
Proportion of angiography patients presenting with chronic total occlusion
5%
Projected annual market growth rate for CTO intervention worldwide
$5.6M
Net present value of projected discounted cash flows (WACC 8%) under base assumptions
Financial projections are based on internal modeling assumptions. Global addressable market estimated at 4 million annual procedures, $500/unit sales price. Market size estimates supported by published literature including Christofferson et al. (2005), Fefer et al. (2012), and Inohara et al. (2020).
Intellectual Property & Status
Protected innovation, clear path to market
SAFER-Device is protected by a multi-jurisdictional patent strategy covering both the device design and the clinical method.
Granted — February 2024
Device / Design Patent
PCT WO 2023/17066 A1 — covering the dual-lumen wire-based catheter architecture
Filed — July 2024
Method / Technique Patent
PCT filing with priority date of July 2023, covering the SAFER procedural technique
Multi-Regional Coverage
US · EU · Japan · China
Device and method patents filed in all major medical device markets
Development milestones
Design for Manufacturing & Contract Manufacturer Transfer
Finalizing engineering drawings and qualifying contract manufacturing partner
Verification Device Assembly & Performance Testing
Bench and preclinical validation of 3rd-generation prototype
First-in-Human Clinical Study
Initial human use to establish safety and feasibility data
FDA Pre-Submission Meeting
Regulatory alignment on IDE pathway and submission requirements
Funding Sought
Haty-Tech is seeking $1.33M – $1.90M in milestone-based tranches to fund prototype completion, clinical validation, and regulatory filings over 24–36 months. Funding is structured with go/no-go gates and an option for follow-on investment, targeting clinical and regulatory inflection points that materially de-risk the program.
Ready to learn more?
For investor inquiries, clinical collaboration, or general information about the SAFER-Device program, reach out to the Haty-Tech team directly.