Providing a real-time, high-resolution view into the artery during intervention may help to identify high-risk plaques associated with cardiovascular events. Additional uses could include views of hard to see stent deployments, and assessment of apposition, stent strut symmetry, side branch interaction, dissection, thrombus formation. Diagnostic applications could include plaque luminal characterization for better device selection, endothelization of prior placed stents.
Targeting Treatment Gaps
CLOSING MANUFACTURING GAPS
To create an imaging device with micro-small components that can enter vessels and provide high-definition, real-time views of obscured lesions and at-risk plaques, requires closing manufacturing gaps by scaling up semi-conductor level manufacturing with highly precise robotics.
VerAvanti is an R&D intensive company developing unique components, software, electronics and robotic manufacturing processes. Engineering endoscopes with micro small probes.
Because the clinical dimensions of the device are too small for conventional manufacturing and larger than most semiconductor techniques, there is a “manufacturing gap” in the current market. To address this VerAvanti has establishedan in-house MEMS manufacturing and ISO-Class 8 Cleanroom assembly using robotic work cells. This enables precision-level quality and de-risks the product by minimizing direct human labor and standardizing assembly.
- June - Awarded $286K NIH Research, Phase 1 Grant. entitled “Optical visualization to efficiently guide coronary intervention of chronic total occlusion”
- May - Awarded $300k NIH Research, Phase 1 Grant entitled “4-Channel Multimodal Ultrathin-Flexible SFE for cancer diagnosis and therapy”
- April – Established in-house MEMS production facility.
- SFE console design complete.
- Quality system certified to ISO 13485 by Notified Body (DEKRA). SFE console design complete.
- David Auth, PhD joined VerAvanti board of directors.
- Patent Issued: "Closed Loop Optical Feedback Synchronization System for Imaging Application" (9,258,108)
- Scale-ready infrastructure, implemented including quality systems, NetSuite ERP, CRM, an accounting system and other automated business processes
- Established Clinical Advisory Board.
- Begin development of automated catheter production.
- Identified and retained sales executives for USA and Europe with known track records.
- Design Concept – Coronary / Peripheral Scanning Fiber Endoscope
- Established manufacturing clean-room environment that operates at Class ISO 8 levels.
- Established corporate offices and R&D center of excellence.
- VerAvanti Inc. founded.
- Acquired exclusive worldwide rights to license SFE technology, consisting of more than 20 patents.
- Hired core development and engineering staff.
- Established automated document control system.