SkyDance Vascular
SkyDance Vascular, Inc., founded in 2017, is dedicated to reimagining peripheral vascular access with innovative products such as the OspreyIV. The company aims to reduce complications, improve procedural success, and enhance patient and healthcare worker safety through patented technologies including Skin Avoidance Technology, Contoured Directional Flow, Passive Needle Retraction, and Bevel Only Technique. Their mission is to set new standards of care in vascular access and address critical issues like bloodstream infections, vessel damage, and needlestick injuries. The company is actively pursuing FDA 510(k) clearance and plans to launch its new family of products in mid-2022, with a focus on improving clinical outcomes, reducing healthcare costs, and increasing patient satisfaction.
Industries
Nr. of Employees
small (1-50)
SkyDance Vascular
Delray Beach, Florida, United States, North America
Patents
Products
Through-the-needle peripheral IV catheter system
Peripheral intravenous catheter architecture using through-the-needle deployment to minimize catheter–skin contact during insertion and to enable bevel-only insertion methods.
Closed-design peripheral IV catheter system
Closed-system peripheral catheter architecture designed to limit external catheter exposure during insertion and to include contoured tip geometry for directional infusion.
Midline / extended-dwell closed IV catheter system
Extended-dwell midline catheter configuration with closed deployment and materials tested for imaging and high-pressure injector compatibility.
OSPREYIV Midline Closed IV Catheter System
The OspreyIV is a peripheral intravenous catheter system designed to improve safety by eliminating catheter exposure to infection-causing skin bacteria, maintaining needle stick safety, and reducing complications associated with traditional PIVCs. It uses Skin Avoidance Technology to house the catheter inside the needle, creating a physical barrier between the skin and catheter.
Osprey catheter delivery system
The OspreyIV is a peripheral vascular access catheter system designed to reduce complications from traditional catheter designs by incorporating innovative features such as Bevel Only Technique, Skin Avoidance Technology, Passive Needle Retraction, and Contoured Directional Flow.
Osprey Peripheral Intravenous Catheter (Osprey PIVC)
The Osprey PIVC features an innovative off-axis catheter tip design that improves infusate flow away from vein walls, minimizing the risk of vein trauma and complications such as phlebitis, infiltration, and thrombosis. It incorporates Skin Avoidance Technology to reduce bloodstream infections and enhance first-attempt success rates, lower complications, improve dwell times, increase therapy completion rates, and boost patient satisfaction.
Through-the-needle peripheral IV catheter system
Peripheral intravenous catheter architecture using through-the-needle deployment to minimize catheter–skin contact during insertion and to enable bevel-only insertion methods.
Closed-design peripheral IV catheter system
Closed-system peripheral catheter architecture designed to limit external catheter exposure during insertion and to include contoured tip geometry for directional infusion.
Midline / extended-dwell closed IV catheter system
Extended-dwell midline catheter configuration with closed deployment and materials tested for imaging and high-pressure injector compatibility.
OSPREYIV Midline Closed IV Catheter System
The OspreyIV is a peripheral intravenous catheter system designed to improve safety by eliminating catheter exposure to infection-causing skin bacteria, maintaining needle stick safety, and reducing complications associated with traditional PIVCs. It uses Skin Avoidance Technology to house the catheter inside the needle, creating a physical barrier between the skin and catheter.
Osprey catheter delivery system
The OspreyIV is a peripheral vascular access catheter system designed to reduce complications from traditional catheter designs by incorporating innovative features such as Bevel Only Technique, Skin Avoidance Technology, Passive Needle Retraction, and Contoured Directional Flow.
Osprey Peripheral Intravenous Catheter (Osprey PIVC)
The Osprey PIVC features an innovative off-axis catheter tip design that improves infusate flow away from vein walls, minimizing the risk of vein trauma and complications such as phlebitis, infiltration, and thrombosis. It incorporates Skin Avoidance Technology to reduce bloodstream infections and enhance first-attempt success rates, lower complications, improve dwell times, increase therapy completion rates, and boost patient satisfaction.
Services
Design and execution of preclinical animal studies and pilot clinical data collection, with outcomes reported in peer-reviewed journals and white papers.
Regulatory strategy, 510(k) dossier preparation, clinical-protocol development, and submission support for peripheral vascular devices.
Support for patent preparation, filing, and management of device-related IP to protect design and safety features.
Early-stage fundraising support, go-to-market planning, and investor communications to enable market entry and scale.
Development of cost-impact models and hospital-level savings estimates associated with reduced complication rates and improved device performance.
Design and execution of preclinical animal studies and pilot clinical data collection, with outcomes reported in peer-reviewed journals and white papers.
Regulatory strategy, 510(k) dossier preparation, clinical-protocol development, and submission support for peripheral vascular devices.
Support for patent preparation, filing, and management of device-related IP to protect design and safety features.
Early-stage fundraising support, go-to-market planning, and investor communications to enable market entry and scale.
Development of cost-impact models and hospital-level savings estimates associated with reduced complication rates and improved device performance.
Expertise Areas
- Peripheral vascular access device engineering
- Clinical study design and preclinical validation
- Regulatory strategy and 510(k) submissions
- Medical device quality systems and global market registrations
Key Technologies
- Through-the-needle catheter deployment
- Passive needle retraction with retained housing
- Contoured/off-axis infusion tip for directional flow
- Skin-avoidance barrier deployment
News & Updates
SkyDance announced it has received 510(k) clearance from the FDA for its Osprey Midline Closed IV Catheter System, a new extended dwell catheter poised to improve PIVC safety and outcomes.
Peer-reviewed study published, showcasing the clinical benefits of the Osprey Peripheral Intravenous Catheter, including potential to reduce vein trauma.
The company introduces the OspreyV2-20, a significant advancement in vascular access following FDA clearance of previous models.
Received 510(k) clearance from the FDA for the Osprey Midline Closed IV Catheter System.
Published peer-reviewed study highlighting the benefits of the Osprey PIVC in reducing vein trauma.
Received FDA clearance and issued new patents for the OspreyIV catheter delivery system.
SkyDance announced it has received 510(k) clearance from the FDA for its Osprey Midline Closed IV Catheter System, a new extended dwell catheter poised to improve PIVC safety and outcomes.
Peer-reviewed study published, showcasing the clinical benefits of the Osprey Peripheral Intravenous Catheter, including potential to reduce vein trauma.
The company introduces the OspreyV2-20, a significant advancement in vascular access following FDA clearance of previous models.
Received 510(k) clearance from the FDA for the Osprey Midline Closed IV Catheter System.
Published peer-reviewed study highlighting the benefits of the Osprey PIVC in reducing vein trauma.
Received FDA clearance and issued new patents for the OspreyIV catheter delivery system.