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Skydance Vascular Announces Issuance Of New U.s. Patent

New patent provides additional safety measures for the use of Peripheral Intravenous Catheters (PIV)

DELRAY BEACH, Florida (November 16, 2021) – SkyDance Vascular (“SkyDance” or “the Company”), a newly formed medical device company dedicated to reimagining the Peripheral Intravenous Catheter (PIV), today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for SkyDance’s patent application No. 17/244,898, strengthening the Company’s claim that its products are designed to reduce the number of known complications associated with the traditional PIV’s.

The patent, entitled “Retractable Needle Catheter Delivery Apparatus”, will have 13 claims covering aspects of the Company’s proprietary product that was designed to reduce contamination, improve safety, and extend catheter dwell times.

“This intellectual property approval is an important milestone that provides significant differentiation from any existing or emerging competitive product aimed at improving catheter safety,” said Bill Bold, CEO. “This represents the strategic foundation underpinning our product roadmap and provides important validation for our Osprey platform. We are very excited to extend our unique and patent-protected technology to patients.”

Mike Anstett, RN, VA-BC, Co-Founder and Chief Clinical Officer, commented, “This patent allowance by the USPTO is a significant milestone in the evolution of the Osprey catheter. And, along with our recent clinical validations, SkyDance is poised to create an entirely new category within vascular access.”

Russ Nassof, Executive Vice President of RiskNomics, LLC commented, “Osprey peripheral vascular access catheter appears to reduce the opportunity for adverse events resulting from potential infection, vessel trauma, and catheter failure all of which are potential indications of a failure to meet the evidence-based standard of care. To the extent that the Osprey vascular access catheter is a viable technology, these improvements may have a significant impact upon the prevention of adverse events with minimal risk, cost, liability, and training. It may result in changing the standard of care and improving patient outcomes.”

The Company is targeting for FDA 510k clearance early next year and expects to commercialize the solution in Q2 2022.

About SkyDance Vascular

SkyDance Vascular, founded in 2017, is working to redesign the Peripheral Intravenous Catheter (PIV). Its new family of products, the Osprey catheter delivery system, will be launched in the first half of 2022 and is expected to provide a positive impact on PIV outcomes by utilizing uniquely designed features such as Skin Avoidance Technology, Contoured Directional Flow Tipping, and Passive Needle Retraction. Its goal is to deliver greater first-attempt success and lower complication rates, improved dwell times, greater completion of therapy rates, and increased patient satisfaction. The company has assembled an executive leadership group comprised of individuals with decades of executive, clinical, regulatory, and engineering experience, and who together have successfully built other companies in the vascular access space. For more information, visit https://www.skydancevascular.comor …

Contact Bill Bold at bill.bold@skydancevascular.com.

LinkedIn: https://www.linkedin.com/company/40779227.

About Russel S. Nassof

Mr. Nassof is an attorney who has been involved in the fields of health risk consulting and clinician education for over 20 years concentrating his work in the areas of infection prevention, and risk/liability minimization for healthcare and environmental risk. He has presented hundreds of seminars and webinars to legal, insurance, loss control, healthcare, and risk management groups throughout the United States, Canada, Europe, and Asia. Mr. Nassof has been involved as a consulting/testifying expert on such diverse events as recent outbreaks of Legionnaires’ Disease, Middle East Respiratory Syndrome (MERS), and Ebola, his passion is focused on managing risk and liability for vascular catheter-associated risk and was the first non-clinician elected to the AVA Board of Directors and also served as a reviewer on the 2016 INS Standards. He has coauthored books on environmental/healthcare issues, holds a patent on a fungal sensing device and recently developed a peripheral catheter matrix addressing clinician best practice issues and liability minimization. Mr. Nassof received his Juris Doctorate and undergraduate degrees from Emory University in Atlanta and currently serves as the AVA National Treasurer.

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Bill Bold

SkyDance Vascular, Inc.

bill.bold@skydancevascular.com

561-573-5360

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561.573.5360

info@skydancevascular.com

1104 Nassau Street, Suite 107, Delray Beach, FL 33483

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SkyDance Vascular, Inc. announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the Osprey Peripheral IV Catheter System (OspreyIV), a revolution in peripheral vascular access. The Company also announced additional patent awards from the United States Patent and Trademark Office (USPTO), strengthening the Company’s claim that its products are designed to reduce the number of known complications associated with the traditional PIVC’s. The product is shipping now in limited supplies.

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Phlebitis and Infiltration

Phlebitis (Rate: 22.7%) and Infiltration (Rate: 23.9%) are the result of inflammation, erosion, or the penetration of the catheter into or through the venous wall.1 Phlebitis and Infiltration can result from loss of surrounding venous wall integrity due to the inflammatory effects of wall shear stress by rapid infusions, chemical injury by caustic infusions, or needle / catheter injury incurred at the time of initial insertion. *

OspreyIV Feature – Contoured Directional Flow

Phlebitis and Infiltration can result from the inflammatory effects of wall shear stress induced by rapid infusions, chemical injuries induced by caustic infusions, or trauma caused by the needle or catheter at the time of initial insertion.

Contoured Directional Flow is designed for atraumatic initial catheter advancement. Once an infusion is initiated, the off-axis opening is intended to deliver fluids away from the delicate vein wall minimizing vessel wall shear stress

* Source references available upon request.

White Papers

The following White Papers are available for download

ADVANCING TOWARD THE EXPANSION OF CATHETER-RELATED BLOOD STREAM INFECTION REPORTING TO INCLUDE PIVS

There are an estimated 200 million PIVs placed per year in the United States. These catheters come with significant risks including hospital-acquired bloodstream infections. Recent studies show these infections occurring at an alarming rate. However, because of inconsistent coding and voluntary reporting, the fiscal and clinical impact on healthcare is likely larger than our current understanding. To begin to control these costs and create a safer patient environment it is expected that the Health and Human Services department of the CDC will mandate surveillance and reporting within the upcoming months.
The full whitepaper is available for download here. Download White Paper

Poor Procedural Success

A typical intravenous catheter (over the needle) consists of an inner needle and an outer catheter. Current intravenous catheters on the market have a gap between the outer catheter and the inner needle, the outer catheter also has a tapering or shoulder. This shoulder creates a significant change in push force. When intravenous catheters require greater penetration force, practitioners may push the wall of the blood vessel ineffectively, resulting in unsuccessful catheterization.

In a pilot study involving staff from 2 medical units, 3 surgical units, 2 pediatric units, and 2 intensive care units, data were collected from 371 patients. The mean number of IV insertion attempts was 2.18 (SD = 1.83) Number of attempts ranged from 1 to 14. 27% of patients required three or more insertion attempts.

OspreyIV – Bevel Only Technique

The traditional PIVC insertion sequence includes entering the vessel with the bevel of the needle and obtaining a blood flash. The angle is then lowered and further advanced, so the catheter enters the vessel as well. These manipulations often lead to unsuccessful insertion attempts.

The catheter of the Osprey IV is within the needle. As the needle enters the vessel, so does the catheter without further device advancement or re-positioning. Bevel Only Technique is designed to promote high procedural success rates.

PIV Related Bloodstream Infections

PIV related bloodstream infections pose a serious risk to hospitalized patients. These infections occur because a contaminant was introduced at some point during the use of the catheter. It is critical to understand the mode of contamination and the timing of the subsequent infection in order to formulate strategies to mitigate these risks.
The full whitepaper is available for download here.
Download White Paper

Clinical Summary

PIVs are an irreplaceable tool within intravenous therapy. They are the most commonly placed vascular access device in healthcare. However, the traditional PIV design of mounting a catheter over a needle leaves the catheter exposed to bacteria on and within the skin. This bacteria contaminates the external surface of the catheter during insertion, matures on the catheter within the biofilm, and ultimately becomes large enough to break free and cause a bloodstream infection. To truly break this cycle, physical barriers must be in place to avoid catheter – skin contact during insertion. The Osprey by SkyDance Vascular is the only vascular access device to provide catheter protection during insertion.
The full whitepaper is available for download here.
Download White Paper

Needlestick Injuries

The Occupational Safety and Health Administration (OSHA) estimates that 5.6 million workers in the health care industry and related occupations are at risk of occupational exposure to bloodborne pathogens, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and others.  Each year, hospital-based health care workers sustain an estimated 384,000 percutaneous (skin puncture) injuries from needles and other sharp devices or more than 1,000 injuries per day. As many as one-third of all sharps injuries occur during the disposal of the device. *

OspreyIV Feature – Passive Needle Retraction

The Occupational Safety and Health Administration (OSHA) reports as many as one-third of all sharps injuries occur during disposal of the device.

Passive Needle Retraction is designed to eliminate exposure to post-procedure sharps. Once the catheter is fully advanced, the needle automatically retracts into the housing. It is then safely and permanently retained without any sharps to transport for disposal.

* Source references available upon request.

Contamination and Infection

Staphlococcus aureus (S.aureus) is a normally occurring bacteria on and within human skin, within hair follicles, and within sebaceous glands.* It has been identified as one of the most common causes of hospital associated bloodborne infections.*


S.aureus cannot be removed from all layers of the skin prior to a PIV insertion. Most antimicrobial agents effectively eradicate bacteria from the surface but not from the stratum corneum. The rates of eradication from the stratum corneum after surface treatment with 70% ethanol chlorhexidine-ethanol and povidone-iodine were not statistically different from those of the control sites (no surface treatment at all). *


It is understood vascular access devices (PIVCs) may be contaminated by infectious bacteria during insertion by the catheter coming in direct contact with bacterial flora throughout the layers of the skin. This bacterium adheres to the extraluminal surface of catheter, forms large microcolonies, and ultimately detaches into the blood stream to cause infection.3, 7 10-50% of hospital related S. aureus bloodborne infections are associated with PIVCs.2 Infections rates for PIVCs have been reported as high as 1.45%.*

OspreyIV Feature – Skin Avoidance Technology

It is understood vascular access devices such as PIVCs may be contaminated by infectious bacteria during insertion by the catheter coming in direct contact with bacterial flora throughout the layers of the skin. 

The Osprey IV deploys the catheter through-the-needle rather than over-the-needle. This unique design is intended to form a physical barrier between the catheter and harmful bacteria on and within the skin and protect the catheter from insertion related contamination.

* Source references available upon request.

Contamination and Infection

A typical intravenous catheter (over the needle) consists of an inner needle and an outer catheter. Current intravenous catheters on the market have a gap between the outer catheter and the inner needle, the outer catheter also has a tapering or shoulder. This shoulder creates a significant change in push force. When intravenous catheters require greater penetration force, practitioners may push the wall of the blood vessel ineffectively, resulting in unsuccessful catheterization.

In a pilot study involving staff from 2 medical units, 3 surgical units, 2 pediatric units, and 2 intensive care units, data were collected from 371 patients. The mean number of IV insertion attempts was 2.18 (SD = 1.83) Number of attempts ranged from 1 to 14. 27% of patients required three or more insertion attempts.

Bloodstream Infections

While healthcare professionals disinfect the skin surface prior to each PIV or EDC insertion, the skin still remains a point of possible infection. Simply put, the skin surface cannot be fully sterilized in preparation for catheter insertion. Furthermore, 20% of the normal skin flora resides below the skin surface, in hair follicles and sweat glands. Therefore, all traditional PIV and EDCs are at inherent risk because they come in direct contact with residual skin flora during each insertion. Flora such as S. aureus adheres to the catheter surface, grows and aggregates into microcolonies, ultimately breaks off into the bloodstream and a catheter-related bloodborne infection is the result. In published studies, colonization of vascular access devices passing through the skin during insertion ranged from 17% – 57.6%.

These infections place the patient at significant risk including developing sepsis and at times, death. It is thought that mandatory CMS reporting will occur within 6-12 months and treatment of these hospital-acquired infections could be subject to non-reimbursement by the Centers for Medicare & Medicaid Services (CMS) at a non-reimbursed average of $30,000 per case. Recent studies indicate that over 36% of catheter blood infections are related to PIVs, with an estimated 200,000 PIV bloodborne infections per year in the U.S., amounting to nearly $6B annual cost.

SkyDance will address bloodstream infections with our Skin Avoidance Technology.
Skin Avoidance Technology

Insertion Success Rate And Vessel Damage

Current catheter designs rely on the needle acting as a “rail” for the correct placement of the catheter, which often results in the damage or perforation of the innermost layer of the vessel known as phlebitis. This damage can also lead to clot formation which may block the flow of fluid out of the catheter. When the catheter is advanced over the needle, it is led straight to, and sometimes through the vessel.
This needle advancement can also cause an infiltration, or the infusion of fluids into the surrounding tissue. If the fluid is chemically irritating it can cause harm to surrounding tissue, referred to as an extravasation. Irritants often cause pain and inflammation at the IV site and along the vein path. This issue can ultimately result in tissue sloughing, loss of mobility in the extremity, and infection.
SkyDance will address these complications with our Bevel Only Technique.
Bevel Only Technique

Bloodstream Infections

While healthcare professionals disinfect the skin surface prior to each PIV or EDC insertion, the skin still remains a point of possible infection. Simply put, the skin surface cannot be fully sterilized in preparation for catheter insertion. Furthermore, 20% of the normal skin flora resides below the skin surface, in hair follicles and sweat glands. Therefore, all traditional PIV and EDCs are at inherent risk because they come in direct contact with residual skin flora during each insertion. Flora such as S. aureus adheres to the catheter surface, grows and aggregates into microcolonies, ultimately breaks off into the bloodstream and a catheter-related bloodborne infection is the result. In published studies, colonization of vascular access devices passing through the skin during insertion ranged from 17% – 57.6%.

These infections place the patient at significant risk including developing sepsis and at times, death. It is thought that mandatory CMS reporting will occur within 6-12 months and treatment of these hospital-acquired infections could be subject to non-reimbursement by the Centers for Medicare & Medicaid Services (CMS) at a non-reimbursed average of $30,000 per case. Recent studies indicate that over 36% of catheter blood infections are related to PIVs, with an estimated 200,000 PIV bloodborne infections per year in the U.S., amounting to nearly $6B annual cost.

SkyDance will address bloodstream infections with our Skin Avoidance Technology.
Skin Avoidance Technology

Insertion Success Rate And Vessel Damage

Current catheter designs rely on the needle acting as a “rail” for the correct placement of the catheter, which often results in the damage or perforation of the innermost layer of the vessel known as phlebitis. This damage can also lead to clot formation which may block the flow of fluid out of the catheter. When the catheter is advanced over the needle, it is led straight to, and sometimes through the vessel.

This needle advancement can also cause an infiltration, or the infusion of fluids into the surrounding tissue. If the fluid is chemically irritating it can cause harm to surrounding tissue, referred to as an extravasation. Irritants often cause pain and inflammation at the IV site and along the vein path. This issue can ultimately result in tissue sloughing, loss of mobility in the extremity, and infection.

SkyDance will address these complications with our Bevel Only Technique.
Bevel Only Technique

Inefficient Fluid Delivery

Because of the over-the-needle design, traditional PIVs are forced to deposit infusions directly from their distal tip and along the sensitive inner lining of the vessel. These infusions can damage this lining and chemically cause inflammation, loss of PIV function, and ultimately PIV failure. To mitigate these complications, infusions should be directed away from the inner lining of the vessel and into its center of the vessel where comparatively faster blood flow dilutes the infusions and protects the vessel. SkyDance will address these complications with our Contoured Directional Flow.
Contoured Directional Flow

Needlestick Injuries

Needlestick injuries are wounds caused by needles that accidentally puncture the clinician’s skin. These injuries are a hazard for people who work with catheters and can occur at any time when healthcare workers use, disassemble, or dispose of the catheter.

A needle stick can cause serious issues to a clinician emotionally and physically by transmitting infectious diseases, especially blood-borne viruses. Concern includes the Human Immunodeficiency Virus (HIV) which leads to AIDS (Acquired Immune Deficiency Syndrome), hepatitis B, and hepatitis C. Injuries have also transmitted many other diseases involving viruses, bacteria, fungi, and other microorganisms to health care workers. SkyDance will address these complications with our Passive Needle Retraction.
Passive Needle Retraction

Poor Procedural Success

A typical intravenous catheter (over the needle) consists of an inner needle and an outer catheter. Current intravenous catheters on the market have a gap between the outer catheter and the inner needle, the outer catheter also has a tapering or shoulder. This shoulder creates a significant change in push force. When intravenous catheters require greater penetration force, practitioners may push the wall of the blood vessel ineffectively, resulting in unsuccessful catheterization. *

In a pilot study involving staff from 2 medical units, 3 surgical units, 2 pediatric units, and 2 intensive care units, data were collected from 371 patients. The mean number of IV insertion attempts was 2.18 (SD = 1.83) Number of attempts ranged from 1 to 14. 27% of patients required three or more insertion attempts. *

OspreyIV Feature – Bevel Only Technique

The traditional PIVC insertion sequence includes entering
the vessel with the bevel of the needle and obtaining a blood flash. The angle
is then lowered and further advanced, so the catheter enters the vessel as
well. These manipulations often lead to unsuccessful insertion attempts.

The catheter of the Osprey IV is within the needle. As the
needle enters the vessel, so does the catheter without further device
advancement or re-positioning. Bevel Only Technique is designed to promote high
procedural success rates.


* Source references available upon request.

Sharon Luboff

Board of Directors / Advisor

Sharon is a career medical device executive with over 30 years of success across multiple therapeutic areas and geographies. Key achievements in international expansion, business development, strategic repositioning and turnaround, and bringing new technologies through the development process and into commercialization. Broad functional expertise and proven leadership capabilities. Experience: Operating Partner; Altamont Capital, Group Vice President; CR Bard, Vice President; Baxter Healthcare

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Inefficient Fluid Delivery - Today

As PIV/EDC catheters advance during insertion, it is belived that the catheter lays along the bottom of the vien delivering fluid that could cause harm to the areas it touches.

Contoured Directional Flow

Designed to deliver fluids more efficiently, lowering the potential risk of chemical damage.

Needle Stick Injuries - Today

Clinicians risk getting stuck by contaminated needles if the don't actively engage the safety mechanisms.

Passive Needle Retraction

The needle passively retracts into the housing without the need for the clinician to engage as a separate safety mechanism.

Bloodstream Infections - Today

Catheter is on the outside of the needle leading to colonized catheters.

Skin Avoidance Technology

The catheter never touches the skin, minimizing the risk of becoming colonized.

Vessel Damage - Today

Patient are at risk of needle manipulation. Multiple attempts often require two or more catheters and kits and risk vessel damage.

Bevel Only Technique

The Needle does not have to penetrate past the initial entry, improving the likelihood of 1st attempt success and reducing the risk of infiltration.