SkyDance is comprised of industry veterans with collective backgrounds that span leading medical device, enterprise software, and vascular access organizations including St. Jude, C.R. Bard, Med-Comp, Medibuy.com, B. Braun, Vascular Pathways, Covidien, Lumitec, and Kimberly Clark.
Chief Executive Officer
Bill is an accomplished medical device executive with significant early-stage start-up and growth companies experience. Bill began his career with CR Bard in the late 1980s as a sales professional and rose to the position of VP Sales. Upon his departure he was part of initially starting PHX, the e-commerce company for Premier (GPO), merging with Medibuy.com and eventually purchased by GHX, the eCommerce engine for Healthcare today. Bill then transitioned over to helping to start Venetec international growing revenue from $1M to $36M over 5 years, and then was instrumental in selling the company for $168M in 2006.
Bill then joined Access Scientific and was engaged in strategic partner formation and capital acquisition. Completing a pre-FDA non-significant risk trail, Bill developed and implemented the go-to-market field strategy leading Access Scientific to be purchased by Smiths Medical.
He then joined Vascular Pathways managing the commercialization efforts to bring three individual vascular access devices to market. Engaged in-field testing and product development, FDA submission, and 510(k) approval, sales and clinical force inception and success expansion, Bill turned the company around leading to a successful exit of $105M and a 4x return for key investors.
Chief Clinical Officer
Michael Anstett is an accomplished clinician, corporate executive, armed services veteran, and entrepreneur. Michael’s clinical career spans nearly 30 years.
Starting his career as US Army Combat Medic, he went on to receive his nursing degree 1994 and became a board-certified in infusion therapy and vascular access. He was the nurse manager over vascular access at a level one trauma center in Tampa, FL.
In 2005, Michael founded his private practice Professional Infusion Consultants, Inc. which later sold in 2012. He then served as the Director of Clinical Operations at Medical Components, Inc. where he supported all aspects of the company’s business including R&D of new products, business development, clinical education, regulatory.
Michael is named on multiple medical device patents. He is a member and strong supporter of the Association for Vascular Access (AVA) and has lectured at both local and national AVA conventions. Michael is published in JAVA 2003 and won clinical manuscript for that year.
He is the Founder of SkyDance Vascular, Inc. and the inventor of the Osprey vascular access device.
Chief Technology Officer
John’s career spans more than 25 years in engineering management, technology design, and research and development. After earning a Master’s Degree in Engineering Management from Stanford University, John spent his early career in Silicon Valley.
John’s is currently the Chief Technology Officer with SkyDance Vascular leading R&D and design efforts on the groundbreaking Osprey catheters, the first and only through-the-needle catheter delivery system..
Prior to joining SkyDance John was founder and CEO of Lumitec, a leader in the design, and manufacture of specialized LED lighting devices for marine, industrial, and law enforcement applications. Recognized for 8 consecutive years on Inc. Magazines prestigious “Fastest Growing Private Companies” list, Lumitec has been a frequent winner of industry Innovation Awards in the US and Europe. In 2018 John was recognized in 2018 by Florida Governor Rick Scott as an “Entrepreneur of Distinction” for his success in building a technology company with local manufacturing and global distribution. John sold Lumitec to the Truck-Light corporation in 2019, which continues to value and nurture Lumitec’s culture of innovation and growth.
Prior to starting Lumitec, John serviced in a variety of management roles at various technology hardware and software companies in Palo Alto, CA and Austin, TX.
Senior VP – Operations
Thomas is a senior manufacturing executive with over 25 years of experience, primarily in the medical device industry. Thomas has held various positions of increasing responsibility, including the Director of Engineering at Baxter Healthcare, managing both the manufacturing engineering and the R&D engineering activities, as well as the Senior Vice President of Manufacturing for Covidien’s International Division, managing 20 manufacturing facilities with 8,500 people located throughout Europe, Asia, Africa, and Latin America.
Thomas is a strategic and operational leader with a highly successful career, having played a key role in growing revenues, increasing operational efficiencies, reducing costs, and bringing new products to the market. His training in both Lean manufacturing and Six Sigma has aided his success in creating World Class Manufacturing environments for several businesses.
Thomas has a strong attraction to new or proprietary medical device start-ups and the process of building and leading a cohesive, high-performance operations team to deliver profitable and strong growth results year after year.
Thomas graduated with a Chemical Engineering degree from Rutgers University where he played 4 years of Varsity Wrestling and 1 year of Varsity Tennis. He also received an MBA from Pepperdine University.
Senior VP – Regulatory Affairs & QA
Scott has over 25 years of experience in the global medical device industry with a wealth of experience in global regulator and quality control systems. Most recently, Scott served as the Sr. VP of Regulatory & Quality at Vestagen Protective Technologies, Inc. Prior to that Scott was the Dir. of Regulatory & Quality Systems for WilMarc Medical and VP of Regulatory Affairs & Quality Assurance of Vascular Pathways, Inc. (VPI), leading to their FDA clearances of AccuCath BC and AccuCath EDC IV Catheters, as well as obtaining both organizations EN ISO 13845 and European Union (EU) Medical Device Directive (MDD) Annex II Certifications.
Scott has held multiple leadership positions in regulatory affairs and quality assurance, while throughout his career as both a consultant or within organizations, he has written or managed staff involved with obtaining market clearances, approvals, and/or registrations for hundreds of medical devices globally. Additionally, Scott worked with the Boards of Companies and Executive/Senior Leadership to develop and maintain strategies ensuring compliance with appropriate global regulations (e.g., FDA, Health Canada, EU MDD, Australia TGA, Japan MHLW-PMDA, etc.,). Scott is RAC (US) and ASQ (CQA & CHA) certified, and has served as the EU MDD Management Representative for many of the companies while leading their efforts in obtaining the necessary certifications to CE Mark their devices.
Chief Financial Officer
Dave has more than 30 years of diversified business experience. His background includes working with large, small and start-up companies. He is skilled at developing and executing successful growth strategies, leading forward-looking change management initiatives, identifying and seizing untapped market opportunities and driving both organic and M&A-based expansions.
Dave is a Co-Founder of SkyDance Vascular Inc., co-Founder and President of Verum TCS, a medical device company focused on Vascular Access, and a Founder and Member of SWSA Medical Ventures, a medical device engineering firm focused on improving and inventing innovative solutions to challenges facing the medical community.
Additionally, Dave has worked as the President of Fort Knox Inc. and both the President, Vice President and Chief Financial Officer for Associated Retail Stores, Treasurer and Vice President of Associated Food Stores, and was recruited to be a member of the turnaround team at Clover Club Inc.
His education includes a BS from Weber State University and a Master’s Degree in Business Administration from Utah State University. Dave has served on the boards of the Cancer Wellness House, SUU College of Business and the Utah Heart Association. He was named Humanitarian of the Year by the Muscular dystrophy Association in 2011. Dave is dedicated to education and has been an Adjunct Professor at Weber State University and Utah Valley University where he has taught various technical business courses.
Board of Directors / Healthcare 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
Marketing Advisor
David is a performance-oriented executive with over 30 years of developing successful strategies, driving profits, and increasing market share. Exceptional strategic and tactical ability to unlock the value of a company and leverage it through the correct fundraising mechanisms, proper messaging and branding, and optimal go-to-market strategy. Experience: President and COO; SkyDance Systems, Executive Roles – Cisco, Avaya, Siemens, and Sony.
David is also the founder and CEO of Thasis, LLC which is advising SkyDance. Thasis is a results-oriented consulting and marketing agency with C-level executives who each has over 25+ years’ experience ranging from large companies to startups. Thasis works with growth-oriented companies and corporate divisions to develop or refine strategy, capitalize, brand, promote, and accelerate go-to-market results.
Please reach out to us for more information…
561.573.5360
info@skydancevascular.com
1104 Nassau Street, Suite 107, Delray Beach, FL 33483
This product is not currently for sale. Commercial availability is expected later in 2022 following FDA 510(k) clearance.
No statement on this site has been evaluated by the FDA. At the current time, and until 510(k) clearance is obtained from the FDA, all expressed claims made and/or indicated are exclusively the belief of SkyDance Vascular, Inc. The Company intends to proceed with obtaining FDA 510(k) clearance to support what it believes to be appropriate claims, but until such time as FDA 510(k) clearance is achieved all information on this site, and other Company documents are for informational purposes only.
Website designed by Thasis LLC
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.
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.
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.
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.
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.
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.
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
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.
Designed to deliver fluids more efficiently, lowering the potential risk of chemical damage.
Clinicians risk getting stuck by contaminated needles if the don't actively engage the safety mechanisms.
The needle passively retracts into the housing without the need for the clinician to engage as a separate safety mechanism.
Catheter is on the outside of the needle leading to colonized catheters.
The catheter never touches the skin, minimizing the risk of becoming colonized.
Patient are at risk of needle manipulation. Multiple attempts often require two or more catheters and kits and risk vessel damage.
The Needle does not have to penetrate past the initial entry, improving the likelihood of 1st attempt success and reducing the risk of infiltration.