ivWatch Enters into Agreement with ICU Medical to Offer Customers Interoperability

Agreement will allow ivWatch technology integration into new devices and systems

HAMPTON, Va., October 4, 2018 – ivWatch, the only provider of continuous monitoring devices for the early detection of intravenous (IV) infiltrations and extravasations, entered into a long-term development and commercialization agreement with ICU Medical, a worldwide leader in the development, manufacture and sale of innovative medical devices used in infusion therapy and critical care applications. The collaboration will offer a way forward for Electronic Health Records (EHR) interoperability by connecting the two companies’ systems in order to exchange and use high-quality data.

“Our two companies can optimize our services with the multi-dimensional interchange of data sets to not just improve the continuum of care, but also patient outcomes,” said Gary Warren, president and CEO of ivWatch. “ICU Medical’s expertise in developing IV-EHR interoperability solutions will support our mission to help advance patient safety.”

The current health care atmosphere emphasizes both efficiency and quality, and clinicians are faced with the challenge of doing more with less.

“Interoperability provides significant value to health care organizations with improvements in safety and efficiency,” said Matthew Hutchings, ICU Medical’s senior director of marketing and innovation for IV Systems. “We see a great opportunity to enhance these benefits through our relationship with ivWatch.”

Industry best practices of peripheral IV insertion, maintenance and assessment have been unable to completely address the issue of infiltration/extravasation. A new standard of care is required to minimize injuries associated with this common complication of IV therapy. The use of continuous monitoring technology for earlier identification will more aggressively take on this potential for patient harm.

“Interoperability is essential for customers and often a requirement during the buying decision process,” said Scott Hensley, vice president of sales and business development at ivWatch. “With ivWatch and ICU Medical working together, we can reach more patients and assist institutions with keeping patients safe from preventable harm and drug delivery errors.”

To learn more about ivWatch, visit www.ivWatch.com.

About ICU Medical:
ICU Medical, Inc. (Nasdaq: ICUI) is one of the world’s leading pure-play infusion therapy companies with global operations and a wide-ranging product portfolio that includes IV solutions, IV smart pumps, dedicated and non-dedicated IV sets and needlefree connectors, along with pain management and safety software technology designed to help meet clinical, safety and workflow goals. In addition, the company manufactures automated pharmacy IV compounding systems with workflow technology, closed systems transfer devices for hazardous IV drugs, and cardiac monitoring systems to optimize patient fluid levels. ICU Medical is headquartered in San Clemente, California. On February 3, 2017, ICU Medical completed the acquisition of the Hospira Infusion Systems business from Pfizer. More information about ICU Medical, Inc. can be found at www.icumed.com.

About ivWatch:
ivWatch, LLC is the leading medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is focused on our company vision of eliminating patient harm caused by infiltrations and extravasations. Through our innovative monitored IV solutions, we help minimize the risks associated with adverse IV events. Follow us on Twitter @ivWatch or Facebook @ivWatchLLC. www.ivwatch.com

MEDIA CONTACTS

ivWatch: Amara Betoney, amara.betoney@ivwatch.com, Direct (757) 224-2606, Office (855) 489-2824 x7007, Mobile (757) 660-4949

ICU Medical, Inc.: Tom McCall, tmccall@icumed.com, 949-366-4368

ivWatch Continues to Expand Global Patent Portfolio

New European and Japanese grants bring total to seven owned patents 

HAMPTON, Va., October 2, 2018 – ivWatch, the only provider of continuous monitoring devices for the early detection of intravenous (IV) infiltrations and extravasations, received two patents granted by the European and Japanese Patent Offices expanding their intellectual property (IP) portfolio.

The granting of European Patent No. 2830488 provides protection of the geometry of optical components in a manner that maximizes signal response from deep tissue while minimizing the size of the sensor. This European grant comes on the heels of the company announcing the CE marking of the ivWatch Model 400, a medical device that provides early detection of a frequent and common IV therapy complication. The company is also pursuing this granting at the national stage in several countries as part of their global expansion plan.

“ivWatch continues to heavily invest in the research and development of our biosensor platform. This investment in our talented engineers, scientists and tooling has produced a rich intellectual property portfolio of applications and grants and is allowing a pipeline of great products to address unmet needs in medicine in a way that has never been done before,” said Gary Warren, president and CEO of ivWatch. “As we continue to execute on our global plan, we must protect our proprietary technology which has secured ivWatch’s position as a first, and only, technology of its kind.”

Japanese Patent Registration No. 6386643 is for a core technology for mitigating the effects of tissue blood volume changes. This is the third granted patent from Japan and corresponds to U.S. Patent No. 9,326,686, for solving motion issues related to continuous PIV therapy monitoring. This patent describes some methods used by ivWatch to extract meaningful signals from biosensors where patient motion produces unwanted noise. ivWatch’s unique method of mitigating the effects of changing tissue blood volume provides a system that minimizes “false” notifications and not contributing to the epidemic of alarm fatigue.

ivWatch now owns seven patents around the world corresponding to three core technologies. More than 90 utility patent applications have been filed to date, including 59 domestic patent applications, eight international patent applications and 26 regional/national applications.

To learn more about ivWatch, visit www.ivWatch.com.

About ivWatch:
ivWatch, LLC is the leading medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is focused on our company vision of eliminating patient harm caused by infiltrations and extravasations. Through our innovative monitored IV solutions, we help minimize the risks associated with adverse IV events. Follow us on Twitter @ivWatch or Facebook @ivWatchLLChttps://www.ivwatch.com/

MEDIA CONTACT: Amara Betoney, amara.betoney@ivwatch.com, Direct (757) 224-2606, Office (855) 489-2824 x7007, Mobile (757) 660-4949

Nationwide Children’s Hospital Becomes First in Columbus with Continuous IV Monitoring Technology

Recent product implementation adds a new layer of care

COLUMBUS, Ohio, September 13, 2018 – Patients at Nationwide Children’s Hospital, one of America’s largest not-for-profit freestanding pediatric health care systems, now have the latest enhancement for intravenous (IV) therapy with the installation of the ivWatch Model 400.

The ivWatch Model 400 is a first-of-its-kind and FDA-cleared device that continuously monitors peripheral IV sites. The device, which is being implemented in the operating room at Nationwide Children’s, provides early detection of inadvertent leakage of fluid or medication from the vein into the surrounding tissue.

“Patients receiving IV therapy during surgery can be at risk for IV complications as the IV site is often not accessible for visual and tactile assessment during the procedure,” said Scott Hensley, vice president of sales and business development at ivWatch.

When the ivWatch system detects a leakage, known as an infiltration, it alerts the medical team to inspect the IV site or supports their own evaluation that an infiltration has occurred.

“Nationwide Children’s is the first institution in Columbus and among the leading pediatric hospitals in the country to adopt ivWatch infiltration detection technology,” said Hensley. “Our goal is to provide a technology platform that offers real-time patient monitoring to support Nationwide’s commitment to delivering the highest quality care and creating the best outcomes for children.”

Approximately 80 percent1 of hospital patients in the U.S. receive peripheral IV therapy during a visit or extended stay. A continuous monitoring solution can provide confidence to clinicians that their patients will be protected from infiltration harm. Clinical studies confirm the device has the capability of detecting these events in as little as 0.22 mL of IV fluid with average detection of an infiltration at just over 3 mL of IV fluid.2

To learn more about ivWatch, visit www.ivWatch.com.

Helm, R. E., Klausner, J.D., Klemperer, J.D., Flint, L.M., and Huang, E. (2015). “Accepted but Unacceptable: Peripheral IV Catheter Failure.” Journal of Infusion Nursing, 38(3), 189-203.

ivWatch Internal Document: DR-1001024: Device Validation for Infiltrated Tissues

About Nationwide Children’s Hospital:
Named to the Top 10 Honor Roll on U.S. News & World Report‘s 2018-19 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric health care systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents, as well as adult patients with congenital disease. Nationwide Children’s has a staff of more than 13,000 providing state-of-the-art pediatric care during more than 1.4 million patient visits annually. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded freestanding pediatric research facilities. More information is available at NationwideChildrens.org.

About ivWatch:
ivWatch, LLC is the leading medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is focused on our company vision of eliminating patient harm caused by infiltrations and extravasations. Through our innovative monitored IV solutions, we help minimize the risks associated with adverse IV events. Follow us on Twitter @ivWatch or Facebook @ivWatchLLChttps://www.ivwatch.com/

MEDIA CONTACT: Amara Betoney, amara.betoney@ivwatch.com, Office (855) 489-2824 x7007, Mobile (757) 660-4949

ivWatch Receives CE Mark for the ivWatch Model 400

Recent regulatory approvals and global certification pave the way for international distribution 

HAMPTON, Va., August 29, 2018 – ivWatch, the only provider of continuous monitoring devices for the early detection of intravenous (IV) infiltrations and extravasations, announced the CE marking of the ivWatch Model 400. In addition to conforming to European standards, the company obtained ISO 13485:2016 Certification through the Medical Device Single Audit Program (MDSAP), a global standard for medical device quality management systems. The first-of-its-kind and FDA-cleared device is currently sold in the U.S. through direct sales by ivWatch utilizing group purchasing contracts from Premier and Vizient, Inc.

“Peripheral IV therapy is among the most common invasive hospital procedures performed worldwide. Having the ability to extend the only surveillance monitoring technology for early detection of these common IV complications to new markets will help improve patient safety and effectiveness of IV therapy on a much larger scale,” said Gary Warren, president and CEO of ivWatch. “Navigating the comprehensive process to secure these regulatory milestones not only makes ivWatch positioned for growth but gives us the ability to respond quickly to new opportunities.”

MDSAP enables medical device manufacturers to contract with an authorized third-party auditing organization to conduct a single audit which satisfies all regulatory authorities in a given market. In addition to the U.S. FDA, other authorities participating in the program include those in Australia, Brazil, Canada and Japan. These achievements come only weeks after ivWatch was issued a medical device license by Health Canada, and supports an ongoing licensing and distribution partnership with Terumo Corporation in Japan.

Because the ivWatch Model 400 continuously monitors the IV site, it offers a significantly improved measure of security to a standard, unmonitored peripheral IV, thereby also reducing costs associated with wasted medications and adverse events. Reliable early detection and notifications of infiltration is the next step for improving patient outcomes during IV therapy.

To learn more about ivWatch and the Model 400, visit www.ivWatch.com.

About ivWatch:
ivWatch, LLC is the leading medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is focused on our company vision of eliminating patient harm caused by infiltrations and extravasations. Through our innovative monitored IV solutions, we help minimize the risks associated with adverse IV events. Follow us on Twitter @ivWatch or Facebook @ivWatchLLChttps://www.ivwatch.com/

MEDIA CONTACT: Amara Betoney, amara.betoney@ivwatch.com, Direct (757) 224-2606, Office (855) 489-2824 x7007, Mobile (757) 660-4949

 

Speakers Highlight Quality Improvement and Patient-Centered Care Using ivWatch Technology

Fall speaking schedule delivers opportunities to hear from ivWatch experts and end-users

HAMPTON, Va., August 23, 2018 – Representatives and customers of ivWatch, the only provider of continuous monitoring devices for the early detection of intravenous (IV) infiltrations and extravasations, will share their experience and discuss current projects at several upcoming association events in multiple health care segments including vascular access, pediatrics and person-centered care.

  • On September 14, panelists from Cincinnati Children’s Hospital and Medical Center will participate in a pre-conference symposium at the Association for Vascular Access (AVA) 2018 Annual Scientific Meeting. Sylvia Rineair MSHA, BSN, RN, VA-BC, clinical director of the Vascular Access Team will be joined by Lindsay Cipriani MSN, RN, M. Ed., an education specialist in the Pediatric Intensive Care Unit (PICU), to discuss a quality improvement project using the ivWatch Model 400 for early detection of peripheral IV complications.
  • On September 18, ivWatch Chief Nursing Officer, Susan Brown MSN, MSED, VA-BC, will facilitate a session at AVA’s 2018 Annual Scientific Meeting titled, “Improve Early Detection of Infiltration and Extravasation Events: Training Non-Vascular Access Team Members on Proven Methods, Protocols, and Technology.”
  • On September 26, all interested parties can register to hear from leaders at Cincinnati Children’s Hospital Medical Center during the webinar, “Paving the Way: Early Detection Technology – PIVIE Harm Reduction” hosted by the Children’s Hospital Association (CHA).
  • On September 28-29, Brown will present at the Emergency Nurses Association (ENA) Annual Conference on “IV Infiltration and Extravasation Risks and Early Detection” covering required skills and tools in the emergency setting for IV therapy care from intake to discharge/transfer.
  • On October 9, Brown will present at the Planetree International Conference on Person-Centered Care. She will discuss improving patient experiences during the session “New Standard of Care for PIVs, Improving Patient Outcomes by Early Detection of Infiltrations for High-Risk Patients.”

“I am thrilled to have been accepted to speak at some of the medical industry’s best trade shows to share what I’ve learned throughout my career, educate future leaders on the new advancements in vascular access, as well as promote the successes of our customers and the quality improvements offered to their patients,” said Brown, whose clinical background is in pediatrics. “Every opportunity we have to speak to hospital leadership and the nurses on the frontlines, the closer we are to keeping more people safe from preventable IV harm.”

Infiltration studies are available, and the awareness of the issue is growing, yet, it remains an underreported occurrence. ivWatch is committed to education on the prevalence of IV complications, identifying the risks of infiltration, assessment methods and how ivWatch technology fits into clinical workflows to improve patient safety and outcomes. The company also sponsors a website that focuses on simplified IV information, myIV.com, which provides resources to medical staff for their patients.

To learn more about ivWatch and upcoming event participation, visit www.ivWatch.com/events/.

About ivWatch:
ivWatch, LLC is the leading medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is focused on our company vision of eliminating patient harm caused by infiltrations and extravasations. Through our innovative monitored IV solutions, we help minimize the risks associated with adverse IV events. Follow us on Twitter @ivWatch or Facebook @ivWatchLLChttps://www.ivwatch.com/

MEDIA CONTACT: Amara Betoney, amara.betoney@ivwatch.com, Direct (757) 224-2606, Office (855) 489-2824 x7007, Mobile (757) 660-4949

Health Canada Issues Medical Device License to ivWatch

Surveillance monitoring to advance IV therapy care now available in Canada

HAMPTON, Va., August 2, 2018 – ivWatch, the only provider of continuous monitoring devices for the early detection of intravenous (IV) infiltrations and extravasations, was recently issued a medical device license (MDL) by Health Canada permitting the company to sell the ivWatch Model 400 to Canadian health care organizations.

“This is yet another milestone allowing more medical care providers and patients access to a first-of-its-kind technology to minimize harm from peripheral IV infiltration/extravasation events (PIVIEs),” said Scott Hensley, vice president of sales and business development at ivWatch. “Canada is one of the most progressive health care markets in the world and acknowledge PIVIEs as serious safety events. Clinicians understand the need for surveillance monitoring to improve patient safety.”

Every infiltration is a medication dosing and delivery error that can impact the patient through prolonged hospital stays, temporary harm or permanent injuries. Beyond the patient safety impact, any of these adverse events may result in increased expenses, significant legal risk and reputation damage for health care providers and facilities.

“We’re excited to work with health systems and pediatric hospitals who have quality improvement measures in place and stand ready to implement technology capable of drastically reducing the time to detect a PIVIE beyond what is currently possible by visual and tactile assessment,” said Hensley.

The MDL is the final step for Canadian market entry and was preceded by the company’s achievement of ISO 13485 Certification, the global standard for medical device quality management systems (QMS) developed by the International Organization for Standardization (ISO).

To learn more about ivWatch and the Model 400, visit www.ivWatch.com.

About ivWatch:
ivWatch, LLC is the leading medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is focused on our company vision of eliminating patient harm caused by infiltrations and extravasations. Through our innovative monitored IV solutions, we help minimize the risks associated with adverse IV events. Follow us on Twitter @ivWatch or Facebook @ivWatchLLChttps://www.ivwatch.com/

MEDIA CONTACT: Amara Betoney, amara.betoney@ivwatch.com, Direct (757) 224-2606, Office (855) 489-2824 x7007, Mobile (757) 660-4949

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