ivWatch Announces Issuance of U.S. Patent for Solving Motion Issues Related to Continuous Peripheral IV Therapy Monitoring

Hampton, VA – May 3, 2016 – ivWatch, a medical device manufacturer focused on improving the safety and effectiveness of intravenous therapy (often referred to as an “IV”) through early detection of infiltrations, today announced that the U.S. Patent and Trademark Office has issued to ivWatch a key patent regarding the use of light to detect if fluids are leaking from an IV.

U.S. Patent No. 9,326,686, titled “System and Method for Mitigating the Effects of Tissue Blood Volume Changes to Aid in Diagnosing Infiltration or Extravasation in Animalia Tissue,” includes claims for detecting such leaks while dealing with the physics associated with patient movement.

The technology behind this patent directly relates to the ability of the ivWatch Model 400 to reduce the number of “false” alarms for our product and not contribute to the ongoing issue and syndrome known as “alarm fatigue”.  This serious issue garnished the attention of the Joint Commission back in June 2013, when alarm safety was set as a national patient goal. A recent WSJ article stated that as many as 90% of alarms are false or don’t require any immediate attention.  But when clinicians become desensitized to the alarms, they can overlook the 10% of the notifications that are critical, and lead to fatal mistakes[1].  A common cause of false alarms from devices is due to patient movement.

The ivWatch Model 400 includes a noninvasive sensor that uses near-infrared light to detect changes in the optical properties of tissue seen during an infiltration. Changes in the tissue blood volume associated with patient movement affect the signal primarily by changing the amount of hemoglobin, a dominant absorber, in the underlying tissue. The reading from the sensor is analyzed by the highly intuitive pole-mounted patient monitor. The ivWatch technology is able to analyze and detect infiltrations in common IV therapy settings, allowing the patient to move freely while still being continuously monitored.  The device will notify clinicians if conditions suggest an infiltration, allowing them to address the issue early to help reduce patient harm.

“This latest patent demonstrates the depth of the science behind the ivWatch technology.  You can’t expect a patient to remain still while they are receiving care.  Our breakthrough technology has allowed the ivWatch Model 400 to accurately detect infiltrations without impacting patient mobility,” states Gary P. Warren, CEO of ivWatch.  “We expect the hard work and dedication of the inventors of this patent to have a meaningful contribution to the improvement of patient safety.  Our product provides a new option for medical professionals – a continuously monitored peripheral IV – that can reduce costs, risk, patient harm and medication dosing errors”.

The technology is a core component of the ivWatch Model 400, a FDA cleared device that continuously monitors a patient’s peripheral IV for the early detection of infiltrations, when medication or fluid leaks outside the vein into the surrounding tissue. Peripheral IVs are one of the most common invasive medical procedures performed with over 300 million IV catheters sold in the U.S. annually. Yet, current medical reports peg the failure rate of IVs in excess of 20% due to infiltrations which can cause drug delivery errors and patient harm.

The ivWatch announced U.S. commercial availability of the ivWatch Model 400 in April.  To learn more, visit www.ivWatch.com.

About ivWatch, LLC

ivWatch, LLC is a medical device manufacturer focused on improving the safety and effectiveness of intravenous (IV) therapy. The company’s technology aids clinicians by continuously monitoring a patient’s peripheral IV, providing early detection of IV infiltrations.

[1] (Landro, 2016)

ivWatch Announces Availability of a New Medical Device to Continuously Monitor IVs

The ivWatch Model 400 will improve patient safety through early detection of IV infiltrations and extravasations and provide a new option for IV therapy.

Hampton, Va. — April 5, 2016 — Medical device manufacturer ivWatch, LLC today announced United States availability of the ivWatch Model 400, a device that continuously monitors a patient’s IV for the early detection of infiltrations – when medication or fluid leaks outside the vein into the surrounding tissue.  Peripheral IVs (PIVs) are one of the most common invasive medical procedures performed with over 150 million IV catheters placed in the U.S. annually.  Yet, current medical reports peg the failure rate of IVs in excess of 20% due to infiltrations.  The ivWatch Model 400 was developed to address this unmet need in healthcare.

“A procedure that is this common in healthcare should not have such a high failure rate,” said Gary Warren, CEO at ivWatch. “IV failure due to infiltrations is commonly accepted. We need to make it unacceptable.”

Complications of PIV infiltration range from pain and redness to severe tissue damage and amputation. To avoid IV failure, clinicians have defaulted to using other, more intrusive vascular access devices. Peripherally inserted central catheters (PICC), for example, unfortunately carry other serious risks, such as central-line-associated bloodstream infections, commonly referred to as CLABSIs.

The ivWatch Model 400 represents a new option for medical professionals – a continuously monitored IV – that can allow peripheral IVs to be an appropriate alternative for infusion therapy that can reduce costs, risk, patient harm and medication dosing errors.  The ivWatch Model is the result of more than 16 years of intensive development and clinical testing. The FDA cleared the device for use in 2015.

“It’s like a seatbelt,” said Warren. “Since it’s difficult to predict when an accident will occur, people wear their seatbelt for the duration of their travel. Similarly, since it’s difficult to predict when an infiltration will occur, and we know it occurs too frequently, the ivWatch Model 400 represents a seat belt for patients with an IV. Our continuous monitoring device not only improves patient safety, but can help minimize the risk and avoidable costs for health care provider organizations.”

The device includes a non-invasive sensor that uses visible and near-infrared light to detect changes in the optical properties of the tissue. The sensor is coupled with a highly intuitive, pole-mounted patient monitor.  The device will notify clinicians if conditions suggest an infiltration, allowing them to address the issue early to help reduce patient harm.

 About ivWatch, LLC

Headquartered in Hampton, Virginia, ivWatch is a medical device manufacturer focused on improving patient safety and effectiveness of IV therapy.  The company’s technology aids clinicians by continuously monitoring a patient’s IV, providing early detection of IV infiltrations and extravasations.

Please contact Melissa Fire, Vice President of Sales, for information on pricing and evaluation opportunities at sales@ivwatch.com or 757-817-9040.

Leah Moore

Director of Marketing, ivWatch, LLC

1.855.489.2824 ext. 7031

Leah.Moore@ivwatch.com

ivWatch, LLC Receives 2016 Virginia Governor’s Outstanding STEM Award for Science Innovation

ivWatch, LLC will be honored for their innovative device that provides early detection of IV infiltrations and can help reduce patient harm.

Williamsburg, VA – ivWatch, a medical devices company, is one of five recipients to receive a Virginia Outstanding STEM Award granted by Governor Terry McAuliffe’s office. ivWatch will be receiving the STEM Award for Science Innovation on February 25th at an event to be held at the Science Museum of Virginia. The STEM award honors professionals and business that have made significant contributions to science.

ivWatch is being honored for their ivWatch Model 400, a device that continuously monitors a patient’s peripheral IV for the early detection of infiltrations – when medication or fluid leaks outside the vein into the surrounding tissue. Peripheral IVs are one of the most common invasive medical procedures performed with over 300 million IV catheters sold in the U.S. annually. Yet, current medical reports peg the failure rate of IVs in excess of 20% due to infiltrations which can cause drug delivery errors and patient harm. To address this unmet need, the dedicated ivWatch team delivered an FDA-cleared device in 2015. The ivWatch Model 400 includes a noninvasive sensor that uses near-infrared light to detect changes in the optical properties of the tissue. The sensor is coupled to a highly intuitive pole-mounted patient monitor. The device will notify clinicians if conditions suggest an infiltration, allowing them to address the issue early to reduce patient harm. The ivWatch Model 400 represents a new option for medical professionals – a continuously monitored peripheral IV – that can reduce costs, risk, patient harm and medication dosing errors.

The ivWatch Model 400 is backed by 16 years of research and development in areas that include photon/tissue interaction modeling, signal processing algorithm development and optimization, user interface research and design and extensive clinical testing. Gary P. Warren, CEO of ivWatch and former NASA Engineer says “The depth of science behind the ivWatch product line is truly amazing. For a small company, our research and associated intellectual property in this area rivals anything I have seen coming from large companies, universities or government labs. We have an incredible team of talented people here and are honored by this award.”

ivWatch was also the winner of the Governor’s Virginia Velocity Competition in September 2015 for the best bio-science business plan.

 

Medical and technology leaders advise ivWatch, LLC on devices to improve patient safety

Williamsburg, Va.—December 23, 2015—Nationally recognized experts in fields ranging from anesthesiology to infusion nursing are helping ivWatch, LLC develop next-generation devices to improve patient safety. The five leaders are members of a Clinical Advisory Council for ivWatch, which soon will launch its continuous monitoring device to minimize injuries from intravenous (IV) therapy.

IV infusion is the most common invasive hospital procedure performed worldwide, but IVs can fail as often as half the time. When they fail, fluid or medication enters the surrounding tissue rather than the patient’s vein — a condition called peripheral IV infiltration — resulting in complications that range from pain and redness to severe tissue damage. Because of this failure, clinicians have defaulted to using other more intrusive vascular access devices that have other serious risks, such as central-line-associated blood stream infections, commonly referred to as CLABSIs.

The ivWatch Model 400 enables an IV to be continuously monitored, aiding clinicians in the early detection of infiltrations by automatically notifying them. The FDA has cleared the device for use with adults and it will be available for sale early in 2016.

“Our Clinical Advisory Council includes highly experienced vascular experts and other clinicians who’ve dedicated themselves to the mission of protecting patients,” said Gary Warren, CEO at ivWatch. “Their input has been invaluable in developing our inaugural safety device, and they are active contributors to other technological advances in our pipeline.”

The ivWatch Model 400 includes a patient monitor, a non-invasive sensor using visible and near-infrared light, and a disposable sensor receptacle applied next to the IV site. A color LCD screen displays the status of the IV and an audible notification sounds if an infiltration occurs.

The Clinical Advisory Council members include:

Gregory J. Schears, MD, Advisory Council Chairman and Chief Clinical Officer

Dr. Schears serves in a variety of roles at Mayo Clinic in Minnesota. He is medical director for ECMO Services, a physician liaison for the Nurse PICC Team, co-medical director of the Cardiovascular Pediatric Surgical ICU and a consultant for the Department of Anesthesiology. Dr. Schears also is a practicing pediatric intensivist and anesthesiologist, and serves as an associate professor of anesthesiology at Mayo Clinic College of Medicine.

Lisa Gorski, RN, MS, CS, CRNI

Ms. Gorski — a clinical nurse specialist with Wheaton Franciscan Home Health and Hospice in Wisconsin — is nationally recognized for her expertise in infusion nursing and chronic illness. Ms. Gorski is widely published on the topic of home-infusion therapy, including the 2010 textbook, “Infusion Nursing in Clinical Practice: An Evidence-Based Approach.” She also is past president of the Infusion Nurses Society.

Melissa C. Whitehead, BSN, RN, CPN, CRNI

Ms. Whitehead is clinical manager for seven teams at Children’s Medical Center in Dallas, Texas. Those teams include Vascular Access, the Wound-Ostomy-Continence Program and Patient Care Technicians. Ms. Whitehead is a member of the Association for Vascular Access and the Infusion Nurses Society. She has presented on numerous topics, including common complications of PIV therapy and current methods used to help minimize complications.

Liz Sharpe, RN, DNP

Ms. Sharpe is a neonatal nurse practitioner and educator, with a special interest in vascular access in neonatal and pediatric patients. An assistant professor at the University of Alabama’s School of Nursing, Ms. Sharpe also serves on the board of the National Association of Neonatal Nurses and the Vascular Access Certification Corporation. She is active in the Association for Vascular Access and the Infusion Nurses Society, and is an author, reviewer and consultant on the topic of vascular access.

Steven Bierman, MD, Chief Medical Officer at Access Scientific

Dr. Bierman founded Venetec International in 1996, which set a worldwide safety standard for management of intravascular and urinary catheters. The company sold to CR BARD in 2006. His new company, Access Scientific, LLC, is dedicated to establishing a new standard of over-wire vascular access.

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About ivWatch, LLC

Headquartered in Virginia, ivWatch develops, markets and sells biomedical sensor technology focused on improving patient safety in infusion therapy and vascular access. The company’s inaugural device, the ivWatch Model 400, is a first-of-its-kind continuous monitoring device, cleared by the FDA, which quickly alerts providers of possible peripheral IV infiltration.

The concept for the ivWatch Model 400 originated in 1999, and is the result of more than 14 years of intensive development and clinical testing. These efforts have led not only to the development of the ivWatch Model 400, but the technology has also resulted in 60+ utility patents that will be used to continue to improve patient safety in other ways.

More information is available at ivwatch.com.

 

Biotech innovator ivWatch LLC expands to Hampton

Oct. 13, 2015 – ivWatch LLC, a biomedical sensor technology company focused on improving patient safety in infusion therapy and vascular access, will soon expand to a 7,000-square-foot location in Hampton.

The new location, within The National Institute of Aeronautics building on Exploration Way, will allow ivWatch to house its manufacturing department under the same roof as the rest of its operations. The company currently has 14 employees and expects to double that number by early 2016. Leah Moore, director of marketing for ivWatch, said they will begin moving into the new location this December.

The company is streamlining its operations and expanding its staff in preparation for the launch of its inaugural medical device. The ivWatch Model 400 is a first-of-its-kind continuous monitoring device used to assist medical professionals in detecting when intravenous fluids have leaked out of a patient’s vein and into surrounding tissue, commonly known as an infiltration. The device has received FDA clearance for use with adults 18 and over.

“By unifying our operations in the NIA building, we’ll have the space we need to grow and the opportunity to contribute to the local economy,” said ivWatch CEO Gary Warren, who worked for NASA early in his career.

“This new location allows us to build our product components on-site, as we continue hiring professionals in the health and engineering industries to expand our portfolio of products and technology that improve patient safety,” Warren said.

Hampton Mayor George Wallace said: “I am pleased to welcome ivWatch as the newest member of Hampton’s business community. The company’s decision to choose Hampton supports the city’s efforts to further diversify our local economy. We look forward to being an active part of ivWatch’s growth as the company provides innovative medical devices from their new headquarters and production facility in Hampton.”

ivWatch recently received the $225,000 grand prize in the bioscience sector of the Virginia Velocity Business Plan Competition. The competition is part of Gov. Terry McAuliffe’s strategy for diversifying the state’s economy by encouraging the growth of innovative bioscience and energy companies.

The NIA is a non-profit research and graduate education institute created in 2002 to conduct leading edge aerospace and atmospheric research, develop new technologies for the nation and help inspire the next generation of engineers and scientists.

For more information about economic opportunities in Hampton, go to the Economic Development Department website at www.hampton.gov/ED.

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ivWatch Partners with Cincinnati Children’s Hospital Medical Center for Pediatric Clinical Trial

Williamsburg, Va. — ivWatch, LLC recently began assessing the efficacy of its inaugural medical device, the ivWatch Model 400, on pediatric patients at Cincinnati Children’s Hospital Medical Center. The medical device company works to improve patient safety in infusion therapy and vascular access.

The ivWatch Model 400 is used to assist medical professionals in detecting when intravenous (IV) fluids have leaked out of the vein and into the surrounding tissue, called a PIV infiltration. The device already has received FDA clearance for use on adults 18 and over.

The goal of the pediatric clinical trial is to measure the performance of the device for detecting infiltrated PIV sites of pediatric patients. The phase II pilot study began on Aug. 25, 2015 and is anticipated to last six to nine months.

PIV therapy is one of the most common invasive procedures performed in U.S. hospitals. Failures can occur when the infusate leaks into surrounding tissue. Pediatric patients may be at higher risk of infiltration due to their heightened activity levels, limited communication skills and small limb size.

“As one of the nation’s top pediatric hospitals, Cincinnati Children’s is committed to advancing patient safety,” said Darcy Doellman MSN, RN, CRNI, VA-BC, principal investigator, clinical manager of the Vascular Access Team, and an industry recognized vascular access expert. “The insights we gain by hosting the ivWatch pediatric trial should contribute to improved understanding of IV therapy monitoring practices for pediatric patients across the U.S.”

Co-investigators of the study include Sylvia Rineair, MSHA, BSN, RN, VA-BC, Candice Fletcher Overly, MSN, RN, NSQIP, SCR and Dr. Neil Johnson, an interventional radiologist.

Current nursing practice for monitoring pediatric patients with a PIV involves regular visual and tactile assessment of the PIV site. The ivWatch Model 400 provides continuous monitoring of the IV site and was developed on the premise that early detection of an infiltration may help to minimize patient harm.

The device includes a patient monitor, a non-invasive sensor using visible and near-infrared light and a disposable sensor receptacle applied next to the IV site. A color LCD screen displays the status of the IV and an audible notification sounds if an infiltration occurs.

Ten patients were enrolled in a pilot group, giving clinicians an opportunity to perform the protocol and operate the ivWatch device while researchers could make any necessary adjustments prior to starting the next phase of testing.

The second phase of the study is now underway and will enroll 150 patients. This phase will allow researchers to compare the difference between the ivWatch Model 400 and standard nursing practices to detect infiltrations. The final phase of the study will enroll another 150 patients and will allow researchers to estimate the notification rate, infiltration size and severity at early stages of an infiltration.

Hospital nursing staff will assess patients’ PIV sites regularly according to the hospital’s existing protocols. The study protocol does not affect the normal care for the pediatric patient.

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Leah Moore, Director of Marketing, ivWatch, LLC
1.855.489.2824 ext. 7031
Leah.Moore@ivwatch.com

 

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