Lineus Medical Wins $50,000 Grant for Pediatric Research

FAYETTEVILLE, Ark. - Oct. 31, 2017 - PRLog -- Lineus Medical was awarded a New England Pediatric Device Consortium (NEPDC) $50,000 grant to address the pediatric need for the company's SafeBreak™ Vascular product.  SafeBreak Vascular is designed to prevent the dislodgement of IVs, which clinical literature shows happens approximately 10.8% of the time. The NEPDC was formed in 2013 as a multidisciplinary consortium with a goal to help inventors accelerate the commercialization of pediatric medical devices through the FDA's Pediatric Device Consortia program. "In the primary care setting, when I see families trying to manage long-term health issues with their kids, we try to look for areas of light. At times the tunnel looks pretty dark," says Dr. Marion Pierson, Pediatrician, Village Pediatrics and NEPDC advisor. "Having to recapture ground when IV access lines are lost or tubes become dislodged can be like traveling backwards in that long, dark tunnel."

Placing, securing and maintaining IVs in children can be different than in adults. Children may have a heightened fear of needles. Infants and toddlers have smaller arms and less skin area for adhesive attachment. The unintended removal of a peripheral IV starts a whole cascade of time consuming and painful events for nurses, the patient and their families. Additional medical supplies are consumed and the patient must endure another needle stick when a nurse attempts to find a new vein.

SafeBreak Vascular is being designed to help prevent IV dislodgements. When a harmful force is placed across an IV line, SafeBreak Vascular relieves the force by separating into two pieces.  Upon separation, a valve on the patient side of the device closes and prevents bleeding, while on the IV pump side, a valve closes to stop the flow of medicine.  The IV pump alarms due to the occlusion of the line, notifying the medical staff that the IV line needs attention.  A new SafeBreak Vascular can be installed in the line, and the patient's medical treatment can resume in a matter of minutes.  Most importantly, there is no need to find a new vein.

"Through in-depth customer discovery interviews and some truly innovative adhesive research, we are confident that SafeBreak Vascular can serve the traditional IV therapy market effectively. There's not much difference between a 15-year old compared to a 30-year-old in terms of placing and securing an IV. However, there are clear differences between those age groups and a 2-year-old," says Spencer Jones, CEO and Founder of Lineus Medical.  "This grant provides us the opportunity to explore and identify the unique challenges that children 3-months to 18-years-old face with IVs so that we can provide a product that meets their needs. While we believe our current version will be effective for the lion's share of pediatric patients, our goal is to provide a solution for every patient in need. This grant allows us to move those efforts up in our timeline, which is precisely the mission of the NEPDC."

ABOUT LINEUS MEDICAL

Lineus Medical is the developer of a unique, patented, break-away technology that works with all types of medical tubing. Dislodgement of feeding tubes, IV lines, urinary catheters and any other type of medical tubing is prevented by the device breaking into two pieces and protecting the patient's catheter insertion site. The company's first product, SafeBreak Vascular fits into any standard IV tubing and will help prevent IV lines from failing, which occurs 46% of the time according to the clinical literature. SafeBreak Vascular is not yet 510(k) cleared and is not yet for sale. More information about Lineus Medical and the NEPDC can be found on their respective websites:  www.lineusmed.com or www.NEPDC.org.

For additional information contact Vance Clement at vance@lineusmed.com or 901-351-9270 or the NEPDC at info@nepdc.org or 603-678-8260.

MKG-0039 11/17