The History of Nexus Medical, LLC

The Beginning – 2000 Nexus Medical LLC began in 2000 when the Company was awarded a grant from the US Army Medical Material Command in Fort Detrick Maryland to solve the problems associated with unintentional Blood Reflux into I.V. catheters and the many unintended consequences it caused for the wounded Army Soldier, Marine and Military Clinicians. Research – 2001 Nexus Medical’s Engineers learned Blood Reflux was caused by a multiplicity of external and internal conditions which occurred during the helicopter airlift evacuation or in the first MASH field hospital. Study and Develop – 2002 Nexus Medical’s Engineers lab tested and studied the human factors associated with the internal and external pressures which cause “Blood Reflux” into PIV, Medline, PICC and CVC Catheters.  The root causes of Blood Reflux can be characterized in two very clear categories which we refer to as mechanical and physiological conditions. Patent – 2002 Nexus Medical filed the first of many Nexus TKO® US and Foreign patent in 2002 for our Dome Shaped Pressure Activated Anti-Reflux Valve Technology FDA Approved Nexus TKO®-1 – 2003 510K:  K024363 Nexus Medical submitted the first FDA 510K for a Luer-Activated Needle Free Device which had the Pressure Activated Anti-Reflux Valve feature.  We called this new “Anti-Reflux” device the TKO (To Keep Open) 1st Clinical Trial – 2004 Clinical Trial for the Nexus TKO®-1 was conducted at Wilford Hall Medical Center, San Antonio, Texas in the Bone Marrow Transplant Area Nexus NIS-2 & NIS-7 – 2004 NIS-2 and NIS-7 Luer-Activated Injection Site Devices (Non TKO) FDA Approved Nexus TKO®-3, Nexus TKO®-4 & Nexus TKO®-4S – 2004 510K:  K041845 Nexus TKO®-3, Nexus TKO®-4 & Nexus TKO®-4S Luer Lock Devices FDA Approved Nexus TKO®-5 – 2005 510K: K053129 Nexus TKO®-5 Split Septum Anti-Reflux Device Nexus TKO®-5 – 2005 While using the Nexus TKO®-5 on PICC and CVC lines, Wesley Medical Center reduced tPA usage by over 71% while eliminating Heparin on all flush procedures FDA Approved Pressure-Rated Extension Sets – 2009/2011 Maximum Pressure = 325 psi 510K: K092382 In 2009 Nexus developed a Standardbore line of pressure-rated extension sets, in 2011 the line was extended with Microbore extension sets 510K Approved Nexus TKO®-6 – 2012 510K: K113398 Nexus TKO®-6 launched in 2012 with the introduction of the markets first crystal clear neutral pressure anti-reflux technology.  Nexus has been committed to a crystal clear fluid pathway from the very first Nexus TKO®-1 in 2003

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