N8 Medical, Inc. wins Grant from the National Heart, Lung, and Blood Institute.

InteliSpark client, N8 Medical Inc. has been awarded a grant from the National Heart, Lung, and Blood Institute for their Phase I SBIR project “a 3D printed resorbable antimicrobial envelope to prevent infection of implanted cardiac devices”. With this award, N8 Medical will be focusing on using 3D printing to fabricate a biodegradable polycaprolactone (PCL)-based antimicrobial envelope to be fitted outside of cardiac rhythm devices, and ultimately prevent infections after surgical implantation.

Surgery to deliver cardiovascular implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter-defibrillators, can lead to serious and potentially life-threatening complications such as infection. Untreated device-related infection has been seen to cause mortality rates as high as 66%. There is currently only one antibiotic-impregnated mesh that has been FDA-approved for placement in surgical incisions to reduce infections associated with the implantation of CIEDs. Yet, studies have shown that staphylococci bacteria, which are commonly found in VIED infections, has built resistance to the combination antibiotics used in the mesh.  Also, the antibacterials can promote the growth of fungi, which is a source of rare but highly fatal CIED infections. The bulky implantable mesh envelopes that are currently used increase the surgical pocket size, which not only restricts a patient from physical activities, it also increases the chance of infection. Moreover, the mesh contributes to space constraints of the surgical pocket, which reduces the size of CEIDs that can be emplaced; even though the majority of patients would prefer larger devices that last longer.

N8 Medical has seen a need to address this issue, in efforts of increasing the length of time between device retrievals and reimplantations, improving the allover quality of life for patients, while directly decreasing the risk of infections associated with surgery. To do so, they plan to use 3D printing to develop a biodegradable polycaprolactone (PCL)-based antimicrobial envelop for the outside of cardiac rhythm devices after surgical implantation. Their idea is that a slow degradation (hydrolysis) of the PCL envelope will gradually release a novel antimicrobial compound (CSA-131, a ceragenin) for antimicrobial and anti-fungal activity. N8 Medical’s device will be the first of its kind in preventing fungal colonization of cardiac devices, while still providing superior and longer lasting inhibition of bacterial growth. By using 3D printing techniques, they will also be able to produce more customized devices which will minimize surgical pocket space constraints. With the help of this award, N8 Medicals will be able to move forward to their next efforts, to compose the antibiotic-loaded filament, demonstrate, and evaluate its effectiveness.