A Medical Device Daily

CircuLite (Saddle Brook, New Jersey) reported that it has been awarded a Fast-Track Phase I-II Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to fund the development of a pediatric circulatory assist device based upon CircuLite's Synergy Pocket Micro-pump.

CircuLite, who will collaborate with the University of Maryland School of Medicine (Baltimore) on the grant, has received funding from the National Heart, Lung, and Blood Institute at NIH to support the first phase of the grant. The total potential award for Phase I and Phase II could reach up to $3.7 million. Synergy is a micro-blood pump, the size of a AA battery, that can be implanted superficially in a "pacemaker-like" pocket. Synergy is the first and smallest device designed for partial circulatory support (up to 3L/min) and long-term use in adult patients with Class IIIb and early Class IV heart failure.

The Synergy device was designed to provide partial circulatory support for the failing adult heart, but its small design makes it a logical candidate for a pediatric application after modification. The aim of Phase I of this grant is to modify the current CircuLite device such that it will be useable in a child and to determine the feasibility of short-term in vivo use. In Phase II, the child system will be finalized and examined in a long-term in vivo study and an infant device will be developed and tested.

In other grant news, PolyMedix, (Radnor, Pennsylvania) an emerging biotechnology company developing acute care products for infectious diseases and acute cardiovascular disorders, and the University of Massachusetts at Amherst, Department of Polymer Sciences and Engineering, reported that they have received a NIH grant to support the development of antimicrobial defensin-mimetic compounds for biodefense and emerging food-borne infectious diseases.

The sponsoring agency for the grant is Cooperative Research Partnerships for Biodefense and Emerging Infectious Disease of the National Institutes of Health. The grant provides PolyMedix and the University of Massachusetts $977,658 for one year, of which PolyMedix expects to receive $265,539. The grant recommends funding for an additional four years, subject to availability of funds and satisfactory performance, which brings the potential value of the grant up to an aggregate of $6.6 million over the five year period.