Hibernicor announces the installation of a new cleanroom at its Jackson, Mississippi facility. This ISO Class 6 cleanroom is intended for the company’s production of high-quality single-use containers for Asporto and other contract products in the single use industry. The 10′ x 14′ clean room allows production of containers in quality-controlled environment designed to reduce
Hibernicor has developed a master plan for a multi-story multipurpose building designed with the primary objective of medical device manufacturing in a urban area with access to an international airport and multiple commuting options. The building will have total floor area goal of ~80,000 square feet with an emphasis on providing employees with plenty of
Hibernicor has established an electronic Quality Management System to ensure the products and services produced to meet the quality standards of the organization and are in compliance with relevant regulatory bodies. Our organization has applied a risk-based approach to the control of the appropriate processes.
The Quality System includes:
The new prototype Asporto // Heart Preservation Device by Hibernicor was launched on April 11th,2018 at the International Heart and Lung Transplant Conference in Nice (Fr). The conference had 2665 attendees from over 45 countries who specialize in the multidisciplinary management and treatment of end-stage heart and lung disease.
Hibernicor has been selected as a finalist for the Boston Pediatric Device Consortium Strategic Partner Challenge after a comprehensive review of applications conducted by the Boston Pediatric Device Consortium (BPDC), the Innovation & Digital Health Accelerator at Boston Children’s Hospital (IDHA), and partner organizations.
The Asporto // Heart Preservation Device is a portable thermoelectric cooler for transporting the donor heart to heart transplant recipients. The device consists of a microcontroller with touch-screen display, insulated container, peristaltic pump, AC to DC converter and a sterile disposable kit. The Asporto microcontroller has been upgraded to software version 5.02. The completely new software allows the microcontroller to
With over 1000 entries to the 2009 Minnesota Cup, Hibernicor ranked in the Top 10 in the Biosciences category following a first round of judging. The Minnesota Cup is an annual, statewide competition, which seeks out aspiring entrepreneurs and their breakthrough ideas. The competition was hosted by the University of Minnesota and Wells Fargo for its fifth year.
Hibernicor met with representatives of FDA’s Center for Devices and Radiologic Health (CDRH) on October 30th, 2008. Based upon the discussions with the FDA, Hibernicor has finalized the pre-clnical research protocol necessary for 510k approval.
A recent study from the University of Minnesota using the Asporto heart preservation device was published in a nationally recognized peer reviewed journal. The study demonstrated that intermittent antegrade cardioplegia maintains a significantly higher pH in donor hearts. The study involved a series of animal hearts preserved using the conventional method of donor heart transportation