Milestones

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 natural lighting in all possible areas.

Basic outline of a possible conceptual configuration of the building is as follows:

Roof Top: Terrace with small garden, roof top bar, generators, clean water supply

Floor 6: Gym, mens/womens locker rooms, hotel rooms, child care facility

Floor 5: Kitchen & employee dining room, terrrace

Floor 4: Offices, meeting rooms

Floor 3: Offices, dry and wet laboratories, hybrid operating room

Floor 2: Clean room, IT equipment

Floor 1: Quarantine, storage, and production, and assembly areas

Ground Floor: Lobby & event space, security, reception, restaurant

Basement: Shipping & receiving, storage, parking, and mechanical

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:

• Quality Manual: a general overview of the Quality System and defines the Quality Policy.
• Quality Policies and Procedures: a more detailed explanation of the Quality System clauses and detail the structure of the Quality System.
• Standard Operating Procedures and Work Instructions: step-by-step instructions on how activities are to be carried out and the requirements of products produced.
• Forms and Records: information, charts, checklists, or other forms of records as evidence to demonstrate conformance to specified requirements and the effective operation of the Quality System.

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 completed the initial production of a prototype light-weight carbon fiber device with an pioneering American carbon-fiber manufacturer. The Hibernicor carbon fiber insulated cooler and perfusion system is designed to double the preservation time of the donor heart.  The system is now ready for pre-clinical testing prior to FDA 510k approval.

Asporto controls the administration and circulation of a saline-based fluid to the donor heart during hypothermic storage in a carbon-fiber insulated shell cooled using thermoelectric technology. The heart is stored in a single-use sterile container.  Dr. Andrew Rivard – the company founder presented the Asporto device as one of 30 companies exhibiting at the ISHLT conference this year.

Dr. Rivard obtained his BA, MS, MD degrees from the University of Minnesota with a concentration on cardiovascular physiology. In 2002 he founded Hibernicor based upon research done in Minnesota at the Experimental Surgical Services.  He also developed an electronic medical record system (Praestro), was an innovator in many health care technologies focusing on heart valves, heart transplantation, and imaging. He is a diagnostic cardio-radiologist trained at the University of Florida and now works for the Cleveland Clinic in Abu Dhabi focusing on advanced cardiac imaging.

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.

• Date/Time: Wednesday, December 6^th, 8:00 am – 6:00 pm
• Location: 300 Longwood Avenue, Boston, MA, 02115

Challenge winners will receive a combination of up to $50,000 in funding and/or mentorship opportunities. Strategic partners – including Boston Scientific, CryoLife, Edwards Lifesciences, Health Advances, Johnson & Johnson Innovation, Smithwise, and Ximedica – will provide strategic support for challenge winners focused on accelerating winning innovations towards commercialization.

The Boston Pediatric Device Consortium (BPDC) provides expertise and resources to device developers and manufacturers at each of the steps necessary for novel pediatric device development, in order to accelerate the pace of innovation. The BPDC is a collaborative of experts in engineering, clinical sciences, clinical trials design and performance, device development specialists, and industry partners whose primary goal is to develop and evaluate novel therapies for children. Leading the BPDC is Pedro del Nido, MD, the Chief of the Department of Cardiac Surgery at Boston Children’s Hospital, the William E. Ladd Professor of Child Surgery at Harvard Medical School, and medical device entrepreneur.

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 have better usage of memory-mapped pages for fault-tolerant and reliable continuation following power interruptions.  The new software takes advantage of a multi-tasking operating system which optimizes touchscreen, display and pump operations.