Hibernicor

Dr. Rivard weighs in at the OPTN organ allocation debate

United Network for Organ Sharing
700 North 4th Street
Richmond, Virgina 23219

Dear Kidney RFI Coordinator,

I am writing this letter in response to the document titled: Kidney Allocation System - Request for Proposals.   In review of the complicated donor profile index as described in the document, I believe that as the algorithm strays from strict objective criteria, i.e. HLA matching - the overall survival of the transplant recipient will be lower.  This statement is supported by an extensive body of work from Cecka, et al. regarding donor-recipient matching.  

From a patient centric viewpoint, I believe that the recipient would benefit the most from a well matched organ than one randomly assigned.  From a cellular viewpoint, the success of the organ depends upon the composite sum of the each cell working in a supportive milieu (the physiology).  Immunosuppression allows that to proceed and unfortunately has separate risk profile which is not clearly reflected in the quality of life studies.  

Unfortunately the changes made in donor allocation are subtle and may take years to develop trends.  Meanwhile, there are new machine perfusion methods for prolonging organ preservation that may obviate the issue of organ degradation from prolonged transport times.  Hence, it is my expert opinion that the first criterion for organ allocation should be made by blood type followed closely by HLA matching and then combined with other objective (scientific) criteria. 

Furthermore, the Life Years from Transplant Formula (LYFT)  is inadequately described in the document.  The full formula is not presented for an adequate public assessment.  The formula description implies that there is a measureable value to be gained from the transplant.  Taken to the extreme, this valuation makes the kidney a commodity of which is negotiable at the transplant center level.  This commoditization of the organ is most likely the reason for failure of the “Kidney Payback System,” of which some transplant centers benefit unequally.  Also, the prediction of recipient life expectancy into decades is highly risky and the generalization cannot be applied to individual patient outcomes.

In conclusion, any movement of the algorithm to dilute strict objective matching criteria will cause a cascade of events leading to worsening transplant recipient survival and failure of equitable organ allocation.  Finally, I cannot emphasize enough how important it is to simplify the algorithm to its essential components.  As proposed the LYFT algorithm is too complicated to be adequately described by the document.  Priority related to dialysis time is based upon the essential element of justice, which is a moral definition; that with centuries of debate remains unreconciled.  Alternatively, providing appropriate navigation through the organ allocation process using objective criteria with regular expert review; the OPTN will inherently provide justice.

Sincerely yours,

Andrew L. Rivard, M.D, M.S.

Pre-clinical research protocol finalized with the FDA.

Hibernicor met with representatives of FDA’s Center for Devices and Radiologic Health (CDRH) on October 30^th, 2007.  Based upon the discussions with the FDA, Hibernicor has finalized the pre-clnical research protocol necessary for 510k approval.

European initiative kickoff in Germany

Hibernicor participated in a business plan competition as one of 65 teams competing for a 55,000 Euro prize financed by the German state of Nordrein-Westalen.  The competition (www.startbahn-ruhr.de) was initiated to provide lifescience startup companies with mentored guidance and the opportunity to meet interested venture capitalists of the Business Angels Agentur Ruhr.

Study shows Asporto limits degredation of the donor heart.

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 (an insulated container) vs. hearts preserved in the Asporto heart preservation device.  Use of the device limited the rapid formation of acidosis that causes irreversible heart muscle damage that occurs during the conventional method. (Progress in Transplantation, 2008; 18(2):127-133)

“Hibernicor” is a registered service mark

Hibernicor recently filed an Allegation of Use with the Commisioner for Trademarks at the United States Patent and Trademark following publication of the mark  (Hibernicor) in the Official Gazette on August 3rd, 2007.  The company name received certification as a registered service mark on February, 12th, 2008 (Reg. No. 3,383,383).

FDA and Hibernicor to have a pre-IDE meeting

Hibernicor LLC will have a preliminary Investigation Device Exemption (pre-IDE) meeting with the Food and Drug Administration (FDA) to discuss the proposed regulatory pathway for the company’s heart preservation device. Dr. Andrew L. Rivard with the company members will meet representatives of FDA’s Center for Devices and Radiologic Health (CDRH) on October 5^th, 2007. The company will discuss draft pre-clinical and clinical protocols as well as a proposal for a pre-clinical heart transplant study.  This meeting is a preliminary FDA review intended to obtain comments to facilate the regulatory submission process.  Based upon the discussions with the FDA, Hibernicor will finalize the research protocols for market clearance.

Praestro software installed at the University of Minnesota

The electronic research record Praestro was implemented this month at the University of Minnesota’s Experimental Surgical Services.  Richard W. Bianco, the GLP laboratory’s director was extremely satisfied with the conversion to the electronic format that will be used initially in the preclinical testing of new heart valves.

Asporto featured at the 27th Annual Meeting of the International Society for Heart and Lung Transplantation

Research completed at the University of Minnesota was presented at the 27th Annual Meeting of the International Society for Heart Lung Transplant.  The study demonstrated the effectiveness of intermittent antegrade cardioplegia in reducing damage during prolonged storage of isolated heart.

Abstract.pdf   Asporto Poster (ppt)

Winner - University of St. Thomas business plan competition

On December 12th, 2006, the University of Thomas Schulze School of Entrepreneurship held its semiannual business plan competition.  Jordan Milan of Hibernicor, LLC was awarded first place for her presentation outlining the startup company to a panel of judges…read more.

Spotlight - Twin Cities Business Magazine

Andrew Rivard, a research consultant at the University of Minnesota’s Department of Surgery and a resident physician at the Unversity of Florida, believes he has a better way to deliver donor hearts.  Traditionally this has been performed via a basic handheld cooler. However, Rivard says this method has a key limitation…read more.