Breonics, Inc.

Science and Technology

BREONICS, Inc. is a biomedical research and development company applying its novel bioengineering technologies to create innovative medical products for the clinical organ transplant and tissue replacement markets. BREONICS Exsanguineous Metabolic Support (EMS) enables continued oxidative metabolism and function in organs while isolated from the rest of the human body providing a number of unique opportunities for medical application.

EMS for Clinical Transplantation

Transplantation is the therapy of choice for people with end-stage organ failure. For end-stage heart, liver and lung disease, transplantation is the only life-saving remedy. In the case of end-stage renal disease (ESRD), transplantation is generally preferred to dialysis because, if the graft is tolerated, it is the only therapy that allows the patient to lead a normal life. However, the use of transplantation as a life saving modality is severely limited by the shortage of organs. In the U.S. there are approximately 400,000 patients with ESRD for whom the number of cadaveric kidneys available for transplantation rarely gets beyond 12,000 in any given year. The reason for this disparity is a combination of technical and ethical factors that limit the donor selection criteria.

Present-day hypothermic organ preservation technology is dependent upon excising and chilling the organ to temperatures between 4-8oC in order to suspend metabolism and limit the effects of warm ischemia (WI), the lack of oxygen normally supplied by the blood. Without the cold to suspend metabolism and without blood flow to provide oxygen the organ rapidly loses its ability to function. Complicating the procurement process is the ethical need to attain consent for donation before acquiring the organ. Consequently, the patients who are preferred for organ donation are primarily heart-beating cadaveric donors (HBD), patients who have suffered trauma and are maintained on life support in an Intensive Care Unit (ICU) prior to declaring death by brain criteria. This accounts for approximately 5% of the trauma patient population. Unfortunately the greatest potential for procuring more organs is in the 95 % of the trauma patient population where circulatory arrest has existed for greater than 30 minutes postmortem without any intervention. These are considered the uncontrolled Deceased by Cardiac Death (DCD) Patients where WI damage would preclude organ donation by current criteria.

The EMS concept is based upon BREONICS’ ability to intervene during the period of WI and reverse the injury cascade by reestablishing cellular equilibrium. EMS restores metabolic function by providing the necessary substrates and nutrients to sustain the organ at near physiologic temperature. Data from BREONICS pre-clinical animal studies demonstrated that EMS could successfully resuscitate kidneys following as much as 2 hours of WI insult. When the resuscitated kidneys were implanted, they confirmed recovery of normal renal function.

EMS Development

By addressing the dynamic and technical barriers associated with overcoming warm ischemic injury, EMS will be the first technology that can be used to intervene after ischemic damage has occurred to resuscitate and repair damaged kidneys. This unique ability of EMS is transformational because it changes today’s limitation of recovering cadaveric kidneys from within minutes of death to within a window of several hours postmortem. EMS’ potential to redefine the existing donor criteria is what makes the technology distinct and why it should not be confused with traditional organ preservation techniques.

Preclinical Studies

The EMS perfusion solution and breadboard delivery system have been developed, tested and optimized over a 10-year period in a large animal model that included approximately 300 canine transplants. The discoveries and results have been published in numerous peer reviewed scientific journals and are the subject of a variety of articles in print.

These preclinical trials have demonstrated the ability of EMS to resuscitate and repair warm ischemic damage providing a rationale for our planned clinical approach to expand organ donor criteria to include patients deceased by cardiac death.

Clinical Development

BREONICS as adopted an integrated clinical development plan that merges together a highly qualified multidisciplinary team that includes the resources and staff from three leading national transplantation programs. The clinical and research physicians, scientist, engineers and business professionals dedicated to the project have a broad spectrum of expertise in clinical transplantation, biomedical engineering, regulatory approval, organ procurement procedures and reimbursement.

Commercialization

BREONICS Perfusion Technologies, Inc. (PFTI) a wholly owned subsidiary of BREONICS, Inc. will work closely with the governing Organ Procurement Organizations (OPOs) to establish EMS treatment centers at each of the pivotal clinical trial sites. Following regulatory approval each EMS treatment center will be able to provide immediate EMS services for kidney procurement to the OPO under contractual arrangements.

Other EMS Applications

Pre-transplant treatment of a graft to overcome rejection and the effects of reperfusion injury.
Targeted delivery system to specific anatomic sites for optimized transfection in gene therapy.
Targeted high-dose chemotherapy delivery to an isolated organ, or regionalized tissue to reduce the effects of whole body toxicity.
Thrombolytic therapy support to re-perfuse and resuscitate ischemically damaged tissue in order to extend the window of opportunity to intervene following and ischemic insult secondary to occlusive disease such as heart attack and stroke.
Prevention of ischemic injury following trauma by supporting tissue integrity and function in order to overcome the effects of clinical shock.
As a technology platform for tissue engineering of biohybrids such as biosynthetic blood vessels and organs.

Science and Technology

September 01, 2010

BREONICS announces the award of a NIH $2.9 Million RC3 BRDG-SPAN SBIR Grant to begin Clinical Development of EMS to Provide more cadaveric kidneys for transplant. More...

August 01, 2010

BREONICS announces $200K second year R43 SBIR Funding for: “The Potential to Immunocloak Renal Allografts”. More...

Investor Relations

BREONICS is currently a privately-held company. For more information please contact breonicsinvest@breonics.com