About Us
ImmutriX Therapeutics, Inc. is a privately funded medical technology company located in Rapid City, South Dakota. Pursuing novel products to modulate and sequester molecules in blood to enhance therapeutic outcomes of life threatening and life altering diseases by means of extracorporeal hemoperfusion. In brief the approach is designed to lessen the commotion in the blood, present in a disease state or inflammatory/toxic condition, by interrupting the pathophysiological cascade caused by an inappropriate immune response to a pathogen or toxin. In some cases, ImmutriX treatments will be designed to complement pharmaceutical therapies by reducing comorbidities that are not addressed by the pharmaceutical agent being administered. By interrupting the inappropriate immune response, ImmutriX’s goal is to allow the pharmacological treatments to perform better. Immutrix is focused on developing an organized platform of multiple uses and implications for its therapeutic technology. The initial indication is currently subject for review by the FDA later in 2017, with other indications in the pipeline of development.
Review 2017
First Indication: Removal of Radiocontrast
Removing contrast imaging agents before they can adversely affect patients is a key concern of physicians, especially cardiologists and nephrologists. ImmutriX understands that there are around 33 million imaging procedures performed each year in the US. Conservative estimates range from 7% to 12% of those patients could react to imaging agents. Both FDA and physicians want a tool to protect those patients from requiring hospitalization and avoid permanent damage or even death. Further, because if the Company’s treatment regimen works, additional images will be a) taken with those patients that physicians were reluctant to use agents with before for safety reasons, and b) repeated with the same patient for diagnosis purposes without fear of stimulating a latent reaction. A specific example is the removal of radio contrast media from diagnostic scanning for heart procedures such as stent placements. Another is removal of contrast media from coronary bypass surgery imaging.
Immutrix believes these factors will grow the market substantially; and ten years from now, four million imaging procedures in the US will be followed up with an ImmutriX removal treatment. The Company believes this is conservative, because the treatment would become a standard of care; and for liability, hospitalization costs and other reasons it may be prescribed up to 25% of the time, with ImmutriX retaining at least a 50% market share for this treatment.
The Radiocontrast removal treatment is on track for review by the FDA later in 2017. It is our goal to have human clinical trials begin as early as the fourth quarter of 2017 and early 2018. Right behind this indication the pipeline of indications includes: Burn Care and Severe Sepsis.
Associated Statistics of market potential associated to Immutrix pipeline of treatments:
Patients with Chronic kidney disease (CKD) have a markedly increased incidence of cardiovascular events and cardiovascular disease (CVD) mortality compared with age-matched counterparts in the general population. There is therefore unequivocal evidence that subjects with CKD are among the highest-risk cohorts for cardiovascular events of any studied population*.
*Cardiovascular Disease in Chronic Kidney Disease; R. Hajhosseiny; K. Khavandi; D. J. Goldsmith; Medscape June 27, 2017
In 2013, aggregate hospital cost for 35.6 million hospital stays totaled $381.4 Billion. The mean expense per stay for hospitalization was over $18,000*.
*National Inpatient Hospital costs: The Most Expensive Conditions by Payer, 2013; Celeste M. Torio, Ph.D., M.H.P., and Brian J. Moore, Ph.D. H-CUP May 2016 Statistical brief #204
A rapid and steady increase in cases of severe sepsis from 415,280 in 2003 to 711,736 in 2007 (a 71% increase) with total costs increasing from $15.4 billion in 2003 to $24.3 billion in 2007 (a 57% increase). The average cost per case in 2007 was $19,330*.
*Hospitalizations, costs, and outcomes of severe sepsis in the United States 2003 to 2007; Lagu T, Rothberg MB, Sheif MS, Pekow PS, Steinrub JS, Lindenauer PK. Crit Care Med. 2012 Oct;40(10):2932.
Severe sepsis is a relatively common and potentially lethal condition among intensive care unit patients. In a study 56,997 patients were identified with severe sepsis, admitted to 124 US academic hospitals during 2011. Each hospital admitted approximately 460 patients with severe sepsis, with a median length of stay 12.5 days and median costs of $26,304*.
*Hospital case volume and outcomes among patients hospitalized with severe sepsis; Walkey AJ, Weiner RS, Crit Care Med 2014; 189:548-555
Currently 1.6 million people are diagnosed with sepsis in the US each year, one every twenty seconds. 258,000 patients will die each year, one every two minutes. 85% of sepsis patients enter the hospital through the emergency department, one in 5 will be readmitted to the hospital within 30 days. Sepsis is the number one cost of hospitalization in the US, costing more than $24 billion dollars each year.
*Sepsis Alliance info graphics Nov. 2016
Indications
ImmutriX’s products are medical devices in which specific molecules in the blood are targeted and bound in a dialysis-like procedure for a broad range of potential indications. These potential indications include, but are not limited to: chronic kidney disease, acute pancreatitis, systemic lupus erythematosus, multiple sclerosis, graves disease, chrohn’s disease, ulcerative colitis, psoriasis, scleroderma, hepatic encephalopathy, severe sepsis, severe burn, anaphylactic shock, autoimmune thyroid disease, diabetes millitus type 1, hepatitis, drug overdose and poisoning, food allergies, certain virus’ (for example: ebola, yellow fever and Zika) plus comorbidities such as angiogenesis and anemia in cancer.
Pipeline
ImmutriX’s first indication is for removing contrast imaging agents before they can adversely affect patients. There currently is no other course of treatment to accomplish this, because of the critical need for a solution both the medical community and FDA have encouraged this targeted indication. Immutrix has identified approximately 50 disease / medical conditions which we believe our blood cleansing approach may positively impact. The opportunity to impact so many needs is paramount to the focus of our research and development. After Radio Contrast the other indications currently planned in the pipeline include Severe Burn Care and Severe Sepsis. With science and technology so rapidly advancing we continue to move forward advancing our pipeline plans to meet the critical needs of the medical community.
History
ImmutriX was incorporated on November 30, 2009 in the state of South Dakota. The company headquarters are located at 3620 Homestead Street, Rapid City, SD, and its analytical laboratory located at, 2329 N. Career Avenue, Suite 112, Sioux Falls, SD 57107. The Company’s material research and manufacturing facility is at the Rapid City, SD location.
The inspiration behind our Company and its technology came from Jill Barnes, daughter of Immutrix CEO Carol Rae. Jill correlated the ability to clean up the ocean as in the aftermath of the 2010 Deepwater Horizon oil spill in the Gulf of Mexico, to the probability of similarly cleansing patient’s blood!
Jill had been diagnosed with a lethal brain cancer (glioblastoma) and, was given weeks or months, not years, to survive. In her quest for treatment, she refused chemotherapy and radiation opting instead for alternative therapies. Her decision for not following standard of care prescription was based on being unable to find anything in medical literature regarding outcomes of such conventional therapies to be consistent with her survival goals. Jill’s pursuit of therapy based on blood cleansing treatments, though not scientifically or medically substantiated at the time, resulted in an additional 7 ½ years of productive and quality years in her career and with her family.
“The more toxins and chemicals we put into our bodies, the more we exacerbate the imbalances that make us sick in the first place” she said. “What needs to happen is to remove the bad actors from blood, and our immune system, perfectly designed by God, can and will restore a better balance within to fight disease.” Clean water is to the world’s survival that clean blood is a person’s survival, she maintained.
The access Jill had to blood cleansing treatments was less than perfect, lacking in the scientific and medical knowledge we have today, but her outcome strongly supports the premise she held. “Take out what’s bad in the blood, and avoid promoting commotion and undesirable consequences by putting into or leaving toxins and chemicals in the body which circulate in the blood.”
Jill pressed on toward the goal, and set an impressive record for survival based on this premise. She stayed abreast of the research and development of ImmutriX until she passed away, August 27, 2012 at the age of 44. Jill’s passing was just two short months prior to the first compelling data being presented by scientists at Texas Tech University, validating the ImmutriX’ adsorbent devices ability to remove the “bad actors” from blood. Her legacy is the basis of the solid scientific data and medical applications being pursued today by ImmutriX. Her memorial is etched with her favorite Scripture, Philippians 3:14; “I press on toward the goal for which I am called heavenward in Christ, Jesus”.
And so, we too, press on with development of new products, based on sound scientific and medical principles, in order to offer life changing alternatives to patients, their unmet needs with current pharmaceutical or surgical options and to increase the arsenal and options of therapies offered by their professional care providers.
