The U.S. FDA Commissioner, recently stated:

 “Antimicrobial resistance is a global public health challenge. Combating antimicrobial resistance continues to be a top priority. Our aim is to reduce overuse of antimicrobial drugs and combat the rising threat of resistance."(6)

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Executive Summary

Aperture Bio is an in vitro diagnostics company dedicated to providing solutions for the global challenges of bacterial infections, including UTI, sepsis (bacteremia), antibiotic resistance and healthcare-associated infections. Aperture Bio’s investors have funded millions of dollars in research and development of its proprietary technology. In addition, it executed a clinical investigation of it's core technology at prestigious institutions like Washington University Medical Center (WashU), Northwestern University Medical Center and University of Vermont Medical Center and has clinically validated its technology, which is now ready for limited commercialization and institutional adoption under an LDT.   

OUR MISSION: The primary mission of Aperture Bio is to offer clinical solutions and technologies aimed at rapid identification of bacterial infections and the improper, over-administration of antibiotics. Misdiagnosis and delayed identification, along with over-prescribed antibiotic treatments, are creating a world health crisis resulting in the life-threatening development of “ANTIBIOTIC RESISTANCE”, which is affecting millions of patients, both in the US and world-wide. This is where we aim to help.  

The World Health Organization states “antibiotic resistance is rising to dangerously high levels in all parts of the world. New resistance mechanisms are emerging and spreading globally. Without urgent action, we are heading for a post-antibiotic era in which common infections and minor injuries can once again kill."(7). Our technology offers a new, unique clinical laboratory platform designed to identify:  

              (1) Urinary Tract Infection live bacterial counts and White Blood Cell (WBC) enumeration    

                    within minutes of receiving the sample; and

             (2) A <3 hour uropathogen confirmation and Antibiotic Predictive Profile;  

             (3) Bacteremia screening assay with results within 8 hours, which includes an Antibiotic 

                   Predictive Profile (APP) for positive samples; and

             (4) A high throughput direct-out-of-positive-blood-culture, Minimum Inhibitory  

                 Concentration (MIC) assay that aims to reduce MIC data by more than 24 hours over current 


To combat this world-wide public health crisis, Aperture Bio now offers a new, revolutionary, high-volume platform (“Rapid-B”) to detect critical levels of bacteria in both urine and blood in minutes and a corresponding test for specific antibiotic resistance within hours rather than days. No other technology is as fast, has the potential to improve outcomes in infectious disease patients, or is as cost effective.

 FUTURE DEVELOPMENT TECHNOLOGY EXPANSION. This same technology may also apply to identifying the proper antibiotic treatment of bacterial meningitis, pneumonias and other bacteriologic diseases. It is not only significantly more efficient and cost effective for hospitals than current culture plating and other technologies, but it also allows hospitals to generate positive laboratory income, rather than acting as a cost center.

           “As many as 80% of sepsis deaths could be prevented with rapid diagnosis and treatment"(8)  


THE STATISTICS ARE STAGGERING. Understanding the prevalence and severity of the world health issue will help position the relevance and potential impact Aperture Bio’s technology can have on a world heath problem; not only in economic terms, but more importantly, in human lives and health outcomes. 

  • According to a 2019 study published in JAMA, medical record of 568 patients from six U.S. hospitals who either died in the hospital or who were discharged to hospice , showed sepsis was present in more than half (300) of the hospitalizations and directly caused death in more than one-third (198) of cases.(9)
  • Every 3-4 seconds someone dies of bacterial sepsis(10) often due to antibiotic resistance or misdiagnosis at an estimated costs of $18,400, double the average cost per stay across all other conditions(11).  
  • According to a study conducted at Henry Ford Health System, UTIs are one of the leading causes of ER visits, cost over $4-billion annually.(12)
  • Bloodstream infections now take more lives than HIV, breast cancer and prostate cancer combined(13).  
  • Infections are now the leading cause of death in U.S. hospitals(3) costing $24 billion per year(4) affecting over 26 million people annually, and is the largest killer of children (more than 5 million children/year)(5). 
  • Infections are also the #1 cause for hospital readmissions generating a 62% rate of 30-day readmissions and an incident rate of more than 1.1 million/year(14) costing U.S. hospitals more than $2 billion, annually(15). 
  • The World Health Organization states “antibiotic resistance is rising to dangerously high levels in all parts of the world. New resistance mechanisms are emerging and spreading globally." (17)
  • Of the 150 million UTI’s per year worldwide (16), 80% of women will contract a UTI(17) and 20%-30% of these women will suffer from recurring bouts of UTIs(18) throughout their lifetimes. 
  • Fifty percent (50%) of the U.S. population suffers from a UTI at least once in their lifetime(19). 
  • Over 100 million UTI tests are performed annually worldwide at a cost of $6 billion/year(1).  
  • In the U.S., there are an estimated 10.5 million office visits  attributed to UTIs(20) 
  • Approximately forty percent (40%) of all nosocomial (hospital acquired) infections are UTIs with more than 1 million catheter-associated UTIs/year in the U.S. alone(21).  
  • The Centers for Disease Control estimates 2 million Americans are afflicted annually by antibiotic-resistant pathogens(2). 
  • More than 1.6 million U.S. adults develop sepsis(24). A reported 258,000 people die from antibiotic resistant bacterial sepsis every year in the U.S., one every 2 minutes(23). As a result, 20-30 million bacterial blood cultures are performed annually in the U.S, alone(24)
  • Estimates regarding the medical cost per patient with an antibiotic-resistant infection range from $18,588 to $29,069.
  • The total economic burden placed on the U.S. economy by antibiotic resistant infections has been estimated to be as high as $20 billion in health care costs and $35 billion a year in lost productivity(24).  

Aperture Bio’s “Rapid-B” Diagnostic Platform is now ready for clinical and commercial deployment in hospitals and clinical laboratories specifically for urinary bacterial analysis with Antibiotic Predictive Profiling on a Laboratory Developed Test (“LDT”) basis. We are completing further development and validation testing, which we are encouraged will expand the capabilities of the Rapid-D platform to include blood and other infected areas.   

 Note: Aperture Bio is completing its FDA submission and documentation paperwork  and plans to file for approval by mid/late summer 2019.

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