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Aperture Bio seeks B Series Funding as it Completes Final FDA Submission and Prepares for Full Commercialization of its RAPID-B and empiriSTAT : Rapid ID of Bacterial Infections and Antibiotic Profiling

06-11-2019 10:07 AM CET | Health & Medicine

Press release from: Aperture Bio

Aperture Bio seeks B Series Funding as it Completes Final FDA

Responding to increased demand for its proprietary RAPID-B(TM) diagnostic platform and empiriSTAT test menu, Aperture Bio has announced its intention to seek B Series investors as it heads to full commercialization. The company is looking to enter the clinical diagnostics market, which is valued at US$168 billion and growing at a 7.3% CAGR, according to data released by Coherent Market Insights in 2015.

In a statement from Aperture’s president, David Potenza, “With growing awareness of our technology, the market’s response and demand for our innovative diagnostic platform has prompted the board’s decision to seek outside investors. With additional funding to support accelerating our timelines for full commercialization and introduction to world markets, we could begin playing a role in curbing antibiotic resistance, potentially saving lives and billions in related healthcare costs.”

The urgent need to reduce the overuse and misuse of antibiotics through empirical prescribing is at the forefront of the world’s public health agencies. Laboratory directors, hospital administrators and world health concerns are seeking technologies and strategies to address the alarming, and unnecessary, overuse of antibiotics in an effort to save lives and billions in providing treatment for the millions that could be affected:

The United Nations (U.N.’s) Interagency Coordination Group on Antimicrobial Resistance released a report in 2019 stating that “drug-resistant infections will kill 10 million people annually by 2050” and specifically calls for “more initiatives aimed at limiting unnecessary antibiotic use.”

The World Health Organization (WHO) 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."

The Commissioner of the Food & Drug Administration (FDA) stated that “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.”

The Infectious Disease Society of American (IDSA) stated "Because treatment of acute uncomplicated cystitis is usually empirical, it is likely that some women will be treated with a drug that does not have in vitro activity against the uropathogen. As the population resistance prevalence of a specific agent increases, the likelihood of failure outweighs the benefits of using the drug empirically."

The overuse and misuse of antibiotics in the healthcare setting is, in great part, due to the necessity of empirical, and often “blind,” over-prescribing of antibiotics. These prescribing habits, primarily done as a defensive response on the suspicion of an infection, are often caused by known inaccuracies in screening technology and delays in actionable lab results. The unintentional consequences created by the defensive response of caregivers is coming to the forefront of community and world health officials and needs to be addressed.

With over 100 million UTIs tests performed each year and tens of millions of blood tests, the impact on reducing the need for empirical prescribing and overuse of antibiotics is a population health issue, impacting communities around the world. In 2013, the Centers for Disease Control (CDC) reported 2 million people get an antibiotic resistant infection, and at least 23,000 people die. New data, due out later this year, suggests those numbers have escalated exponentially. The costs to the U.S. healthcare system tops over $5 billion annually and is estimated to reach $100 trillion world-wide by 2050, according to amr-review.org.

The RAPID-B(TM) is poised to address these growing concerns by offering healthcare providers access to a highly accurate, low cost and fast screening technology coupled with Antibiotic Profiling. This clinically available technology could greatly reduce the need for empirical prescribing and reduce the costs of unnecessary add-on testing or further delays in treatment. In the fight against antibiotic resistance, the negative predictive value, knowing which patients do not require treatment with in minutes, could be as impactful as knowing which patient do need treatment. Providing Antibiotic Predictive Profiling (APP) with in hours helps ensure only those patients that need treatment are prescribed the most appropriate medications, greatly reducing their misuse and potential to build resistance.

The RAPID-B(TM) has completed over two years of clinical evaluations and is working on expanded indications for blood and cerebral spinal fluid (meningitis). Additionally, Aperture Bio is in collaboration with Nuview Life Sciences to fully automate their prostate cancer screening assay on the RAPID-B(TM) platform. For uncomplicated UTIs the platform was able to achieve 98% sensitivity and 89% specificity, out-performing other known technologies.

To accomplish these fast and accurate results, the RAPID-B(TM) utilizes highly customized and fully robotic next-generation flow cytometric technology (nFC), coupled with proprietary chemistry and customized platting. Through these proprietary and patent pending methodologies, the system enumerates only viable bacteria and white blood cells (for urine) within minutes and provides Antibiotic Predictive Profiling (APP) within hours.

In a follow-up statement from Aperture’s president, “There is a real need for technology that can help address overuse and misuse of antibiotics throughout the world. We believe our first-of-its-kind, disruptive technology can play a role in helping curb the proliferation in antibiotic resistance and could redefine how infections are identified and treated …. This technology is ready to make a difference and needs to be in the hands of healthcare providers today.”

David Potenza
President
1-214-707-8710
dpotenza@aperturebio.com
20 Winter Sports Land
Williston, VT 05495

About Aperture Bio – Aperture Bio is a privately held laboratory diagnostic company whose focus is to bring emerging technologies to market aimed at addressing antibiotic resistance and other world health issues. The company is currently seeking B Series investors to further expand its product offering and the commercialization of its proprietary RAPID-BTM platform. For investment opportunities, please contact Mr. David Potenza dpotenza@aperturebio.com

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