Infinitum Bio-Med
A Medical Device Company
Infinitum Bio-Med is a business partnership between UV ONE Hygienics and SiO2 Innovates and is fully funded by UV ONE Hygienics, Inc.
Infinitum BioMed operates out of the UV ONE Hygienics lab located at 1432 S. Dobson Rd, Ste. 202, Mesa, AZ 85202 on the Banner Desert Medical Hospital Campus. Infinitum BioMed receives assistance from by the National Science Engineering Research Council Of Canada of Elements Detection in Blood via Ion Beam Analysis, X-Ray Fluorescence, and for Iron In Hemoglobin at the Canadian Light Source (CSL).
Our 2000 square feet lab includes 5 sterile filtered air biosafety level II bays with Class 100 laminar flows, 1 ppb water filtering, and sterilization & endotoxin testing. Devices include medical UV-C sterilizers and Small Blood Volume Diagnostics such as InnovaStripTM (Whole Blood testing), InnovaDropTM (Fetal Monitoring), InnovaBugTM (Pathogen Triaging) and AlzBioSsTM (Early Stage Alzheimer Detection/ Monitoring 0.
We commercialize innovative, accurate In-Vitro Diagnostics for access to healthcare, regardless of location or economic status.
Medical Device Technology
ClearEndoscope™ is a new compact, effective, sterile, medical-grade silicone applicator and bio-comptable anti-fog solution. Application takes just 3 seconds to apply a smooth, flat, hyper-hydrophilic sterile flim on lenses that lasts for a minimum of three hours.
ClearEndoscope™ is an FDA-Cleared ophthalmological compound which is benign, bio-compatible, and pH neutral (7.2-7.4) that overcomes the shortfalls for existing products.
The ClearEndscope coating can be easily removed during scope cleaning.
ClearEndoscope™ outperforms existing products in size, costs, safety and effectiveness in direct side-by-side comparisons.
Blood Testing Technology
InnovaStrip™ is a low volume, fast, accurate, handheld comprehensive whole blood testing unit.
Over 4 billion Blood Diagnostics (BD) tests are performed annually worldwide. Current diagnostics use High-Performance Liquid Chromatography (HPLC). HPLC requires hours to days for results and uses 2-10 mL of blood. Drawing tens of mL of blood for multiple tests leads to hospital-acquired anemia at a rate of 74% in the chronically ill. Faster and more comprehensive whole blood tests are needed in ERs, ORs, and ICUs to diagnose incoming patients immediately for dehydration, anemia, etc.
InnovaStrip™ yields simultaneously more accurate and comprehensive blood diagnostics for electrolytes (Na‚ Mg‚ Ca‚ Cl‚ K‚ Ca)‚ metals (Fe‚ Cu‚ Se‚ I)‚ toxins (As‚ Cd‚ Hg‚ Pb)‚ and radio-nuclides (87Sr‚ 131I‚ 235U‚ 239 Pu). It can diagnose presenting conditions at intake with one single initial Small Volume Blood Diagnostics (SVBD) test, instead of several, within minutes.
InnovaStrip™ includes three components:
- Low-cost blood drop collection strips
- A hand-held X-Ray Fluorescence (XRF) analyzer
- An innovative SVBD algorithm, “Fast Accurate Blood Analysis ” or FABA™, deployed via an app,“Fast Hand-held Analysis for XRF’ ‘ or FHAX™.
The blood collection strips, made of off-the-shelf components, are coated with a new Hyper-Hydrophilic coating‚ ‘HH HemaDrop™’. These coatings rapidly planarize and solidify µLs of blood into Homogenous Thin Solid Films (HTSFs) in minutes. The collection strips include three HSTFs of pre-solidified calibration solutions for rapid conversion of XRF relative concentrations into medical units of mg/dL for blood diagnostics.
Besides XRF, other solid-state analyses such as Ion Beam Analysis via compact ion sources like 241Am can be incorporated in the analyzer. The medical ‘gold’ standard for SVBD – such as blood glucose monitors – requires relative errors ≤ +/-10%‚ in other words‚ less than 10% false negatives or positives.
Current XRF analysis commercial software is not accurate for trace elements such as blood electrolytes. They have poor background fitting‚ yield false positives/negatives‚ and yield large errors (> 50%) for trace elements quantitation. Instead, FABA™ computes fast, direct Riemann sums of counts for raw signals of selected elements only and subtracts the actual background, and is optimized for each specific element, instead of using an all-encompassing curve fit. FABA then interfaces with handheld XRF analyzers via the FABA App to generate accurate blood diagnostic results. ORs‚ ERs‚ Primary Care, Field Hospitals, Refugee Camps‚ Mining Facilities, and other medical settings can use InnovaStrip™ to quickly and accurately diagnose initial patient status for blood electrolytes and iron – thus hydration and anemia – from one single 10 µL blood drop.
InnovaStrip™ has market placement both internationally with governments in emerging nations such as Liberia, Nigeria, Ghana, Kenya, Dominican Republic, Jamaica, and Mexico via our international sales team and via US medical sales. These markets have little access to blood testing of any kind due to high costs and/or remote locations.
In first world markets, Infinitum Bio-Med has direct access to the Veterans Associations and the US Mining Industries as well as an entry point into the American College of Occupational and Environmental Medicine. We have targeted a strategic rollout focused on these three valuable organizations/markets.
Additionally, as part of our FDA submission, we are also working on reimbursement paths for insurance billing by securing CPT codes. This will allow InnovaStrip™ and all subsequent blood testers to be insurance billable.
InnovaBug™ can detect the presence of pathogens in blood. While it does not YET identify the pathogen, it allows the user to determine the next best course of action.
As there is more detailed testing to be performed, this unit will require at least 15 months before it’s ready to be submitted for FDA approval.
About 30% of pathogen cultures yield false positives. For example, at least 25% of positive blood cultures and almost 40% of urine cultures are false positives.
In the case of Blood Cultures, US hospitals waste over $1Million per year on these non-existent infections, or about $8,000 per false infection in 2020.
The unreliability of pathogen cultures leads to large antibiotic and antiviral overuse, in turn creating more drug-resistant pathogens and more anxious testing.
The CDC’s Antibiotic Resistance Threats in the US states that more than 2.8 million per year of antibiotic-resistant infections occur in the U.S., leading to more than 35,000 deaths per year In addition, blood cultures require large blood volumes (10-60 mL), with at least two vials.
When performed daily in hospitals, this leads to Hospital-Acquired Anemia (HAA) in 74% of patients and 100% of infants in the NICU.
Both blood and urine cultures also require more than 72 hours for results as culture flasks can be incubated for up to 5 days depending on pathogens.
Patients are prescribed antibiotics and antivirals preemptively well before the culture results, leading to even more overuse and resistance.
The 4th issue for BPC are laboratory costs, which are out of reach for disaster areas, refugee camps, MD offices, and areas without health care infrastructure.
The goal is to increase reliability, accuracy, speed, portability, and access to both urine and blood cultures.
In the case of blood, the added goal is to decrease Hospital-Acquired Anemia, its costs, by decreasing blood volumes.
Our new hand-held, portable blood diagnostic device called InnovaBug™ can detect in minutes, pathogen load in from 0.03 – 0.3 mL fluid drops. It uses a fluorescent colorimetric reaction, a rapid, compact technology parallel to the technology in well-established blood plasma glucose meters.
Because detection can happen in minutes, and can be used at the bedside, camps and remote areas, or MD offices, border crossings, etc., it reviews a pathogen load present in the blood or urine at the time of collection instead of growing a new load due pathogen contamination when time elapses with day-long blood cultures. InnovaBug avoids detecting contamination that grows, multiplies and loads blood and urine later.
InnovaBug can help:
- Eliminate quickly and cheaply truly negative urine and blood samples with just a few drops to detect the actual presence of a pathogen load before contaminants have a chance to grow.
Since 80% of pathogen culture come back negative, InnovaBug reduces unnecessary cultures, and associated costs by 80%.
- Detects pathogen loads already grown and present in blood and urine at the time of collection in minutes, without the risk of pathogen loads from growing contamination seeded during collection. InnovaBug can identify direct pathogen loaded blood and urine samples that need to be cultured for identification. This constitutes about a 1/5th in average of all samples collected.
Alz BiosSTM
A rapid, low volume, fast and accurate handheld Alzheimer’s blood testing device for detecting Methyl-Glyoxal (MGO), a substance present in all stages of Alzheimer’s .
In 2021, at least 44 million people worldwide suffer from Alzheimer’s Disease (AD). Diagnosing Alzheimer’s and monitoring progression is key to possible prevention, treatment and present attempts at slowing Alzheimer’s inexorable progression.
State-of-the-art diagnosis methods for Alzheimer’s involve complex, expensive and equipment-intensive techniques. These include brain imaging via Positron Emission Tomography (PET-scans) to detect Alzheimer’s Disease characteristic amyloid plaques, Magnetic Resonance Imaging to identify brain lesions, and cerebro-spinal tap. Reporting by family members and evaluation with a General Medical Practitioner (GP) are the most prevalent diagnostic methods. Reporting can often times be subjective and so family and patients often delay reporting, making any interventions made by the GP ineffective.
In 2018, the cost of Alzheimer’s care was $277 Billion. By 2050, the world’s aging population and ever rising rates of chronic illness such as diabetes mellitus, obesity and hypertension is increasing the risk of Alzheimer’s threefold. Hence, the cost of the disease is expected to reach $1.1 Trillion in the next 30 years – not accounting for inflation, a cost to be borne by the next generation being born presently during Covid-19.
Developing inexpensive, portable diagnostics to diagnose Alzheimer’s Disease effectively, early on, and monitor progress and treatment is the first step in addressing this issue. In 2019, Haddad et al. showed that the level of a blood plasma biomarker, Methyl-Glyoxal (MGO) can be correlated with the development of Mild Cognitive Impairment (MCI), and is present in the stages of Alzheimer’s, from mild to advanced. Presently, no portable device detecting and measuring MGO exists. Alz BiosSTM, is the first rapid, testing device that features a measurement protocol for a hand-held, inexpensive ‘MGO-meter’.
To date, Alz BiosSTM has successfully demonstrated its ability to identify MGO in prototypes. We are now ready to move into the calibration phase to ensure the device detects better than the gold standard of +/-10%. Once this is done, we will complete the final rounds of testing required before we can submit to the FDA for approval. We estimate 12-18 months before it’s ready to go to market.
UVx is our Cutting Edge-Medical Grade Sterilization Technology
UVx is being developed into several products targeted specifically for medical sterilization. Our mobile sterilization unit is designed for field, battleground hospitals, bush hospitals, remote and rural medical centers and emergency response centers. The OR unit is designed to speed up the process of sterilizing individual instruments on the fly in the surgery setting. UVx sterilization units have a low energy use and eliminate the need for water supplies required for traditional steam sterilization.
Infinitum Bio-Med is always looking for our next team member.
If you’re looking to join a team on the cutting edge of medical device technology then you owe it to yourself to learn more about Infinitum Bio-Med. We are a fast growing company and always looking for creative thinking engineers and lab technicians.
Contact Us
1432 S. Dobson Rd, Ste. 202, Mesa, AZ 85202 on the Banner Desert Medical Hospital Campus.