Our work at Ativa has the potential to disrupt healthcare across the globe by decentralizing diagnostic testing and applying machine-learning A.I. at the point-of-care.

 

The global market for clinical lab services is worth about $140 billion in 2019. It is long overdue for a shake-up.

Ativa has developed the first “disease-learning” analyzer which will be trained by a consortium of specialist groups to rapidly create a new class of advanced tests. This platform creates a huge dataset that will be monetized in several ways. With this breakthrough technology, we are at the forefront of the coming healthcare revolution that will reshape primary care. Our A.I. based Screening Apps will disrupt the industry by providing new clinical value at a much lower cost.

 

Investors and Partners

 

Ativa’s mission is supported by major investors and partners who represent large potential end users globally, including insurance, pharma and lab services partners with direct patient relationships.

Our work is backed by three global Fortune 100 companies and multiple global Fortune 500 companies, with best-in-class strategic footprints in the United States and China across the blood-testing value chain. We have leveraged the expertise of 3M, Honeywell and Bosch as major technology partners and LabCorp as a strategic investor, among others.

Ativa also has received a variety of grants, most recently from the U.S. Department of Defense, the National Institutes of Health (NIH), NASA and Massachusetts General Hospital.

 

Markets

 

The diagnostic workstation has applications and adds value across the full spectrum of care settings. Ativa’s highest-priority markets include:

  • Emergency Departments – 5,000 in the U.S., some with a turnaround time of more than 30 minutes for test results
  • Primary Care Clinics – 70,000 in the U.S., two-thirds of which rely primarily on send-out services for blood testing
  • Pharmacies and Retail Clinics – 52,000 pharmacies and 2,800 retail clinics in the U.S.
  • Healthcare Big-Data – Growing to a $67 Billion market by 2020, Ativa will collect massive cellular-level data valuable to drug-development and research companies.
  • Global Markets – With a product designed for low-cost consumables and software diagnostics, Ativa is well placed to compete and disrupt the global $140B lab market.

 

Product Differentiators

 

While there are other point-of-care analyzers on the market, only Ativa’s diagnostic workstation can perform all five of the major diagnostic panels – and allow clinicians to run the panels themselves. Our key points of differentiation include:

  • First system capable of performing all five of the major blood, metabolic and urine test panels needed for patient diagnosis
  • First system capable of both blood and urine analysis.
  • First system to upload raw cellular data from routine testing to the cloud
  • Easy for all clinicians to use; no specialized training or staff required
  • Comparable performance to large blood and urine analyzers
  • Low blood sample volume (40uL) suitable for venous or finger-stick (one drop is 50uL)
  • Combination of detector fusion and machine learning will enable our machine-learning panel to “learn” the signature of several serious diseases for advanced detection

 

Proven Performance

 

A performance evaluation of the Complete Blood Count (CBC) on Ativa’s diagnostic workstation took place in May 2018 at Massachusetts General Hospital. The study focused on samples from seriously ill patients, as they often present problems in blood counts to even the most complex and expensive laboratory hematology analyzers. In each of the measured parameters, Ativa’s diagnostic workstation compared well with the reference system, achieving statistical levels of performance that exceed our product specifications.

The next round of clinical studies will begin soon to support our FDA 510(k) submission.

 

Product Portfolio Timeline

 

Our working schedule for commercialization of the diagnostic workstation includes a multi-year rollout beginning in 2021.

The launch menu will include the CBC, BMP and Urine Sediment Panel. Subsequent menu expansions will include the Comprehensive Metabolic Panel with Liver Function, Ca/Mg/PO4, Inflammation Panel (CBC/CRP/ESR), HbA1C, TSH and Lipid Panel.

A.I. based “Screening Apps” will focus on hematological disorders (anemias, thalassemia, sickle cell), serious acute diseases (sepsis, kidney injury), infectious diseases (malaria, dengue, infectious mononucleosis, toxoplasmosis) and various cancers (leukemia, bladder, kidney).

Our advanced Screening Apps will be offered on a subscription basis for an annual fee providing a significant additional revenue stream. Patients can opt-out for both screening apps and cellular-data upload to the cloud. All data is de-identified to protect privacy and Ativa meets and exceeds HIPAA standards.

The FDA recognises A.I. based Software as a Medical Device and is currently defining guidelines in which Ativa will participate.