Core Innovations

In order to bring vast capabilities to digital health, there needs to be fundamental innovations.  We have worked hard to invent the future.  Below are the patented and patent pending innovations that enable our hardware:

 
 Nanostrips and blood cells

Nanostrips and blood cells

  Spiral micromixer and three essential components of design: inlet, spirals, and detection point.

 Spiral micromixer and three essential components of design: inlet, spirals, and detection point.

 rHEALTH diagnostics work on the principle of laser-induced fluoresence. 

rHEALTH diagnostics work on the principle of laser-induced fluoresence. 

 Sample consumable

Sample consumable

 Individual applying the SKYE sensor. 

Individual applying the SKYE sensor. 

Nanostrips are rectangular microparticles that can be barcoded to allow for massive multiplexing with small sample volumes. These are similar to traditional test strips, except they are shrunk in volume by over a billion-fold.

 

Spiral Vortex Micromixer achieves chaotic advection necessary to overcome laminar flow within the microfluidic channels and enable micromixing of small blood samples.  US Patent 9,194,780.

 

Miniaturized Optical Block.  Major advances in the miniaturization of complicated and large optical systems make it possible for us to deliver the rHEALTH in its handheld form.   The optical block is 1000x smaller in mass and volume than comparable performance optical assemblies.

 

Microvolume sample loader.  Innovation for collection of small volumes of biological sample.  This allows us to collect less than 10 uL of sample for analysis.  The entire sample is analyzed with minimal residual volume.

 

The SKYE sensor includes integrated sensing technology for measuring vitals with a single device.  The following is a list of targeted vitals for the SKYE Sensor: 

  • ECG and Heart Rate
  • Respiratory Rate
  • SpO2 (oxygen saturation)
  • Accelerometer
  • Core Temperature
  • Cuffless Blood Pressure
 
 

Technologies above are limited by federal law to investigational and research use only. Not approved for sale in any market.

Nanostrip and Lumibead Assays

The advantage...

The high binding capacity combined with the low autofluorescence of rHEALTH hydrogel microparticles allow for superior analytical sensitivity. 

Right Figure. Spiked TNFa samples were analyzed via conventional polystyrene beads, ELISA, and Nanostrips using the same antibody pair. The assays were performed in a similiar manner, except for technology platform. 

The results are demonstrated in a 3-way comparison of Nanostrips with ELISA and bead-based assays in the figure to the right. Using the same antibody pair, the nanostrips have the best senstivity at < 0.1 pg/mL compared with chemifluorescent ELISA at 10 pg/mL and other conventional polystyrene bead-based assays at 10s of pg/mL. 

 

 Results are plotted with arbitrary units (AU) versus [TNFa] (pg/mL). Open symbols indicate the LOD. LOD for Nanostrips is &lt; 0.1 pg/mL for Nanostrips as compared to 10  pg/mL  for ELISA and 80  pg/mL &nbsp;for conventional beads.&nbsp;

Results are plotted with arbitrary units (AU) versus [TNFa] (pg/mL). Open symbols indicate the LOD. LOD for Nanostrips is < 0.1 pg/mL for Nanostrips as compared to 10 pg/mL for ELISA and 80 pg/mL for conventional beads. 

 A wide variety of assay formats are possible including: (A)&nbsp;sandwich immunoassay, (B) competitive immunoassay, and (C) nucleic acid detection. Other assay formats are possible as well.

A wide variety of assay formats are possible including: (A) sandwich immunoassay, (B) competitive immunoassay, and (C) nucleic acid detection. Other assay formats are possible as well.

Our particles are well-suited for immunoassays, nucleic acids, and other types of molecular assays that are conventionaly performed in various laboratory settings. Nanostrips are capable of exceptionally high levels of multiplexing based on unique 1D barcodes implemented in the blue fluorescence channel. LumiBeads are utilized when high-sensitivity is desired along with moderate levels of multiplexing. 

 
 Capabilities of Nanostrips and LumiBeads compared with conventional assay approaches.

Capabilities of Nanostrips and LumiBeads compared with conventional assay approaches.

 

Microparticle Technology

 

rHEALTH Hydrogel Particles

A wide variety of assays are possible using rHEALTH hydrogel assay particles. Nanostrips are rectangular format particles and Lumibeads are spherical format.

 
rhealth microparticles.PNG

A. Hydrogel microparticles are high surface area microparticles that allow for biomolecule immobilization within its matrices

B. Nanostrips are rectangular microparticles that can be barcoded with the blue fluorescence channel.

C. LumiBeads are spherical forms of the hydrogel microparticles with exceptional monodispersity.

 

Low autofluorescence material. The material of our microparticles has much lower autofluorescence than conventional polystyrene or latex beads, allowing for greater signal-to-noise ratio.

Higher surface area. Our particles have a much higher surface area than conventional particles. Their hydrogel composition allows analytes to bind internally within the microparticles, allowing for molecule binding and thus greater assay performance.

High uniformity. Our hydrogels are made to exceptional precision with size CVs in the 1% range. 

 
  &nbsp; The high binding capacity combined with the low autofluorescence of rHEALTH hydrogel microparticles allow for superior analytical sensitivity.&nbsp;Above chart compares c apabilities of Nanostrips and LumiBeads with conventional assay approaches.

 The high binding capacity combined with the low autofluorescence of rHEALTH hydrogel microparticles allow for superior analytical sensitivity. Above chart compares capabilities of Nanostrips and LumiBeads with conventional assay approaches.

 

Spiral Vortex Mixer

 
  • Does not rely on powered mechanical subcomponents to function.
  • Achieves chaotic advection necessary to overcome laminar flow within the microfluidic channels.
  • Design delivers all entering fluid downstream so that one sample run does not affect the next.
 
 
 

Optical Block Miniaturization

 

rHEALTH diagnostics work on the principle of laser-induced fluorescence using solid-state lasers, at different wavelengths. The sample is flow-focused into a flow cell using sheath fluidics. The lasers excite fluorescence dyes on cells and particles. The fluorescence is collected by detectors and the fluorescence intensity versus time data is collected and analyzed. 

Major advances in the miniaturization of complicated and large optical systemspatent pending innovationsmake it possible for us to deliver the rHEALTH in its hand held form.

  • Optical block technology: complete, matchbox-sized optical detection unit within instrument.
    • Photon counting detectors. Individual photon events are recorded by detectors.
    • Fixed alignment. Robust, alignment-free optical system.
    • All solid-state design. All detectors and lasers in the system are solid-state, thus leading to increased robustness and simplicity. 
    • Miniaturized high precision sheath flow. Our optical block utilizes sheath flow to attain the greatest precision. Our system does not require flow cell replacement.
  • Compact fluidics. The instrument utilizes an air pump to pressurize fluid vials in the back of the instrument. Flow stability is ensured using a precision regulator and robust fluidic connections managed by a patent pending fluidics module
nanostrips and blood cells image.jpg
 

Institutions

These collaborations between rHEALTH and not-for-profit institutions provide institutions access to rHEALTH technology platforms, our team's broad expertise, and our proprietary biomaterials.  

 

Academic

Access to rHEALTH instruments is typically limited to selected labs within defined research areas, thereby providing our academic partner a unique position in generating publications and grants. 

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Government

rHEALTH is honored to work with government research institutions in developing valuable intellectual property and new commercialization opportunities for basic scientific research, space medicine, and defense.

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personal diagnostics

Growth of miniaturized devices along with wireless communication tools have fundamentally changed the structure of how we connect. In order for proper healthcare to be more attainable and efficient, technological innovation and tools must similarly be made available. We believe that structural change in basic healthcare delivery begins with personal diagnostics.

 

rHEALTH collaborates with biotech, pharma, academic as well as government institutions to explore mutual areas of interest for furthering early detection of disease, management of chronic conditions, personal diagnostics, and companion diagnostics. These partnerships may consist of one or a combination of the following frameworks or other structures:

Framework 1

Collaboration in developing diagnostic tests on the rHEALTH platform enables collaborators to more effectively monitor patient response to ongoing therapy that is available through prescription or in clinical trials. 

Framework 2

License to rHEALTH diagnostic tools and integrated technology suite give partners a competitive advantage towards a successful product launch.