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Voxeleron at ARVO 2023

Voxeleron at ARVO 2023

An ARVO in April in New Orleans is certainly an exciting prospect, so we look forward to our time in this historic city.   Ahead of that, we’re taking the opportunity to share some updates as a year is a long time in the world of software development, and both iNebula and Orion have come a long way since then.  While Orion, our ophthalmic image analysis software, has been used in clinical trials for years, iNebula, our cloud-based clinical trial management software, is only in its first year of trial usage.  But this has been a significant year as it has shown how compelling iNebula, as a solution for the management of imaging-based trials in ophthalmology, is.

To learn more, please visit our booth (#919) where we’d be glad to update you further and also demonstrate our solutions.  Below is a brief synopsis of our recent news.

iNebula Updates

As a reminder, iNebula is the only truly vendor-neutral ophthalmic clinical trial management solution.  Images from any device can be uploaded in their native format and available for immediate review by anyone, anywhere in the world.  It’s worth understanding the difference between just supporting DICOM and true vendor neutrality as (1) some devices do not support DICOM export, and (2) the need to convert to DICOM is a significant workflow impediment.  But yes, we also support DICOM (indeed, that’s our storage format in the cloud, such that we can integrate with any larger EMR/PACS systems); and yes, and in conjunction with Orion, these solutions uniquely answer the NEI’s call for standardization in this space.

In terms of updates, first and foremost, we recently released a version of iNebula that is 21 CFR Part 11 compliant.  This is, of course, a requirement for use in pivotal trials, as are scheduled for this coming year.  Secondly, we are, as an organization, GDPR compliant, and this covers, therefore, the current version of iNebula.  This means that clinical trials can now extend to the EU area, as well as the UK.  On the features side of things, a number of workflow enhancements have also been added, including

  • A dashboard for clinical trial managers to see each trial’s progress at a glance.
  • Support for multiple reading flows (e.g. single read, double read with adjudication, etc.).
  • Full Orion integration for 2D and 3D analyses.
  • Customizable eCRF forms.

Orion Updates

We’ve actually had four different releases since the last ARVO, which, while painful in terms of the required supporting documentation, have been very well received by our customers.  Indeed, our customers are the sources of the changes, so we’ve been glad to oblige.  Among the major additions are:

  • We have added several new optimizations to our patented 3dEdit tool (blog post here) that speed up OCT reads by 2-3 times (and we were already a zillion times faster than any OEM solution).
  • We have enhanced our 2d analysis offerings allowing us to fully support segmentation and annotations/measurements for all 2d imaging modalities. We are very happy to be able to say that Orion is now not only a tool for OCT, but for comprehensive ophthalmic image analysis.
  • The GUI has changed allowing customizations of display settings, as well as, for example, a configurable thumbnail of the thickness map to appear in full-screen mode allowing the user to better navigate their way through B-scans.

Voxeleron in the Press

The following is a list of publications since last year’s ARVO that are based either on our software or our research:

  • “Quantitative Assessment of Automated Optical Coherence Tomography Image Analysis using a Home-Based Device for Self-Monitoring Neovascular Age-Related Macular Degeneration” Oakley, Jonathan PhD; Steven, Verdooner MD; Russakoff, Daniel PhD; John, Seaman PhD; Jayashree, Sahni MD; Mariano, Cozzi MSc; John, Rogers PhD; Giovanni, Staurenghi MD.  Retina: November 17, 2022 – Volume – Issue – 10.1097/IAE.0000000000003677 doi: 10.1097/IAE.0000000000003677
  • “Corneal Nerve Changes Observed by In Vivo Confocal Microscopy in Patients Receiving Oxaliplatin for Colorectal Cancer: The COCO Study”, Tyler, McGhee, Lawrence et al. J. Clin. Med. 2022, 11(16), 4770.
  • “Proof-of-Concept Analysis of a Deep Learning Model to Conduct Automated Segmentation of OCT Images for Macular Hole Volume.”, Pereira A, Oakley JD, Sodhi SK, Russakoff DB, Choudhry N.  Ophthalmic Surg Lasers Imaging Retina. 2022 Apr;53(4):208-214. doi: 10.3928/23258160-20220315-02. Epub 2022 Apr 1. PMID: 35417293.

ARVO 2023 Presentations and Posters

And the following is a list of presentations that we have collaborated on for this year’s ARVO:

  • “Utilization of En Face OCT and Deep Learning-Based Automated Segmentation to Quantify Area of GA (ECLIPSE)”, Samantha Orr et al., Posterboard#: C0144, Abstract Number: 307 – C0144. Sun, Apr 23, 8:00am – 9:45am, Session #23
  • “Retinal Neurodegeneration and retinal vessel changes assessed by Optical Coherence Tomography Angiography in type 1 Diabetes Mellitus”, Carolina Bernal-Morales et al., Posterboard#: B0507, Abstract Number: 2685 – B0507. Tue, Apr 25, 8:45am – 10:30am, Session #147
  • “Assessment of OCT image layer segmentation results using a common platform system compared to original equipment manufacturer software”, Hanna Rodriguez Coleman et al., Posterboard#: B0151, Abstract Number: 3383 – B0151. Tue, Apr 25, 3:30pm – 5:15pm, Session # 193
    • A press release related to this study can be found here.
  • “Optic nerve head morphology as biomarker in Leber hereditary optic neuropathy (LHON)”, Alice Galzignato et al., Posterboard#: B0410, Abstract Number: 4093 – B0410. Wed, Apr 26, 10:30am – 12:15pm, Session # 226

And Finally

We hope that you have found these updates to be of interest.  It has been a busy year in terms of software development, but growth also as an organization as we cater for the needs of international and pivotal clinical trials.  In that regard we would like to take this opportunity to thank NCATS for their generous research/commercialization grant.  It has allowed us to build and evolve iNebula into the product it is today; a product without peer in terms of ophthalmic imaging interoperability.  And the same can be said for Orion!

So we are very much looking forward to demonstrating this in person at ARVO. If you can’t make it, please do reach out via email.  We would be delighted to hear from you.

With best regards,

The Voxeleron team.

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