The 20 Most Disruptive Healthcare Solution providers The 20 Most Disruptive Healthcare Solution Provide | Page 15

3D processing and imaging of diseased tissue being
adopted initially into the research use only (RUO) market
and eventually entering the clinical market as adoption
increases and clinical utility is established.”
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We aim to
deliver an
unprecedented
way to visualize
and quantify
3D relationships
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within the tissue
microenvironment
Future Business Plans
Reorganization of leadership in recent months, has resulted
in changes to several aspects of the company, including a
name change to more accurately portray the revised
business model of the company and future potential
commercialization plan. By the fourth quarter of 2019 or
first quarter of 2020, the company will be launching a
Research Use Only (RUO) in-house service model along
with limited beta platform testing in the field, for 3-4
academic sites. The in-house custom service model will be
offered to academic and pharmaceutical customers in any
field, like preclinical, clinical drug development,
exploratory inclusion in clinical trials; as a means to grow a
profitable business over the next five years. These Beta
platform studies will allow the company to validate the
system and facilitate the generation of key clinical utility
data, informing about its future potential.
Following long term adoption of the RUO product by
pharma, academics, and CROs, ClearLight has plans to
enter the Laboratory-Derived Testing Clinical Market or a
Potential FDA-cleared platform/companion diagnostic with
potential partners, although the plans for this have not been
established at this time. The strategy of the company is to
first establish the RUO and potential clinical utility and
develop the market for the technology. It foresees this
timeline for FDA approval and clinical utility to be similar
to NGS technology market adoption.
“With any new disruptive and revolutionary technique,
adoption takes time and patience but the rewards are
extensive for a company like ClearLight Biotechnologies
since it holds exclusive intellectual property rights to
develop the CLARITY technology for diagnostic,
prognostic, and predictive future clinical applications,”
asserts the CEO.