The Operating Theatre Journal - Journal - Page 6
‘Diagnose on the spot’: Optiscan’s platform brings together
surgeons and pathologists for better cancer outcomes
• Optiscan (ASX:OIL) is pioneering new standard of care in digital pathology and precision surgery
• Platform particularly useful in diagnosis and excision of malignant tumours in operating theatres
• US FDA De Novo clearance for Optiscan InVivage product intended for oral cancer imaging
Optiscan is on a path to revolutionise healthcare
with its unique technology bringing together
surgeons and pathologists to diagnose, treat
and monitor patients with cancer.
Optiscan Imaging (ASX:OIL) CEO and managing
director Dr Camile Farah says the company has
been developing, 昀椀eld testing and perfecting
its single 昀椀bre optic miniaturised confocal
endomicroscope for the past two decades.
“Basically, we’ve taken a beam of light and
focused it to a single point to penetrate
tissue,” he says.
“By penetrating the tissue and focusing that
light purposefully we can obtain microscopic
images, which can be used to diagnose on the
spot because of the high-昀椀delity of imaging
resolution.”
Farah is a trained clinician and pathologist
who has been leading the company for the
last two years, transforming it from an OEM
manufacturer to a pure play digital solutions
provider.
He says the OIL platform is particularly useful
for intraoperative pathology during surgery
for the diagnosis and excision of malignant
tumours and premalignant lesions.
He says the company’s technology allows
surgeons and pathologists to work more
closely together in real time to ensure the
whole tumour is removed with a clear margin
rather than waiting for results from a lab and
often having to undertake revision surgeries.
“The technology also enables the surgeon to
make an informed decision on the spot or have
a pathologist help the clinician decide on the
spot.”
“Our probe can scan a 3D lump in real
time to obtain imaging at the single cell
microscopic level, so the pathologist gets all
the information they need to make a diagnosis
on the spot,” he says.
“They can turn around to the surgeon who is
in still in the operating theatre and say ‘I have
examined the whole tumour for you’.”
Farah says one third of patients who have
breast lumpectomy surgeries as an example
return to the operating theatre for repeat
surgery because the whole tumour has not
been removed completely.
“Current surgical practice is not a precise
science so what we’re trying to do is provide
the surgeon with a precision tool to determine
the clearance of their resection,” he says.
Improving ef昀椀ciency in
healthcare
Farah says with OIL’s platform, imaging is
instant, bringing the surgical and pathology
teams together to provide answers to patients
in real time and creating ef昀椀ciencies in health
care.
6
“Independent calculations show that our
technology can reduce lumpectomy operating
time by at least 46%, with industry wide direct
operating room savings of more than US $120
million annually in the US alone.
Farah says integrating OIL’s technology into
GI endoscopy has the potential to generate
substantial monetary gains for providers
estimated at US$8 billion in additional revenue
annually in the US alone.
“This would result in surgeons completing
their operations sooner with more accuracy,
and greater capacity for other procedures to
be carried out in freed up operating theatres.
He says earlier detection of colorectal cancers
in the US could save the health system another
US$3.8 billion.
“From an ef昀椀ciency point of view, hospitals
would be able to utilise their facilities for
more procedures daily and generate more
revenue while cutting down on waiting lists at
the same time.”
“Insurers and payors should support the
adoption of such new digital pathology
technology because of the ef昀椀ciencies it brings
and the clinical gains for their customers.”
$$ billion global market
potential
While OIL is focused on oncology, their
platform can be applied to other health
domains.
Farah says there is broad appeal for the
technology including:
• Doctors’ outpatient clinics for oral cancer
diagnosis
• Operating theatres
surgical assessment
for
intraoperative
• Endoscopy suites for monitoring chronic
conditions such as Crohn’s disease
• In the pathology lab to modernise current
analogue procedures
“If we take the US for example, the total
addressable market for our technology in
breast surgery is around US$2.6 billion.
“If we consider the total recurrence costs
are over US$6.4 billion, the potential for our
technology and the bene昀椀t to health systems
is signi昀椀cant, so being in the operating room
makes sense for us strategically.”
Farah says in the case of pathology procedures
the frozen section has remained unchanged
over the last century.
“Transition to our slide-free, biopsy-free
dynamic digital pathology work昀氀ow is
revolutionary,” he says.
“It essentially replaces the frozen section with
a digital equivalent, providing all the bene昀椀ts
of assessing pathology samples while scaling
down the surgical pathology time by at least
a quarter.
“That’s a signi昀椀cant amount of time and
cost savings for both the surgeon and the
pathologist.”
THE OPERATING THEATRE JOURNAL
Seeking FDA clearance
of InVivage
OIL is currently seeking US Food and Drug
Administration (FDA) De Novo clearance
for its InVivage product intended for oral
cancer imaging, after earlier this year getting
feedback from the FDA.
The FDA told OIL because of the 昀椀rst-inclass nature of InVivage and novelty of its
intended use, it could not evaluate substantial
equivalence of its device/drug combination
product due to the absence of a predicate.
“Because of our novel technology, Optiscan
is pursuing the De Novo pathway and has
accelerated completion of its submission to
the FDA, which is anticipated shortly,” he says.
Furthermore, OIL is now also working towards
other FDA De Novo applications for use of
its technology in other clinical procedures
including breast surgery and real-time digital
pathology.
“We’re trying to accelerate the path to
market, developing multiple hardware and
software combinations and running parallel
studies for new FDA submissions,” he says.
As Farah is focussed on expansion into the US,
OIL last week announced the appointment of
Brendan Fa昀椀ani as chief operating of昀椀cer.
Fa昀椀ani is highly experienced in the introduction
of new technologies into existing treatment
pathways and will assume responsibility for
operations at OIL’s Melbourne headquarters.
This article was developed in collaboration
with Optiscan, a Stockhead advertiser at the
time of publishing.
This article does not constitute 昀椀nancial
product advice. You should consider obtaining
independent advice before making any
昀椀nancial decisions.
The post ‘Diagnose on the spot’: Optiscan’s
platform brings together surgeons and
pathologists for better cancer outcomes
appeared 昀椀rst on Stockhead.
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