A lung biopsy can be problematic at times and end up
requiring hospitalisation. That’s because a needle is inserted into the lungs
to collect a tissue sample during the procedure. This can cause the air to leak
out of the punctured hole, leading to a condition called pneumothorax or
collapsed lung. Patients may then need hospitalisation instead of just
undergoing a day procedure and develop complications.
While the idea seems simple,
developing the material was not. “The reason there aren’t any good sealants for
the lungs is that it is one of the hardest organs to work with – it expands and
contracts continuously and has a lot of fluids around. The lungs also face
extreme pressure when a person coughs. Any sealant has to be sticky enough to
not pop out during a coughing bout and elastic enough to move along with the
lung tissue,” says Gupta.
The team used a base polymer called pleuronic, which is already in use in
several medical procedures, and added various substances called excipients at
the end of the polymer chain to modify its properties. Although they have
worked on a sealant for the lungs at the moment, the base polymer can be
modified and used for other organs such as the kidney where procedures
typically lead to a lot of bleeding.The sealant developed by the team is also
bio-degradable, so it dissolves on its own within 30 days.
How does it differ from various medical
sealants available today? “Most of the sealants, including some that are used
for the heart, are topical – they are applied on top of the organ to close an
incision made by the surgeon. The sealant developed by us is actually going
within the organ, so it has to move along with the organ. And this is essential
when it comes to lung biopsy,” says Gupta.
There is an FDA-approved sealant for
pneumothorax but it plugs the lung after the procedure, hence it is not very
effective. “The air starts rushing out the moment the lung is poked; 75 per
cent of the time pneumothorax happens during the procedure. So, closing it
afterwards doesn’t always help,” he explains.
The only real competition that Pneumonix
faces is from another start-up in Ireland but the latter does not have
published data yet. “We have patent priority,” says Gupta, adding that the team
would get the product approved in the US first and then bring it to India.
Manufacturing the polymer is simple enough and can be done locally.
The
team, which has received a $1 million grant from the National Science
Foundation in the US among others, will now work on generating more data on the
product. Gupta says if the data is good enough, a phase III trial in patients
might not be needed for an FDA approval.
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