Press release

IME Medical Electrospinning launches MediSpin XL™, a cutting-edge high-volume electrospinning production platform for Medical Devices

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IME to host a special electrospinning session (number S64), Wednesday
May 29, from 11am – 1pm, during the
upcoming TERMIS
European Chapter Meeting
, 27 – 31 May 2019, Rhodes, Greece.

Managing Director Judith Heikoop presenting on ‘Mimicking the tissue
specific extracellular matrix composition’.

Dutch MedTech company IME Medical Electrospinning is the worldwide
leader and scientific partner in electrospinning equipment development
and services for medical devices and regenerative medicine. The company
today announced the launch of its newly developed revolutionary MediSpin
XL™ platform for large-scale industrial manufacturing of reproducible
and scalable fiber-based scaffolds for Class I, II and III medical
devices.
The launch of the platform marks a global breakthrough in the controlled
large-scale production of well-defined scaffolds for implants and
membranes using fibers ranging from nanometer up to micrometer scale.

Applying specific polymers, IME’s advanced equipment creates fiber-based
medical device solutions that mimic the natural human extracellular
matrix in nanometer and micrometer format for implants and membranes in
the human body. Human cells recognize this artificial matrix (scaffold)
as the body’s own facilitating the repair of the damaged tissue for
heart valves, blood vessels, nerves, tendons, skin and bone etc. This is
in contrast to implants and membranes of traditional structures, which
are seen as foreign and therefore can lead to scar tissue or rejection
phenomena. The MediSpin™ XL platform has been developed specifically for
MedTech industrial manufacturing of medical devices and ensures the firm
control of the crucial parameters of the electrospinning process,
leading to identical and consistent end-products.

Judith Heikoop, Managing Director of IME Medical Electrospinning,
says:

“The global launch of our state of the art production platform is
testimony to our strong belief in the strategic goal of becoming the
leading developer and producer of the most advanced electrospinning
equipment for both large-scale production and R&D purpose, and
broadens
our trusted partnership worldwide in co-developing electrospun medical
devices, which are seen as true game changers in the MedTech industry.”

Ramon Solberg, Founder and Managing Director of IME Medical
Electrospinning, says:

“This technology enables the large-scale manufacturing of
reproducible and scalable fiber-based scaffolds, the wonderful pieces of
art that will substantially transform the medical device market for a
wide variety of medical applications and thus revolutionize regenerative
medicine.”

MediSpin XL™, resolving distorting factors in electrospinning

The electrospinning process is governed by a number of variables that
are crucial for success in research and development, but certainly also
for large-scale manufacturing of fiber-based medical device solutions.
Crucial parameters in fiber diameter and structure, porosity, mesh
thickness and tensile strength are vital for the in-vitro and in-vivo
functionality of products, but were challenging to control in the past.
In particular, changes in temperature and relative humidity between the
seasons and during the day, could lead to inconsistencies within one
batch as well as between batches.

The groundbreaking MediSpin XL™ platform resolved all this and is the
result of IME’s pioneering research and more than a decade of medical
electrospinning experience in manufacturing smaller scale R&D equipment.
MediSpin XL™ is the first large-scale production platform that
eliminates all the important factors that might distort the
electrospinning process, enabling an optimal process set-up and
stability, including climate control and on-line quality monitoring
measurements, ensuring a consistent end-product.

The MediSpin XL™ equipment is built using state-of-the-art materials &
process controls in compliance with tight regulatory requirements for
medical products to minimize the chance of product contamination during
the process. Down-stream process steps such as cutting and blistering
can be easily included in the system. And lastly, ultimate automation
minimizes the need for operator intervention, which further adds to a
reproducible process and minimization of product contamination during
the process.

New world standard

With the introduction of the MediSpin XL™ platform, IME has further
strengthened its global standard for the joint development and
production of scalable and reproducible nanometer and micrometer
scaffolds. To this respect the company recently commissioned its brand
new high-end GLP Laboratory and set of ISO 7 cleanrooms. With these, IME
is now able to not only develop and manufacture its top-end proprietary
electrospinning equipment, but to also produce the actual scaffolds for
the intended medical implants for their customers. The cleanroom
facilities enable the production of Class I, II and III medical devices.

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About IME Medical Electrospinning

For over ten years, IME Medical Electrospinning has been a leading
player in the field of developing and implementing electrospinning
processes and equipment for the manufacturing of medical devices for
(regenerative) medicine. Electrospinning is a flexible process for
producing extremely thin fibers and structures that have excellent
properties to help regenerate human tissue. IME Medical Electrospinning
has developed an unique set of innovations in electrospinning technology
for the reproducible and scalable production of electrospun material
under tightly controlled conditions required for the MedTech market.
Customers and scientific partners include the MedTech industry,
scientists and health institutions.

Shareholders in the company are Dutch economic development company De
Brabantse Ontwikkelings Maatschappij (BOM) and informal investor network
TIIN Capital (TIIN).

More information available at http://www.ime-electrospinning.com