First Patients Treated in First-in-Human Trial for Innovative Liver and Pancreas Sealant Patch
September 15, 2018 – Other –
GRONINGEN, The Netherlands, September 15, 2020 / B3C newswire / — Polyganics,
a medical technology company developing, manufacturing and
commercializing bioresorbable medical devices, today announced treatment
of the first patients in its first-in-human study for ACTISEAL, its Liver and Pancreas Sealant Patch.
The ëSHIELDSí trial is a prospective, multicenter study, evaluating the safety and
performance of ACTISEAL in reducing fluid leakage following elective
hepato-pancreato-biliary (HPB) surgery. The trial will involve 80 adult
patients, enrolled and treated across seven renowned European clinical
centers.
Despite post-operative fluid leakage being one of the most common
complications of HPB procedures, with potentially life-threatening
consequences, there are currently no clinically effective treatment
options available. As a result of this high unmet need combined with
Polyganicsí convincing research data, the US Food and Drug
Administration (FDA) awarded the Companyís Liver and Pancreas Sealant
Patch a Breakthrough Device Designation in 2018.
ACTISEAL functions both as a sealant, withstanding the impact of
aggressive bile and pancreatic fluids, and a hemostat, controlling
mild-to-moderate bleeding. The easy-to-use, 100% synthetic device is
optimized to adhere to and seal the treated tissue throughout the
critical healing period following HPB surgery. After this it degrades
safely within the body.
Prof. Dr. Med. Dr. Jakob Izbicki, Chairman of the Department
of General, Visceral and Thoracic Surgery, Surgeon-in-Chief at
University Medical Center Hamburg-Eppendorf (UKE), Polyganicsí
development partner for ACTISEAL, and Principal Investigator of the
study commented: ‘There is a clear and urgent need for a device
capable of effectively controlling fluid leakage following HPB surgery.
Such post-operative leakage represents a high burden to both patientsí
well-being and our healthcare system. I applaud Polyganics for
responding directly to the demands of surgeons and needs of patients
with ACTISEAL. The initiation of the first-in-human study is a
significant step towards reducing leakage associated complications,
which adversely affect surgical success and patient outcomes’.
Rudy Mareel, CEO of Polyganics, added: ‘As the first
product to enter the clinic from our General Surgery portfolio,
ACTISEAL is spearheading Polyganicsí expansion into this challenging
field. The patch is key to our strategy to increase the strength and
breadth of our offering by diversifying our pipeline of bioresorbable
tissue support, repair and regeneration devices. This announcement adds
to the string of varied successes Polyganics has enjoyed since inception
across product development, R&D, manufacturing and
commercialization.’
About fluid leakage after HPB surgery
Fluid
leakage is a common complication of hepato-pancreato-biliary (HPB)
procedures and represents a significant healthcare burden. Up to 27% of
liver resections are affected by complications with bile leakage (1),
and postoperative pancreatic fistula impact up to 41% of pancreatic
resection patients (2). With life-threatening consequences such as
infection, abdominal abscesses and sepsis, post-operative bleeding and
leakage of aggressive enzymatic fluids into the abdominal cavity result
in increased morbidity and mortality, prolonged hospital stays and
enhanced costs. There are currently no approved and clinically effective
treatment options to reduce fluid leakage after HPB surgery.
About ACTISEAL
ACTISEAL,
Polyganicsí Liver and Pancreas Sealing Patch, is an easy-to-use and
100% synthetic device, made of the Companyís bioresorbable and
biologically safe polymers. The patch is optimized to significantly
reduce fluid leakage during the critical healing period after HPB
surgery, as a sealant, withstanding the impact of aggressive bile and
pancreatic fluids, and as a hemostat, controlling mild-to-moderate
bleeding.
The patch is the first product in Polyganicsí General Surgery portfolio and was designated as a Breakthrough Device by the US Food and Drug Administration (FDA) in 2018. It is being
developed in close association with the surgical department of the
University Medical Center Hamburg-Eppendorf (UKE). To support clinical
validation of the device, in May 2020 Polyganics was awarded EUR 1.2 million from the European Fund for Regional Development (EFRO) through the
Northern Netherlands Alliance (SNN) and the city and province of
Groningen.
About Polyganics
Polyganics
is a medical technology company with multiple versatile polymer
platforms. The company develops, manufactures and commercializes
innovative bioresorbable medical devices that facilitate tissue repair
and regeneration.
Polyganicsí portfolio comprises of products
developed in-house and in collaboration with leading medical technology
companies and academic centers of excellence. The portfolio includes
marketed products in the fields of Peripheral Nerve Repair (PNR) and
Neurosurgery: VIVOSORB, for minimizing unwanted tissue adhesions after
surgery; NEUROLAC, for supporting PNR following hand surgery;
NEUROCAP, for the management of symptomatic neuromas; and LIQOSEAL, a
dura sealant patch for the effective control of cerebrospinal fluid
leakage. Products in development include ACTISEAL, a Liver and Pancreas
Sealant Patch in the field of General Surgery.
In 2014, Polyganics
sold its Ear, Nose & Throat (ENT) surgery business unit (the
NASOPORE product family including HEMOPORE, SINUPORE and OTOPORE and
NASOPORE-FD) to Stryker, one of the worldís leading medical technology
companies. Polyganics continues to manufacture the NASOPORE product
range for Stryker.
Polyganics is a privately held company based in
Groningen, The Netherlands, a center of biomedical engineering
excellence, where it has an ISO 13485-certified manufacturing facility.
The Companyís polymer platform technologies are protected by a broad
portfolio of patents and its products have received clearance from the
US FDA, CE-approval, and approval from CFDA and other international
authorities. To date, Polyganics has produced and delivered more than 5
million devices.
For more information, visit: www.polyganics.com, or follow us on LinkedIn: Polyganics BV
