Oakland, N.J., Groningen, The Netherlands, October 5, 2022 – Collagen Matrix, Inc. (“Collagen Matrix”), a global leader in regenerative medicine and a Linden Capital Partners (“Linden”) portfolio company, today announced the acquisition of Polyganics, B.V (“Polyganics”). Polyganics is a medical technology company that develops and manufactures bioresorbable medical devices. The acquisition expands Collagen Matrix’s portfolio […]
Groningen, The Netherlands, May 21 2021 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announced treatment of the first patient in its ENCASE II clinical trial for LIQOSEAL.
LIQOSEAL is an easy-to-use, synthetic dura sealant patch indicated for use as an adjunct to standard methods of cranial dural repair, to provide watertight closure of the dura mater and reduce cerebrospinal fluid (CSF) leakage. In addition, LIQOSEAL also supports regeneration of the dura mater by acting as a scaffold for new fibrotic layer formation (‘neodura’).
ENCASE II is randomized, two-arm, multicenter study, evaluating the safety and efficacy of LIQOSEAL® in reducing intra- or post-operative CSF leakage in patients undergoing elective cranial surgery. The trial will involve 228 patients, enrolled and treated at up to 20 clinical centres across the US and Europe. Patients will be randomly treated at a 1:1 ratio with either LIQOSEAL or an FDA-approved sealant as a control.
Polyganics achieved CE mark certification for LIQOSEAL in early 2020, based on positive 3-month data from its ENCASE I clinical trial, and immediately launched the device in Europe. The Company has seen good uptake, and now, just over a year after the initial launch, LIQOSEAL is commercially available throughout Europe via a dedicated network of distribution partners and is registered for use in other countries including Turkey, Israel, Jordan, Argentina. Other registrations are also in progress.
Dr. Andrew Carlson, Neurosurgeon at the University of New Mexico Hospitals in Albuquerque, New Mexico, and Global Coordinating Investigator for the study commented: “Cerebrospinal fluid leakage is one of the most common complications of neurosurgical procedures and a significant burden to patients and healthcare systems. LIQOSEAL is a potentially game-changing device, which may offer a unique opportunity to make a meaningful impact on the lives of patients by reducing these CSF leak rates. I am excited to be part of the ENCASE II study where we are rigorously testing this hypothesis.”
Prof. Dr. Med. Tristan van Doormaal, Neurosurgeon at the University Hospital Zurich and University Medical Center (UMC) in Utrecht, and Coordinating Investigator for the study in Europe said: “Having worked on the LIQOSEAL project since inception, I am proud that the device is now entering this large-scale ENCASE II clinical trial. I was delighted with the follow-up results of ENCASE I, showing that there was no CSF leakage and no clinically significant swelling, while there were no device-related adverse events following the first 40 LIQOSEAL surgeries. I am pleased to continue playing my part to critically study this device, ultimately to maximally reduce CSF leakage in our patients.”
Rudy Mareel, CEO of Polyganics, added: “Despite many COVID-related delays to elective procedures during the past year, we are happy that Polyganics has seen strong interest and uptake of LIQOSEAL throughout Europe and in other countries. We are proud to have numerous world-renowned clinical centres participating in our ENCASE II study. They are a testament to the unique, life-altering potential of our dura sealant device.”
– ENDS –
For more information please contact:
Polyganics
Paul Roos, Chief Financial Officer
Marleen Schoonen, Director Corporate Communication & Corporate Affairs
T: +31 50 588 65 88
E: p.roos@polyganics.com | m.schoonen@polyganics.com
Instinctif Partners
Melanie Toyne-Sewell / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com
Notes to editors
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.
Polyganics’ 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 world’s 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. The Company is ISO 13485-certified, and its products have received clearance from the US FDA, CE-approval, and approval from the CFDA and other international authorities. Polyganics’ polymer platform technologies are protected by a broad portfolio of patents.
For more information, visit: www.polyganics.com, or follow us on LinkedIn: Polyganics BV
About CSF leakage
Cerebrospinal fluid (CSF) leakage is a widely recognized complication of neurosurgical procedures. It represents a significant patient burden, resulting in increased morbidity, prolonged hospital stays, possible surgical revisions, and enhanced costs.1,2 Incidence rates vary depending on age, indication, location of surgery and underlying pathology, but in total CSF leakage occurs in 4-32% of surgical cases.3,4
About LIQOSEAL
LIQOSEAL® is a safe and easy-to-use patch indicated for use as an adjunct to standard methods of cranial dural repair during surgery. By ensuring watertight closure of the dura mater, the patch provides effective control of CSF leakage throughout the critical healing period, as well as supporting regeneration of the dura mater by acting as a scaffold for new fibrotic layer formation (‘neodura’). The patch uses Polyganics’ proven proprietary synthetic bioresorbable polymer technology. It is commercially available throughout Europe and in selected other countries via a network of experienced distributors.
For more information, visit: https://polyganics.com/portfolio/neurosurgery/
References
Groningen, The Netherlands, 20 April 2021 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announces its move to a state-of-the art, purpose-built facility on the Zernike Campus, Groningen. The new building will house Polyganics’ research laboratories, manufacturing and packaging facilities, and its offices.
The expansion is essential to accommodate Polyganics’ growing workforce and enable the Company to respond to the increasing demand for its commercial and pipeline products. This includes its own portfolios in PNR (Peripheral Nerve Repair), and Neurosurgery, with LIQOSEAL® gaining commercial traction in Europe, as well as the Stryker-owned NASOPORE® portfolio for ENT (Ear, Nose and Throat) surgery. In the near future, it will also include Polyganics’ new Liver and Pancreas sealant patch, ACTISEAL®, which is currently in clinical trials with first patients treated in Q3 2020.
Polyganics is committed to quality, safety, and sustainability in the development, manufacturing and commercialization of its medical devices, and the Company is determined to operate responsibly to improve environmental sustainability. These values have guided the design and construction of its new facility. Numerous measures have been taken to reduce and optimise energy use, minimize the use of water and enhance safety. For example, more than 600 solar panels have been installed, providing a renewable, clean energy source.
Rudy Mareel, CEO of Polyganics, said: We are happy to be moving into our new facility on schedule, just one year after we broke ground. The new building provides increased manufacturing capacity and space for up to 140 employees, to enable us to meet growing demand. Our lab facilities will be doubled in size, and our manufacturing facilities tripled. We are also delighted to be remaining in Groningen, with our established network of local partners and access to a high-quality talent pool. We look forward to joining the vibrant Zernike Campus, with the further collaborative opportunities this will afford.”
Jan Disbergen, COO of Polyganics added: “On behalf of the Company, I would like to thank the partners that have supported the development of our new facility and helped kickstart the next phase in Polyganics’ evolution. Particular thanks go to the City and the Province of Groningen which awarded us a RIG subsidy. The new building has further increased our focus on the environment and the health and safety of our employees. I would also like to extend my personal thanks to the construction, installation and equipment companies that have played an integral role in this journey.”
Edward van der Meer, Director of Campus Groningen, remarked: “We warmly welcome Polyganics to Campus Groningen, known as Northern Netherland’s Capital of innovation. Polyganics encompasses the collaborative spirit that resides here, where entrepreneurs, researchers and clinicians unite to pursue groundbreaking projects that have a tangible social and economic impact locally and worldwide. With a history of excellence in polymers, Groningen is a fitting home for industry leader, Polyganics and we are confident the Company will bring tremendous value to the campus.”
– ENDS –
For more information please contact:
Polyganics
Paul Roos, Chief Financial Officer
Marleen Schoonen, Director Corporate Communication & Corporate Affairs
T: +31 50 588 65 88
E: p.roos@polyganics.com | m.schoonen@polyganics.com
Instinctif Partners
Melanie Toyne-Sewell / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com
Notes to editors
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.
Polyganics’ 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 world’s 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. The Company is ISO 13485-certified and its products have received clearance from the US FDA, CE-approval, and approval from the CFDA and other international authorities. Polyganics’ polymer platform technologies are protected by a broad portfolio of patents.
For more information, visit: www.polyganics.com, or follow us on LinkedIn: Polyganics BV
Groningen, The Netherlands, 15 September 2020 – 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 ‘SHIELDS’ 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 Polyganics’ convincing research data, the US Food and Drug Administration (FDA) awarded the Company’s 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), Polyganics’ 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 patients’ 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 Polyganics’ 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.”
– ENDS –
For more information please contact:
Polyganics
Paul Roos, Chief Financial Officer
Romke Ribbels, Director Marketing & Business Development
T: +31 50 588 65 88
E: p.roos@polyganics.com
Instinctif Partners
Dr Christelle Kerouedan / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com
Notes to editors
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 leakage1, and postoperative pancreatic fistula impact up to 41% of pancreatic resection patients2. 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®, Polyganics’ Liver and Pancreas Sealing Patch, is an easy-to-use and 100% synthetic device, made of the Company’s 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 Polyganics’ 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.
For more information, visit: https://polyganics.com/portfolio/general-surgery/
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.
Polyganics’ 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 world’s 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 Company’s 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
References
Groningen, The Netherlands, 13 May 2020 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, announced today that it has received EUR 1.2 million in funding from the European Fund for Regional Development (EFRO) through the Northern Netherlands Alliance (SNN) and the city and province of Groningen, to support clinical validation of its Liver and Pancreas Sealant Patch. The grant will support a safety and performance study, which is scheduled to take place later this year in multiple renowned clinical centres across Europe.
Polyganics’ easy-to-use device is made of the Company’s synthetic and safe bioresorbable polymers and optimized to effectively adhere to and seal-off the surgically treated tissue throughout the critical healing period after hepato-pancreato-biliary (HPB) surgery. The patch functions both as a sealant, withstanding the impact of aggressive bile and pancreatic fluids, and as a hemostat, controlling mild-to-moderate bleeding. It is being developed in close association with the surgical department of the University Medical Center Hamburg-Eppendorf (UKE), Germany, and with MercachemSyncom, a contract research organization located in Groningen.
EFRO aims to strengthen the regional economy by supporting local businesses to improve their competitive position, economic growth, and sustainable development, as well as by increasing employment opportunities. As the first product in Polyganics’ General Surgery portfolio, the innovative Liver and Pancreas Sealant Patch is integral to the Company’s growth strategy. It will pave the way for additional future applications in the field, increasing the strength and breadth of the Company’s offering.
IJzebrand Rijzebol, member of the Provincial Executive of Groningen, commented: “We are proud to be able to support innovative companies that provide and inspire future investment in our region. Polyganics is an exemplary candidate for this grant, having enjoyed continued success in R&D, manufacturing and commercialization of medical devices, and provided attractive employment opportunities in Groningen for over 20 years. We congratulate the team and wish them luck with the upcoming study.”
Rudy Mareel, CEO of Polyganics, commented: “We are grateful to the EU, SNN and city and province of Groningen for their support towards progressing our Liver and Pancreas Sealant Patch into the next phase of development, particularly in the current unprecedented climate resulting from COVID-19. The grant is testament both to the quality of the preclinical data for this product, and to Polyganics’ strong growth outlook. As demand for products throughout our existing commercial portfolio continues to increase, we are pleased to be expanding into the challenging area of General Surgery, as we strive to provide unique bioresorbable medical devices to address unmet clinical needs.”
– ENDS –
For more information please contact:
Polyganics
Paul Roos, Chief Financial Officer
Romke Ribbels, Director Marketing & Business Development
T: +31 50 588 65 88
E: info@polyganics.com
Instinctif Partners
Dr Christelle Kerouedan / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com
Notes to editors
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.
Polyganics’ 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 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 world’s 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 company’s 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
About fluid leakage after HPB surgery
Fluid leakage is a common complication of hepato-pancreato-biliary (HPB) procedures and represents a significant healthcare burden. Bile leaks are one of the most common complications after liver resection with incidence rates up to 27%.1 Postoperative pancreatic fistula (POPF) remains the major cause of morbidity after pancreatic resection, affecting up to 41% of cases.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 Polyganics’ Liver and Pancreas Sealing Patch
Polyganics’ Liver and Pancreas Sealing Patch is an easy-to-use and 100% synthetic device, made of the Company’s 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, reducing bleeding.
The patch is the first product in Polyganics’ General Surgery portfolio and was designated as a Breakthrough Device by the US Food and Drug Administration (FDA) in 2018. It is currently under pre-clinical development, in close association with the surgical department of the University Medical Center Hamburg-Eppendorf (UKE).
For more information, visit: https://polyganics.com/portfolio/general-surgery/
References
Groningen, The Netherlands, 3 March 2020 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, announced the ground-breaking of a new facility at the Zernike Campus, Groningen. Polyganics aims to move into its new facility, which will house its headquarters, state-of-the-art research laboratories and expanded manufacturing and packaging facilities, in 2021.
The continued increase in demand for its ENT (Ear, Nose, Throat) and PNR (Peripheral Nerve Repair) portfolio, together with the strong commercial launch of LIQOSEAL® and a highly promising growth outlook for various pipeline products, makes the move to a larger facility essential for Polyganics. This purpose-built facility will provide the space to ensure that the company can continue to develop and deliver a reliable supply of bioresorbable medical devices to its customers and remain at the forefront of research and manufacturing excellence.
Paul de Rook, vice mayor of the city Groningen commented: “As an innovative medical technology company with customers world-wide, Polyganics is an excellent example of a thriving Groningen University spin out with strong economic growth potential. I am pleased that a RIG subsidy (Regional Investment Aid Groningen) helped secure this investment, and supporting the company’s long term sustainable future in Groningen. It will not only create and safeguard a significant number of high-quality jobs but will also support the local economy through cooperation with various regional companies.”
Edward van der Meer, Director Campus Groningen remarked: “We are delighted to welcome Polyganics at Campus Groningen, location Zernike; the Northern Netherland’s driver of innovation. More than 4000 researchers, employees and a few hundred entrepreneurs work here on innovative solutions which are of importance to the future. Polyganics is a perfect fit within the focus of Campus Groningen on energy, chemistry, life sciences and big data. In addition, Polyganics will be able to benefit from the strong connections of Campus Groningen and its stakeholders such as the University Medical Center Groningen (UMCG), the University of Groningen, the Hanze University of Applied Sciences and multiple Life-Science oriented firms located at this campus. Without doubt, Polyganics will provide a significant contribution to the exciting synergies that exist between residents of this campus.”
Rudy Mareel, CEO of Polyganics commented: “We are proud of our continuing successes in R&D, product development, manufacturing and commercialization, which are reflected in the need for increased capacity, that cannot be achieved at the current location. We are grateful to our partners, especially to the city and province of Groningen, who have supported this expansion. Ground-breaking of the new facility is another major milestone in our ultimate goal to transform patient recovery after surgical procedures.”
– ENDS –
For more information please contact:
Polyganics
Paul Roos, Chief Financial Officer
Romke Ribbels, Director Marketing & Business Development
T: +31 50 588 65 88
E: info@polyganics.com
Notes to editors
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.
Polyganics’ 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 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 world’s 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 company’s 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
Groningen, The Netherlands, 07 January 2020 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, announced today that it has obtained CE marking for LIQOSEAL®, its easy-to-use and innovative dural sealant patch, and will launch the device in Europe with immediate effect.
Approval of the CE mark is based on outstanding data from Polyganics’ ENCASE I clinical trial, evaluating the safety and performance of LIQOSEAL® in reducing cerebrospinal fluid (CSF) leakage after elective cranial surgery. 3-month follow-up results showed the absence of CSF leakage, as confirmed by MRI, no clinically significant swelling, and no device-related adverse events following surgery.
Initially, Polyganics will commercialize LIQOSEAL® in selected European countries with renowned distribution partners which have extensive experience in neurosurgical products. During 2020, the Company will then grow its network with the addition of multiple distributors throughout Europe.
Polyganics is also preparing to launch LIQOSEAL® in selected non-European countries. In addition, arrangements are well underway for the start of ENCASE II, a randomized controlled trial, which will enable the Company to submit the patch for pre-market approval to the US Food and Drug Administration.
Rudy Mareel, CEO of Polyganics, commented: “CSF leakage remains a devastating complication of neurosurgical procedures and represents a significant patient burden with high associated cost. The CE approval of this product is testament to the strength and quality of the clinical data from ENCASE I, showing that LIQOSEAL® establishes effective and enduring watertight dural closure. This is a key milestone in our journey to deliver our dural sealant patch to surgeons and patients in Europe and ultimately worldwide.”
– ENDS –
For more information please contact:
Polyganics
Paul Roos, Chief Financial Officer
Romke Ribbels, Director Marketing & Business Development
T: +31 50 588 65 88
E: info@polyganics.com
Instinctif Partners
Dr Christelle Kerouedan / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com
Notes to editors
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.
Polyganics’ 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 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 world’s leading medical technology companies. Polyganics continues to manufacture the NASOPORE® product range for Stryker. To date, Polyganics has produced and delivered more than 5 million devices.
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 company’s 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.
For more information, visit: www.polyganics.com, or follow us on LinkedIn: Polyganics BV
About CSF leakage
Cerebrospinal fluid (CSF) leakage is a widely recognized complication of neurosurgical procedures. It represents a significant patient burden, resulting in increased morbidity, prolonged hospital stays, possible surgical revisions, and enhanced costs.1,2 Incidence rates vary depending on age, indication, location of surgery and underlying pathology, but in total CSF leakage occurs in 4-32% of surgical cases.3,4
About LIQOSEAL
LIQOSEAL® is a safe and easy-to-use patch indicated for use as an adjunct to standard methods of cranial dural repair during surgery. By ensuring watertight closure of the dura mater, the patch provides effective control of CSF leakage throughout the critical healing period, as well as supporting regeneration of the dura mater by acting as a scaffold for new fibrotic layer formation (‘neodura’). The patch uses Polyganics’ proven proprietary synthetic bioresorbable polymer technology. It is commercially available throughout Europe via a network of experienced distributors.
For more information, visit: https://polyganics.com/portfolio/neurosurgery/
About ENCASE I
ENCASE I, the first-in-human trial of LIQOSEAL®, is a single-arm, open-label study evaluating the safety and performance of LIQOSEAL® in reducing CSF leakage following elective cranial surgery. 40 adult patients have been recruited at three sites across the Netherlands and Switzerland, with follow-up due to span a period of 12 months. The protocol for the ENCASE I study was published in 2019 in Neurosurgery.5
References
Groningen, The Netherlands, 17 September 2019 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, has today announced positive data from its ENCASE I* clinical trial.
The ENCASE I trial is focused on the evaluation of the safety and performance of LIQOSEAL® in reducing cerebrospinal fluid (CSF) leakage following elective cranial surgery. The 3-month results of ENCASE I show the absence of CSF leakage as confirmed by MRI, no clinically significant swelling, and no device-related adverse events following surgeries that used LIQOSEAL® for dural closure. Polyganics has submitted its filing for the CE Mark of LIQOSEAL® based upon these positive data from the ENCASE I trial.
LIQOSEAL® is a safe, synthetic, easy-to-use dura sealant patch, developed using Polyganics’ proprietary bioresorbable polymer technology, already applied worldwide in multiple clinical areas. The patch is indicated for use as an adjunct to standard methods of cranial dural repair to provide a watertight closure of the dura mater and reduce CSF leakage. In vivo studies show that LIQOSEAL® also supports regeneration of the dura mater during the critical healing period, by acting as a scaffold for new fibrotic layer formation (‘neodura’).
Dr Tristan van Doormaal, Neurosurgeon at the University Hospital Zurich and University Medical Center (UMC) in Utrecht, Principal Investigator of the study and leader of the initial research project at the Brain Technology Institute (BTI) commented: “CSF leakage remains a devastating complication for neurosurgical patients. These follow-up results from ENCASE I support previous in vitro and in vivo observations and indicate that LIQOSEAL® is safe to use in patients and seemingly shows better reduction of CSF leakage over standard of care methods as referred to in clinical literature. Interestingly, the unique scaffolding characteristic of this purely synthetic resorbable product, promotes the formation of a new layer of native dura, the layer that surrounds the brain and the spinal cord and which is responsible for keeping in the cerebrospinal fluid.” He continued: “I am pleased with the submission, as CE approval will enable surgeons and patients to benefit from LIQOSEAL®’s unique properties. I look forward to further assessing LIQOSEAL®’s value in our area of surgery in the future randomized controlled study, ENCASE II.”
Rudy Mareel, CEO of Polyganics, commented: “The submission of LIQOSEAL® for CE marking is another important step as we work towards commercializing this product, which is the first in our Neurosurgery portfolio. We are very encouraged by the positive data that enabled us to file this submission. Following CE approval, we plan to launch LIQOSEAL® in a number of countries across Europe, and ultimately plan to submit the product for pre-market approval (PMA) to the US Food and Drug Administration.”
Polyganics will be present at EANS 2019 (European Association of Neurological Societies) in Dublin, 24th-28th September, at the Company booth (#56). Dr. Tristan van Doormaal will provide an overview of the development of LIQOSEAL® in an oral presentation at Poster booth 1 in the 10:00 – 10:40 am session on Friday 27th September.
* ENCASE I: Single-arm, open-label, multi-center study to Evaluate the safety and performaNCe of DurA Sealant Patch in reducing CSF leakage following Elective cranial surgery
– ENDS –
For more information please contact:
Polyganics
Paul Roos, Chief Financial Officer
Romke Ribbels, Director Marketing & Business Development
T: +31 50 588 65 88
E: info@polyganics.com
Instinctif Partners
Dr Christelle Kerouedan / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com
Notes to editors
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.
Polyganics’ portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. In the Peripheral Nerve Repair (PNR) field, the portfolio includes three marketed products: VIVOSORB® for minimizing unwanted tissue adhesions after surgery; NEUROLAC® for supporting PNR following hand surgery; and NEUROCAP® for the management of symptomatic neuromas. In the Neurosurgery and General Surgery field, products in development include a sealant for the dura membrane (LIQOSEAL®) and the Liver and Pancreas Sealant Patch.
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 world’s leading medical technology companies. Polyganics continues to manufacture the NASOPORE® product range for Stryker. To date, Polyganics has produced and delivered more than 5 million devices.
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 company’s 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.
For more information, visit: www.polyganics.com , or follow us on LinkedIn: Polyganics BV
About CSF leakage
CSF leakage is a widely recognized complication of neurosurgical procedures. It represents a significant patient burden, resulting in increased morbidity, prolonged hospital stays, possible surgical revisions, and enhanced costs.1,2 Incidence rates vary depending on age, indication, location of surgery and underlying pathology, but in total CSF leakage occurs in 4-32% of surgical cases.3,4
About ENCASE I
ENCASE I, the first-in-human trial of LIQOSEAL®, is a single-arm, open-label study evaluating the safety and performance of LIQOSEAL® in reducing CSF leakage following elective cranial surgery. 40 adult patients have been recruited at three sites across the Netherlands and Switzerland, with follow-up due to span a period of 12 months.
Details of the ENCASE I study can be found at: https://clinicaltrials.gov/ct2/show/NCT03566602
References
Groningen, The Netherlands, 10 April 2019 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, is expanding its capacity with a new facility at the Zernike Campus, Groningen, to enter a new phase of commercial and R&D growth. Polyganics has been awarded a subsidy of €3.8 million by the Regional Investment Aid Groningen (RIG) initiative to support this development.
To-date, Polyganics has enjoyed significant growth and success in manufacturing, commercialization and R&D. After selling its leading NASOPORE® portfolio to Stryker in 2014, Polyganics continues to manufacture these products. In addition, Polyganics’ proprietary Peripheral Nerve Repair (PNR) portfolio continues its international roll-out. LIQOSEAL®, the Company’s lead Neurosurgery product, has entered clinical trials, and its Liver and Pancreas Sealant Patch has achieved multiple milestones on its path to the clinic, including being granted Breakthrough Designation by the FDA.
Polyganics will build a dedicated new site, which will house its headquarters, state-of-the-art research laboratories and expanded manufacturing and packaging facilities. The purpose-built facility will provide the space to ensure that the company can continue to develop and deliver a reliable supply of bioresorbable medical devices to its customers and remain at the forefront of research and manufacturing excellence.
To support the development of this new site, Polyganics has been awarded a €3.8 million RIG subsidy. The RIG initiative was created to support innovative and sustainable companies with the aim to boost the economy and increase employment in the Eems Delta region and at the Zernike Campus. At the Zernike Campus the primary focus is on companies in the fields of energy, chemistry, life sciences and big data.
Rudy Mareel, CEO of Polyganics, commented: “With the continued increase in demand for the ENT and PNR portfolios, and a strong growth outlook for the various highly promising products in our pipeline, our move to the larger facility at the Zernike Campus is absolutely essential. We are grateful to receive a RIG subsidy to support our expansion, which will enable us to continue to do what we are doing best: providing unique bioresorbable medical devices, addressing unmet clinical needs.”
Patrick Brouns, member of the Provincial Executive of Groningen, commented: “This investment is well aligned with our strategy to enable innovation and stimulate growth in the region. Polyganics has a track record of success and it provides attractive employment opportunities. The province of Groningen is proud to support such companies, which provide and motivate ongoing investment in our region.”
Polyganics is preparing to start building by the end of 2019, with the aim to move into its new facility in 2021.
For more information please contact:
Polyganics
Paul Roos, Chief Financial Officer
Romke Ribbels, Director Marketing & Business Development
T: +31 50 588 65 88
E: info@polyganics.com
Instinctif Partners
Dr Christelle Kerouedan / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com
Notes to editors
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.
Polyganics’ portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. In the Peripheral Nerve Repair (PNR) field, the portfolio includes three marketed products: VIVOSORB® for minimizing unwanted tissue adhesions after surgery; NEUROLAC® for supporting PNR following hand surgery; and NEUROCAP® for the management of symptomatic neuromas. In the Neurosurgery and General Surgery field, products in development include a sealant for the dura membrane (LIQOSEAL®) and the Liver and Pancreas Sealant Patch.
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 world’s leading medical technology companies. Polyganics continues to manufacture the NASOPORE® product range for Stryker. To date, Polyganics has produced and delivered more than 5 million devices.
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 company’s 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.
For more information, visit: www.polyganics.com.
About the RIG
The Regional Investment Aid Groningen (RIG) has been set up with the aim to strengthen the regional economy and increase employment for industrial companies in the Eems Delta region and at the Zernike Science Park. In 2014, €40 million was made available by the Ministry of Economic Affairs, the Economic Board Groningen and the province of Groningen. An additional €12 million has been made available via the National Program Groningen. The RIG is managed on behalf of the province of Groningen by the Samenwerkingsverband Noord Nederland (SNN).
Groningen, The Netherlands, 22 October 2018 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announced that it has initiated enrollment of patients into a first-in-human clinical trial of LIQOSEAL®, its dura sealant patch. The self-adhesive patch has been developed to reduce cerebrospinal fluid (CSF) leakage following brain surgery
The trial, titled ‘ENCASE’ is a single-arm, open-label study, evaluating safety and performance of LIQOSEAL® in reducing CSF leakage following elective cranial surgery. Up to 40 adult patients will be recruited at three sites across the Netherlands and Switzerland, with follow-up spanning a 90-day period.
CSF leakage is a common complication of neurosurgical procedures and can lead to life-threatening infections such as meningitis. LIQOSEAL®, developed using Polyganics’ bioresorbable polymers, is designed as an adjunct to closure of the outer protective membrane (‘dura’) surrounding the brain after brain surgery, thereby minimizing leakage of cerebrospinal fluid (CSF). The patch has been engineered to encourage regeneration of the dura and to degrade naturally and safely within the body over time, once the membrane has healed.
Dr. Tristan van Doormaal, a neurosurgeon at the University Medical Center (UMC) in Utrecht, the Netherlands, Principal Investigator of the study and leader of the initial research project at the Brain Technology Institute (BTI) commented: “Having worked on the Dura Sealant Patch from its conception, I am very excited about the device entering the clinic. There is an urgent need to effectively manage CSF leakage following brain surgery, to reduce post-operative complications and the associated impact on patient outcomes and recovery time, as there are currently no sealants on the market that have proven effectiveness in reducing post-operative leakage. We look forward to evaluating the performance of this novel approach in patients for the first time.”
Rudy Mareel, CEO of Polyganics, commented: “LIQOSEAL® is our first neurosurgery product to enter the clinic, further diversifying our strong pipeline of bioresorbable tissue repair and regeneration products. Preclinical data reveal an excellent ease-of-use and safety profile for the device as well as a highly promising performance, and we therefore have high expectations for its impact in the clinic. We strongly believe in the device’s potential to reduce the risk of infection and improve patient recovery following cranial surgery, meeting an urgent unmet need for patients and surgeons. This milestone builds on our success in nerve repair and ear, nose and throat surgery, and our strong progress in other types of surgery – including our Liver and Pancreas Sealant Patch which received a breakthrough device designation from the FDA earlier this year.”
Details of the ENCASE study can be found at: https://clinicaltrials.gov/ct2/show/NCT03566602
About cerebrospinal fluid leakage
Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical procedures, occurring in 4-32% of surgical cases.1 Incidence rates vary depending on age, indication, location of surgery and underlying pathology. CSF leakage leads to a significant patient burden, increased morbidity, prolongation of hospital stay, surgical revision, and enhanced costs as well as possible surgical revisions.2,3
About LIQOSEAL®
LIQOSEAL® has been developed using Polyganics’ proprietary bioresorbable polymers, and is indicated for use as an adjunct to standard methods of dural closure, such as suturing, to provide a watertight closure of the dura mater to prevent CSF leakage after a dural closure procedure. The sealant patch has been engineered to encourage tissue regeneration, and to degrade naturally and safely within the body over time, once the membrane has healed. Polyganics is developing LIQOSEAL® in collaboration with the Brain Technology Institute (BTI), located in Utrecht.
In December 2017, Polyganics was awarded funding from the European Fund for Regional Development (ERDF) by the European Union, to support clinical validation of LIQOSEAL®. Together with contributions from the city and province of Groningen, the grant totaled EUR 1.2 million.
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.
Polyganics’ portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. In the Peripheral Nerve Repair (PNR) field, the portfolio includes three marketed products: VIVOSORB® for minimizing unwanted tissue adhesions after surgery; NEUROLAC® for supporting PNR following hand surgery; and NEUROCAP® for the management of symptomatic neuromas. In the Neurosurgery and General Surgery field, products in development include a sealant for the dura membrane (LIQOSEAL®) and a liver and pancreas sealant patch.
In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the Nasopore® product family including Hemopore®, Sinupore®, Otopore® and Nasopore-FD®) to Stryker, one of the world’s leading medical technology companies. Polyganics continues to manufacture the Nasopore® product range for Stryker. To date, Polyganics has produced and delivered more than 4.5 m devices.
Polyganics is profitable and privately held. The Company is based in Groningen, The Netherlands, a center of biomedical engineering excellence, in an ISO 13485-certified manufacturing facility. The Company’s 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.
For more information, visit: www.polyganics.com
Polyganics
Paul Roos, Chief Financial Officer
Romke Ribbels, Director Marketing & Business Development
Telephone: +31 50 588 65 88
Email: info@polyganics.com
Instinctif Partners
Dr Christelle Kerouedan / Alex Bannister
Telephone: +44 (0)20 7457 2020
Email: polyganics@instinctif.com
References
1. van Doormaal T, Kinaci A, van Thoor S, Redegeld S, Bergmann W, van der Zwan A. Usefulness of Sealants for Dural Closure: Evaluation in an In Vitro Model. Oper Neurosurg (Hagerstown). 2018 Oct 1;15(4):425 432
2. Hutter G, von Felten S, Sailer MH, Schulz M, Mariani L. Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial. J Neurosurg. 2014 Sep;121(3):735-44
3. Grotenhuis JA. Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases. Surg Neurol. 2005 Dec;64(6):490-3, discussion 493-4.
