Polyganics Announces Start Building New Facility

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

Polyganics Achieves CE Mark Certification for LIQOSEAL®

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

  1. Hutter G, von Felten S, Sailer M, 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. Neurosurgery. 2014. Sep; 121:724-744
  2. Grotenhuis J. Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases. Surg Neurol. 2005, Dec; 64(6)|:490-3
  3. Kinaci A, Algra A, Heuts S, O’Donnell D, van der Zwan A, van Doormaal T. Effectiveness of Dural Sealants in Prevention of Cerebrospinal Fluid Leakage After Craniotomy: A Systematic Review. World Neurosurg. 2018 Oct;118:368-376
  4. 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.
  5. van Doormaal TPC, Germans MR, Sie M, Brouwers B, Fierstra J, Depauw PRAM, Robe PA, Regli L. Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery: The ENCASE Trial Study Protocol. Neurosurgery. 2019 Oct 1. [Epub ahead of print] PubMed PMID: 31574157.