First Patients Treated in First-in-Human Trial for ACTISEAL® – Polyganics’ Innovative Liver and Pancreas Sealant Patch

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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

  1. Spetzler VN, Schepers M, Pinnschmidt HO, Fischer L, Nashan B, Li J. The incidence and severity of post-hepatectomy bile leaks is affected by surgical indications, preoperative chemotherapy, and surgical procedures. Hepatobiliary Surg Nutr. 2019 Apr;8(2):101-110
  2. Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P,Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande, SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591

 

Polyganics Awarded €1.2 Million for Clinical Development of Liver and Pancreas Sealant Patch

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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

  1. Spetzler VN, Schepers M, Pinnschmidt HO, Fischer L, Nashan B, Li J. The incidence and severity of post-hepatectomy bile leaks is affected by surgical indications, preoperative chemotherapy, and surgical procedures. Hepatobiliary Surg Nutr. 2019 Apr;8(2):101-110
  2. Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P,Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande, SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591

 

Polyganics Announces Start Building New Facility

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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®

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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.