International Federation of Societies for Surgery of the Hand (IFSSH) and International Federation of Societies for Hand Therapy (IFSHT)

International Federation of Societies for Surgery of the Hand (IFSSH) and International Federation of Societies for Hand Therapy (IFSHT)
17 – 21 Jun 2019
Berlin, Germany

Trauma Meeting

Trauma Meeting
24-26 October 2018
Riccione, Italy

Polyganics Initiates First-in-Human Trial of LIQOSEAL®, its Innovative Approach for Dural Closure

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.

Polyganics Strengthens Global Distribution Network with Appointment of Synovis MCA as US-wide Distributor of NEUROCAP®

Groningen, The Netherlands – 10 September 2018 – Polyganics, a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices, today announced that it has signed an agreement with Synovis Micro Companies Alliance Inc. (“Synovis MCA”), a subsidiary of Baxter International Inc., to be the exclusive distributor of its nerve capping device, NEUROCAP®, in the US.

Synovis MCA is an experienced distributor of nerve repair devices that enjoys excellent sales records on the strength of its established networks and portfolio. The new agreement with Synovis MCA in the US will cover the entire country, helping to meet the growing distribution demand for NEUROCAP® and improving its availability for patients.

NEUROCAP® is a novel treatment option for end-neuromas, a swelling that occurs at the end of a nerve which develops in response to trauma. The NEUROCAP® device, made from Polyganics’ unique synthetic, transparent polymer, protects the peripheral nerve end, separating it from the environment to prevent further damage and pain. The device is an alternative to surgical procedures that are complex or require material of human or animal origin.

The effectiveness of NEUROCAP® is supported by a strong body of evidence. A multicenter post-market clinical follow-up study is currently underway in both the US and Europe, with patient enrollment successfully completed this summer. The study is designed to evaluate the clinical value of NEUROCAP® in the upper and lower extremities over a 2-year period of patient monitoring.

Michael K Campbell, President of Synovis MCA, commented: “We are committed to providing the latest surgical innovations to our customers, and Polyganics’ NEUROCAP® ideally complements our existing portfolio of peripheral nerve repair products. We look forward to working with Polyganics to enable reliable access to NEUROCAP® across the US and help surgeons provide patients with the best care possible.”

Rudy Mareel, CEO of Polyganics, commented: “The clinically proven NEUROCAP® device provides a unique solution to the pain experienced by patients due to nerve damage. We continue to strengthen and expand the evidence for NEUROCAP® with ongoing clinical studies.” He continued, “The initial interest in the product has been promising, and we are now expanding our NEUROCAP® distribution network in the US to improve efficiency of delivery and consistency of product availability for surgeons and patients. We are pleased to be working with Synovis MCA with their renowned expertise and established sales networks within the sector.”

Polyganics and Synovis MCA are both attending the 73rd ASSH (American Surgery for Surgery of the Hand) Annual Meeting on 13-15 September in Boston, MA, USA.

About NEUROCAP®

Launched in 2016, NEUROCAP® is a novel treatment option for end-neuromas, a swelling that occurs at the end of a nerve which is often very painful. The condition develops in response to trauma to the nerve, either through injury or surgery. The NEUROCAP® device has the unparalleled potential to revolutionize surgeries by protecting the peripheral nerve end, separating it from the environment to prevent further damage and pain. The device is made from a unique synthetic, transparent polymer with proven safety and efficacy. Alternative treatments for peripheral nerve injury require complex surgical procedures or material of human or animal origin. Easy access to NEUROCAP® throughout the USA will help surgeons to provide optimal patient care.

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) and neurosurgery 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. Products in development include a sealant for the dura membrane and a liver sealant patch.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE®) to Stryker, one of the world’s leading medical technology companies. NASOPORE®, a reliable, easy-to-use, nasal wound care dressing made of biodegradable foam, has been used in over 3.5m procedures globally. Polyganics continues to manufacture the NASOPORE® product range for Stryker.

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

At Polyganics
Paul Roos, Chief Financial Officer
Romke Ribbels, Director Marketing & Business Development
T: +31 50 588 65 88
E: info@polyganics.com

At Instinctif Partners (ROW):
Dr Christelle Kerouedan / Alex Bannister
T: +44 (0) 20 7457 2020
E: polyganics@instinctif.com

FESSH Congress 2018 – Working for the Future

FESSH Congress 2018 – Working for the Future
13-16 June 2018
Copenhagen, Denmark

Visit stand 14

Workshop Session
Peripheral Nerve Repair Solutions, Transforming Patient Recovery (S85)
Date and Time: 13:00 – 13:50, Friday, 15 June 2018
Location: Arkaden 8, Tivoli Congress Center
Speakers: Michael Wheatley, Dominic Power, Nefer Fallico
Agenda available, here.

Poster Presentation
Neuroma prevention with NEUROCAP® in a rat sciatic nerve model (A-0319)
Authors: Steven L Peterson 1, Harm de Vries 2, Hilde Geraedts 2, Michael J Wheatley 3
Session: S70 Nerve and Brachial Plexus
Date and Time: 10:30 – 12:00, Saturday, 16 June 2018
Location: Arkaden 8, Tivoli Congress Center
Abstract available, here.

1 Portland Veterans Affairs Medical Center, Portland, USA;
2 Polyganics B.V., Groningen, the Netherlands;
3 Kaiser Permanente, Portland, USA