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

FDA Grants Breakthrough Device Designation to Polyganics’ Liver and Pancreas Sealant Patch

Groningen, The Netherlands, 8 March 2018 – Polyganics, a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices, today announced that the US Food and Drug Administration (FDA) has granted Polyganics’ request for Breakthrough Device designation to its Liver and Pancreas Sealant Patch. The Liver and Pancreas Sealant patch is considered a unique breakthrough in the prevention of fluid leakage after hepato-pancreato-biliary (HPB) procedures, for which currently no approved or cleared alternatives exist.

The Liver and Pancreas Sealant Patch is made of Polyganics’ proprietary bioresorbable and biologically safe polymers, designed to seal-off the surgically treated tissue during the critical healing period. The polymer formulation of the Liver and Pancreas Sealant has been optimized specifically for HPB surgery, withstanding the interference of aggressive bile and pancreatic fluids. It aims to prevent post-operative leakage of fluids from the site of surgery into the abdominal cavity after HPB surgery, and as an adjunctive hemostatic device to control minimal to moderate bleeding.

A ‘Breakthrough Device’ is a device that may prevent or treat a life-threatening or irreversibly debilitating disease or condition. Under the Breakthrough Devices program, the FDA will provide its support to advance the Liver and Pancreas Sealant Patch from development to marketing decision. As part of this, the FDA is committed to be closely involved in the design of efficient and flexible clinical trials, as well as the collection of pre- and post-market data. It is anticipated that this support, combined with priority review, will enable a reduced regulatory timeline.

Prof.Dr.Med.Dr.Jakob Izbicki, Chairman of the Department of General, Visceral and Thoracic Surgery, Surgeon-in-chief, University Medical Center Hamburg-Eppendorf (UKE), Polyganics’ development partner for the Liver and Pancreas Sealant Patch, commented: “There is a clear need for a device that can effectively control the leakage of fluids in HPB surgery, that can be applied easily and can seal and withstand the enzymatic action and acid substances such as bile and pancreatic fluids. If an effective closure of the surgically treated tissues can be achieved, post-operative morbidities such as infection, abdominal abscesses and sepsis, often leading to a prolonged hospital stay, will be significantly reduced, positively affecting patients’ post-operative quality of life.”

Rudy Mareel, CEO of Polyganics, commented: “We are excited about the FDA’s decision to grant Breakthrough Device designation to our Liver and Pancreas Sealant Patch. It is a great recognition of the potential clinical benefit this device may offer to patients. We look forward to working with the FDA to progress the device more swiftly to market and thereby drive better outcomes for surgical patients.”

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
Telephone: +31 50 588 65 88
Email: info@polyganics.com

In The Netherlands:
Leon Melens
Telephone: +31 (20) 705 95 90
Email: lmelens@lifespring.nl

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

Polyganics awarded €1.2 million to complete clinical development of dura sealant patch

First-in-human clinical studies of the device expected to begin in early 2018

Groningen, The Netherlands, 1 December 2017 – Polyganics, a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices, today announced it has been awarded funding from the European Fund for Regional Development (ERDF) by the European Union, to support clinical validation of its dura sealant patch. The grant, together with contributions from the city and province of Groningen, totals EUR 1.2 million.

The device has been developed using Polyganics’ proprietary bioresorbable polymers, creating a dressing suitable for resealing the outer membrane (‘dura’) surrounding the brain after brain surgery, minimizing leakage of cerebrospinal fluid (CSF). The dressing 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 its dura sealant patch under a collaboration with the Brain Technology Institute (BTI), located in Utrecht, and Syncom, a contract research organisation located in Groningen.

Following recently completed animal studies of the dura sealant patch, Polyganics is currently finalizing preparations for the start of a clinical study, to demonstrate safety and performance in humans.

Rudy Mareel, CEO of Polyganics, commented: “We are hugely appreciative to the EU, as well as the city and province of Groningen for their support in progressing the device into the next phase of its development. The grant is a great recognition of the potential of this application of our synthetic polymers, and we are pleased to have benefitted from the skills and expertise of both the BTI and Syncom in its development. The work has important implications for improved recovery following brain surgery, including helping to prevent potentially fatal complications such as meningitis.”

Dr Tristan van Doormaal, a neurosurgeon at the University Medical Center Utrecht (UMCU), and leader of the research project at BTI, commented: “This is a completely novel approach to reducing CSF leakage following brain surgery. The recent successful animal studies of the dura sealant patch were very promising, and we expect to see similarly positive results in humans in the clinical studies next year.”

About the dura sealant patch

CSF leakage is one of the most common complications of neurosurgical procedures. Estimated incidence of any type of CSF leakage is in total 10%-15% of all intradural neurosurgical procedures. In approximately 25-50% of all intradural neurosurgical procedures, any adjunct to dural sealing is used to prevent CSF leakage and to allow the dura to heal after surgery. If the quality of dural closure is improved, complications associated with CSF leakage, including meningitis, pseudomeningoceles, impaired wound healing, and subgaleal fluid collection, could be reduced. Effectively sealing dural incisions during surgery is therefore important because it may prevent CSF leakage and related complications.

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

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

Polyganics Extends Global Distribution Network with the Addition of Multiple US Distributors

Groningen, The Netherlands, 5 September 2017 – Polyganics, a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices to promote peripheral nerve reconstruction and regeneration, announces the appointment of six US distributors for its peripheral nerve repair (PNR) portfolio.

New agreements with Southern Orthopaedics, Medex Surgical, Rascher Medical Solutions, Med Rep Corporation, South Coast Orthopedics and OJI Surgical will provide regional distribution of Polyganics’ PNR portfolio, which includes its NEUROCAP®, NEUROLAC®, and VIVOSORB® products. The portfolio uses Polyganics’ patented bioresorbable polymers to support nerve repair and recovery following surgery or injury.

Southern Orthopaedics LLC will provide distribution services to South Carolina, Alabama and Georgia. Medex Surgical LLP will cover the southern states of Texas, New Mexico, Oklahoma, Arkansas and Louisiana. Rascher Medical Solutions Inc. will distribute to Illinois and Wisconsin, and Med Rep Corporation Inc. will provide distribution for the states of Virginia, Maryland, Washington DC, Pennsylvania and Delaware. South Coast Orthopedics will serve the Southern Florida region. Finally, OJI Surgical Inc. will serve the western states of Oregon, Washington and Idaho.

Launched in 2016, NEUROCAP® is an innovative treatment option for symptomatic end-neuromas, providing a great potential for revolutionizing the previous treatment options of complex surgery, which leaves many patients still in pain. NEUROCAP® achieves this by protecting the peripheral nerve end, separating it from the surrounding environment, in turn preventing further damage and pain from occurring. This new method enables surgeons to provide more effective therapy for their patients, which will now be accessible across the US in addition to in Europe. Early positive signals from multiple hand and plastic surgeons that are affiliated with prominent international institutes involved in the PROTECT study – a prospective cohort evaluation of the product’s performance – drive the adoption of the complete Polyganics PNR portfolio, including NEUROCAP®.

Rudy Mareel, CEO of Polyganics, said: “Our PNR products provide clinically approved solutions to complex and painful conditions that can arise following nerve injury. The expansion of our distribution network in the US is in response to a high demand for these products in the region, and will enable us to provide more efficient services across a large number of states.  The US additions follow distribution agreements in Western Europe with Orthomed (France), Tapmed (Germany) and Osteotec (UK). Alongside our rapidly growing global distributor network, the continued momentum of our PNR portfolio is also demonstrated by the recent approval of NEUROCAP® in Australia.”

Greg Broms, CEO of Southern Orthopaedics, said: “Healthy nerve repair is vital to ensuring an easy and full recovery following surgery, and Polyganic’s advanced polymer technology will enable us to provide the best possible care to our patients. The adoption of Polyganics’ PNR products is part of a larger initiative we have underway to expand our portfolio and be able to offer the latest technologies available in orthopedic surgery.”

Keith Barcal, CEO of Med Rep Corporation, said: “It’s important to be able to provide high-tech, quality products to physicians, and so Polyganics’ peripheral nerve repair portfolio is an ideal fit for us. We’re hugely supportive of the work Polyganics is doing to further the field of nerve repair, and we’re delighted to be able to play a part in its distribution.”

Contact details for Polyganic’s US distributors are available here: http://polyganics.com/partners/distributors

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, for use in post brain surgery.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE®) to US Company 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

Polyganics signs up multiple distributors in Europe to accelerate roll-out of Peripheral Nerve Repair portfolio

Groningen, The Netherlands, 8 June 2017 – Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, announced today that it has signed agreements with leading medical technology distributors in Europe, to meet the growing distribution demands for Polyganics’ Peripheral Nerve Repair (PNR) products.

Orthomed is an experienced PNR distributor in France that will provide Polyganics’ products to their established clinical network. Tapmed will take charge of the distribution in Germany, Austria and Switzerland whilst and Osteotec will look after the UK distribution. The new distributors will join the broad European network already in place. Amongst others, the existing distributors include, JB-Implants (The Netherlands), Medcomtech (Spain and Portugal), DMR (Italy), Next Medical (Italy) and Swemac (Denmark and Sweden).

NEUROCAP®, launched in 2016, created a novel dedicated treatment option for the treatment of end-neuromas and has completed Polyganics’ PNR product portfolio. The combination of a purely synthetic and transparent polymer with an extensive proven safety and efficacy record is unique in the PNR medical device market. Alternatives for peripheral nerve injury treatment tend to require either complex surgical procedures or material of human or animal origin. Polyganics’ PNR product range offers surgeons a complete toolbox to support their surgical procedures and to provide optimal care for their patients.

Rudy Mareel, CEO of Polyganics said: “Our reinforced PNR focus has resulted in a unique product portfolio that has been acknowledged by highly reputable medical centres, with the clinical community recognizing the benefits of our PNR products. We have initiated multiple clinical trials including post marketing studies to show the positive effects our portfolio has on symptomatic end neuroma pain. The appointment of new distributors enables us to meet the growing demand in Europe and simultaneously prepare for further growth in this market.”

Bruno Deguzman of Orthomed said: “We provide products to a vast network of physicians and we look forward to maintaining our market leading position in France with the addition of Polyganics’ PNR portfolio.”

Bill Stringer of Osteotec said: “Neurolac and Neurocap are being used in trials in The Queen Elizabeth University Hospital Birmingham. We are looking forward to serve additional clinical centers in the UK with Polyganics’ PNR products.”

Monika Rinne of Tapmed commented: “With our reach in Germany, Austria and Switzerland, we provide the best medical technology to the hospitals that we work with. We choose the right products for our clients and Polyganics’ PNR products will complement our current portfolio.”

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, for use post brain surgery.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including NASPORE FD®, HEMOPORE®, and OTOPORE®) to US Company 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

Polyganics Announces Enrollment of the First Patient in its PROTECT NEURO Study

Groningen, The Netherlands, 20 April 2017 – Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, announced today that it has enrolled the first patient in its international PROTECT NEURO study to treat and prevent symptomatic neuroma. The first patient was treated at Stanford Medicine by Catherine Curtin, MD, associate professor of surgery.

The PROTECT NEURO (Prospective Cohort Evaluation Of NEUROCAP® in the Treatment of Symptomatic Neuroma) study is aimed to collect additional evidence for the long-term effectiveness of NEUROCAP®, in the reduction of symptomatic nerve pain in patients with a history of having painful neuroma. PROTECT is a prospective cohort evaluation of NEUROCAP®’s performance in the surgical management of peripheral nerve-ends in both upper and lower extremities including amputation. 92 patients will be enrolled for the study which will run in 17 leading medical centres in both Europe and the United States. Completion of the study enrollment is due to take place in Q4 2017 and final results including two year patient follow-up are expected in 2019.

Polyganics’ NEUROCAP® is a transparent tubular device with a sealed end, a first-in-kind transparent nerve capping device that combines synthetic and bioresorbable qualities. NEUROCAP® is currently the only regulatory cleared dedicated device for the surgical management of symptomatic neuromas.

The Principal Investigator of this study is Professor L. Scott Levin, MD, FACS, from the University of Pennsylvania School of Medicine, a renowned surgeon in orthopaedic, plastic and reconstructive surgery.

Professor Levin said; “NEUROCAP is a promising solution for the treatment of neuromas, a peripheral nerve problem where there are currently limited effective treatment options available. NEUROCAP has the potential to positively impact the quality of life of many patients that suffer from neuromas. This study could provide evidence that this novel treatment is effective in reducing long term neuroma pain and disability.”

Rudy Mareel, CEO of Polyganics said, “Demonstration of long term efficacy is a key milestone for the global recognition of our game changing nerve capping device. NEUROCAP is now being accepted by the clinical community as a solution for the surgical management of symptomatic neuroma. Following the publication of the highly promising interim data of our STOP NEUROMA study in March, which showed an average pain reduction of 84% after three months following surgery using the NEUROCAP, we are focused on continuing our efforts to obtain additional evidence for the prevention of neuroma after nerve injury”.

Notes to Editors

About NEUROCAP®

NEUROCAP® is intended to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma. NEUROCAP® is a tubular device with one open end and one closed end. Dislocation of the nerve stump is prevented by suturing the nerve end into the cap. A hole at the sealed end of the tube allows easy fixation of the nerve stump with a suture to the surrounding tissue. This allows an effective capping technique without the necessity of drilling a hole into bones, or sacrificing other tissue.

About the PROTECT study

To examine the long-term effectiveness of NEUROCAP®, Polyganics is working with 17 hospitals across Europe and the United States in an open non-randomized clinical investigation (PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma: PROTECT NEURO). The study has been designed to obtain data on the long-term clinical performance of NEUROCAP®’s ability to isolate the nerve-end, and its effectiveness in both reducing pain from the symptomatic neuroma and the prevention of its reoccurrence. More information on the PROTECT NEURO study including all 17 participating centres can be found on www.clinicaltrials.gov (identifier: NCT02993276).

About Neuromas

A neuroma is a painful condition, also referred to as a “pinched nerve” or a nerve tumor. It is a benign growth of nerve tissue. It brings on pain, a burning sensation, tingling, or numbness and seriously affects the patient’s daily life. Approximately 3-5% of all patients involved in peripheral nerve injury develop a symptomatic neuroma. In the US alone there are approximately 600,000 nerve repair procedures per year. It is estimated that around 185,000 persons in the US undergo amputations of a limb each year of which around 20% will develop symptomatic neuromas. There are several options for treating these neuromas, but an entirely effective treatment remains elusive. To date there are on average 2.8 re-interventions for every Symptomatic Neuroma treatment. In 86% of the cases there is little to no improvement. NEUROCAP® is intended to be used for symptomatic neuromas that occur after nerve repair and for amputation stump neuromas.

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 dural membrane, for use post brain surgery.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE®) to US Company 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

Polyganics’ “STOP NEUROMA” Study Interim Data Shows Reduction in Pain

  • NEUROCAP® 3-month interim data show an average pain reduction of 84%
  • Final patient recruited in “STOP NEUROMA” clinical study, full data due to be reported by Q3 2018.

Groningen, The Netherlands 16 February 2017 – Polyganics, a privately held medical technology company, announced today that interim results show a sharp improvement in pain reduction observed across patients currently enrolled within the “STOP NEUROMA” study.

Enrolment was recently completed for the European “STOP NEUROMA” (Surgical Treatment Of symPtomatic Neuroma) which was designed to gather evidence for the long-term effectiveness of NEUROCAP® in the reduction of painful neuroma formation. The patients that have reached the 3 month endpoint show an average pain reduction of 84% on the Visual Analogue Scale (VAS), where each patient reports a score between 0 and 100 for the experienced pain. The first patients that reached the 12 month endpoint show that the pain relief is maintained together with a significant improvement in daily functioning and quality of life.

Polyganics’ unique proprietary technology NEUROCAP® is a transparent tubular device with a sealed end, a first-in-kind transparent nerve capping device that combines synthetic and bioresorbable qualities. NEUROCAP® is currently the only approved dedicated device for the surgical management of symptomatic neuromas.

Mariëtta Bertleff, MD PhD, Principal Investigator of the STOP NEUROMA trial said: “Symptomatic neuroma may develop after a nerve dissection or bruising of a nerve following any blunt or sharp trauma to a peripheral nerve, whether accidental or during planned surgery. Neuroma-induced neuropathic pain and morbidity seriously affect the patient’s daily life and socioeconomic functioning. Currently, there is no effective treatment for this extremely disabling condition which may affect over 300,000 patients worldwide. Several patients enrolled in the trial have undergone prior neuroma surgery without beneficial results. Our promising interim data could indicate a breakthrough in the treatment and future prevention of peripheral end-neuroma.”

Rudy Mareel, CEO of Polyganics, commented: “The STOP NEUROMA study was designed to provide surgeons with clinical evidence about NEUROCAP®’s benefits in the much needed management of symptomatic neuroma pain. Over 12 months, the interim data shows the effectiveness of NEUROCAP® in terms of reducing pain symptoms, improving patients’ daily life and functioning. We are confident that our first-in-kind device can be used in prevention of neuroma pain in the long term, following amputations or accidental damage.”

Please click here for more information about NEUROCAP®.

Notes to Editors

About NEUROCAP®

NEUROCAP® is intended to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic end-neuroma. NEUROCAP® is a tubular device with one open end and one closed end. Dislocation of the nerve stump is prevented by suturing the nerve end into the cap. A hole at the sealed end of the tube allows easy fixation of the nerve stump with a suture to the surrounding tissue. This allows an effective capping technique without the necessity of drilling a hole into bones, or sacrificing other tissue.

About the STOP NEUROMA study

To examine the effectiveness of NEUROCAP®, Polyganics is working with several European hospitals in an open non-randomized clinical investigation (STOP NEUROMA study: Surgical Treatment Of symPtomatic Neuroma), which has recruited 10 patients. The study has been designed to obtain data on the clinical performance of NEUROCAP®’s ability to isolate the nerve end, and its effectiveness in both reducing pain from the symptomatic neuroma and prevention of its reoccurrence. For more information on the STOP NEUROMA study visit www.clinicaltrials.gov (identifier: NCT02528266).

About Neuromas

A neuroma is a painful condition, also referred to as a “pinched nerve” or a nerve tumor. It is a benign growth of nerve tissue. It brings on pain, a burning sensation, tingling, or numbness. Approximately 3-5% of all patients involved in peripheral nerve injury develop a symptomatic neuroma. In the US alone there are approximately 600,000 nerve repair procedures per year. It is estimated that around 185,000 persons in the US undergo amputations of a limb each year of which around 20% will develop symptomatic neuromas. NEUROCAP® is intended to be used for neuromas that occur after nerve repair and for amputation stump neuromas.

About Polyganics

Polyganics is a medical technology company with multiple versatile polymer platforms. The company develops and manufactures innovative bioresorbable medical devices that facilitate tissue repair and regeneration. Commercialization is performed through a worldwide distributor network.

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 surgery of the extremities; and NEUROCAP® for the management of symptomatic neuromas. Products in development include a sealant for the dural membrane, for use post brain surgery.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE®) to US Company 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 3.5 million procedures globally.

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 announces Birmingham Hand Centre efficacy study of nerve conduit NEUROLAC® in finger surgery

  • NEUROLAC® nerve conduit to be evaluated in 170+ patient CONNECT study over 36 months, with interim results due in Q4 2017 and full results in H2 2019
  • Study centre – the Birmingham Hand Centre, part of the NHS’s Queen Elizabeth Hospital in Birmingham, a leading UK centre in hand and reconstructive surgery

Groningen, The Netherlands, 7 December 2016 – Polyganics, a privately held medical technology company focused on the development, manufacturing and commercialization of innovative bioresorbable medical devices that facilitate tissue repair and regeneration, announced today the launch of the CONNECT study, in collaboration with the Birmingham Hand Centre, part of the University Hospitals Birmingham NHS Foundation Trust in the UK. The study has been developed to deliver improvements in peripheral nerve repair after injury.

The CONNECT (COnduit Nerve approximation versus Neurorrhaphy Evaluation of Clinical outcome Trial) study will evaluate the benefits of using Polyganics’ NEUROLAC® nerve guide in a novel technique called “tensionless repair” for finger nerve surgery, to improve the quality of nerve regeneration. Complex nerve injuries to the hand are quite common, with approximately 300,000 cases a year in Europe alone, according to a recent publication in Biomaterials1. Such injuries can create a long term or even permanent issue for patients, some of whom will experience chronic pain or never recover full feeling in their hands. This study will assess the advantages of using a nerve conduit as an addition to microsurgical neurorrhaphy, or nerve suturing for recovering sensitivity of injured fingers. The Birmingham Hand Centre, at the Queen Elizabeth Hospital in Birmingham, is part of the University Hospitals Birmingham NHS Foundation Trust. It is a leading UK centre in hand and reconstructive surgery.

CONNECT’s Chief Investigator Mr. Dominic Power will lead the “tensionless repair” efficacy study of around 170 patients (or 240 lesions to the hand) enrolled across three equal sized lesion groups over 18 months, with a 12-month follow-up, giving an anticipated duration (including analysis) of 36 months. One group will receive direct microsurgical suture, one will receive suture with NEUROLAC® nerve conduit augmentation, and the third group will receive NEUROLAC® nerve conduits with remote suture away from the injury site. Interim results are expected in Q4 2017 and full results in H2 2019.

Mr. Dominic Power, Consultant Hand and Peripheral Nerve Surgeon of the Birmingham Hand Centre, said; “Birmingham has been leading the way in nerve research in the UK and I hope that the results of this CONNECT study will lead to further benefits for patients worldwide.”

Rudy Mareel, CEO of Polyganics, said; “Our nerve conduit NEUROLAC® is designed to help patients recover sensitivity in injured fingers where a nerve has been cut, thereby helping them to a full recovery, whilst significantly reducing the risk of painful neuroma formation. This collaboration with the internationally recognized center of excellence for hand surgery in the UK should demonstrate conclusively that many more patients with finger injuries can benefit from Polyganics’ innovative peripheral nerve repair products.”

Polyganics will provide financial support for the trial. The Birmingham Hand Centre is the initiator of the CONNECT study, which will be based at the Institution for Translational Medicine and the Surgical Reconstruction and Microbiology Research Center at the University Hospitals Birmingham NHS Foundation Trust.

1 Haastert-Talini K, Geuna S, Dahlin LB, Meyer C, Stenberg L, Freier T, et al. Chitosan tubes of varying degrees of acetylation for bridging peripheral nerve defects. Biomaterials. 2013;34:9886–904. doi:10.1016/j.biomaterials. 2013.08.074 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4727346/

Notes to Editors

About NEUROLAC®

NEUROLAC® is a unique synthetic and resorbable nerve conduit designed to support regeneration of peripheral nerve discontinuities up to 20 mm in patients who have sustained a complete division of a nerve, which commonly occurs from a knife wound to the hand whilst cooking, gardening or decorating. Such wounds are also common in military personnel injured by combat-related trauma. Conduits support nerve recovery by bridging small nerve gaps and avoid the need for a graft, or suturing the wound with tension. Such cases of complex nerve injuries to the hand number approx. 600,000 cases a year globally. About a third of patients who have current standard of care treatment involving microsurgical repair never regain useful sensitivity of the injured finger, resulting in impaired function of the hand.

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 dural membrane, for use post brain surgery.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE®) to US Company 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 2.5m procedures globally.

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.

About the Birmingham Hand Centre

The Hand Unit at Queen Elizabeth Hospital Birmingham (QEHB) is one of the largest in the country. With the addition of the elective care provided at the Royal Orthopaedic Hospital (ROH), it provides a comprehensive service to treat all conditions of the adult hand. At the heart of the unit there are five orthopaedic and four plastic surgery consultant hand surgeons.

QEHB is the main centre for hand trauma in Birmingham and not only deals with simple hand injuries but is also the regional centre for digital and hand replantation following amputation, the regional Major Trauma Centre (MTC) and the national centre for repatriated injured military patients who often have very complex explosion injures to their hands.

The West Midlands peripheral nerve injury service was established at the Birmingham Hand Centre at the Queen Elizabeth Hospital in Birmingham in 2010. The team provides a comprehensive range of treatment options for patients with paralysis after nerve injury, spinal cord injury or stroke. Research activity is undertaken through the Hand and Peripheral Nerve (HaPN) Research Network and includes a number of clinical trials in nerve repair, rehabilitation and spasticity.

For more information, visit: www.polyganics.com

Polyganics Announces CE Mark for NEUROCAP®, the Nerve Capping Device for Treatment and Prevention of Symptomatic Neuroma

Groningen, The Netherlands, 21 June 2016 – Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, announced today that it has received the CE mark for NEUROCAP®, its nerve capping device. Polyganics intends to launch NEUROCAP® in several European countries later this year.

NEUROCAP® is an absorbable implant for the treatment and reduction of symptomatic neuroma in peripheral nerves. The device was cleared for sales in the United States in January 2016, and Polyganics introduced NEUROCAP® during the Annual Meeting of the American Society of Surgery of the Hand in Phoenix last January.

In February, the European STOP NEUROMA study started to gather evidence for the long-term effectiveness of NEUROCAP® in the reduction of painful neuroma formation. The first patients have been successfully enrolled at the MC Groep hospital in Emmeloord, The Netherlands, by Coordinating Investigator Mariëtta Bertleff, MD. Through this study, Polyganics is collecting more data on the clinical performance of NEUROCAP®’s ability to isolate the nerve end, and the product’s effectiveness with respect to the reduction of pain from the symptomatic neuroma and prevention of pain reoccurrence.

Rudy Mareel, CEO of Polyganics said, “CE regulatory approval is a key milestone for our nerve capping device. We strongly believe NEUROCAP® represents an important addition to the surgeons’ tool-box in the treatment of peripheral nerve injuries enhancing surgical outcomes and patient recovery.

Furthermore, if NEUROCAP® shows effectiveness in terms of preventing pain symptoms to return over a one-year period, the device could be used in the prevention of painful neuroma formation following amputations. This is an additional, even more significant population which is steadily increasing due to the growing prevalence of diseases such as diabetes.”

A delegation from Polyganics, including Rudy Mareel, CEO, Romke Ribbels, Director Marketing & Business Development and Raoul Beex, Director Sales, will be attending the Federation of European Societies for Surgery of the Hand (FESSH) on 22-25 June in Santander, Spain and will be present at Exhibitor Booth 21 throughout the conference.

Notes to Editors

About NEUROCAP®

NEUROCAP® is intended to protect a peripheral nerve end and to separate the nerve from surrounding environment to prevent the development of a symptomatic end-neuroma. NEUROCAP® is a tubular device with one open end and one closed end. Dislocation of the nerve stump is prevented by suturing the nerve end into the cap. A hole at the sealed end of the tube allows easy fixation of the nerve stump with a suture to the surrounding tissue. This allows an effective capping technique without the necessity of drilling a hole into bones, or sacrificing other tissue.

About the STOP NEUROMA study

To examine the effectiveness of NEUROCAP®, Polyganics is working with several European hospitals in an open non-randomized clinical investigation (STOP NEUROMA study: Surgical Treatment Of symPtomatic Neuroma). The study has been designed to obtain data on the clinical performance of NEUROCAP®’s ability to isolate the nerve end, and its effectiveness in both reducing pain from the symptomatic neuroma and prevention of its reoccurrence. More information on the STOP NEUROMA study can be found on www.clinicaltrials.gov (identifier: NCT02528266) or the earlier press-releases in www.polyganics.com

About Neuromas

A neuroma is a painful condition, also referred to as a “pinched nerve” or a nerve tumor. It is a benign growth of nerve tissue. It brings on pain, a burning sensation, tingling, or numbness and seriously affects the patient’s daily life. Approximately 3-5% of all patients involved in peripheral nerve injury develop a symptomatic neuroma.  In the US alone there are approximately 600,000 nerve repair procedures per year. It is estimated that around 185,000 persons in the US undergo amputations of a limb each year of which around 20% will develop symptomatic neuromas. There are several options for treating these neuromas, but an entirely effective treatment remains elusive. To date there are on average 2.8 re-interventions for every Symptomatic Neuroma treatment. In 86% of the cases there is little to no improvement. NEUROCAP® is intended to be used for neuromas that occur after nerve repair and for amputation stump neuromas.

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 dural membrane, for use post brain surgery.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE®) to US Company 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 2.5m procedures globally.

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