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

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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

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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

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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

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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

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  • 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