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 73^rd 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

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

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

• 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

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