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

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  • 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

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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

Polyganics Announces Enrollment of First Patients in Multicenter Study for NEUROCAP® Nerve Capping Device

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Groningen, The Netherlands, 9 May 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 the first four patients have been enrolled in the “STOP NEUROMA” study.

The STOP NEUROMA study (Surgical Treatment Of symPtomatic Neuroma) will examine the effectiveness of the company’s device NEUROCAP® in the reduction of painful neuroma formation. NEUROCAP® is a transparent tubular device with a sealed end, and is the first and only synthetic nerve capping device cleared for the treatment of symptomatic neuromas. The patients have been enrolled at the MCGroep hospital in Emmeloord, The Netherlands, by Coordinating Investigator, Marietta Bertleff, MD.

Dr Bertleff said, “Neuropathic pain caused by symptomatic neuromas is an important problem following peripheral nerve injury. The treatment of such disabling neuropathic pain following nerve injury is a topic that is of timeless interest to surgeons but an entirely effective treatment remains elusive. The STOP NEUROMA study is designed to support surgeons with clinical evidence about NEUROCAP for the much needed management of symptomatic neuroma pain to improve patients’ daily life and functioning.”

Rudy Mareel, CEO a.i. of Polyganics said, “Our active recruitment to the STOP NEUROMA study, which uses our nerve stump barrier NEUROCAP, is another significant milestone for Polyganics. This work helps us to gain traction in an important market: in the US alone there are approximately 600,000 nerve repair procedures per year. We strongly believe NEUROCAP represents an important addition to our peripheral nerve repair portfolio of products designed to enhance patient recovery and surgical outcomes.”

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 is due to recruit 30 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, 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

Polyganics appoints Dr Jan Öhrström to Supervisory Board

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Groningen, The Netherlands, 15 March 2016 – Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve repair, neurosurgery, general surgery, as well as ear, nose & throat surgery, today announced it has appointed Dr Jan K. Öhrström to its Supervisory Board. The appointment is effective immediately.

Dr Öhrström’s industry experience spans 25 years working at public and private biotechnology and pharmaceutical companies, both in the US and Europe, including over 15 years in senior leadership and Board member positions focused on medical development and business operations.

Dr Öhrström was instrumental in the US$240M acquisition of ProFibrix BV by The Medicines Company in August 2013.

Rudy Mareel, CEO of Polyganics, commented: “Jan’s impressive international experience in senior leadership roles, together with his clinical expertise and strong track record of bringing medical technology products to market, further strengthens the Supervisory Board of Polyganics. We welcome Jan to our team as we continue to adapt our proprietary technology for a variety of clinical applications.”

Dr Öhrström added: “Having spent much of my career working in biotech and pharmaceutical companies, I look forward to adding to the excellent work that Polyganics has already done in developing multiple versatile polymer platforms for use in medical technology and achieving international commercial success.”

Additional background on Dr Jan Öhrström:
Dr Öhrström was responsible for the incorporation of ProFibrix Inc and ProFibrix BV, which included a full private fundraising and development through Phase III of a product/device combination (Fibrocaps/Raplixa) as well as securing product approval in US and EU. He has also held executive positions including Senior Vice President at ZymoGenetics, Seattle, WA, USA, and CEO at ProFibrix BV, The Netherlands, and is currently Chairman of the Board & President at Biomup SA, Lyon, France, and a board director at Blaze Bioscience inc, Seattle, WA, USA. Dr Öhrström began his career as a clinician and held a number of clinical positions at Novo Nordisk before moving into business orientated positions. Dr Öhrström is a Danish citizen and resident in the Netherlands.

Polyganics recently received CFDA approval for its bioresorbable nerve conduit NEUROLAC® and received FDA 510(k) clearance for its nerve capping device NEUROCAP

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, the Company 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 has a supportive shareholder base, including the investment agency of the Northern Netherlands (NOM), and the University of Groningen. The Company has a research partnership with the non-profit organization the Brain Technology Institute, an international group of neurosurgeons.

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 FDA, CE-approval, approval from CFDA, and from other international authorities.

For more information, visit: www.polyganics.com

Polyganics Receives Chinese Food and Drug Administration (CFDA) Approval for NEUROLAC®

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Beijing, China, 26 February 2016 – Polyganics today announced it has received Chinese FDA (CFDA) clearance for NEUROLAC®, 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.

Rudy Mareel, CEO a.i.:  “NEUROLAC® offers a valuable treatment option for surgeons dealing with peripheral nerve discontinuities and for Polyganics this approval to market NEUROLAC® in China is an important step in further expanding the global distribution of our products.”

The clearance was realized in close collaboration with PolyCare Technology (Beijing) Co., Ltd (www.polycare.com.cn), the exclusive distribution partner of Polyganics’ PNR portfolio for China.
Davy Zhu, Chief Executive Officer of Polycare: “With NEUROLAC® Polycare can contribute our surgeons with a high quality peripheral nerve repair product that enhances the patient’s functional nerve recovery.”

For more information on NEUROLAC®, please use this link

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, the Company 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 has a supportive shareholder base, including the investment agency of the Northern Netherlands (NOM), and the University of Groningen. The Company has a research partnership with the non-profit organization the Brain Technology Institute, an international group of neurosurgeons.

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 FDA, CE-approval, and approval from CFDA and from other international authorities.

Polyganics Receives FDA 510(k) Clearance for Nerve Capping Device NEUROCAP®

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Groningen, The Netherlands, 26 January 2016 – Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve repair, neurosurgery, general surgery, as well as ear, nose & throat surgery, today announced it has received FDA 510(k) clearance for NEUROCAP, an innovative device designed to reduce painful neuroma formation and thereby facilitate tissue repair and regeneration.

Rudy Mareel, CEO a.i. of Polyganics said, “Neuroma-induced neuropathic pain and morbidity can seriously affect the quality of a patient’s daily life. NEUROCAP, a transparent tubular device with a sealed end, is the first and only synthetic nerve capping device cleared for the management of symptomatic neuromas. Current approaches are based on surgical removal of the neuroma and surrounding scar tissue, then placing the nerve stump in tissue subjected to minimal mechanical stimulation. However, these approaches have in many cases unsatisfactory outcomes. With our bioresorbable medical device NEUROCAP we offer orthopedic and hand surgeons a valuable new tool that contributes to the clinical management of neuromas and that can improve the daily life of patients. Receiving US FDA 510(k) clearance for NEUROCAP is another major milestone for Polyganics.”

NEUROCAP is available in the USA through MicroAire Surgical Instruments LLC (www.microaire.com), the exclusive distribution partner of Polyganics’ PNR portfolio for the USA, Canada and Puerto Rico.

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, the Company 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 has a supportive shareholder base, including the investment agency of the Northern Netherlands (NOM), and the University of Groningen. The Company has a research partnership with the non-profit organization the Brain Technology Institute, an international group of neurosurgeons.

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 FDA, CE-approval, approval from CFDA and from other international authorities.

Polyganics and MicroAire sign exclusive distribution agreement for peripheral nerve repair portfolio in the US, Canada and Puerto Rico

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Groningen, The Netherlands, 21 January 2016 – Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve repair, neurosurgery, general surgery, as well as ear, nose & throat surgery, today announced it has signed an exclusive distribution agreement with its strategic partner MicroAire Surgical Instruments LLC for the company’s entire peripheral nerve repair (PNR) portfolio in the US, Canada and Puerto Rico.

Rudy Mareel, CEO a.i. of Polyganics said, “It is a significant milestone to have closed such an agreement with MicroAire Surgical Instruments LLC. MicroAire is a well-known company in this arena with a dedicated sales force and an excellent track-record in marketing specialized devices for orthopedic and hand surgeons. This partnership will help us bring our products to patients at an accelerated pace.”

Greg Jones, General Manager of MicroAire Surgical Instruments LLC added, “With this partnership MicroAire has broadened its product portfolio with new high quality devices in the area of peripheral nerve repair. With the addition of the NEUROLAC® nerve conduit and the VIVOSORB® surgical sheet, we can offer our surgeons a wide portfolio of peripheral nerve repair products to enhance 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 two marketed products: VIVOSORB® for minimizing unwanted tissue adhesions after surgery; and NEUROLAC® for supporting PNR following hand surgery. Products in development include a product-candidate for preventing the formation of neuromas following amputation or other injury, and a sealant for the dural membrane, for use post brain surgery.

In 2014, the Company 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 has a supportive shareholder base, including the investment agency of the Northern Netherlands (NOM), and the University of Groningen. The Company has a research partnership with the non-profit organization the Brain Technology Institute, an international group of neurosurgeons.

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 FDA, CE, CFDA and other international registrations.

For more information, visit: www.polyganics.com or www.microaire.com