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

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®

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

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

Polyganics announces divestment of its ENT activities

Groningen, the Netherlands, 7 November 2014 – Polyganics today announces it has signed an agreement to sell its activities in the field of Ear, Nose and Throat (ENT) surgery to Stryker. The ENT activities comprise a portfolio of sinunasal and otological dressings, including the marketed products NASOPORE®, HEMOPORE®, OTOPORE® and NASOPORE-FD®. As part of the agreement, Polyganics will continue to manufacture these products in the coming years.

This is a very important step in our strategy to focus on the successful medical device development based on our proprietary synthetic polymer platforms,” says Rudy Mareel, CEO of Polyganics. “We strongly believe Stryker is the best partner to maximize the commercial potential of our ENT 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.

The existing portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. Surgical applications include peripheral nerve repair, neuro-, general, as well as ear, nose & throat surgery.

Polyganics is profitable, privately held, and based in Groningen, The Netherlands, a center of biomedical engineering excellence. The Company’s polymer platform technologies are protected by a broad portfolio of patents.

For more information, please visit www.polyganics.com

Polyganics obtains FDA 510k clearance to market HEMOPORE®

Groningen, the Netherlands, 23 October 2014 – Today, Polyganics announces it has obtained FDA clearance for HEMOPORE®. HEMOPORE® offers two forms of post-op hemostatic control in one bioresorbable sinunasal dressing. The clearance comes after the CE regulatory approval of NASOPORE FD® in April 2014 and FDA 510k approval of NASOPORE FD® in October 2014.

This a significant step in the extension of our successful NASOPORE® product family”, says Rudy Mareel, CEO of Polyganics. “We believe the unique characteristics of HEMOPORE® offer a valuable new treatment option to doctors.”

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.

The existing portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. Surgical applications include peripheral nerve repair, neuro-, general, as well as ear, nose & throat surgery.

Polyganics is profitable, privately held, and based in Groningen, The Netherlands, a center of biomedical engineering excellence. The Company’s polymer platform technologies are protected by a broad portfolio of patents.

For more information, please visit www.polyganics.com

Polyganics obtains FDA 510k clearance to market NASOPORE-FD®

Groningen, the Netherlands, 7 August 2014 – Today, Polyganics announces it has obtained FDA clearance for NASOPORE-FD®, a sinunasal dressing with a rapid clearance time. The approval comes after the CE regulatory approval of NASOPORE-FD® in April 2014 and marks a next step in the commercialization Polyganics’ front-running bioresorbable nasal dressing portfolio marketed under the NASOPORE® brand.

This is another important milestone in the extension of our successful NASOPORE® product family”, says Rudy Mareel, CEO of Polyganics. “We believe the unique characteristics of NASOPORE-FD® offer a valuable new option to doctors and are very excited that it now becomes available on the US market.

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.

The existing portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. Surgical applications include peripheral nerve repair, neuro-, general, as well as ear, nose & throat surgery.

Polyganics is profitable, privately held, and based in Groningen, The Netherlands, a center of biomedical engineering excellence. The Company’s polymer platform technologies are protected by a broad portfolio of patents.

For more information, please visit www.polyganics.com

Polyganics obtains CE approval to market NASOPORE-FD®

Groningen, the Netherlands, 17 April 2014 – Polyganics today announces the CE regulatory approval of NASOPORE- FD®, a sinunasal dressing with a rapid clearance time. NASOPORE-FD® is the latest addition to Polyganics’ front-running bioresorbable nasal dressing portfolio marketed under the NASOPORE® brand. After insertion, NASOPORE-FD® exerts moderate elastic compression on the surrounding tissue for 36-48 hours while absorbing surrounding fluids.

This is an important milestone in the extension of our successful NASOPORE® product family”, says Rudy Mareel, CEO of Polyganics. “We believe the unique characteristics of NASOPORE-FD® offer a valuable new option to doctors.”

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.

The existing portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. Surgical applications include peripheral nerve repair, neuro-, general, as well as ear, nose & throat surgery.

Polyganics is profitable, privately held, and based in Groningen, The Netherlands, a center of biomedical engineering excellence. The Company’s polymer platform technologies are protected by a broad portfolio of patents.

For more information, please visit www.polyganics.com

Polyganics wins High Growth Award 2012

Groningen, the Netherlands, 29 November 2012 – Today, Polyganics announces it has won the High Growth Award 2012. The High Growth Award is a prize for Dutch companies that combine growth, both in quality and quantity, with a clear vision of the future. Polyganics effectively proves that entrepreneurship and innovation continue to bear fruit, also in the current economic climate.

Polyganics has a leading patents portfolio in the field of biodegradable materials and related medical applications. The company was founded in 1999 as a spin-off of the University Medical Centre Groningen, The Netherlands. Close collaboration in between Polyganics and the UMC Groningen has lead to a groundbreaking contribution in the innovation of medical applications that are worldwide used nowadays. Polyganics develops and makes products that are currently used worldwide by surgeons on millions of 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.

The existing portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. Surgical applications include peripheral nerve repair, neuro-, general, as well as ear, nose & throat surgery.

Polyganics is profitable, privately held, and based in Groningen, The Netherlands, a center of biomedical engineering excellence. The Company’s polymer platform technologies are protected by a broad portfolio of patents.

For more information, please visit www.polyganics.com