Adapting versatile polymers to deliver a pipeline of medical devices serving unmet clinical needs

We have developed and commercialized three products in the PNR space. NEUROCAP^® is a nerve capping device indicated for the surgical management of symptomatic neuroma.

Safe and Effective Management of Symptomatic Nerve-End Neuroma

Peripheral nerve dissection following trauma due to injury or surgery may result in symptomatic end-neuromas, a swelling at the end of the nerve which can cause significant pain. Neuroma-induced neuropathic pain and morbidity causes serious difficulties in the daily lives and socio-economic functioning of patients.

The incidence rate of symptomatic neuromas after peripheral nerve injury is estimated at 3-5%. However, for certain surgeries, including autograft procedures and amputations, this increases to 30%.

Although there are several existing procedures used to treat symptomatic end-neuromas, these require complex surgeries or use materials of human or animal origin and show highly variable results. The most common is to surgically remove the neuroma and surrounding scar tissue and burying the proximal stump in an area of minimal mechanical stimulation. Using these procedures, 86% of patients experience minimal to no improvement and on average must undergo 2.8 re-interventions after initial treatment of the neuroma.

NEUROCAP^® Properties

Synthetic material; co-polymer of lactide and caprolactone; these are well known biocompatible and safe polymers
Transparency of the device, facilitating optimal nerve stump positioning and easy detection of blood clots, preventing growth of nerve fibers

Degradation at a predictable rate, supporting encapsulation of the nerve stump
Controlled mechanical strength and flexibility for a period of 10 weeks, providing a mechanical barrier to minimize stimulation of the nerve stump during the critical period

Product Information

Launched in 2016, NEUROCAP^® is a novel treatment option for symptomatic end-neuromas, which has the unparalleled potential to revolutionize surgeries. By protecting dissected peripheral nerve ends and separating them from the environment, the device reduces the development of symptomatic neuromas and prevents further damage and pain.

The transparent, tubular device is made from unique synthetic biocompatible and biodegradable co-polymers with proven safety and efficacy. It has one open end, into which the nerve stump is sutured, and one closed end, which forms a cap. A hole across the sealed end of the tube allows the capped nerve stump to be easily fixed to the surrounding tissue by suturing. This enables the effective capping of unprotected nerve ends without excessive manipulation, such as drilling into bones, or sacrifice of other tissues.

NEUROCAP^® has been carefully designed to best support clinical needs. The simple, transparent tube is easy to handle, enabling optimal positioning during surgery. The mechanical strength and flexibility are optimal to prevent axonal sprouting and unwanted adhesion of the nerve ends to muscle or scar tissue. Finally, the bioresorbability is tailored to facilitate sustainable encapsulation of the nerve stump.

NEUROCAP^® is a commercialized product, available worldwide through a number of distributors.

Clinical Information

A strong body of evidence supports the effectiveness of NEUROCAP^®:

1. Pre-clinical study	2. STOP Neuroma (Surgical Treatment Of symPtomatic Neuroma)	3. PROTECT Neuro (PRospective cohOrt evaluaTion of nEuroCap in the Treatment of symptomatic NEUROma)
The modes of action of the device to create a full barrier with the surrounding tissues, prevent axonal sprouting, and avoid the formation of end-neuromas, are clearly demonstrated in a pre-clinical study. Preliminary results can be found here.	A pivotal study is being conducted to assess the clinical performance of NEUROCAP^® in isolating the nerve end, to reduce the pain caused by symptomatic neuroma and prevent reoccurrence. Preliminary follow-up data after one year confirms the safety and performance of the device, indicating considerable and lasting pain reduction in treated patients. Details of the study can be found here. Preliminary results were presented at FESSSH 2018 and can be found here.	A multicenter, post-market clinical follow-up study in the US and Europe is designed to evaluate the clinical value of NEUROCAP^® in the upper and lower extremities over a two- year period of patient monitoring. The first patient was treated in April 2017 and patient enrollment successfully concluded in summer 2018. Details of the study, including all participating hospitals across Europe and the US, can be found here. Preliminary results of the PROTECT Neuro study can be found here, final data are expected in 2020.

1. Pre-clinical study

2. STOP Neuroma (Surgical Treatment Of symPtomatic Neuroma)

3. PROTECT Neuro (PRospective cohOrt evaluaTion of nEuroCap in the Treatment of symptomatic NEUROma)

The modes of action of the device to

create a full barrier with the surrounding tissues,
prevent axonal sprouting, and
avoid the formation of end-neuromas,

are clearly demonstrated in a pre-clinical study.

Preliminary results can be found here.

A pivotal study is being conducted to assess the clinical performance of NEUROCAP^® in isolating the nerve end, to reduce the pain caused by symptomatic neuroma and prevent reoccurrence. Preliminary follow-up data after one year confirms the safety and performance of the device, indicating considerable and lasting pain reduction in treated patients. Details of the study can be found here.

Preliminary results were presented at FESSSH 2018 and can be found here.

A multicenter, post-market clinical follow-up study in the US and Europe is designed to evaluate the clinical value of NEUROCAP^® in the upper and lower extremities over a two- year period of patient monitoring.

The first patient was treated in April 2017 and patient enrollment successfully concluded in summer 2018. Details of the study, including all participating hospitals across Europe and the US, can be found here.

Preliminary results of the PROTECT Neuro study can be found here, final data are expected in 2020.

Regulatory Information

Our quality management system is ISO13485:2016 certified by Dekra Certification BV, a standard for quality management systems for design, manufacturing and distribution of medical devices. We also comply with the USA FDA 21 CFR 820 corresponding subparts and other applicable regulatory requirements for medical devices.

Classification details

European market	Device class: Class III
EC Notified Body	Identification number: 0344
Notified body	Dekra

US market	Device Class 2; FDA 510(k) number: K152648 (TW)
Product Code	JXI
Regulation number	21 CFR 882.5275
Medical Specialty	Neurology
Owner/Operator	Polyganics
Owner/Operator number	9057333
Establishment registration number	3004504732

Resource Library

Further information on NEUROCAP^®, including technical specifications and regulatory certificates, can be found in our Media centre.

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