As the COVID-19 pandemic continues to cause global disruption, we are all learning the vital importance of staying in touch with our associates, colleagues, and friends. We are therefore delighted to be sending you this first issue of our new series of quarterly newsletters focused on our PNR (Peripheral Nerve Repair) portfolio. The newsletters will provide a clinical and commercial update on the portfolio. You can expect to find information on markets, meetings, clinical and regulatory news, user experiences and more.
In this issue, look out for:
- New Publication on NEUROCAP® used in Head and Neck region
- Updates on our PROTECT NEURO® and CONNECT studies
- Compelling NEUROCAP® patient testimonial
- New availability and uses for our products
Functional recovery after peripheral nerve repair is one of the biggest challenges in surgery. Polyganics offers a portfolio of three PNR products as key additions to the surgeons’ toolkit, to improve surgical outcomes and support patient recovery. Our products facilitate diverse repair approaches by capping (NEUROCAP®), bridging (NEUROLAC®), and protecting (VIVOSORB®) the nerve.
NEUROCAP®
- New case study shows marked reduction in pain scores for three patients
A recently published article describes the results of three surgeries in which iatrogenic neuromas were excised and the nerve stump subsequently capped with NEUROCAP®. Prior to the surgeries, the three patients suffered from significant pain, reducing their quality of life, and had undergone multiple ear, frontal sinus, and parotid gland surgeries, which had been unsuccessful in alleviating this. The patients were desperate for a therapy with sustained effect.
All three patients showed a marked reduction in pain score post-surgery. The authors of the article conclude that neuroma excision combined with capping of the proximal stump with NEUROCAP® might be a viable treatment option for iatrogenic neuropathic pain in the head and neck region.
“The good effect of the NEUROCAP® might be due to its properties in that it takes two years to dissolve and therefore prevent nerve regrowth both by mechanical obstruction and that nerve sprouting stimulating factors from surrounding tissues do not reach the stump. Moreover, blocking the infiltration of the nerve stump with inflammatory cells was thought to be the primary mechanism of autotomy inhibition in a rat model. Last but not least, just the insertion of the nerve stump in a nerve cap, for which no contraindications exist, seems to be a much simpler technique than the use of vein grafts or other conduits.” (De Ru et al., 2020).”
- Patient testimonial video – Adam’s story
In this patient testimonial Adam kindly agree to being interviewed for a compelling account of his experience prior to and post-surgery, and the extraordinary impact the treatment has had on his quality of life. We hope this video will be a useful resource in conveying the potential value of our device to your customers.
- 24-month data from our PROTECT NEURO follow-up study has been accepted for poster presentation at ASSH 2020, 12-month data confirm performance, safety and ease of use of device
PROTECT NEURO ((PRospective cohOrt evaluaTion of nEuroCap in the Treatment of symptomatic NEUROma) is a multi-center (EU and US), post-market clinical follow-up study, investigating the long-term (up to 24-months) performance and ease of use of NEUROCAP® in reducing development of peripheral symptomatic end-neuroma in the upper and lower extremities. The ultimate patient’s last visit is expected in July 2020, and an abstract on the 24-month data has been accepted for poster presentation at ASSH 2020.
Our 12-month data (N=68) show a significant reduction in pain (measured by VAS Pain Score and Elliot score), a reduction in disability (measured by QuickDash and Goals questionnaire) and a significant reduction in the use of pain medication (especially the use of opioids), a low recurrence of symptomatic neuroma, a low adverse event rate and no unexpected device-related AE. In addition, the ease-of-use of the device was confirmed.
Learn more about the study and results from Dr Dominic Power, Consultant Hand and Peripheral Nerve Surgeon:
These new data confirm the pivotal outcomes of the STOP NEUROMA trial, which was conducted to assess safety, performance and ease of use of NEUROCAP® to reduce recurrence of peripheral symptomatic end-neuroma during 12-month follow-up. In this cohort study, a significant decrease of pain and disability was observed, with seven of the twelve patients being able to stop all pain medication after 12 months. The STOP NEUROMA manuscript is currently being finalized for submission.
NEUROLAC®
- Recruitment for our CONNECT study is ongoing, with >145 patients recruited to-date
The CONNECT (COnduit Nerve approximation versus Neurorrhaphy Evaluation of Clinical outcome Trial) study is a randomized controlled trial assessing the advantages of using a nerve conduit in addition to microsurgical neurorrhaphy or nerve suturing for recovering sensitivity of injured fingers. The study has three arms of investigation; suturing alone, suturing with the application of NEUROLAC® as ‘wrap around’, and finally tensionless repair using NEUROLAC® as a connector to bridge a 3-5 mm gap. In 2019, Parthiban et al. published on the experiences with recruitment in the CONNECT study.
Hear more about the study and results from Dr Dominic Power, NHS Surgeon at the Birmingham Hand Centre, Queen Elizabeth Hospital:
VIVOSORB®
- Post-market data collection is ongoing
To improve our understanding of the safety and performance of VIVOSORB® in clinical practice, we are continuing to collect valuable post-market data.
