LIQOSEAL®, the first product in our Neurosurgery portfolio, is indicated for use as an adjunct to standard methods of cranial dural repair to provide watertight closure of the dura mater and reduce cerebrospinal fluid (CSF) leakage.
After achieving CE certification for LIQOSEAL® earlier this year, we immediately started commercializing our easy-to-use and innovative dural sealant patch in selected European countries, working with renowned distribution partners with extensive neurosurgical experience. Shortly after the launch, we were confronted with the global disruption caused by COVID-19, which further emphasized the importance of staying in close contact with our strategic partners and key opinion leaders.
We therefore decided to launch a quarterly newsletter to keep our distributors updated with the latest on LIQOSEAL®. We will share information on markets, meetings, clinical studies, regulatory news, user experiences and more, which we hope you will find helpful in your day-to-day contact with surgeons. We are happy to share this first issue with you today.
First LIQOSEAL® surgeries
So far, 2020 has been a challenging year to launch a new surgical device. However, despite many elective procedures being delayed due to COVID-19, we have encountered a strong interest in LIQOSEAL® across Europe. Surgeons have successfully completed the first surgeries using LIQOSEAL® in multiple countries, including Switzerland, Italy, Germany, The Netherlands and Greece.
Surgeons have been very positive about using the patch, particularly the ease-of-use and adhesive strength. Dr. Zenga (Division of Neurosurgery, Citta della Salute e della Scienca, Torino, Italy) commented:
“LIQOSEAL® was easy to use, no leaks were observed, it provided an optimal outcome in this challenging surgical case”
Feel free to share the full experience of Dr. Zenga with your customers. If you are interested in hearing from other users about their experiences with the device, please contact us.
Cost-saving potential of LIQOSEAL®
CSF leakage is widely recognized as a significant socio-economic burden, resulting in increased morbidity, prolonged hospital stays, possible surgical revision, and enhanced costs.
The Healthcare Innovation Centre (THINC), University Medical Centre, Utrecht (The Netherlands), performed a multi-center retrospective analysis in 2018 looking at the impact of CSF leakage. The study included more than 2000 patients undergoing cranial surgery across four clinical centres (three in Europe and one in US). The authors concluded that CSF leakage results in an average increase in hospital stay of 6 days. A potential cost reduction of more than 9,000 EURO per patient can be obtained, for each avoided case of CSF leakage.
Please find a summary of our Health Economics Assessment (HEA) here. You are welcome to share this report with your customers. We trust this will be another useful resource in highlighting the value of LIQOSEAL® to hospitals, particularly in terms of cost savings.
Online training program
To continue providing our full support to clinical activities during these challenging times, we have developed an online training module to instruct surgeons on how to use LIQOSEAL® for dural repair. This programme has proven to be very usefull in recent months. The training programme includes animation and video content and step-by-step instructions for application of the patch.
As well as being a vital resource for surgeons using the device, we hope that this content will assist you in conveying the ease-of-use of LIQOSEAL® to your customers.
The training is protected by a secure login. Please contact us if you have any questions regarding this program or would like to receive your login details.
ENCASE II study
After achieving CE Mark certification for LIQOSEAL® earlier this year, preparations are well underway for the start of ENCASE II. The ENCASE II randomized controlled trial (RCT) will assess the safety and efficacy of LIQOSEAL® in reducing CSF leakage following elective cranial surgery and will enable us to submit the patch for pre-market approval to the US Food and Drug Administration (FDA).
The study will involve specialised neurosurgery centers in both America and Europe, where it will serve as a post-market clinical follow-up (PMCF) study. The interested investigational sites are shown on the map.
Obtaining CE mark was based on outstanding data from our ENCASE I clinical trial, evaluating the safety and performance of LIQOSEAL® in reducing CSF leakage after elective cranial surgery. 3-month follow-up results showed the absence of CSF leakage, as confirmed by MRI, no clinically significant swelling, and no device-related adverse events following surgery. The study protocol was published in Neurosurgery. By using the 3-month data and this publication, we hope you’ll be able to highlight to your customers the great impact LIQOSEAL® can have. We are now also preparing the publication of the 12-month follow-up results.
We will keep you updated on the start of ENCASE II
New product registrations
We are continuing with the international roll-out of LIQOSEAL® via trusted and specialist distributors with experience in the neurosurgical market. We are increasing product availability and use, as well as looking to expand into new geographical areas. We are currently pursuing new product registrations outside Europe, in Australia, Argentina, Brazil, Colombia, Japan and China.
Upcoming conferences
To stay up to date with progress in our fields of interest as well as disseminate our own new data, we are committed to attending and presenting at national and international congresses. Over the next year we plan attend the EANS Congress and AANS Annual Scientific Meeting.
These meetings also provide us with a great opportunity to meet directly with users to help drive successful uptake of our products. With this in mind, we recommend you to reach out to your customers and let us know if they will be attending these two events.
