Shareholder Letter, July 2022
It has been an eventful year so far, however the next couple of years are expected to be even more event-filled with multiple key milestones on a shoestring.
As we transition SpinChip from an R&D organization into a leading European diagnostic point-of-care company, one of the key success factors is our ability to recruit the best people and house them under one roof at Hoffsveien 21/23.
We are pleased that we have been able to employ very experienced industry professionals, as we have expanded our workforce to 45 employees, mainly in the areas of production and new assay development. We have doubled our footprint to be able to accommodate for production of cartridges and analyzers according to cGMP (Current Good Manufacturing Practice). All to have maximum speed towards commercialization.
Successful first manufacturing of cartridges and analyzers
The cartridge pilot production line has been completed and successfully installed. We are pleased to announce that we produce 500-750 cartridges daily with high yield throughput. We are already on the way to reaching 1,000 cartridges per day. This is very encouraging as this is the blueprint for a fully automated production line that will allow us to be a low-cost high-quality manufacturer.
We have also started the assembly of the instruments in-house and have already manufactured 20 analyzers and expect to reach 100 before year-end.
Revised time schedule for Verification
We have had COVID-related delivery issues and technical hurdles which have resulted in a delay in design verification.
Design verification is an important milestone, consisting of 27 studies that need to be completed satisfactorily before we can start clinical trials.
We expect to start the design verification in November 2022 and estimate that we will be able to start pivotal clinical trials in April 2023.
Collaboration agreement signed with Ahus
We have signed a collaboration agreement with one of Norway’s leading hospital centers to conduct required clinical trials for hs cTnI and other cardiac biomarker tests.
In addition to this, we are in negotiations with several other hospital centers in Europe regarding the multicentre prospective hs cTnI clinical diagnostic performance study which will be initiated next year after the completion of the hs cTnI verification studies.
The diagnostic performance study will be conducted at several sites in Europe. This will reduce the timelines for the approval, but it is also important to have data in the intended use settings and in the key markets where we plan to soft launch the SPINCHIP platform.
Strategic partnering agreement with top European distributor
The SPINCHIP platform will first be released in a limited number of markets in the Nordics, the BeNeLux countries, and the DACH countries before we expand globally.
A key element in the commercialization strategy is to partner with capable commercial partners on the sale, marketing and distribution of the SPINCHIP platform for our soft launch in selected European markets. In this context, we are pleased to announce that we have signed a term sheet for a strategic partnership regarding both pre- and post-launch activities in Europe.
The limited release launch is important as it will allow us to i) resolve any teething issues there may be with our platform, ii) gain first sales with reference customers, iii) provide a start-kit for our market access, trial sale and re-sale activities for our global expansion and iv) demonstrate to large international commercial players that we have a platform with blockbuster potential. To ensure that our limited release launch is a success, we are already collaborating with our commercial partner on key pre-launch activities.
Cardiac Advisory Board established, and the first meeting was held with top Key Opinion Leaders
Seven of the world’s top Key Opinion Leaders have agreed to join SpinChip’s Cardiac Advisory Board:
- Prof. Dan Attar (Chairman)
- Prof. Roland Bingisser
- Prof. Frank Peacock
- Prof. Christian Müller
- Prof. Allan Jaffe
- Prof. Kristin Moberg Aakre
- Prof. Fred Apple
We have signed agreements with them all and the first meeting was held in Zürich on 28-29 June, where we also demonstrated the SPINCHIP Analyzer and Cartridge technology. We received excellent feedback on everything from study design to future assay development strategy. We plan to implement our clinical trials together with our Cardiac Advisory Board to maximize market impact.
Transition to revenue stage
The next years are packed with important milestones, and we have started to work on a financing plan for the transition from verification to validation, to regulatory approval, to market launch to menu expansion and more. We intend to come back with more information, probably in September, when we have concluded our yearly strategy meeting.
On behalf of everyone at SpinChip, we would like to thank you for your continued support and wish you all a wonderful summer.
Åse Aulie Michelet Morten Jurs