BBS-Bioactive Bone Substitutes Oyj, Investor News, 15 November 2023 at 12.50 p.m.
Last week, Juliusz Rakowski officially started as CEO of BBS-Bioactive Bone Substitutes Oyj (BBS). The first week included getting to know the personnel and owners as well as the company's offices and production facilities in Oulu and Reisijärvi.
In the very beginning, Juliusz's focus will be strictly on finalizing the CE marking process of the company's first product, currently in its final stages, but under his leadership, the company is already determinedly planning steps related to the upcoming commercial phase.
“Artebone has hardly any competitors on the EU market”
Having become familiar with BBS and its first product, ARTEBONE® Paste, Juliusz believes that the company's solution has the potential to displace the currently common single-component solutions, so-called synthetic bone fillers.
"There are currently over 600 of these synthetic solutions on the market. ARTEBONE's unique competitive advantage over them is that it combines bone minerals with bone growth factors, which makes it as effective as when using the patient's own bone graft. The synthetic solutions currently on the market do not contain growth factors. That's why ARTEBONE has hardly any competitors on the EU market," describes Juliusz.
The new CEO is satisfied with the progress of the CE marking process
Juliusz has followed BBS's journey and, despite past delays, is satisfied with the progress of the CE marking process. Earlier in the spring, the approval of the product classification was the most important milestone for the company so far.
ARTEBONE was a new type of borderline case between a medical device and medicines, and the company became a significant precedent from a regulatory point of view on how such products can overall be given approvals. This is also evidenced by the fact that the company was even included as an example in the industry manual published in 2018 (Manual on borderline and classification in the community regulatory framework for medical devices, version 1.19 (04 2018)).
Just before Juliusz started (company bulletin 2 November 2023) the company received information from the Notified Body that the approval of the quality system was expected sooner than had been previously announced. According to the new CEO, this further reduced the remaining risks related to the schedule.
"It is the company’s management’s view, that we are at a stage where the technical requirements have mostly been fulfilled and it is now mostly about the schedule. What remains is the consultation of the Finnish Medicines Agency starting this month and the official product approval is proceeding alongside it. We still expect to receive the final CE marking during the second quarter of 2024, hopefully sooner of course.”
The implementation of the new industry-wide MDR regulation in 2022 was poorly timed for the company and its peers, as approvals could no longer be granted based on documentation prepared under the old regulation. Furthermore, the delays caused by Brexit and the Covid-19 pandemic are now behind us.
"Each company has been impacted by the backlog in official processing, leading to significant delays and uncertainty in their CE marking processes. However, progress is now being made."
The CEO's focus is already on the product launch
Juliusz is already looking beyond the CE marking phase, aiming to steer the company decisively into the next stage, which includes the product launch, establishing a distribution network, and market expansion.
"With over 15 years of experience in commercial roles within the life sciences industry, I think it is important that we rapidly advance developing our marketing and sales functions. I am confident that my expertise will benefit the company in this endeavor. Of course, we will do this in the most cost-effective manner, staying within the financial boundaries set by the company's funding."