BBS - Bioactive Bone Substitutes | Top Orthopedic Solution Company in Europe 2020

MedTech Outlook Magazine

BBS - Bioactive Bone Substitutes
Delivering Unique Products for Effective and Natural Bone Healing

Ilkka Kangasniemi, CEO, BBS - Bioactive Bone Substitutes Ilkka Kangasniemi, CEO
Bone grafting has been a preferred way of treating bone defects with several kinds of bone substitutes available. These substitutes can be either obtained from biological sources such as bone matrix and plasma or synthetic such as ceramic materials. Biological substitutes cannot be used for every clinical use and have to be chosen based on their availability and effectiveness. Even though these bone substitutes have been used to treat bone defects for long, they bring their own share of problems. “If you look at the vast majority of products in the market today, they are mostly synthetic or ceramic, which are generally found to be less efficient. Even the bone grafting has the obvious downside of having to go through the second surgery and the associated potential complications such as infections, pain, and long-term healing problems,” says Ilkka Kangasniemi, the CEO of BBS - Bioactive Bone Substitutes. Considering the various problems associated with the products available in the market, BBS came up with a more natural way of healing bones.

The company introduced a reindeer bone protein extract and the combinations that the firm develops using the extract, which are sold as medical devices. This product is the first of its kind and is safe, efficient, and cost-effective. “This is something new to the market and will help us in gaining an edge,” claims Kangasniemi. The protein product helps the complete healing of damaged bones. It aids the healing process as naturally as possible as compared to other artificial materials, which do not possess the biological component of bone.

This offering is an outcome of BBS’s decades of legacy in the bone substitute industry from the time when research regarding bone grafting and its substitutes had just kicked off at the Oulu university in Finland.
The company was formally established in 2003, with the aim of developing and commercialising bone substitute products.

BBS’s mission is to optimise methods and products in bone healing and improve the surgical outcomes in bone substitutes


Ever since, the company has come a long way with its key product—ARTEBONE—which consists of bone proteins and mineral scaffold and differs greatly from the existing conventional ones. It is a cost-effective offering, used while treating bone defects and healing foot or ankle extremities.

In addition to designing and manufacturing bone graft substitutes, this Finnish health technology company also provides unique bioactive implants that offer clinical and financial benefits for patients suffering from bone defects. “The company’s mission is to optimise more methods and products in bone healing and improve the surgical outcome of bone substitutes, which BBS has excelled at over the last two decades with extensive research and development,” adds Kangasniemi. BBS also takes pride in its unique bioactive implants that are protected by global patent families.

Talking about BBS’s position in the market, Kangasniemi adds, “The market growth is slow for start-up companies like ours. Initially, BBS had its aim on getting the Food and Drug Addministrations approval, in order for the sale of our products. However now, we are going to divert our resources into local marketing, creating distribution chain, and partnering with companies.” Considering the roadmap, partnering with companies is essential for BBS, as it will prove beneficial in creating protein combinations. Over the years, BBS has earned a reputation for ensuring improved surgical outcomes of bone substitutes, and its future too looks promising, considering its vision of operating as a game-changer in bone healing.

Top 10 Orthopedic Solution Companies in Europe - 2020

Company
BBS - Bioactive Bone Substitutes

Management
Ilkka Kangasniemi, CEO

Description
BBS offers a reindeer bone protein extract and the combinations that the firm develops using the extract, which are sold as medical devices. This product is the first of its kind and is safe, efficient, and cost-effective. The company has come a long way with its key product—ARTEBONE—which consists of bone proteins and mineral scaffold and differs greatly from the existing conventional ones. It is a cost-effective offering, used while treating bone defects and healing foot or ankle extremities. In addition to designing and manufacturing bone graft substitutes, this Finnish health technology company also provides unique bioactive implants that offer clinical and financial benefits for patients suffering from bone defects

BBS - Bioactive Bone Substitutes News

BBS-Bioactive Bone Substitutes Plc – Insider information: Plan to complete minor open issues approved – the Company updates its outlook on the schedule of the CE marking

BBS-Bioactive Bone Substitutes Plc, Company announcement, Insider information, 13 September 2023 at 4:45 p.m.
BBS-Bioactive Bone Substitutes Plc – Insider Information: Plan to Resolve Minor Open Issues Approved – Company Revises CE Marking Schedule Update
The CE marking process for BBS-Bioactive Bone Substitutes Plc's ("BBS") inaugural product, ARTEBONE® Paste, involves two primary components: the approval of the quality system and the approval of the product.
In regard to the quality system approval, BBS has received approval from the Notified Body for the plan submitted to address four minor open issues. It is anticipated that these measures will be fully addressed between March and May 2024, subsequently allowing for the approval of the quality system.
As for the product approval process, regulatory authorities are actively reviewing the documentation, in coordination with the Medicines Agency consultation. The Finnish Medicines Agency (Fimea) is prepared to initiate this consultation process. Once commenced, the Company anticipates that the consultation will require 3-7 months for completion.
In light of the revised schedule for quality system approval, the Company has updated its expectations regarding the CE marking approval timeline.
Ilkka Kangasniemi, CEO:
"The backlog of application processing by the authorities and the additional measures required of BBS during the process have caused delays in the application process. However, we remain satisfied with how the CE marking process has progressed regarding the substance. No significant non-conformities have been discovered during the audits which we have not been able to solve. Now that the schedule has been clarified, the Company has started the preliminary commercialization measures and engaged with potential distributors."
Revised Outlook:
• On March 9, 2022, the Company submitted its CE marking application for its inaugural product, ARTEBONE® Paste, to the notified body. The Company now anticipates that authorities will make a decision regarding the application's approval in the second quarter of 2024.
• To ensure adequate funding for executing its plans after obtaining CE marking approval, the Company is actively engaged in discussions to secure additional financing. This funding is crucial for ongoing development efforts and the initiation of commercial activities.
Previous Outlook:
• On March 9, 2022, the Company submitted its CE marking application for its inaugural product, ARTEBONE® Paste, to the notified body. The Company previously expected authorities to decide on the application's approval in 2023.
• Preparations for commencing commercial operations were originally planned to commence towards the end of 2023.
• The Company had also recognized the need for additional financial measures to ensure sufficient funding for its plans following CE marking approval. Discussions were underway to secure additional funding for continued development work and the initiation of commercial activities.