Clinical trial results
Title: Investigation of the benefit of using an autologous platelet-rich fibrin matrix (Obsidian® ASG) for treatment of anastomosis during rectal surgery – a single-blind, randomized, multicenter pilot study (explorative design).
Patients: Approx. 250
Study design: Multicenter (15 sites/6 countries), prospective, randomized, single-blind
Result: Final results are delayed. The delay is caused by Covid-19 and post-covid-19 complications as described in the deliverables, critical risks and progression meetings. 277 patients have been enrolled and Vivostat will execute completion of the clinical trial.
Final Commercialization and Marketing Strategy Report with Distributor Agreements (Finalized)
The market and stakeholder need for a solution to lower the AL rate is significant
• Patients’ burden of disease is high
• Surgeons are challenged and need new innovative solutions
• Payers seek to increase productivity
• The total market potential is great
Obsidian® ASG will address stakeholder needs
• Obsidian® ASG can address current gaps/needs in the market for resection surgery
• Assuming a 50% reduction of AL by using Obsidian® ASG payers will save costs in the range of €400-1600 per patient
• Marketing tools to ensure a successful Obsidian® ASG market uptake focus on training
Situational analysis
• As Vivostat is a small organization a train-the-trainer concept will help facilitate training through ambassadors
• Challenges and regulatory requirements in the transition to MDR can still pose a significant threat
• Difficult and lengthy process to obtain reimbursement and establishing CPT codes requires focus
Go-to market strategy to launch Obsidian® ASG is ready
• With the Vivostat distributor business model, long-term commitment from distributors and selection of the right distributors are vital elements
• Launch waves and key strategic markets are selected based on distributor readiness/experience and market size/conditions plus regulatory approval status (for more conclusions re market access and reimbursement see below)
Strategic and operational business/marketing plan
• Serviceable obtainable market is great with 146,151 surgeries yearly across all markets in the three launch waves
• Based on the distributor business model, the time-consuming training needed, and the needed change in behavior in terms of adding a step in standard colorectal resection surgery, the goals are set conservatively, but still the numbers are significant and gives a solid business case
• Critical success factors, specific initiatives and tactics to reach the goals have been defined ensuring a successful launch
Detailed and Final Market Access Report with Reimbursement Strategy and Applications (Finalized)
• Obsidian® ASG is regulatory approved in the EU, RS, ZA, IL and UAE
• Registration of Obsidian® ASG in BR, JP, RU and SA is in process
• Regulatory status of Obsidian® ASG in the US has been clarified with the FDA as a Pre-Market Approval (PMA) or a Biologics License Application (BLA). Therefore, partnerships in the US has not been pursued further.
• No specific reimbursement code for Obsidian® ASG exists – current payment is under the existing DRG/Reimbursement framework
• Specific OPS code covering Obsidian® ASG has been granted in Germany by January 2024
• Reimbursement for Obsidian® ASG has been granted in ZA
• A Core Value Communication document has been developed to support local distributors in their market access and reimbursement negotiations
Dissemination and Communication Framework (Finalized)
The Framework illustrates all activities carried out or planned for the future to communicate and disseminate objectives and results of the EU-funded research. The Framework is uploaded below.
