Periodic Reporting for period 2 - OBSIDIAN (A powerful and efficient tissue regeneration method for reducing the anastomotic leakage rate in gastrointestinal surgery)
Periodo di rendicontazione: 2022-05-01 al 2024-04-30
Vivostat has together with Rivolution been working to develop Obsidian® ASG as an adjunct to standard anastomosis treatment with the aim to reduce anastomotic leakage (AL) in gastrointestinal (GI) surgery. Obsidian® ASG is an autologous bioactive platelet rich matrix with sustained release of active cells and growth factors improving sealing and healing. A preliminary retrospective, single-arm study with 261 patients indicates that application of Obsidian® ASG at anastomotic site following colorectal resection is safe and associated with a low rate of anastomotic leakage of 2.3% (1). Obsidian® ASG may therefore reduce leakage by more than 50% in GI resections.
GI resections often result in AL:
• In Europe more than 538.000 new cases of colorectal cancer every year - most will undergo surgery. 34% of cases are located at rectum/rectosigmoid junction
• AL following GI surgery is one of the most dreaded complications. The risk and rates of AL have been found to vary depending on the anatomic site and grade of the cancer: Colon: 4%; Rectum: 10% and Esophagus: 10%
• Costs per patient experiencing AL is up to 4x higher compared to an uncomplicated procedure
The EIC Accelerator funding allows Vivostat to conduct a multi-center clinical trial across the EU with approx. 250 patients. Main objective: To investigate whether the application of Obsidian® ASG during rectal resection reduces the rate of anastomotic insufficiency compared to standard anastomotic technique. Market access and reimbursement strategy with focus on Germany, marketing strategy with product launch and market expansion plans are also key elements of the project. These activities will strengthen and accelerate the commercialization of Obsidian® ASG to the benefit of patients, surgeons, hospitals as well as job creation.
(1) Shamiyeh et al. Obsidian ASG® Autologous Platelet Rich Fibrin Matrix and Colorectal Anastomotic healing: A Preliminary Study. Surg Tech Int, V39, 2021.
GI resections often result in AL:
• In Europe more than 538.000 new cases of colorectal cancer every year - most will undergo surgery. 34% of cases are located at rectum/rectosigmoid junction
• AL following GI surgery is one of the most dreaded complications. The risk and rates of AL have been found to vary depending on the anatomic site and grade of the cancer: Colon: 4%; Rectum: 10% and Esophagus: 10%
• Costs per patient experiencing AL is up to 4x higher compared to an uncomplicated procedure
The EIC Accelerator funding allows Vivostat to conduct a multi-center clinical trial across the EU with approx. 250 patients. Main objective: To investigate whether the application of Obsidian® ASG during rectal resection reduces the rate of anastomotic insufficiency compared to standard anastomotic technique. Market access and reimbursement strategy with focus on Germany, marketing strategy with product launch and market expansion plans are also key elements of the project. These activities will strengthen and accelerate the commercialization of Obsidian® ASG to the benefit of patients, surgeons, hospitals as well as job creation.
(1) Shamiyeh et al. Obsidian ASG® Autologous Platelet Rich Fibrin Matrix and Colorectal Anastomotic healing: A Preliminary Study. Surg Tech Int, V39, 2021.
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.
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.
Clinical trial results
Final results are delayed. The delay is caused by Covid-19 and post-covid-19 complications as described in Deliverables, Critical Risks and progression meetings. 277 patients have been enrolled. Vivostat will execute completion of the clinical trial and project and will follow the time schedule below:
• Last patient enrolment: 31.03.2024
• Last patient visit: 31.08.2024
• Data cleaning and data lock: 15.11.2024
• Statistical analyses/report: 06.02.2025
• Key result meeting: 01.03.2025
• Final Pivotal Clinical Trial Results Report 30.04.2025
Socio-economic impact
The clinical trial will on an explorative level validate and support the implementation of Obsidian® ASG and the new procedure into routine clinical practice. As described, results of the clinical trial will be ready April 2025, however it is expected to support Obsidian® as an effective and life-enhancing medical treatment.
As clinical trial results still remain, cost/benefit assessment of implementing Obsidian® ASG is based on assumptions:
• Implementing Obsidian® ASG as a standard in resection surgery may be a cost-effective solution for anastomosis sealing and healing
• Assuming Obsidian® ASG decreases the AL rate with 50%, the economic benefit may range between €400-€1600 per patient
• Additional benefits may be lower morbidity and mortality and faster recovery also leading to economic benefits
The expected wider societal implications are that the introduction of Obsidian® ASG will help patients undergoing GI resection surgery by increasing safety by lowering the rate and severity of anastomotic leakages, their surgeons by lowering the rate of post-operative complications and payers by keeping hospital budgets down.
Final results are delayed. The delay is caused by Covid-19 and post-covid-19 complications as described in Deliverables, Critical Risks and progression meetings. 277 patients have been enrolled. Vivostat will execute completion of the clinical trial and project and will follow the time schedule below:
• Last patient enrolment: 31.03.2024
• Last patient visit: 31.08.2024
• Data cleaning and data lock: 15.11.2024
• Statistical analyses/report: 06.02.2025
• Key result meeting: 01.03.2025
• Final Pivotal Clinical Trial Results Report 30.04.2025
Socio-economic impact
The clinical trial will on an explorative level validate and support the implementation of Obsidian® ASG and the new procedure into routine clinical practice. As described, results of the clinical trial will be ready April 2025, however it is expected to support Obsidian® as an effective and life-enhancing medical treatment.
As clinical trial results still remain, cost/benefit assessment of implementing Obsidian® ASG is based on assumptions:
• Implementing Obsidian® ASG as a standard in resection surgery may be a cost-effective solution for anastomosis sealing and healing
• Assuming Obsidian® ASG decreases the AL rate with 50%, the economic benefit may range between €400-€1600 per patient
• Additional benefits may be lower morbidity and mortality and faster recovery also leading to economic benefits
The expected wider societal implications are that the introduction of Obsidian® ASG will help patients undergoing GI resection surgery by increasing safety by lowering the rate and severity of anastomotic leakages, their surgeons by lowering the rate of post-operative complications and payers by keeping hospital budgets down.