Periodic Reporting for period 1 - FETALIX (FETALIX - REJUVENATING THE SPINE TO SET YOU FREE)
Reporting period: 2023-07-01 to 2024-06-30
Joana Caldeira is a forward-thinking researcher, PhD in Biomedicine and FETALDISC’s CEO, whose passion is to contribute to the generalized life quality improvement of an increasingly ageing society. Following her expertise as a researcher in the field of extracellular matrix modulation, improving current regenerative therapies, namely intervertebral disc disease, Joana was faced with a problem that is many times overlooked: Low Back Pain (LBP).
Although it may pose as a straightforward health condition to address, LBP, frequently caused by intervertebral disc degeneration (IVDD), affects up to 80% of the population, having a tremendous socioeconomic impact. This condition often requires expensive, lengthy, and invasive treatment, which rarely tackles the underlying issue, impacting patient’s life quality by affecting mobility, ability to work and sleep. Moreover, this health challenge is also prevalent in dogs, with many breeds suffering from continuous pain, limited mobility, and immobilization at older ages. To address this challenge, Joana co-founded FETALDISC, LDA to mainstream innovative, and sustainable deep tech biomedical solutions, especially for IVDD treatment, having FETALIX as its core product – THE FIRST REGENERATIVE FETAL-INSPIRED BIOMATERIAL TO TREAT LBP.
This solution will change the market dynamics, by achieving better intervertebral disc regenerative results, being more affordable and eliminating existing treatments setbacks.
As such, FETALIX identified the following main project objectives:
•Validate and consolidate the business model setting a robust foundation for FETALIX market uptake;
•Gain strategic and business-related tools and skills needed to successfully reach the targeted markets, thus bringing the company to the next level;
•Foster multidisciplinary networks of industry experts and investors with different skills as the key to growing stronger.
Although it may pose as a straightforward health condition to address, LBP, frequently caused by intervertebral disc degeneration (IVDD), affects up to 80% of the population, having a tremendous socioeconomic impact. This condition often requires expensive, lengthy, and invasive treatment, which rarely tackles the underlying issue, impacting patient’s life quality by affecting mobility, ability to work and sleep. Moreover, this health challenge is also prevalent in dogs, with many breeds suffering from continuous pain, limited mobility, and immobilization at older ages. To address this challenge, Joana co-founded FETALDISC, LDA to mainstream innovative, and sustainable deep tech biomedical solutions, especially for IVDD treatment, having FETALIX as its core product – THE FIRST REGENERATIVE FETAL-INSPIRED BIOMATERIAL TO TREAT LBP.
This solution will change the market dynamics, by achieving better intervertebral disc regenerative results, being more affordable and eliminating existing treatments setbacks.
As such, FETALIX identified the following main project objectives:
•Validate and consolidate the business model setting a robust foundation for FETALIX market uptake;
•Gain strategic and business-related tools and skills needed to successfully reach the targeted markets, thus bringing the company to the next level;
•Foster multidisciplinary networks of industry experts and investors with different skills as the key to growing stronger.
The project counted with 6 complementary tasks focused on business and market tools, training, mentoring, and investors’ networking as a means to achieve the abovementioned objectives:
• Task 1 - Technical and clinical assessment
• Task 2 - Growth strategy and business model validation
• Task 3 - Business plan consolidation
• Task 4 - Entrepreneurial business mentoring and training
• Task 5 - Industry and Investors’ Networking
• Task 6 - Communication and impact outreach
The completion of these tasks contributed to the team’s skills improvement and will heavily guide the company towards a successful market entry, resulting in:
-an updated company image and communication strategy, supported by a LinkedIn page and a website.
-strategic planning of in vivo & clinical studies completed.
-an improved pitch deck and business plan.
-team's improved skills on networking, business and entrepreneurship through the participation on dedicated programmes, trainings, workshops and events.
-improved industry knowledge and robust network with investors, due to the participation in several pitch and investor-oriented events/one-to-one meetings.
• Task 1 - Technical and clinical assessment
• Task 2 - Growth strategy and business model validation
• Task 3 - Business plan consolidation
• Task 4 - Entrepreneurial business mentoring and training
• Task 5 - Industry and Investors’ Networking
• Task 6 - Communication and impact outreach
The completion of these tasks contributed to the team’s skills improvement and will heavily guide the company towards a successful market entry, resulting in:
-an updated company image and communication strategy, supported by a LinkedIn page and a website.
-strategic planning of in vivo & clinical studies completed.
-an improved pitch deck and business plan.
-team's improved skills on networking, business and entrepreneurship through the participation on dedicated programmes, trainings, workshops and events.
-improved industry knowledge and robust network with investors, due to the participation in several pitch and investor-oriented events/one-to-one meetings.
The strategic planning and assessment of in vivo studies have laid the groundwork for future clinical trials in dogs, opening the door to the veterinary market and providing important cues for further human intervention. The business model was revisited and validated, ensuring the technical solution is better prepared for commercialization, and a new pitch deck was developed to attract investors. An exploratory market assessment identified regulatory issues and opportunities in the veterinary sector, particularly among dog owners, with a focus on expanding into Spain and the UK. The business plan was further improved with updated financials, market analysis, and customer validation, aided by collaboration with Catholic University Porto Business School. FETALDISC engaged in mentoring and training activities to enhance skills in business, financials, entrepreneurship, and leadership, with the CEO participating in several key programs. A strong valorisation strategy was developed to attract investors, leveraging the adjusted business model and knowledge from mentoring activities.
Participation in various events provided valuable networking opportunities and insights into investor expectations. Communication efforts included developing a website, promotional videos, and social media content to promote the project and its impact. The Spine Innovation Forum, organized in collaboration with i3S, brought together diverse stakeholders to discuss and innovate in the spinal health field, fostering collaborations and showcasing groundbreaking research.
To ensure further uptake and success, FETALDISC needs to continue in vivo and clinical studies to validate the safety and efficacy of the biomaterial, and to conduct further research to address veterinarians' concerns about biomaterials of fetal origin. Engaging with investors through the new pitch deck is crucial for securing funding for development and commercialization. Exploring partnerships and collaborations will enhance market access, while developing a comprehensive business plan based on the validated model and securing intellectual property rights will support commercialization efforts. Initial expansion should focus on Europe, particularly Spain and the UK, leveraging connections to the American continent for long-term growth.
Engaging with regulatory entities like DGAV and INFARMED to determine the classification of FETALIX and ensuring compliance with regulatory standards is essential for market entry.
Insights from the collaboration with Catholic University Porto Business School already defined the business plan and financial strategies, with support from Women Leadership Programme business coaches.
Continued participation in mentoring and training programs will enhance business growth, stakeholder negotiation, pitching, and market entry skills. Building a strong valorisation strategy, leveraging networking events, and developing communication materials will attract investors and promote the project's impact. Engaging in science communication activities will continue to raise awareness and inspire future generations reducing the gender gap in the entrepreneurial field.
Participation in various events provided valuable networking opportunities and insights into investor expectations. Communication efforts included developing a website, promotional videos, and social media content to promote the project and its impact. The Spine Innovation Forum, organized in collaboration with i3S, brought together diverse stakeholders to discuss and innovate in the spinal health field, fostering collaborations and showcasing groundbreaking research.
To ensure further uptake and success, FETALDISC needs to continue in vivo and clinical studies to validate the safety and efficacy of the biomaterial, and to conduct further research to address veterinarians' concerns about biomaterials of fetal origin. Engaging with investors through the new pitch deck is crucial for securing funding for development and commercialization. Exploring partnerships and collaborations will enhance market access, while developing a comprehensive business plan based on the validated model and securing intellectual property rights will support commercialization efforts. Initial expansion should focus on Europe, particularly Spain and the UK, leveraging connections to the American continent for long-term growth.
Engaging with regulatory entities like DGAV and INFARMED to determine the classification of FETALIX and ensuring compliance with regulatory standards is essential for market entry.
Insights from the collaboration with Catholic University Porto Business School already defined the business plan and financial strategies, with support from Women Leadership Programme business coaches.
Continued participation in mentoring and training programs will enhance business growth, stakeholder negotiation, pitching, and market entry skills. Building a strong valorisation strategy, leveraging networking events, and developing communication materials will attract investors and promote the project's impact. Engaging in science communication activities will continue to raise awareness and inspire future generations reducing the gender gap in the entrepreneurial field.