4DMedical Limited
Climate Impact & Sustainability Data (2018, 2020, 2021, 2023)
Reporting Period: 2018
Environmental Metrics
Social Achievements
- Implemented a Salary Sacrifice Offer and Fee Sacrifice Offer under the Employee Equity Plan to allow employees and directors to build shareholdings in a tax-effective manner and align interests with shareholders.
- Relocated to larger office premises in Melbourne to accommodate operational expansion.
- Established a Regulatory and Quality Committee and a People and Remuneration Committee to promote good governance practices.
Governance Achievements
- Established a Regulatory and Quality Committee in December 2017 and a People and Remuneration Committee in May 2018.
- Appointed new non-executive directors Julian Sutton, Lusia Guthrie, and John Livingston to strengthen the board.
Climate Goals & Targets
Short-term Goals:
- Grow current collaborators from 3 to 10 by the end of 2018 (subject to available resources).
Environmental Challenges
- Net loss after tax of $3,936,980 (2017: $3,973,937).
- FDA Request for Additional Information regarding 4Dx Limited’s 510(k) submission for its radiotherapy monitoring software product (RTx), leading to withdrawal of the application.
- Ongoing operational resourcing requirements and need for further capital raising.
Mitigation Strategies
- Withdrew RTx application to focus resources on 4DxV’s core product.
- Entered the FDA Pre-Submission Program and attended a pre-submission meeting to gain valuable feedback.
- Commenced a Series B fundraising round to address operational resourcing requirements and investor interest.
- Developed hardware product lines to support accelerated validation of the 4DxV software platform and outsourced/licensed commercial hardware production.
Supply Chain Management
Climate-Related Risks & Opportunities
Reporting Period: 2020
Environmental Metrics
Social Achievements
- Expanded team in Melbourne and Los Angeles, welcoming 16 new employees, including 6 sales and marketing staff, bringing the total to 41 full-time employees.
Governance Achievements
- Appointed new Non-Executive Directors, Bruce Rathie and Lilian Bianchi. Bruce was subsequently appointed as Chairman of the Board.
Climate Goals & Targets
Medium-term Goals:
- Continue to develop and commercialise the Group’s product pipeline, which includes VQ and Contrast Free Pulmonary Angiography (CFPA) products.
Short-term Goals:
- Continue recruitment of sales and marketing staff in the U.S. to drive revenue generation.
- Accelerate the roll out of the Group’s XV LVAS product to priority hospitals and clinics located in the U.S.
- Increase the number of hospital X-ray systems compatible with 4DMedical’s technology.
- Prepare for ISO 13485 certification of the Group’s QMS under the Medical Device Single Audit Program (MDSAP).
- Initiate the validation and verification process for XV LVAS in preparation for its Australian TGA submission in FY21.
Environmental Challenges
- COVID-19 pandemic temporarily impacted ability to interact with potential customers face-to-face; medical conferences were cancelled, postponed, or reconfigured to be online only.
Mitigation Strategies
- Created a world-leading virtual experience for the launch of XV LVAS at the ATS 2020 virtual conference.
Supply Chain Management
Climate-Related Risks & Opportunities
Reporting Period: 2021
Environmental Metrics
Social Achievements
- More than doubled the size of its workforce to 95 employees.
- Introduced a broad based ‘Tax Exempt’ Employee Share Plan in June 2021, with 100% participation.
- Partnered with the American Thoracic Society during its annual international conference to raise funds towards diversity initiatives.
Governance Achievements
- Actively developed existing, and implemented new corporate governance structures to foster a culture of integrity, aligning the interests of shareholders, employees and other stakeholders, through the promotion of accountability and transparency for sustainable value creation.
Climate Goals & Targets
Environmental Challenges
- COVID-19 imposed restrictions temporarily limited access to key decision makers in U.S. hospitals.
Mitigation Strategies
- Implemented remote working practices across two continents.
- The Company embraced the challenge without any significant detriment to its strategy.
Supply Chain Management
Climate-Related Risks & Opportunities
Reporting Period: 2023
Environmental Metrics
Social Achievements
- Rollout of My4D platform to inspire, appreciate, and engage employees.
- Employee Satisfaction: yearly average Net Promoter Score of 32.5.
- Employee wellbeing survey results averaging 3.95 (out of 5).
Governance Achievements
- Appointment of Dr. David Shulkin as advisor.
- Successful $45 million capital raise.
Climate Goals & Targets
Environmental Challenges
- Uncertainty of future profitability.
- Need for additional funding.
- Foreign exchange fluctuations (USD:AUD).
- Risk of intellectual property infringement.
- Retention of key personnel.
- Changes in law and regulatory requirements.
- Risk of regulatory delays or non-approval.
- Risk of superseding technology and competition.
- Technology supplier risks.
- Product liability risks.
- Failure to achieve commercialisation and distribution goals.
- Risks associated with future acquisitions.
- Privacy risks.
Mitigation Strategies
- Cloud-based SaaS service provider to reduce market penetration risks.
- Successful $45 million capital raise.
- Appointment of Dr. David Shulkin as advisor.
- Risk management framework to identify, assess, and manage risks.
- Development and ownership of proprietary intellectual property.
- Focus on attracting, motivating, and retaining competent and committed people.
- Risk management systems to maintain confidentiality and privacy of personal information.
Supply Chain Management
Climate-Related Risks & Opportunities
Awards & Recognition
- Dr. Andreas Fouras appointed Honorary Professorial Fellow by University of Melbourne.