Can you discuss the significance of your recent Series A funding round and its impact on SpinaFX's operations?
Following our successful Cad$6.88 million Series A funding, we embarked on a Series B round with the goal of raising additional funding to support our operations, product manufacturing, and the development of a path to regulatory approval. To date we have raised an aggregate of Cad$18 million. This funding is crucial in providing working capital to generate a path to commercialization.
What sets your minimally invasive therapy apart from other treatments currently available?
Our approach to minimally invasive image guided therapy is fundamentally different from conventional surgical procedures as it fills a therapeutic gap up the continuum of care accessing a broader range of physicians other than surgeons, including pain specialists, interventional radiologists, and physiatrists. This not only broadens the pool of healthcare providers capable of performing our procedures but also significantly reduces the patient's recovery time. Our focus is on outpatient procedures that require no hospital stay, making it a highly convenient option for patients with contained herniated discs. This ease of treatment and the avoidance of hospitalization are key differentiators for our therapy.
What are the main challenges SpinaFX faces in bringing your product to market?
The foremost challenge is obtaining the necessary regulatory approvals. Beyond that, a significant part of our strategy involves educating spine and neurosurgeons about our treatment to foster referrals to pain specialists for early intervention, and the increased visibility and uptake of our treatment option as a mainstream alternative. Addressing the long waits patients currently face for surgical procedures and creating a more efficient referral system to alternative treatments like ours are critical. Additionally, we aim to secure reimbursement in the U.S. through clinical work, which would significantly enhance market access and patient adoption .
Does SpinaFX plan to expand to markets outside of Canada?
Absolutely, we're not only targeting the Canadian market, where we're already making strides with special access cases, but also eyeing expansions into Europe and the U.S., with further plans for Australia, Japan, and China. Our strategy involves careful selection of markets. We hope to achieve and leverage regulatory milestones, such as CE mark submission in Europe and planning for FDA submissions in the U.S., to ensure a successful global rollout.
Could SpinaFX's technology be the solution to the perennial problem of back pain?
While surgery will remain a necessary treatment for some patients, our technology offers a promising alternative for a significant portion of the population, particularly younger patients who could benefit from early intervention. Our non-invasive image guided injection-based therapy provides an option that doesn't preclude future surgical interventions, if necessary, thereby offering a more flexible approach to managing low back pain. By focusing on specific indications like contained herniated discs, we aim to improve quality of life for a broad range of patients by offering an effective alternative to opioids and other conservative treatments.
What is your long-term vision for SpinaFX?
Our vision extends beyond being just a provider of innovative medical devices; we aspire to be a patient-centric company that enhances patient outcomes and quality of life.
This involves developing tools and resources for both physicians and patients that support diagnosis, treatment, and long-term health management. We envision a future where SpinaFX is synonymous with patient-focused care, offering a comprehensive platform that empowers individuals to manage their spinal health effectively.
Is Canada the gateway for SpineFX's technology to other markets?
Canada serves as an ideal launching pad for our technology, offering an opportunity to pilot and refine our approach in a smaller market before scaling to larger regions. We expect to demonstrate high treatment efficacy in Canada through special access cases, which we anticipate will pave the way for our expansion into Europe and the U.S. This strategic focus on Canada leverages our local presence and insights to build a solid foundation for global growth.
