What have been the highlights for SpinaFX Medical over the past year?
SpinaFX Medical completed the full acquisition of the largest portfolio of patents, trademarks, and pre-clinical and clinical evidence for Triojection—a minimally invasive image-guided procedure for contained lumbar disc herniation.* We partnered with our contract manufacturing partner, StarFish Medical, in late 2021. In June 2022, we attended the Society of Interventional Radiology (SIR) Annual Meeting, where one of our medical advisors presented the results of his research on “the effectiveness of intradiscal oxygen-ozone treatment compared to microdiscectomy for contained lumbar disc herniation with radiculopathy.” This study, published in the Spine Journal in 2022, was recognized by SIR as one of the 2022 Abstracts of the Year.
SpinaFX also achieved important fundraising milestones. In the past 12 months, we raised over US$12 million in funding from outside investors, US$5 million in our Series A round, which closed in November 2021, and approximately US$8 million in our Series B round. This is extremely exciting considering current economic conditions, and our hope, based on how we have mapped out the use of proceeds, is that the series B round will get us through global commercialization.
Additionally, we achieved ISO 13485:2016/MDSAP and EN ISO 13485:2016 certifications, which are required to pursue regulatory approvals in the U.S., Canada and Europe. We will pursue approvals for Canada and Europe first, and then we will focus on our pre-submission with the FDA, with the goal of commercializing Triojection in the U.S. in early 2025. We will continue to build our team, recruiting top talent to join our company as we move forward.
* Triojection is not currently available for promotion or sale in North America, the EU or the UK. Triojection was previously awarded CE Mark under MDD and is undertaking re-registration under MDR.
In terms of investment, have you noticed a shift in terms of where money is coming from?
In the current economic environment, the biggest shift we are seeing is that investors are slower to react or holding off on investments altogether. Many of the venture capitalists (VCs), private investors and family offices that we are speaking with right now are very reserved and more selective than what we have seen in the past. We are talking with several strategics in the marketplace that have strong interest in us and have meetings coming up with VCs and other family offices that are interested.
Our hope is that investors will become increasingly interested in us and see Triojection as a technology that fits within the continuum of care for back pain, filling a therapeutic gap for patients. Triojection is designed to be an outpatient procedure, which means the patient would get the injection and go home the same day. The benefit for the patient is that they are not staying in the hospital for long periods of time. The procedure eliminates costly hospital stays for payers, and it potentially enables physicians to increase their procedure volume as compared to surgery.
What is SpinaFX’s vision for entering the U.S. in 2025?
SpinaFX has partnered with an experienced regulatory team in Silicon Valley to help us develop a submission plan for the FDA, which will help us determine the most efficient pathway to pursue FDA approval. Our plan will likely require a small clinical study with the guidance of the FDA, and once we get feedback from that, our goal would be to start to identify sites to launch the full clinical study in 2023. While there is no assurance as to if and when we might receive regulatory approval, our current plan is to complete our submissions in a timely matter so that our timeline for entry into the U.S. market would be sometime in late 2025 or 2026.
Do you have any other growth or expansion plans for the years ahead?
Our flagship Triojection product is a single use, disposable injection therapy for back pain. We look forward to adding minimally invasive, image-guided procedures to our portfolio that support existing procedures and address the needs of patients, payers, and physicians. Our focus now is to launch Triojection and make that successful.
Our customer base is very broad. We will focus on pain specialists, interventional radiologists, interventional neuroradiologists, spine surgeons, physiatrists and neurosurgeons.
We are focused on understanding referral pathways, where patients fit within the continuum of care for back pain and when would be the best time for a patient to get a therapy like ours.
Educating and building awareness of our technology is the secondary piece. We’re letting people know that we are working on a technology that could potentially transform the lives of patients that have back and leg pain due to a herniated disc.
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