Key Takeaways
- MedVasc was founded in 2013 by interventional radiologist Michael Åkesson after observing painful tumescent anaesthesia during endothermal varicose‑vein ablation.
- The Solutio catheter delivers anaesthetic from inside the vein, exploiting the lack of pain receptors in the vascular wall to reduce patient discomfort.
- After early animal work and a small human feasibility study (2019), progress stalled during the COVID‑19 pandemic; funding resumed and a second‑generation prototype was built.
- A recent 24 million SEK financing round enables MedVasc to pursue FDA 510(k) clearance, with a clinical trial of 30 patients planned for mid‑April 2026.
- The company aims to submit the technical file to the FDA in summer 2026 and expects clearance by Q4 2026.
- European MDR pathways have become more comparable to the US process post‑2021, allowing MedVasc to leverage its clinical data for both markets.
- The multidisciplinary team at the Scandinavian Venous Centre includes interventional radiologists, vascular and general surgeons, with leadership shifting to a Gothenburg‑based vascular surgeon as the new principal investigator.
- The overarching goal is to simplify varicose‑vein treatment for patients and physicians by making tumescent anaesthesia virtually painless and the procedure faster.
Background and Founding
MedVasc originated in 2013 when Michael Åkesson, an interventional radiologist at the Scandinavian Venous Centre in Malmö, noticed that patients consistently reported high levels of pain during the tumescent anaesthesia step of endothermal varicose‑vein ablation. Recognising that the interior of blood vessels lacks nociceptors, he hypothesised that delivering the anaesthetic from within the vein could eliminate discomfort. This insight stemmed from his work on subintimal recanalisation at Malmö’s University Hospital SUS, where arterial perforations were painless. Åkesson consulted former collaborators on device development, and the idea matured into a company focused on improving patient comfort and procedural ease.
Early Development and Pre‑clinical Work
The initial concept evolved into a prototype catheter designed to infuse tumescent solution directly into the target vein. Early animal studies demonstrated that the technique achieved adequate anaesthetic distribution without triggering pain responses, giving the team confidence to move toward human testing. By 2019, MedVasc had completed a small safety and feasibility study at its own clinic in Malmö. Participants reported minimal pain during anaesthetic placement, confirming the core premise. However, the study also revealed practical challenges, chiefly the need for a catheter compatible with various endothermal modalities (laser, radiofrequency, and steam).
Impact of the COVID‑19 Pandemic
Just as the team was preparing to refine the device and plan larger trials, the COVID‑19 pandemic erupted in early 2020. Clinical activities were halted, fundraising dried up, and development work stalled for approximately three years. The pause forced MedVasc to conserve cash and revisit its financial strategy. When the pandemic’s acute phase eased, the company re‑engaged investors, secured new capital, and brought on Cathrin Johansson as chief executive officer to drive the financing and commercialisation efforts.
Post‑Pandemic Progress and Second‑Generation Prototype
With renewed funding, MedVasc revisited the original design, incorporating lessons from the feasibility study and addressing catheter versatility. The result was a second‑generation prototype that retains the intra‑venous delivery principle but features improved ergonomics, better compatibility with multiple ablation platforms, and enhanced manufacturability. The team conducted additional animal work to verify that the updated device maintained safety and efficacy profiles, setting the stage for a more robust human trial.
Current Financing and FDA Clearance Plans
In late 2025, MedVasc closed a financing round of 24 million Swedish Krona (approximately US $2.2 million), providing the resources needed to advance toward regulatory submission. The company intends to pursue a 510(k) pathway with the US Food and Drug Administration, leveraging bench‑test data, pre‑clinical findings, and forthcoming clinical results. A pre‑submission dialogue with the FDA has already clarified the required documentation, and the team is preparing to launch a pivotal clinical study involving 30 patients in mid‑April 2026. Assuming positive outcomes, MedVasc aims to compile the technical file and submit it to the FDA during the summer of 2026, targeting clearance by the fourth quarter of that year.
European Regulatory Landscape
Historically, obtaining CE marking in Europe was quicker and less burdensome than navigating the FDA process. However, the 2021 transition to the Medical Device Regulation (MDR) tightened European requirements, narrowing the gap between the two jurisdictions. MedVasc notes that, under MDR, a well‑documented clinical study similar to the one planned for the FDA could support a CE mark application within roughly six months—far shorter than the multi‑year timelines previously common. Consequently, the data generated for the US submission will also satisfy many MDR obligations, facilitating parallel market entry.
Study Team and Collaborative Structure
The ongoing clinical investigation is being conducted at the Scandinavian Venous Centre in Malmö, drawing on a multidisciplinary group of specialists. Michael Åkesson, an interventional radiologist, remains involved as a co‑investigator, while the principal investigator role has shifted to a vascular surgeon based in Gothenburg who will travel to Malmö for the study. Additional team members include vascular surgeons, general surgeons, and interventional radiologists, ensuring diverse expertise in procedural technique, patient safety, and data collection. This collaborative structure aims to generate robust, generalisable evidence across practitioner types.
Vision and Potential Impact
Åkesson articulates the overarching ambition: to render varicose‑vein treatment as simple and painless as possible for both patients and clinicians. By eliminating the most uncomfortable component—tumescent anaesthesia—the Solutio catheter could shorten procedure times, reduce the need for analgesic adjuncts, and improve overall patient satisfaction. Physicians may benefit from a more streamlined workflow, potentially increasing case throughput and decreasing operator fatigue. If successful, the technology could become a new standard of care, representing a meaningful advancement in minimally invasive venous therapy.