In an artery, calcium behaves like concrete poured into a pipe. It stiffens the vessel wall, resists the balloons cardiologists use to reopen blockages, and can stop a stent from ever seating properly. For decades, the tools for this problem were blunt. Spectrumedics Medical, a Singapore company founded in 2018, bet that the answer was not a sharper blade but a sound wave.
The company builds active, minimally-invasive cardiovascular devices. Its flagship is the Sonico-CX intravascular lithotripsy - or IVL - system, a balloon catheter paired with a generator console. Threaded into a calcified coronary artery and inflated at low pressure, the catheter emits pulses of acoustic pressure. Those waves pass harmlessly through soft tissue and blood but fracture the rigid calcium, both the superficial deposits and the deep ones buried in the vessel wall. Once the calcium cracks, the artery becomes pliable again, and the interventional cardiologist can restore blood flow and place a stent. A single Sonico-CX catheter can deliver up to 120 pulses across seven balloon sizes ranging from 2.5 to 4.0 millimeters.
What makes the approach quietly clever is the physics. The energy is circumferential - it radiates 360 degrees around the balloon - so it reaches calcium on every side of the vessel at once. And because the pressure waves are tuned to shatter brittle mineral rather than tear soft tissue, the procedure carries a short learning curve and a low crossing profile. For a cardiologist, that means a familiar workflow with a new capability bolted on, not a whole new discipline to master.
Who It Serves, And The Problem It Solves
Spectrumedics is a business-to-business medical device maker. Its customers are interventional cardiologists, cath labs and hospitals - the people who treat patients whose coronary or peripheral arteries have hardened with calcified plaque. That patient population is large and growing as the world ages, and calcified lesions are among the most technically difficult cases a cardiologist faces. When a lesion is too rigid, standard angioplasty can fail outright or leave a stent poorly expanded, which raises the long-term risk of the artery closing again.
The problem Spectrumedics solves is therefore not a niche one. It is a persistent bottleneck in one of medicine's most common procedures. By making calcium modification safer and more predictable, the company aims to expand who can be treated effectively - and to do it with a device that is designed to be affordable and available beyond the wealthiest markets.
How It Is Different
Intravascular lithotripsy is a small and exclusive field. After Spectrumedics received its EU CE mark under the Medical Device Regulation in January 2026, it became one of only three companies in the world with an EU-approved coronary IVL system, alongside Johnson & Johnson MedTech's Shockwave Medical and Elixir Medical. For a startup of roughly eleven people, sharing that shortlist with a company the size of J&J is the differentiator in itself.
The broader alternatives to IVL - rotational and orbital atherectomy, which grind calcium away, and specialty balloons - are more established but also more operator-dependent and, in the case of atherectomy, carry their own procedural risks. Spectrumedics' wager is that energy-based lithotripsy, delivered through a catheter that feels familiar in the hand, is the more forgiving and more scalable approach. Its regulatory clearances in Asia Pacific and Latin America, earned before Europe, suggest a deliberate strategy: prove the device in accessible markets first, then move into the most demanding ones.
The Platform Behind The Product
Sonico-CX did not appear from nowhere. The company's earlier work centered on the Sonico-PX peripheral platform, which used electrohydraulic lithotripsy emitters - components that convert electrical energy into shockwaves - to break up calcium in peripheral arteries while protecting the surrounding vessel. That platform entered peripheral trials in late 2021 and moved into coronary studies soon after. The coronary Sonico-CX is the maturation of that engineering, and Spectrumedics describes its ambition not as a single product but as a high-end active cardiac and vascular intervention platform.
That framing matters for how the company sells. Like most of interventional cardiology, the model is razor-and-blades: hospitals buy the generator once as capital equipment, then purchase single-use catheters for every procedure. It is a structure that rewards clinical adoption with recurring revenue, and it is why regulatory approvals - each one a gate to a new market - are the currency Spectrumedics trades in.