With the help of a small California startup, Cardiovascular Systems has laid out plans to build a full portfolio of minimally invasive medical hardware designed to remove blood clots.
The devicemaker has tapped Innova Vascular to assist in the development of both mechanical and aspiration-powered systems, aimed at treating peripheral vascular disease, deep vein thrombosis and pulmonary embolisms.
Cardiovascular Systems envisions the products as a potential complement to its core offerings focused on removing calcified plaque from the insides of arteries feeding the heart and the legs, such as its Diamondback 360 orbital atherectomy system, which uses a rotating, diamond-coated bit to grind down obstructions and clear the way for the placement of a stent.
The company has agreed to provide Innova with an undisclosed amount of funding for the devices’ development in return for an exclusive acquisition option that could be triggered following the completion of certain clinical and regulatory milestones.
Pending regulatory clearances, Cardiovascular Systems aims to begin commercializing blood clot retrieval devices, starting in peripheral vascular disease, within its 2023 fiscal year. After that, it plans to expand into DVT and pulmonary embolism following additional clinical trials.
The company also has its own lines of guidewires and balloon catheters—including the Scoreflex NC scoring balloon, developed in collaboration with OrbusNeich, which was approved by the FDA last month for coronary angioplasty procedures.
“In total, developing novel drug-coated balloons, intravascular lithotripsy, mechanical circulatory support and thrombectomy devices target some of the fastest-growing segments within interventional cardiology,” with a total addressable market expected to reach over $18 billion in the coming years, Cardiovascular Systems President and CEO Scott Ward said in a statement.
Late last year, Cardiovascular Systems recalled its Wirion embolic protection system including a small filter inserted into an artery to catch any floating debris knocked loose during an atherectomy procedure. The recall came after reports that the filter could tear or separate from its catheter within the blood vessel.
The company recalled all of the devices produced and distributed from January to November 2021, which was less than a year after it made its commercial debut. Last month, the FDA gave the recall a Class I rating, its most serious label; no deaths had been linked to the device at the time.
Recalling the nearly 700 devices cost about $2.8 million, according to Cardiovascular Systems’ latest quarterly earnings report. For the second quarter of its 2022 fiscal year, which ended December 31, the company reported revenues of $59.1 million, a drop of 7.8% from 2021’s $54.1 million. After expenses, it posted a second-quarter net loss of $9 million.
“Our second-quarter revenues reflect another period where our domestic business was pressured primarily by lower procedure volumes related to hospital capacity issues and staffing shortages caused by COVID-19,” Ward said.
“Our recovery from the delta variant was suppressed by the arrival of omicron in December,” he added. “Consistent with past surges, the impact was more acute in the peripheral claudication segment of our business, which is deemed more deferrable and is more susceptible to the long-term havoc created by COVID.”
After the latest pandemic wave recedes and hospital backlogs begin to clear, Cardiovascular Systems estimates sales of between $235 million and $245 million for the remainder of its fiscal calendar, through the end of June, with a net loss in the range of 15% to 18% of revenues.
Meanwhile, the company has recently launched coronary atherectomy products in six new countries and aims to be commercial in over 30 countries by the end of the fiscal year.