Akura Medical secures $35M to pursue FDA clearance for thrombectomy device

Dive Brief:

  • Akura Medical has closed a $35 million series B financing that it plans to leverage to apply for FDA 510(k) clearance for its mechanical thrombectomy platform to remove blood clots.
  • Leading the funding round were The Capital Partnership and Cormorant Asset Management, with participation from the PA MedTech VC Fund, AMED Ventures, Lilly Asia Ventures, Unorthodox Ventures and Shifamed angel investors.
  • While there are multiple mechanical thrombectomy devices on the market, Akura’s platform is intended to be easier to use, with a smaller bore, for the removal of both soft and hard clots, the company said.

Dive Insight:

As many as 60,000 to 100,000 Americans die annually from deep vein thrombosis (DVT) or pulmonary embolism, according to estimates from the Centers for Disease Control and Prevention. Medtech companies eyeing growth in the thrombectomy market include Boston Scientific, Abbott, BD, AngioDynamics, Penumbra and Inari Medical.

Akura’s system is designed to treat both DVT, a blood clot in a deep vein, and pulmonary embolism, which occurs when a DVT breaks free and travels to the lungs, blocking blood supply.

“Despite the proliferation of mechanical thrombectomy devices, significant challenges remain,” Gautam Kainth, managing director of The Capital Partnership, said in a statement.

Akura believes it has a differentiated treatmentThe system has a steerable sheath that lets physicians bring the tip of the catheter to the proximal end of the clot without having to cross the clot. Integrated aspiration and maceration technology enables removal of clots with varied structural characteristics, while pressure sensors provide real-time hemodynamic data, according to the company.

“The system’s continuous monitoring of hemodynamics will allow physicians to assess physiologic changes when a substantial clot has been removed,” Kainth said.

The company’s series B round follows the closing of a $25 million financing in January 2022. Akura Medical is a privately held portfolio company of medical technology incubator Shifamed.