Alesi Surgical wins FDA clearance for smoke management device and lands new funding

Alesi Surgical has received FDA 510(k) clearance of its Ultravision2 IonPencil for cutting and coagulating soft tissue in open surgery while managing surgical smoke.

The latest clearance builds on the company’s Ultravision2 system, cleared in 2023 for the removal of smoke and particulate matter generated by electrosurgical equipment during laproscopic operations.

Cardiff, U.K.–based Alesi Surgical says its Ultravision2 system is now cleared for all open, laparoscopic, and robotic procedures that create surgical smoke.

“We have been overwhelmed with the positive surgeon feedback we have received during the development of the IonPencil,” Alesi CEO Dominic Griffiths said in a statement shared with MassDevice. “The hazards of surgical smoke in the operating room are increasingly recognized, and we are delighted to be able to offer U.S. surgeons and nurses this new, unique, and innovative way of addressing the problem.”

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The company also announced that a new funding round brought in £5 million (about $6 million), led by Mercia Ventures as a new investor. That latest round also included existing investors IP Group in the U.K. and Milan-based Panakès Partners, and brings the company’s total funding above £21 million (above roughly $26 million), Griffiths told MassDevice.

“We are thrilled to welcome Mercia Ventures as an investor in Alesi Surgical,” Griffiths said. “Alongside our other supportive investor base, we are eager to put the capital to work and fuel our future growth.”

Mercia Ventures Investor Director Robert Hornby said he expects new regulations in the years ahead to drive the adoption of smoke management devices.

“Alesi’s technology offers many advantages over current systems,” he said in a statement.  The company has already established a name for itself with its laparoscopy systems, but the introduction of the IonPencil will open up a much wider market. We look forward to supporting Dominic and the team in this new chapter in the company’s growth.”

Alesi said it will use the new funding to support the commercialization of the IonPencil, Ultravision2 system and its other accessories in the U.S., and to secure MDR clearance for the system in Europe and PMDA clearance in Japan.

Alesi Surgical Ltd. spun out from Cardiff University in 2009 and now has a subsidiary, Alesi Surgical Technologies Inc., overseeing its U.S. operations. The company’s board of directors includes Todd Usen, the chair of the Massachusetts Medical Device Industry Council (MassMEDIC) and former president and CEO of Minerva Surgical.

Read more about Alesi Surgical’s technology and the industry trends behind it at Medical Design & Outsourcing.