Spectrawave Inc. has scooped up $13.2 million in a series A-2 financing led by prior investor Deerfield Management. The funds will be used to complete development and regulatory filing for its flagship cardiac imaging technology.

Prior unnamed seed investors also participated in the round. With this latest infusion, Spectrawave has raised a total of approximately $30 million to date.

“This is an exciting day for the Spectrawave team, who have made incredible progress developing a cost-effective, high-quality, easy-to-use product for interventional cardiologists,” said Eman Namati, Spectrawave’s CEO. “The continued commitment from Deerfield, in addition to the significant follow-on investments from prior investors, further validates our intravascular imaging technology and its potential to help patients globally.”

The round was fully subscribed and the funding based on milestones, the first of which was achieved, Namati told BioWorld.

Reducing future risks

“The Spectrawave technology combines two clinically proven intravascular imaging technologies and is designed to provide a complete set of actionable information to optimize stents during PCI [percutaneous coronary intervention], and to assess a patient’s risk of future coronary events” he said. “We provide both high resolution structural imaging as well as chemical content of coronary vessels and plaques, something competitors only supply a subset of.”

There are more than 965,000 percutaneous coronary interventions performed in the U.S. each year. According to Idata Research, that number is expected to exceed 1 million in 2026.

Currently, one in five coronary artery disease patients who undergo percutaneous coronary intervention experience adverse events. Of those, half are due to high-risk plaques that were left untreated.

The Bedford, Mass.-based company is on an ambitious path to finalize product development and perform verification and validation testing to support the filing of a 510(k) with the U.S. FDA. It recently moved into a new facility to expand development activities and prepare for future scale up of manufacturing. It has also built out its talent team with hires in image analysis, clinical affairs and regulatory and quality affairs, and it has created a clinical advisory board of world-renowned experts.

Namati, himself, is relatively new to Spectrawave, joining as CEO in June. He earned his postdoctoral degree at Harvard’s Wellman Center for Photomedicine, where Spectrawave’s proof-of-concept testing was performed. Later, he served as president and CEO of Ninepoint Medical Inc., which produces an optical coherence tomography imaging platform for use in gastroenterology.

“The team has more than doubled in size during 2020 and continues to add key talent to accelerate the development and future operational support,” he said.

H1 2021 filing

Clinical study plans are in the works, although this is not required for the regulatory filing of the phototonic imaging technology, Namati noted.

The company is targeting FDA clearance in the first half of 2022.

“Spectrawave’s novel multimodality imaging catheter aids physicians in targeted coronary interventions and has the opportunity to make a fundamental impact on the lives of coronary artery disease patients,” said Steve Hochberg, partner at Deerfield Management. “The complexity of mid-procedure visualization and its impact on clinical decision making requires a truly unique product and a talented team to bring it to market. Spectrawave has shown immense progress, and we’re pleased to continue our support as it rapidly moves towards its first regulatory filing.”

Spectrawave isn’t the only company looking to improve PCI. Last month, Israeli startup Cathworks Ltd. completed a $30 million series D round to expand commercialization of its FDA-cleared FFRangio system. The software derives measurements of the fractional flow reserve (FFR) and 3D images of the heart from X-rays that are routinely conducted as part of an intraprocedural angiogram during PCI to reconstruct a 3D model of the coronary anatomy, aiding physicians in coronary artery disease decision making and stent placement.