FDA clearance triggers $1.15M payment for Conavi Medical
Conavi Medical Corp. received a $1.25 million payment from the Province of Ontario, Canada, for securing U.S. Food and Drug Administration (FDA) 510(k) clearance for its Novasight Hybrid System. It is the first system to co-register and co-align intravascular ultrasound (IVUS) and optical coherence tomography (OCT) intravascular imaging for coronary arteries.
The money from the Life Sciences Scale-Up Fund (LSSUF) provides financial support to help small-to-medium sized companies scale up in the competitive life sciences market. LSSUF aims to help build a pipeline of strong innovative companies based in Ontario so they are ready to respond to market opportunities. The goal of the LSSUF program is to build Canadian domestic manufacturing capacity in the healthcare sector and enable a faster commercialization of new products.
Conavi said the funding will help the company commercialize the hybrid imaging system as it expands its U.S. presence. The company has now received a total of $1.75 million under the program to date and is eligible to receive more funding based on achieving additional milestones.
The Novasight Hybrid System uses single-use a combined IVUS-OCT catheter on a single console. The two modalities complement each other with deeper vessle tissue penetration with IVUS, and high resolution imaging from the OCT to see more detail. It offers pullback speeds up to 25mm/s (100 fps), allowing for faster IVUS image acquisition.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]