Crystalline Medical Awarded $3 Million
SBIR Grant to Commercialize the Vu-PathTM Ultrasound System
BALTIMORE, MD - May 29th, 2018 - Crystalline Medical, LLC, a medical device company developing minimally-invasive, image-guidance solutions for the areas of cardiology, emergency medicine, and interventional radiology, announced today that it has been awarded a Phase IIB Small Business Innovation Research (SBIR) grant by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). The award provides up to $3 million in funding to complete the product development and clinical work required to commercialize Crystalline Medical’s first product, the Vu- PathTM Ultrasound System. This award comes as Crystalline Medical completes work on a $1.4 million Phase II award from the NHLBI.
The purpose of the NHLBI SBIR Phase IIB Bridge Award is to facilitate and accelerate the capital-intensive steps that are required to transition the product to the commercialization stage. "We are proud and fortunate to have the continued support of the NIH," said Todd Chappell, CEO of Crystalline Medical. "The Phase IIB award signifies an important milestone for the company as we advance Vu-Path to a clinical study and commercialization."
The Vu-PathTM Ultrasound System seeks to improve efficiency and patient outcomes for minimally- invasive, point-of-care procedures. Vu-Path is a miniaturized, forward-viewing ultrasound probe combined with an interventional channel for needles, guide wires, and other tools. Crystalline Medical will seek central vascular access for its first regulatory approval. Vu-Path’s clinical advantage is that it provides health care providers with continuous real-time "always-in-plane" ultrasound guidance for safer and more efficient vascular access.
The NIH award will support product development, regulatory-directed safety and efficacy studies required for FDA approval, and a multi-center clinical study. "I am delighted that Vu-Path is progressing to commercialization and look forward to seeing Vu-Path in the hands of clinicians," said Dr. Theodore Abraham. "Vu-Path addresses a significant unmet need by reducing complication rates and increasing efficiency." Dr. Abraham founded Crystalline Medical as a cardiologist at Johns Hopkins Hospital and is now the clinical chief of cardiology at the University of California at San Francisco.
About Crystalline Medical:
Crystalline Medical, LLC is a medical device company headquartered in Baltimore, MD. Our mission is to improve patient outcomes and efficiency for procedures in the areas of cardiology, emergency medicine, and interventional radiology. Our focus is on innovations that promote improvements in the quality, safety, efficiency, and cost of image-guidance at the bedside. For more information, please visit www.perceptivenavigation.com.
This press release contains "forward-looking statements" concerning the development of Crystalline Medical’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Crystalline Medical undertakes no obligation to update any forward-looking statements for any reason.
Todd Chappell, CEO email@example.com