HOUSTON, Sept. 8, 2020 /PRNewswire/ -- Nanospectra Biosciences, Inc., a medical device company pioneering a novel use of nanomedicine for selective thermal ablation, today announced that it has closed on an initial $3 million in a Series B-1 financing with total approved capital of up to $6 million in the raise. The equity round was led by Sirtex Medical as a strategic investor with additional participation from existing and new investors. Sirtex is a leading U.S. based provider of targeted liver cancer therapies via their proprietary SIR-Spheres® Y-90 microspheres with global operations. Kevin P. Smith, Sirtex's General Counsel and Executive Vice President, Business Development, will join the Nanospectra Board of Directors.
AuroLase®, Nanospectra's lead product, is the first and only ultra-focal ablation therapy designed to maximize treatment efficacy while minimizing side effects typically associated with surgery, radiation and alternative focal therapies. Proceeds from the financing will be used to further develop AuroLase, including full completion of the ongoing pivotal study for prostate cancer tissue ablation, filing of a 510(k) with the U.S. Food and Drug Administration (FDA) for marketing clearance, and preparing for commercialization. In addition, Sirtex and Nanospectra have agreed to exclusively negotiate for a defined period of time for access to AuroLase in certain geographies outside of the U.S.
"We are thrilled to welcome Sirtex Medical as a strategic investor due to their shared commitment and understanding of the clinical and patient benefits of minimally-invasive oncology therapies," said David Jorden, CEO of Nanospectra. "With established global operational capabilities and distribution, they are well positioned to advise on our commercialization efforts in both the U.S. and other geographies. We look forward to Sirtex's active engagement as we proceed with our clinical programs."
The AuroLase pivotal study for the focal ablation of prostate tissue via nanoparticle directed near infrared irradiation is approved by the FDA under the original Investigational Device Exemption (IDE) and follows the successful first-in-human pilot study that enrolled 46 subjects at three U.S. sites. The ongoing pivotal study will enroll up to 60 patients at up to eight clinical trial sites throughout the U.S. and the combined dataset from both studies will constitute the clinical package Nanospectra will submit to the FDA.
"Nanospectra's AuroLase is a perfect complement to our technology approach and corporate strategic focus on minimally-invasive therapies," said Kevin R. Smith, CEO of Sirtex Medical. "We look forward to collaborating with Nanospectra to explore and develop innovative therapies to meet unmet medical needs in patients with various cancer conditions."
About Nanospectra Biosciences Nanospectra Biosciences is a privately-held medical device company, pioneering the patient-centric use of nanomedicine for selective thermal ablation. AuroLase®, the company's lead product, is the first ultra-focal therapy for prostate cancer. Nanospectra's ultra-focal approach maximizes treatment efficacy while minimizing side effects associated with current treatments, including surgery, radiation, and alternative focal therapies. Implementing a multi-prong growth strategy, Nanospectra is focusing on clinical advancements, exclusive partnering agreements and ongoing research and development. Nanospectra's technology development has been funded to date by a series of grants, private equity investments and corporate partnerships.
About Sirtex Sirtex is a global healthcare business with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Sirtex's current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres®Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 45 countries. For more information, visit www.sirtex.com.
SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd.