InvestmentPitch Media Video Discusses Voyageur Pharmaceuticals and Beneficial Ruling by the D.C. Circuit Court of Appeals Qualifying Voyageurs Products as Devices not Drugs - Video Available on Investmentpitch.com
Vancouver, British Columbia--(Newsfile Corp. - April 21, 2021) - Voyageur Pharmaceuticals (TSXV: VM) (OTC Pink: VYYRF) announced that the D.C. Circuit Court of Appeals has upheld a prior ruling that concluded radiographic contrast agent barium sulfate qualifies as a device rather than a drug.
This ruling has a significant impact on Voyageur's planned product roll out into the United States with management estimating significant cost savings and reduced timelines to bring Voyageur's products to the US markets.
For more information, please view the InvestmentPitch Media "video" which provides additional information about this news and the company, including video comments by Brent Willis, President and CEO of Voyageur Pharma. If this link is not enabled, please visit www.InvestmentPitch.com and enter "Voyageur" in the search box.
As a result of this ruling, the timelines to finalize and gain approval of each device varies depending on the device but are expected to be significantly shorter than a drug registration, with the filing fees estimated to be reduced from US$196,868 to US$12,432 per product certification. Until the FDA formulates the rules and regulations for filing and approvals of barium as a device, Voyageur will be working closely with the FDA Center for Devices and Radiological Health (CDRH) to secure approval of Voyageur's barium contrast media product line under a medical device pathway.
For those of you new to the company, contrast materials, which may be taken orally or rectally, are used to improve pictures of the inside of the body helping to distinguish or "contrast" selected areas of the body from surrounding tissue allowing the radiologist to distinguish normal from abnormal conditions. The company recently received Health Canada approval for three of its drugs, with two more in the offing. These approved drugs are used for procedures such as MRIs, CT Scans and X-rays.
Voyageur has engaged a world class group of consultants through Dash Consulting LLC, a consortium of barium and iodine radiographic contrast media experts, to further accelerate the product roll out of its barium radiographic contrast products. Dash has expertise in barium contrast manufacturing, marketing of contrast media and related devices and accessories used during fluoroscopy, CT imaging and endoscopy procedures. Voyageur, by working with Dash, has commenced work on preparing for product applications in markets globally, including the US, United Kingdom, South America and South East Asia.
Voyageur is unique, as it is sourcing its own main ingredients from its own mineral deposits. The company owns a 100% interest in three barium sulfate projects in British Columbia including two properties suitable in grade for the industrial barite marketplace, as well as significant interests in a high-grade iodine, lithium & bromine brine project located in Utah, USA.
For more information, please visit www.VoyageurPharmaceuticals.ca, contact Brent Willis, President and CEO, by email at email@example.com, or Ron Love, CFO, at 403-818-6086 or by email at firstname.lastname@example.org.
About InvestmentPitch Media
InvestmentPitch Media leverages the power of video, which together with its extensive distribution, positions a company's story ahead of the 1,000's of companies seeking awareness and funding from the financial community. The company specializes in producing short videos based on significant news releases, research reports and other content of interest to investors.
Barry Morgan, CFO
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/81143