Precision Biopsy Expanding Clinical Trial of Its ClariCore Biopsy System in Prostate Cancer Patients
Precision Biopsy said that its application for an Investigational Device Exemption (IDE) was approved by the U.S. Food and Drug Administration (FDA), allowing the company to expand its clinical trial for the ClariCore Biopsy System by enrolling prostate cancer patients in the Transrectal Ultrasound (TRUS) and MR/Fusion arms of its study.
According to a release, ClariCore is designed to provide accurate, real-time classification of prostate tissue during biopsy procedures.
Precision Biopsy's Cohort A clinical trial aims to collect prostate tissue and associated optical signatures to help develop the ClariCore System's real-time tissue classification algorithm. About 200 patients will be included in the three arms of the trial, which is taking place across the U.S. at sites including the University of Colorado, Johns Hopkins Hospital in Baltimore and Memorial Sloan Kettering Cancer Center in New York. Additional patients for the Cohort A are expected to be enrolled at three new sites, including Carolina Urologic Research Center in Myrtle Beach, South Carolina; Associated Medical Professionals in Syracuse, New York; and The Urology Center of Colorado in Denver.
Precision Biopsy has already enrolled 33 patients in its Retropubic Radical Prostatectomy (RRP) study at Johns Hopkins Hospital, Memorial Sloan Kettering Cancer Center and the University of Colorado, more than half the number of patients required to complete this arm of the trial.
"The approval from the FDA marks an important step forward in our efforts to finalize development of the ClariCore Optical Biopsy System and help to improve the biopsy process for patients being evaluated and monitored for prostate cancer, the second-most deadly cancer in men," said Amir Tehrani, Chief Executive Officer of Precision Biopsy.
"We are looking forward to enrolling prostate biopsy patients in the Cohort A clinical trial using the ClariCore Optical Biopsy system. ClariCore is a breakthrough technology that should both benefit patient outcomes and also reduce healthcare costs," said Dr. Neal D. Shore, Director of Carolina Urologic Research Center.
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THE DAILY VIEW
Tea Forté Introduces ‘Matcha’ Collection
Convenience meets tradition in Tea Forté’s new Ceremonial Matcha Bowl Set and the Matcha Single Steeps.
The company said its spring harvested, shade grown, stone ground, organic matcha tea is best served in a centuries-old Japanese tea ceremony called chanoyu: a preparation technique known for its centering meditative qualities.
"The launch of Tea Forté's Matcha collection represents our continued commitment to wellness and cultivating all the potential mental and physical health benefits of tea," says Tea Forté CEO Michael Gebrael. "In addition to our high quality Pure Matcha, we've also blended four distinct flavored Matcha varieties. Prepackaged in pouches measured out for a single serving, our Single Steeps Matcha is ideal for the office, travel, or to keep with you for a boost anytime."
Tea Forté noted its handcrafted ceremonial tea bowl, handmade bamboo whisk and measuring ladle “encourages serene enjoyment of our premium Kosher, gluten-free and vegan matcha blends.” These include: Pure Matcha, Chocolate Matcha, Coconut Matcha, Ginger Matcha, and Chai Matcha.
According to a release, in addition to its distinctive taste, matcha is prized for its health benefits. Steeped green tea contains only the antioxidants that can be extracted in water, while with matcha, the whole leaf is consumed.
Available now in select stores and online at teaforte.com.
Expedia.com has released a year-end look at U.S. traveler behavior and trends for 2017, analyzing data to identify the most in-demand destinations, hotels, activities and more.
Among other insights, the roundup revealed:
- Labor Day was the busiest weekend for car rental
- Disney Theme Parks topped the list of things to do
- The average hotel stay was two nights
- Top destinations based on 2017 air travel included major global cities like New York, London and Bangkok
- Popular tourist destinations included Orlando, Cancun and Las Vegas