Health & Beauty

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.

More information:

www.precisionbiopsy.com

www.alliedminds.com

((Comments on this story may be sent to newsdesk@closeupmedia.com))

THE DAILY VIEW

  • Alexandra Scarborough
    Papyrus Joins Forces with Designer Lela Rose

    Papyrus is looking to bring the “elegance and style” of fashion to its greeting cards via a new designer collaboration series.

    According to a release, the collaboration marks the first time a fashion design house and greeting card brand have joined forces to develop a custom greeting card collection.

    Papyrus said it is partnering with American fashion designer Lela Rose to introduce the series. Rose will feature her "sophisticated yet modern style" in the debut card and gift collection, slated to launch during New York Fashion Week. The collection will be available in New York City Papyrus stores and select retailers in September, with availability expanding to all Papyrus locations and retailers in October.

    "The fashion designer collaboration series is a celebration of the commitment Papyrus has to the arts, including a focus on the fashion industry, quality craftsmanship and trend-forward design," said Christy Kaprosy, President of Papyrus-Recycled Greetings. "We are delighted to have Lela Rose's elegant line lead the first Papyrus fashion designer collaboration program, and we are excited to bring more fashion designers to our loyal customers in the future."

    The company noted the collection, which draws inspiration from some of Rose's recent runway designs, consists of 16 cards and five gift accessories, including gift bags, gift tissue, roll wrap and a gift tag set. It also will be available online at papyrusonline.com

    "I'm thrilled to be the first designer to collaborate with Papyrus on their exclusive new fashion series," said Lela Rose. "This is a unique way to showcase our designs, silhouettes and prints, and extend the brand into a new category."

 

QUICK 5

Ebola Philanthropy

Ebola Philanthropy

  1. Big Gift: Bill Gates, founder and co-chair of the Bill & Melinda Gates Foundation, has committed $50 million to fight the epidemic.
  2. Early Donation: In August, Paul G. Allen Family Foundation donated $2.8 million toward the outbreak in West Africa.
  3. Latest Pledge: Facebook founder Mark Zuckerberg and his wife Priscilla Chan this month pledged $25 million to the CDC.
  4. Corporate Funds: World Bank Group in August pledged up to US $200 million in emergency funding to help Guinea, Liberia, and Sierra Leone contain the spread of infections.
  5. Crowdfunding: Scripps Research Institute's Erica Ollman Saphire seeks to raise $100K for equipment to speed her work, partially funding by U.S. government.