Precision Biopsy Expands Clinical Trial of ClariCore™ Biopsy System

AURORA, Colo.–(BUSINESS WIRE)–Precision Biopsy announced 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.
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.
Equipped with an optical fiber and companion console, Precision Biopsy’s
ClariCore system performs spectral analysis of prostate tissue during a
prostate biopsy, providing in-vivo tissue classification that
seeks to minimize the number of normal core samples taken by up to 90
percent, while offering actionable diagnostic information at the time of
the biopsy.
“The ability to expand the trial is an important milestone in the
development of the ClariCore system and we are excited by the progress
achieved by the Precision Biopsy team,” said Omar Amirana, MD, Precision
Biopsy Board member and Senior Vice President at its parent company,
Boston-based Allied Minds.
More than 2 million men worldwide undergo TRUS-guided prostate biopsies
each year due to risk factors that include elevated PSA levels, physical
exam abnormalities and family history. Of the 12 million biopsy core
samples that are analyzed, less than 10 percent are shown to be positive
for cancer — at a cost of nearly $1 billion dollars in the U.S. alone.
These TRUS-guided prostate biopsies also miss as much as 30 percent of
cancers that require therapy. Reducing that error rate could have
measurable impact: In the U.S., about 28,000 men die each year from
prostate cancer, according to the American
Cancer Society.
More information about Precision Biopsy can be found at www.precisionbiopsy.com.
The company is a subsidiary of Boston-based Allied Minds (LSE: ALM).
About Precision Biopsy
Precision
Biopsy, Inc., a subsidiary of Allied Minds (LSE: ALM), aims to develop
and commercialize a novel technology for the accurate real-time
classification of tissue initially focused on prostate biopsies — a
procedure that is performed in an estimated 1.75 million patients each
year in the U.S. and Europe. It is also developing a Focal Therapy
system, which incorporates the ClariCore technology. The company’s
diagnostic technology, licensed from the University of Colorado, uses
advanced spectroscopy imaging techniques in combination with tissue
biopsy. After developing a first-generation system in 2011, Precision
Biopsy evaluated human subjects in 2012. The success of that first human
study led Precision Biopsy to focus on developing its next-generation
product, the ClariCore Optical Biopsy System™, as it prepares for global
commercialization. More information about Precision Biopsy can be found
at: www.precisionbiopsy.com.
About Allied Minds
Allied Minds is a diversified holding
company focused on venture creation within the life science and
technology sectors. With unparalleled access to hundreds of university
and federal labs across the U.S., Allied Minds forms, funds, and
operates a portfolio of companies to generate long-term value for its
investors and stakeholders. Based in Boston, with nationwide presence in
Los Angeles and New York, Allied Minds supports its businesses with
capital, central management, and shared services. For more information,
please visit www.alliedminds.com.
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