Blue Earth Diagnostics Announces AxuminTM (Fluciclovine F 18) Presentations at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting

BURLINGTON, Mass. & OXFORD, United Kingdom–(BUSINESS WIRE)–Blue Earth Diagnostics, a molecular imaging diagnostics company, today
announced the presentation of results from Axumin (fluciclovine F 18)
injection studies in biochemically recurrent prostate cancer at the
Society of Nuclear Medicine and Molecular Imaging Annual Meeting
(SNMMI), from June 11-15, 2016 in San Diego, Ca. The Company will also
participate in a panel presentation on new imaging agents. Details of
Axumin presentations by Blue Earth Diagnostics and its collaborators are
listed below.

Blue Earth Diagnostics invites participants at this year’s SNMMI Annual
Meeting to visit the Company at Exhibit Booth 337.
About Axumin^TM (fluciclovine F 18)
Axumin (fluciclovine F 18) injection is a novel product indicated for
use in positron emission tomography (PET) imaging to identify suspected
sites of prostate cancer recurrence in men. Recurrence of prostate
cancer is suspected by an increase in prostate specific antigen (PSA)
levels following initial therapy. PET imaging with Axumin may identify
the location and extent of such recurrence. Axumin was developed to
enable visualization of the increased amino acid transport that occurs
in many cancers, including prostate cancer. It consists of a synthetic
amino acid that is preferentially taken up by prostate cancer cells
compared with surrounding normal tissues, and is labeled with the
radioisotope F18 for PET imaging. Axumin was approved by the U.S. Food
and Drug Administration on May 27, 2016 following Priority Review, and
is the first product commercialized by Blue Earth Diagnostics, which
licensed the product from GE Healthcare. The molecule is being
investigated by Blue Earth Diagnostics for other potential cancer
indications, such as glioma.
Indication and Important Safety Information
About Axumin
INDICATION
Axumin™ (fluciclovine F 18) injection is indicated for positron emission
tomography (PET) imaging in men with suspected prostate cancer
recurrence based on elevated blood prostate specific antigen (PSA)
levels following prior treatment.
IMPORTANT SAFETY INFORMATION

• Image interpretation errors can occur with Axumin PET imaging. A
  negative image does not rule out recurrent prostate cancer and a
  positive image does not confirm its presence. The performance of
  Axumin seems to be affected by PSA levels. Axumin uptake may occur
  with other cancers and benign prostatic hypertrophy in primary
  prostate cancer. Clinical correlation, which may include
  histopathological evaluation, is recommended.
• Hypersensitivity reactions, including anaphylaxis, may occur in
  patients who receive Axumin. Emergency resuscitation equipment and
  personnel should be immediately available.
• Axumin use contributes to a patient’s overall long-term cumulative
  radiation exposure, which is associated with an increased risk of
  cancer. Safe handling practices should be used to minimize radiation
  exposure to the patient and health care providers.
• Adverse reactions were reported in ≤ 1% of subjects during clinical
  studies with Axumin. The most common adverse reactions were injection
  site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1
(1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full Axumin prescribing information is available at www.axumin.com.
About Blue Earth Diagnostics
Blue Earth Diagnostics is a molecular imaging diagnostics company
focused on the development and commercialization of novel PET imaging
agents to inform clinical management and guide care for cancer patients
in areas of unmet medical need. Formed in 2014, Blue Earth Diagnostics
is led by recognized experts in the clinical development and
commercialization of innovative nuclear medicine products. The Company’s
first approved and commercially available product is Axumin^TM (fluciclovine
F 18), a novel molecular imaging agent for use in PET imaging to detect
and localize prostate cancer in men experiencing suspected biochemical
recurrence. Blue Earth Diagnostics Inc. of Burlington, Mass., is the
wholly-owned U.S. subsidiary of U.K.-based Blue Earth Diagnostics Ltd.
The Company is funded by Syncona LLP, an independent subsidiary of the
Wellcome Trust. For more information, visit www.blueearthdx.com.