CeloNova BioSciences Receives Expanded Indication for Benign Prostatic Hyperplasia (BPH)

CeloNova BioSciences, Inc., today announced that it has received an expanded indication (CE Mark) in Europe for its EMBOZENE^TM embolic microspheres to include the treatment of benign prostatic hyperplasia (BPH).

Prostatic artery embolization (PAE), offers a minimally invasive procedure when compared to the current surgical standard of care, transurethral resection of the prostate (TURP), that gives men suffering from BPH an important treatment alternative.

BPH is an enlargement of the prostate. When enlarged, the prostate gland presses against the urethra and interferes with the passage of urine out of the body. Symptoms can include frequent urination, weak urine stream and a persistent feeling of having to urinate. BPH is a common condition in men, which increases with age. Symptomatic BPH typically occurs in the sixth and seventh decades of a man’s life, reaching an estimated 40% of men in their 70s¹.

“The symptoms of benign prostatic hyperplasia can cause significant impact in a patient’s quality of life and prostatic artery embolization offers a safe and effective treatment option for men²,” said Prof. Dr. Ulf Teichgraeber, Director of Radiology at University Hospital, Jena, Germany.

“The expanded indication in Europe for benign prostatic hyperplasia provides continuing support to interventional radiologists and urologists working in tandem to offer men relief from the symptoms of BPH,” said Jörg Menten, President International of CeloNova BioSciences.

“Embozene microspheres go through a sophisticated manufacturing process that ensures precisely calibrated size and shape,” said Jane Ren, Ph.D., Chief Technology Officer of CeloNova BioSciences. “The Embozene microspheres are uniquely designed to give the interventional radiologist the highest level of confidence in performing the procedure.”

CeloNova BioSciences Embozene microspheres first received a CE mark in November 2005 and have been successfully used in thousands of procedures and are currently available in more than 45 countries.

About the Company

CeloNova BioSciences, Inc., headquartered in San Antonio, Texas, is a global medical device company that develops, manufactures and markets a family of Interventional Cardiology and Endovascular products. Our products are developed and manufactured in Carlsbad, California, U.S.A. and Ulm, Germany. The Company’s regional offices are located in Germany, France, United Kingdom, Netherlands and Austria. For additional information about CeloNova BioSciences, see the company website at www.celonova.com

Forward-looking statements contained in this press release are based on estimates and assumptions of CeloNova management and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made. We do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied based on a number of factors, including but not limited to, unexpected clinical trial timing and outcomes, results of expanded clinical experience and unanticipated impacts of regulatory decisions

References:

1. Emberton M, Andriole GL, de la Rosette J, et al. Benign prostatic hyperplasia: a progressive disease of aging men. Urology. Feb 2003;61(2):267-273.
2. 2. Early results from a United States trial of prostatic artery embolization in the treatment of benign prostatic hyperplasia.
   Bagla S ¹, Martin CP ², van Breda A ¹, Sheridan MJ ³, Sterling KM ⁴, Papadouris D ¹, Rholl KS ¹, Smirniotopoulos JB ⁵, van Breda A ¹
   J Vasc Interv Radiol. 2014 Jan;25(1):47-52. doi: 10.1016/j.jvir.2013.09.010. Epub 2013 Oct 28.

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Contact information

CeloNova BioSciences, Inc.
Jim Dublin, 210-227-0221
jdublin@dublinandassociates.com