Merit Medical Sponsors Educational Forum on New Multidisciplinary Treatment for Benign Prostatic Hyperplasia

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Worldwide, 50 percent of men over the age of 50 have benign prostatic hyperplasia (BPH), a prostate condition that for many causes acute urinary retention. This week at CIRSE, a worldwide conference for interventional radiologists, Francisco Cesar Carnevale, MD, PhD, presented the first video case procedures demonstrating a non-surgical option for the management of benign prostatic hyperplasia (BPH) using a new minimally invasive technique called prostatic arterial embolization (PAE).

The Brazilian Interventional Radiologist Francisco Cesar Carnevale, MD, PhD recognized for pioneering the new therapy using Prostatic Arterial Embolization (PAE)

Unlike TURP, which removes a section of the prostate through the urethra, in PAE the prostatic arteries supplying the [prostate] blood flow are accessed through a percutaneous puncture in the upper thigh ... and occluded.

An emerging men’s health therapy for benign prostatic hyperplasia (BPH) was reported at the CIRSE scientific symposium (http://www.cirse.org) on September 11 in Munich, Germany. The Brazilian Interventional Radiologist Francisco Cesar Carnevale, MD, PhD, recognized for pioneering the new therapy using Prostatic Arterial Embolization (PAE), reported promising results from the initial BPH PAE clinical study. He also presented the first video case studies of this new PAE technique to interventional radiologists attending the annual CIRSE conference. Merit Medical Systems, Inc. (NASDAQ: MMSI) was the education sponsor of the CIRSE Emerging Therapies Symposium.

Marc Sapoval, MD, PhD, an Interventional Radiologist from Paris, France, moderated the symposium commenting, “BPH is the progressive enlargement of the prostate gland, and when advanced, causes acute urinary retention. Prostatic Arterial Embolization is of great interest to interventional radiologists and urologists. Studies to date are demonstrating great promise as an alternate treatment option.”

“In this patient population, mainly middle-aged men ages 50 years and older, we have more and more significant co-morbidities that can potentially enhance the interest of minimally invasive treatments compared to surgery,” added Sapoval.

The aim of the ongoing BPH PAE clinical study by Carnevale and his urology colleague Alberto Antunes, MD, is to develop an outpatient minimally invasive therapy that reduces the prostate size so urinary function resumes and avoids the complications that come from long-term medical therapy or surgery.

“Merit Medical has a history of supporting innovative medicine,” said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. “Our embolic product Embosphere® Microspheres and the Embocath® microcatheter are well-suited for emerging therapies. Dr. Carnevale and his colleagues at the University of Sao Paulo are making great strides to better understand prostate disease and we applaud their interventional radiology and urology multidisciplinary approach to managing this major men’s health issue.”    

“An estimated 25 percent of benign prostatic hyperplasia patients fail or experience clinical complications from medical treatment,” said Carnevale. “Currently, approximately 500,000 men undergo surgery every year in the U.S. for BPH.”

Carnevale reported at CIRSE that ten of 11 patients demonstrated an average 30 percent reduction in prostate volume following the PAE procedure. Symptom relief and catheter removal were achieved in 10 patients with a mean time of 12 days. After a three-year follow-up in two patients and a minimum 10-month follow-up in all patients, 91 percent clinical success was achieved based on 12 PAE procedures. Overall, the quality of life factors significantly improved for ten of the 11 patients. Of the 11, one patient had a mean prostate reduction of 5% and after two bilateral embolizations was referred for transurethral resection of the prostate (TURP). “The surgeon indicated this patient experienced a much smaller blood loss compared to other TURP procedures,” added Carnevale.

The PAE technique was developed at the University of Sao Paulo Medical School through the Interventional Radiology Unit and in cooperation with the Urology Department as a potential outpatient procedure. Unlike TURP, which removes a section of the prostate through the urethra, in PAE the prostatic arteries supplying the blood flow to the prostate are accessed through a percutaneous puncture in the upper thigh. Embosphere® Microspheres 300-500 µm (Merit Medical) are used in this study to occlude the blood supply to the prostate. This microsphere has been successfully used for over a decade to treat women with uterine fibroids. Microcatheters Embocath Plus (Merit Medical) and Progreat (Terumo) were used to navigate the prostate arteries in this initial PAE study.

The recently posted medical monograph on BPH management as well as SIR and AUA annual meeting conference coverage reports on this issue are available at http://urotoday.com. These reports provide additional data from the BPH PAE clinical study by Drs. Carnevale and Antunes.

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All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit’s forecasted revenues, net income and other financial results, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit's Annual Report on Form 10-K for the year ended December 31, 2010. Such risks and uncertainties include risks relating to product recalls and product liability claims; potential restrictions on Merit’s liquidity or its ability to operate its business by its current debt agreements; possible infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; the potential of fines, penalties, or other adverse consequences if Merit’s employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws and regulations; expenditures relating to research, development, testing and regulatory approval or clearance of Merit’s products and the risk that such products may not be developed successfully or approved for commercial use; greater governmental scrutiny and regulation of the medical device industry; reforms to the 510(k) process administered by the U.S. Food and Drug Administration; laws targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in, or failure to comply with, governing regulations; increases in the price of commodity components; negative changes in economic and industry conditions in the United States and other countries; termination or interruption of relationships with Merit’s suppliers, or failure of such suppliers to perform; Merit's potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through recent, proposed or future acquisitions, including the Biosphere acquisition; fluctuations in Euro and GBP exchange rates; Merit’s need to generate sufficient cash flow to fund its debt obligations, capital expenditures, and ongoing operations; concentration of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit’s existing products obsolete; market acceptance of new products; volatility in the market price of Merit's common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in health care markets related to health care reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; uncertainties associated with potential healthcare policy changes which may have a material adverse effect on Merit; introduction of products in a timely fashion; price and product competition; availability of labor and materials; cost increases; fluctuations in and obsolescence of inventory; and other factors referred to in Merit's Annual Report on Form 10-K for the year ended December 31, 2010 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.About this releaseEmbosphere(R) MicrospheresEmbosphere® Microspheres 300-500 µm (Merit Medical) are used in this study to occlude the blood supply to the prostate.Embosphere Microspheres is the most clinically studied round embolic, providing consistent and predictable results for effective embolization, specifically UFE. This microsphere has been successfully used for over a decade to treat women with uterine fibroids.Fred P. LampropoulosFred P. LampropoulosChairman and Chief Executive Officer, Merit MedicalMarc Sapoval, MDMarc Sapoval, MDAn Interventional Radiologist from Paris, France moderated the symposium.