Healthcare Industry News:  Y-90 resin 

Devices Oncology Interventional

 News Release - August 13, 2015

Sirtex Medical Inc. Announces 21.2 Percent Dose Sales Growth of SIR-Spheres(R) Y-90 resin microspheres in Fourth Quarter

Increase of 18 Percent in Hospitals Certified to Administer Procedure

WOBURN, Mass.--(Healthcare Sales & Marketing Network)--Sirtex Medical Inc., a subsidiary of Sirtex Medical Limited (SRX.AX), a leading manufacturer of targeted, liver cancer therapies, today announced dose sales of SIR-Spheres® Y-90 resin microspheres grew 21.2 percent, in the America’s region for the fiscal year ending June 30, 2015, compared to the previous corresponding period. Revenue also climbed, up 28.5 percent to $113.4M, with over 7,075 doses being supplied across the region. SIR-spheres Y-90 resin microspheres are available at more than 490 hospitals in the region, up 18 percent from the previous fiscal year.

“The Americas region had another strong year, and this excellent performance has again led to outstanding sales results,” said Mike Mangano, president of Sirtex Medical, Inc. “This solid growth in dose sales and revenue is a direct reflection of the team and strategies that we have put in place to expand our regional presence and differentiate ourselves in the oncology and interventional radiology disciplines.”

Mr. Gilman Wong, CEO of Sirtex Medical commented, “The strong financial performance of Sirtex in 2015 was driven by an acceleration in global demand for our SIR-Spheres Y-90 resin microspheres targeted radiotherapy treatment for inoperable liver cancer, with all regions delivering double-digit growth in dose sales.”

Sirtex’s Level 1 clinical data generated by the SIRFLOX study, which was presented to the world’s leading oncologists at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in late May, has created an increased awareness in the oncology community.

“We are now focused on helping to educate as many professionals in the oncology community to support improved clinical outcomes for patients facing this disease as well as extending relevant information to the patient community,” continued Mangano. “It is clear the Level 1 clinical data generated by the SIRFLOX study will help facilitate an increase in the use of SIR-Spheres microspheres at an earlier stage of patient treatment.”

The Americas remains the key driver for dose sales and revenue growth and currently represent 69.0 percent of the company’s global mix by volume and 77.6 percent by revenue. Dose sales in Europe, Middle East and Africa (EMEA) of 2,273 units were up 18.6 percent compared to the same period last year, with revenues growing 17.3 percent. Dose sales in the Asia Pacific (APAC) region of 903 units increased 11.6 percent compared to the same period last year with revenue growth of 20.5 percent.

Globally, Sirtex’s two remaining major studies, SORAMIC and SIRveNIB reached the 85 percent recruitment level by the end of the financial year. The results of the SARAH study, which completed enrollment in March, are expected in late calendar year 2016. In addition, results of the combined overall survival analysis of the FOXFIRE, FOXFIRE Global and SIRFLOX studies will be available during calendar year 2017.

The Level 1 evidence generated from the maturation and presentation of the SIRFLOX results further support key marketing and reimbursement initiatives. Adoption into earlier treatment lines, including first-line, will therefore gain momentum over time.

About Selective Internal Radiation Therapy using SIR-Spheres Y-90 resin microspheres

SIR-Spheres Y-90 resin microspheres are a medical device used in an interventional radiology procedure known as selective internal radiation therapy (SIRT), or radioembolization, which targets high doses of radiation directly to liver tumors. The treatment consists of tens of millions of radioactive Y-90 coated resin particles, each no bigger in diameter than a human hair. Interventional radiologists inject these resin particles, or microspheres, into the hepatic artery via a catheter inserted into the femoral artery through an incision in the groin. The Y-90 resin microspheres become lodged in the capillaries that surround liver tumors, where they deliver a high dose of short-range (mean 2.5 mm; maximum 11 mm) beta radiation to the liver tumors, while sparing healthy liver tissue. The low specific gravity of the Y-90 resin microspheres allows the blood flow to evenly distribute the radioactivity within and around the liver tumors.

Available at more than 490 treatment centers in the U.S., more than 50,000 doses of SIR-Spheres Y-90 resin microspheres have been supplied worldwide.

SIR-Spheres Y-90 resin microspheres have a Premarket Approval (PMA) by the FDA and are indicated in the United States for the treatment of non-resectable metastatic liver tumors from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using Floxuridine. SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumors in Australia, the European Union (CE Mark), Argentina (ANMAT), Brazil, and several countries in Asia, such as India and Singapore.

About Sirtex

Sirtex Medical Limited (SRX.AX) is an Australian-based global healthcare business working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 50,000 doses have been supplied to treat patients with liver cancer at more than 800 medical centers in over 40 countries.

For more information, visit

SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd.

Source: Sirtex Medical

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