• Novel imaging agent allows detection of lymph node metastases at earlier stage, allowing more effective treatment

NIJMEGEN, Netherlands–(BUSINESS WIRE)–SPL Medical announced today that the first patient has been successfully diagnosed with suspected lymph node metastases of prostate cancer with Ferrotran^® (Ferumoxtran) at the University Hospital Zurich. This follows approval (Sonderbewilligung acc. to Swiss AMBV) by Swissmedic to Universitätsspital Zurich, Institut für Diagnostische und Interventionelle Radiologie, for restricted use of Ferrotran^® under a compassionate use program. Ferrotran^® (Ferumoxtran) is a novel contrast agent for use in MRI (magnetic resonance imaging) developed for the detection of lymph node metastases of prostate cancer. It is the first contrast agent for the use in MRI that is able to identify metastases as small as 1.5 mm. The rise of prostate specific antigen (PSA) is often the first symptom of suspected recurrent lymph node metastases. Being able to detect small metastases in prostate cancer early enough should enable a better chance of successful treatment.

SPL Medical is the manufacturer of Ferrotran^® and responsible for the worldwide commercialization. The company is about to start a large multicenter trial of Ferrotran^® that will be conducted in 10 top radiology centers in Germany, Switzerland and the Netherlands, enrolling a total of 180 patients with prostatic cancer.

The development of Ferrotran^® was initially enabled and accelerated by Prof. Jelle Barentsz of the Radboud university medical center in Nijmegen, the Netherlands. He discovered the unique features of Ferrotran^® for the early detection of lymph node metastases when he used it as contrast agent for prostate cancer patients. So far, he has diagnosed metastases in more than 1,500 patients using this agent.

“We have built a vast experience with Ferrotran^® and have started to train radiologists from participating clinical centers to bring them up to speed with the latest use of the product and interpretation of the imaging results,” said Prof. Barentsz.

“Ferrotran^® represents a major opportunity to improve the diagnosis of lymph node metastases from prostate cancer, with patients subsequently having potentially better treatment outcomes and fewer side-effects,” stated Dr. Jürgen Feuerstein, Chief Executive Officer of SPL Medical. “The compassionate use program at the University Hospital Zurich provides vital access for prostate cancer patients to this game-changing product. Meanwhile, at SPL Medical, we will continue advancing our clinical development plan to enable potential registration of Ferrotran^®.”

b.e.imaging GmbH, a shareholder of SPL Medical, is the distributor of Ferrotran^® in Germany, Austria and Switzerland.

About Ferrotran^®:

Ferrotran^® belongs to the group of USPIO’s (Ultrasmall Superparamagnetic Particles of Iron Oxide) and is the only contrast agent that can detect lymph node metastases as small as 1.5mm. Standard MRI, CT or PET scan are normally not able to detect metastatic nodes smaller than 7 – 8 mm. Since most prostate cancer patients are dying due to metastases, a precise diagnosis is of utmost importance. The detection of small metastases, combined with a very clear and contrast rich MRI image with the administration of Ferrotran^®, and excellent visualization of vessels enables an earlier and more precise treatment.

About SPL Medical:

SPL Medical is a spin-off of the Radboud university medical center and is funded additionally by Oost NL, a Dutch regional venture capital company, and b.e.imaging GmbH, a German company specialized in the commercialization of contrast agents.

About b.e.imaging GmbH:

b.e.imaging GmbH (Baden-Baden) is a company developing, marketing and supplying contrast media and medical devices to radiologists and urologists in Germany, Austria and Switzerland.

For further information please visit: www.ferrotran.com

Contacts

For more information about the clinical trial centers or SPL Medical:
Dr. Juergen Feuerstein (CEO)

+49 171 173 5476 or

Harrie van Baars MD (CBO)

+31 6290 77828

Media
Mike Sinclair,

Halsin Partners,

+44 20 7318 2955