New generation equipment operating on the principle of electronic brachytherapy for the treatment of breast cancer, cervical cancer and skin cancer (non-melanoma) will be launched within a few months in 4 hospitals in Bulgaria.

Delivery and installation as well as service maintenance of the innovative technology will be performed by Molecular Solutions Bulgaria and the hospitals that will have this technology on site are UMBAL Dr. Georgi Stranski in Pleven, UMBAL St. Georgi, in Plovdiv, UMBAL Alexandrovska Hospital and SBAL of Oncology Hospital in Sofia.

The innovative therapy allows for cancer cells to be targeted and destroyed faster, safer and painlessly compared to the standard procedures used so far.

One of the main advantages of this method, is the use of the intraoperative radiation therapy (IORT) method in breast cancer treatment. After lumpectomy and subsequent IORT, the patient may be discharged on the same day for home treatment. 

This type of therapy is much more precise than the conventional radiation therapy methods, as administering it allows to minimize or completely exclude additional radiotherapy. Another advantage is that it is extremely gentle on the decreased immunity of the patient and on the surrounding healthy tissue, and last but not least, it is safe for the health of medical professionals working with the equipment.

The manufacturers from Xoft, and we, the exclusive representatives from Molecular Solutions Bulgaria believe in the quality and benefits of the product, which is used in more than 180 hospitals in the US, Western Europe, and now in Bulgaria. The investment is under the Regional Development Operational Programme 2007 – 2013 – Grant Scheme in support for reconstruction, renovation and equipment of medical and healthcare facilities in urban agglomerations, financed by the EU.

iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® for the treatment of early-stage breast cancer using intraoperative radiation therapy (IORT) was selected as a winner in the health category of Popular Science magazine’s “Best of What’s New” awards for 2015. The award, selected by the editors of Popular Science, recognizes products and technologies that represent innovations that will shape the future.

IORT is a procedure in which early-stage breast cancer is treated with just one dose of targeted radiation.  Traditional breast cancer treatment involves daily radiation five days per week, for six to eight weeks.  IORT allows radiation oncologists and breast cancer surgeons to work together to deliver a full dose of radiation at the time of lumpectomy for eligible patients. A growing body of favorable clinical data supports the use of IORT in candidates meeting specific selection criteria. iCAD is currently conducting one of the largest IORT clinical studies to date using the Xoft System, which compares Xoft IORT to traditional external beam radiation therapy.

“The Xoft System and IORT are revolutionizing cancer treatment, and we are honored that the Xoft System was selected to receive this esteemed award,” said Ken Ferry, CEO of iCAD. “We hope this recognition will help more patients who are appropriate candidates for IORT avoid unnecessary radiation treatments administered daily over six to eight weeks, which can be detrimental to patient health and disruptive to their lives.”

After the lumpectomy procedure, the Xoft System’s proprietary miniature x-ray source is inserted into a flexible balloon-shaped applicator, which is then temporarily placed inside the lumpectomy cavity. The miniature x-ray source delivers one concentrated dose of radiation directly to the lumpectomy cavity, targeting cancer cells while sparing healthy surrounding tissue such as the heart, lungs, and ribs.

IORT offers a number of potential patient benefits, including convenience, lower costs, fewer side effects, and shorter treatment times compared to traditional radiation therapy.  Most patients treated with IORT are able to return to their normal daily activities, including going to work and family activities, within days rather than weeks.

“IORT is a major medical advancement that may also help select patients avoid the substantial financial and emotional burden typically associated with traditional treatment,” said Mr. Ferry. “When patients meeting selection criteria are given the choice, they typically prefer a shorter course of radiation rather than being required to make daily visits to a treatment center for a significant number of weeks.”

“The ‘Best of What’s New’ awards honor the innovations that surprise and amaze us—those that challenge our view of what’s possible in the future,” said Cliff Ransom, editor-in-chief of Popular Science. “The award is Popular Science‘s top prize, and the 100 winners—chosen from among thousands of nominees—are each a revolution in their respective fields.”

More than 50 leading healthcare facilities around the world have adopted Xoft IORT and have successfully treated more than 2,000 patients. IORT has also been included in the Cleveland Clinic’s list of “Top 10 Medical Innovations for 2015.”

The Xoft System is FDA-cleared, CE marked and licensed in Canada for the treatment of cancer anywhere in the body, including non-melanoma skin cancer, gynecological cancers and early-stage breast cancer.  Candidates for IORT with the Xoft System should meet specific selection criteria and be treated under IRB-approved protocols to ensure they are treated in accordance with all federal, institutional and ethical guidelines.  For more information about the Xoft System and IORT, visit www.xoftinc.com.

About Xoft Axxent Electronic Brachytherapy System

The Xoft System is an isotope-free radiation treatment that is FDA cleared, CE marked, and licensed in Canada for the treatment of cancer anywhere in the body, including treatment of early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. It utilizes a proprietary miniaturized x-ray as the radiation source that delivers precise treatment directly to cancerous areas while sparing healthy tissue and organs. The Xoft System requires only minimal shielding and therefore does not require room redesign or construction investment. Minimal shielding also allows medical personnel to remain in the room with the patient during treatment. The mobility of the Xoft System makes it easy to treat patients at multiple locations and to easily store the system when not in use. Xoft is a wholly owned subsidiary of iCAD, Inc. For more information about Xoft visit www.xoftinc.com, like us on Facebook or follow us on Twitter at @xofticad.

The participation of Molecular Solutions Bulgaria in the project is for the supply of the main high-tech medical equipment from Siemens, which was delivered, installed and commissioned as follows:

• Nuclear Magnetic Resonance (1.5 Tesla)
• PACS – system for archiving of data and images
• CT Scanner – 16-slice
• Digital-scopic Graphic X-ray Machine
• C-arm X-ray System
• 4D ultrasound scanner

A large portion of the investment is provided through EU funds.

The European Regional Development Fund granted BGN 4 678 477.21, the Bulgarian state budget – BGN 825 613. 63 and BGN 31 517.93 is the hospital’s own contribution. The project was successfully completed in December 2015.

In 2015, MSB delivered and installed a cyclotron for production of radioactive isotopes in UMBAL Alexandrovska. In-house production of radio-isotopes for examination of patients with PET-scanner provides good opportunities for the hospital for better planning, increasing the number of diagnosed patients and a major cost optimization related thereto.

The cyclotron system consists of a mini cyclotron (so-called Baby Cyclotron) for the production of single patient doses of radioactive isotopes 18F and FDG-radiopharmaceuticals with capacity for approximately 300 patients per month, who will be examined with the device for positron emission tomography /computed tomography (PET / CT) in the Nuclear Medicine Clinic of the hospital.  

A hot trend in the nuclear medicine reducing the volume of cyclotron systems and automating the production of small doses of short-lived radiopharmaceutical to feed the scanner throughout the work schedule, thereby ensuring optimal use of its resources and increase in the number of examined patients. The use of a cyclotron for the hospital’s needs has a number of other benefits:

• Guaranteed supply of radiopharmaceuticals for the PET scanner – the short half-life of the 18F isotope (~ 110 min.) does not allow the use of road transport, thus the use of aircraft is required for doses transportation on long distances. This not only increases the cost of supplies, but makes them largely dependent on weather conditions.
• More patients can be examined with the equipment of the Nuclear Medicine Clinic – for the period since first installation of the PET/CT in 2011 until September 2015, an average of 1,300 patients per year passed for various examinations with PET scanner, considering that examinations are performed only 2-3 days a week, due to the lack of regular FDG supplies. This in turn significantly increases the waiting list for PET diagnostics. With its own production of isotopes the hospital could examine more than 3 000 patients a year.
• Reducing the cost of a single dose radioisotope 18F (FDG) for PET – the consumables needed for the production of radioisotope (cartridges and reagents) are times cheaper than the end product provided by an external supplier. The initial investment for providing premises for the mini cyclotron and its purchase equals the funds needed to purchase the radiopharmaceutical from an external supplier for just several years.
• More sterile and safe production without the need to hire additional qualified staff – due to the fully automated processes and easier regulation.

The cyclotron system in UMBAL Alexandrovska is the second mini cyclotron system installed in Bulgaria and the third in Europe. The funds for the equipment are provided by the Ministry of Health through the Revolving Fund under a loan from the International Bank for Reconstruction and Development (Loan № 4565 BUL).

Thus prepared, the personalized drug for each patient guarantees absolute accuracy and security and excludes any possibility of dosing errors in intravenous chemotherapy drug preparations. Another major advantage is that the solutions are prepared within minutes and dissolution takes place in special compartments under strict rules thus reducing contamination and hazardous exposure, both for the premises and for the operators. The robot for the dissolution of cytostatic drugs in UMBAL Sv. Marina is the first in Bulgaria and only a few hospitals in Europe are equipped with this modern system.

The implementation of the robot will save millions of levs, improve significantly the quality of chemotherapy and the misappropriation of expensive oncological drugs will be severely reduced.

The manufacturer of the automated system is the world famous company Loccioni Humancare, with its official representative for Bulgaria – Molecular Solutions Bulgaria.

The project has been funded through the Operational Programme for Competitiveness of Bulgarian Economy 2007 – 2013, co-financed by the European Union through the European Regional Development Fund.