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Healthcare systems around the world are continuing to evolve to meet ever-growing demands for improved patient care and value for money.
Interventional Medicine can help healthcare providers and payers meet these goals. Delivering targeted therapies through minimally invasive procedures can provide cost-effective solutions and improve treatment outcomes.
Our aim is to establish leadership positions in selected therapy areas where there are large patient populations with unmet needs. We develop and acquire differentiated products, and invest in activities that support their growth. These include generating clinical data to access new patient populations and to provide evidence to payers to support appropriate reimbursement. We also undertake regulatory and commercial activities to enable geographic expansion, and product innovation to maintain our technology leadership.
Customers are at the centre of everything we do. Our sales, medical and product development teams work closely with our customers to ensure that we can provide the leading-edge products they desire. We also provide the clinical data, training and other support our customers need to enable them to treat more patients.
Over the past decade we have been transforming BTG from a royalties business into a product sales business with diverse, sustainable revenue streams. We have built the capabilities and infrastructure that support ongoing business growth, by investing our strong cash flows to develop leading positions in selected Interventional Medicine markets and to maintain a strong Pharmaceuticals business.
We have national sales forces for Interventional Oncology in the US and the EU and an Interventional Vascular sales force in the US. Multiple investments in product innovation, clinical studies and geographic expansion, together with a focused acquisition strategy, support sustained high-growth in these businesses and increasing operating leverage over time.
While continuing to source external innovation, we are investing to build an organic development pipeline. We are exploiting our existing technology platforms to deliver new products to enhance our position in existing markets and to access new organs and therapy areas. These investments give us confidence that we can continue to grow our Interventional Medicine business over the next decade and beyond.
BTG has delivered a good operational performance over the year. As a leader in Interventional Oncology, significant progress has been made with multiple activities to support the sustained high-growth of this business. Geographic expansion has continued, with regulatory approvals and the start of commercial activities in a number of territories in Asia, EMEA and Latin America.
The TheraSphere® Phase III trials are progressing well, with data expected in 2019. Our cryoablation business received 510(k) and CE Mark regulatory clearances for Visual-ICE® MRI, a new cryoablation system and needles from Galil Medical that are compatible with all Magnetic Resonance Imaging (MRI) scanners.
Our Interventional Vascular business was strengthened by the acquisition of Roxwood Medical in October 2017. Roxwood’s anchoring catheters complement our existing EKOS® product by allowing physicians to cross complex lesions and arterial blockages, thus enabling them to treat patients with some of the most complex arterial diseases. One-year data from the OPTALYSE PE study reinforced the safety and efficacy of shorter, lower-dose EKOS® therapy for PE, and we also initiated a further PE registry to build upon our leadership in this field.
Varithena®, the novel treatment for varicose veins, received finalised category 1 CPT reimbursement codes in the US, effective from January 2018. While these codes have led to renewed physician interest, we will have a better understanding of their impact on physician ordering and reordering patterns, and on insurer coverage and payment practice, by the end of 2018.
European sales of the PneumRx® Coils have been disappointing. We continue to believe that over the long term this product can help address a significant unmet need in treating severe emphysema. However, market development, including securing appropriate reimbursement, is taking longer than expected and we recognise that it will take some years to develop this therapy area and to build product sales. We are therefore focusing activities to build long-term value while appropriately reducing the cost base. These include conducting the ELEVATE clinical study to support market development including accessing reimbursement, and progressing our pre-market approval (PMA) application in the US.
In our Pharmaceuticals business growth was driven by strong performances from CroFab® and Voraxaze®. We expect continued strong cash generation in this business. While there is likely to be some impact over time on sales of our antivenin CroFab® from a different antivenin product that could enter the US market from October 2018, we are implementing strategies to ensure we maintain our market leadership. We were disappointed with the court judgement concerning the commercial dispute over Vistogard®. However, despite having lost a potential revenue contributor our Pharmaceuticals business will continue to provide us with a strong financial underpin. Licensing revenues performed well as a result of new clinical data supporting earlier use of Johnson & Johnson’s prostate cancer treatment, Zytiga®.
As we enter a period of financial transition, we have built a scalable platform, with a broad portfolio of differentiated products, strong customer relationships, and multiple investments to support sustained growth. As the use of minimally invasive therapies continues to grow, we have the financial resources and capabilities to continue to make targeted new investments, so that we can continue building our Interventional Medicine business and developing leadership positions in attractive growth markets.
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