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OUR MANIFESTO

In Interventional Medicine we’re making giant leaps with smaller, increasingly less invasive steps. Today we can pinpoint the problems inside us and journey within blood vessels to deliver ingenious treatments exactly where they’re needed most. And as medicine moves from major surgery to minor procedure, from the systemic to the local, no company endeavors to do more than BTG to help doctors in their quest to see more, reach further and treat smarter. Our growing family of innovators already equip clinicians with tools and techniques that would have seemed like science fiction only a generation ago. We’ve set the standards for others to follow, but we’re not resting there. Proud as we are of what we do now, we are busy shaping what happens next, because for BTG the race to conquer inner space is always on. With relentless curiosity we’ll work with clinicians to find elegant new ways to extend our power over disease. We’ll reach the day when intelligent technologies travel through the body as freely as a blood cell, to seek out and eliminate threats to health with molecular accuracy. There are no limits to where our ideas will take us.

LATEST NEWS IN
INTERVENTIONAL MEDICINE.

BTG and SciClone Announce that DC Bead® has been approved by China Food and Drug Administration
Release Date: 28/08/2014

London, UK, 28 August 2014: BTG plc (LSE: BTG), the specialist healthcare company, and its partner SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN), a China-focused specialty pharmaceutical company, today announce that the China Food and Drug Administration has approved the registration of DC Bead® for the embolisation of malignant hypervascularised tumours. 

BTG and SciClone previously entered into an agreement granting SciClone exclusive licensing and distribution rights to DC Bead® in China. Under the agreement, SciClone will purchase product from BTG at a specified price for sale in China. Commercial launch plans are now underway.

Louise Makin, Chief Executive Officerat BTG, said: “Approximately half of the world’s liver cancer patients are in China and there is a great interest among Chinese physicians to offer new, differentiated treatment options. Today’s news marks an important step toward bringing our first interventional oncology product, DC Bead®, to the Chinese market where we can help address this need.”

Friedhelm Blobel, SciClone Chief Executive Officer commented: “Together with our partner BTG, we will now focus our efforts on preparing for the introduction of the product in the Chinese market. Oncology is a core business focus for SciClone, and our sales team and academic marketing liaisons have established high quality relationships with the medical professionals and institutions that specialize in cancer treatment. We believe DC Bead® has the potential to be a valuable addition to SciClone’s oncology product portfolio.”

DC Bead® is a novel treatment for liver cancer which is currently approved in 40 countries worldwide, including Europe. DC Bead® is an embolic bead delivered through a minimally invasive, non-surgical procedure to block the blood flow to tumours. 

DC Bead® is registered in China for the embolisation of malignant hypervascularised tumours such as hepatocellular carcinoma (“HCC”), the most common form of primary liver cancer. The majority of people with HCC have cirrhosis, usually from chronic hepatitis B or hepatitis C infection, or chronic alcoholism.  Because of the country’s high incidence of hepatitis, China accounts for approximately one-half of the world’s liver cancer cases. More than 350,000 people die from primary liver cancer in China annually[i].

DC Bead® and/or all indications may not be available in all territories. DC Bead® is not currently cleared by the FDA for sale or distribution in the USA.

For further information please contact:

BTG

Chris Sampson, Director of Corporate Communications
+44 (0)20 7575 1595

Mobile: +44 (0)7773 251178
chris.sampson@btgplc.com

Ashley Tapp, Communications Manager
+44 (0)20 7575 1513

Mobile: +44 (0)7790 811554
ashley.tapp@btgplc.com        

Stuart Hunt, Investor Relations Manager

+44 (0)20 7575 1582

Mobile: +44 (0)7805 354134
stuart.hunt@btgplc.com                                                                                                                                                                                                                                                                                                                                       

Ben Atwell/Simon Conway, FTI Consulting

+44 (0)20 3727 1000

SciClone

Wilson W. Cheung, Chief Financial Officer

+1 650 358 3434

wcheung@sciclone.com

Jane Green, Investors/Media

+1 650 358 1447

jgreen@sciclone.com

About BTG

BTG is an international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at www.btgplc.com.

About SciClone

SciClone Pharmaceuticals is a revenue-generating, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio spanning major therapeutic markets including oncology, infectious diseases and cardiovascular disorders. SciClone's proprietary lead product, ZADAXIN® (thymalfasin), is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV), and certain cancers, and as a vaccine adjuvant, according to the local regulatory approvals. Through its promotion business with pharmaceutical partners, SciClone markets multiple branded products in China which are therapeutically differentiated. The Company has successfully in-licensed products with the potential to become future market leaders and to drive the Company's long-term growth. SciClone is a publicly-held corporation based in Foster City, California, and trades on the NASDAQ Global Select Market under the symbol SCLN. For additional information, please visit www.sciclone.com.



 

First Varicose Vein Patient Treated with FDA-Approved Varithena® (polidocanol injectable foam) 1%. Varithena® is now available in the US
Release Date: 11/08/2014

West Conshohocken, PA,  August 11, 2014: BTG International Inc. announces that the first varicose vein patient has been treated with Varithena® (polidocanol injectable foam), the only FDA-approved foam for the treatment of incompetent great saphenous veins (GSV), accessory saphenous veins and visible varicosities of the GSV system both above and below the knee.

Varithena® improves symptoms related to or caused by varicose veins, and the appearance of varicose veins, and is proven to reduce the five symptoms patients consider most important – heaviness, achiness, swelling, throbbing, itching (HASTI symptoms).

Marlin Schul, M.D., M.B.A., of the Lafayette Regional Vein & Laser Center in Indiana, who conducted the first Varithena® procedure, said, “I am proud to now be able to offer Varithena® as a new treatment option for my patients with varicose veins. Varithena® is a convenient, minimally invasive treatment and patients can return to normal activities shortly after treatment.”

Paul McCubbin, Head of Varithena® at BTG, commented, “Varithena® is the first and only FDA-approved comprehensive treatment that improves the symptoms and appearance of varicose veins. We are delighted that this clinically proven product is now commercially available to qualified physicians.”

Varithena® is a uniform, low-nitrogen, polidocanol microfoam, dispensed from a proprietary canister device. The physician injects a small amount of Varithena® into the malfunctioning vein through a small tube (catheter) or a needle. It displaces the blood from the vein to reach and treat the vein wall; the diseased vein collapses and blood flow is diverted to healthy veins nearby.

Vein specialists practicing in the US who are interested in using Varithena® can connect with a BTG Territory Sales Manager by calling the Varithena Solutions Center™ at 855-971-VEIN (8346). To learn more about Varithena®, go to www.varithena.com.

About BTG
BTG is a growing international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programs and products to develop and market to specialist physicians. For further information about BTG, please visit our website at www.btgplc.com.

About Varithena®
Varithena® (polidocanol injectable foam) 1% is a prescription medicine used to treat varicose veins caused by problems with the great saphenous vein (GSV) and other related veins in the leg’s GSV system. Varithena® helps improve the symptoms of heaviness, achiness, swelling, throbbing, itching (HASTI symptoms) related to or caused by varicose veins, and the appearance of varicose veins. Treatment is a nonsurgical procedure (no incision is required). Treatment usually takes less than one hour and patients may resume light activities as quickly as the same day of treatment. For further information, please visit www.varithena.com.

Indications

Varithena® (polidocanol injectable foam) is a prescription medicine used to treat varicose veins caused by problems with the great saphenous vein (GSV) and other related veins in the leg’s GSV system. Varithena® improves symptoms related to or caused by varicose veins, and the appearance of varicose veins.

IMPORTANT SAFETY INFORMATION

You should not be treated with Varithena® if you are allergic to polidocanol or have clots in your blood vessels.

Severe allergic reactions have been reported in people treated with liquid forms of polidocanol and some patients have died from these reactions. Varithena® is a microfoam made from polidocanol. A healthcare professional will observe you for signs of allergic reactions for at least 10 minutes after you are treated with Varithena®.


Tell your doctor about all of your medical conditions, including if you

  • have arterial disease (a disease of the blood vessels)
  • have reduced mobility
  • have a history of blood clots in the veins or lungs
  • have had major surgery in the past 3 months
  • have recently had a long hospital stay
  • are pregnant or have recently been pregnant

The most common side effects seen with Varithena® are leg pain or discomfort, injection site bruising or pain, and potentially serious blood clots in the leg veins. These are not all of the possible side effects of Varithena®. Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 800-FDA-1088.

Varithena® is administered by your doctor. Doctors using Varithena® must be experienced in vein procedures and trained in using Varithena®.

See full Prescribing Information for Varithena® online at www.varithena.com.

Varithena, HASTI and Varithena Solutions Center are trademarks of Provensis Ltd., a BTG International group company.  BTG and the BTG roundel logo are registered trademarks of BTG International Ltd.

For further information please contact:

BTG                                                                                                                       

Chris Sampson, Director of Corporate Communications

+44 (0) 20-7575-1595

Mobile: +44 (0) 7773-251178

chris.sampson@btgplc.com

Ashley Tapp, Communications Manager

+44 (0) 20-7575-1513

Mobile: +44 (0) 7790-811554

ashley.tapp@btgplc.com                                                                                 
 

Vox Medica

Rhonda L. Lipschutz, Account Supervisor

+1 215-446-8027

Mobile: +1 215-341-7975

rlipschutz@voxmedica.com

EkoSonic® Endovascular System receives FDA Clearance for the Treatment of Pulmonary Embolism in the USA
Release Date: 23/05/2014

Bothell, WA, USA, 23 May 2014: EKOS Corporation, a BTG International group company (BTG plc (LSE: BTG)), today announced that the U.S. Food and Drug Administration (FDA) has cleared the EkoSonic® Endovascular System for the ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism (PE).

The EKOS® ultrasonic devices are designed to gently accelerate the penetration of thrombolytic agents into thrombus, providing high levels of lysis. EKOS® is the only minimally invasive endovascular therapy on the market that has been FDA cleared for the treatment of PE.

PE occurs in approximately 600,000 patients in the US, causing or contributing to 200,0001 deaths each year. PE also causes or contributes to 15%2,3 of all hospital deaths. Samuel Z. Goldhaber, MD, Professor of Medicine, Harvard Medical School and Director, Thrombosis Research Group, Brigham and Woman’s Hospital (Boston, MA) said, “The EKOS® clinical data established that patients stricken with a life-threatening pulmonary embolism can be successfully and safely treated with the EkoSonic® system. This is the first FDA cleared treatment option for PE since the approval of the drug, tPA, in 1990.”

“Interventional radiologists, cardiologists, cardiothoracic and vascular surgeons at leading institutions around the world use our system to provide faster, safer and more complete dissolution of thrombus,” commented Matt Stupfel, General Manager of EKOS. “We are proud to have completed the world’s only randomized controlled trial (ULTIMA) and the largest prospective single-arm trial (SEATTLE II) on the safety and effectiveness of EKOS® therapy in the treatment of PE. The positive outcomes of those trials, combined with our expanded indication will allow a better standard of care for thousands of patients who suffer from PE.”

In January of 2014, the outcomes of ULTIMA were published in American Heart Association’s Journal, Circulation. The trial demonstrated that for PE patients at intermediate risk of adverse events, EKOS® treatment was clinically superior to anticoagulation with heparin alone in reversing right ventricular dilation at 24 hours, without an increase in bleeding complications.

Following ULTIMA, the results of SEATTLE II, the prospective single arm multi center trial of 150 patients, were released at this year’s American College of Cardiology. SEATTLE II trial demonstrated that ultrasound-facilitated catheter-directed low-dose fibrinolysis for acute PE minimizes the risk of intracranial hemorrhage, improves RV function, and decreases pulmonary hypertension. 

 

For further information please contact:                            

BTG                                                                                        
Andy Burrows, VP, Corporate and Investor Relations
+44 (0)20 7575 1741
Mobile: +44 (0)7990 530605                                                                                             

Greentarget Communications
Chris Gale, Vice President
+1.646.695.2883
Mobile: +1.203.570.4681

(For US trade and media inquiries)

 

About BTG

BTG is a growing international specialist healthcare company that is developing and commercialising products targetingacute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programs and products to develop and market to specialist physicians.To find out more about the BTG International group companies and our products, visit www.btgplc.com.                                                                                                                     

About EKOS Corporationand the EkoSonic® Endovascular System

EKOS Corporation, a BTG International group company, pioneered the development and clinical application of ultrasound infusion technologies in medicine, introducing its first system for the treatment of vascular thrombosis in 2005. Today,interventional radiologists, cardiologists, cardiothoracic and vascular surgeons at leading institutions around the world use the EKOS EkoSonic® Endovascular System to provide faster, safer and more complete dissolution of thrombus. To find out more about the EKOS EkoSonic® Endovascular System, visit www.ekoscorp.com.

EKOS, EkoSonic, and MicroSonic are the trademarks of EKOS Corporation, a BTG International group company. BTG and the BTG roundel are registered trademarks of BTG International Ltd in US, EU and certain other territories and trademarks of BTG International Ltd elsewhere.  

Statements of indications:

USA FDA Cleared Indications:
The EkoSonic® Endovascular System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EkoSonic® Endovascular System is intended for the infusion of solutions into the pulmonary arteries. The EkoSonic®Endovascular System is indicated for the ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism. 

Contraindications:
Not designed for peripheral vasculature dilation purposes. The system is contraindicated when, in the medical judgement of the physician, such procedure may compromise the patient’s condition. See device instructions for use for complete prescribing information.

The CE Mark (CE0086) has been affixed to the EkoSonic® product with the following indications for use:
Peripheral Vasculature
The EkoSonic®Endovascular Device, consisting of the IntelligentDrug Delivery Catheter (IDDC) and the MicroSonic™ Device (MSD), is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic®Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent.
Pulmonary Embolism
The EKOS EkoSonic®Endovascular System is intended for the treatment of pulmonary embolism patients with ≥ 50% clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure ≥ 25mmHg) or echocardiographic evaluation.

Notes to Editors

Pulmonary embolism is a sudden blockage in a lung artery. The blockage usually is caused by a blood clot that travels to the lung from a vein in the leg.

Right ventricular dilation is the extent to which right ventricle is dilated in relation to the left ventricle. Also known as an indicator for the right heart dysfunction.

Pulmonary hypertension is increased pressure in the pulmonary arteries. These arteries carry blood from heart to lungs to pick up oxygen. It causes symptoms such as shortness of breath during routine activity, tiredness, chest pain, and a racing heartbeat.

 

References:

1. According to http://www.sirweb.org/patients/deep-vein-thrombosis/.

2. Kasper W, Konstantinides S, Geibel A, Olschewski M, Heinrich F, Grosser KD, Rauber K, Iversen S, Redecker M, Kienast J. Management strategies and determinants of outcome in acute major pulmonary embolism: Results of a multicenter registry. J Am Coll Cardiol. 1997;30:1165-1171.

3. Kucher N, Rossi E, De Rosa M, Goldhaber SZ. Massive pulmonary embolism. Circulation. 2006;113:577-582.

BTG becomes a major supporter of ESIRonline, CIRSE’s online educational database for Interventional Radiologists
Release Date: 06/05/2014

London, UK and Vienna, Austria;6 May 2014: BTG1and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), are pleased to announce that BTG has become a major supporter of ESIRonline, CIRSE’s extensive database of educational materials on interventional radiology. 

BTG will provide an educational grant over three years to support further development of ESIRonline for CIRSE members and other physicians, scientists and healthcare personnel with an active interest in Interventional Oncology.  BTG joins Cook Medical and Siemens who are already major supporters.

ESIRonline is the world’s most comprehensive database for minimally invasive medicine, providing more than 7,200 scientific presentations and posters from 25 industry events since 2006. The database features a powerful search engine, allowing users to find files easily and quickly. The files are available for online viewing. In addition files can be downloaded and shared with colleagues. An interactive feature enables users to contact the authors to obtain more information or discuss certain topics. Subscribers receive a monthly e-newsletter to help keep them up-to-date on the latest developments on the platform. ESIRonline is enjoying great popularity. Over 2,000 subscribers clicked the download button more than 25,000 times during 2013 alone.

BTG’s General Manager of Interventional Oncology, Mike Motion, explains the importance of BTG’s collaboration with CIRSE: “CIRSE is a significant partner in the interventional radiology community. BTG is committed to providing education to clinicians, and as a multifaceted educational platform, ESIRonline provides an ideal resource for BTG to support.”

BTG and CIRSE have a common interest to support education and science in the field of Interventional Oncology (IO) and to position ESIRonline as a leading IO online platform in Europe and abroad.

About BTG

BTG is an international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programs and products to develop and market to specialist physicians.

For further information about BTG please visit our website at www.btgplc.com and for more information on our Interventional Medicine products please visit
www.btg-im.com.

1This agreement is between the legal entity Biocompatibles UK Ltd, a BTG International group company and CIRSE.

About CIRSE

The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) is a non-profit scientific and educational society which aims to support research, education, clinical practice and patient care in the ever-expanding field of interventional radiology (IR). Interventional radiology provides minimally invasive image-guided treatments for a wide range of conditions. CIRSE organises the largest annual congress in IR with high attendance numbers of over 6000 people. Through the European School of Interventional Radiology (ESIR), the society offers a variety of courses for its nearly 6000 members to further expand their medical expertise.

For more information on CIRSE, ESIRonline and BTG please visit www.cirse.org and www.esir.org . 

For further information please contact:
 

BTG                                                                                                                       

Ashley Tapp, Communications Manager

+44 (0)20 7575 1513; Mobile: +44 (0)7790 811554

ashley.tapp@btgplc.com

 

 

Acute Pulmonary Embolism Trial Confirms Safety and Efficacy of Ultrasound Accelerated Endovascular Thrombolysis
Release Date: 30/03/2014

Results show no intracranial hemorrhageand extended survival among patients at high risk of death

Bothell, WA, US, 30 March 2014: EKOS Corporation, a BTG International group company (BTG plc (LSE: BTG)), notes the presentation of the results of the SEATTLE II trial this afternoon at ACC.14, the 63rd Annual Scientific Session and Exposition of the American College of Cardiology in Washington, DC in the United States. The results were presented by Dr. Gregory Piazza, MD, Staff Physician, Cardiovascular Division, Brigham and Women’s Hospital and Instructor of Medicine, Harvard Medical School.

The SEATTLE II study is a prospective, single-arm, multi-center trial to evaluate the safety and efficacy of ultrasound-facilitated catheter-directed low-dose thrombolysis, using the EKOS EkoSonic® Endovascular System, for treating 150 patients with acute massive (N=31) or submassive (N=119) pulmonary embolism (PE). Chest computed tomography had to demonstrate proximal PE and a dilated right ventricle (RV/LV ratio ≥ 0.9) for patients to be eligible to participate. A dose of 24 mg tPA (thrombolytic) was used in the trial, administered either as 1 mg/hour for 24 hours with a unilateral catheter or 1 mg/hour/catheter for 12 hours with bilateral catheters. The mean RV/LV ratio in the study decreased from 1.55 pre-procedure to 1.13 at 48 hours post-procedure, a difference of 0.42 (p<0.0001).

Massive PE has a mortality rate of about 52% at 90 days.1 In the SEATTLE II study, there were 31 patients presenting with massive PE manifested by syncope and hypotension.  However, no patients with massive PE died within the 30 day follow up period. Of 150 patients in the overall study, only one death was directly attributed to PE. 

There were no intracranial hemorrhages and no fatal bleeding events. Major bleeds occurred in 17 patients and was comprised of one severe bleed and 16 moderate bleeds. Six of the major bleeds occurred in patients with co-morbidities known to be associated with an increased risk of bleeding during thrombolytic therapy.

The abstract concluded that ultrasound-facilitated catheter-directed low-dose fibrinolysis for acute PE minimizes the risk of intracranial hemorrhage, improves RV function, and decreases pulmonary hypertension.  

Samuel Z. Goldhaber, MD, Professor of Medicine, Harvard Medical School and Director, Thrombosis Research Group, Brigham and Woman’s Hospital (Boston, MA), and Principal Investigator for SEATTLE IIsaid, “This trial represents a breakthrough in demonstrating the safety and efficacy of thrombolytic therapy for acute PE. The reduction of the RV/LV ratio by 0.42 is substantial and clinically significant, without any intracranial hemorrhage and using a much reduced lytic dose. These findings establish a new rationale for considering thrombolysis in both massive and submassive PE.”   

Dr. Stavros Konstantinides, MD, Professor for Clinical Trials and Deputy Scientific Director, Center for Thrombosis and Hemostasis, Johannes Gutenberg University of Mainz, Germany, and principal investigator of PEITHO trial explains, “Aside from the massive PE patients who are in need of emergent therapy, the submassive PE patients while hemodynamically stable exhibit an elevated risk of clinical deterioration if managed conservatively, as observed in the PEITHO trial. The SEATTLE II study presents promising data in support of a catheter-based modality to provide rapid unloading of the right heart, thus reducing the risk of further deterioration.”   

Matt Stupfel, General Manager at EKOS Corporation, added, “The recently published ULTIMA trial results demonstrated that EKOS treatment was clinically superior to anticoagulation with heparin alone in reversing right ventricular dilation at 24 hours, without an increase in bleeding complications. Together, the SEATTLE II and ULTIMA trial results provide compelling evidence that treatment with the EkoSonic® Endovascular System improves the standard of care for patient with acute pulmonary embolism.”

For further information please contact:                                           

BTG
Ashley Tapp, Communications Manager                                                        
+44 (0)20 7575 1513; Mobile: +44 (0)7790 811554
(For European media inquiries)                                                                    

Greentarget Communications
Chris Gale, Vice President
+1.646.695.2883; Mobile: +1.203.570.4681
(For US trade and media inquiries)

 

About BTG
BTG is a growing international specialist healthcare company that is developing and commercialising products targetingacute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programs and products to develop and market to specialist physicians.To find out more about the BTG International group companies and our products, visit www.btgplc.com.

 

About EKOS Corporationand the EkoSonic® Endovascular System
EKOS Corporation, a BTG International group company, pioneered the development and clinical application of ultrasound infusion technologies in medicine, introducing its first system for the treatment of vascular thrombosis in 2005. Today,interventional radiologists, cardiologists, cardiothoracic and vascular surgeons at leading institutions around the world use the EKOS EkoSonic® Endovascular System to provide faster, safer and more complete dissolution of thrombus. To find out more about the EKOS EkoSonic® Endovascular System, visit www.ekoscorp.com.


EKOS, EkoSonic, MicroSonic are the trademarks of EKOS Corporation, a BTG International group company. BTG and the BTG roundel are registered trademarks of BTG International Ltd in US, EU and certain other territories and trademarks of BTG International Ltd elsewhere.  


Statements of indications:

USA FDA Cleared Indications:

  • The EkoSonic®Endovascular Device is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EkoSonic®System is cleared for the infusion of solutions into the pulmonary arteries.


Contraindications:

  • Not designed for peripheral vasculature dilation purposes. The system is contraindicated when, in the medical judgement of the physician, such procedure may compromise the patient’s condition. See device instructions for use for complete prescribing information.


The CE Mark (CE0086) has been affixed to the EkoSonic® and MicroSonicTM products with the following indications for use:

Peripheral Vasculature

The EkoSonic®Endovascular Device, consisting of the IntelligentDrug Delivery Catheter (IDDC) and the MicroSonicTM Device (MSD), is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic®Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent.
The MicroSonicTM SV Endovascular Device is intended for the controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.

Pulmonary Embolism

The EKOS EkoSonic®Endovascular System is intended for the treatment of pulmonary embolism patients with ≥ 50% clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure ≥ 25mmHg) or echocardiographic evaluation.

 

Notes to Editors
Submassive Pulmonary Embolism (PE) definition – patients with pulmonary embolism that have normal systemic blood pressure and confirmed heart dysfunction.

Massive Pulmonary Embolism (PE) definition – patients with pulmonary embolism that have systemic hypotension (systemic blood pressure that is <90 mmHg) and confirmed heart dysfunction.

rt-PA – recombinant tissue plasminogen activator – a recombinant protein involved in the breakdown of blood clots.

RV/LV ratio is the extent to which right ventricle is dilated in relation to the left ventricle. Also known as an indicator for the right heart dysfunction.

PE occurs in approximately 1 million patients in Europe annually and 600,000 in the US, causing or contributing to 200,000 deaths each year. (According to http://www.sirweb.org/patients/deep-vein-thrombosis/and company internal data.)

Pulmonary hypertension (PH) is increased pressure in the pulmonary arteries. These arteries carry blood from heart to lungs to pick up oxygen. It causes symptoms such as shortness of breath during routine activity, tiredness, chest pain, and a racing heartbeat.

PEITHO trial - this trial confirmed the benefit of thrombolytic therapy among submassive PE patients, but also demonstrated that systemic IV infusion of thrombolytic drugs carries significant bleeding risk. 

Syncope – transient loss of consciousness.

References:

1.     Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER), Goldhaber et al. Lancet. 1999 Apr 24;353(9162):1386-9.

BTG announces Varithena® data demonstrating continued improvement at one year at the American Venous Forum Annual Meeting
Release Date: 21/02/2014

Data show clinically meaningful, ongoing improvements in patients with varicose veins caused by saphenofemoral junction incompetence

London, UK, 21 February 2014: Today at the 26th Annual Meeting of the American Venous Forum in New Orleans, LA, Dr. Kenneth Todd, an American College of Phlebology Committee Member from the Southeast Vein and Laser Center and a Principal Investigator for VANISH-2, presented one-year data from the VANISH-2 clinical trial, one of the two pivotal trials for Varithena® (polidocanol injectable foam). Varithena®, which was developed by the specialist healthcare company BTG, received US approval from the FDA in November 2013 for the treatment of varicose veins caused by saphenofemoral junction (SFJ) incompetence. Commercial launch in the US is planned in the second quarter of this year.

One-year results from VANISH-2, a study in which patients with symptomatic and visible varicose veins caused by saphenofemoral junction (SFJ) incompetence were treated with Varithena®, indicate that treatment with Varithena® led to clinically meaningful and ongoing improvements in symptoms, as measured by the VVSymQ® score.

The VVSymQ®electronic daily diary is the first and only patient-reported outcomes instrument that measures the burden of varicose vein symptoms developed in accordance with FDA guidelines. The VVSymQ®score measures the five most relevant symptoms to patients: heaviness, achiness, swelling, throbbing, and itching. VVSymQ®scores range from 0 to 25, where 0 represents no symptoms and 25 represents all 5 symptoms experienced all of the time.

At baseline, 12% of patients treated with Varithena® 1% reported a VVSymQ®score of 3 or less, whereas 84% of patients reported a VVSymQ®score of 3 or less at Year 1. The mean improvement in VVSymQ®score relative to baseline was 4.7 points at Week 8 and 6.2 points at Year 1.

Continued improvement at Year 1 was also shown in:

 

  • Appearance, as measured by a blinded independent panel review of photographs (IPR-V3) and a patient-reported outcome instrument (PA-V3),
  • Disease severity, as measured by the Venous Clinical Severity Score (VCSS), and
  • Varicose vein-related quality of life, as measured by the Venous Insufficiency Epidemiological and Economic Study−Quality of Life (VEINES-QOL) score.

 

Serious adverse events reported in the long-term follow-up period were typical of those that would be expected of the patient population studied and were unrelated to treatment. “The one-year data from VANISH-2 are important because they show that clinically meaningful improvements in symptoms and appearance are sustained one year after treatment,” said Dr. Kenneth Todd, MD, “On-going improvements as shown in the VANISH-2 analysis support the recent FDA approval of Varithena®, which offers a new treatment option for patients with varicose veins.”

About Varithena®
Varithena® (polidocanol injectable foam) is the first and only FDA–approved foam for the treatment of incompetent veins and visible varicosities of the great saphenous vein (GSV) system. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.1 Varithena® is a low-nitrogen (less than 0.8%) foam with controlled properties for consistent performance. Varithena® has been studied in over 1,300 patients in 12 clinical trials, including two Phase III placebocontrolled trials, VANISH-1 and VANISH-2.

About BTG
BTG is an international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at www.btgplc.com.

IMPORTANT SAFETY INFORMATION ABOUT VARITHENA®
For more complete information about the use of Varithena®, please see the full Prescribing Information available at Varithena.com.

Indications
Varithena® (polidocanol injectable foam) is a prescription medicine used to treat varicose veins and the associated affected veins in the great saphenous vein (GSV) system. Varithena® can be used to treat veins above and below the knee. Varithena® improves varicose vein symptoms and appearance.

IMPORTANT SAFETY INFORMATION FOR PATIENTS
Varithena® is administered by a doctor and is for intravenous use only in the affected veins. Doctors must be trained in the administration of Varithena®.

You should not receive Varithena® if:

  • you have a known allergy to polidocanol,
  • you have an acute vein or blood clotting disease, or
  • you are pregnant.

 

Warnings and Precautions
Because severe allergic reactions, including anaphylactic reactions, have occurred with other forms of polidocanol, patients should be observed for such reactions for at least 10 minutes following injection with Varithena®.

Injection of polidocanol into arteries or into the tissue outside the vein can cause severe necrosis, ischemia, or gangrene. If Varithena® is injected into an artery, a vascular surgeon should be consulted immediately.

Varithena® can cause blood clots (venous thrombi). Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing blood clots.

Drug Interactions
No specific drug interaction studies have been performed. There are no known drug interactions with Varithena®.

Adverse Reactions
In clinical trials, the most common side effects (occurring in 3% or more of patients treated with Varithena®) were leg pain/discomfort, retained coagulum (pocket of blood in the treated vein), injection site hematoma (bruise) or pain, superficial thrombophlebitis (clot in a superficial vein) and extravasation (accidental administration of drug outside the vein).

References:
1. Varithena® prescribing information. Provensis Ltd, a BTG International group company. November 2013.

Varithena® is a trademark of Provensis Ltd. VVSymQ, BTG, and the BTG roundel logo are registered trademarks of BTG International Ltd. Provensis Ltd and BTG International Ltd are BTG International group companies.

For further information please contact:

BTG
Ashley Tapp, Communications Manager, UK/Europe
+44 (0)20 7575 1513
Mobile: +44 (0)7790 811554
ashley.tapp@btgplc.com

Vox Medica
Courtney Prizer, Account Supervisor, United States
267-322-1181
cprizer@voxmedica.com          

Melissa Scherkoske, Senior Vice President, United States
215-817-6399
mscherkoske@voxmedica.com

Pulmonary Embolism Trial Comparing Endovascular Ultrasound to Standard of Care Anticoagulation Published in the American Heart Association’s Journal, Circulation
Release Date: 20/01/2014

Experts Agree Published Study May Change Treatment Paradigm for Pulmonary Embolism

Pulmonary Embolism Trial Comparing Endovascular Ultrasound to Standard of Care Anticoagulation Published in the American Heart Association’s Journal, Circulation

Experts Agree Published Study May Change Treatment Paradigm for Pulmonary Embolism

Miami, FL, US: 20 January 2014: EKOS® Corporation, a BTG International group company (BTG plc (LSE: BTG)), located in Bothell, Washington in the United States, today announced the publication of the results of its Ultrasound Accelerated Thrombolysis of Pulmonary Embolism (PE) trial (ULTIMA) in the peer-reviewed journal of the American Heart Association, CIRCULATION. The announcement was made at The International Symposium on Endovascular Therapy (ISET) in Miami, Florida in the United States.

The ULTIMA study is the world’s first and only prospective randomized controlled clinical trial of patients with submassive PE treated with either standard of care intravenous anticoagulation or the EKOS® EkoSonic® Endovascular SystemM and rt-PA (Actilyse®, Boehringer Ingelheim). EKOS®’ unique technology uses ultrasound to accelerate the action of clot-dissolving drugs. Dr. Nils Kucher, Director of the Venous Thromboembolism Research Group at the University Hospital in Bern, Switzerland, is the lead author and principal investigator of the ULTIMA study.

In the ULTIMA study, patients treated with the EKOS® EkoSonic® Endovascular System demonstrated a statistically significant reduction in right heart strain within 24 hours with no adverse effects from the catheterization, whereas the patients treated only with the anticoagulant heparin showed no significant improvement. In the EKOS® group, the mean RV/LV ratio was reduced from 1.28±0.19 at baseline to 0.99±0.17 at 24 hours (p<0.001); in the heparin group, mean RV/LV ratio was 1.20±0.14 and 1.17±0.20, respectively (p=0.31). The mean decrease in RV/LV ratio from baseline to 24 hours was 0.30±0.20 versus 0.03±0.16 (p<0.001), respectively. There were no serious bleeding events in either group. There was one death in the non-EKOS® group within 90 days for reasons other than PE.

For PE patients at intermediate risk of bad outcomes, the ULTIMA trial demonstrated that EKOS® treatment was clinically superior to anticoagulation with heparin alone in reversing right ventricular dilation at 24 hours, without an increase in bleeding complications.

Dr. Barry Katzen, Medical Director, Baptist Cardiac and Vascular Institute (Miami, FL), said, “The outcome and safety data are compelling. This study suggests we should be employing a more aggressive therapeutic approach to these patients with life threatening pulmonary emboli.”

Dr. Victor Tapson, Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, commented, “The ULTIMA study targets a patient population that is under-recognized and under-treated. Findings of the study support the role of the EKOS® catheter-based technique as a treatment option for these patients in need.”

Matt Stupfel, General Manager at EKOS® Corporation, added, “PE occurs in approximately 1 million patients in Europe annually (600,000 in the US), causing or contributing to 200,000 deaths each year.” Stupfel concluded, “The findings in this study will give hope to patients worldwide who may face chronic pulmonary hypertension or death, if inadequately treated.”

For further information please contact:

BTG
Andy Burrows, Corporate and Investor Relations
+44 (0)20 7575 1741

Mobile: +44 (0)7990 530605
(For UK corporate and investor enquiries)

PTM Healthcare Marketing
Pauline T. Mayer, President
+1 631 979 3780
(For US trade and media enquiries)About BTG

 

BTG is a growing international specialist healthcare company that is developing and commercialising products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. To find out more about the BTG International group companies and our products, visit www.btgplc.com.

About EKOS® Corporation and the EkoSonic® Endovascular System

EKOS® Corporation, a BTG International group company, pioneered the development and clinical application of ultrasound infusion technologies in medicine, introducing its first system for the treatment of vascular thrombosis in 2005. Today, interventional radiologists, cardiologists, cardiothoracic and vascular surgeons at leading institutions around the world use the EKOS® EkoSonic® Endovascular System to provide faster, safer and more complete dissolution of thrombus. To find out more about the EKOS® EkoSonic® Endovascular System, visit www.ekoscorp.com.

EKOS® and the EKOS® logo are the trademarks of EKOS® Corporation, a BTG International group company. BTG and the BTG roundel are registered trademarks of BTG International Ltd in US, EU and certain other territories and trademarks of BTG International Ltd elsewhere.

Statements of indications:
USA FDA Cleared Indications:
The EkoSonic® Endovascular Device is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EkoSonic® System is cleared for the infusion of solutions into the pulmonary arteries.
Contraindications:
Not designed for peripheral vasculature dilation purposes. The system is contraindicated when, in the medical judgement of the physician, such procedure may compromise the patient’s condition. See device instructions for use for complete prescribing information.

The CE Mark (CE0086) has been affixed to the EkoSonic® and MicroSonicTM products with the following indications for use:
Peripheral Vasculature
The EkoSonic Endovascular Device, consisting of the Intelligent Drug Delivery CatheterTM (IDDC) and the MicroSonic Device (MSD), is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent.
The MicroSonic SV Endovascular Device is intended for the controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
Pulmonary Embolism
The EKOS® EkoSonic Endovascular System is intended for the treatment of pulmonary embolism patients with ≥ 50% clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure ≥ 25mmHg) or echocardiographic evaluation.

Notes to Editors

Submassive Pulmonary Embolism (PE) definition – patients with pulmonary embolism that have normal systemic blood pressure and confirmed heart dysfunction.

rt-PA – recombinant tissue plasminogen activator – a recombinant protein involved in the breakdown of blood clots.

RV/LV ratio is the extent to which right ventricle is dilated in relation to the left ventricle. Also known as an indicator for the right heart dysfunction.

PE occurs in approximately 1 million patients in Europe annually (600,000 in the US), causing or contributing to 200,000 deaths each year. (According to http://www.sirweb.org/patients/deep-vein-thrombosis/ and company internal data.)                                           

BTG plc: FDA approves Varithena® (polidocanol injectable foam) for the treatment of patients with varicose veins
Release Date: 26/11/2013

London, UK, 26 November 2013: BTG plc (LSE: BTG), the specialist healthcare company, today announces that the US Food and Drug Administration (FDA) has approved Varithena® (polidocanol injectable foam) for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system.1

Varithena® (formerly known as Varisolve® PEM) is a pharmaceutical-grade, low-nitrogen, polidocanol foam dispensed from a proprietary canister device. In two pivotal, placebo-controlled Phase III trials, VANISH-1 and VANISH-2, Varithena® achieved a clinically meaningful improvement in the symptoms of superficial venous incompetence and the appearance of visible varicosities and addressed the underlying venous incompetence in the majority of patients treated.

More than 30 million adults in the US aged 18 to 70 have varicose veins, with women twice as likely as men to develop varicosities. Varicose veins often require treatment for symptoms including leg pain, aching, heaviness, restless legs, cramps, throbbing, fatigue, itchiness, tingling and oedema. These symptoms are frequently the cause of absenteeism from work, disability and decreased quality of life.2

Current treatments for varicose veins include thermal ablation and surgery. Varithena® provides US physicians with the only approved comprehensive therapy to improve symptoms and appearance for a wide range of varicose veins, including incompetent GSV, accessory saphenous veins and visible varicosities of the GSV system both above and below the knee. Treatment is a minimally invasive, non-surgical procedure that requires neither tumescent anesthesia nor sedation.

Louise Makin, CEO at BTG, said: “We are delighted to receive US approval for Varithena®, which we believe sets a new standard for the treatment of both the symptoms and appearance of varicose veins. We look forward to the commercial US launch in the second quarter of 2014, and to continuing to advance our plans to expand use into other geographies and into non-symptomatic veins.”

IMPORTANT INFORMATION

INDICATIONS
Varithena® (polidocanol injectable foam) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

IMPORTANT SAFETY INFORMATION
For intravenous use only. Varithena® is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities.

Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena®.

Contraindications
The use of Varithena® is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.

Warnings and Precautions
Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.

Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.

Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis.

Adverse Reactions
In clinical trials, the most common related adverse events (occurring in ≥3% of patients treated with Varithena®) were pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial, and extravasation.

Use in Specific Populations
Pregnancy Category C. Do not use Varithena® in pregnant women.

See Full Prescribing Information for Varithena® online at Varithena.com.

References:

  1. Varithena® prescribing information. BTG International Inc. November 2013.
  2. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53(5 Suppl):2S-48S.

For further information please contact:

BTG
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741

Mobile: +44 (0)7990 530605

Rolf Soderstrom, Chief Financial Officer
+44 (0)20 7575 0000

FTI Consulting
Ben Atwell
+44 (0)20 7831 3113

 

 About BTG

BTG is an international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at www.btgplc.com.                                         

TheraSphere® Recommended by the National Institute for Health and Care Excellence (NICE) for the Treatment of Primary and Secondary Liver Cancer
Release Date: 30/07/2013

London, UK, 30 July 2013: BTG plc (LSE: BTG), the specialist healthcare company, today announces that the National Institute for Health and Care Excellence (NICE) has issued guidance recommending the use of Selective Internal Radiation Therapy (SIRT)1, which includes TheraSphere®, for patients with liver cancer across the NHS. The guidance supports the use of this innovative treatment for patients with primary hepatocellular carcinoma as well as for those with intrahepatic cholangiocarcinoma2 and follows the previous recommendation for its use in patients with colorectal cancer liver metastases3.


The NHS in England is currently preparing guidelines on how SIRT should be used as a treatment option for patients with liver cancer, including those with colorectal cancer liver metastases and cholangiocarcinoma, after recently issuing an interim policy on how this therapy should be funded4. It is anticipated that this latest NICE guidance will result in a similar evaluation for patients with primary liver cancer. “NICE’s guidance further highlights the growing acceptance and understanding of radioembolization in the treatment of liver cancer,” said Peter Pattison, General Manager TheraSphere®. “With over 4,000 new liver cancer cases diagnosed annually in the UK5, this new guidance will potentially provide patients with access to a broader range of treatment options.”


Pattison added: “With many countries looking to the UK for direction on their own reimbursement decisions and processes, this guidance should lead to greater awareness amongst physicians and patients and may also prompt similar guidance in other geographies. In addition to increasing liver cancer treatment options for physicians and patients in the UK, this guidance will assist BTG as we continue to explore other reimbursement opportunities in various regions across the world.”


About TheraSphere®


TheraSphere®is a form of radioembolization therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90 (Y-90). The product is injected by physicians into the artery of the patient’s liver through a catheter, which allows for a high dose of radiation to be delivered directly to the tumour via blood flow thereby limiting the damage to surrounding healthy tissue and side effects to the patients.


TheraSphere®is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters. Since its introduction in Europe, more than 1,000 patients have been treated with TheraSphere®.


Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere® package insert/instructions for use at www.therasphere.com


1 National Institute of Care Excellence. IPG460 Selective internal radiation therapy for primary hepatocellular carcinoma: guidance. London. 24 July 2013.
2 National Institute of Care Excellence. IPG459. Selective internal radiation therapy for primary cholangiocarcinoma. London. 24 July 2013.
3 National Institute of Care Excellence. IPG401. Selective internal radiation therapy for non-resectable colorectal metastases of the liver: guidance. London. July 2012 (updates May 2013).
4 NHS England. Interim Clinical Commissioning Policy Statement: Selective Internal Radiotherapy (SIRT). June 2013. 5 http://www.cancerresearchuk.org/cancer-info/cancerstats/types/liver/

For further information please contact:

BTG  
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741
Mobile: +44 (0)7990 530605

FTI Consulting    
Ben Atwell/Simon Conway
+44 (0)20 7831 3113 

 

About BTG

BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and varicose veins. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at www.btgplc.com.

BTG Announces Positive Results from VANISH-2 Study Data Published in the Journal Phlebology
Release Date: 25/07/2013

Full data show a clinically meaningful reduction in symptom burden in patients with varicose veins caused by saphenofemoral junction incompetence

London, UK, 25 July 2013: BTG, the specialist healthcare company, today announced the online publication of VANISH-2, a study in which patients with symptomatic and visible varicose veins caused by saphenofemoral junction (SFJ) incompetence were treated with polidocanol endovenous microfoam (PEM).

VANISH-2, the first of two US pivotal Phase III trials of PEM, was published online in the journal Phlebology (PHL) on July 17, 2013. The first author, Dr. Kenneth Todd, MD, an American College of Phlebology Committee Member from the Southeast Vein and Laser Center, was a Principal Investigator for VANISH-2.

Full data from the published study indicate that PEM provides a clinically meaningful benefit in treating symptoms and appearance in patients with varicose veins caused by SFJ reflux. The study achieved all primary, secondary and tertiary efficacy endpoints in patients with vein diameters ranging from 3.1 to 19.4 mm.

Patients treated with PEM demonstrated a statistically significant improvement in symptoms at week 8, the study primary endpoint as measured by the VVSymQ score, compared with patients who received placebo (P<0.0001). The VVSymQ score is a patient-reported outcome measure of varicose vein symptom burden. The study’s co-secondary endpoint, improvement of appearance as measured by both a patient-reported outcome (PA-V3) and by a blinded independent panel review of photographs (IPR-V3), was also met. Patients treated with PEM achieved a statistically significant improvement in appearance in both the PA-V3 and IPR-V3 scores compared with patients who received placebo (P<0.0001 for both).

At week eight, eight out of 10 patients in the pooled PEM group (composed of PEM 0.5% and PEM 1.0%) reported clinically meaningful improvements in symptoms compared to 20 percent in the placebo group. Additionally, treatment with PEM was superior to placebo in improving symptoms when either a duration or intensity scale was used to measure patients’ symptoms. The improvement in symptoms was supported by statistically significant improvements in the Venous Clinical Severity Score (VCSS) and Venous Insufficiency Epidemiological and Economic Study−Quality of Life (VEINES-QOL) score compared to placebo.

Elimination of SFJ reflux and/or complete occlusion of the target vein(s) at week eight, a tertiary endpoint, was achieved by 85 percent of patients in the pooled PEM group (P=.0002, compared with the control group PEM 0.125%). This endpoint was achieved in 83 percent and 86 percent of patients receiving PEM 0.5% and PEM 1.0%, respectively.

There were no serious or unexpected adverse events associated with the use of PEM. No pulmonary emboli were detected and no clinically important neurologic or visual adverse events were reported. Of the 230 PEM-treated patients (including open-label patients), 60 percent had an adverse event compared with 39 percent of placebo; 95 percent were mild or moderate. The most common adverse events in patients treated with PEM were retained coagulum, leg pain and superficial thrombophlebitis; most were related to treatment and resolved without sequelae.

“VANISH-2 is an important study because it is the first time improvement in symptoms has been shown using a patient-reported outcome measure in a randomized controlled clinical trial in patients with varicose veins,” said Todd. “The publication of the full results for VANISH-2 demonstrates that PEM, if approved, could offer a new treatment option for patients with symptomatic varicose veins.”

PEM is a patent-protected experimental drug/device combination product that produces engineered polidocanol endovenous microfoam and was manufactured in accordance with GMP standards for the clinical trial. PEM is delivered from a canister through a syringe into the incompetent vein under ultrasound guidance. PEM first displaces blood and then the polidocanol chemically ablates the inner lining of the vein wall, causing the vein to close. A compression bandage and stocking are worn continuously for the first 48 hours, and the compression stocking only is worn day and night for an additional 12 days.

For further information please contact:

BTG
Ashley Tapp, Communications Manager, UK/Europe
+44 (0)20 7575 1513; Mobile: +44 (0)7790 811554
ashley.tapp@btgplc.com

Vox Medica
Courtney Prizer, Account Supervisor, United States
215-446-8049
cprizer@voxmedica.com

About BTG

BTG is an international specialist healthcare company that is developing and commercializing products targeting critical care, cancer and varicose veins. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programs and products to develop and market to specialist physicians. For further information about BTG please visit our website at www.btgplc.com

EVENTS IN
INTERVENTIONAL MEDICINE:

14/11/2014
Synergy (University of Miami)
Miami Beach, FL

lcbeadtherasphere
17/11/2014
AIM / VEITH
New York, NY

ekoslcbeadtheraspherevarithena

OUR INTERVENTIONAL
MEDICINE PORTFOLIO:

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DC BeadM1
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+1 877 626 9989 (Toll Free)        +1 800 268 5299

beads@biocompatibles.com

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TheraSphereCustomerSupport@btgplc.com

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© BTG International Ltd 2014 All rights reserved.
DC Bead, LC Bead and Bead Block are trademarks and/or registered trademarks of Biocompatibles UK Ltd. EKOS, the EKOS logo and EkosSonic are trademarks and/or registered trademarks of EKOS Corporation. TheraSphere is a trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd. Varithena is a registered trademark of Provensis Ltd. “See More, Reach Further, Treat Smarter” and “Imagine where we can go.” are trademarks of BTG International Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. Biocompatibles UK Ltd, EKOS Corporation and Provensis Ltd are BTG International group companies. For full prescribing information please click here:
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