BTG plc Release: Varithena Earns FDA Approval For 30 Day Post-Activation Shelf Life

WEST CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--BTG plc (LSE:BTG), the specialist healthcare company, announced that the U.S. Food and Drug Administration has approved an extension of the post-activation shelf life of Varithena (polidocanol injectable foam) 1% to thirty days from seven.

“It highlights our continued work to provide a non-thermal chemical ablation solution that best fits practices’ needs.”

“This approval provides physicians with greater flexibility,” said John Sylvester, Corporate Development Officer for BTG. “It highlights our continued work to provide a non-thermal chemical ablation solution that best fits practices’ needs.”

“Varithena has become an important part of my practice, in particular for patients with tortuous or difficult to treat veins, or for patients that do not want to undergo thermal ablation,” said Dr. Brian Ferris, Chief of Surgery, Overlake Hospital Medical Center. “With the FDA’s approval of a longer shelf life – once I have activated the canister - I have more flexibility in scheduling patients. This will help ensure that more patients who can benefit from Varithena will get the treatment.”

The update enhances the ease of scheduling for a comprehensive, above and below the knee solution for great saphenous vein system incompetence and for veins that other procedures cannot reach effectively. Physicians can adapt the Varithena procedure to the unique demands of their practice both in terms of timing of procedures, and the wide range of vein sizes and shapes they can treat, including tortuous veins and visible varicosities.

Varithena’s UDSS formulation with Uniform Density, Size and Stability results in a long dwell time and thorough cohesion with the vein wall. It addresses underlying venous incompetence, improves vein appearance and shows significant improvements with an established safety profile. Tumescent anesthesia is avoided, and a cohesive, low-nitrogen microfoam allows for consistent performance.

About BTG

BTG is a growing international specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of liver tumors, severe blood clots, varicose veins and advanced emphysema, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today’s most complex healthcare challenges. To learn more about BTG, please visit: 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.

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