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The latest information in the industry, including BioForm licensing U.S. rights to a leading European varicose vein treatment, Hercules Technology providing $10 million venture debt to Diomed Holdings, SIGVARIS announcing a new support therapy collection and more.
BioForm Licenses U.S. Rights to Leading European Varicose Vein Treatment
BioForm Medical, Inc., a privately held medical aesthetics company, announced in August that it entered into an exclusive licensing and distribution agreement in the United States with Chemische Fabrik KREUSSLER & Co. GmbH (Kreussler) for the development and commercialization of Aethoxysklerol®, the current leading sclerotherapy treatment in Europe for varicose veins. Aethoxysklerol is currently under clinical evaluation in a Phase III multi-center study for use in treating spider and reticular veins. This trial is designed to support U.S. Food and Drug Administration (FDA) approval requirements and is being conducted pursuant to a Special Protocol Assessment (SPA) with the FDA. Enrollment in this trial has been completed and BioForm and Kreussler intend to submit a New Drug Application (NDA) to the FDA in 2008, if the study is successful.
Aethoxysklerol is an injectable sclerosing solution which was developed by Kreussler in the early 1960s and has been used safely and effectively as the leading sclerotherapy injectable agent outside of the United States for more than 40 years. It is approved broadly outside of the United States in various concentrations for visible small to medium varicose veins, such as spider and reticular veins, and for larger varicose veins. During the last two decades, Aethoxysklerol has been used in more than 35–40 million patients, with several million patients undergoing treatment with this therapy each year. BioForm believes the key advantages of Aethoxysklerol are its active ingredient’s anesthetic properties and its low incidence of adverse events, such as necrosis and hyperpigmentation.
Under the terms of the agreement, Kreussler will be responsible for conducting the clinical trial and regulatory filings for approval of Aethoxyskerol by the FDA, and, assuming approval is received, will exclusively manufacture the product for BioForm following approval. BioForm will be the exclusive distributor of the product in the United States, responsible for all sales, marketing, and clinical training.
The American Society of Aesthetic Plastic Surgery reported that approximately 559,000 sclerotherapy procedures and about 158,000 laser vein removal procedures were performed in 2006. The rate of treatment in Europe, where Aethoxysklerol is the leading sclerotherapy agent, is substantially higher than in the United States.
For more information, visit www.bioformmedical.com
Hercules Technology Provides $10 Million Venture Debt to Diomed Holdings
Hercules Technology Growth Capital, Inc., the specialty finance company providing venture debt and equity to venture capital and private equity backed technology and life science companies at all stages of development, announced that on September 28, it provided a $10 million commitment of venture debt to Diomed Holdings, Inc. Diomed, a publicly traded developer and marketer of medical technologies, specializes in laser treatment for varicose veins.
“Laser treatment is acknowledged by the market as the most validated and efficacious treatment for varicose veins,” said Bryan Jadot, principal at Hercules. “Diomed’s record of strong revenue growth and its leadership position in a competitive market makes the company an ideal candidate for Hercules’ funding.”
Diomed’s EndoVenous Laser Treatment (EVLT) is a minimally invasive treatment for alleviating and eliminating varicose veins. The company was the first to introduce the diode laser for surgery and pioneered its use in EVLT. Diomed also offers Photo Dynamic Therapy (PDT) for cancer and pre-cancer treatments.
James A. Wylie, president and chief executive officer of Diomed, says, “The venture debt provided by Hercules will help support our operations and prospects for continued revenue growth.”
For more information, visit www.HTGC.com or www.diomed.com
SIGVARIS Annoucnes New Support Therapy Collection
SIGVARIS is proud to present the new Support Therapy Collection of hosiery and socks. This new product line was created to appeal to a broader consumer base, to appeal to a more energetic and active lifestyle. All support therapy products are designed to deliver 15–20 mmHg of controlled graduated compression to ensure medical efficacy.
The new SIGVARIS Support Therapy Collection introduces the elegant Sheer Fashion stocking, a brand-new addition to their quality line of over-the-counter hosiery that replaces the existing Classic 140 Delilah stockings. The Sheer Fashion hosiery is fashionably sheer and is ideal for tired, aching legs and swollen feet and ankles, as well as for post-vein therapy and sclerotherapy. In addition to new product, the SIGVARIS Support Therapy Collection features a new sheer hosiery sizing system developed to fit the sizes of today’s consumers. With this new sizing system, a comfortable fit is assured for every wearer, resulting in improved therapeutic benefits.
In addition, SIGVARIS is launching the Casual Cotton sock for men and women. Made with premium Supima® cotton for optimum softness and durability, the new Casual Cotton sock is available in classic black or white to match any wardrobe and is available as a 15–20 mmHg graduated compression sock. As with all SIGVARIS products, both the Sheer Fashion stocking and the Casual Cotton are ideal for travel.
The SIGVARIS Support Therapy Collection also commences the launch of redesigned product packaging. These new and updated box designs stand out on any shelf, clearly differentiate between men’s and women’s products and reflect the recent revision of the SIGVARIS corporate branding.
SIGVARIS medical therapy line is known for its premium quality, providing patients with effective solutions and highest user compliance for optimal therapeutic outcome. Using the unique Precise Fit Sizing System, SIGVARIS medical compression socks and hosiery deliver a custom fit and accurate therapeutic efficacy to users. SIGVARIS products are available in a wide range of styles, fabrics and colors to meet the contemporary lifestyle of men and women.
For more information, visit www.ganzoni.com
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Gary H. Dworkin, MD was born in Cleveland Ohio and is a board-certified cardiovascular and thoracic surgeon... (read more)
