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| The Science of FzioMed |
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FzioMed develops, manufactures, and commercializes absorbable medical devices created from our patented polymer science. We are pioneering the development of advanced biomaterials to improve the outcomes of procedures in the fields of spine/orthopedics, gynecology/general surgery and aesthetic surgery.
FzioMed's science is based on the combination of well-studied, biocompatible medical polymers, carboxymethylcellulose (CMC) and polyethylene oxide (PEO). These polymers are used separately in pharmaceuticals, medical devices, and nutritional products. Combined together, they make an ideal and versatile technology platform with key advantages over other biomaterial technologies.
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| Advantages |
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The viscoelastic properties of FzioMed biomaterials allow us to design medical products that overcome the shortcomings of other biomaterials.
Key characteristics of FzioMed's biomaterial science:
Non-Animal and Non-Bacterial. FzioMed biomaterials contain no animal or bacterial by-products.
Biocompatible. Pre-clinical and clinical data have demonstrated the safety and biocompatibility of FzioMed biomaterials when used in a variety of surgical procedures. The polymers CMC and PEO have been used extensively for decades in the medical device and pharmaceutical industries. Over 100,000 spine surgery patients have been treated safely with our world-leading Oxiplex Gel.
Bioabsorbable. FzioMed biomaterials are naturally absorbed by the body over time and cleared via normal processes. They do not need to be removed after application.
Tissue Adherent. FzioMed biomaterials can be formulated to adhere to tissues, so that they remain in place for a period of time for site-specific applications.
Versatile. FzioMed biomaterials can be formulated into a variety of bioabsorbable product types - gels, films, solutions, foams, sponges, and powders - with specific characteristics such as tissue adherence, elasticity, strength, viscosity and absorption. This allows us to tailor products for use in targeted medical applications.
Handling, Packaging & Storage. FzioMed products can be stored at room temperature and are provided sterile and ready to use. They require no mixing or assembly before use.
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| Focus: Tissue Protection |
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A key corporate focus is the development of biomaterials used intraoperatively (during surgery) to protect tissues within a surgical site.
FzioMed products for tissue protection include Oxiplex/SP Gel. Outside the United States, Oxiplex/SP is the leading adhesion barrier for spine surgery. The viscoelastic and bioabsorbable properties of Oxiplex/SP Gel, together with studies that show that it does not interfere with normal healing processes, support its use as an intraoperative, protective coating around traumatized tissues in lumbar spine surgery. FzioMed sells Oxiplex/SP outside the U.S. through world-class distributors.
In the U.S., FzioMed has completed clinical trials of Oxiplex as an intra-operative gel used in lumbar spine surgery for the reduction of postoperative pain and neurological symptoms.
For abdominal and pelvic surgery, FzioMed developed a site-specific, absorbable gel for adhesion prevention. This FzioMed product is distributed by Ethicon Women's Health and Urology, a division of ETHICON, Inc, a Johnson & Johnson company, under the trade name ETHICON INTERCOAT*. ETHICON INTERCOAT is a clear, flowable gel applied during surgery as a temporary coating barrier to separate apposing tissues that could potentially develop into adhesions after surgery. ETHICON INTERCOAT is currently available in Europe, Middle East and Africa.
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| Soft Tissue Augmentation |
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FzioMed's Laresse Dermal Filler is an injectable space-filling gel indicated for the correction of facial soft tissue contour deficiencies such as wrinkles, nasolabial folds and lip enhancement. Laresse is a clear, smooth, non-permanent gel designed as an alternative to hyaluronic acid and collagen fillers. Laresse is currently available in the European Union.
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| New Developments at FzioMed |
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We are actively expanding the research of our technology for new surgical and medical applications, including:
Osteoarthritis Osteoarthritis is the most common type of arthritis and the most common chronic disease affecting the elderly. FzioMed is developing a gel with cushioning properties similar to the body's synovial fluid, as an injectable treatment for osteoarthritic joints.
Drug Delivery FzioMed biomaterials are absorbed over time, making them ideal candidates for indications requiring the delivery of drugs. Potential applications include the stimulation of bone growth and cartilage repair, and the control of pain, infection or inflammation, using our technology to develop a synthetic, absorbable carrier for an active substance. In 2005, FzioMed acquired the exclusive, worldwide rights to a broad portfolio of patents and intellectual property covering synthetic peptides for the regeneration of bone, cartilage and skeletal tissue. We have been studying these peptides, in combination with our gel technology as a delivery vehicle, for use in spine and orthopedic surgery applications. The promising results of these preclinical studies, demonstrating effective, local drug delivery, have been reported at leading surgical congresses.
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Oxiplex
Bioabsorbable Gel
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