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28632 Roadside Drive, Suite 260
Agoura Hills, CA 91301-6099 USA
phone:818.879.6555
fax:818.879.6556
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Private |
| Founded |
2002 |
| Employees |
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| www.calderamedical.com
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| Research Sector |
Medical Devices & Tech |
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| Summary Description |
| Sling Systems Counteracting Pelvic Floor Prolapse |
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| Management |
| Bryon L. Merade, CEO; Dov Tamler, VP of Business Development and Operations; Sandra Muhlfeld, Director of Marketing; Albert Beran, Director of Sales and Marketing, International Markets |
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| Keywords |
| women's health, womens, womenshealth, urology |
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| Description |
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Caldera Medical focuses exclusively on developing and marketing products in gynecology, urology, and urogynecology. The company's offerings are designed to support the pelvic floor muscles and to reduce or eliminate the occurrence of prolapse. Prolapse is a condition arising when weak muscles no longer provide adequate support for the pelvic floor area and/or genital tissues, thereby enabling the upper portion of a pelvic organ to descend within (or protrude outside of) the body. |
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| Products / Services |
Caldera's trademarked product pipeline includes: the Desara sling system for the treatment of female stress urinary incontinence and vaginal vault prolapse (the upper portion of the vagina drops into or outside the vaginal canal); the T-Sling with Centrasorb, a centimeter-wide absorbable central section placed directly under the urethra; and the Hydrix XM, a treatment for pelvic organ prolapse.
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| Technology / Differentiation |
| Desara is designed to meet surgeons' needs for open knit construction merging increased flexibility with stability. The mesh design of the sling system is constructed from large pore microfilament polypropylene, and its tapered tips enable optimal placement and help reduce tissue trauma. The sleeve design of Desara allows for precise tension adjustments, smooth guidance through tissue and mesh protection during implantation; a gap in the sleeve helps surgeons easily locate the center of the sling during placement. Centrasorb is composed of a polydioxanone suture weave that is absorbed in one hundred days. At that point, fibroblastic ingrowth of the mesh and central section provide support to patients with long-term incontinence while minimizing the opportunity for erosion. The Hydrix XM, derived from non-cross linked bovine pericardium, decellularizes and stabilizes the tissue immunologically; bovine cells are removed from the pericardium, while the extracellular matrix serves as a scaffold for human pelvic floor cell development. It is processed using the patented Veritas Collagen Matrix developed by Synovis Surgical Innovations. |
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| Market / Customers |
Prolapses occur only in women and become more common with increasing age, although one major study has found that half of the women seeking care are between 30 and 60 years of age. The United States currently spends over $10 billion per year on pelvic reconstructive surgery and $26 billion to manage urinary incontinence-a common symptom of prolapse-in patients over sixty-five years of age.
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| Status |
| Desara received CE Marking in September 2007. In January 2008, Caldera Medical signed a patent license agreement with Coloplast A/S granting Caldera sole custody of patent rights (among privately held companies) related to the transobturator method used to treat female stress urinary incontinence. |
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