Vertessa Lite Launch

Caldera Medical Announces FDA Clearance for new generation of Vertessa® Lite Polypropylene Mesh for Sacrocolpopexy

Device Maker Continues to Broaden Product Portfolio with a Unique Blue, Lightweight, Flexible yet Strong, Mesh for Sacrocolpopexy.

AGOURA HILLS, CA, July 1, 2015 – Caldera Medical, a medical device company leading the development of innovative abdominally placed products for Pelvic Organ Prolapse, announced the release of an improved Vertessa® Lite mesh that is lightweight, flexible and strong for sacrocolpopexy procedures. Vertessa Lite is a large pore, monofilament, polypropylene mesh that is uniquely blue in color for exceptional visibility. The new Vertessa Lite is lighter, weighing only 20.9 g/m2. The new Vertessa Lite is also 31% stronger than the market-leading mesh with a suture pull-out strength that is 32% greater. In addition, Vertessa

Lite also boasts larger pores of approximately 1500 microns. Large pore and lightweight mesh is widely recognized to improve host tissue acceptance, while strength and flexibility is important for the durability of the repair. The new Vertessa Lite will be offered in configurations including Y-mesh, flat mesh sheets and mesh strips.

Pelvic Organ Prolapse is the condition in which one or more pelvic organs bulges or herniates into or out of the vagina. According to several studies, 40% of women have some form of prolapse and it is estimated that up to 250,000 surgical procedures are performed each year to treat Pelvic Organ Prolapse. A sacrocolpopexy procedure restores the vagina to its normal position to correct the prolapse of the vaginal vault in women who have had a previous hysterectomy. Abdominal sacrocolpopexy with mesh placement is considered to be one of the most effective surgical procedures with one of the highest long-term success rates for vaginal vault prolapse.

“As part of our continuous product development efforts we are excited to announce the launch of a new generation of Vertessa Lite,” commented Bryon Merade, CEO of Caldera Medical, adding, “our mission is to improve the quality of life for women and every day we work towards that goal. I am proud to say that we took another step forward with our new Vertessa Lite mesh for sacrocolpopexy, which will improve the quality of life for women suffering from Pelvic Organ Prolapse.”

About Caldera Medical

Caldera Medical is dedicated to improving the quality of life for women. Caldera Medical develops and markets differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence with its Desara Sling System and Pelvic Organ Prolapse with Vertessa Lite across the gynecology, urology and urogynecology specialties. Caldera Medical is a privately held company located in Agoura Hills, California.

Contact:
Caldera Medical, Inc.
Lavinia Kandy
Tel: 818-483-7614
[email protected]