Softcup Coverage
La Jolla, Calif. (January 25, 2008) – In 1996, Instead, Inc. pioneered a new alternative to tampons and pads with the development and release of its innovative Softcup. Now in 2008, Instead is proud to announce that it has sold its 100 millionth Softcup.
Originally developed and introduced by a female athlete, for female athletes, the Softcup has gained popularity for its many advantages over traditional methods of feminine protection including greater safety, longer wear-time, and clean sex during “that time of the month.” After hearing numerous accounts of mothers who had successfully become pregnant using the Softcup as an aid to conception, Instead filed for FDA clearance to market and sell the cup for this purpose. Additionally, studies are now being conducted on the use of the Softcup as a cervical barrier along with Instead’s candidate microbicide, Amphora.
“Because the Softcup was uniquely designed for the modern-day woman, it has grown tremendously and developed staying power in the market, proving an excellent alternative to tampons and pads,” said Joseph Pike, CEO of Instead. “Women have embraced the concept of the Softcup because of the greater flexibility and control it gives them over their lives.” In fact, when the Softcup is not offered somewhere, women seek it out rather than buy the alternatives.
The Softcup is an FDA-approved, disposable menstrual product made from a non-absorbent, nonirritating polyethylene plastic that has been used for over 20 years in medical devices and contains no latex. It has undergone extensive toxicology, biocompatibility and microbiological tests as well as human clinical testing, and contains no drying chemicals or fibers. There is also little to no risk of Toxic Shock Syndrome, since it collects rather than absorbs flow.
“We continue to hear from women who are just discovering the Softcup,
Tuesday August 01, 2006 12:00 pm ET
Tommy Thompson Chairs Instead Sciences
LA JOLLA, Calif.--(BUSINESS WIRE)--Aug. 1, 2006--Local women's health company Instead Inc. and Tommy Thompson have formed a new company called Instead Sciences, Inc. to complete the final stage of clinical trials, product development and market launch of its promising microbicide Amphora(TM) (clinically known as Acidform).
"Amphora--which already has FDA safety clearance for human use--is in the best position to be the first approved microbicide that will be available over-the-counter to protect women from HIV/AIDS," Thompson said. "By forming a company to focus exclusively on its testing and development, we think we can be to market first."
Worldwide, the market for a woman-controlled, over-the-counter microbicide/contraceptive is estimated to be $10 billion, according to a report commissioned by the European Union Commission on HIV/AIDS and presented at the Geneva World AIDS Conference in 1998. The report estimated that the U.S. market would be $900 million.
"Up until now, all of the research and development costs have been funded by government and private foundation grants," explained Instead President Joe Pike. "Now we are going to raise private capital so we can coordinate the final steps required to bring the product to market."
Read more...Women’s Health Company Files 510(k) Device Clearance
To Include Marketing Product for Fertility
La Jolla, CA (January 24, 2006) – Women’s health company Instead Inc. filed a 510(k) application with the U.S. Food and Drug Administration (FDA) this week to obtain clearance to market its Instead Softcup product as an over-the-counter (OTC) fertility aid. A decision from the FDA is expected within 90 days.
The move to seek new claims on the Softcup, currently marketed as a feminine hygiene product, was stimulated by an underground movement of Softcup users. These women were employing the product as an internal device to hold semen close to the cervix. Instead vice president and general manager, Teri Hirschfeld, said the trend was first discovered in letters from users and on the company’s online message boards at www.softcup.com.
“These users, who represent a portion of the one in ten people of reproductive age affected by infertility, were seeking a simple and affordable option before going to more extreme measures,” Hirschfeld said.