Single-size Caya® contoured diaphragm is the first new diaphragm design to enter the US market in over 50 years

Contacts:
PATH: Claire Hudson, chudson@path.org, 206.302.4521
CONRAD: Annette Larkin, alarkin@conrad.org, 703.772.6427
Kessel medintim GmbH: Martin Kessel, kessel@medintim.de, +49 6105 203 720
HPSRx Enterprises, Inc.: Bob Patane, bob@hpsrx.com, 540.375.9380. http://www.caya.us.com/.

Seattle, June 25, 2015–With the launch of the Caya®* contoured diaphragm this June, women in the United States will have access to a method of contraception that is nonhormonal, has few side effects, and can be used for up to two years. Last fall, the United States Food and Drug Administration cleared the single-size Caya® contoured diaphragm for marketing in the US, and now the diaphragm is available by prescription from healthcare providers.

PATH, CONRAD, and research collaborators in the US and other countries developed this single-size diaphragm to expand women's options for nonhormonal barrier contraception. PATH first identified features that make traditional diaphragms that come in multiple sizes difficult to supply, provide, and use, and then addressed these issues through a user-centered design process. Women and their partners, as well as family planning providers, assessed prototypes and shared feedback to refine the design. Their insights resulted in design elements, such as a removal dome, that make this diaphragm easy for women to use, especially for new users. During product development and clinical studies, this technology was called the SILCS diaphragm.

Worldwide, nearly 225 million women who want to avoid pregnancy are not using modern contraception. In the US, nearly half of all pregnancies annually are unplanned. Providing women and couples with a range of contraceptive options allows them to find the methods that fit their needs. Some women cannot or do not want to use hormonal products. Other women do not have frequent sex and want a method that can be easily started and stopped that provides protection when needed. The Caya® diaphragm addresses several of these reasons for unmet contraceptive need.

In 2010, PATH licensed the SILCS technology to Kessel medintim GmbH (Kessel) to manufacture and commercialize the product. Kessel markets this as the Caya® contoured diaphragm, and, since 2013, the Caya® has been introduced in Europe, Canada, Malaysia, and Australia. Recently, Kessel selected HPSRx Enterprises, Inc., to introduce Caya® to the U.S.

"HPSRx is excited to bring the Caya® diaphragm to the U.S. market," said Bob Patane, founder of HPSRx. "In talking with family planning providers about this single-size diaphragm over the past few months, their eyes 'light up' when they hear that a new diaphragm is coming to market and no fitting exam is required. Reducing barriers at the provider level could help bring this new method to a whole new generation of women who have not known that diaphragms are even an option. We are working to ensure women will have access through clinics, pharmacies, and additionally offer mail order pharmacy options where we know product is in stock and ready for patient order fulfillment."

PATH's research collaborator CONRAD conducted multiple clinical studies that demonstrated the safety, acceptability, and effectiveness of the Caya® contoured diaphragm for women, helping facilitate US market clearance. The contraceptive effectiveness study showed the effectiveness is similar to that of a traditional, fitted diaphragm when both are used with a contraceptive gel.1 Similar to traditional diaphragms, the Caya® is inserted into the vagina before sex and prevents sperm from entering the uterus by covering the cervix. But unlike traditional diaphragms, Caya® is made of an innovative contoured nylon spring and has a silicone cup.

"Clinical studies confirm the single-size design fits most women who could wear a traditional diaphragm," said Gustavo Doncel, MD, PhD, scientific and executive director of CONRAD. "In the recently published contraceptive effectiveness study, 76 percent of women were able to insert and correctly position the diaphragm simply using instructions. With coaching, 94 percent of women were able to insert, correctly position, and remove the diaphragm. This should make it easier to provide and use consistently."

Reproductive health professionals have been watching the development of this product, and waiting for this announcement. "The Association for Reproductive Health Professionals (ARHP) supports the availability of a broad range of safe, effective contraceptive methods, so women can choose the method that is best for them," said Wayne C. Shields, president and CEO at ARHP. "We are excited the launch of this new diaphragm provides one more option to women."

"PATH has been working to improve access to high quality contraceptives for nearly 40 years," said David Kaslow, vice president of Product Development at PATH. "This multi-sector collaboration has already led to the introduction of this product in more than 25 countries. PATH and our partners in low- and middle-income countries are building pathways to introduction where diaphragms have not been available in recent decades."

"USAID has supported this single-size diaphragm from the early days of its development, and we are pleased to see this new contraceptive technology reach women in the United States," said Ellen Starbird, director of USAID's Office of Population and Reproductive Health. "We see new technologies, like the SILCS diaphragm, as essential to meeting global family planning goals, including reaching 120 million more women and girls with family planning information and services by 2020."

CONRAD (www.conrad.org) was established in 1986 and is a Division of the Department of Obstetrics and Gynecology at Eastern Virginia Medical School (evms.edu) in Norfolk, VA, where it has laboratories and a clinical research center. Thanks to funders, which include USAID, the United States President's Emergency Plan for AIDS Relief, and the Bill and Melinda Gates Foundation, CONRAD is a leader in researching and developing new contraceptive options and products to prevent HIV and sexually transmitted infections. The main office is located in Arlington, VA, and CONRAD collaborates with academic and research institutions around the world.

KESSEL was established in 1987 as the Sales Division of the German Family Planning Organization PRO FAMILIA. Today, KESSEL is a small, family-run company that is an ISO certified manufacturer of medical devices for contraception and sexual health care products. They are based in Frankfurt, Germany. Kessel has more than 25 years of experience producing and selling contraceptive and sexual health products and has distribution channels into more than 45 countries. KESSEL launched the Caya® contoured diaphragm in Europe in 2013. Currently, it is marketed in more than 25 countries. https://www.caya.eu/ and https://www.medintim.de/home-en

The U.S. Agency for International Development is leading the U.S. Government's efforts to end extreme poverty and promote resilient, democratic societies. USAID has been the leading donor in international family planning for more than 50 years–both in terms of financial resources, advancing the development of safe, effective, and acceptable contraceptives and multipurpose prevention technologies designed specifically for provision and use in low-resource settings, and supporting program innovation, implementation, and evaluation.

¹ Schwartz JL; Weiner DH; Lai, JJ; Frezieres RG; Creinin MD; Archer DF; Bradley L; Barnhart KT; Poindexter A; Kilbourne-Brook M; Callahan MM; Mauck CK. Contraceptive Efficacy, Safety, Fit, and Acceptability of a Single-Size Diaphragm Developed With End-User Input. Obstetrics & Gynecology. 2015: (4) 895—903

* Caya is a registered trademark of Kessel medintim GmbH.