CerMed is focused on two major market segments:

Cervical Cancer Screening    

Contraceptive / Sexually Transmitted Disease (STD) Prevention

Cervical Cancer Screening

Cancer is essentially a disease characterized by abnormal or uncontrolled growth. Cervical cancer originates in epithelial cells lining the interior and exterior surfaces of the cervix, the point of entry into the uterus, and affects nearly 500,000 women each year, with the highest incidence and death rates occurring in developing regions of the world. The etiological agent for cervical cancer is subset of strains of the human papillomavirus (HPV), a DNA virus that is sexually transmitted. Overall, HPV infections are common and are frequently self-limited by the immune system. However, in a number of cases the DNA of high-risk strains of HPV becomes integrated in the host cell genome leading to specific cellular changes associated with transformation and cancer development. As with many other cancers, the key to survival is early detection and appropriate treatment.

A major finding relating to the etiology of cervical cancer is that it generally develops from a persistent infection caused by a high-risk type of human papilloma virus (HPV), which infects epithelial cells. It is spread by skin-to-skin contact, frequently as a result of sexual activity. The prevalence of infection is age related with approximately 25% of women in their 20’s, 12% of women in their 30’s, etc. in the United States being infected at any one time. Although in almost 90% of cases of HPV infection, the infection will spontaneously regress; in a small percentage the virus integrates into the patient’s genome, leading to changes in protein production in cervical cells, and the development of dysplasia and neoplasia. It is for this reason that the American College of Obstetrics and Gynecology recently recommended a reduction in the number of screening tests in young women; it also highlights the problems with Pap test specificity (false positives).

Cervical screening collection methods have not changed significantly over the last 60 years. Typically, a sample of cervical cells is collected by gently scraping the opening of the cervix with a cervical brush or spatula or both and the cells are either smeared directly on a glass slide or deposited into a liquid preservative prior to preparation of smears. The collected samples are then sent to a lab for microscopic analysis.  The limitations of this approach are obvious:  incomplete sample collection, dirty sample with blood and mucous, and variable slide preparation. Additionally, the intrusive process can be uncomfortable to the patient.  Limited and/or poor sample collection contributes to the number of false positives and negative results.

Cells infected with HPV that has induced the transformation to a cancerous state undergo morphological changes that are observed by trained personnel. The extent of these changes form the basis of a cancer grading system used to categorize cervical intraepithelial neoplasia (CIN), which describes low risk, CIN 1, to high risk neoplasia, CIN 3. The process however, is very time- and laboratory-intensive, require highly trained personnel (pathologist, cytologist), are subjective, and prone to high false positive and negative rates that may submit patients to unnecessary treatments, or fail to identify the presence of cervical lesions. Although this process is generally accepted practice in the developed world, the demand on clinical resources, personnel and time frame, remain significant barriers to implementing this approach in low resource or developing regions, contributing to the lack of care and wide disparity in cancer deaths. Additionally, the generally low rates of sensitivity and specificity attainable with this method suggest that improvements in detection modalities would also be applicable to the developed world, supplanting the current screening approach.

Clearly, there is a pressing world-market need for a test that provides information on the presence of HPV but also informs the patient as to whether the virus has induced a neoplastic or dysplastic state. This test must be a low- cost, quick, disposable, point-of-care, molecular, cervical cancer screening system. The test should be inexpensive enough to be employed as a primary screen globally. In addition, the disposability and point-of-care aspects mean that no laboratory infrastructure or instrumentation should be required to screen the cervical samples and provide analysis and diagnoses.

CerMed intends to replace the current methods of cervical screening with the Cervical Cancer Screening Test System, a point of care cervical cancer screening system that satisfies these needs. 

Cervical Cancer Screening Market Size and Segmentation

The factors determining CerMed’s market potential are cervical cancer statistics and trends, current medical treatment and practices, and chain of distribution considerations. 

Worldwide, cervical cancer is the second most common cancer among women. There are nearly 500,000 new cases diagnosed each year throughout the world. Eighty percent of new cases are in developing markets.

Cervical pre-cancerous abnormalities, when detected early, have an excellent cure rate with appropriate treatment. The 5-year relative survival rate is 88% for women with an initial diagnosis of localized cancer, but only 13% when the cancer has spread to organs away from the cervix.

In developed countries, cervical cytology, the examination of cells sampled from the cervix, generally called the Pap test, has been the only practical means of cancer screening; yet it is problematic in two significant ways:

• The accuracy provided by cervical cancer screening is less than satisfactory.
• Cervical cytology is expensive and requires extensive laboratory infrastructure as well as highly trained cytotechnologists to screen samples collected by physicians; the predominant reason women do not have access.

Every year 1.6 billion women worldwide should be screened for cervical cancer. Approximately 160 million or 10% of eligible women are actually screened.  Currently, in developed markets, 100 million women are screened or approximately 50% of eligible women.  This means that less than 13% of women in the developing world are screened annually for cervical cancer.

WHO Global Female Population – 2005 (millions)

Contraception and Sexually Transmitted Disease (STD) Prevention

Control of human female fertility has many medical, economic, social, political and ethical issues that have affected trends in the popularity and use of various birth control methods. The use of barrier methods of birth control dates back to Biblical times. One of the earliest barrier methods was the male condom, described as early as 1350 BC. Barrier methods of birth control are categorized as being controlled by the male or female, although in most relationships, the choice of method is mutually negotiated in certain markets. Non-hormonal, barrier methods for birth control include the condom (male and female), sponge, diaphragm and cervical cap.  Hormonal methods include “the pill” and hormonal implants.  Other methods of contraception include intrauterine devices (IUDs) and surgical sterilization of either the male or female.

There has been renewed interest in the use of barrier contraceptive methods over the past few years, prompted by the desire for woman-controlled non-invasive methods of contraception that simultaneously prevent transmission of sexually transmitted diseases. Overall, use of non-hormonal barrier methods is currently estimated at about five percent. 

In 2007 the WHO reported that over 340 million new cases of STDs occurred with 50% of these in women. There are currently 33 million people living with HIV/AIDS with 2.7 million new cases per year, over 50% of which are women. While most STDs can be treated at reasonable costs, the WHO estimates total cost for treating an HIV patient FOR LIFE ranges from $400,000 in developed markets to $50,000 in developing markets where drugs are offered to health agencies at discounted prices. This means that developed markets will need to budget in excess of $40 billion per year to treat 100,000 new cases and developing markets will need in excess of $260 billion to treat the remaining 2.7 million new cases. Thus the key priority of all major World Health Organizations is to find an effective microbicide to control the sexual transmission of  HIV/AIDS and a female-controlled mechanism for the delivery of the microbicides. The 8th, 9th, and 10th International AIDS Conferences have already recommended Cervical Caps to prevent AIDS transmission to women. 

Currently there are no microbicides available in the market which have been recognized by WHO, UNAID or USAID as effective for prevention of the sexual transmission of HIV. However, several microbicides in recent clinical trials are shown to be safe, acceptable and have some level of effectiveness. Over $1B is committed in 2009 for microbicide research and testing.

HIV – 2007

CerMed will offer a unique cervical cap to these markets.The current market opportunity for barrier contraceptive users is $864 million, but the real market opportunity is immense with over 500 million women in developing countries at risk for HIV/AIDS. At an estimated cost of $7.50 per cervical cap the market potential is in excess of $45 billion (assumes use of 1/per month). 

CerCap HIV provides simultaneous contraception and prevention of HIV. With the apparent and dramatic spread of sexually transmitted diseases (STDs) including HIV there will be increased opportunities for a barrier contraceptive capable of delivering localized drug treatment.

Global Market Potential