There have been many research studies showing that cervical cancer is linked to failure to receive regular annual exams. Which leaves the question, “Why are so many women reluctant to receive regular annual exams”? It may be because the exam presents a slight discomfort which many women try to avoid. Some woman may experience more discomfort than others and the discomfort ranges from pressure or cramping during the exams to slight bleeding after the Pap smear is completed. But in this ever changing world of medical advancements, researchers and doctors are looking for ways to help make it a more comforting visit, and this presents a welcome call for companies like CytoCore, Inc., a company that develops cost-effective cancer screening systems and its patented SoftPAP™ Cervical Cell Collector.
The FDA has approved the SoftPAP™ Cervical Cell Collector, which consists of a small disposable balloon that is shaped to fit the cervix. This is a dramatic change from the spatula and brush currently used to collect patient cytology samples. The brush and spatula has limitations and is dependent upon the technique used. For example, to get an accurate Pap test, the brush and spatula are precisely placed and maneuvered to scrape the entire cervix including in between folds of tissue, which is where the discomforts comes in for patients. In order to make this process less uncomfortable and minimize collection time, 30% of physicians do not use both devices, which can result in errors and inadequate specimen sampling.
The revolutionary new SoftPAP™ Collector is designed to provide a quicker and more accurate specimen collection while minimizing the possibility of user error. The single-step device employs a small silicon balloon that collects a full 360-degree specimen simultaneously from both the cervical canal and the outer surface of the cervix, resulting in a more complete and comprehensive sample for more consistently reliable Pap test results. Since there is no need to rotate the device, there is greater comfort for the patient and increased ease of use for the physician.
The SoftPAP™ Collector is expected to encourage reluctant patients to have this important screening performed by eliminating the so-called ‘adverse effects’ common with the traditional test, as well as provide a greater avenue to increase early detection of the human papillomavirus (HPV) and cervical cancer.
Annually there are over 60 million Pap tests given in the US, close to 45 million in Europe, 180 million worldwide and more than 1.5 billion women who require annual Pap testing. This presents a huge market for Cytocore. So far the company has made the SoftPAP™ available in the US through the Seattle-based CoMedical, Inc., which will target healthcare professionals in Washington, Oregon, Idaho, Montana, Wyoming and Alaska. The company has also made it to Europe with its first delivery of SoftPAP™ cell collectors to M.O.S.S. srl, a leading medical equipment distributor based in Lesa, Italy, as well as Spain through Palex Medical SA., a leading medical equipment and solutions distributor to the Spanish hospital market based in Sant Cugat del Vallès (Barcelona).
The company recently completed the sale of approximately 5 million shares of newly issued common stock at the price of $2.00 per share to certain institutional and accredited investors. In addition, approximately 2.5 million 3 year warrants exercisable at a fixed price of $2.00 per share will be issued. The proceeds will be used to fund equipment purchases and working capital. They are also getting help from private investments made by the company’s Chairman of the Board, Daniel Burns, and CEO Robert McCullough Jr., who have recently invested $600,000 and $200,000 respectively. Together, Burns and McCullough own approximately 10% of CytoCore’s common shares outstanding.
With an FDA approved product that is needed in the medical industry, this company is a welcome comfort to woman all over the globe. The healthcare industry is highly competitive, and there is always ongoing research for new innovations, including companies who may introduce new products to compete with SoftPAP™. Some of these competitors include companies such as Cytyc Corporation, Tripath Imaging Inc., Digene Corporation, Ventana Medical Systems, Inc., Clarient, Inc. (NASDAQ:CLRT), and Applied Imaging Corp. whose technologies are similar to CytoCore.
Compounding the competitive disadvantage is that these companies have financial, marketing, and research and development resources that are substantially greater than CytoCore. But bigger is not always better, as long as CytoCore’s products can compete primarily on the basis of accuracy, effectiveness and functionality. If they continue to successfully implement their business plan, they should find their product in many clinics and doctors’ offices around the world.
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