CytoCoreinc. 414 North Orleans St. Suite 502 Chicago, IL p: cytocoreinc.com. core solutions for innovative care.
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1 CytoCore, Inc. is a biomolecular diagnostics company engaged in the design, development and commercialization of cost-effective screening systems for the early detection of cancer and cancer-related diseases. For more information, visit us online at CytoCoreinc. core solutions for innovative care. 414 North Orleans St. Suite 502 Chicago, IL p: cytocoreinc.com 1 Coste J, et al (2003). Cross sectional study of conventional cervical smear, monoplayer cytology and Human Papillomavirus DNA testing for cervical cancer screening. British Medical Journal 326 (7392): Wright TC et al. (2002) 2001 Consensus Guidelines for the Management of Women with Cervical Cytological Abnormalities. Journal of the American Medical Association 287 (16): Linder J et al. (1998): Thin Prep Papanicolaou Testing to Reduce False-Negative Cervical Cytology. Archives of Pathology and Laboratory Medicine 122: Mayo Clinic Staff (2006): Pap smear: Screening Test for Cervical Cancer. Mayoclinic.com. 5 Association of Reproductive Health Professionals (2007). Understanding Pap Test Result. Health Matters Patient Education Fact Sheets. 6 Garcia M, Jemal A, Ward EM, Center MM, Hao Y, Siegel RL, Thun MJ, Global Cancer Facts & Figures Atlanta, GA: American Cancer Society, American Cancer Society. Cancer Facts & Figures Atlanta: American Cancer Society; 2007.
2 The new SoftPAP cervical cell collector Cervical cancer is a leading cause of female cancer deaths worldwide. (6) More than 11,000 American women are diagnosed with invasive cervical cancer each year, and about 4,000 women will die each year from the disease. (7) Developing tools for early detection has never been more critical. The truth about false-negatives: 6 million cases misdiagnosed worldwide in one year alone. Recent reports in medical literature suggest that liquid-based Pap tests produce inconsistent results with up to 35% false-negatives being reported. (1,2,3,4) This equates to approximately 6 million false-negative Pap tests globally 2 million in the U.S. alone. It is estimated that at least 50% of false-negative Pap tests are caused by inadequate sampling due to limitations of the spatula and brush design and variability in collection technique. (3,5) It is also estimated that current Pap methodology results in 15% false-positives, costing the healthcare system almost $1 billion annually to obtain reliable test results. Early detection goes full circle. A soft silicon balloon is the identifying feature of the SoftPAP collector. When inflated, the balloon captures a 360º sample from the ectocervical and endocervical surfaces simultaneously. What s more, SoftPAP utilizes a touch method for cell collection, improving the patient experience and the accuracy of the Pap test by replacing the current spatula and brush scraping technique. Significantly reduce false-negative Pap tests* Contoured for collection, SoftPAP is a more accurate, more consistent and more reliable way of collecting a cervical specimen. Endocervical and ectocervical specimens collected simultaneously One-step collection of complete 360º sample Uterus Vagina SoftPAP TM technique Less invasive and less traumatic specimen collection Significant reduction in error attributable to inadequate or minimally adequate samples For more information, visit us online at cytocoreinc.com Cervix or call *Data available upon request SoftPAP is a trademark of CytoCore, Inc. U.S. Patent Number: 6,475,164 During inflation, the soft balloon gently presses against the cervix to collect the sample.
3 Trial Results This trial was conducted at seven sites within the continental US. The same IRB protocol was followed at all sites. The objective of the trial was to assess the adequacy, efficacy, and safety between the SoftPAP cervical cell collector and the standard Cytobrush/Spatula technique. Analysis from 703 data samples follow. SoftPAP Totals Brush Totals Adequacy of Cells for Diagnosis % Satisfactory/Not Limited 98.6 % 99.2 % SoftPAP -All Slides Brush All Slides Efficacy (2 of 3 consensus) False Positives 15.6% 22.9% False Negatives 7.3% 9.9% Reduction SoftPAP vs. Brush 33% 26% ** Sensitivity (the ability to detect abnormal cells) for SoftPAP was 89.7% vs. 86.3% for Brush/Spatula ** Results show a lower number of endocervical cells, but a higher number of metaplastic cells collected by the SoftPAP
4
5 SoftPAP Physician Programs CytoCore, Inc. values the physicians who have made the choice to offer their patients a comfortable and more effective collection device for Pap testing. As a partner in their success, we offer these free programs. New physician programs Free starter kit includes first handle and 25 collectors. Free patient informational materials, including cards and posters. Credit card program allows ease of ordering and prevents paperwork build-up associated with a new product. Technical assistance programs for physicians to discuss any question, including lectures such as Mitigating Risks and Navigating the Implications of Off-label Use. Physicians directly benefit from the vast knowledge and experience of CytoCore s technical team. There is no charge for normal use of our experts. Participation in ongoing quality control and usage surveys; access to summary results of all physicians. This step is required to achieve Gold status. Gold physician programs Automatic replenishment programs for existing customers with at least six months sales history. Customers specify desired on-hand inventory levels, send their usage to CytoCore, and automatically receive shipments that make sure the right amount is on hand at all times. Free Marketing Listing on as a certified SoftPAP physician Waiting room materials to inform patients of the SoftPAP certified physicians in the practice Access to internet marketing undertaken by CytoCore, Inc. Access to sample patient testimonial videos for use on physician s web site Invitations to participate in trials which CytoCore, Inc. would attempt to have published, garnering publicity for the physician s office.
6 Suggested Receptionist Script for introducing the SoftPAP Cervical Cell Collector I would like to make you aware of a new collection device called SoftPAP for your pap test. Our office is one of the first in the United States to offer it to our patients This device is more accurate and patients who have had their pap test with this device say that it is more comfortable Here s some information about the SoftPAP collector and a consent form if you are interested.
7 Patient Consent Form for SoftPAP Cervical Cell Collector I have been advised that my insurance company does not pay for the SoftPAP Cervical Cell Collector at this time. I understand that my insurance company will pay for the Pap test, but not for the product used to perform the test. I agree to pay for this product as a private pay patient and understand it will not be billed to my insurance company. I will be responsible to pay at the time of service. Patient s signature Date Patient s printed name Frequently Asked Questions Q. Why is SoftPAP not covered by insurance? A. Like many newly approved FDA products and technologies, there is a gestation period for Insurance Providers to provide reimbursement for a new product. Q. Can I submit this to my HSA or FSA? A. Yes. You can submit it to your HSA or FSA.
8 Want More Accurate Pap Results? Choose SoftPAP To provide you with the best possible care, your doctor now offers SoftPAP, a whole new generation of cell collection for cervical cancer detection. Better Tools Mean Greater Peace of Mind Lab findings from SoftPap samples more accurately indicate healthy tissue, so you can have more confidence in your test results. *True negative results in clinical trials 62% 34% SoftPAP Traditional Cell Collection Devices *More information available upon request. Make your annual test a more accurate test. Ask your doctor about the new SoftPAP today. For more information visit: soft-pap.com
9 Choose Comfort! Inflates to fit your body s natural contour Rev B FDA cleared No more scraping or brushing With SoftPAP your doctor can get a better sample without the sharp edges. Request the new SoftPAP Cervical Sample Collector for your Pap test today. Because SoftPAP is a new technology, your insurance company may not yet cover the cost of the device. The receptionist should be able to tell you if this is currently a reimbursable upgrade.
10 SoftPAP Demonstration Key The SoftPAP cell collection system facilitates consistency in cervical cytology specimens and improves accuracy of corresponding Pap test results. PReparation Fig 1 Push the SoftPAP handle button to release any residual air pressure, then firmly attach the SoftPAP disposable collector until you hear a click. Do not twist the disposable collector. Fig 2 Once the collector is engaged, the balloon should appear stretched as shown. Fig 3 Withdraw the syringe plunger to the 10mL position. Fig 4 Gently twist the syringe onto the base of the handle. Do not over tighten. Fully depress the plunger then remove the syringe PREPARATION Specimen Collection Fig 5 After wiping any blood or mucus from the cervix, fully insert the SoftPAP balloon tip into the os of the cervix. Fig 6 Press and hold the SoftPAP handle button for five seconds. Release the button and remove the SoftPAP Cervical Cell Collector from the vaginal canal. Fig 7 Carefully detach the disposable collector from the handle. Fig 8 Fully immerse the balloon in a liquid cell preservative and stir for ten seconds, then discard the disposable collector. Clean the reusable Handle and store in the tray between patients COLLECTION This document is intended for sales purposes only. Complete instructions for SoftPAP use are included with the packaged device.
11 SoftPAP Reference Guide Intended Use: For the collection of cervical cytology specimens for Pap test analysis. The SoftPap Cervical Cell Collector should not be used after the first ten weeks of gestation in pregnant patients. Caution: Do not use with women under 18 years of age or women who have had a hysterectomy. Do not touch the balloon surface prior to specimen collection. 3. For best specimen quality, the SoftPAP Cervical Cell Collector should only be used by persons experienced in collecting cervical samples. 4. The performance of the SoftPAP Cervical Cell Collector for patients with squamous cell cancer, adenocarcinoma, or AIS has not been demonstrated in clinical studies. 5. Use only the syringe included in the SoftPAP Cervical Cell Collector carton for pressurizing the SoftPAP reusable handle. Discard the syringe after all the SoftPAP disposable collectors in the carton have been used. 6. The SoftPAP disposable collector and the SoftPAP reusable handle are designed to operate as a system. Items Required SoftPAP disposable collector SoftPAP handle (reusable) 10mL syringe (reusable, included with SoftPAP disposable collectors) Liquid cell preservative (not included) Powder free gloves (not included) Rev B FDA cleared (877) CYTOCORE soft-pap.com
12 SoftPAP Packaging and Pricing Packaging: This is how our collectors are packaged: 25 collectors, plus 1 syringe = 1 kit 4 kits (25 x 4 = 100 collectors) = 1 box 8 boxes (100 x 8 = 800 collectors) = 1 carton Handles are packaged separately, 1 handle per tray. Please remember that the collector is disposable while the handle is reusable. Pricing: Pricing structure is as follows: Collectors: 1 8 boxes = $800 each ($8 per collector) 9 40 boxes = $750 each ($7.50 per collector) 41+ boxes = $700 each ($7 per collector) Handles: 1 8 handles = $75 each 9-40 handles = $65 each 41+ handles = $55 each Samples: For trial, we send one sample handle and one kit of 25 collectors absolutely free. Payment and Shipping: You will be responsible for the shipping. Payment can be made through any major credit card, wire transfer or check. Your product will be shipped after funds have been received or check cleared at our bank. You may also apply for credit terms subject to approval. The SoftPAP system is to be used with a liquid based preservative (ThinPrep or SurePath). We currently do not provide the preservative with the SoftPAP collectors. However, this option (Preservative packaged with SoftPAP collectors) will soon be available to our clients.
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