Cryopen as an excellent solution for Low to Middle Income Country cervical cancer prevention and treatment
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1 Africa Regional Conference on New Opportunities and Innovations in Cervical Pre- Cancer Prevention: HPV Vaccination, Screening, and Treatment Cryopen as an excellent solution for Low to Middle Income Country cervical cancer prevention and treatment Michael J.Haas, BSBME, M.D. President, CryoPen, Inc.
2 WHAT IS THE CRYOPEN? The CryoPen is a medical device created for cryosurgical destruction without the use of cryogenic liquids or gasses.
3 WHY CREATE A NON-CRYOGEN CRYOSURGERY DEVICE? End user safety & comfort issues (medical) Consistency of technique associated with cryogens was lacking Availability and cost of cryogens (LMIC s) Ideal for Cervical Cancer prevention and treatment
4 CERVICAL CANCER Cervical cancer prevention in the US 3 step process Pap Colposcopy Treatment (Laser, LEEP, Cryo, Cold knife) LMIC s don t have Pathologist to do Pap's Skilled Colposcopist Widespread treatment options (LASER, LEEP) Most importantly minimal follow up infrastructure
5 CERVICAL CANCER TREATMENTS Cryo / Nitrous Oxide Always correct temperature zone Safe Temperature Zone, but OSHA requires vent due to teratogenic and infertility issues XModerate upfront and gas cost, tank rental and tank cost XHave to deal with compressed gases, venting XDangerous (impairs judgment, reduces fertility) XMassive, heavy tanks and large equipment XFlammable/explosive XRequires ordering and maintaining gas supply LEEP Precise, inexpensive Local anesthesia Outpatient Limited bleeding compared to laser and cold-knife Fast Tissue available for pathology XLEEP has a higher rate of cervical incompetency XCan cause persistent oozing or bleeding XRequire smoke evacuator Laser Fast Required local or general anesthesia Versatile Easy to use XNo tissue pathology XNo indicated for high lesions in endocervical canal XExpensive equipment: XRequires significant training and attention to safety issues CryoPen Complete tissue destruction No anesthesia required Simple / Inexpensive Temperature Indicator: Allows for verification of consistent, optimal treatment temperature to maximize efficacy and minimize variations between procedures Easy to use / Painless Minimal post-procedure wound care or bleeding XCannot be used for high endocervical lesions XNo pathology available Parma - Vaccines Less invasive XVery expensive XRequires multiple treatments XUnknown long term risks XTypical for younger population only
6 Cervical Cancer In the US, Cryo is used as a treatment 10-15% of the time In LMIC s, Cryo is used 95% or more of the time LMIC s with high AIDS prevalence have increased cervical cancer rates HPV vaccine will decrease cervical cancer incidence, but will take generations Cervical cancer is the biggest cause of death for women in many LMIC s (unlike the US)
7 TREATMENT IN THE US Cryo was popular in the US 25 years ago (ablative) Gas used is Nitrous Oxide (no one vents it) LASER was developed and popular for about 10 years (ablative) Then LEEP (Loop Electrosurgical Excisional Procedure) became popular due to Path specimen available (excisional) (legal friendly) If a patient has 2 or more LEEP s, cervix doesn t work any more, not true for Cryo
8 TREATMENT IN LMIC s Most treatments are done by trained technicians (not professional medical people) LEEP has too many complications LASER unavailable Less worry about legal issues Gas used for Cryo is usually CO 2 (Nitrous not always available) CO 2 / Nitrous is also very expensive ($500- $800 a tank!) and not medical grade CO 2 also not as cold or effective as Nitrous
9 CRYO IN LMIC S See and treat process Patient has quick HPV test Visual Assessment with Acetic acid (VIA) Decision to treat or not treat is made Cervix is treated with Cryo (patient never leaves stirrups) Follow up may not be for years Multiple Cryo treatments have no long term cervical damage like LEEP Nitrous / CO 2 Cryo Guns use J-T valve system and get frequent clogging with poor quality gasses
10 CRYOPEN First developed for skin treatments in the US Awarded a grant from the state of Texas to develop a cervical treatment attachment Requires no depletable cryogens Helium Sterling Cry-cooler technology, so only electricity is needed in the LMICs FDA cleared for skin and cervical treatments Extremely Cost effective way of delivering Cervical Cryosurgery
11 CryoPen is EFFECTIVE CryoPen maintains surface tissue temperatures which are ideal for effective deep tissue destruction, preserving extracellular matrix, resulting in excellent cosmesis The CryoPen cryosurgical system offers the reliability and convenience of an in office minimally invasive procedure that is safe and effective in treating diseased or abnormal tissue. This system is portable, easy to use, and brings state of the art technology directly to the patient in a patient friendly setting. Mark S. Keating, MD
12 CRYOPEN TECHNOLOGY ISSUES Users are medical people, not cryo scientists Temperatures in the C range Consistent temps needed (+/- 5%) A way for Doctors to know if the system is ready Small enough to place through a vaginal speculum Ability to clean / sterilize Needed to perform as well as prior Cryo guns (FDA Substantial Equivalency) Ease of use (simple, intuitive)
13 cryobiology during freeze ice crystals form in the cell osmotic gradient occurs rupture of membranes & organelles vascular changes When the liquids inside the cells freeze, an increased concentration of solutes causes a trans membrane osmotic gradient. Membranes rupture from ice crystals and osmotic pressure changes. Vascular changes include an initial decrease in flow due to the cold, with flushing after thawing. 13
14 LN 2 CryoPen N 2 O CO 2 Organic Compressed gases -196 C -100 C -88 C -78 C -55 C~ -75 C Each modality has a different and characteristic temperature and relative effectiveness profile. These temperatures are not the actual temperatures on the surface of the skin. 14
15 CryoPen is SIMPLE The device is ready 24/7/365 Different reusable tips No need to screw on and off small little pieces to control the cryogenic liquids or gases Just grab the right size tip and treat the patient No need to fill up tanks or risk spilling dangerous products on staff or patients CryoPen is an excellent way to increase the efficiency with which I treat lesions. My staff no longer uses valuable time pouring liquid nitrogen from one container to another. [With CryoPen] I simply tell the nurse what size pen I want to use and it is ready for immediate use I consider CryoPen one of my better equipment purchases. Kyle Dean, M.D
16 The CryoPen Platform Technology Delivering Cryosurgery to Primary Care and Women s Health There is no comparison. The CryoPen is always ready. It s strong. It s powerful. - Dana Fouchi, M.D
17 FDA approved for CIN 1,2,3 About 2,000 in use in the US, Embassy s and military bases around the world Ethanol is the only consumable (about 500ml / 6 months) Can operate on Car batteries (Direct current) Ruggedized system in the development stages Price point of LMIC unit $4,000 US Show HAND PIECE ANIMATION
18 END
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