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    Bio Derm Press Kit Bio Derm Press Kit Presentation Transcript

    • The first new technology for male b ladder c ontrol in 50 years
    • be aware
      • There are 4 million men in the United States that deal with b ladder c ontrol ( BC ) everyday.
      • There are over 12 diseases and diagnosis that can cause BC challenges for men, but our users share one very important need: they all want their lives to be long and fulfilling.
      Demographics Current BC Methods References THE PROBLEM Statistics
    • be aware
      • Current methods for managing male incontinence are decades old and unsafe. Each method greatly increases risk of urinary tract infection and can be harmful to the skin and internal tissue.
      Current BC Methods THE PROBLEM Learn more about… Demographics Current BC Methods References Statistics DIAPERS & PADS FOLEY CATHETERS CONDOM CATHETERS
    • be aware
      • FOLEY CATHETERS
      • Increase hospital morbidity and mortality
      • even when used for as little as one day.
      • Risk injury to urinary tract and are identified as having the most costly complications
        • “ Catheter-associated urinary infections account for
        • about 40% of all Nosocomial Infections and increase the duration of hospital stays, the costs, and mortality.”
      • Hospital acquired catheter-associated UTI will no longer be reimbursed by Medicare: CMS 1533
      Learn more about… THE PROBLEM Current BC Methods References: Kunin 1,2,3 , CMS 100-07 4 Demographics Current BC Methods References Statistics DIAPERS & PADS CONDOM CATHETERS
    • be aware
      • DIAPERS & PADS
      • Rapidly cause pressure sores by
      • trapping urine against the skin.
      • 38% UTI rate
      • 4-6 daily changes increase
      • labor and laundry costs
      • exponentially (by more than 200%).
      • Not reimbursable under Medicare and most private insurances
      • Uncomfortable smell and social isolation contribute to the stigma of incontinence
      Learn more about… Current BC Methods THE PROBLEM References: CMS100-07 4 , Kernon 5 , Braden Score 6 , Leung 7 Demographics Current BC Methods References Statistics FOLEY CATHETERS CONDOM CATHETERS
    • be aware Learn more about… Current BC Methods THE PROBLEM
      • CONDOM CATHETERS
      • High condom catheter pop-off rates in
      • hospital setting.
      • Skin Breakdown/Tearing
      • Inflammation/Discomfort
      • Difficult to fit retracted, small and
      • uncircumcised anatomy
      • 63% Catheter Associated UTI rate
      References: Saint 8 , FDA 9 , Doughty 10 , Johnson 11 Demographics Current BC Methods References Statistics DIAPERS & PADS FOLEY CATHETERS
    • be aware Demographics THE PROBLEM The 4 million incontinent men in the U.S. suffer from one or more of these diagnoses. References: BioDerm Incontinent Male Population 15 Demographics Current BC Methods References Statistics
      • Catheter‐associated urinary infections account for about 40% of all infections acquired in the hospital.
      • 38% of indwelling urinary catheters inserted in the hospital have no justifiable indication.
      • (In 2000) the total cost of UTI was $19.5 billion .
      • The estimated annual cost of nosocomial urinary tract infection in the United Sates ranges between $424 and $451 million
      • Catheter‐associated UTIs add an additional 90,000 hospital days per year.
      • Nosocomial (hospital-acquired) UTIs contribute to an additional 6500 deaths per year.
      • Effective October, 2008 , Medicare will no longer reimburse payors for the costs of treating catheter associated urinary tract infections acquired while in the hospital.
      be aware Statistics THE PROBLEM References: Kunin 2 , CMS 4 , Munasinghe 12 , The-Wei 13 , Gokula 14 Demographics Current BC Methods References Statistics
    • be innovative
      • WHAT IS LIBERTY?
      • Liberty is the first new method for male BC in over 50 years. The completely external design and gentle seal make it the safest, simplest solution for BC in the world.
      • Liberty is about a state of being!
      • Being dry and comfortable – all day, everyday.
      • Being free to do what you want to do, when you want to do it.
      • Being able to live an active lifestyle
      • Liberty gives men the opportunity to overcome BC challenges. With Liberty, men are victors, free to work, free to travel, free to play and free to live. Liberty is designed to make life easy.
      • Easy to get
      • Easy to use
      • Easy to fit into every man’s lifestyle
      THE SOLUTION Cost Analysis Features & Benefits Coverage Testimonials References
    • be innovative THE SOLUTION Features & Benefits Cost Analysis Features & Benefits Coverage Testimonials References
    • be innovative THE SOLUTION Cost Analysis  Cost of Product  Cost of Complications When considering the costs of BC methods, it is important to note the cost of their complications. References: R. Kernon 5 , Newman 16 , Golgi 17 , Bejany 18 , NCHS 19 , Pajk 20 , Kumar 21 , Resnick 22 Cost Analysis Features & Benefits Coverage Testimonials References
      • LIBERTY IS COVERED UNDER THE FOLLOWING:
      • Medicare
      • Medi-Cal
      • Most state Medicaids
      • Most private insurances
      • GSA Advantage (www.gsaadvantage.gov)
      • Keyword: BioDerm
      • VA Formulary
      • FOR MEDICARE REIMBURSEMENT:
      • Medicare requires a Letter of Medical Necessity and Nurse’s (Progress) Note to be supplied before offering coverage of Liberty to their patients. It includes information about the patients’ diagnosis as well as why they are not medically eligible to use a condom catheter.
      THE SOLUTION Coverage be innovative Cost Analysis Features & Benefits Coverage Testimonials References
    • be innovative
      • “ I have ALS, and I didn’t think there was a bladder control device on the market that would enable me to have the quality of life I have with Liberty. Thank you!”
      • Gary in Colorado
      • “ Liberty is terrific. I can keep doing what I want to do, without having to worry about running to the bathroom or changing my clothes. It’s a Godsend.”
      • John in Arizona
      • “ Liberty saved my husband’s life.”
      • Mrs. B in Arizona
      • “ It was impossible for me to put on a condom catheter without a caregiver. Sometimes the condom catheter would kink. I generally had two pop offs a week. I wish I had tried it [Liberty] years ago when my doctor first recommended it.”
      • Greg in Florida
      THE SOLUTION Testimonials Cost Analysis Features & Benefits Coverage Testimonials References
    • be advanced THE COMPANY Company Values Mission Statement History Products Media Contact BASED out of Largo, Florida, BioDerm, Inc. is a locally owned and operated durable medical device manufacturer. BIODERM was founded in 1990 by Dr. Dennis Kay, a physician with extensive medical device industry experience. Before founding BioDerm, Dr. Kay provided consulting services to the senior management of several major medical device manufacturers, focused on product research and business development for incontinence, wound care, infection control and ostomy products. Dr. Kay invented the External Continence Device (ECD) for men, which was introduced in 1998. In 1999, NASA adopted the device for use during manned space flight missions. Subsequently, BioDerm has grown its family of products to include: CathGrip TM Tube Holder, BioPad TM Skin Adhesive Barrier Prep, and Liberty. WE have a talented team of hardworking persons, who are fueled by the dedication of our meaningful and worthwhile mission – creating products that adhere to the highest standards of quality and health.
    • be advanced
      • BIODERM will strive to continually improve upon outdated methods of practice in healthcare, utilizing innovation and leading-edge technology to create medical devices that will improve patient outcomes, physically and financially.
      • Through consistent analysis of the stagnant areas of healthcare, BioDerm will always deliver on it’s pledge of finding and offering “a better way”.
      THE COMPANY Mission Statement Company Values Mission Statement History Products Media Contact
    • be advanced THE COMPANY Company Values Company Values Mission Statement History Products Media Contact UALITY We are inspired by the impact quality healthcare can make in the lives of the people we help. We focus on creating improved methods in healthcare products and ensuring the well-being of each person our products aid. NDERSTANDING We empathize with the challenges that patients face when managing activities of daily living and create products that help them overcome their challenges with comfort and dignity. XCELLENCE We continuously look for ways to exceed expectations in every facet of our performance. Our continued success is a direct result of the leadership each member of our team demonstrates. ERVICE We provide our customers and constituents with the highest level of respect at every interaction. We always keep in mind that quality service creates success. ECHNOLOGY We strive to make all of our products more innovative than any others on the market. By challenging industry standards, we challenge ourselves to maintain the leading-edge.
    • be advanced THE COMPANY History Company Values Mission Statement History Products Media Contact
      • CATHGRIP TM
      • The BioDerm CathGrip TM anchors a wide array of tubing. The tube locks allow repeated removal and replacement of tubing without trauma to the skin or the tube. Once locked in place, tubing will not shift or move. Fits 18-36 French size tubing.
      be advanced ECD (EXTERNAL CONTINENCE DEVICE) The ECD utilizes the same hydrocolloid technology and innovative design as Li be rty . The ECD is sold in international markets, providing a safe solution for male bladder control the world over. BIOPAD TM The BioPad TM provides a safe, protective barrier film over the skin that is useful for wound protection, incontinence and peristomal care. The alcohol-free, skin-friendly formula is gentle and will not interfere with wound healing. THE COMPANY Products Company Values Mission Statement History Products Media Contact
    • be advanced
      • LESLIE MATTERN
      • PUBLIC RELATIONS COORDINATOR
      • Mail:
      • BioDerm, Inc.
      • 12320 73 rd Court N
      • Largo, FL 33773
      • E-mail:
      • [email_address]
      • Telephone:
      • 727.507.7655, ext. 2015
      • Fax:
      • 727.507.7645
      • Website:
      • www.BioDerm.us
      THE COMPANY Media Contact Company Values Mission Statement History Products Media Contact
    • be current
      • URINE CONTROL FOR MEN: THE RIGHT PRODUCT FOR THE BEST HEALTH
      • By Marilyn Lou Webb, PhD, NP-BC, CCCN. SCI Life July/August, 2006
      • Dr. Webb discusses “the good, the bad, and the ugly” issues regarding male bladder control.
      IN THE PRESS Home
      • A NEW OPTION FOR THE MANAGEMENT OF MALE URINARY INCONTINENCE
      • By Dorothy Doughty, MN, RN, FNP, CWOCN, FAAN. Extended Care Product News. September/October, 2003.
      • Doughty elaborates on the indications and contraindications of various methods for managing urinary incontinence.
      • THE BIODERM EXTERNAL CONTINENCE DEVICE: EVIDENCE & ASSESSMENT FOR USE
      • By Mandy Wells, British Journal of Nursing. Vol. 17, No. 9, 2008
      • Wells identifies demographics who could benefit most from BioDerm’s ECD (Liberty for international markets)
      • THE BIODERM EXTERNAL CONTINENCE DEVICE: EVIDENCE & ASSESSMENT FOR USE
      • By Sue Woodward, Editor-in-Chief, British Journal of Neuroscience Nursing. Vol.3, No. 12, December 2007
      • Woodward compares the advantages and disadvantages of BioDerm’s ECD (Liberty for international markets) with Condom Catheters
      If you have questions or ideas for specific content, contact: Leslie Mattern Previously Published Articles
    • be informative
      • ENGINEER WITH MS PERFORMS DEFENSE WORK FROM HOME Bill Cosner
      • Incontinence does not trump leading a fulfilling life, as exemplified by one Li be rty user.
      • PDF or Word Document
      STOCK ARTICLES Home If you have questions or ideas for specific content, contact: Leslie Mattern Articles for Publication THE TOP 15 THINGS YOU NEED TO KNOW ABOUT URINE CONTROL Dr. Dennis Kay A list of 15 hints that help people with bc challenges overcome and keep going. PDF or Word Document GERM WARFARE – HEALTHY HABITS TO DEFEAT UTI Dr. Dennis Kay Simple tips to avoid UTIs, plus bonus cranberry recipes ripe with UTI fighting power. PDF or Word Document MEN FIND FREEDOM WITH NEW BLADDER CONTROL PRODUCT Bill Cosner Li be rty was the solution for one man who didn’t want to be give up his hobbies. PDF or Word Document
    • be assured
      • Kunin C.M., Douthitt S., Dancing J., Anderson J. and Moeschberger M. “The Association Between the Use of Urinary Catheters and Morbidity and Mortality among Elderly Patients in Nursing Homes” American Journal of Epidemiology 1992; Vol. 135, No. 3: 291-301.
      • Kunin, Calvin M. “Nosocomial Urinary Tract Infections and the Indwelling Catheter: What is New and What is True?” Chest 2001; 120: 10-12.
      • Kunin, Calvin M. “Urinary-Catheter-Associated Infections in the Elderly” International Journal of Antimicrobial Agents . 2006 Aug; 28 Supplement 1:S78-81. E-Publication 2006 Jul 10
      • Centers for Medicare and Medicaid Services (CMS). CMS Manual System Pub. 100-07 State Operations Provider Certification). Transmittal 8. June 28, 2005.
      • R. Kernon. Administrator, Indigo Manor Nursing Home, Daytona Beach, Florida.  Personal Communication, 2005.
      • Braden Score. “By the Numbers: Braden Score Interventions” Advances in Skin & Wound Care , April 2004.
      • Leung, K.S. Et al. “Urinary Incontinence: an Ignored Problem in Elderly Patients”. Hong Kong Medical Journal . 1997; 3:27-33.
      • Saint S., Kaufman S., Rogers M., Baker P., Ossenkop K., Lipsky B. “Condom Versus Indwelling Urinary Catheters: A Randomized Trial.” Journal of American Geriatric Society , 2006 Jul; 54(7): 1055-61.
      • FDA Center for Devices and Radiological Health Database. <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM> 2008.
      • Doughty, Dorothy B. “A New Option for the Management of Male Urinary Incontinence.” Extended Care Product News . p. 30-2; September/October 2003.
      • Johnson, Edwin T. “The Condom Catheter Urinary Tract Infection and Other Complications.”  Southern Medical Journal . 1983 May;76(5):579-82.
      • Munasinghe, Rajika L. MD. Et al. “Appropriateness of Use of Indwelling Urinary Catheters in Patients Admitted to the Medical Service”. Infection Control and Hospital Epidemiology . October, 2001. Vol.22 No.10. 647-9
      • The-Wei Hu, et al. “Costs of Urinary Incontinence and Overactive Bladder in the United States: A Comparative Study”. Urology . 63(3), 2004.
      References: PAGE 1 References: Page 3 References: Page 2
    • be assured
      • Gokula, Radha Ramana Murthy, et al. “Inappropriate use of urinary catheters in elderly patients at a midwestern community teaching hospital”. American Journal of Infection Control . June, 2004. 196-9.
      • BioDerm Analysis of Male Incontinent Population by Diagnoses
        • National Spinal Cord Injury Statistical Center from http://www.spinalcord.uab.edu
        • About MS: What is Multiple Sclerosis? National Multiple Sclerosis Society brochure, www.nationalmssociety.org/what%20is%20MS.asp
        • Brook, Michael H. A Clinician’s View of Neuromuscular Diseases. Baltimore: Williams & Wilkins, c1986.
        • Oklahoma University Medical Center, Carson Wong, MD, FRCSC, FACS - www.oumedcenter.com
        • Kidney & Urologic Disease Statistics for the US - www.kidney.niddk.nih.gov/kudiseases/pubs/kustats/index.htm
        • National Cancer Institute - The Prostate Cancer Outcomes Study - www.nci.nih.gov/newscenter/pcos
        • Spina Bifida Association - www.spaa.org
        • Tri-state Incontinence Support Group - Help for Incontinent People (HIP) www.tis-group.org
        • Internet Stroke Center - www.strokecenter.org/pat/stats.htm
        • National Institute of Neurological Disorders and Stroke - www.intelihealth.com/IH/ihtPrint/WSHIHW000….
        • United Cerebral Palsy Cerebral Palsy Facts and Figures Retrieved from the World Wide Web at http://www.ucp.org/ucp_generaldoc.cfm/1/9/37/37-37/447
        • National Library of Medicine, PubMed, Dev Med Child Neurol 2001, Feb;43(2):75 - www.ncbi.nlm.nih.gov/entrez/query
        • Amyotrophic Lateral Sclerosis Association Who Gets ALS? http://www.alsa.org/als/who.cfm?CFID=43828&CFTOKEN=48446726
        • Centers for Disease Control and Prevention (CDC); cited in Christopher & Dana Reeve Paralysis Resource Guide
        • Traumatic Brain Injury: Hope Through Research: National Institute of Neurological Disorders and Stroke www.ninds.nih.gov/disorders/tbi/detail_tbi_pr.htm
        • Centers for Disease Control and Prevention (CDC) Injury Fact Book 2001-2002 Atlanta, GA: Centers for Disease Control and Prevention, 2001
        • National Parkinson Foundation, www.parkinson.org
        • We Move - Movement Disorders Virtual University www.mdvu.org/emove/article.asp?ID=823
      References: PAGE 3 References: Page 3 References: Page 1
    • be assured
      • Newman, E., Price, M. “Bacteriuria in Patients with Spinal Cord Lesions: Its Relationship to Urinary Drainage Appliances,” Archive of Physical Medicine Rehabilitation , Vol. 58, October 1977.
      • Golji, H. “Complications of External Condom Drainage,” Paraplegia . 1981; 189-197.
      • Bejany, D.E., Lockhart, J.L., Rhamy, R.K. “Malignant Vesical Tumors Following Spinal Cord Injury.” The Journal of Urology . Vol. 138, December 1987; 1390-1392.
      • National Center for Health Statistics (NCHS). National Nursing Home Survey. 1999; 12, 24.
      • Pajk, Marilyn. “Pressure Sores,” Merck Manual of Geriatrics . Section 15, Chapter 124. Internet Edition provided by Medical Services, USMEDSA, USHH. Published by Merck and Co. Inc, 2000.
      • Kumar, R.N., Gupchap, G.V., Dodd, M.A., Shah, B., Iskedjian, M., Einarson, T.R., Raisch, D.W. “Direct Health Care Costs of 4 Common Skin Ulcers in New Mexico Medicaid Fee for Service Patients.” Advances in Skin Wound Care . April 2004; 17(3), 143-9. University of Michigan College of Pharmacy, Ann Arbor, MI.
      • Resnick, Neil M. “Urinary Incontinence.” Merck Manual of Geriatrics . Section 12, Chapter 99. Published by Merck and Co. Inc, 1995-2002.
      References: PAGE 3 References: Page 2 References: Page 1