flexitouch plus head and neck

/Type /Page I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. /Rotate 0 Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Contents [61 0 R 62 0 R 63 0 R 64 0 R 65 0 R 66 0 R 67 0 R 68 0 R] The Flexitouch System is not used for nor intended for use to treat cellulitis. Managing my lymphedema requires attention and an assortment of tools. . /Resources << The Flexitouch Plus system applies mild, dynamic pressure to stimulate lymphatic function and direct fluid away from impaired areas toward healthy, functioning regions where the fluid can be managed. Toll-free: 1.833.3TACTILE (1.833.382.2845) >> >> Thank you for sharing your husbands success with a pump. (p <0.001)**Statistically Significant Results, (p=.016)**Statistically Significant Results, (p=0.008)**Statistically Significant Results, Late-effect fibrosis seven years post cancer treatment, Ability to control lymphedema at home (p=0.003_, Severity of soft tissue symptoms (p=0.008), Results are based on the median change in scores from baseline measurements, Ridner, S.H., Dietrich, M.S., Deng, J. et al. /XObject << Negative value shows a decrease in pain. Dr. Shelia Ridner Dr. Barbara Murphy /Contents 53 0 R When I first went to physical therapy, she was running through some more common contibuters to swelling. Call us at 1.833.3TACTILE (1-833-382-2845), 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday. /Im0 24 0 R endobj /BS << They are in contact with patients who could benefit from a pneumatic pump. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 Explain the situation to them. Adams, KE, Rasmussen JC, Darne C, et al. /S /URI Many head and neck cancer survivors are faced with an additional challenge: lymphedema. stream I have been suffering from lymphedema for the past 2 years. /URI (http://www.fda.gov/) Last updated March 2021. The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). /StructParent 1 << 35 0 R] /TT1 70 0 R Except for my wrist, all my measurements showed reduction. << Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. /Tabs /S stream Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /CropBox [0.0 0.0 612.0 792.0] Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional /Im0 60 0 R Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. Hi Kristie, Thank you for sharing your story. I have a pump system left and right leg also stomach wraps. /Tabs /S View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. /TT0 69 0 R Thank you for sharing and being an advocate for lymphedema! What really gripes me is that my nurse practitioner wouldnt even consider ordering one. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. /Rect [40.95 36 85.101 45.216] >> D/N500187-000-00 Rev. I have lymphedema in my right arm, breast and axilla. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. /Length 412 /Group << * American Society of Clinical Oncology 1. HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 Minneapolis, MN 55416 USA I just received it yesterday and Im super hopeful that it will help. The woman from Idaho said her arm was softer and found the machine easy to use. They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. /W 0 >> We rely on the generosity of individuals and sponsors who support our mission and activities. /CropBox [0 0 612 792] With the enrollment of our first patient, we are pleased to initiate the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema, said Sheila Ridner, PhD, RN, FAAN, Professor of Nursing, Emerita, Vanderbilt University School of Nursing, a principal investigator of the trial. >> For these patients, Flexitouch Plus for head and neck lymphedema is the first and only pneumatic compression device cleared and commercially available to treat this condition at home. /Length 680 I was rather startled at how wrapped up I was. Having to search it all out including bandaging and reducing myself, learning from You Tube, finding supplies online and dealing with physical therapists and oncologists and radiation oncologists who dont know anything about this chronic disease and putting all the pieces together myself because there are people to help but no one knows where they are was emotially depressing. /Length 470 2. << For more information, https://tactilemedical.com/about-us/. Hope it works out. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. I have one new for sale. >> This combination of products and services ensures that tens of thousands of patients annually receive the at-home treatment necessary to better manage their chronic conditions. 1 0 obj The whole process, though limiting my ambulation, was comfortable and relaxing. Pain will be assessed using the VAS Pain Scale. endobj /Rect [40.95 36 85.101 45.216] /Annots [10 0 R 11 0 R 12 0 R] Non-cancer related lymphedema patients demonstrated a: 75% decline in the rate of cellulitis, a 40% reduction in the rate of out-patient hospital visits, a 34% reduction in rate of physical therapy visits, and a 36% reduction in lymphedema-related costs. /TT3 74 0 R /TT2 51 0 R 2013; Vol. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. Sign up today for your free Reader Account. /ProcSet [/PDF /Text /ImageC] /StructParents 6 If Im out late, I use it in the morning and then resume again in the evening. 11 0 obj Michelin Man came to mind as I stretched out on the couch. He just never could get use to using it and being able to don the garments. /Length 498 << /ProcSet [/PDF /Text /ImageC] /MediaBox [0 0 612 792] The initiation of this clinical trial underscores Tactile Medicals commitment to supporting the development of quality clinical evidence and expanding access to effective lymphedema treatment for this underserved patient population., For additional information about the trial, please visit: https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. Required fields are marked *. << First of all I cant drive, and second I have to pay a $60 copay every time I go. But in reading the users manual I found that you should consult your physician before using a FlexiTouch garment that covers your chest if you have a tissue expander. << /Resources << In conducting this rigorous clinical trial, we hope to build on the initial body of evidence by evaluating the effectiveness of Flexitouch Plus in comparison to usual care, using a variety of measures to assess the benefits of this at-home treatment for patient health and quality of life.. Support Care Cancer (2020). Negative value shows a decrease in symptoms/problems. /Rotate 0 Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. /S /URI I was told purchased high priced left garments which I dont think I needed. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Thumbs up for Flexi-Touch!! The Head & Neck Program is just 32 minutes long. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. The study, published in October 2015 and authored by Pinar Karaca-Mandic, PhD, Alan T. Hirsch, MD, Stanley Rockson, MD, and Sheila Ridner, PhD, RN, showed promising results when a patient used the Flexitouch System for one year. Overview Product Features Details Benefits The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. I went through a period of reducing with bandaging and compression bras and sleves and swell spots, tribute night garmets, flatknit sleeves and gauntlets, hours of MLD myself (still using the arm that I need to not be using) paying out of pocket thousands of dollars for professional lymph massage that insurance wouldnt pay for. Upper set (head and neck). endobj Flexitouch Plus provides flexible program options. >> Material and methods Design and participants I wanted to talk to some people who had actually used the pump. I have had it some 10 years now and when it gets to the point of cellulitis I take medication which I feel is not the thing to do but it takes the pain away and eventually relieves the fever and some of the swelling. The initiation of this clinical trial underscores Tactile Medicals commitment to supporting the development of quality clinical evidence and expanding access to effective lymphedema treatment for this underserved patient population., For additional information about the trial, please visit: https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. The Companys unique offering includes advanced, clinically proven pneumatic compression devices, as well as continuity of care services provided by a national network of product specialists and trainers, reimbursement experts, patient advocates and clinicians. >> Has anyone else had any experience with this? Breast cancer and treatment in itself was an awful journey. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. The woman from Idaho said her arm was softer and found the machine easy to use. x 4. >> /Font << bic)xPt%Iss>2N'1`G fbpi&xFChr?T)=3@:uUe.kEK&{Ox0;b {*H / #w`pTP+vmA x{iy[ewq#):I)_CCQ.*oIw|o'ckU([:xzW% )8g&6 2:8P-j+c Its_vz;9~3CF!,Eu^F!'T{ J^ Actually they dont know much about lymphedema. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Hi Karyn, I will post your comment and see if Sarah still has the pump available. /CS /DeviceRGB 2. Please remove one or more studies before adding more. Minneapolis, MN 55416 USA Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Can I use the machine on lower limbs with compression garments above? Phone: 1.612.355.5100 Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. >> If you still have the system, I am interested. PW!\v(jfz:yX 8$W"wqHbxQDL All reviewers. endobj Percentage of each response captured. For general information, Learn About Clinical Studies. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. It will consist of approximately 250 subjects enrolled at six clinical sites: Vanderbilt University Medical Center, University of Michigan, Johns Hopkins University, University of Kentucky, Rush University and University of Alabama. Top reviews. https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/. /MediaBox [0.0 0.0 612.0 792.0] /S /Transparency Numerous garment and program options to meet each patient's unique treatment needs Its brand new, used 1 time. In head and neck cancer, lymphedema can be caused by: Surgery: When lymph nodes and vessels are removed during surgery for cancer, it becomes harder for the body to move lymph fluid out of the area. Positive value shows an increase in swelling. endstream Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. >> %PDF-1.4 14(4): p. 198-205. /Tabs /S /Type /Page The head and neck garment set is easy to use and features the clinically proven Flexitouch technology that tens of thousands of lymphedema patients rely on every day to effectively treat their extremities. 0 T The trial will compare the short- and long-term effectiveness of Tactile Medicals Flexitouch Plus system to usual care, such as complete decongestive therapy (CDT), for the management of lymphedema and fibrosis in head and neck cancer survivors. /S /URI More than 90% of patients treated for head and neck cancer develop lymphedema1 resulting in swelling, fibrosis, difficulty swallowing, pain and other symptoms impacting quality of life with few viable options for long-term treatment, said Dr. Thomas F. ODonnell, Jr., Tactile Medicals Chief Medical Officer. The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. >> The content is not intended to substitute manufacturer instructions. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N /F 4 Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. endobj Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Symptom/Problem Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Function (Range of Motion) Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life-Overall From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Pain From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Change in Swelling From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Ease of Use/Satisfaction [TimeFrame:Assessed at 6 months], A diagnosis of head and/or neck lymphedema, Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! /Tabs /S (Note: There are other well regarded pumps on the market. >> 3701 Wayzata Blvd, Suite 300 /CropBox [0 0 612 792] << All stars. /C2_0 38 0 R 10 0 obj /Parent 2 0 R Yes, taking care of ones body requires several interventions. Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. Head and Neck Lymphedema Treatment Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. /Type /Action XJ The Flexitouch Plus system applies mild, dynamic pressure to stimulate lymphatic function and direct fluid away from impaired areas toward healthy, functioning regions where the fluid can be managed. https://doi.org/10.1007/s00520-020-. /TT2 71 0 R I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). The Flexitouch Plus helps to improve the lives of patients who have struggled with the pain, swallowing, speaking and breathing difficulties brought on by head and neck lymphedema. /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R My insurance paid for all of it and the Tactile rep will help you get that. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Pembrolizumab plus cetuximab in patients with recurrent . /Contents [13 0 R 14 0 R 15 0 R 16 0 R 17 0 R 18 0 R 19 0 R 20 0 R] Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. << I did send them an email and asked them to look at your case again. Heart failure (acute pulmonary edema, decompensated acute heart failure) In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with Advanced Techniques in Canine and Feline Neurosurgery - Brigitte A. Brisson,Andy Shores - Advanced Techniques in Canine and Feline Neurosurgery <br />An up-to-date discussion of the latest advanced neurosurgical techniques for dogs and cats <br />In Advanced Techniques in Canine and Feline Neurosurgery, a team of distinguished veterinary practitioners delivers an authoritative . Tactile Systems Technology, Inc. MINNEAPOLIS, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (Tactile Medical) (Nasdaq: TCMD), a medical technology company focused on developing medical devices for the treatment of chronic diseases at home, today announced the enrollment of the first patient in a randomized, controlled clinical trial evaluating the effectiveness of its Flexitouch Plus system for the treatment of head and neck lymphedema. Muluk SC, Hirsch AT, Tafe EC. Lymphatic drainage via pneumatic compression, Flexitouch Plus is the only FDA cleared pneumatic, compression device for head and neck cancer-related lymphedema and can be prescribed. >> /Font << 2016;14(4):198205. The best thing is that after only 6 days of pumping my breast and axilla is are much smaller and I have no dull grating pain for many hours in the day! The company approached Nottingham Spirk to develop a first-to-market pneumatic compression garment for use on the head and neck and to create the next generation Flexitouch Plus System. The leg garments that I received are for a much taller person. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. /TT1 50 0 R >> At-Risk Patient: Pressure Ulcers/Injuries, At-Risk Patient: Surgical Site Infections, Burns, Deep Partial-Thickness (Deep Second-Degree), Burns, Full-Thickness (Third- and Fourth-Degree), Burns, Superficial Partial-Thickness (Second-Degree), Peristaltic gradient sequential compression. The feeling of devloping a chronic disease after surviving cancer was almost debilitating. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) Rockson floated to my ears. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) << NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( /Resources << /Parent 2 0 R History of the Northwest Lymphedema Center. Write a review. It delivers a noninvasive therapy that patients can administer themselves at home. I just finished 6 weeks of radiation. endobj Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. Its amazing how we are communicating so much more through technology because of Covid. Ive heard from many people that they saw good results with their pump. Im only 44 years old , and I have kids that need mom back. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. I chatted with a woman from Tacoma and another from Idaho. /TT1 70 0 R << Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Sort by. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. Subjects enrolled in the trial will be randomized to one of two arms, where they will either self-administer once daily treatment with Flexitouch Plus or receive usual care as would typically be directed at their site, which may include CDT by a lymphedema therapist or other conservative management measures as directed by the therapist. /TT0 23 0 R Flexitouch Plus is an advanced intermittent pneumatic compression device (lymphedema pump) that gives patients a comfortable and convenient way to self-manage lymphedema and non-healing venous leg ulcers. I wish you success! I am looking for a left arm garment for the flexitouch plus. S /Parent 2 0 R >> Subject overall health and quality of life in the past week-EORTC C30. She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. I am on a fixed income and have to pay almost 1K for something that Tactile Medical SHOULD have measured fortheyre the experts and SHOULD have measured correctly. >> /CropBox [0.0 0.0 612.0 792.0] Venous Ulcers. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! It was a blow to the life I had that I once had. My skin appears more like the skin on my right arm. Forward-looking statements are generally identifiable by the use of words like may, will, should, could, expect, anticipate, estimate, believe, intend, continue, confident, outlook, guidance, project, goals, look forward, poised, designed, plan, return, focused, prospects or remain or the negative of these words or other variations on these words or comparable terminology. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. The trials primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. Ridner, S.H., Dietrich, M.S., Deng, J. et al. /TT0 69 0 R /Type /Action Yes. Developing Lymphedema and not being able to get the help that I neededwas awful. Type of Use (Select one or both, as applicable) lXI . My best to you. I can relate all too well to what you have been through. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. I have skipped 1 or 2 days just 3 or 4 times since March. /Rect [90.257 252.64 421.33 266.44] >> For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . Its also a relief not to manually MLD my arm every night. The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone. Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) In June 2017, we announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system. /MediaBox [0.0 0.0 612.0 792.0] 14(4): p. 198-205, 2. did you sell it yet? In the last year and a half I was getting cellulitis in my right leg about every 3-4 months and the last straw was in both. /Filter /FlateDecode Tactile Medical is a leader in developing and marketing at-home therapies for people suffering from underserved, chronic conditions including lymphedema, lipedema, chronic venous insufficiency and chronic pulmonary disease by helping them live better and care for themselves at home. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. endobj /C2_0 48 0 R Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. /C2_1 55 0 R >> The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. Information provided by (Responsible Party): The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Positive value shows an increase in quality of life/overall health. My husband has a brand new system that Im trying to sell. /Filter /FlateDecode Thank you for writing. /TT3 52 0 R I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. (Therapists couldnt afford themselves to take insurance payments because most insurances do not reinburse them enough to make it worthwhile) All in all I finally found the Lymphedema Center (why dont doctors know this) and took some classes and found an amazing therapist who has helped and has been trained in lymphedema and a few massage therapists that know what they are doing and are trained. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of the Companys control that can make such statements untrue, including, but not limited to, the impacts of the COVID-19 pandemic on the Companys business, financial condition and results of operations; the course of the COVID-19 pandemic and its impact on general economic, business and market conditions; the Companys inability to execute on its plans to respond to the COVID-19 pandemic; the adequacy of the Companys liquidity to pursue its business objectives; the Companys ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives, including prior to identifying a successor; adverse economic conditions or intense competition; loss of a key supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of the Companys products; technical problems with the Companys research and products; the Companys ability to expand its business through strategic acquisitions; the Companys ability to integrate acquisitions and related businesses; price increases for supplies and components; the effects of current and future U.S. and foreign trade policy and tariff actions; or the inability to carry out research, development and commercialization plans.

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