The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. 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. >> Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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! by Flexitouch. /W 0 (Note: There are other well regarded pumps on the market. Thanks. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N (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. I have a co/ pay of $422.57 yet to pay, But not until they get it so it can be used I kind of wish I had never got it. >> Adams, KE, Rasmussen JC, Darne C, et al. /Contents 73 0 R This is not anadvertisement for Flexitouch.). 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. I decided to purchase one without insurance. Michelin Man came to mind as I stretched out on the couch. They are in contact with patients who could benefit from a pneumatic pump. >> She explained that compression pumps force air into sleeves with multiple chambers. >> I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. For more information, https://tactilemedical.com/about-us/. Two years on pump controller and garments. 7 0 obj >> My husband?s pump system arrived yesterday. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Tactile Medical takes pride in the fact that our solutions help increase clinical efficacy, reduce overall healthcare costs and improve the quality of life for patients with chronic conditions. << It was a blow to the life I had that I once had. /Type /Catalog I used it a few times and Im good now. Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. Choosing to participate in a study is an important personal decision. /Length 450 Negative value shows a decrease in pain. /CS /DeviceRGB 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 the Flexitouch Plus device. HTo0~G6)BjH7u My best to you. I dont know if it will make a difference. Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. 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). /Parent 2 0 R The head garment and vest for head and neck for the Flexitouch Plus system should not be used on patients who have one or more of the following conditions: Pneumatic compressor, segmental home model with calibrated gradient pressure, Chronic Venous Insufficiency When I first went to physical therapy, she was running through some more common contibuters to swelling. So its fairly new for sale, Let me know if the pump system and right and left leg with stomach wraps are still for sale. /XObject << << Oral Oncology. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events. 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. 1. >> Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. All subjects will receive a single intervention. << The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. Important Notice: The contents of the website such as text, graphics, images, and other materials contained on the website ("Content") are for informational purposes only. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). >> You have reached the maximum number of saved studies (100). /BS << If anyone has one, or knows of one, please contact me. /Rotate 0 How customer reviews and ratings work See All Buying Options. Biomedical Optics Express. /Font << Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. So we appealed 3 times. /Font << >> /Parent 2 0 R H]O0+=) ES >> Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Since using the Flexitouch for almost a year, she had not experienced cellulitis. /Filter /FlateDecode Yes. >> Im sorry for the experience you had with Tactile Medical. /Type /Group Deng J, et al. & weigh 126 lbs. What is encouraging is that you have had success with managing your lymphedema! /Annots [10 0 R 11 0 R 12 0 R] The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. Its New, Your email address will not be published. It delivers a noninvasive therapy that patients can administer themselves at home. >> For more information, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/, Tactile Medical is a leader in developing and marketing at-home therapy devices that treat chronic swelling conditions such as lymphedema and chronic venous insufficiency. << did you sell it yet? /Contents 53 0 R Overview Product Features Details Benefits What really gripes me is that my nurse practitioner wouldnt even consider ordering one. It has become so bad that I can barely walk. For more information, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/, Tactile Medical is a leader in developing and marketing at-home therapy devices that treat chronic swelling conditions such as lymphedema and chronic venous insufficiency. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? 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. Thumbs up for Flexi-Touch!! Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Its been tough . * American Society of Clinical Oncology 1. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. /Rotate 0 Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. /F 4 /Filter /FlateDecode /CropBox [0 0 612 792] Yes, taking care of ones body requires several interventions. 14(4): p. 198-205, 2. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Minneapolis, MN 55416 USA 8 0 obj >> endobj /TT3 74 0 R /TT1 23 0 R Hope it works out. /TT3 72 0 R 7nwJ@6]?t~.} >> /Subtype /Link /CropBox [0.0 0.0 612.0 792.0] /Tabs /S /StructParents 0 /S /URI /MediaBox [0.0 0.0 612.0 792.0] Many, many of my patients love their pump. /TT1 50 0 R >> 11 0 obj Its amazing to me how little doctors know about lymphedema. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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 just received it yesterday and Im super hopeful that it will help. /TT2 58 0 R 3701 Wayzata Blvd, Suite 300 Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. /TT0 49 0 R If you dont mind, would you be willing to tell me what insurance company you have because it sounds like they were willing to help you? For more information, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 2016;14(4):198205. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. /Contents 36 0 R 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. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. D/N500187-000-00 Rev. /Parent 2 0 R /Resources << The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. /CS /DeviceRGB Swelling will be assessed using the ALOHA measurement protocol. 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^ The lymphedema seen in patients treated for head . Ridner, S.H., Dietrich, M.S., Deng, J. et al. %PDF-1.4 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. 18 0 obj /ProcSet [/PDF /Text] Free shipping for many products! /S /URI The one I bought from Amazon for $100 has more pressure, Does anyone know if the trunk is to run its cycle before the legs start, The flexi touch plus is a high priced machine to have that youre not able to use. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. 1. /TT2 72 0 R Has anyone else had any experience with this? I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. Try contacting different people. Looking at his ankles there IS no swelling now. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Study record managers: refer to the Data Element Definitions if submitting registration or results information. /BS << Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. I have a uniboot compressions on both of my calves. /S /URI >> Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. Please cross your fingers for me that this works. 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.. 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. /StructParents 2 Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? /A << >> Ml6(|a\!A.;Q#[. I have had the doctors look at my leg and rewrite a prescription for me but never try to see if my insurance will cover an air compression unit for my leg. The warranty was the same as a new machine. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. >> The Flexitouch Plus system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema. 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. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. 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 . 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.. Pembrolizumab plus cetuximab in patients with recurrent . I dont like that I have to do it but it has changed my legs back to normal. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. 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. /C2_0 54 0 R 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. K-ZB: Toll-free: 1.833.3TACTILE (1.833.382.2845) /Type /Group /TT3 52 0 R /Resources << Support Care Cancer (2020). /ExtGState << Minneapolis, MN 55416 USA It was up to me to piece it together. 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. /Font << Im only 44 years old , and I have kids that need mom back. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 2015;151(11):11871193. Hi Kathi, The FaceTime call might work! Numerous garment and program options to meet each patient's unique treatment needs /Rect [40.95 36 85.101 45.216] stream 10 0 obj The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. << stream Hi Wandalynn . 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. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. /StructParents 7 The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Toll-free: 1.833.3TACTILE (1.833.382.2845) /Tabs /S The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. 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. /Tabs /S 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. /Rotate 0 /A << Heart failure (acute pulmonary edema, decompensated acute heart failure) /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] Thank you for sharing and being an advocate for lymphedema! Learn More Take the steps now to help your head and neck cancer survivors. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. /Group << Talk with your doctor and family members or friends about deciding to join a study. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment 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. 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. I was rather startled at how wrapped up I was. 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. Except for my wrist, all my measurements showed reduction. It takes just 32 minutes per day. Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. /Rotate 0 Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. endobj /Rect [40.95 36 85.101 45.216] /Im0 60 0 R 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. 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. I will always have Lymphedema but the Flexitouch Plus was the last peice of the puzzle that I needed and I am so thankful and emotionally grateful that I am able to have it. /W 0 Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /TT0 69 0 R /Tabs /S Hi Wally, Hope someone is able to meet your request. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. /F 4 Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. /Parent 2 0 R The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. >> Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. /TT2 74 0 R Everything in my life that I do and love and I am passionate about invloves using my hands and arms. >> /Filter /FlateDecode The pump is called the Flexitouch System by Tactile Medical. << Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. /Type /Action /W 0 /Tabs /S /TT3 59 0 R During pregnancy (applies only to the Flexitouch Plus trunk accessory). /MediaBox [0 0 612 792] /F 4 The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. Do you know of anyone whom would want to buy it? << A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. This is a long story but I have managed it as best as I can but when I finally was ready to prove to my insurance that the Flexitouch was needed the insurance denied me coverage. 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. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. Positive value shows an increase in Function/Range of Motion. You have reached the maximum number of saved studies (100). /MediaBox [0.0 0.0 612.0 792.0] Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 5. >> /Pages 2 0 R Your email address will not be published. Tactile Systems Technology, Inc. stream ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. /Font << I have little confidence that the FaceTime call offered will be of much use. Lymphat Res Biol, 2016. I am looking for a left arm garment for the flexitouch plus. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. 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. My go to place when I need calming. 9 0 obj I really need this system and had such desperate hope. I use it everyday for an hour. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. /S /Transparency I would be interested to hear how your husbands experience with his new pump. It delivers a noninvasive therapy that patients can administer themselves at home. << Flexitouch Pd32-u Lymphedema Treatment System Pump. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Internal lymphedema measurement [TimeFrame:2 hours], External lymphedema measurement [TimeFrame:2 hours], Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan, Significant surgical resection of pharyngeal constrictor muscles, Patients with persistent or recurrent disease, Patients who have contraindications to use Flexitouch Plus device. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. Positive value shows an increase in symptoms/problems. /Rect [90.257 252.64 421.33 266.44] 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. Numerous clinical studies show achievement of major clinical benefits and cost savings https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) /Resources << k Positive value shows an increase in pain. . 14(4): p. 198-205. 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. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. Refer to the Legal Notice for express terms of use. The head & neck of non-human animals - | Cambridge SMART Vocabulary HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. Choosing to participate in a study is an important personal decision. It seems a lot of pumps are preprogrammed for the individual. 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. /Filter /FlateDecode endstream endobj 2 0 obj Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? 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.