News Article | May 15, 2017
SAN FRANCISCO--(BUSINESS WIRE)--AMERICAN SHARED HOSPITAL SERVICES (NYSE MKT:AMS) (the "Company", "AMS"), a leading provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, today announced financial results for the first quarter of 2017. For the three months ended March 31, 2017, medical services revenue increased 16.0% to $4,914,000 compared to medical services revenue of $4,238,000 for the first quarter of 2016. First quarter revenue for the Company's initial proton therapy system installed at The Marjorie and Leonard Williams Center for Proton Therapy at UF Health Cancer Center-Orlando Health in Florida was $1,155,000. Revenue for the Company's Gamma Knife operations decreased to $3,619,000 for the first quarter of 2017 compared to $4,125,000 for the first quarter of 2016, primarily because two sites were offline during this year's first quarter for Cobalt-60 reload. Net income attributable to the Company for the first quarter of 2017 increased to $293,000, or $0.05 per share. This compares to net income attributable to the Company for the first quarter of 2016 of $51,000, or $0.01 per share. Medical services gross margin for the first quarter of 2017 increased to 47.7% of revenue, compared to medical services gross margin of 40.9% of revenue for the first quarter of 2016, primarily reflecting the increase in revenue from proton therapy. Operating income increased 51.1% to $754,000 for the first quarter of 2017 compared to operating income of $499,000 for the same period a year earlier. Income before income taxes increased 91.4% to $758,000 for the first quarter of 2017 compared to $396,000 for the first quarter of 2016. Non-GAAP pre-tax income, net of income attributable to non-controlling interest, was $509,000 for the first quarter of 2017. This compares to non-GAAP pre-tax income, net of income attributable to non-controlling interest, of $115,000 for the first quarter of 2016. Selling and administrative expenses for the first quarter of 2017 increased to $1,139,000, compared to selling and administrative expenses of $949,000 for the first quarter of 2016. Interest expense increased to $453,000 for the first quarter of 2017, compared to interest expense of $285,000 for the first quarter of 2016, primarily reflecting the addition of the proton center in Orlando. Adjusted EBITDA, a non-GAAP financial measure, was $2,616,000 for the first quarter of 2017, compared to $2,129,000 for the first quarter of 2016. Please refer to the financial statements included with this press release for a reconciliation of GAAP to this non-GAAP financial measure. At March 31, 2017, cash and cash equivalents was $2,403,000, compared to $2,871,000 at December 31, 2016. Shareholders' equity at March 31, 2017 was $27,774,000, or $4.87 per outstanding share. This compares to shareholders' equity at December 31, 2016 of $27,173,000, or $4.97 per outstanding share. Chairman and Chief Executive Officer Ernest A. Bates, M.D. said, "Patient treatments that began in April 2016 at our proton center at UF Health Cancer Center-Orlando Health continue to drive improved financial performance for AMS. Treatment volume at this center increased to 1,220 fractions in the first quarter, compared to 1,019 fractions performed in last year's fourth quarter, 869 fractions performed in the third quarter and 442 fractions performed in the second quarter. The reliability and throughput of the MEVION S250 proton system we supplied Orlando Health is meeting or exceeding our expectations, and we believe there is room for further growth in treatment volume. "The decrease in revenue in our Gamma Knife business in this year's first quarter was the anticipated consequence of routine Cobalt-60 reload at two of our centers. As previously announced, we will lose one of our sites due to the expiration of its contract term in this year's second quarter; however, we expect the Gamma Knife® Perfexion™ system we recently contracted to supply to Bryan Medical Center in Lincoln, Nebraska to begin treating patients in this year's second half. We also expect patient treatments to begin in this year's third quarter on a Gamma Knife located at the Air Force Hospital in Lima, Peru. "We are focused on taking advantage of the attractive growth opportunities available to us in both our proton and Gamma Knife businesses. Building on the success we have achieved to date, we are confident that AMS will deliver further growth in the years ahead." American Shared has scheduled a conference call at 12:00 p.m. PDT (3:00 p.m. EDT) today. To participate in the live call, dial (800) 588-4973 at least 5 minutes prior to the scheduled start time, and mention confirmation number 4493 2897. A simultaneous WebCast of the call may be accessed through the Company's website, www.ashs.com, or www.streetevents.com (institutional investors). A replay will be available for 14 days at these same internet addresses, or by dialing 888-843-7419 and entering 4493 2897# when prompted. American Shared Hospital Services provides turnkey technology solutions for advanced radiosurgical and radiation therapy services. AMS is the world leader in providing Gamma Knife radiosurgery equipment, a non-invasive treatment for malignant and benign brain tumors, vascular malformations and trigeminal neuralgia (facial pain). The Company also offers proton therapy, and the latest IGRT and IMRT systems. AMS owns a common stock investment in Mevion Medical Systems, Inc., developer of the compact MEVION S250 Proton Therapy System. This press release may be deemed to contain certain forward-looking statements with respect to the financial condition, results of operations and future plans of American Shared Hospital Services (including statements regarding the expected continued growth in treatment volume of the MEVION S250 system, the expansion of the Company's proton therapy business, the growth of the Company, and the timing of treatments by new Gamma Knife systems) which involve risks and uncertainties including, but not limited to, the risks of variability of financial results between quarters, the risks of the Gamma Knife and radiation therapy businesses, the risks of developing The Operating Room for the 21st Century program, the risks of investing in Mevion Medical Systems, Inc., and the risks of the timing, financing, and operations of the Company’s proton therapy business. Further information on potential factors that could affect the financial condition, results of operations and future plans of American Shared Hospital Services is included in the filings of the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2016, and the definitive Proxy Statement for the Annual Meeting of Shareholders to be held on June 27, 2017. None of Adjusted EBITDA and non-GAAP pre-tax income, the non-GAAP measures presented in this press release and supplementary information, is a measure of performance under the accounting principles generally accepted in the United States ("GAAP"). These non-GAAP financial measures should not be considered as substitute for, and investors should also consider, income (loss) before income taxes, income from operations, net income attributable to the Company, earnings (loss) per share and other measures of performance as defined by GAAP as indicators of the Company's performance or profitability. We use these non-GAAP financial measures as a means to evaluate period-to-period comparisons. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding our performance by excluding certain expenses and charges that may not be indicative of the operating results of our recurring core business, such as the loss on early extinguishment of debt. We believe that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance.
News Article | March 30, 2016
New research bolsters evidence that a simple blood test may someday be used to detect concussions. It suggests that a protein linked with head trauma may be present in blood up to a week after injury, which could help diagnose patients who delay seeking treatment. The study involved patients at one hospital in Florida and the results are preliminary - a concussion blood test based on the two proteins studied or on other so-called biomarkers under review is likely at least a few years away from routine use. But the new findings "are a substantial step" in developing a test that could be used in broad settings, from the battlefield to sports events and doctors' offices. That's according to an editorial published with the study Monday in JAMA Neurology. Dr. Ramon Diaz-Arrastia, co-author of the editorial and a researcher at the government's Uniformed Services University of the Health Sciences, said it's likely that several biomarkers will be found to be useful for diagnosing concussions, "each of which will tell us something slightly different" about the injury. Dr. Linda Papa, an Orlando Health emergency medicine specialist and colleagues tested nearly 600 adults treated at Orlando Regional Medical Center. About half had concussions from car crashes, falls, sports and other activities. Most were mild, with symptoms that included loss of consciousness, amnesia or feeling disoriented. The rest of the adults had fractures or other types of non-brain trauma. Blood samples were taken starting four hours following the injury, then periodically for seven days. The tests measured two proteins nicknamed GFAP and UCH-L1, which are present in brain cells. In a head injury, the proteins can leak into the bloodstream, Papa said. Other research has shown blood levels of the proteins are highest with the most severe injuries. In this study, levels of both proteins were much higher in concussion patients. The proteins were found in low levels in some non-concussion patients, probably from a head bump or jostling during an accident but not true concussions, Papa said. Levels of the UCH protein rose quickly but declined substantially within two days, while GFAP levels were detectable during the week following injury. Many concussion patients put off going to the doctor because they think the injury isn't serious, but end up seeking treatment a few days later when symptoms persist, Papa said. She said blood tests could help diagnose these patients, and could help determine whether neurological testing or other medical treatment is needed. Typically doctors advise rest from work, school and other taxing activities until after concussion symptoms have disappeared. Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, called the data encouraging and said finding an easily detectable biomarker for concussions is "the holy grail for head injury" research. His agency paid for the study and the U.S. government has spent millions of dollars on concussion research. More than 2 million people nationwide get emergency room treatment for concussions and other brain trauma each year. Damage may not be visible on imaging tests so doctors typically rely on symptoms. Diagnosis is important because repeated head blows have been linked with lasting memory problems and potentially a degenerative brain disease found in some retired NFL players. Southern Illinois University neuroscientist Michael Hylin noted that some concussion symptoms, including dizziness and fatique, can also be caused by dehydration, which is another threat to athletes involved in rigorous sports. A test that could distinguish between the two conditions would be useful to help guide treatment, he said. Papa noted that there are blood tests to diagnose problems with other organs, including the heart, liver and kidneys, "and now we're really coming close to having something for the brain." She is an unpaid scientific consultant for Banyan Biomarkers, Inc. The Florida company announced earlier this year that is working with Royal Philips to develop a hand-held device that would analyze blood samples and display results within minutes showing if the proteins are present.
Corey G.R.,Duke University |
Kabler H.,Sunrise Medical |
Mehra P.,Sharp Chula Vista Medical Center |
Gupta S.,Hospital and Research Center |
And 9 more authors.
New England Journal of Medicine | Year: 2014
BACKGROUND: Oritavancin is a lipoglycopeptide with bactericidal activity against gram-positive bacteria. Its concentration-dependent activity and prolonged half-life allow for single-dose treatment. METHODS: We conducted a randomized, double-blind trial in which adults with acute bacterial skin and skin-structure infections received either a single intravenous dose of 1200 mg of oritavancin or a regimen of intravenous vancomycin twice daily for 7 to 10 days. Three efficacy end points were tested for noninferiority. The primary composite end point was defined as cessation of spreading or reduction in lesion size, absence of fever, and no need for administration of a rescue antibiotic 48 to 72 hours after administration of oritavancin. Secondary end points were clinical cure 7 to 14 days after the end of treatment, as determined by a study investigator, and a reduction in lesion size of 20% or more 48 to 72 hours after administration of oritavancin. RESULTS: The modified intention-to-treat population comprised 475 patients who received oritavancin and 479 patients who received vancomycin. All three efficacy end points met the prespecified noninferiority margin of 10 percentage points for oritavancin versus vancomycin: primary end point, 82.3% versus 78.9% (95% confidence interval [CI] for the difference, -1.6 to 8.4 percentage points); investigator-assessed clinical cure, 79.6% versus 80.0% (95% CI for the difference, -5.5 to 4.7 percentage points); and proportion of patients with a reduction in lesion area of 20% or more, 86.9% versus 82.9% (95% CI for the difference, -0.5 to 8.6 percentage points). Efficacy outcomes measured according to type of pathogen, including methicillin-resistant Staphylococcus aureus, were similar in the two treatment groups. The overall frequency of adverse events was also similar, although nausea was more common among those treated with oritavancin. CONCLUSIONS: A single dose of oritavancin was noninferior to twice-daily vancomycin administered for 7 to 10 days for the treatment of acute bacterial skin and skin-structure infections caused by gram-positive pathogens. (Funded by the Medicines Company; SOLO I ClinicalTrials.gov number, NCT01252719.) Copyright © 2014 Massachusetts Medical Society.
Friedell M.L.,Orlando Health
Journal of Surgical Education | Year: 2010
In summary, remembering the core principles of teaching surgical skills outside of the operating room will allow decisions about space and equipment needs to ensure achieving the goal of bringing a better prepared resident to the valuable educational classroom of the patient's bedside and the operating room. The plan outlined above should achieve this in most surgery training programs. © 2010 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.
Herrera-Soto J.A.,Orlando Health
Orthopedics | Year: 2011
Unstable slipped capital femoral epiphysis can have disastrous complications including osteonecrosis and chondrolysis. It has been shown that 20% to 80% of patients may develop a contralateral slip ≤18 months after diagnosis. The purpose of this article is to report and characterize patients who developed bilateral unstable slips. After Institutional Review Board approval, the patients included were only those with bilateral unstable slipped capital femoral epiphyses. A minimum 2-year follow-up was required. Seven patients, all female, were included in the study, with an average age of 11.4 years at the time of their first slips. The interval between slips averaged 127 days (range, 0-245 days). All but 1 patient presented with a severe slip. The second slip was also severe in 3 patients and less severe in 4 patients. The triradiate cartilage was open in 3 patients. Two patients required corrective osteotomies. Chondrolysis developed in 2 patients with no osteonecrosis reported. The incidence of bilateral unstable slips ranged from 4% to 20% of all unstable slipped capital femoral epiphyses based on our findings. Skeletal immaturity was not a risk factor. The surgeon must be vigilant for the possibility of bilateral slips. The family must be instructed on precautions patients must take while recuperating from unstable slipped capital femoral epiphyses. Contralateral fixation of the unaffected side may be warranted in patients with initial severe unstable slipped capital femoral epiphyses to prevent this condition. Copyright 2011, SLACK Incorporated.
News Article | February 28, 2017
WASHINGTON, Feb. 28, 2017 /PRNewswire/ -- Evolent Health, a company providing an integrated value-based care platform to the nation's leading health systems and physician organizations, announced today its partnership with Orlando Health. Evolent and Orlando Health will partner to manage b...
News Article | March 21, 2016
Dr. Jamin Brahmbhatt is co-director of The Personalized Urology & Robotics (PUR) Clinic at South Lake Hospital, in affiliation with Orlando Health. He contributed this article to Live Science's Expert Voices: Op-Ed & Insights. In the next few years, men may have more options for birth control than ever before. Researchers are developing, and already testing, a number of new methods in China and India, and in Europe, an implantable on/off switch developed by a German carpenter is generating a lot of buzz. The switch, known as the Bimek SLV, has been tested on only one man so far — Clemens Bimek, the guy who invented it — but it's garnering a lot of attention. I guess if you develop a new method for contraception, you should be the first to try it. But for the rest of us, there is too much at stake to experiment with birth control. With that in mind, here is a rundown of various methods: what's known, what's not known and what's next (including more on that on/off switch). First, here is what we know works. You're probably well aware of these methods, but it's worth reiterating that these are the only tried and true methods on this list. So, if birth control is your goal, these are your best bets. Vasectomy: A procedure used to block, cut or close the vas deferens, the tubes that carry sperm. Vasectomies are quick, relatively painless and nearly 100 percent effective — eventually. It's important to remember that it can take several months for remaining sperm to completely clear the vas deferens. In the meantime, pregnancy is still possible. A doctor will conduct semen analysis tests in the months following the procedure, but men should remember to take additional birth control precautions until they get the "all clear" from their physician. A vasectomy is one of the most effective forms of birth control, but it does come with some risks. For example, the tubes could reconnect, or the procedure could result in chronic pain. Therefore, before undergoing a vasectomy, men should be sure to ask their doctor the right questions. Condoms: When used properly, condoms are also nearly 100 percent effective. The problem is, men make mistakes, and user error is the biggest reason for driving down condoms' effectiveness to 82 percent. That means that, for every 100 couples that use only condoms as birth control, 18 will be shopping for cribs at some point this year. When it comes to condoms, patience and practice make perfect. Well, nearly perfect — so be careful to use them properly. Abstinence or withdrawal: The only sure way to completely avoid pregnancy is to avoid having sexual intercourse. If that's not possible, the withdrawal method is 96 percent effective if you do it right, but only 73 percent effective if your timing is off. Also, though the jury is still out on a definitive answer, some experts believe that clear fluid that appears before ejaculation can contain enough sperm to cause pregnancy. Do-it-yourself heat methods: There are a lot of anecdotes about the effectiveness of using heat as a natural contraceptive. It's imperative to remember, however, that these are not definitively proven methods of birth control. Some claim that sitting in a hot tub or sauna for an extended period of time works. Others claim that wearing tight, brief-style underwear raises the core temperature of the testes, which causes a decrease in sperm count. In the 1950s, Dr. Martha Voegeli a Swiss physician and pioneer in the field of male contraception, had men in India sit in tubs of water heated to 116 degrees Fahrenheit (about 47 degrees Celsius). Taking 45-minute baths for 21 straight days resulted in six months of contraception, she claimed, although her work was never published. Others suggest that men expose themselves to incandescent light bulbs as a means of contraception, but in my opinion, that's not the brightest idea. Herbal options for men: We are not there yet, but some claim there are herbal and natural supplements that come in pill form that can act as birth control. Gossypol, derived from cottonseed, has been studied in China, Africa and Brazil. It appears to be well tolerated and effective in low doses, but the National Institutes of Health cautions that the results of extended use may not be reversible. Tripterygium wilfordii is another herb that may hold promise. Derived from a vine that grows in southern China, it has been used to treat everything from fever to hepatitis to rheumatoid arthritis. Although it's been studied extensively in China, most studies have been in animals or are retrospective studies in men. The bottom line is that it may not be easy to find these herbs, and there are no absolute guarantees that they work. The "on/off" switch: Technically known as the Bimek SLV, these small switches are surgically implanted just under the skin, and around the vas deferens, the tubes that carry sperm from each testicle. Through the skin, you can flip the switch "on," and sperm flow freely. Switch it to the "off" position, and much like turning off a faucet, the tubes are blocked, and the sperm is diverted. There is even a "safety lock" that requires pushing two buttons simultaneously to turn the switches back on. The switches are still in the testing stage and are likely years away from commercial use, but it's one of the more novel approaches to male contraception in decades. [Guys, Put a Cork In It: Tomorrow's Contraceptives ] Vasalgel: Another approach that's showing promise is an injectable polymer called Vasalgel. Instead of performing a surgical vasectomy to sever the vas deferens, doctors inject a gel that blocks them. Sperm are too large to pass through the gel and are reabsorbed by the body. If a man wishes to reverse the process, he gets a second injection that dissolves the polymer and reopens the vas deferens tubes. The first clinical trial of Vasalgel is expected to begin this year. Clean Sheets Pill: Researchers in the United Kingdom are hoping to develop a temporary, on-the-spot pill that men can take that may dramatically inhibit the release of semen. The pill was discovered inadvertently after researchers noticed side effects of common medications intended to treat conditions like high blood pressure and schizophrenia. Though it's only been tested in animals so far, it offers a variety of benefits: It's easy, it works (at least in animals), and the effects are immediate but temporary. The drawbacks? Will men really take responsibility for buying, carrying and stopping to take a pill before sex? A survey of Americans conducted by the Parsemus Foundation men found that 60 percent wanted to learn more about the pill, and 20 percent flat out said no, they would not take a pill — but 20 percent said they definitely would. That's a higher percentage than the portion of men who say they use condoms, so there still may be hope for the Clean Sheets Pill. We may be years away from viable new options for male birth control, but we are moving in that direction. Most research is currently taking place in areas where birth control is more urgent due to population spikes, like China, India and Africa. The idea and the products will eventually find their way to the United States, provided they are alluring enough to investors and attractive enough to a large number of men. But please remember: Birth control does not equal protection from sexually transmitted diseases . You still have to protect yourself by taking steps like practicing monogamy, limiting your number of sexual partners and wearing a condom. Follow all of the Expert Voices issues and debates — and become part of the discussion — on Facebook, Twitter and Google+. The views expressed are those of the author and do not necessarily reflect the views of the publisher. This version of the article was originally published on Live Science . Essure Birth Control Controversy: 5 Things You Should Know Male Birth Control Treatment Could Focus on Sperm Proteins, Not Hormones Copyright 2016 LiveScience, a Purch company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
News Article | February 17, 2017
Objective Response Rate (ORR) of 31%, One Confirmed Complete Response (CR) and Ten Confirmed Partial Responses (PRs) ORLANDO, Fla., Feb. 17, 2017 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or “the Company”) today announced that sacituzumab govitecan (IMMU-132) is active in patients with metastatic urothelial cancer (UC) and has the potential to become a second line or later treatment to platinum-based or immuno-oncology therapy for these patients. “With larger numbers than the initial report, I remain impressed with the safety and efficacy results produced by sacituzumab govitecan in a difficult-to-treat patient population that had a median of two prior therapies and had extensive metastatic disease,” commented Dr. Scott T. Tagawa, the Richard A. Stratton Associate Professor in Hematology and Oncology, and an Associate Professor of Clinical Medicine and of Clinical Urology at Weill Cornell Medicine and an oncologist at NewYork-Presbyterian, who presented the results at the GU conference. “While patients with metastatic UC usually respond well to initial therapy with a platinum-containing regimen, few options are available after they become refractive. Second-line immune checkpoint-inhibitor (IO) therapy was recently approved by the FDA, such as atezolizumab and nivolumab, with expected approval of pembrolizumab as well. Although responders to the new IO therapy may do well for a prolonged period of time, about three-fourths do not respond and overall median PFS is less than 2.5 months and median OS less than 13 months have been reported,” added Dr. Tagawa, who has served as a consultant to Immunomedics. In the ongoing Phase 2 study with sacituzumab govitecan in metastatic UC, the ORR among 36 assessable patients was 31% (11/36), including one confirmed CR and ten confirmed PRs. The median duration of response for these ten patients was 7.5 months (95% confidence interval [CI], 4.4 to 12.9 months), with one patient having a PR for more than 18 months and continuing therapy. Overall, 69% of patients showed tumor shrinkage from baseline with sacituzumab govitecan therapy, and 14 patients are still under therapy. For the 41 intention-to-treat patients, median PFS was 7.2 months (95% CI, 6.7 to 11.7 months) and median OS was 15.5 months (95% CI, 8.9 to 17.2 months). Of the twelve patients with progression after prior IO therapy and chemotherapy, there were one unconfirmed PR and six patients with stable disease following sacituzumab govitecan treatment. The Company announced on February 10, 2017 that an exclusive global licensing agreement was entered into with Seattle Genetics (NASDAQ:SGEN), providing Seattle Genetics worldwide rights to develop, manufacture and commercialize sacituzumab govitecan in multiple indications, including UC. “We are pleased with these promising results, especially the long-term control of advanced disease in patients who failed multiple prior therapies, and look forward to working closely with Seattle Genetics to bring this important investigational product to cancer patients expeditiously,” stated Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. Ms. Sullivan added, “We remain on target to commence our Phase 3 randomized trial in patients with advanced triple-negative breast cancer in March, and are working diligently to complete the submission of our Biologics License Application to FDA for Accelerated Approval of this indication.” In addition to Dr. Tagawa, other clinical investigators participating in this study include Drs. Allyson J. Ocean, Bishoy Faltas, and Ana Molina, his colleagues at NewYork-Presbyterian and Weill Cornell Medicine, New York, NY; Dr. Elaine Lam, University of Colorado Cancer Center, Aurora, CO; Drs. Philip Saylor and Aditya Bardia, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; Dr. Julio J. Hajdenberg, UF Health Cancer Center-Orlando Health, Orlando, FL; Dr. Alicia K. Morgans, Vanderbilt-Ingram Cancer Center, Nashville, TN; Drs. Kevin Kalinsky and Emerson Lim, NewYork-Presbyterian/Columbia University Medical Center-Herbert Irving Comprehensive Cancer Center, New York, NY; and Dr. Matthew D. Galsky, Icahn School of Medicine Mount Sinai, Tisch Cancer Institute, New York, NY. A total of 44 patients with metastatic UC had been enrolled into this open-label multicenter study. Sites of metastases included liver (N=9; 25%), lymph nodes (N=14; 39%), lungs (N=14; 39%, pelvis (N=9, 25%), and bone (N=4; 11%). Patients received a median of six doses (range, 1-50) of sacituzumab govitecan, which was administered at 8 or 10 mg/kg on days 1 and 8 of 3-week cycles. Despite repeated dosing, grade 3 or higher adverse events were limited to neutropenia (30%), febrile neutropenia (11%), fatigue (11%), and diarrhea (3%). Treatment response was assessed by computed tomography (CT) every 8 weeks. Patients with more than 30% tumor shrinkage required confirmation within 4 to 6 weeks after the initial response in accordance with by RECIST 1.1 for single-arm studies. About Immunomedics Immunomedics (the “Company”) is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics’ advanced proprietary technologies allow the Company to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these technologies, Immunomedics has built a pipeline of eight clinical-stage product candidates. Immunomedics’ portfolio of investigational products includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxic effects that are usually found with conventional administration of these chemotherapeutic agents. Immunomedics’ most advanced ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. IMMU-132 has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer who have failed at least two prior therapies for metastatic disease. Immunomedics has a research collaboration with Bayer to study epratuzumab as a thorium-227-labeled antibody. Immunomedics has other ongoing collaborations in oncology with independent cancer study groups. The IntreALL Inter-European study group is conducting a large, randomized Phase 3 trial combining epratuzumab with chemotherapy in children with relapsed acute lymphoblastic leukemia at clinical sites in Australia, Europe, and Israel. Immunomedics also has a number of other product candidates that target solid tumors and hematologic malignancies, as well as other diseases, in various stages of clinical and preclinical development. These include combination therapies involving its antibody-drug conjugates, bispecific antibodies targeting cancers and infectious diseases as T-cell redirecting immunotherapies, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies, created using its patented DOCK-AND-LOCK® protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 306 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. For additional information on the Company, please visit its website at www.immunomedics.com. The information on its website does not, however, form a part of this press release. Important Additional Information Immunomedics, Inc. (the “Company”), its directors and certain of its executive officers will be deemed to be participants in the solicitation of proxies from Company stockholders in connection with the matters to be considered at the Company’s 2016 Annual Meeting. The Company has filed a definitive proxy statement and form of WHITE proxy card with the U.S. Securities and Exchange Commission (the “SEC”) in connection with any such solicitation of proxies from Company stockholders. COMPANY STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ THE DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS), THE ACCOMPANYING WHITE PROXY CARD AND ANY OTHER RELEVANT DOCUMENTS THAT THE COMPANY FILES WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Information regarding the identity of participants, and their direct or indirect interests, by security holdings or otherwise, is set forth in the proxy statement and other materials filed by the Company with the SEC. Stockholders will be able to obtain the proxy statement, any amendments or supplements to the proxy statement and other documents filed by the Company with the SEC for no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge at the Company’s website at www.immunomedics.com, by writing to Immunomedics, Inc. at 300 The American Road, Morris Plains, New Jersey 07950, or by calling the Company’s proxy solicitor, MacKenzie Partners, Inc. at (212) 929-5500, or by calling Dr. Chau Cheng, Senior Director, Investor Relations & Corporate Secretary, (973) 605-8200, extension 123. Forward-Looking Statements This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, out-licensing arrangements (including the timing and amount of contingent payments under the licensing and development agreement with Seattle Genetics), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations, new product development (including clinical trials outcome and regulatory requirements/actions), the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and competitive risks to marketed products, and the Company’s ability to repay its outstanding indebtedness, if and when required, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
News Article | December 6, 2016
CAMBRIDGE, Mass. & ORLANDO, Fla.--(BUSINESS WIRE)--In his first National Forum keynote as President and CEO of the Institute for Healthcare Improvement (IHI), Derek Feeley focused on a topic that has been central to the organization’s mission and work since its founding: patient safety and the necessity for all health care systems to remain focused on reducing harm. Feeley addressed nearly 5,000 health care professionals, health leaders, students, patient advocates, and community improvers in Orlando at the 28th Annual National Forum on Quality Improvement in Health Care. He argued for a more ambitious approach to patient safety, which would include broadening the safety lens to consider the millions of patients impacted by inequities in care, and by indignities in care. Feeley remarked: “Thanks to years of hard work by doctors, nurses, leaders, and many, many improvers on the frontlines of care, we now know that certain types of harm can be eliminated. We must apply that same ambition and rigor to driving out all the harms patients suffer needlessly, including those resulting from the absence of equity and lack of respect. This requires not just focusing on what actions need to be avoided, but what needs to be done right.” Feeley added that culture change, continuous learning, and looking at safety as a system that links settings across the continuum of care are necessary to further progress. He also identified opportunities to better engage patients and families in ensuring that care is as safe as it can be. A leader in health and health care improvement worldwide, IHI has convened the four-day event (December 4-7, 2016) to showcase multiple fronts where improvers are driving new approaches to achieve better care, better health, and lower cost for patients and populations. These strategies include working to reduce disparities and improve health equity; creating community partnerships that extend beyond the walls of the health care system to address more upstream determinants of health; and tapping into the talents and knowledge of students and patients to co-create new models of care. While the recent US presidential election and the future of the Affordable Care Act were very much on people’s minds, the National Forum continues to offer the improvement community a way to stay focused on transformations that need to occur no matter what. Feeley says having a common purpose matters. “There’s no question that health reform at the national level is about to face some major challenges,” stated Feeley. “This reality makes IHI more determined than ever to work closely with our partners and colleagues to demonstrate the positive changes that are possible and to stay the course, especially during times of uncertainty. We have a particular responsibility to those who lack access to care or who experience inequity or social injustice. Together, we must make care better, populations healthier, and costs more affordable.” Feeley shared the podium with Abraham Verghese, MD, a nationally bestselling author and a prominent voice in medicine with a uniquely humanistic view of the future of health care in his role as Senior Associate Chair, Stanford University School of Medicine. Dr. Verghese spoke about the importance of empathy in patient care. Additional speakers at this year’s Forum include NASA astronaut Captain Scott Kelly; IHI Senior Fellow and President Emeritus, Dr. Don Berwick; and a team of clinicians and leaders from Orlando Health, detailing stories and insights about mass trauma events and caring for injured patients, following the June 2016 Pulse nightclub shooting in Orlando. A number of Forum sessions this year spotlight measurement – a subject of high interest to attendees given the heavy burden faced by health care systems to collect, review, and report on hundreds of measures aligned with safety initiatives and payment programs that increasingly reward value and quality outcomes over volume or frequent utilization of care. Sessions such as “D29/E29: Applying Meaningful Measurement in Health and Health Care” aim to ease the measurement burden by offering guidance on which measures are truly necessary, which might be eliminated, and how to ensure that measures that matter are tracked, analyzed, and transparently used to improve care, not just to satisfy reporting. To help address these changing dynamics, a recently published IHI White Paper – Whole System Measures 2.0: A Compass for Health System Leaders – offers health care system leaders and boards a new set of 15 measures grouped together for the first time under the broad domains of health, experience of care, and per capita cost, or the IHI Triple Aim. The goal of WSM 2.0 is to help those at the helm better understand how to deliver better care to patients in conjunction with improving the health of the communities where they reside. In collaboration with like-minded organizations, communities, and individuals, IHI applies improvement methods and tools to reduce unjust, costly, and persistent inequities in health and health care. At this year’s Forum, health equity is a major theme headlining some 15 sessions – including ones on reducing unconscious bias in decision making, advancing health care for the transgender community, and addressing patients’ social needs as a standard part of quality care. Over the course of the Forum, attendees will hear about a wide range of outstanding work being done to improve the quality and safety of health care in the US and abroad, with more than 100 sessions covering topics such as identifying ethical issues in quality improvement, understanding top health IT safety hazards, making a better resident experience, and engaging harmed patients for healing and safety. More than 600 improvement storyboards will also be on display, including a significant number that reflect improvement initiatives launched by students in the health professions from all over the world who are active in IHI’s Open School. About the Institute for Healthcare Improvement IHI is a leader in health and health care improvement worldwide. For more than 25 years, we have partnered with visionaries, leaders, and front-line practitioners around the globe to spark bold, inventive ways to improve the health of individuals and populations. Recognized as an innovator, convener, trustworthy partner, and driver of results, we are the first place to turn for expertise, help, and encouragement for anyone, anywhere who wants to change health and health care profoundly for the better. To advance our mission, IHI’s work is focused in five key areas: Improvement Capability; Person- and Family-Centered Care; Patient Safety; Quality, Cost, and Value; and Triple Aim for Populations. Learn more at ihi.org.
News Article | November 21, 2016
Doctors who work in one of the busiest ERs, in one of the busiest tourist areas of the US, offer tips for healthy travel Orlando, Fla. - If you've ever had to seek medical attention for an illness or an injury during a vacation, you're not alone. A new national survey by Orlando Health finds one in four vacations includes a trip to the ER and doctors say many patients are simply not prepared for the situation. "When you're going on vacation the last thing you want to think about is a medical emergency, but with just a few simple steps, you can rest assured that you will be prepared for any situation" said Steven Corbett, MD, an emergency medicine physician with Dr. P. Phillips Hospital at Orlando Health. Because it's located in the heart of one of the most popular tourist destinations in the world, the emergency department at which Corbett works is one of the busiest in the country, treating more than 80,000 patients per year. "We really see the gamut," said Corbett. "If you can think it or imagine it, quite honestly, we've seen it." The facility is so busy, in fact, that it offers overnight accommodations through the Cynthia C. and William E. Perry Pavilion to friends and family who bring in loved ones for emergency care. "We have an entire department that does nothing more than help the families and friends of our patients," said Corbett. "Not only are they welcome to stay here for a per-night donation, but we will ferry them back and forth to their hotels and even pick up their car for them from the theme park where they may have left it." Corbett says many travelers make the same mistakes when it comes to medical emergencies on vacation, and he offers a few tips to make sure you're prepared for your next trip: Don't Force it - If you are sick or injured before your vacation begins, stay home. "I understand that we only get so many days off throughout the year and we spend a lot of time planning our vacations," said Corbett, "but I see people every day who think they can manage their conditions only to wind up in the ER, which ruins the trip for everyone involved." Carry Your Medical Information with You - If you are dealing with a medical issue at the time of your trip or if you have a chronic condition, be sure to carry pertinent information with you. "You can store a lot of information on your phone," said Corbett. "Make a list of allergies you might have, take photos of your prescriptions and upload images to your phone like x-rays, MRIs or EKG results. The more information you can provide to us, the more efficiently we can treat you." There is a side note, however: be sure someone else knows how to unlock your phone and retrieve that information. "It's great if you have those things, but it does no good if we can't get to it. Make sure your phone is unlocked and the information is readily available." Refill Prescriptions Before You Leave - One of the most common mistakes people make is that they run out of their medications in the midst of their vacation. Getting a refill in an unfamiliar place can be a challenge and going without your medication is never a good idea, so be sure you have enough to cover the duration of your trip. Also, in case your luggage is lost, be sure to pack all medications in a carry-on bag so you can have it with you at all times. Speak Up if You Don't Feel Well - Corbett says many patients wind up in the emergency department because they didn't speak up when they first started feeling ill. "They don't want to be responsible for ruining everyone else's fun, so they don't just keep quiet," he said. "That can be very dangerous, especially if someone is having symptoms like chest pains or dizziness that can be sign of something serious. So, if something doesn't seem right, speak up immediately." Invest in Travel Insurance - Healthcare is expensive and it's important to remember that your insurance may not work. Medicare and even some private plans don't cover medical costs outside the United States and the rules for Medicaid can vary by state. Corbett suggests investing in travel insurance, especially if you are traveling out of the country. Everything in Moderation - Perhaps the most common mistake tourists make is simply overdoing it. "They spend too much time in the heat and humidity and get dehydrated, they're on their feet much longer than normal or they go on rides they shouldn't," said Corbett. "I treat hundreds of patients each year who would never have come to the ER had they only paced themselves." Drinking too much alcohol and overeating are common mistakes as well, especially indulging in exotic foods you're not used to eating. B-ROLL, SOUND BITES, WEB ELEMENTS & HI-RES STILL PHOTOS ?- Photos, interviews and HD video are available for free and unrestricted use by the news media: http://bit. Courtesy: Orlando Health For assistance in downloading, or if you have any questions, contact: email@example.com or call: 614.932.9950. Orlando Health is a $2.1 billion not-for-profit health care organization and a community-based network of physician practices, hospitals, and outpatient care centers throughout Central Florida. The organization is home to the area's only Level One Trauma Centers for adults and pediatrics and is a statutory teaching hospital system that offers both specialty and community hospitals. Nearly 3,000 physicians have privileges at Orlando Health, which is also one of the area's largest employers with more than 15,000 employees who serve nearly 2 million Central Florida residents and more than 4,500 international patients annually. Additionally, Orlando Health provides more than $270 million in support of community health needs. More information can be found at http://www. .