News Article | October 31, 2016
Treatment Effect of AC5-Significantly Shortening of Time To Hemostasis vs Control- Was Consistent Whether Patients Were Taking Antiplatelet Therapy or Not FRAMINGHAM, MA--(Marketwired - Oct 31, 2016) - Arch Therapeutics, Inc. ( : ARTH) ("Arch" or the "Company"), developer of devices for use in controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, reports additional positive data in its recently completed single-center, randomized, single-blind prospective clinical study (NCT 02704104) of the AC5 Topical Hemostatic Device™ ("AC5™") in skin lesion patients with bleeding wounds. On August 15, 2016, the Company reported top-line data from the clinical study that indicated that AC5 was safe and that it reduced time to hemostasis in wounds versus controls. Today, the Company released the results of additional analysis of the subgroup of 10 patients who were taking a prescribed antiplatelet medication, commonly known as a blood thinner, such as aspirin, which indicated that AC5 had similar effects for the subgroup of patients taking an antiplatelet agent. In particular, in this newly reported analysis of the primary and secondary outcomes for wounds among patients treated with an antiplatelet agent, the primary objective of safety throughout the surgical procedure and until the end of a 30-day follow-up period post procedure was met and AC5 was well tolerated. Moreover, AC5 shortened time to hemostasis ("TTH") versus a control whether or not patients were taking antiplatelet therapy, suggesting that AC5 performance is not affected by antiplatelet therapy. The reduced median TTH of the AC5 treated wounds versus the control wounds was statistically significant for both the overall group of 46 patients (p<0.001) and for the subgroup of 10 patients on antiplatelet therapy (p=0.005). Further, the median TTH for wounds treated with AC5 was less than 30 seconds for both the overall study group and for the subset of patients taking antiplatelet therapy. Terrence W. Norchi, MD, President and CEO of Arch Therapeutics, said, "We have eagerly awaited initial data to support the hypothesis that the mechanism of action of AC5 is independent of a patient's underlying bleeding or coagulation status. These results are an important first step in highlighting an important differentiating feature of AC5 and our self-assembling peptide technology platform." Jack Kelly, MD, Principal Investigator of the study, and a plastic, reconstructive and aesthetic surgeon and Professor of Surgery at Galway University Hospital, Galway, Ireland, said, "We have been impressed with how patients in this study responded to treatment and how easy AC5 was to use. The favorable safety and efficacy profile of AC5 in the overall study was supported when looking at the subset of patients taking antiplatelet therapy, which is particularly noteworthy. Many patients have perturbed hemostasis pathways, whether from natural disease or the use of prescribed or over the counter blood thinners, therefore we always have a concern about more bleeding in these patients. AC5 may provide their care providers a valuable tool to address those challenges." As previously reported, this first study assessing the safety and performance of AC5 in humans served to evaluate the safety and performance of AC5 in patients scheduled to undergo excision of skin lesions on their trunk or upper limbs. Of the 46 patients enrolled in the human study, 10 patients were taking an antiplatelet agent and 36 were not. Each patient had two wounds, of which one was treated with AC5 and the other received standard care plus a sham treatment according to a randomization process. Consequently, each patient served as her/his own control. The study's overall primary objective of safety throughout the surgical procedure and until the end of a 30-day follow-up period post procedure was met and AC5 was well tolerated. No serious adverse events were reported. A secondary endpoint was performance as assessed by time to hemostasis. The median time to hemostasis of wounds in the AC5 treatment group was 41% faster than for those in the control group. This result was statistically significant (p<0.001, Wilcoxon signed rank test). An additional secondary endpoint of healing of treated wounds was assessed as measured by the ASEPSIS wound score at Days 7 and 30. The majority of patients had an ASEPSIS score of 0 in both wounds on both days, and all AC5-treated wounds healed satisfactorily as per wound healing scoring criteria. Previously, Arch's clinical advisory committee deemed the study results to be clinically significant and have recommended submitting a manuscript to a peer-reviewed medical journal for publication. In light of this new data, the committee added, "This first human study assessing the safety and performance of AC5 has revealed an impressive and statistically significant result in patients on an antiplatelet agent, indicating that it may have broad potential scope in different applications." The advisors include Arthur Rosenthal, PhD, Professor of Practice, Emeritus, Department of Biomedical Engineering, Boston University, and a former member of Arch's Board of Directors; Steven Schwaitzberg, MD, Professor and Chairman of the Department of Surgery at the University of Buffalo's Jacobs School of Medicine and Biomedical Sciences and past President of the Society of American Gastrointestinal Endoscopic Surgeons; Paresh Shah, MD, Vice Chair of Surgery, Director of General Surgery and Professor of Surgery at New York University Langone Medical Center, New York University Langone School of Medicine; and William Denman, MD, anesthesiologist at Massachusetts General Hospital, past Chief Medical Officer of GE Healthcare and past Chief Medical Officer of Covidien. The Company expects to submit further study details and data to a peer-reviewed journal for publication. The Company also plans to include data from this trial in its regulatory filings, including in a CE mark application for AC5, which is currently anticipated to be filed at the earliest by the end of this year. Arch is currently planning its next clinical-regulatory steps for both the EU and the US. The study, conducted at University College Hospital, Galway, Ireland, was carried out in collaboration with CÚRAM, Science Foundation Ireland Centre for Research in Medical Devices and the HRB Clinical Research Facility based at National University of Ireland Galway. Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate, known as the AC5 Surgical Hemostatic Device™, is being designed to achieve hemostasis in surgical procedures. The HRB Clinical Research Facility, Galway (CRFG) is a joint venture between Galway University Hospitals (GUH), Saolta, and National University of Ireland, Galway (NUIG) and has been in operation since March 2008. The HRB-CRFG provides the infrastructure, physical space, facilities, expertise and culture needed to optimally support clinical research. It focuses on studies aimed at understanding a range of diseases and speedily translating the knowledge obtained through this research work into advances in patient care. CÚRAM is the Science Foundation Ireland Centre for Research in Medical Devices, based at NUI Galway. Supported by Science Foundation Ireland (SFI) and industry partners, CÚRAM enhances Ireland's standing as a major hub for the global medical devices industry. Its goal is to radically improve quality of life for patients with chronic illness by developing the next generation of smart, implantable medical devices. CÚRAM's innovative approach incorporates biomaterials, drug delivery, cell based technologies, glycosciences and device design to enhance, develop and validate both traditional and new combinational medical devices, from molecular design stage to implant manufacturing. CÚRAM's devices are being developed with strong clinical collaborations to enable rapid translation of research findings to clinical application. Key to the approach is the establishment of unique networks of national and international collaborations, integrating world class clinical, academic and industrial partners This news release contains "forward-looking statements" as that term is defined in Section 27(a) of the Securities Act of 1933, as amended, and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements in this press release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, references to novel technologies and methods, our business and product development plans and projections, or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company, our ability to retain important members of our management team and attract other qualified personnel, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, our ability to obtain required regulatory approvals, our ability to develop and commercialize products based on our technology platform, and market conditions. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in the reports and other documents we file with the SEC, available at www.sec.gov. On Behalf of the Board, Terrence W. Norchi, MD Arch Therapeutics, Inc.
McDonnell J.G.,Galway University Hospital |
Finnerty O.,Galway University Hospital |
Laffey J.G.,Galway University Hospital
Anaesthesia | Year: 2011
We report the successful use of a stellate ganglion block as part of a multi-modal postoperative analgesic regimen. Four patients scheduled for orthopaedic surgery following upper limb trauma underwent blockade of the stellate ganglion pre-operatively under ultrasound guidance. Patients reported excellent postoperative analgesia, with postoperative VAS pain scores between 0 and 2, and consumption of morphine in the first 24 h ranging from 0 to 14 mg. While these are preliminary findings, and must be confirmed in a clinical trial, they highlight the potential for stellate ganglion blockade to provide analgesia following major upper limb surgery. © 2011 The Authors. Anaesthesia © 2011 The Association of Anaesthetists of Great Britain and Ireland.
Blanco R.,King's College |
Parras T.,University of London |
McDonnell J.G.,Galway University Hospital |
Prats-Galino A.,University of Barcelona
Anaesthesia | Year: 2013
We present a novel ultrasound-guided regional anaesthetic technique that may achieve complete paraesthesia of the hemithorax. This technique may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade, which can be technically more challenging and have a higher potential side-effect profile. We performed the serratus block at two different levels in the midaxillary line on four female volunteers. We recorded the degree of paraesthesia obtained and performed fat-suppression magnetic resonance imaging and three-dimensional reconstructions of the spread of local anaesthetic in the serratus plane. All volunteers reported an effective block that provided long-lasting paraesthesia (750-840 min). There were no side-effects noted in this initial descriptive study. While these are preliminary findings, and must be confirmed in a clinical trial, they highlight the potential for the serratus plane block to provide analgesia following surgery on the thoracic wall. We suggest that this novel approach appears to be safe, effective, and easy to perform, and is associated with a low risk of side-effects. This article is accompanied by an Editorial by Tighe and Karmakar, pp 1103-1106 of this issue. © 2013 The Association of Anaesthetists of Great Britain and Ireland.
Liew A.,McMaster University |
Eikelboom J.W.,McMaster University |
O'Donnell M.,Galway University Hospital
Current Opinion in Cardiology | Year: 2012
Purpose of review: The prevalence of atrial fibrillation is increasing because of an aging population. Vitamin K antagonists have been the standard therapy for stroke prevention in atrial fibrillation but are underutilized and often poorly managed because of their inherent limitations. This study critically reviews the recently completed phase 3 randomized controlled trials of new oral anticoagulants (OACs) for stroke prevention in patients with nonvalvular atrial fibrillation: RE-LY (dabigatran), AVERROES (apixaban), ARISTOTLE (apixaban) and ROCKET-AF (rivaroxaban). Recent findings: On the basis of their favorable pharmacological characteristics and excellent efficacy and safety profile as demonstrated by the results of the randomized controlled trials, the new OACs have the potential to replace vitamin K antagonists as the first-line treatment for stroke prevention in atrial fibrillation, with warfarin reserved for patients with contraindications to the new OACs and those unable to afford them. Summary: The new OACs represent a major advance for patients with atrial fibrillation with the potential to reduce morbidity and mortality due to cardioembolic stroke. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Ten-year technical and clinical outcomes in TransAtlantic Inter-Society Consensus II infrainguinal C/D lesions using duplex ultrasound arterial mapping as the sole imaging modality for critical lower limb ischemia
Sultan S.,Galway University Hospital |
Tawfick W.,Galway University Hospital |
Hynes N.,Galway Clinic
Journal of Vascular Surgery | Year: 2013
Objective: The aim of this study was to evaluate duplex ultrasound arterial mapping (DUAM) as the sole imaging modality when planning for bypass surgery (BS) and endovascular revascularization (EvR) in patients with critical limb ischemia for TransAtlantic Inter-Society Consensus (TASC) II C/D infrainguinal lesions. Methods: This was a retrospective review evaluating the accuracy of DUAM as the sole imaging tool in determining patient suitability for BS vs EvR. Primary outcomes were the sensitivity and specificity of DUAM compared with intraoperative digital subtraction angiography. Secondary outcomes were procedural, hemodynamic, and clinical outcomes, amputation-free survival, and freedom from major adverse clinical events. Results: From 2002 to 2012, a total of 4783 patients with peripheral arterial disease were referred, of whom 622 critical limb ischemia patients underwent revascularization for TASC C and D lesions (EvR: n = 423; BS: n = 199). Seventy-four percent of EvR and 82% of BS were performed for TASC D (P =.218). The DUAM showed sensitivity of 97% and specificity of 98% in identifying lesions requiring intervention. Of the 520 procedures performed with DUAM alone, there was no difference regarding the number of procedures performed for occlusive or de novo lesions (EvR: 65% and 71%; BS: 87% and 78%; P =.056). Immediate clinical improvement to the Rutherford category ≤3 was 96% for EvR and 97% for BS (P =.78). Hemodynamic success was 79% for EvR and 77% for BS (P =.72). Six-year freedom from binary restenosis was 71.6% for EvR and 67.4% for BS (P =.724). Six-year freedom from target lesion revascularization was 81.1% for EvR and 70.3% for BS (P =.3571). Six-year sustained clinical improvement was 79.5% for EvR and 66.7% for BS (P = .294). Six-year amputation-free survival was 77.2% for EvR and 74.6% for BS (P =.837). There was a significant difference in risk of major adverse clinical events between EvR and BS (51% vs 70%; P =.034). Only 16.4% of patients required magnetic resonance angiography, which tended to overestimate lesions with 84% agreement with intraoperative findings. Six-year binary restenosis was 71% for DUAM procedures compared with 55% for magnetic resonance angiography procedures (P =.001), which was solely based on the prospective modality. Conclusions: The DUAM epitomizes a minimally invasive, economically proficient modality for road mapping procedural outcome in BS and EvR. It allows for high patient turnover with procedural and clinical success without compromising hemodynamic outcome. The DUAM is superior to other available modalities as the sole preoperative imaging tool in a successful limb salvage program.
Liew A.,McMaster University |
Eikelboom J.W.,McMaster University |
O'Donnell M.,Galway University Hospital |
Hart R.G.,McMaster University
Canadian Journal of Cardiology | Year: 2013
Warfarin is effective for the prevention and treatment of thromboembolism but produces variable anticoagulant effects and requires routine monitoring of the international normalized ratio (INR) to optimize the balance between efficacy and safety. The new oral anticoagulants (NOACs) have a more predictable anticoagulant effect and were recently demonstrated to be at least as efficacious and safe as warfarin despite being administered in fixed doses without routine coagulation monitoring. Specific laboratory tests have been developed to measure the anticoagulant effect of the NOACs but are not yet widely available, and the relation between drug levels and both coagulation test results and outcomes is uncertain. It remains to be demonstrated whether adjustment of the dose of NOACs, according to the results of laboratory testing, may lead to even greater efficacy and safety. The principles of bleeding management in patients treated with NOACs compared with patients receiving warfarin are similar. Most patients can be safely managed by interrupting drug treatment, performing local measures to stem the bleeding, and providing transfusion support as required. In patients with major or life-threatening bleeding and those requiring surgery, the anticoagulant effects of warfarin can be reversed using oral or intravenous vitamin K, fresh frozen plasma (FFP), and prothrombin complex concentrates (PCCs). Specific antidotes are under development for the NOACs but are not yet approved for clinical use. PCCs and recombinant factor VIIa may improve hemostasis in patients in whom bleeding develops during treatment with a NOAC, but their efficacy is unproven. © 2013 Canadian Cardiovascular Society.
Walker V.,University of Southampton |
Stansbridge E.M.,University of Southampton |
Griffin D.G.,Galway University Hospital
Annals of Clinical Biochemistry | Year: 2013
Background: Because the causes of stones are uncertain, interventions to prevent recurrence have an insecure foundation. Progress depends on careful evaluation of stone formers. Methods: A descriptive retrospective database study of 1983 men and 816 women from the Southampton stones clinic from 1990 to March 2007. Anonymized data from the first attendance were analysed using non-parametric statistical tests. Results: Sex ratio (2.43:1), age (median 49 y, 2.5th-97.5th percentiles, 23-77 y men, 20-79 y women), recurrent stone formers (30%) and type of stone were similar to other centres. Women more often had a positive family history (24% versus 19% men), previous urinary infection (31% versus 5%) and structural urinary tract abnormality (14% versus 7%); more men had gout (5% versus 1%) and bladder outlet obstruction (3% versus <1%). Calcium, oxalate and uric acid excretion were increased in 43%, 17% and 22% respectively of men and 31%, 7% and 10% of women. Urinary calcium, oxalate and uric acid correlated significantly, r ranging from 0.149 to 0.311 for 24 h excretion and 0.510 to 0.695 for concentrations per litre. Twenty-two percent of men and 8% of women with normal parathyroid hormone had phosphaturia (excretion of phosphate corrected for glomerular filtration rate (TmPO4/GFR) < 0.70 mmol/L); 6% men and 1.6% women also had low plasma phosphate. Many variables correlated significantly but often weakly with age. Creatinine clearance, pH and (men) TmPO4/GFR decreased from 50 y, urine creatinine, calcium and citrate from 60 y. Conclusions: Risk factors for stones differ between men and women, change with ageing and in some may have a genetic basis. The role of phosphaturia merits further exploration.
Angland S.,Galway University Hospital |
Dowling M.,National University of Ireland |
Casey D.,National University of Ireland
International Emergency Nursing | Year: 2014
There has been an increase in violence and aggression in emergency departments (EDs) in recent years. Among professional health care workers, nurses are more likely than other staff members to be involved in aggressive incidents with patients or relatives. This research study was undertaken to determine nurses' perceptions of the factors that cause violence and aggression in the ED. Using a qualitative approach, twelve nurses working in an Irish ED were interviewed. Thematic analysis of the interview data revealed that environmental and communication factors contributed to violence and aggression in the ED. Participants perceived waiting times and lack of communication as contributing factors to aggression, and triage was the area in the ED where aggression was most likely to occur. A number of key recommendations arise from the study findings and they all relate to communication. To address the aggression that may arise from waiting times, electronic boards indicating approximate waiting times may be useful. Also, information guides and videotapes on the patient's journey through the ED may be of benefit. Consideration to the appointment of a communication officer in the ED and communication training for ED staff is also recommended. © 2013 Elsevier Ltd.
O'Sullivan G.J.,Galway University Hospital
Phlebology | Year: 2016
Deep vein thrombosis, and the resultant development of post-thrombotic syndrome, is a significant health issue. Recent evidence demonstrates that the severity of post-thrombotic syndrome symptoms is directly related to the level of venous thrombosis and following treatment these subsequent symptoms are inversely related to the degree of thrombus removal. If we can improve, and preferably standardise the terminology associated with pre-treatment assessment of thrombus load and post-treatment success of thrombus removal techniques, we should then be able to choose more tailor-made techniques to greater benefit our patients. A number of scoring systems have been devised for the assessment of venous thrombus burden, with a majority impractical for everyday usage. In order to provide a more practical solution, the lower extremity thrombosis classification has been developed, using information on anatomical location for venous thrombus combined with a clinical indicator as to the likely sequelae. Anatomical success following venous thrombolysis can be defined by assessing restoration of anterograde flow in the treated vein or the percentage degree of thrombolysis, using venography. The second option is the method most frequently utilised, with the Venous Registry grading system applied. Data from recent trials have given us conflicting and confusing data mainly because we are not using standardised terminology. We urgently need to agree on a standard method of description of thrombus removal before stent placement which also incorporates the likely clinical impact of the area involved in the thrombosis. © 2016, © The Author(s) 2016.
Osnabrugge R.L.J.,Erasmus Medical Center |
Mylotte D.,McGill University |
Mylotte D.,Galway University Hospital |
Head S.J.,Erasmus Medical Center |
And 7 more authors.
Journal of the American College of Cardiology | Year: 2013
Objectives The purpose of this study was to evaluate the prevalence of aortic stenosis (AS) in the elderly and to estimate the current and future number of candidates for transcatheter aortic valve replacement (TAVR). Background Severe AS is a major cause of morbidity and mortality in the elderly. A proportion of these patients is at high or prohibitive risk for surgical aortic valve replacement, and is now considered for TAVR. Methods A systematic search was conducted in multiple databases, and prevalence rates of patients (>75 years) were pooled. A model was based on a second systematic literature search of studies on decision making in AS. Monte Carlo simulations were performed to estimate the number of TAVR candidates in 19 European countries and North America. Results Data from 7 studies (n = 9,723 subjects) were used. The pooled prevalence of all AS in the elderly was 12.4% (95% confidence interval [CI]: 6.6% to 18.2%), and the prevalence of severe AS was 3.4% (95% CI: 1.1% to 5.7%). Among elderly patients with severe AS, 75.6% (95% CI: 65.8% to 85.4%) were symptomatic, and 40.5% (95% CI: 35.8% to 45.1%) of these patients were not treated surgically. Of those, 40.3% (95% CI: 33.8% to 46.7%) received TAVR. Of the high-risk patients, 5.2% were TAVR candidates. Projections showed that there are approximately 189,836 (95% CI: 80,281 to 347,372) TAVR candidates in the European countries and 102,558 (95% CI: 43,612 to 187,002) in North America. Annually, there are 17,712 (95% CI: 7,590 to 32,691) new TAVR candidates in the European countries and 9,189 (95% CI: 3,898 to 16,682) in North America. Conclusions With a pooled prevalence of 3.4%, the burden of disease among the elderly due to severe AS is substantial. Under the current indications, approximately 290,000 elderly patients with severe AS are TAVR candidates. Nearly 27,000 patients become eligible for TAVR annually. © 2013 by the American College of Cardiology Foundation Published by Elsevier Inc.