About Arch Therapeutics, Inc. (OTCQB: ARTH) is a biotechnology 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 minimally invasive and open surgical procedures and is intended to be regulated as a medical device. Find out more at www.archtherapeutics.com. Website: www.archtherapeutics.com Share Structure Product Hemostatic Agent: AC5™ for control over surgical bleeding. The AC5 Surgical Hemostatic Device™ - more than just a better mousetrap The hemostasis market is clearly in search of products that work better, faster, and more reliably. The AC5 Surgical Hemostatic Device™ is designed to do that. Arch believes its products will be significantly superior to what is currently available. AC5™ is a synthetic peptide comprising naturally occurring amino acids. Evidence to-date supports that it is biocompatible. When squirted or sprayed onto a wound, AC5™ promptly intercalates into the nooks and crannies of the connective tissue where it builds itself into a physical, mechanical structure. That structure provides a barrier to leaking substances, including blood and other bodily fluids, regardless of type of surgery or, based on early data, clotting ability. Healing occurs normally. The structural building process is called self-assembly, and it provides a new and improved approach to addressing “stasis and barrier applications.” The Need: Modern Surgical Procedures Drive Demand For Improved Therapies Every day, around the world, millions of surgical procedures are taking place. Many are planned months in advance, while many more are in response to emergency needs. Because these procedures are invasive, surgeons and other medical specialists focus on optimizing patient outcomes – and they constantly strive for fewer complications, including reduced fluid and blood loss in order to obtain the best results while maximizing safety and minimizing time to recovery. They also operate today through smaller incisions in the body, in procedures known as minimally invasive or laparoscopic surgery. The Solution: AC5™ Stasis And Barrier Technology AC5™ itself is designed at the nano-scale. It's a synthetic peptide comprised of naturally occurring, non-animal, amino acids using straight-forward manufacturing techniques. AC5™ is applied directly onto a surgical or traumatic wound, where it rapidly creates a physical barrier in the nooks and crannies of the tissue and promptly stops bleeding and fluid leaks. It's not sticky or glue-like, and is very easy to prepare and handle. It's also a clear transparent gel enabling doctors to see through it as they work, performing “Crystal Clear Surgery™.” The Result: Faster and Safer Surgical Outcomes Once applied, AC5™ works quickly to stop bleeding with rapid onset of hemostasis. With AC5™, surgeons are able to perform surgery through the protective barrier safely. Once the incision heals, AC5™ is naturally absorbed and passes from the body. This could be one of the best penny stocks to be looking at
Stochastic oscillator and RSI are triggering a buy signal. A potential breakout above 0.54. http://www.allotcbb.com/quote.php?symbol=arth
$ARTH ~ Arch Therapeutics Reports AC5 Topical Hemostatic Device Meets Primary and Secondary Endpoints in First Clinical Study http://finance.yahoo.com/news/arch-therapeutics-reports-ac5-topical-105700951.html
$ARTH Premarket News! Radar! Arch Therapeutics Reports AC5 Topical Hemostatic Device Meets Primary and Secondary Endpoints in First Clinical Study FRAMINGHAM, MA--(Marketwired - Aug 15, 2016) - Arch Therapeutics, Inc. ( OTCQB : 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, successfully met the objectives of its recently completed single-center, randomized, single-blind prospective clinical study (NCT 02704104) of the AC5 Topical Hemostatic Device in skin lesion patients with bleeding wounds. This was the first study assessing the safety and performance of AC5 in humans. The objectives of the study were to evaluate the safety and performance of AC5 in patients scheduled to undergo excision of skin lesions on their trunk or upper limbs. The primary endpoint was safety throughout the surgical procedure and until the end of a 30-day follow-up period post procedure. Safety of the clinical investigation device was determined by monitoring for treatment related adverse events. The primary objective was met, as the safety outcomes of both the AC5 treatment group and the control group were similar. 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. There was no evidence, at either follow-up day, of an adverse effect of AC5 treatment on the wound ASEPSIS score. The ASEPSIS score did not appear to be compromised, as the majority of patients had an ASEPSIS score of 0 in both wounds at Days 7 and 30. All AC5-treated wounds healed satisfactorily as per wound healing scoring criteria. Terrence W. Norchi, MD, President and CEO of Arch Therapeutics, said, "As we had anticipated, these top-line data support that AC5 was safe and performed as expected in the patients enrolled in this study throughout the completion of the patient assessments post-treatment and as supported in the subsequent statistical analysis. These successful results mark a significant milestone in the development of AC5 and we are grateful to all of those involved in the process. We look forward to further advancing our self-assembling peptide technology platform for this and other applications, including through conducting additional studies." The clinical study enrolled 46 patients, including 10 who were taking antiplatelet monotherapy. Each patient had bleeding wounds created as a result of the excision of at least two skin lesions under local anesthetic in the same setting. On a randomized basis, one lesion received AC5 and the other(s) received a control treatment consisting of standard therapy plus a sham. Each subject was followed-up for safety assessment both on Day 7 and again on Day 30, which marked the end of the subject's participation in the clinical study. 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, "These study results indicate significant potential for AC5 in the treatment of bleeding skin wounds. The safety and efficacy outcomes for AC5 in this study were impressive and reassuring. While possessing a safety profile at least as good as that of the control group, AC5 was associated with a clinically significant improvement in time to hemostasis. We are encouraged by how patients responded to the unique formulation of AC5 and how easy it was for a clinician to use." Arch's clinical advisory committee has deemed the study results to be clinically significant and have recommended submitting a manuscript to a peer-reviewed medical journal for publication. The committee said, "In completing its first human study assessing the safety and performance of AC5, Arch has obtained impressive safety and efficacy data. We are incredibly enthusiastic about AC5 and its potential scope for other 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, including subgroup analysis, to a peer-reviewed journal for publication. The Company also plans to include data from this trial 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 Clinical Research Facility based at National University of Ireland in Galway. "These results demonstrate significant improvement in efficacy without compromising patient safety. We believe that AC5 represents a unique technology that will provide both rapid and sustained hemostasis and important differentiable clinical benefits," concluded Norchi. READ FULL: https://finance.yahoo.com/news/arch-therapeutics-reports-ac5-topical-105700951.html
Arch Therapeutics, Inc. ($ARTH) is a developer of the AC5 Surgical Hemostatic Device™ (AC5™) for use in controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care. http://www.archtherapeutics.com
$ARTH Reports AC5 Topical Hemostatic Device Successfully Stopped Bleeding in Recently Completed Clinical Study https://finance.yahoo.com/news/arch-therapeutics-reports-ac5-topical-115700428.html
Data is most impressive. Prospectus supplements issued as well to keep them current. Peer review should be well received imo.
$ARTH radar, news out! Arch Therapeutics Reports AC5 Topical Hemostatic Device Successfully Stopped Bleeding in Patients on Antiplatelet Therapy in Recently Completed Clinical Study FRAMINGHAM, MA--(Marketwired - Oct 31, 2016) - Arch Therapeutics, Inc. ( OTCQB : 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. Read Full: https://finance.yahoo.com/news/arch-therapeutics-reports-ac5-topical-115700428.html
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