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News Article | May 18, 2017
Site: www.businesswire.com

VALENCIA, Calif. & PERTH, Australia--(BUSINESS WIRE)--Avita Medical Limited (ASX:AVH; OTCQX:AVMXY), a regenerative medicine company focused on the treatment of wounds and skin defects, today said it achieved both co-primary endpoints in its pivotal clinical trial which will soon be submitted for U.S. market approval of its ReCell® device to treat severe burns. The company also released supportive results from a previous burns trial in a dual data release. These data will be submitted to the U.S. Food and Drug Administration as part of an application to support Premarket Approval (PMA) for the ReCell® Autologous Cell Harvesting device. The Company is now focused on fulfilling requirements for remaining non-clinical data needed for the PMA submission, which is on track for mid-2017. Based on expected timelines, approval could occur by Q2 2018, the Company said. “ The positive results from both clinical trials clearly demonstrate the efficacy of ReCell® for treating burn injuries,” said Dr James Holmes, from Wake Forest Medical Center, North Carolina, who led the pivotal trial. “ Submission of the PMA, and FDA approval, will be the final steps on a long road to improve burn care. The addition of ReCell® to the U.S. burn surgeon's armamentarium is eagerly awaited and will undoubtedly advance burn care in the U.S.” The 30-patient trial was conducted at seven leading U.S. burn centers between 2015 and early 2017. Co-primary endpoints were designed to demonstrate the effectiveness of ReCell® when combined with widely meshed (expanded) skin grafting in the closure of deep-partial and full-thickness burn injuries. Within the trial design, treatment was randomly allocated to two separate parts of each patient’s burn wound such that a controlled comparison of outcomes could be made for conventional skin grafting versus the combination of ReCell® with a more expanded skin graft. Independent analyses of the study data showed that the co-primary endpoints have both been met. The first co-primary effectiveness endpoint gauged superiority of donor skin expansion, to resolve whether using ReCell® could lead to less donor skin being needed. This difference in donor skin expansion with ReCell® was found to be significant (p<0.001) and resulted in use of an average of just over 30% less donor skin than the Control and a commensurate reduction in donor site size. The second co-primary effectiveness endpoint explored the incidence of healing within 8 weeks, which was similar in wounds that received ReCell® compared to those that received control treatment. Healing with ReCell® was found to be statistically non-inferior relative to conventional treatment. Three secondary endpoints evaluated (1) patient preference of scar outcomes along with (2) patient- and (3) blinded-observer overall opinion ratings using a standardized scar assessment scale and no statistical difference was observed between ReCell® and Control on these measures. The Company said it was encouraged by the equivalent secondary endpoint data because more expanded meshed skin grafts are expected to result in a worse long-term scar outcome, but this was not the case with the adjunctive use of ReCell® with these autografts. The results of the co-primary endpoints suggest the use of ReCell®, relative to conventional autografting, can result in use of over 30% less donor skin to achieve comparable short-term healing and long-term scar outcomes. This is important for patients dealing with burn injuries, because the harvesting of donor skin adds discomfort and increases the effective size of their injury. The Biomedical Advanced Research and Development Authority (BARDA) has supported Avita’s late-stage clinical development of ReCell® through a USD 61.9m contract. The successful completion of this trial is a major Avita milestone under the BARDA contract, supporting the Department of Health and Human Services mission toward burn care preparedness in the response to a mass casualty event. The other U.S. trial was conducted between 2010 and 2014, and involved 101 burns patients treated under the same Investigational Device Exemption (IDE) as used for the PMA pivotal trial. Participants in this trial were treated under a different protocol that compared the effectiveness of the cell suspension alone to that of conventional meshed autografting on partial-thickness injuries. These data showed superiority in healing of donor sites used for ReCell®. It also showed superiority of scar outcomes in terms of scar height, in the straight comparison between ReCell® and autografting. The data did not show statistical non-inferiority of burn injury healing using ReCell® compared to standard treatment, although analysis of the group concluded this outcome was due to post-operative care rather than treatment. The Company said this earlier work could support Avita’s PMA submission by providing additional safety and effectiveness information. Avita received support for this trial from the Armed Forces Institute of Regenerative Medicine (AFIRM), a six-way partnership among the U.S. Army, Navy, Air Force, Veterans Administration, the Defense Health Program and the National Institutes of Health. “ Both studies validate our broader view that this unique regenerative approach will transform the way burns are treated in the U.S., a sector that has been starved of innovation for many years,” said Andy Quick, Avita’s Senior VP of Clinical Development. “ The successful trial data represent years of hard work and commitment from patients and physicians across the U.S., all of whom we would like to thank for their participation. We look forward to publication of the complete data set in a peer-reviewed journal.” Avita CEO Adam Kelliher agreed, saying: “ This significant data readout, from a total of 131 burns patients evaluated under randomized controlled settings, takes us one step further along the approval pathway. The Avita team will now push ahead with completing and submitting the PMA, our next big milestone as we work towards launching ReCell® into the U.S. burns market.” Avita’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. Our medical devices work by preparing a Regenerative Epithelial Suspension (RES™), an autologous suspension comprised of the patients’ own skin cells and wound healing factors that are necessary to regenerate natural healthy skin. This is then applied to the area to be treated. In all countries outside of Europe, our portfolio is marketed under the ReCell® brand to promote skin healing in a wide range of applications, including burns, chronic wounds and aesthetics. ReCell® is TGA-registered in Australia, and CFDA-cleared in China. In the United States, ReCell® is an investigational device limited by federal law to investigational and compassionate use. In Europe, our portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. ReCell® is designed for the treatment of burns and plastic reconstructive procedures; ReGenerCell™ has been formulated for chronic wounds, including leg and foot ulcers; and ReNovaCell™ is tailored for aesthetic applications, including the restoration of pigmentation. This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.


Fudge E.B.,Childrens Medical Services Center | Constantacos C.,Wake Forest Medical Center | Fudge J.C.,University of Florida | Davenport M.,University of North Carolina at Chapel Hill
Hormone Research in Paediatrics | Year: 2014

Background/Aims: Turner syndrome (TS) is associated with increased mortality due to cardiovascular disease and a dramatically higher rate of aortic dissection. The recognition and treatment of hypertension in this population is critical. We sought to assess the ability to detect blood pressure (BP) abnormalities comparing ambulatory blood pressure monitoring (ABPM) with conventional BP measurement methods. We hypothesized that ABPM would improve detection of hypertension and alter management strategies. Methods: Twenty-three girls with TS underwent BP measurements using an automated oscillometric method and a manual mercury sphygmomanometer. Twenty-four-hour ABPM was performed (Spacelabs 90217, Issaquah, Wash., USA). BP values were compared to normative data based on height and sex for ABPM, and for age, height and sex for automated oscillometric and manual measurements. Results: Five (22%) subjects were found to have ambulatory hypertension (3 of these with severe hypertension). Three subjects had prehypertension using ABPM measurements. Only 1 of the 5 patients with ambulatory hypertension was categorized as hypertensive using manual BP measurements. Twelve subjects (52%) had nocturnal hypertension. ABPM data led to a change in medical management of hypertensive patients with initiation of antihypertensive therapy. Conclusions: ABPM is advantageous in TS, as it improves detection of hypertension, identifies those with non-dipping BP patterns, and changes medical management of patients. © 2013 S. Karger AG, Basel.


News Article | February 22, 2017
Site: globenewswire.com

NEW YORK, Feb. 22, 2017 (GLOBE NEWSWIRE) -- Dr. Sharon Metcalfe, Interim Director of Nursing at Western Carolina University, has been selected to join the Education Board at the American Health Council. She will be sharing her knowledge and expertise on Nursing Education and Clinical / Didactic Testing. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0ead4c6b-51d4-40e9-90ea-cb328bbfeb1a With over a decade of experience in the field of Nursing Education, Dr. Metcalfe offers valuable insight in her role as the Interim Director of Nursing at Western Carolina University. Located in Cullowhee, North Carolina, Western Carolina University is a public regional institution of higher education that is committed to offering quality education at an affordable rate.  Ranked as one of the top fifteen public regional institutions in the South, WCU give prospective students an opportunity to choose from more than a hundred and fifteen majors and concentrations ranging from Biology, Computer Information Systems, Spanish, Business Administration and much more. As the Interim Director of Nursing at Western Carolina University, Dr. Metcalfe’s day-to-day responsibilities include oversight of programs and forty facilities, management of scholarships, the university budget, and community groups. Prior to her role as the Interim Director, Dr. Metcalfe gained leadership experience as the Dean of Nursing for at Lees-McRae College and Mayland Community College. In the clinical setting, Dr. Metcalfe has served as the Director of Pediatrics (Denver, Colorado Children's Hospital), Director of Neonatal Services at Rose Medical Center (Denver, Colorado), and Nursing Administrator of Pediatrics, Critical Care, Intensive Care, and Neonatal Intensive Care at Wake Forest Medical Center-Baptist Hospital (Winston-Salem, North Carolina). In 1997, Dr. Metcalfe earned her Doctorate of Education in Adult and Community College Education from the North Carolina State University. She went on to complete a Bachelor of Science in Nursing degree and receive certification as a Registered Nurse from the University of Colorado. Dr. Metcalfe maintains affiliations with the North Carolina Nurses Association and Sigma Theta Tao. She serves on the Board of Directors for the Mountain Area Health Education Minority and Underrepresented Students Council, and the Board of Directors for the Social Services division of Asheville, North Carolina. Dr. Metcalfe’s desire to pursue Nursing Education developed through a natural progression. Looking back, she attributes her success to her supportive husband Lee and her loving son Trevor. Due to her commitment and dedication to the field of Nursing Education, Dr. Metcalfe has been awarded the 2016 Health Science College Award, 2006 100 Best Nurses Award, and 2005 Native American Teacher of the Year. Among her many accomplishments, Dr. Metcalfe has published three significant articles on mentoring, social determinants and educational barriers for diverse students, and the nature of cultural competency. In her free time, she enjoys traveling to Europe. As a certified Parent Child Interventionist, Dr. Metcalfe volunteers her time being a high risk parenting educator for the Department of Social Work conducting seminars for foster parents that struggle with difficult children during the fall of each year. Considering her future, Dr. Metcalfe hopes for continual growth in research, and education by teaching a RN to BSN program.


Nabors L.B.,University of Alabama at Birmingham | Mikkelsen T.,Ford Motor Company | Hegi M.E.,University of Lausanne | Ye X.,Sidney Kimmel Comprehensive Cancer Center | And 9 more authors.
Cancer | Year: 2012

Background: Cilengitide is a selective integrin inhibitor that is well tolerated and has demonstrated biologic activity in patients with recurrent malignant glioma. The primary objectives of this randomized phase 2 trial were to determine the safety and efficacy of cilengitide when combined with radiation and temozolomide for patients with newly diagnosed glioblastoma multiforme and to select a dose for comparative clinical testing. Methods: In total, 112 patients were accrued. Eighteen patients received standard radiation and temozolomide with cilengitide in a safety run-in phase followed by a randomized phase 2 trial with 94 patients assigned to either a 500 mg dose group or 2000 mg dose group. The trial was designed to estimate overall survival benefit compared with a New Approaches to Brain Tumor Therapy (NABTT) Consortium internal historic control and data from the published European Organization for Research and Treatment of Cancer (EORTC) trial EORTC 26981. Results: Cilengitide at all doses studied was well tolerated with radiation and temozolomide. The median survival was 19.7 months for all patients, 17.4 months for the patients in the 500 mg dose group, 20.8 months for patients in the 2000 mg dose group, 30 months for patients who had methylated O6-methylguanine-DNA methyltransferase (MGMT) status, and 17.4 months for patients who had unmethylated MGMT status. For patients aged ≤70 years, the median survival and survival at 24 months was superior to what was observed in the EORTC trial (20.7 months vs 14.6 months and 41% vs 27%, respectively; P =.008). Conclusions: Cilengitide was well tolerated when combined with standard chemoradiation and may improve survival for patients newly diagnosed with glioblastoma multiforme regardless of MGMT methylation status. The authors concluded that, from an efficacy and safety standpoint, future trials of this agent in this population should use the 2000 mg dose. © 2012 American Cancer Society.


Kempton S.J.,University of Wisconsin - Madison | Cho D.C.,Straub Clinic and Hospital | Thimmappa B.,Wake Forest Medical Center | Martin M.C.,Loma Linda University
Annals of Plastic Surgery | Year: 2016

Background: Current trends in the management of medial orbital wall fractures are toward the development of transconjunctival incisions and the use of endoscopic-assisted methods. Different authors have suggested variations of the medial transconjunctival approach. Methods: (1) In 30 fresh cadaver orbits, the classic transcaruncular approach was compared with the precaruncular and retrocaruncular approach under magnified dissection. (2) A retrospective analysis was conducted on a series of 20 consecutive patients that underwent primary repair of medial orbital wall fractures using a retrocaruncular approach without endoscopic assistance. Postoperative computed tomography scanswere obtained for all patients andwere evaluated by 3 experienced clinicians. Results: (1) Anatomic dissections showed that all 3 approaches provided excellent exposure of the entire medial orbital wall. The transcaruncular and precaruncular approaches, however, (a) both resulted in exposure of the upper and lower tarsi when incisions greater than 10 mm were used; (b) both required a transition from the preseptal plane to the postseptal plane when combined with inferior fornix incisions. (2) A clinical study of 20 patients showed all reconstructions were possible without endoscopic assistance, resulting in no postoperative complications. Postoperative computed tomography scans showed anatomic orbital reconstruction in all patients judged as excellent by the clinicians. Conclusions: Medial orbital wall fractures can be successfully repaired using transconjunctival incisions without using endoscopes. The retrocaruncular approach surpasses the transcaruncular and precaruncular methods due to its decreased risk of postoperative lid complications and its ability to be directly carried to the inferior conjunctival fornix. © 2016 Wolters Kluwer Health, Inc. All rights reserved.


Mazer L.M.,Beth Israel Deaconess Medical Center | Chiakof E.L.,Beth Israel Deaconess Medical Center | Goodney P.P.,Dartmouth Hitchcock Medical Center | Edwards M.S.,Wake Forest Medical Center | Corriere M.A.,Emory University
American Surgeon | Year: 2012

Endovascular abdominal aortic aneurysm repair (EVAR) requires both endovascular and open surgical skills. Although usually performed by a single operating specialist, EVAR may alternatively involve multiple teams from different specialties performing separate procedural components. We examined the relative frequencies of single versus multi-specialty EVAR in the 2005 to 2008 American College of Surgeons National Surgical Quality Improvement Participant Use Datafile and explored the influence of multi-specialty EVAR on 30-day mortality. EVARs were identified and classified as single or multiple-specialty procedures based on Current Procedural Terminology codes. Baseline and procedural characteristicswere compared using χ 2 or Fisher's exact test for categorical variables and t test for continuous variables. The association between multispecialty EVAR and 30-day mortality was examined using a multivariate logistic regression model. Of 7269 EVAR patients identified, 7086 were single and 183 were multi-specialty. Multi-specialty patients had higher frequency of brachial or iliac artery exposure and longer operative times, but were otherwise similar in baseline and procedural characteristics. In the multivariate model, multi-specialty EVAR was associated with increased risk of 30-day mortality (odds ratio 2.35; 95% confidence interval 1.08-5.11; P value 0.031). Multi-specialty participation in EVAR procedures is associated with significantly higher 30-day mortality. Further research is warranted to determine whether multi-specialty participation reflects provider experience, institutional protocols, procedural complexity, non-surgical or other factors.


PubMed | Jewish Hospital, Mayo Medical School, Wake Forest Medical Center and Medical Center Haaglanden
Type: Journal Article | Journal: Acta neurochirurgica | Year: 2016

Intraneural hemangiomas and vascular malformations are rare, with approximately 50 cases reported in the literature. They present a therapeutic challenge; surgical resection can result in damage to the nerve and lesion recurrence is common. We introduce a new framework to classify intraneural vascular anomalies in relation to the anatomic compartments of the nerve and assess amenability to surgical resection.We retrospectively reviewed cases of intraneural hemangiomas and vascular malformations treated at our institution between 2003 and 2013 that had high-resolution 3-T magnetic resonance imaging (MRI). A review of the literature was also performed. Our cases and reports in the literature with available MRI data were sub-categorized according to their relationship to the paraneurium and epineurium of the nerve.Nine patients were identified with intraneural (subparaneurial or subepineurial) vascular lesions. Two patients had a predominantly subparaneurial involvement of the nerve, six patients had predominantly subepineurial involvement, and one patient exhibited extensive involvement in both compartments. Four patients were managed surgically and the rest conservatively. Targeted resection of two subparaneurial hemangiomas provided complete relief of symptoms and freedom from recurrence at 18 month and 24 months respectively. One patient with extensive subepineurial and extraneural vascular malformations did not appear to benefit from sub-total resection with interfascicular dissection. No surgical morbidity was noted in any of the cases.We believe that the subparaneurial compartment-a potential space between the epineurium and paraneurium-provides a tissue plane within which benign vascular lesions can occur. Hemangiomas and vascular malformations are complex and can occupy different intraneural and extraneural compartments. The anatomic framework aids surgical decision-making and ensures that all components of the lesion are considered. We advocate a multimodal approach in the treatment of these rare lesions.


PubMed | University of Washington, U.S. National Institutes of Health, Wake Forest Medical Center, University of North Carolina at Chapel Hill and 4 more.
Type: Journal Article | Journal: Chest | Year: 2016

Mortality after smoke inhalation-associated acute lung injury (SI-ALI) remains substantial. Age and burn surface area are risk factors of mortality, whereas the impact of patient- and center-level variables and treatments on survival are unknown.We performed a retrospective cohort study of burn and non-burn centers at 68 US academic medical centers between 2011 and 2014. Adult inpatients with SI-ALI were identified using an algorithm based on a billing code for respiratory conditions from smoke inhalation who were mechanically ventilated by hospital day 4, with either a length-of-stay 5days or death within 4days of hospitalization. Predictors of in-hospital mortality were identified usinglogistic regression. The primary outcome was the odds ratio for in-hospital mortality.A total of 769 patients (52.9 18.1 years) with SI-ALI were analyzed. In-hospital mortality was 26%in the SI-ALI cohort and 50%in patients with 20%surface burns. In addition to age > 60 years (OR 5.1, 95%CI 2.53-10.26) and 20%burns (OR 8.7, 95%CI 4.55-16.75), additional risk factors of in-hospital mortality included initial vasopressor use (OR 5.0, 95%CI 3.16-7.91), higher diagnostic-related group-based risk-of-mortality assignment and lower hospital bed capacity (OR 2.3, 95%CI 1.23-4.15). Initial empiric antibiotics (OR 0.93, 95%CI 0.58-1.49) did not impact survival. These new risk factors improved mortality prediction by 9.9%(P< .001).In addition to older age and major surface burns, mortality in SI-ALI is predicted by initial vasopressor use, higher diagnostic-related group-based risk-of-mortality assignment, and care at centers with< 500 beds, but not by initial antibiotic therapy.


Mullany S.A.,Wake Forest Medical Center | Moslemi-Kebria M.,Mayo Medical School | Rattan R.,Mayo Medical School | Khurana A.,Mayo Medical School | And 6 more authors.
Clinical Cancer Research | Year: 2011

Purpose: The purpose of this study was to determine if loss of serine protease HtrA1 in endometrial cancer will promote the invasive potential of EC cell lines. Experimental design: Western blot analysis and immunohistochemistry methods were used to determine HtrA1 expression in EC cell lines and primary tumors, respectively. Migration, invasion assays and in vivo xenograft experiment were performed to compare the extent of metastasis between HtrA1 expressing and HtrA1 knocked down clones. Results: Western blot analysis of HtrA1 in 13 EC cell lines revealed complete loss of HtrA1 expression in all seven papillary serous EC cell lines. Downregulation of HtrA1 in Hec1A and Hec1B cell lines resulted in a three- to fourfold increase in the invasive potential. Exogenous expression of HtrA1 in Ark1 and Ark2 cells resulted in three- to fourfold decrease in both invasive and migration potential of these cells. There was an increased rate of metastasis to the lungs associated with HtrA1 downregulation in Hec1B cells compared to control cells with endogenous HtrA1 expression. Enhanced expression of HtrA1 in Ark2 cells resulted in significantly less tumor nodules metastasizing to the lungs compared to parental or protease deficient (SA mutant) Ark2 cells. Immunohistochemical analysis showed 57% (105/184) of primary EC tumors had low HtrA1 expression. The association of low HtrA1 expression with high-grade endometrioid tumors was statistically significant (P = 0.016). Conclusions: Collectively, these data indicate loss of HtrA1 may contribute to the aggressiveness and metastatic ability of endometrial tumors. ©2010 AACR.


Tamam C.,Wake Forest Medical Center | Poehling G.G.,Wake Forest Medical Center
Sports Medicine and Arthroscopy Review | Year: 2014

In recent years, development of computer graphics and haptic feedback technology enabled the use of virtual reality. Virtual reality provides the opportunity to combine 3D visual imagery with interactivity, visual, and tactile realism. Robotic-assisted orthopedic surgery is defined as the use of computers and robotic technology to assist the orthopedist in providing musculoskeletal care, in which machine has the capability of precision and accuracy. Robotic-assisted orthopedic surgery is used in simulating diagnosis, preoperative and intraoperative planning, and actual surgery. One of the main areas for computer-assisted surgical applications is unicompartmental or bicompartmental knee arthroplasty, in which the clinical efficacy is improved by providing enhanced component positioning with dynamic ligament balancing. Copyright © 2014 by Lippincott Williams & Wilkins.

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