|Macrocure Announces Results for Phase III Clinical Trial of CureXcell(R); Amgen and Cytokinetics Announce Positive Top-Line Results From COSMIC-HF Phase 2|
|By Mary Davila|
|Tuesday, 27 October 2015 19:43|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 27, 2015.
Macrocure Ltd. (NASDAQ:MCUR), announced results from a pivotal Phase 3 multicenter, randomized, double-blind, parallel-group, sham-controlled study (MC-102) of CureXcell® in the treatment of diabetic foot ulcers (DFUs) did not meet its primary endpoint. CureXcell, the Company's lead product candidate, did not show a statistically significant proportion of subjects with complete closure at 16 weeks and sustained complete closure for four additional weeks. In addition, CureXcell did not meet the secondary endpoints of the study.
"We plan to further analyze data from this Phase 3 study of CureXcell in DFU to understand why this trial did not meet its study endpoints, and determine the potential ongoing merits of the underlying technology," said Nissim Mashiach, President and Chief Executive Officer of Macrocure. "With today's announcement, we remain focused on the interests of all stakeholders of Macrocure and are committed to maximizing the value of the Company. Therefore, we will analyze all strategic options for the Company and continue to focus on managing and conserving our existing cash," Mr. Mashiach concluded.
As of September 30, 2015, the Company had a preliminary estimated and unaudited cash balance of approximately $30 million. The Company had no debt outstanding.
About CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes: Official Title: A Phase III Multicenter, Randomized, Double-Blind, Parallel-Group, Sham-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Wound Care in Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus (https://clinicaltrials.gov/ct2/show/NCT01421966)
Primary Outcome Measures: Proportion of patients with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up. [Time Frame: up to 20 weeks] [Designated as safety issue: No]
Proportion of patients whose Target Ulcer completely closed during the core double blind treatment phase and remained closed at the FU12 follow-up visit.
Proportion of patients with a negative ulcer-related outcome, defined by any of the following events during the double-blind treatment phase: new or worsening infection, early discontinuation from study due to inadequate ulcer-healing or adverse events, or the development of cellulitis, osteomyelitis, increased ulcer size and severity or need for amputation.
Proportion of patients whose Target Ulcer recurred during the follow up period after achieving closure during the core double blind treatment phase.
Amgen (NASDAQ: AMGN) and Cytokinetics Incorporated (NASDAQ: CYTK) today announced that data from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, showed statistically significant improvements in several measures of cardiac function, including systolic ejection time, stroke volume and N-terminal-pro-brain natriuretic peptide, at 20 weeks following randomization. The pharmacodynamic effects of omecamtiv mecarbil were generally dose dependent. Omecamtiv mecarbil, a novel investigational cardiac myosin activator, enhances cardiac function by increasing cardiac contractility and is being developed for the potential treatment of heart failure.1,2
The expansion phase of COSMIC-HF was designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of oral omecamtiv mecarbil in 448 patients with chronic heart failure and left ventricular systolic dysfunction. Data from the expansion phase showed that pharmacokinetic-based dose titration adequately controlled patient exposure to omecamtiv mecarbil and resulted in statistically significant decreases in cardiac dimensions and heart rate in the dose-titration group.
Adverse events, including serious adverse events, in patients on omecamtiv mecarbil appeared comparable to those on placebo. A small increase in troponin was seen among subjects receiving omecamtiv mecarbil. Events of increased troponin were independently adjudicated and none were determined to be myocardial ischemia or infarction. There was no imbalance in deaths, and cardiac adverse events were generally balanced between placebo and active treatment groups.
The full trial results will be submitted to a future medical conference and for publication.
"The positive results from the COSMIC-HF trial of omecamtiv mecarbil are encouraging," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are committed to working with Cytokinetics to better understand the data and its potential role in the treatment of heart failure patients."
"We are pleased that this Phase 2 trial of omecamtiv mecarbil met the objectives related to safety, tolerability, pharmacokinetics and pharmacodynamics in a population of chronic heart failure patients," said Robert I. Blum, president and CEO at Cytokinetics. "Omecamtiv mecarbil has the potential to offer a new treatment option for patients with heart failure; we look forward to working with Amgen and the medical community to better understand the potential clinical application of this novel drug candidate."
Heart failure is a common condition that affects more than 23 million people worldwide,3,4 about half of whom have reduced left ventricular function.5 It is the leading cause of hospitalization and readmission in people age 65 and older.6,7 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.8 An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure will die within five years of initial hospitalization.9,10
COSMIC-HF Trial Design
COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) is a double-blind, randomized, placebo-controlled, multicenter, Phase 2 trial designed to evaluate an oral formulation of omecamtiv mecarbil in chronic heart failure patients with reduced ejection fraction. The trial consisted of two parts, a dose escalation phase and a larger and longer expansion phase. The dose escalation phase, which completed in 2013, assessed the pharmacokinetics and tolerability of three oral modified-release formulations of omecamtiv mecarbil and was used to select one formulation for further evaluation in the expansion phase. In the dose escalation phase, 96 patients were randomized 1:1:1:1 to placebo or one of three omecamtiv mecarbil oral modified-release formulations in two cohorts (25 mg twice daily or 50 mg twice daily). Each patient cohort was followed for 35 days.
The expansion phase evaluated 448 chronic heart failure patients with reduced ejection fraction who were dosed with the selected oral formulation of omecamtiv mecarbil for 20 weeks and followed for a total of 24 weeks. Patients were randomized 1:1:1 to receive either placebo or treatment with omecamtiv mecarbil 25 mg twice daily or 25 mg with dose escalation to 50 mg twice daily depending on plasma concentrations of omecamtiv mecarbil after two weeks of treatment. The primary endpoints for the expansion phase were to assess the maximum and pre-dose plasma concentration of omecamtiv mecarbil. The secondary endpoints were to assess changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide (a biomarker associated with the severity of heart failure) at week 20, as well as the safety and tolerability of omecamtiv mecarbil including incidence of adverse events from baseline to week 24.
COSMIC-HF was not designed to assess the impact of omecamtiv mecarbil on cardiovascular outcomes in heart failure patients.
COSMIC-HF was conducted by Amgen in collaboration with Cytokinetics.
Amicus Therapeutics (Nasdaq:FOLD) today announced a conference call and live audio webcast on Tuesday, November 3, 2015 at 4:30 p.m. ET to discuss financial results for the third quarter ended September 30, 2015. The call will be hosted by John F. Crowley, Chairman and Chief Executive Officer. He will be joined on the call by additional members of the Amicus management team. Interested participants and investors may access the conference call at 4:00 p.m. ET by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international). A live audio webcast can also be accessed via the Investors section of the Amicus Therapeutics corporate web site at http://ir.amicustherapeutics.com/events.cfm, and will be archived for 30 days. Web participants are encouraged to go to the website 15 minutes prior to the start of the call to register, download and install any necessary software. A telephonic replay of the call will be available for seven days beginning at 7:30 p.m. ET on November 3, 2015. Access numbers for this replay are 855-859-2056 (U.S./Canada) and 404-537-3406 (international); participant code 65781940.
Applied Genetic Technologies Corporation (Nasdaq:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced that it will report financial results for the quarter ended September 30, 2015 after the market closes on Thursday, November 5, 2015. AGTC management will host a conference call beginning at 5:00 pm Eastern Time that day to review results and provide a corporate update. To access the call, dial 888-437-9445 (US) or 719-457-2648 (outside of the US). The passcode is 184929. A live webcast will be available in the Events and Presentations section of the Investor Relations page at ir.agtc.com/events.cfm. Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events and Presentations section of the company's website.
BioBlast Pharma Ltd., (Nasdaq:ORPN), a clinical-stage biotechnology company developing meaningful therapies for patients with rare and ultra-rare genetic diseases, announced positive interim results from a Phase 2 open label clinical study of its lead compound, Cabaletta® (IV trehalose), in 25 patients with oculopharyngeal muscular dystrophy (OPMD), a rare progressive muscle-wasting disease characterized by severe swallowing difficulties (dysphagia) leading to malnutrition, dehydration, and aspiration of food into the lungs, as well as more generalized, progressive muscle weakness. Aspiration pneumonia and severe emaciation are frequently the cause of death. The HOPEMD study was designed as a proof–of-concept open-label clinical study in 74 patients for 24 weeks, following which all patients would be randomized into a treatment arm or non-treatment control group, and followed for an additional 12 months in a continuation study. The primary objective was to assess the safety and tolerability of Cabaletta. Secondary endpoints were to determine if Cabaletta improves or prevents worsening of OPMD disease markers. As previously reported, based on the positive signals seen in the first 25 patients enrolled in Canada and Israel, further recruitment has been terminated, with the aim of beginning a Phase 3 study. These 25 patients remain in the Phase 2 study. To date, 22 patients have completed 24 weeks of treatment. Of these patients, 19 have now been randomized into the continuation study. Although unplanned, an analysis was done on clinical data accumulated as of September 1, 2015 on these 25 patients. In this analysis, Cabaletta was observed to be safe and well-tolerated with no drug-related serious adverse events. Statistically significant improvement or numerical improvement versus baseline, was observed on multiple efficacy endpoints. Ten out of 12 patients (83.3%) were observed to stabilize or improve on an efficacy endpoint related to dysphagia, the Penetration Aspiration Score as measured by Video Fluoroscopy (VFS-PAS).
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), today announced that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer, will participate in the Credit Suisse Healthcare Conference on November 11, 2015 at 9:30 am MT, or 11:30 am ET, in Scottsdale, Arizona. To access the live webcast, please visit the investor section of the BioMarin website, www.BMRN.com. A replay will also be archived on the site for at least one week following the event.
Endocyte, Inc., (NASDAQ:ECYT) announced today that the company will host a conference call on Tuesday, Nov. 3rd, at 4:30 p.m. EST to discuss its third quarter financial results and provide an operational update. Investors and the general public are invited to listen to a live webcast of the call, which can be accessed in the Investors & News section of the Company's website at www.endocyte.com or by dialing (877) 845-0711 (U.S./Canada) or (760) 298-5081 (International). The webcast will be recorded and available on the Company's website for one week following the call.
Galil Medical, a global leader in delivering innovative cryotherapy ablation solutions, and Perseon Corporation (NASDAQ:PRSN) (NASDAQ:PRSNW), a leading provider of medical systems that utilize energy to treat cancer, today announced the signing of a definitive agreement in which Galil Medical will acquire Perseon to create a leader in ablation treatment for both cancerous and non-cancerous tumors. Under the terms of the agreement, Galil Medical will pay $1.00 per share in cash, plus $0.02 per warrant for each of the publicly traded warrants, for a total transaction value of approximately $10.6 million. The transaction has been approved by the boards of directors of both companies. "We believe this transaction propels us to a market leadership position in minimally invasive treatment of cancerous and non-cancerous tumors, with a broadened product offering that delivers both 'hot and cold' ablation solutions for our growing base of interventional radiologists," said Martin J. Emerson, President and CEO of Galil Medical. "We see tremendous opportunity to scale sales of both Perseon's microwave and our cryotherapy ablation solutions, both of which represent high growth, high margin opportunities attacking a large and growing global market for tumor ablation." "We believe Galil Medical is the ideal partner to allow Perseon to continue our efforts to build awareness and increase sales of MicroThermX®, which is a companion technology to cryotherapy ablation and is used by the same interventional radiologists, streamlining our sales efforts. Our companies are also closely aligned in our commitment to investing in robust product development pipelines and clinical research activities to stay at the forefront of ablation technology," said Clint E. Carnell, President and CEO of Perseon. "Marty and his team have built a well-respected brand and reputation as pioneers in the interventional radiology market. We look forward to leveraging their world-class distribution channel, which includes relationships with more than 300 hospital units in the U.S. alone, to accelerate MicroThermX sales both in the U.S. and around the world."
Greatbatch, Inc. (NYSE:GB) today announced it has completed the acquisition of Lake Region Medical. With combined revenues of approximately $1.5 billion and more than 9,000 Associates globally, Greatbatch becomes one of the largest medical device outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, orthopaedics, vascular, advanced surgical and portable medical markets. Greatbatch is now able to offer a substantially more comprehensive portfolio for customers through the Greatbatch Medical, Lake Region Medical and Electrochem brands. The company is at the forefront of innovating technologies and products that help change the face of healthcare, providing customers with a distinct advantage as they bring complete systems and solutions to market. In turn, customers will be able to accelerate patient access to life enhancing therapies. "Through this transformative deal, Greatbatch has added scale and diversification to enhance customer access and experience," said Thomas J. Hook, president and chief executive officer, Greatbatch. "We will continue to execute our strategy to provide customers with a comprehensive portfolio of technologies and services while maintaining a strong financial profile to drive shareholder return." In connection with the Lake Region Medical acquisition, Greatbatch secured a $1.96 billion financing package led by M&T Bank Corporation, Credit Suisse, and KeyBanc Capital Markets. The financing comprises $1.6 billion of senior secured credit facilities, and $360 million of 9.125% senior notes due 2023.
GW Pharmaceuticals plc (NASDAQ:GWPH) (AIM:GWP) and Otsuka Pharmaceutical Development & Commercialization, Inc., today reported top-line results from the remaining two Phase 3 trials for the investigational product Sativex® in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy. Consistent with the previously reported Phase 3 trial, Sativex did not meet the primary endpoint in these trials. However, a pre-specified pooled analysis of patients across the two Phase 3 trials which involved clinical sites in the U.S. showed a statistically significant improvement for Sativex compared with placebo (p=0.024), with several secondary efficacy endpoints exhibiting p-values of less than 0.05. GW and Otsuka have submitted a request to meet with the U.S. Food and Drug Administration (FDA) to discuss the clinical relevance of these data and to determine potential paths forward. "In light of the missed primary endpoint in the first trial earlier this year, these additional results are not a surprise. Nevertheless, we are encouraged by data across the trials which consistently show positive outcomes for U.S. patients when analysed as a separate cohort," stated Justin Gover, GW's Chief Executive Officer. "We believe that this finding may provide important guidance in determining the optimal target patient population for Sativex and look forward to a discussion with the FDA on a potential path forward." "While the results overall have been disappointing, and not necessarily wholly consistent with clinical experience, nonetheless they suggest that Sativex may have a useful role in the treatment of certain subgroups of patients with advanced cancer pain who have exhausted opioid treatments," stated Dr. Marie Fallon, Professor of Palliative Care, University of Edinburgh and a principal investigator in the Phase 3 program. "In particular, the U.S. patients enrolled in this program showed a useful therapeutic benefit whereas results in European patients were generally not favorable. These U.S. patients were less frail, hence the Sativex intervention was subjected to less "noise," providing clearer results and valuable guidance in determining the optimal target patient population for Sativex. This is a patient population with a significant unmet need and I believe that this important observation for Sativex warrants further investigation."
GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that a Memorandum of Understanding (MOU) has been signed with the Government of New South Wales (NSW) in Australia to progress a research program for Epidiolex® (cannabidiol or CBD) and cannabidivarin (CBDV) in children with severe, drug resistant childhood epilepsy. "GW is pleased to have been able to respond to the needs of the New South Wales government and its citizens by establishing this research program for cannabinoid-based medicines in children with treatment resistant epilepsy," stated Justin Gover, GW's Chief Executive Officer. "As part of this research partnership, GW expects to advance clinical trials in Australia for both Epidiolex and our earlier stage pipeline product CBDV." "This confirms NSW's position as a world leader in cannabinoid research and demonstrates the determination of our Government to ensure we secure these groundbreaking trials," stated NSW Premier Mike Baird. "Our research and development is driven by compassion for those suffering so we hope that these initiatives will bring relief to many children and their loved ones."
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications, announced today that Lee R. McCracken has been appointed to its Board of Directors. Mr. McCracken is an executive leader whose experience spans start-ups to commercial organizations with significant revenues. In addition, he has substantial experience in the diagnostic and pharmaceutical sectors. In 2014, Mr. McCracken was appointed Chief Executive Officer of Gensignia Life Sciences, a privately held molecular diagnostics company focused on the development and global commercialization of miRNA diagnostics for the early detection of lung cancer and other cancers using digital information technology. Mr. McCracken was previously President and CEO of Pathwork Diagnostics, a venture capital-backed company commercializing the Pathwork® Tissue of Origin Test, an FDA-cleared and Medicare-reimbursed molecular diagnostic test. Previously, Mr. McCracken served as Corporate Head of Business Development at Prometheus Laboratories, a leading personalized medicine company with diagnostic and pharmaceutical products in gastroenterology and oncology, which grew to over $500 million in sales prior to its acquisition by Nestle Health Science. Earlier, Mr. McCracken was SVP Pharma Business Development of Diversa, a genomic technology company, which merged into Verenium, President & CBO of GenStar Therapeutics, a pre-clinical gene therapy company, which merged into Corautus, and SVP Corporate Development of CombiChem, a venture capital-backed start-up company, which was acquired by DuPont Pharmaceuticals. "Lee brings significant executive experience in developing successful strategies for early stage high growth diagnostic and genomic businesses. We are privileged to have him on our board of directors and I look forward to working with Lee as we build HTG Molecular Diagnostics into a leader in molecular profiling," said TJ Johnson, President and CEO of HTG Molecular Diagnostics. "I'm excited about the opportunity to work with TJ, the board and the management team to assist them in realizing HTG's significant potential in NGS-based diagnostics," said Mr. McCracken. "HTG's technology enables a unique opportunity to democratize molecular profiling and improve patient care delivered at the local level."
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, announced that it will release its financial results for the third quarter of 2015 after market close on Tuesday, November 10, 2015. The Company will host a corresponding conference call beginning at 1:30pm PT/4:30pm ET. Individuals interested in listening to the conference call may do so by dialing (855) 427-4393 for domestic callers or (484) 756-4258 for international callers. Please reference Conference ID: 46886862. To listen to a live webcast, please visit the investor relations section of Inogen's website at: http://investor.inogen.com. A replay of the call will be available beginning November 10, 2015 at 4:30pm PT/7:30pm ET through midnight on November 11, 2015. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference ID: 46886862. The webcast will also be available on Inogen's website for one year following the completion of the call. Inogen has used, and intends to continue to use, its Investor Relations website, http://investor.inogen.com, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. For more information, visit http://investor.inogen.com.
Invuity, Inc. (NASDAQ:IVTY), an advanced medical technology company, today announced that it will release its 2015 third quarter and nine-month financial results after the market closes on Tuesday, November 10, 2015. In conjunction with the release, the Company will host a conference call with the investment community at 5:00 p.m. Eastern Time on Tuesday, November 10, 2015, to discuss the financial results and other business developments. Interested parties may access the live call via telephone by dialing 1-855-539-0900 (U.S.) or 1-412-455-6044 (International). To listen to the live call via Invuity's website, go to www.invuity.com, in the Events & Presentations section. A webcast replay of the call will be available following the conclusion of the call in the Events & Presentations section of the website.
IPC Healthcare, Inc. (NASDAQ:IPCM), a leading national acute hospitalist and post-acute provider group practice, today announced financial results for the third quarter ended September 30, 2015. All operating results referred to as "adjusted" exclude the change in fair market value of contingent consideration ("net change in fair value") for acquisitions, transaction costs related to the pending merger with Team Health, Inc., and increased costs related to the False Claims Act litigation. See "Reconciliation of Non-GAAP Financial Measures" below for explanations of these non-GAAP financial measures and reconciliation to GAAP financial measures. Third Quarter 2015 Highlights (comparisons are to third quarter 2014): Headcount growth of 16% or 291 net providers added over prior year quarter, bringing the total to 2,129 providers. Net revenue increased 9% to $184.8 million, despite cessation of Medicaid Parity at the end of 2014. Patient encounters increased 14% to 1,998,000. Nine Months Ended September 30, 2015 Highlights (comparisons are to nine months ended September 30, 2014): Net revenue increased 7% to $549.6 million, despite cessation of Medicaid Parity at the end of 2014. Patient encounters increased 13% to 5,925,000. Adam D. Singer, M.D., Chief Executive Officer of IPC Healthcare, said, "We continue to generate strong top line growth with patient encounters growing 14% over the prior year quarter, and despite the cessation of Medicaid Parity at the end of 2014, net revenue grew by 9% for the same period. While our practice margins were challenged this quarter, we remain confident in the fundamentals of our business model and our ability to manage our margins to normalized levels."
Macrocure Ltd. (NASDAQ:MCUR), a clinical-stage biotechnology company focused on advancing its novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that results from a pivotal Phase 3 multicenter, randomized, double-blind, parallel-group, sham-controlled study (MC-102) of CureXcell® in the treatment of diabetic foot ulcers (DFUs) did not meet its primary endpoint. CureXcell, the Company's lead product candidate, did not show a statistically significant proportion of subjects with complete closure at 16 weeks and sustained complete closure for four additional weeks. In addition, CureXcell did not meet the secondary endpoints of the study. "We plan to further analyze data from this Phase 3 study of CureXcell in DFU to understand why this trial did not meet its study endpoints, and determine the potential ongoing merits of the underlying technology," said Nissim Mashiach, President and Chief Executive Officer of Macrocure. "With today's announcement, we remain focused on the interests of all stakeholders of Macrocure and are committed to maximizing the value of the Company. Therefore, we will analyze all strategic options for the Company and continue to focus on managing and conserving our existing cash," Mr. Mashiach concluded. As of September 30, 2015, the Company had a preliminary estimated and unaudited cash balance of approximately $30 million. The Company had no debt outstanding.
MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today reported financial results for the three and nine months ended September 30, 2015. Highlights of the third quarter of 2015 and recent weeks include: Awarded contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) valued at up to $112 million for the development and procurement of NexoBrid for the U.S. Completed enrollment in second Phase 2 clinical trial with EscharEx® to treat chronic and other hard-to-heal wounds; Received approval from Argentina's Ministry of Health for NexoBrid® to treat severe burns; NexoBrid highlighted in more than two dozen clinical presentations at the 16th European Burns Association Congress. Management Commentary ----- "Throughout the third quarter we advanced our global commercial and clinical programs while significantly elevating the profile of both our lead product and our company. Our contract with BARDA provides up to $24 million of non-dilutive funding for our ongoing U.S. development program for NexoBrid, along with an initial commitment to procure $16 million of product for stockpiling and provides BARDA with options for additional funding of up to $72 million. Importantly, this contract also highlights an additional opportunity to aid countries in their efforts for preparedness in advance of mass casualties, whether military or civilian," stated Gal Cohen, President and Chief Executive Officer of MediWound. "We have completed enrollment in our second Phase 2 clinical study with EscharEx for the debridement of chronic wounds and are on track to report top-line results around the end of the year. We believe that since EscharEx is based on the same technology as NexoBrid, the wealth of development data supporting NexoBrid, which is an approved drug, as well as the clinical data from our first Phase 2 feasibility study in treating chronic and hard-to-heal wounds, de-risks EscharEx development. The enthusiasm for the potential of EscharEx to treat chronic and hard-to-heal wounds is supported by the results of the market study that surveyed more than 200 health care professionals as well as the feedback of a U.S. advisory board, both indicating that EscharEx represents a significant commercial opportunity within the multibillion-dollar chronic wound care market, where more than a million patients with diabetic foot ulcers and venous leg ulcers in the U.S. alone undergo debridement every year.
Metabolix, Inc. (NASDAQ:MBLX), an advanced biomaterials company focused on sustainable solutions for the plastics industry, announced today that it will be releasing its third quarter 2015 financial results after the market close on Tuesday, November 10, 2015. The full text of the earnings release also will be available on the Company’s website at www.metabolix.com. The Company will host a conference call on the same day at 4:30 p.m. (ET), during which time senior management will provide an update on the business and answer questions from the investment community. While shareholders participate in the call in listen-only mode, Metabolix invites shareholders to submit questions for consideration to [email protected] with the subject line: “Questions for Third Quarter Call.” Questions submitted in advance of the call will be reviewed and some of them may be addressed in management's prepared remarks or in the Q&A portion of the call. A live webcast of the call with slides can be accessed through the “Investors” section of the Company’s website at www.metabolix.com. To participate in the call, dial toll-free (877) 709-8150 or (201) 689-8354 (international). Interested parties unable to participate in the live call may access an archived version of the webcast on the Company’s website. To listen to a telephonic replay of the conference call, dial toll-free (877) 660-6853 or (201) 612-7415 (international) and enter passcode 13623265. The replay will be available beginning at 7:30 p.m. (ET) on Tuesday, November 10, 2015 and will last through 11:59 p.m. (ET) on Monday, November 23, 2015. In addition, the webcast will be archived on the Company’s website in the investor relations section.
Micron Products, Inc. (Micron), a wholly-owned subsidiary of Arrhythmia Research Technology, Inc. (NYSE MKT:HRT), announced today it has expanded its sales organization in two key areas with the appointment of Mr. Christopher Foley as Vice President of Sales and Marketing – Machined Components and Ms. Elaine B. Holland as Vice President of Sales and Marketing – Plastic Products. "We are expanding our sales and marketing organization to address the growing contract manufacturing market while bringing a specialized focus in plastic injection molding, machining, and value-added services," said Salvatore Emma, Jr., President and CEO. "Ms. Holland's strong plastic molding experience and industry knowledge is a terrific addition as more medical device and other OEMs look for highly competent engineering and manufacturing support. Mr. Foley has experience across multiple industries with a deep understanding of machined medical device components." Mr. Emma added, "Ms. Holland and Mr. Foley complement each other well and will be an excellent addition as we look to expand Micron's capabilities and offerings. I have great confidence that their drive, relationships, and industry knowledge will help us to grow market share and sales in their respective areas of focus." Ms. Holland's experience includes executive-level business development and direct sales positions with a strong concentration in injection molding, micro-molding, prototyping, tooling and assembly. Prior to joining Micron, Ms. Holland was Business Development Manager for SMC, Ltd., a medical devices contract manufacturer, where she was instrumental in tripling the sales of the company. Her experience in marketing contract manufacturing of medical devices is extensive both as the owner of a manufacturing representative firm and as a sales manager for SRC Medical, Inc. and Phoenix Custom Molders. Mr. Foley brings more than 20 years of sales and marketing experience in positions of progressively increasing responsibility for contract manufacturing companies for OEMs in multiple industries, including medical devices, defense, aerospace and energy. He was most recently Vice President of Sales and Marketing for FMI Hansa Medical, a contract manufacturing company servicing medical device OEMs. His executive sales management experience prior to FMI Hansa Medical includes positions at Federated Precision, Brinkman International Group and MSK Precision Products.
National Research Corporation (NASDAQ:NRCIA) (NASDAQ:NRCIB) announced the appointment of Donald Berwick, M.D., MPP, to its Board of Directors. Dr. Berwick is a leading authority in the advancement of patient-centered healthcare. Dr. Berwick is the former President and CEO of the Institute for Healthcare Improvement (IHI), which he co-founded and led for almost 20 years, and where he now serves as President Emeritus and Senior Fellow. In 2008, Dr. Berwick and colleagues at IHI developed the Triple Aim framework for the goals of high-value care—improving the care of individuals; improving the health of populations; and reducing the per capita cost of healthcare. In 2013, the IHI added “Joy in Work” to its strategic goals for healthcare. National Research Founder and Chief Executive Officer, Michael D. Hays said, “At National Research, we believe in measuring what matters most to patients, families, and staff to deliver care at a lower cost, with better outcomes and a more personalized experience. We are privileged to have Don Berwick on our board to guide us in this mission and provide the kind of direction that only his decades of experience and leadership in the improvement of healthcare can bring.” “I am honored to join the board of National Research, a company that has demonstrated unwavering dedication to ensuring that each patient is treated as a person, not just a condition,” said Dr. Berwick. “I look forward to working with the company to broaden the healthcare world’s definitions of patient-centered care to encompass the unique needs of patients, care providers, and our communities, and to ensure all people are treated with understanding and respect.”
Natural Health Trends Corp. (NASDAQ:NHTC), a leading direct-selling company that markets premium quality personal care, wellness and "quality of life" products under the NHT Global brand, today announced its financial results for the quarter ended September 30, 2015. Third Quarter 2015 Financial Highlights: Total revenue increased 154% to $80.8 million, compared to $31.8 million in the third quarter of 2014. Revenue from the Company's Hong Kong operations, which represents 94% of total revenue, increased 168% to $75.9 million, compared to $28.3 million in the third quarter of 2014. Revenue outside of Hong Kong increased 38% to $4.9 million, compared to $3.5 million in the third quarter of 2014. Operating income increased 171% to $14.8 million, compared to $5.5 million in the third quarter of 2014. Net income available to common stockholders was $14.5 million, or $1.18 per diluted share, compared to $5.4 million, or $0.42 per diluted share, in the third quarter of 2014. The number of Active Members-1 increased 24% to 94,700 at September 30, 2015, compared to 76,400 at June 30, 2015. 1-Natural Health Trends defines Active Members as those that have placed at least one product order with the Company during the preceding twelve month period.
SmallCapVoice.com, Inc. today announced it conducted a new audio interview with PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions. In the interview, which can be heard at http://smallcapvoice.com/blog/10-26-15-smallcapvoice-interview-with-positiveid-corporation-psid, William J. Caragol, Chairman and CEO of PositiveID, discusses the Company’s recent acquisition news and overall acquisition strategy. Last week PositiveID announced it entered into an agreement to acquire Thermomedics Inc. and the FDA-cleared Caregiver® non-contact thermometer. The acquisition is a part of the Company’s overall growth strategy to add revenue-generating, complementary products with significant market penetration potential to its portfolio. PositiveID expects to close the acquisition during the fourth quarter of 2015. Caregiver®, the world’s first non-contact device with TouchFree™ technology, is a clinical-grade, infrared thermometer for measurement of forehead temperature in adults, children, and infants. Since there is no skin contact and Caregiver does not require probe cover supplies, it reduces the risk of cross-contamination and decreases costs for healthcare facilities. PositiveID remains focused on its Firefly Dx polymerase chain reaction (“PCR”) breadboard prototype pathogen detection system, designed to provide real-time, accurate diagnostic results in less than 20 minutes from a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment, highly trained personnel, and can take hours or even days to provide results. Firefly's applications include point-of-need, lab-quality, detection of pathogenic organisms; agricultural and food screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction.
UBIC, Inc. (Nasdaq:UBIC) (TSE:2158), a leading provider of international litigation support and big-data analysis services, today announced that it will work together with M3 Inc. (TSE:2413) to develop services using artificial intelligence (AI) technology in the fields of healthcare and pharmaceuticals. As the first step of the business partnership, Mediscience Planning Inc. ("MPI"), a subsidiary of M3, and UBIC MEDICAL Inc., a UBIC subsidiary, will cooperate to provide the first AI-based pharmacovigilance ("PV") support service in Japan by combining MPI's expertise in PV and UBIC MEDICAL's AI technology. Pharmacovigilance refers to the science of, and activities related to, detecting, evaluating, understanding and preventing harmful side effects and various problems of pharmaceutical products. MPI is engaged as a contract research organization that supports various operations related to clinical drug trials conducted by pharmaceutical manufacturers, or implements such operations on their behalf on a contractual basis, while UBIC MEDICAL provides AI-based medical data analysis solution services. Through their partnership, M3 and UBIC aim to provide high-quality services that help to further enhance the safety of pharmaceuticals. The two companies will also consider developing a broad range of services in the field of healthcare and pharmaceuticals through AI-based data analysis.