Gilead Submits NDA to FDA for Fixed-Dose Combination of Sofosbuvir/Velpatasvir; AMAG Pharma Announces 3 Trial Evaluating Feraheme(R) Print E-mail
By Mary Davila   
Wednesday, 28 October 2015 18:52
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 28, 2015.     
   
   
Gilead Sciences, Inc. (NASDAQ: GILD) announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for patients with decompensated cirrhosis.
      
"As the first fixed-dose combination of two pan-genotypic, direct-acting antivirals, SOF/VEL represents an important step forward in the treatment of patients with hepatitis C," said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. "Genotype 1 is the most prevalent form of HCV in the United States, but worldwide, more than half of people living with HCV are infected with other genotypes. SOF/VEL complements our current HCV portfolio of Sovaldi and Harvoni, offering high cure rates and
the potential to simplify treatment and

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eliminate the need for HCV genotype testing."
      
The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for SOF/VEL is supported by data from four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Those who received SOF/VEL plus RBV for 12 weeks achieved an SVR12 rate of 94 percent, while those who received SOF/VEL for 12 weeks and
24 weeks achieved SVR12 rates of 83 percent and 86 percent, respectively.
      
Patients treated with SOF/VEL for 12 weeks in ASTRAL-1, ASTRAL-2 and ASTRAL-3 had similar adverse events compared with placebo-treated patients in ASTRAL-1. The most common adverse events were headache, fatigue and nausea. The most common adverse events in ASTRAL-4 were fatigue, nausea and headache.
       
Gilead plans to submit a regulatory application for approval of SOF/VEL in the European Union by the end of the year.
     
The SOF/VEL fixed-dose combination is an investigational product and its safety and efficacy have not been established.
  
   
   
   
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AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced it has commenced start-up activities for its head-to-head Phase 3 clinical trial evaluating the safety of Feraheme® (ferumoxytol) compared to Injectafer® (ferric carboxymaltose injection) in adults with iron deficiency anemia (IDA).
    
The planned safety trial follows the Complete Response Letter (CRL) AMAG received from the U.S. Food and Drug Administration (FDA) in January 2014 regarding its supplemental new drug application (sNDA) to broaden the use of Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment.
    
"We have worked closely with the FDA to develop a path forward for potentially broadening the indication for Feraheme to include all patients with iron deficiency anemia. This safety trial represents a significant step forward in that process," said Dr. Julie Krop, chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. "Approximately 4.5 million Americans suffer from the debilitating effects of IDA, and we believe healthcare providers need additional treatment options to help care for their IDA patients."
    
The randomized, double-blind, multicenter non-inferiority trial will evaluate the incidence of moderate to severe hypersensitivity reactions (including anaphylaxis), and moderate to severe hypotension with Feraheme compared to ferric carboxymaltose injection in adults with IDA. Two thousand patients will be randomized in a 1:1 ratio into one of two treatment groups – 1.02 grams of Feraheme intravenous (IV) infusion or 1.5 grams of ferric carboxymaltose injection. While the trial's primary endpoint is safety, the study will also assess efficacy.
    
"Moving forward with this head-to-head clinical trial to support potential FDA regulatory approval for a broader indication of Feraheme highlights our commitment to not only the IDA community but also to maternal health," said William Heiden, chief executive officer of AMAG. "Today, 1.5 million of the 4.5 million Americans already diagnosed with IDA are women with abnormal uterine bleeding, or who are pregnant or post-partum. Many of these women are under the care of the obstetricians who are called upon by our maternal health commercial team. We believe an expanded indication would allow us to help these women, as well as other patients whose IDA has not been successfully treated with oral iron."
    
AMAG expects to begin enrolling patients in the trial in the first quarter of 2016, with a potential sNDA approval and launch in 2018.
    
    
    
    
    
Also Wednesday:
   
   
   
   
   
Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), today issued an update on the company's HBV pipeline, including plans to progress lead pipeline candidate TKM-HBV into a multi-dose Phase II study in HBV infected patients by year-end.
TKM-HBV Progressing to Phase II in HBV Infected Patients  --  TKM-HBV, Arbutus' RNAi product candidate for HBV, is progressing to a Phase II multi-dosing study in HBV infected patients based on results to date from a Phase I single ascending dose study. TKM-HBV, which comprises three RNAi triggers that target all HBV transcripts, has been shown in preclinical studies to reduce all viral antigen levels as well as cccDNA. TKM-HBV's design will target hepatitis B surface antigen (HBsAg) expression regardless of its source. The Phase I clinical trial is a randomized, single-blind, placebo-controlled study, involving single ascending doses of TKM-HBV. The study is assessing the safety, tolerability and pharmacokinetics of intravenous administration of two LNP formulations (third and fourth generation) of TKM-HBV in healthy adult subjects. In order to enable maximum TKM-HBV dose escalation, steroid premedication was added to the Phase I protocol. At this time, a maximum tolerated dose has not yet been reached and evaluation of higher doses is under consideration.
TKM-HBV Phase II Study  --  Pending confirmation from the relevant regulatory authorities, the Phase II study will evaluate two dose levels of TKM-HBV administered as three monthly doses in chronic HBV infected patients who are on stable background nucleot(s)ide analog therapy. In the proposed protocol, eight subjects will be enrolled in each of the dose cohorts with six subjects receiving TKM-HBV, and two receiving placebo. Dosing in this study is expected to begin by year-end. HBsAg reduction results are expected to be reported in 2016. The TKM-HBV product candidate that will be studied in Phase II will be referred to as ARB-1467.
   
   
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced that it has received a third U.S. patent covering FHACT® (U.S. Patent No. 9,157,129), its proprietary FISH (fluorescent in situ hybridization)-based HPV-Associated Cancer Test. FHACT® is primarily used as a diagnostic tool for the detection of cervical cancer and pre-cancers. This patent is part of a series of patents received for FHACT® that provide protections for CGI’s proprietary capabilities for the detection of HPV-associated cancers, which include cervical, anal, head and neck, penile, and vulvar cancers. Cervical cancer is one of the most common HPV-associated cancers, with approximately 528,000 new cases diagnosed annually worldwide.2
FHACT® uses DNA FISH-probes in the evaluation of biomarkers indicative of HPV-associated cancers in cervical or other cytology specimens. The results provided by the test have the potential to not only improve the clinical management of HPV-positive patients, but also to reduce costs of treatment for patients with abnormal cytology or positive HPV results.
The Company recently illustrated the clinical utility and sensitivity of the FHACT® test when it presented the results of two clinical studies at the HPV 2015 conference in Lisbon, Portugal. In the first study, which was conducted with the National Cancer Institute (NCI) on 296 patients, the FHACT® test demonstrated 96.9% sensitivity. In the second study, which included 200 women, conducted in partnership with Kamineni Hospitals in Hyderabad, India, the FHACT® test was used in conjunction with molecular detection of HPV and demonstrated 94% sensitivity and specificity.
“Having a total of three patents directed to separate proprietary aspects of our unique FHACT® test further strengthens our position in this important and underserved category, and highlights the test’s unique ability to advance HPV-associated cancer detection and patient management,” said Panna Sharma, CEO of Cancer Genetics, Inc. “The test has benefits that are important for both patients and providers as FHACT® has the ability to repurpose patient samples to avoid additional invasive, time consuming, and costly procedures while also offering high-sensitivity genomic testing with robust performance.”
   
   
CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value, diagnostic surveillance solutions for transplant recipients, today announced that it will release financial results for the third quarter 2015 after the close of trading on Wednesday, November 11, 2015. Peter Maag, Chief Executive Officer and President, and Ken Ludlum, Chief Financial Officer, 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) 420-0616 for domestic callers or +1 (678) 304-6848 for international callers. Please reference Conference ID 43132259. To listen to a live webcast, please visit the investor relations section of CareDx's website at: www.caredx.com.
A replay of the call will be available beginning November 11, 2015 at 4:30pm PT/7:30pm ET through midnight on November 12, 2015. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference ID: 43132259. The webcast will also be available on CareDx's website for one year following the completion of the call.
   
    
Endologix, Inc. (NASDAQ:ELGX) today announced the pricing of its underwritten public offering of $110.0 million aggregate principal amount of its convertible senior notes due 2020 (the "Notes"), which represents a decrease of $40.0 million from the aggregate principal amount of the Notes the Company previously announced it was offering. The Company made the decision to reduce the size of the offering in light of market conditions and the price of the Company's common stock at the time of pricing. The Company granted an option to the underwriter for up to an additional $15.0 million aggregate principal amount of the Notes solely to cover overallotments, if any. Piper Jaffray & Co. is acting as the sole underwriter for the offering.
The Notes will pay interest semiannually at a rate of 3.25% and will be convertible into shares of the Company's common stock ("Common Stock"), cash or a combination of cash and shares of the Company's Common Stock, at the Company's election, based on the applicable conversion rate at such time. The Notes have an initial conversion rate of 89.4314 shares of Common Stock per $1,000 principal amount of the Notes (which is equal to an initial conversion price of approximately $11.18 per share of Common Stock), representing an initial conversion premium of approximately 27.5% above the closing price of $8.77 per share of Common Stock on October 27, 2015. The Notes will mature on November 1, 2020, unless repurchased, redeemed or converted in accordance with their terms prior to such date. Prior to August 1, 2020, the Notes will be convertible only upon the occurrence of certain events and during certain periods, and thereafter, at any time until the second scheduled trading day immediately preceding the maturity date. On or after November 1, 2018, the Company may from time to time redeem for cash all or part of the Notes in certain circumstances. The Company expects to close the sale of the Notes on or about November 2, 2015, subject to the satisfaction of various customary closing conditions.
   
   
Entellus Medical, Inc. (NASDAQ:ENTL), a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced that Jeff Kogl has been named Vice President of Business Development and Strategy effective immediately. Mr. Kogl will report directly to Entellus Medical's President and CEO, Robert White.
Mr. Kogl joins Entellus with extensive experience in the medical device market creating and executing effective business development and marketing strategies. For the past two years, he was the Vice President of Strategy and Corporate Development at Tornier, a company specializing in the design, development, and commercialization of devices for joint replacement and soft tissue repair.  Prior to his tenure at Tornier, Mr. Kogl was the Senior Director of Corporate Development and Portfolio Strategy at Medtronic where he held various business development roles of increasing responsibility from June 2002 to June 2011.
"We are pleased to have Jeff join the Entellus team. With extensive industry experience in strategic planning and business development, he brings strong leadership skills and expertise that will strengthen our overall growth strategies," said Robert White, President and Chief Executive Officer. "I am excited to have him on board as we continue to drive broad adoption of our products and look forward to his contributions to the Company."
     
     
Enzymotec Ltd., (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid based nutritional ingredients and medical foods, announced today it was granted a new patent by the United States Patent and Trademark Office for Vayacog®, a proprietary prescription medical food for the dietary management of lipid imbalances associated with early memory impairment.
The granted patent covers a method of improving a condition in the elderly suffering from specified cognitive disorders using Vayacog®. The disorders covered by the patent include pre-Alzheimer's disease and pre-dementia syndrome.
Vayacog® is a unique lipid composition essential for the management of key biochemical modifications underlying losses in brain function. There is currently a 24-month, multi-center clinical trial being conducted to evaluate its long-term efficacy in patients with Mild Cognitive Impairment ("MCI"). Vayacog® has been shown to be safe and efficacious in earlier clinical trials in non-demented subjects with memory complaints.
Rob Crim, President of VAYA Pharma, a division of Enzymotec, commented, "We continue to strengthen our intellectual property portfolio with the grant of this patent. While we work toward statistical data to make Vayacog® a standard protocol for the management of MCI, this new patent reinforces our competitive advantage. With the support of our IP, we remain focused on trial data to illustrate the effectiveness of our marketed products."
   
    
Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapeutics for the treatment of cancer and immune disorders, announced today that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,169,490 on October 27, 2015. The compositions described in the patent are foundational to the generation of induced pluripotent cells, which are a source of cells offering unique potential for off-the-shelf adoptive immunotherapy.
"Our novel induced pluripotent cell approach to cancer immunotherapy, which combines genetic engineering with rapid and efficient generation of immune cells, is designed to enable the unlimited production of engineered T cells and NK cells in a consistent, scalable and efficient manner," said Scott Wolchko, Chief Operating and Financial Officer of Fate Therapeutics. "Supported by an intellectual property portfolio of over 30 issued patents and 60 pending applications, we believe we are uniquely positioned to develop and deliver on the potential for off-the-shelf cell-based cancer immunotherapies utilizing our proprietary pluripotent cell platform as an alternative approach to patient-sourced cells."
The newly issued U.S. patent, which is owned by the Whitehead Institute for Biomedical Research and licensed exclusively to Fate Therapeutics for all therapeutic purposes, provides broad protection for cell compositions expressing a sufficient amount of octamer-binding transcription factor 4 (Oct4) to enable pluripotency. The production of Oct4 protein within a cell is a critical requirement to consistently and efficiently induce pluripotency. Fate Therapeutics is utilizing its novel platform to engineer the immunological properties of pluripotent cells, creating a continual source for the generation of engineered T- and NK-cell immunotherapeutics.
The first named inventor of this patent is Rudolf Jaenisch, M.D., a scientific founder of Fate Therapeutics. Dr. Jaenisch, a Professor of Biology at Massachusetts Institute of Technology, a founding member of the Whitehead Institute for Biomedical Research, and a member of the National Academy of Sciences, is a world-renowned scientist whose laboratory has made seminal contributions to the field of biological sciences, including understanding epigenetic regulation of gene expression in mammalian development and disease.
   
   
Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, will report its third quarter 2015 financial results on Wednesday, November 4, 2015 after the U.S. financial markets close. Five Prime will host a conference call and live audio webcast on Wednesday, November 4, 2015 at 5:00 p.m. (ET)/2:00 p.m. (PT) to discuss the company's financial results and provide a general business update.
The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company's website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 66963339.
The archived conference call will be available on Five Prime's website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.
   
    
LifeVantage Corporation (Nasdaq:LFVN), announced today it would expand its operations and distributor network into the European Union beginning with the United Kingdom and the Netherlands. The company intends to begin conducting business-building meetings within the two countries in February 2016.
According to the World Federation of Direct Selling Associations (WFDSA), the European Union represented nearly $33 billion in retail sales in 2014. LifeVantage is taking a deliberate approach to international market expansion, and both the United Kingdom and Netherlands play a critical role for the company to successfully expand into the European Union.
“It is our intent that these are the first of many launches into the European Union countries,” said LifeVantage President and Chief Executive Officer, Darren Jensen. “The United Kingdom represents one of the fastest growing markets within the Direct Selling Association (DSA), and their distributors are product-oriented business builders who leverage technology to drive their organizations. It’s an ideal fit with the culture of our Distributors here at LifeVantage. The Netherlands represents nearly $150 million in retail sales with more than 48,000 distributors in the country. Additionally, the Netherlands will become our logistics hub for the entire region.” Jensen continues, “This announcement is in alignment with our strategic approach of opening gateway markets throughout the world; these two countries are our initial entry into this critical region.”
   
   
    
Novadaq Technologies Inc. (NASDAQ:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, today announced financial results for its third quarter ended September 30, 2015. Unless otherwise indicated, all dollar amounts in this press release are expressed in United States ("U.S.") dollars.
For the three months ended September 30, 2015, NOVADAQ reported revenues of $17.0 million, an increase of 40% from $12.1 million in the third quarter of 2014. Product sales increased by $5.2 million, or 47%, primarily due to a 53% increase in capital sales and a 38% increase in recurring revenue.
    
    
Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced that Company management will present at the BIO-Europe 2015 Conference in Munich on Tuesday, November 3, 2015, at 9:15am CET.
   
   
Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today the presentation schedule for four (4) Triferic clinical abstracts that will be presented at the ASN Kidney Week 2015 Annual Meeting, November 3-8 at the San Diego Convention Center in San Diego, CA. Triferic is the only FDA approved iron product indicated to replace iron and maintain hemoglobin in hemodialysis patients in the United States.
   
   
Sientra, Inc. (NASDAQ:SIEN), a medical aesthetics company, announced today that the Company will host an investor and analyst update conference call on Wednesday October 28, 2015 at 4:15 p.m. ET/1:15 p.m. PT.
The dial-in numbers are (844) 464-3933 for domestic callers and (765) 507-2612 for international callers. The conference ID is 70422813. A live webcast of the conference call will be available on the Investor Relations section of the Company's website at www.sientra.com.
A replay of the call will be available through October 29, 2015 at 8:59 p.m. PT/11:59 p.m. ET. To access the replay, dial (855) 859-2056 for domestic callers and (404) 537-3406 for international callers, and use the replay conference ID 70422813. The webcast will be available on the Investor Relations section of the Company's website for 30 days following the completion of the call.
   
   
Sientra, Inc. (NASDAQ:SIEN), a medical aesthetics company, today provided an update regarding its business, including additional details regarding its contract manufacturer, Silimed.
Update on Fire at Silimed's Manufacturing Facility  ---  Sientra's management team is in contact with Silimed regarding the facts related to a fire on October 22, 2015 at one of Silimed's two buildings in Rio de Janeiro, Brazil. Based on these preliminary discussions with Silimed, the Company can confirm that the fire occurred in the building where Sientra's breast implants are primarily manufactured (building F2).
However, Silimed has indicated to the Company that a smaller production facility in Silimed's second building (building F1), which was not impacted by the fire, has the potential to be modified for breast implant manufacturing. In order to commence the manufacturing of breast implants, certain areas in this facility would need to be reconfigured and receive certification and approval by appropriate regulatory bodies.
The Company is working with Silimed to assess this option and the associated timeframe, but does not have any additional update at this time. Fire officials have not yet allowed anyone access to building F2, and therefore, information regarding its status is currently limited. Over the coming weeks, the Company expects to have a more comprehensive understanding of the near and long-term capabilities of Silimed's manufacturing operations including:
  • The operational state of building F2, including the status of equipment that is used to manufacture breast implants; and
  • The potential feasibility, production capacity and timing related to Silimed's ability to manufacture breast implants in building F1.
  • As the fire investigation winds down and Silimed is allowed additional access, the Company will work with Silimed to seek additional clarity on these points.
   
    
SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug products to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced positive results from the completion of a Phase 1 pharmacokinetic (PK), tolerability and safety, proof of concept clinical study with ketorolac, a non-steroidal anti-inflammatory drug (NSAID) used for the short-term treatment of moderately severe acute pain post-surgery. The results from this study were favorable and support further development of the Company's SMT-201 At Home Patient Analgesia (AHPA) program. SMT-201 is a combination of SteadyMed's PatchPump® technology and ketorolac, that is intended to provide patients with up to five days of post-surgical pain relief at the opioid level in the home setting from a non-opioid therapy.
The current standard of care for ketorolac therapy must be initiated in the hospital or surgical center with either intravenous (IV) infusion or multiple intra-muscular (IM) injections. The study data demonstrated that a continuous subcutaneous infusion of ketorolac over 24 hours resulted in equivalent bioavailability compared to IM injections administered at six-hour intervals over 24 hours. In addition, this continuous 24-hour subcutaneous infusion avoided the peaks and troughs in plasma concentration that were associated with the ketorolac IM injections.
Jonathan Rigby, President and CEO of SteadyMed, commented, "Over 70 million surgeries are performed annually in the United States. The inability to effectively manage post-surgical pain can delay recovery from surgery and may result in an increased length of hospital stay, increased hospital readmission rates and higher healthcare costs. Despite the introduction of new pain management modalities, both patients and their health care providers continue to face issues with treating post-surgical pain in the home setting."
Mr. Rigby continued, "Ketorolac provides pain relief at the opioid level but currently has limited utility because of the need for therapy initiation by IV infusion or IM injection in the hospital over a 24-hour period. SteadyMed's goal is to change this and bring effective post-surgical pain management into the home setting. We believe that these positive Phase 1 results support this goal and, by advancing the clinical development of SMT-201, may ultimately allow patients to return home sooner after minor surgery while continuing to receive effective, non-opioid pain relief."
SteadyMed's Phase 1 PK proof of concept clinical study enrolled 12 healthy subjects who received 120 mg of ketorolac over 24 hours as either a continuous subcutaneous infusion (5 mg/hr) or 4 IM injections of 30 mg each every 6 hours over 24 hours in a randomized, crossover study design. The bioavailability of both treatments demonstrated similar area under the curve (AUC) results. The continuous infusion demonstrated zero order kinetics consistent with ketorolac concentration levels needed for a therapeutic effect without the peaks and troughs in plasma concentration seen in the IM arm of the study. Both routes of administration were generally safe and well tolerated. Ketorolac is a potent NSAID that provides analgesia comparable to some opioids but without the side effects associated with a narcotic agent.  
     
   
Steiner Leisure Limited (NASDAQ:STNR) today announced financial results for the third quarter and nine months ended September 30, 2015. During the third quarter of 2015, as a result of current conditions, circumstances, and in connection with Accounting Standards Codification No. 350, Intangibles – Goodwill and Other, we recorded a non-cash impairment charge of $29.5 million and associated income tax benefit of $3.5 million, related to the impairment of goodwill and other indefinite lived intangible assets at our Schools reporting unit. 
During 2015, our Schools reporting unit continued to operate in an environment with increased regulatory compliance obligations that continued to adversely affect our enrollments and our overall financial performance. During the third quarter of 2015, our actual enrollments and overall financial performance at the Schools reporting unit were below our plan, which also adversely affected our projections of future results for this business. As a result of the decline in recent and forecasted performance of this reporting unit, during the third quarter of 2015, we have reduced our carrying values in certain of our assets as reflected in the impairment charge discussed above. These charges are not expected to have any impact on the Company's cash position or liquidity under its Credit Facility. 
    
    
Symmetry Surgical Inc. (Nasdaq:SSRG) announced today that it will release third quarter 2015 financial results for the period ending October 3, 2015 before the market opens on Thursday, November 5, 2015. Symmetry Surgical will host an accompanying conference call at 8:00 a.m. ET on Thursday, November 5, 2015.
A live webcast of the conference call will be available online from the investor relations page of the Company's corporate website at www.symmetrysurgical.com. The dial-in numbers are (877) 783-7531 for domestic callers and (530) 379-4683 for international. The reservation number for both is 56025237. After the live webcast, the call will remain available on Symmetry Surgical's website through December 5, 2015. In addition, a telephonic replay of the call will be available until November 12, 2015. The replay numbers are (855) 859-2056 for domestic callers (404) 537-3406 for international callers. Please use reservation code 56025237.
    
     
Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing the ELAD® System, a cell-based therapy targeting the treatment of liver failure, today announced the closing of its previously announced underwritten public offering of 6,272,727 shares of its common stock at a price to the public of $5.50 per share, including 818,181 shares sold pursuant to the underwriter's full exercise of its option to purchase additional shares. The aggregate gross proceeds from this offering were approximately $34.5 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Vital Therapies.
BofA Merrill Lynch acted as sole book-running manager for the offering.  ---  The securities described above were offered pursuant to a shelf registration statement (File No. 333-204097) that was filed with the Securities and Exchange Commission on May 12, 2015, and that was declared effective on May 26, 2015. The final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from BofA Merrill Lynch, 222 Broadway, New York, NY 10038, Attn: Prospectus Department, Email: dg.prospectus_requests@baml.com. An electronic copy of the final prospectus supplement and accompanying prospectus relating to the offering are available on the website of the Securities and Exchange Commission at www.sec.gov.
   
    
WaferGen Bio-systems, Inc. (NASDAQ:WGBS) today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent 9,132,427 and has issued a Notice of Allowance for U.S. Patent Application 12/624,399 with both method and system claims utilizing multi-well chips, respectively. With the grant and allowance of these applications, WaferGen now owns five total issued patents, and one allowed application, that cover multiple salient attributes of the Company's SmartChip™ technology.
This family of patents provides greater strength for WaferGen's core SmartChip products and applications. These products include the recently launched ICELL8™ Single-Cell System, as well as the existing SmartChip Target Enrichment and Real-Time PCR systems. The ICELL8 System is a revolutionary single-cell system for processing thousands of single cells for downstream analysis, including Next Generation Sequencing (NGS). The system has the potential to accelerate the drug discovery and development process, and could uncover discoveries leading to clinical single-cell applications. The SmartChip Target Enrichment and Real-Time PCR systems are currently used in multiple clinical research applications, such as the identification of variants within the BRCA1 and BRCA2 genes via NGS.
"The granting and allowance of these applications complements our growing patent portfolio related to the SmartChip technology, and provides a solid foundation for our ICELL8 Single-Cell System, which employs the SmartChip technology," commented Rollie Carlson, President and CEO of WaferGen Bio-Systems. "Our additional filings of 17 U.S. and international patent applications related to single-cell analysis using the SmartChip technology, including single-cell capture, dispensing, counting, visualizing, and analysis, is expected to further strengthen WaferGen's position as the large-scale single cell analysis leader."



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