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Biotech News

Biotech Releases 'Unequivocally Positive' Topline NASH Study Results
June 13, 2018 (Investorideas.com Newswire) An H.C. Wainwright & Co. report relayed the highlights of the new trial data from this Israel-based firm.

Biotech Targeting Alzheimer's Disease Advances Toward Phase 1
June 13, 2018 (Investorideas.com Newswire) Having secured a manufacturing partner for its proprietary antibody candidate, this precision medicine company charts progress toward a Phase 1 trial in Alzheimer's disease.

Target Price Raised Ninefold on Biotech After Share Consolidation
June 7, 2018 (Investorideas.com Newswire) A Canaccord Genuity analyst provided an update on this late-stage Canadian life sciences firm targeting metastatic breast cancer.

Company with Platform to Reduce Healthcare Supply Costs Grows Revenue 39% QOQ
June 1, 2018 (Investorideas.com Newswire) A platform that allows hospitals to buy and sell excess supplies and equipment is gaining traction in the United States.

iCo Therapeutics (TSXV: ICO) (OTCQB: ICOTF) Announces First Quarter 2018 Financial Results And Update On Phase 1 Clinical Trial
Vancouver, British Columbia - May 31, 2018 (Newsfile Corp.) (Investorideas.com Newswire) iCo Therapeutics (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or "the Company"), reported financial results for the quarter ended March 31, 2018.

CSE New Listing - Izotropic Corporation (IZO)
May 30, 2018 (Investorideas.com Newswire) The common shares of Izotropic Corporation have been approved for listing on the CSE. Listing and disclosure documents will be available at www.thecse.com on the trading date.

CANCER News Alert: Fewer Men Are Being Screened, Diagnosed, and Treated for #ProstateCancer
May 24, 2018 (Investorideas.com Newswire) A new study reveals declines in prostate cancer screening and diagnoses in the United States in recent years, as well as decreases in the use of definitive treatments in men who have been diagnosed.

Cardiol Therapeutics Closes CDN$10.5 Million Private Placement; #Nanotherapeutics
Toronto, Ontario - May 24, 2018 (Newsfile Corp.) (Investorideas.com Newswire) Cardiol Therapeutics Inc. ("Cardiol" or the "Company"), a nanotherapeutics company focused on advancing the treatment of heart failure by developing proprietary formulations designed to deliver cannabinoids and other drugs to inflamed tissue in the heart

#Rheumatoid #Arthritis Drugs Taken During Pregnancy May Not Be Linked to Large Infection Risk in Children
May 24, 2018 (Investorideas.com Newswire) New research indicates that when pregnant women take certain rheumatoid arthritis (RA) drugs that may cause immunosuppression, their children do not have a marked excess risk of developing serious infections.

Biotech Announces Encouraging HIV Vaccine Results
May 23, 2018 (Investorideas.com Newswire) Ram Selvaraju, an analyst with H.C. Wainwright & Co., explained the recently released data from a study of one of this immunotherapy firm's therapeutics.

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Biotech Stock ETF's

First Trust NYSE Arca Biotech ETF ( NYSEArca: FBT ) The investment seeks investment results that correspond generally to the price and yield (before the fund's fees and expenses) of an equity index called the NYSE Arca Biotechnology Index(SM). The fund will normally invest at least 90% of its net assets plus the amount of any borrowings for investment purposes in common stocks that comprise the index. The index is an equal-dollar weighted index designed to measure the performance of a cross section of companies in the biotechnology industry that are primarily involved in the use of biological processes to develop products or provide services. The fund is non-diversified.

iShares US Healthcare ( NYSEArca: IYH ) The investment seeks to track the investment results of an index composed of U.S. equities in the healthcare sector. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. It seeks to track the investment results of the Dow Jones U.S. Health Care Index (the "underlying index"), which measures the performance of the healthcare sector of the U.S. equity market. The fund is non-diversified.

iShares US Healthcare Providers ( NYSEArca: IHF ) The investment seeks to track the investment results of an index composed of U.S. equities in the healthcare providers sector. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. It seeks to track the investment results of the Dow Jones U.S. Select Health Care Providers Index (the "underlying index"), which measures the performance of the healthcare providers sector of the U.S. equity market. The fund is non-diversified.

iShares US Medical Devices ( NYSEArca: IHI ) The investment seeks to track the investment results of an index composed of U.S. equities in the medical devices sector. The fund seeks to track the investment results of the Dow Jones U.S. Select Medical Equipment Index (the "underlying index"), which measures the performance of the medical equipment sector of the U.S. equity market. The underlying index includes medical equipment companies such as manufacturers and distributors of medical devices such as magnetic resonance imaging (MRI) scanners, prosthetics, pacemakers, X-ray machines, and other non-disposable medical devices. The fund is non-diversified.

iShares Nasdaq Biotechnology ( NasdaqGIDS IBB ) The investment seeks to track the investment results of an index composed of biotechnology and pharmaceutical equities listed on the NASDAQ. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. The underlying index contains securities of NASDAQ® listed companies that are classified according to the Industry Classification Benchmark as either biotechnology or pharmaceuticals and that also meet other eligibility criteria determined by the NASDAQ OMX Group, Inc. The fund is non-diversified.

Market Vectors Biotech ETF ( NYSE MKT:BBH ) seeks to replicate as closely as possible, before fees and expenses, the price and yield performance of the Market Vectors® US Listed Biotech 25 Index. The fund normally invests at least 80% of its total assets in securities that comprise the fund's benchmark index. The Biotech Index is comprised of common stocks and depositary receipts of U.S. exchange-listed companies in the biotechnology sector. Such companies may include medium-capitalization companies and foreign companies that are listed on a U.S. exchange. It is non-diversified.

PowerShares Dynamic Biotech & Genome ETF ( NYSEArca: PBE ) The investment seeks investment results that generally correspond (before fees and expenses) to the price and yield of the Dynamic Biotechnology & Genome IntellidexSM Index. The fund generally will invest at least 90% of its total assets in common stocks of biotechnology companies and genome companies that comprise the underlying intellidex. The underlying intellidex was composed of common stocks of 30 U.S. biotechnology and genome companies. These companies are engaged principally in the research, development, manufacture and marketing and distribution of various biotechnological products, services and processes, etc. It is non-diversified.

Biotech/ Pharma Stock Directory

Preview

4SC (XETRA: VSC.DE) is an innovative biotech company with a strong focus on clinical development. We discover and develop targeted small molecule drugs with an epigenetic mode of action for the treatment of cancer in indications with a high unmet medical need and major economic potential.

Aastrom Biosciences, Inc. (NasdaqCM: ASTM) is the leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. Aastrom markets two autologous cell therapy products in the United States for the treatment of cartilage repair and skin replacement. Aastrom is also developing MACI(TM), a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient-specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy.

ABBOTT LABORATORIES (NYSE: ABT) is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 69,000 people.76

Abeona Therapeutics Inc. (NasdaqCM:ABEO) develops and delivers gene therapy and plasma-based products for severe and life-threatening rare diseases. Abeona's lead programs are AB0-101 (AAV NAGLU) and ABO-102 (AAV SGSH), adeno-associated virus (AAV)-based gene therapies for Sanfilippo syndrome (MPS IIIB and IIIA). We are also developing ABO-201 (AAV CLN3) gene therapy for juvenile Batten disease (JBD); and ABO-301 (AAV FANCC) for Fanconi anemia (FA) disorder using a novel CRISPR/Cas9-based gene editing approach to gene therapy program for rare blood diseases. In addition, we are also developing rare plasma protein therapies including SDF Alpha™ (alpha-1 protease inhibitor) for inherited COPD using our proprietary SDF™ (Salt Diafiltration) ethanol-free process.

Ablynx (Brussels: ABLX.BR) is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, thrombosis, oncology and pulmonary disease.

Acadia Pharmaceuticals Inc. (NasdaqGS: ACAD) is a biopharmaceutical company focused on the development and commercialization of innovative medicines that address unmet medical needs in neurological and related central nervous system disorders. ACADIA has a pipeline of product candidates led by pimavanserin, for which we have reported positive Phase III trial results in Parkinson's disease psychosis and which has the potential to be the first drug approved in the United States for this disorder. We are currently completing NDA-enabling clinical and manufacturing activities for pimavanserin and are planning to submit an NDA with the FDA near the end of 2014. Pimavanserin is also in Phase II development for Alzheimer's disease psychosis and has successfully completed a Phase II trial in schizophrenia. ACADIA also has clinical-stage programs for chronic pain and glaucoma in collaboration with Allergan, Inc. and two preclinical programs directed at Parkinson's disease and other neurological disorders. All product candidates are small molecules that emanate from internal discoveries.

Access Pharmaceuticals, Inc. (OTC:ACCP) is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and ProctiGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.

AcelRx Pharmaceuticals, Inc. (NasdaqGM:ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. The Company's late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg), designed for the treatment of moderate-to-severe acute pain in medically supervised settings; and Zalviso® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. Zalviso is approved in the EU as well as Norway, Iceland, and Liechtenstein and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx retains all other world-wide rights.

Acorda Therapeutics, Inc. (NasdaqGS:ACOR) is a biotechnology company focused on developing therapies that improve the lives of people with neurological disorders. Acorda markets three FDA-approved therapies including: AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS); ZANAFLEX CAPSULES® (tizanidine hydrochloride) and Zanaflex tablets, a short-acting drug for the management of spasticity; and QUTENZA® (capsaicin) 8% Patch, for the management of neuropathic pain associated with postherpetic neuralgia. AMPYRA is marketed outside the United States as FAMPYRA® (prolonged-release fampridine tablets) by Biogen Idec under a licensing agreement from Acorda. Acorda has one of the leading pipelines in the industry of novel neurological therapies. The Company is currently developing six clinical-stage therapies and one preclinical stage therapy that address a range of disorders including post-stroke deficits, epilepsy, stroke, peripheral nerve damage, spinal cord injury, neuropathic pain, and heart failure.

Acrux Limited (ASX:ACR.AX) is a dynamic Australian drug delivery business developing and commercialising a range of patient-preferred pharmaceutical products for global markets, using innovative, patented technology to administer drugs through the skin. Fast drying, non-occlusive topical sprays or liquids provide an enhanced transdermal delivery platform with low or no skin irritation, superior cosmetic acceptability, and simple, accurate and flexible dosing.

See the full stock directory here

Biotech News from Global Newswire

INSYS Therapeutics Provides an Update on Its Ongoing Transformation

PHOENIX, June 18, 2018 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, today reiterated its ongoing efforts to fundamentally transform the company. Below is a synopsis of these ongoing efforts.

New Governance, New Employee Base, New Vision and Culture

President and Chief Executive Officer Saeed Motahari joined INSYS in April 2017.

Since then:

  • Two-thirds of the members of the Board of Directors are new, and all are independent except for one member of management (the company’s CEO);
  • The vast majority of management across the entire organization, including sales and marketing, are new to the company;
  • More than 40 percent of the employee base of approximately 330 people are new to the company; and
  • Nearly 50 percent of the company’s field force are new to the company.

These changes have been essential in building the foundation for a strong culture, which is supported by well-defined compliance practices and, above all, ethical business behavior and values focused on patient needs.

Unwavering Commitment to R&D as Company’s Driving Force

  • INSYS has invested approximately $250 million in research and development (R&D) since 2014, including nearly $140 million in 2016 and 2017.
  • Our company has advanced a new R&D vision, commencing a shift of resources from opioids to a clear, internal focus on cannabinoids, including clinical trials in infantile spasms (Phase 3), childhood absence epilepsy (Phase 2) and Prader-Willi syndrome (Phase 2), as well as the collaboration in autism research with UC San Diego’s Center for Medicinal Cannabis Research. Additional research partnerships under consideration include addiction, childhood schizophrenia/early psychosis and post-traumatic stress disorder (PTSD).  
  • Consistent with our mission to serve the interests of patients in need of innovative therapies, our company has prioritized research programs of two life-saving investigational products (naloxone and epinephrine) as part of fulfilling our commitment to be a socially-responsible, healthcare community citizen.
  • Initial clinical trials of these two product candidates—naloxone nasal spray for opioid overdose and epinephrine nasal spray for anaphylaxis—showed promising results, thereby providing hope for our company to file NDAs for these two life-saving potential products in 2018 and 2019, respectively.   
  • Filing these two NDAs would support our company’s aspirational goal of filing at least one NDA per year over the next five years. 

Our company continues to put behind it the significant challenges caused by the inappropriate actions of certain former employees, most of which is over four or more years ago. It is our hope that our actions can help us continue regaining the trust of the healthcare community as we focus on the matters we can control. We believe that we have established a strong foundation to accomplish our stated mission and to bring value to patients and other stakeholders we have the privilege to serve.

About INSYS

INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with a significant unmet need.

Forward-Looking Statements 

This news release contains forward-looking statements including discussions regarding the results of our R&D programs and our hope to file NDAs for certain programs and to file at least one NDA per year over the next five years. These forward-looking statements are based on management’s expectations and assumptions as of the date of this news release. Actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2017 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.

CONTACT:Corporate CommunicationsInvestor Relations
 Joe McGrathJackie Marcus or Chris Hodges
 INSYS TherapeuticsAlpha IR Group
 480-500-3101312-445-2870
 jmcgrath@insysrx.comINSY@alpha-ir.com

Arbutus Biopharma to Present at First Annual Roivant Pipeline Day

VANCOUVER, British Columbia and WARMINSTER, Pa., June 18, 2018 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today announced that it will present at the first annual Roivant Pipeline Day on July 10, 2018, at 4:00 p.m. ET.

A live webcast will be available via the Investors section, under Events and Presentations of Arbutus' website at www.arbutusbio.com. Please connect to the company's website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 30 days following the conference.

About Roivant Pipeline Day

Roivant Pipeline Day will be held on Tuesday, July 10, 2018, in New York City. The event will feature presentations, fireside chats, and Q&A sessions from executives across the Roivant family of companies. The event is scheduled to begin at 2:00 p.m. ET and will continue until approximately 5:30 p.m. ET. Due to limited capacity, attendance is by invitation only but a live webcast will be available to interested parties. To request access to the webcast or to learn more about the event, please email pipelineday@roivant.com.

About Arbutus

Arbutus Biopharma Corporation is a publicly traded (Nasdaq:ABUS) biopharmaceutical company dedicated to discovering, developing, and commercializing a cure for patients suffering from chronic Hepatitis B (HBV) infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care (SOC) and contribute to a curative combination regimen to improve patient outcomes and deliver a potential cure for HBV. For more information, visit www.arbutusbio.com.

Contact Information

Investors
Mark Murray
President and CEO
Phone: 604-419-3200
Email: ir@arbutusbio.com

Media
David Schull
Russo Partners
Phone: 858-717-2310
Email: david.schull@russopartnersllc.com

Myriad’s BRACAnalysis CDx® Supplementary PMA Accepted by FDA for Review as a Companion Diagnostic for Talazoparib in Metastatic Breast Cancer

SALT LAKE CITY, June 18, 2018 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplementary premarket approval (sPMA) application for BRACAnalysis CDx® to be used as a companion diagnostic with Pfizer’s PARP (poly ADP ribose polymerase) inhibitor, talazoparib.  The New Drug Application (NDA) for talazoparib has been granted priority review by the U.S. Food and Drug Administration and has a Prescription Drug User Fee Act (PDUFA) goal date of December 2018.

Myriad’s sPMA and Pfizer’s NDA submissions are based on results from the Pfizer-sponsored EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC).  The primary results of the study were presented at the San Antonio Breast Cancer Symposium in December 2017.

"Myriad was the pioneer in developing companion diagnostics for PARP inhibitors and this submission is another milestone in our collaborations to expand access to this class of drugs across multiple cancers,” said Mark C. Capone, president and CEO, Myriad Genetics.  “We are excited to pursue a simultaneous diagnostic approval along with talazoparib, as another outstanding opportunity to advance personalized medicine for oncology patients.”

Myriad estimates there are approximately 125,000 patients with metastatic breast cancer who would immediately qualify for the BRACAnalysis CDx test, followed by 60,000 new patients per year on an ongoing basis. 

About BRACAnalysis CDx®
BRACAnalysis CDx® is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA.  Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing.  Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying cancer patients with deleterious or suspected deleterious germline BRCA variants who may be candidates for a PARP inhibitor.  This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.

About Myriad Genetics
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on five strategic imperatives:  build upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020.  For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the submission and timing for approval of the Company’s supplementary premarket approval (sPMA) application to the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx® to be used as a companion diagnostic with Pfizer’s PARP (poly ADP ribose polymerase) inhibitor, talazoparib; the Company’s efforts to expand access to PARP inhibitors across multiple cancers; pursuing a simultaneous diagnostic approval along with talazoparib; the estimated number of patients with metastatic breast cancer who would immediately qualify for the BRACAnalysis CDx test, and new patients per year on an ongoing basis; and the Company’s strategic directives under the caption “About Myriad Genetics.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.

Media Contact:
Ron Rogers
(801) 584-3065
rrogers@myriad.com

Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com

 

Arrayit Corporation Announces Nationwide Allergy Testing Sales and Distribution Network

Sunnyvale, June 18, 2018 (GLOBE NEWSWIRE) -- Arrayit Corporation Announces Nationwide Allergy Testing Sales and Distribution Network

June 18, 2018 - Sunnyvale, CA – Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, announces that the company has engaged a nationwide network of professional sales representatives (“sales reps”) to sell and distribute the company’s allergy tests across the Continental United States, with focus areas in the Pacific Northwest, West, Southwest, Rocky Mountain, Midwest, Northeast and Southeast regions.  The network comprises 1,700 sales professionals including 500 sales reps with specific training in finger stick sampling, blood card collection and microarray technology.  This extensive professional network will be used to enroll hospitals, health maintenance organizations (HMOs), doctor’s and dentist’s offices, health clinics and retail stores into the allergy-testing program.

Arrayit allergy tests utilize non-invasive and convenient finger stick sampling and blood card collection, in conjunction with patented and proprietary protein microarray technology, to rapidly and accurately measure immunoglobulin E (IgE) antibodies in the human bloodstream produced by exposure to 120 common food and environmental allergens. Personalized allergy testing assists health care professionals to more easily identify, treat and prevent allergy and asthma by combining molecular testing with a patient’s medical history, symptomology and a physician’s diagnosis.  Arrayit allergy tests are manufactured and processed in the company’s Clinical Laboratory Improvement Amendments (CLIA) laboratory licensed by the State of California and the Centers for Medicare and Medicaid Services (CMS), and benchmarked by the leading laboratory proficiency testing organization, the College of American Pathologists (CAP).

Arrayit CEO Rene Schena states, “We perceive significant synergies between our highly automated allergy testing technology and our newly-contracted network of medical sales professionals working on our behalf to promote allergy testing nationally to patients covered by private and public health insurance.  Arrayit finger stick allergy tests are particularly beneficial to pediatric patients, special needs children, seniors, and immunotherapy patients requiring testing at frequent intervals.”    

About Arrayit
Arrayit Corporation, headquartered in Sunnyvale, California, leads and empowers the research, biotechnology, pharmaceutical, clinical and healthcare sectors through the discovery, development and manufacture of proprietary life science and personalized medicine products and services to advance biomedical research and improve wellness and human health. Please visit www.arrayit.com for more information.

Safe Harbor Statement
We have identified forward-looking statements by using words such as "expect", "believe", and "should". Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company's public filings.

CONTACT
Public Relations
Arrayit Corporation
Tel: 408-744-1331
Email: arrayit@arrayit.com
Web: www.arrayit.com

CONTACT: Public Relations
Arrayit Corporation
Tel: 408-744-1331
Email: arrayit@arrayit.com
Web: www.arrayit.com

Avinger Announces First Patients Enrolled in Post-Market Study Comparing Pantheris OCT Imaging to Intravascular Ultrasound

SCAN Clinical Trial Results Intended to Support CPT Code Application for Incremental Diagnostic Reimbursement

REDWOOD CITY, Calif., June 14, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the initiation of the SCAN study, a post-market study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries. OCT is a light-based, high definition imaging modality, which generates no X-ray radiation. Avinger’s proprietary Lumivascular technology utilizes OCT to provide real-time intravascular imaging during the treatment of peripheral artery disease. The Company’s Pantheris image-guided atherectomy and Ocelot image-guided chronic total occlusion (CTO) crossing catheters are the only catheters available worldwide that incorporate the additional benefits of real-time intravascular imaging during PAD treatment.

While the FDA has already cleared OCT diagnostic claims for Avinger’s Pantheris and Ocelot catheters, and reimbursement codes applicable to therapeutic peripheral interventions with the Company’s Lumivascular catheters already exist, the results of the SCAN study are intended to support an initiative to gain incremental reimbursement for OCT diagnostic imaging in the peripheral arteries similar to the reimbursement currently provided for the use of IVUS in this setting. The study will enroll up to 20 subjects diagnosed with peripheral artery disease at two centers in the United States, with the goal to acquire at least 115 matched images generated by OCT and IVUS imaging for analysis. More specifically, OCT and IVUS images will be captured at identical positions within vessel segments so that a comparison can be made between the two imaging modalities. Dr. Edward Pavillard, a vascular surgeon at PA Vascular Institute, and Dr. Luke Sewall, an interventional radiologist and president of Vascular and Interventional Professionals, will serve as physician investigators in this study. Dr. Suhail Dohad, an interventional cardiologist in Los Angeles, will also serve as an advisor to the study.

Dr. Edward Pavillard, who enrolled the first cases in the SCAN study, noted, “As a regular user of diagnostic IVUS to plan treatment and assess results after the delivery of therapy, I have found that having an intravascular view of arterial structures and disease distribution leads to better results for my patients versus if I relied solely on fluoroscopy. Given the correlation between the use of intravascular imaging and clinical outcomes, I am excited to participate in a study that will help expand the incorporation of OCT into the treatment paradigm for peripheral interventions.”

Dr. Luke Sewall commented, “OCT and IVUS have been well accepted imaging modalities for the diagnosis and treatment of atherosclerotic disease. Published data have shown that intravascular imaging may allow a clinician to more accurately assess vessel size, plaque characteristics, anatomical features, and the adequacy of interventional results. OCT and IVUS imaging also have the potential to limit the amount of radiation to which physicians and cath lab staff are exposed, and also reduce the volume of contrast agent used in the intervention, which can be particularly important in successfully treating patients suffering from impaired kidney function.”

“This trial represents an important component of our growth strategy. If successful, the results from this study should help support our application for incremental diagnostic reimbursement in procedures incorporating our Lumivascular technology,” said Jeff Soinski, Avinger’s president and CEO. “With diagnostic reimbursement already in place for IVUS imaging in the peripheral arteries, we believe that the reimbursement structure should also support the use of OCT for these types of interventions, especially given the high quality of intravascular imaging provided by OCT.”

About Avinger, Inc.

Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the PantherisÒ family of atherectomy devices. Avinger is based in Redwood City, CA. For more information, please visit www.avinger.com.

Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the results of the SCAN study, reimbursement changes, reductions in radiation and contrast media exposure, and increased use of OCT imaging. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include our dependency on a limited number of products; our ability to demonstrate the benefits of our Lumivascular platform; the resource requirements related to Pantheris; the outcome of clinical trial results; potential exposure to third-party product liability, intellectual property and other litigation; lack of long-term data demonstrating the safety and efficacy of our Lumivascular platform products; experiences of high-volume users of our products may lead to better patient outcomes than those of physicians that are less proficient; reliance on third-party vendors; dependency on physician adoption; reliance on key personnel; and requirements to obtain regulatory approval to commercialize our products; as well as the other risks described in the section entitled “Risk Factors” and elsewhere in our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2018. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements.

Public Relations Contact:
Phil Preuss
VP of Marketing & Business Operations
Avinger, Inc.
(650) 241-7900
pr@avinger.com

Investor Contact:
Matt Ferguson
Chief Business Officer & CFO
Avinger, Inc.
(650) 241-7916
ir@avinger.com

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