|CASMED Receives FDA Approval for FORE-SIGHT ELITE; Provectus Opens Patient Enrollment of PV-10 for Melanoma|
|By Josh Gee|
|Wednesday, 15 April 2015 18:39|
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 15, 2015.
CAS Medical Systems, Inc. (NASDAQ: CASM), a leader in medical devices for non-invasive patient monitoring, announces receipt of an expanded label for its FORE-SIGHT® ELITE oximeters from the FDA to include its new medium and small sensors for use with pediatric and neonatal patients.
"The approval of the FORE-SIGHT ELITE in this patient population came somewhat earlier than we had expected, and allows us to complete our product offering while opening new opportunities both in the U.S. and around the world," said Thomas M. Patton, President and Chief Executive Officer of CASMED. "With the launch of the FORE-SIGHT ELITE for pediatric and neonatal patients, we will have the ability to address additional sales channels and call points within a hospital with the exact same monitor. We are on track to introduce the FORE-SIGHT ELITE in this market segment in the late third or early fourth quarter of this year.
"We based our regulatory filing on a significant number of clinical evaluations of pediatric patients conducted at multiple sites around the world, including some of the nation's leading children's hospitals. Feedback on the performance of the FORE-SIGHT ELITE from these sites was overwhelmingly positive," added Mr. Patton.
CASMED also announces that it sponsored a lunch symposium at the 37th Society for Cardiac Anesthesia Annual Meeting & Workshops held earlier this week in Washington, D.C. The hour-long symposium featured a panel of leading physicians discussing the clinical benefits of monitoring cerebral oxygenation in a broad variety of cardiac surgeries through the use of case studies, personal experience and the latest clinical evidence.
"We are delighted that more than 200 cardiac anesthesiologists joined us for this standing-room-only discussion," added Mr. Patton. "Cerebral oxygenation is a major concern during cardiac surgery, and we were able to showcase the patient benefits of monitoring with our FORE-SIGHT ELITE oximetry to anesthesiologists who are the target customers for our product."
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT), a clinical-stage oncology and dermatology biopharmaceutical company, enters phase 3 and has opened enrollment of patients for its phase 3 international FDA comparative clinical trial of PV-10 for melanoma. The Company is seeking 225 patients and enrollment has begun at St. Luke's University Hospital and Health Network, Bethlehem, PA, the first study site to be opened, with additional sites to be added in the coming weeks and months.
“Phase 2 study of Intralesional PV-10 for Metastatic Melanoma” -- The study is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600 wild-type and have failed or are not otherwise candidates for ipilimumab or another immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms. The Primary Outcome Measure is progression-free survival (PFS) to be assessed every 12 weeks up to 18 months.
The Secondary Outcome Measures include complete response rate (CRR) and its duration (to be assessed every 12 weeks up to 18 months); and Overall survival (OS) to be assessed every 12 weeks up to 18 months.
Safety and tolerability will be assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs.
Angie's List (Nasdaq:ANGI) today announced that William S. Oesterle plans to step down as Chief Executive Officer and member of the Board of Directors. Mr. Oesterle has agreed to remain in his current role as CEO until a successor is appointed, and he will serve on the Board of Directors at least through the remainder of his current term.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that Chief Medical Officer Dr. Joseph Stauffer will present data from Cara's human abuse liability (HAL) study of I.V. CR845 in an oral session at the 3rd Conference on the Therapeutic Potential of Kappa Opioids, held in Chapel Hill, North Carolina.
Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced the initiation of patient dosing in a proof-of-concept trial of I-131-CLR1404 in patients with relapsed or refractory multiple myeloma, an indication for which I-131-CLR1404 previously received orphan drug designation from the U.S. Food and Drug Administration.
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced the pricing of its initial public offering of 4,800,000 shares of common stock, an increase of 800,000 shares from the number of shares originally offered, at a public offering price of $16.00 per share.
Coherus BioSciences, Inc. (Nasdaq:CHRS) and Baxter International Inc. (NYSE:BAX) today announced that they have amended certain financial terms of their collaboration agreement established in August 2013 regarding the development and commercialization of CHS-0214, an etanercept biosimilar product candidate, for Europe, Canada, Brazil, and certain other markets.
Cryo-Cell International, Inc. (OTCQB:CCEL), the world's first private cord blood bank to separate and store stem cells in 1992, announced results for the fiscal first quarter ended February 28, 2015.
DS Healthcare Group, Inc. (Nasdaq:DSKX), a leading developer of personal care products has released financial results for the fourth quarter and full year for 2014.
Heat Biologics, Inc. (Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that it will present a poster entitled "Immunotherapy Meets Epigenetics: Gp96-Ig Cellular Vaccine Genetic Signature is Modulated by the Inhibition of Histone Modifications," at the 2015 American Association for Cancer Research Annual Meeting, at the Pennsylvania Convention Center in Philadelphia, April 22 at 8:00 a.m. Eastern.
Immune Design (Nasdaq:IMDZ) today announced the pricing of an underwritten public offering of 3,000,000 shares of its common stock at a price to the public of $26.50 per share for total gross proceeds of approximately $79.5 million, before deducting underwriting discounts and commissions and estimated expenses.
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, will report its financial results for the first quarter ended March 31, 2015 on Wednesday, April 29, 2015, after the market close.
MTBC (Nasdaq:MTBC), a leading provider of proprietary, web-based electronic health records, practice management, medical billing and mHealth solutions, today announced that it has partnered with X-Link to connect MTBC's highly ranked platform to X-Link's extensive network of healthcare IT platforms.
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, will announce financial results for the first quarter of 2015 after market close on Tuesday, April 28, 2015.
Pacific Biosciences of California, Inc. (Nasdaq:PACB) will hold its quarterly conference call to discuss its First Quarter 2015 Financial Results on Tuesday, May 5, 2015, at 4:30pm Eastern Time.
Pazoo, Inc. (OTC Pinks:PZOO) (German WKN#: A1J3DK), is pleased to announce that as of yesterday, the company has completely repaid the total of its obligations on its Convertible Promissory Notes to LG Capital Funding LLC and Macallan Partners LLC. In addition, Pazoo has given notice of its intention to fully pay off the Convertible Promissory Notes held by Union Capital LLC by the end of next week and Eastmore Capital LLC within the next two weeks.
PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced its first quarter highlights, primarily related to the Company's continued progress with the development and testing of its Firefly Dx, a handheld, point-of-need, real-time PCR (polymerase chain reaction) pathogen detection system.
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2015, for substantive review of the Company's New Drug Application (NDA) for its enclomiphene citrate product candidate, formerly known as Androxal®. In addition, the FDA has informed the Company that the FDA is currently planning to hold an advisory committee meeting on the NDA during the review.
ScripsAmerica, Inc. (OTCBB:SCRC), a leading provider of a range of specialty prescription and over the counter pharmaceuticals and medical supplies, today announced that it will be unable to file its 2014 Annual Report on Form 10-K with the Securities and Exchange Commission by the extension deadline of April 15, 2015.
Tandem Diabetes Care®, Inc. (Nasdaq:TNDM), a medical device company and manufacturer of the t:slim® and t:flex™ Insulin Pumps, plans to release its first quarter 2015 results after the financial markets close on Thursday, April 30, 2015.
Tetraphase Pharmaceuticals, Inc. (Nasdaq:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced the appointment of Gerri Henwood, President and Chief Executive Officer of Recro Pharma, to the Company's Board of Directors.
Tornier N.V. (Nasdaq:TRNX), a global medical device company focused on providing solutions to orthopaedic extremity surgeons, announced today that it will report financial results for the first quarter ended March 29, 2015 after the close of the regular trading market on Tuesday, May 5, 2015.
uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced the closing of its previously announced follow-on public offering of 3,000,000 ordinary shares at an offering price of $29.50 per ordinary share.
ZS Pharma (Nasdaq:ZSPH), a biopharmaceutical company focused on the development and commercialization of highly selective, non-absorbed drugs to treat renal, cardiovascular, liver and metabolic disorders, announced publications related to ZS-9, the Company's lead product candidate for the treatment of hyperkalemia, in two peer reviewed medical journals.