Four notes on area businesses for nov. 30, 2018 – news – wicked local waltham – waltham, ma tgask


Arch Therapeutics, a Framingham-based developer of novel liquid, gel and solid hemostatic and wound care devices, has submitted the required documents for AC5 Topical Hemostat to its notified body as it seeks a CE mark, which is a next step on the path to commercialization in countries governed by the European Medical Devices Directive (MDD). gas mask drawing This first such submission by Arch to a European regulatory body follows the recent submission of a 510(k) pre-market notification to the U.S. Food and Drug Administration. Receipt of a CE mark would allow AC5 to be commercialized for use on external wounds, and in particular, for controlling bleeding by mechanically sealing areas of leakage and managing wounds in skin. The CE mark represents a company’s claim that a product meets the essential requirements of relevant European directives, and it is a legal prerequisite in order to place a device on the market in the European Union. gas density formula AC5 will be assessed as a Class IIb device. Arch Therapeutics expects that the review process could take up to six months. A notified body is an independent third-party selected by a competent authority to assess a medical device manufacturer’s compliance by conducting a conformity assessment under the MDD. wd gaster theory Each country has one competent authority, which is a local government body responsible for, among other things, ensuring that the MDD requirements are placed into national law. As previously disclosed, Arch is seeking regulatory clearance in the United States and, following this initial clearance, potential clearance or approval for expanded indications. The company is also pursuing commercial opportunities for other AC5-related products, including use in open and laparoscopic surgical procedures. Arch continues to evaluate commercialization options and will provide updates when appropriate.

Histogenics Corp., a Waltham-based developer of restorative cell therapies that may offer rapid-onset pain relief and restored function, this week provided an update on the NeoCart regulatory pathway based on its ongoing dialogue with the U.S. Food and Drug Administration (FDA). gas oil ratio for leaf blower Since the initial Type C meeting in October, Histogenics and the FDA have continued their discussions on the clinical data generated to date, the potential need for any additional supplemental clinical data (which may include longer-term data from the ongoing Phase 3 trial or additional studies) and potential alternative regulatory pathways for the NeoCart Biologics License Application (BLA). gas nozzle stuck in car The FDA has not yet made a final decision regarding a potential BLA submission. Histogenics intends to provide a further update by the end of 2018 or early 2019 based on additional feedback from the FDA, once available. For more information on Histogenics and NeoCart, visit

As part of the company’s annual grant program to support research to reduce preterm birth and preeclampsia and associated complications, AMAG Pharmaceuticals Inc. has awarded grants totaling nearly $300,000 to independent researchers in the maternal health field. The 2018 grant recipients were selected by an independent external review panel of maternal fetal medicine specialists with extensive research experience. The grant recipients are Dr. Monica Longo at the University of Texas Health Science Center at Houston, Biana Godin at the Houston Methodist Research Institute Department, Dr. gas vs electric oven cost Anna Palatnik at the Medical College of Wisconsin, Sarah England at Washington University School of Medicine in St. Louis and Dr. Maisa Feghali at the University of Pittsburgh School of Medicine.

Spring Bank Pharmaceuticals Inc., a Hopkinton-based clinical-stage biopharmaceutical company developing therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, has announced additional pre-clinical data from its second-generation STimulator of Interferon Genes (STING) agonist program. Spring Bank will present the data in three poster presentations at the AACR Special Conference on Tumor Immunology and Immunotherapy being held this week in Miami Beach. For more information, visit