EPI

North America Silicon EPI Wafer Market Report 2023: Rising Demand for Epitaxial Wafers in Consumer Electronics Bolsters Growth - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 12, 2023

An epitaxial wafer, also known as an EPI wafer, is created by placing a layer of epitaxial silicon single crystal on a single crystal silicon wafer.

Key Points: 
  • An epitaxial wafer, also known as an EPI wafer, is created by placing a layer of epitaxial silicon single crystal on a single crystal silicon wafer.
  • The North America silicon EPI wafer market is segmented on the basis of wafer size, application, end user, type, and country.
  • By end user, the North America silicon EPI wafer market is segmented into consumer electronics, automotive, healthcare, aerospace and defense, and others.
  • Based on country, the North America silicon EPI wafer market is segmented into the US, Mexico, and Canada.

First Wave BioPharma Provides Update on IND Filing For Phase 2 Trial of Enhanced Microgranule Formulation of Adrulipase for Exocrine Pancreatic Insufficiency

Retrieved on: 
Friday, January 13, 2023

Under FDA’s policy guidelines, the agency strives to complete its review of Phase 2 protocols within 60 days, but may take longer depending on available resources.

Key Points: 
  • Under FDA’s policy guidelines, the agency strives to complete its review of Phase 2 protocols within 60 days, but may take longer depending on available resources.
  • The Company previously announced that it submitted the IND amendment to the FDA on November 30, 2022.
  • First Wave BioPharma has been in conversations with FDA and expects a forthcoming response around the end of January.
  • “We are eager to evaluate the potential of our enhanced microgranule delivery formulation of adrulipase in the proof-of-concept Phase 2 clinical trial, which we are prepared to initiate immediately after the IND protocol amendment is cleared,” said James Sapirstein, President and CEO of First Wave BioPharma.

EPI Health, a Novan Company, Enters into Exclusive License Agreement with Sato Pharmaceutical Co., Ltd. for RHOFADE® in Japan

Retrieved on: 
Wednesday, December 21, 2022

“Since 2017, our relationship with Sato has been a valuable component of our strategy and we are pleased to further deepen and expand our partnership with Sato through this license agreement.

Key Points: 
  • “Since 2017, our relationship with Sato has been a valuable component of our strategy and we are pleased to further deepen and expand our partnership with Sato through this license agreement.
  • President and CEO of Sato Pharmaceuticals, Seiichi Sato, added, “We are pleased to significantly build on our longstanding relationship with Novan with this agreement.
  • Sato will be responsible for obtaining regulatory approval in Japan and will have the right to access EPI Health’s U.S. dossier for RHOFADE.
  • Sato will also have a right of first negotiation related to RHOFADE in certain other countries in the Asia Pacific region.

First Wave BioPharma to Participate in BIO Partnering @ JPM During “J.P. Morgan Week 2023”

Retrieved on: 
Monday, December 12, 2022

First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

Key Points: 
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP).
  • First Wave BioPharma is headquartered in Boca Raton, Florida.
  • This press release may contain certain statements relating to future results which are forward-looking statements.

First Wave BioPharma Announces Initial Clinical Sites for its Phase 2 Trial of Enhanced Microgranule Delivery Formulation of Adrulipase

Retrieved on: 
Monday, December 5, 2022

First Wave BioPharma met with each of the investigators during the recently-held North American Cystic Fibrosis Conference in Philadelphia.

Key Points: 
  • First Wave BioPharma met with each of the investigators during the recently-held North American Cystic Fibrosis Conference in Philadelphia.
  • This ‘pill burden’ presents a substantial challenge for EPI patients,” said Dr. Steven Boas, M.D, founder of the Cystic Fibrosis Institute and Cystic Fibrosis Center of Chicago.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP).

Olympus Announces EMEA Expansion of Exclusive Partnership with EndoClot Plus, Inc.

Retrieved on: 
Thursday, December 8, 2022

WESTBOROUGH, Mass., Dec. 8, 2022 /PRNewswire/ -- Olympus, a global medical technology company focused on designing and delivering innovative solutions for medical and surgical procedures, announced today a new exclusive distribution agreement with EndoClot® Plus, Inc. (EPI) that extends our strategic partnership to the Europe, Middle East and Africa (EMEA) region. This news follows a successful commercialization of the EndoClot product portfolio in the United States, announced in April 2022.

Key Points: 
  • This news follows a successful commercialization of the EndoClot product portfolio in the United States, announced in April 2022.
  • EPI technologies complement Olympus' comprehensive portfolios in GI (gastrointestinal) endoscopy and the company's overall medtech strategy.
  • "We are very excited to expand our global partnership with Olympus," said Stephen Heniges, President, EPI.
  • "With Olympus' support in the U.S. and now EMEA, we expect that more healthcare providers and their patients will be able to benefit from our solutions.

EPI Health, a Novan Company, Executes a $15.0 Million Financing Agreement

Retrieved on: 
Friday, December 2, 2022

DURHAM, N.C., Dec. 02, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that EPI Health, LLC, a fully consolidated subsidiary of the Company, has signed an accounts receivable-backed factoring agreement, to support its operations, with Bay View Funding, a wholly owned subsidiary of Heritage Bank of Commerce (Nasdaq: HTBK).

Key Points: 
  • The new $15.0 million factoring facility will provide capital in an amount that is up to 70% of EPI Health's gross eligible receivables.
  • We are excited to work with the commercial team at EPI Health and the corporate team at Novan.
  • Novan, Inc. is a medical dermatology company primarily focused on researching, developing, and commercializing innovative therapeutic products for skin diseases.
  • Novan also has a pipeline of potential product candidates using our proprietary nitric oxide-based technology platform, NITRICIL, to generate new treatments for multiple indications.

First Wave BioPharma Files Investigational New Drug Application for Enhanced Microgranule Delivery Formulation of Adrulipase

Retrieved on: 
Wednesday, November 30, 2022

BOCA RATON, Fla., Nov. 30, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ:FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that it has submitted an Investigational New Drug (IND) application seeking authorization from the U.S. Food and Drug Administration (FDA) to evaluate an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) in human clinical trials. Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.

Key Points: 
  • Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.
  • Filing the IND is an important step in enabling First Wave to initiate the planned Phase 2 trial of our new formulation for adrulipase, said James Sapirstein, President and CEO of First Wave BioPharma.
  • In vitro data suggest the microgranule drug delivery formulation offers improved protection against the acidic pH in the stomach followed by the rapid release of adrulipase in the small intestine where the drug is expected to mix with food and deliver its therapeutic benefit.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

First Wave BioPharma Announces Distribution of Series F Preferred Stock to Holders of Its Common Stock

Retrieved on: 
Friday, November 25, 2022

Subject to certain limitations, each outstanding share of Series F Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per 0.001of a share of Series F Preferred Stock).

Key Points: 
  • Subject to certain limitations, each outstanding share of Series F Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per 0.001of a share of Series F Preferred Stock).
  • The Series F Preferred Stock will be uncertificated, and no shares of Series F Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Companys common stock held by such holder.
  • In that case, a number of one one-thousandths (1/1000ths)of a share of Series F Preferred Stock equal to the number of shares of the Companys common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.
  • Further details regarding the Series F Preferred Stock will be contained in a Form8-Kto be filed by the Company with the Securities and Exchange Commission.

First Wave BioPharma, Inc. Announces Closing of Private Placement

Retrieved on: 
Tuesday, November 22, 2022

The Company has agreed to call a special meeting of stockholders to seek the required stockholder approval.

Key Points: 
  • The Company has agreed to call a special meeting of stockholders to seek the required stockholder approval.
  • H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • These forward-looking statements are subject to risks and uncertainties including, among other things, the intended use of proceeds from the private placement.