Good tissue practice

Pluristyx and the Advanced Regenerative Manufacturing Institute to Commercialize Clinical-Grade Stem Cells

Retrieved on: 
Tuesday, July 11, 2023

Pluristyx, Inc. today announced an agreement with the Advanced Regenerative Manufacturing Institute | BioFabUSA to manufacture and commercialize Pluristyx’s clinical-grade reprogrammed induced Pluripotent Stem Cells (iPSCs).

Key Points: 
  • Pluristyx, Inc. today announced an agreement with the Advanced Regenerative Manufacturing Institute | BioFabUSA to manufacture and commercialize Pluristyx’s clinical-grade reprogrammed induced Pluripotent Stem Cells (iPSCs).
  • This collaboration will make it possible to accelerate the scalable, consistent, and cost-effective manufacturing of stem cell derived products for patient administration.
  • The agreement provides ARMI | BioFabUSA, its affiliates, and Members streamlined access to high-quality clinical grade- iPSCs for cell and gene therapy manufacturing.
  • For more information on Pluristyx, please visit www.pluristyx.com
    The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is a member-based, nonprofit organization whose mission is to advance the bioeconomy of the United States.

Pluristyx/panCELLa Become Industry Resource Partner with the California Institute for Regenerative Medicine

Retrieved on: 
Monday, June 12, 2023

Pluristyx and panCELLa, a merged biotechnology company with offices in Seattle, WA and Toronto, Ontario, CA, are excited to announce their acceptance as an Industry Resource Partner (IRP) with the California Institute for Regenerative Medicine (CIRM).

Key Points: 
  • Pluristyx and panCELLa, a merged biotechnology company with offices in Seattle, WA and Toronto, Ontario, CA, are excited to announce their acceptance as an Industry Resource Partner (IRP) with the California Institute for Regenerative Medicine (CIRM).
  • This partnership provides CIRM awardees with improved access to Pluristyx/panCELLa’s highly-characterized and genetically-modified induced Pluripotent Stem Cells (iPSCs) containing industry-leading FailSafe™ and iACT Stealth Cell ™ technologies.
  • Benjamin Fryer, Chief Executive Officer at Pluristyx, said: “We are honored to be an Industry Resource Partner and provide our research and clinical-grade iPSCs to CIRM awardees.
  • "We are thrilled to welcome Pluristyx/panCELLa to our network of partners who share our unwavering commitment to advancing transformative regenerative medicine therapies for patients."

MIMEDX Appoints Ricci S. Whitlow as Chief Operating Officer

Retrieved on: 
Tuesday, January 3, 2023

MARIETTA, Ga., Jan. 03, 2023 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a pioneer and leader in placental biologics, today announced that it has appointed Ricci S. Whitlow as Chief Operating Officer, a role that will lead the efforts of the Company’s manufacturing, supply chain, procurement, quality, and regulatory functions. Ms. Whitlow joins MIMEDX from Catalent, where she most recently served as President, Clinical Supply Services.

Key Points: 
  • MARIETTA, Ga., Jan. 03, 2023 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a pioneer and leader in placental biologics, today announced that it has appointed Ricci S. Whitlow as Chief Operating Officer, a role that will lead the efforts of the Company’s manufacturing, supply chain, procurement, quality, and regulatory functions.
  • Ms. Whitlow joins MIMEDX from Catalent, where she most recently served as President, Clinical Supply Services.
  • “We are happy to begin 2023 with the addition of Ricci Whitlow to the MIMEDX leadership team,” stated Todd Newton, MIMEDX interim Chief Executive Officer.
  • We believe Ricci is this leader.”
    “I am excited to be joining the MIMEDX team during this important period in the Company’s history,” stated Ms. Whitlow.

MIMEDX to Present at Upcoming Investor Conferences

Retrieved on: 
Thursday, November 10, 2022

MARIETTA, Ga., Nov. 10, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (MIMEDX or the Company), a transformational placental biologics company, today announced that senior management will present at the following investor conferences:

Key Points: 
  • MARIETTA, Ga., Nov. 10, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (MIMEDX or the Company), a transformational placental biologics company, today announced that senior management will present at the following investor conferences:
    Institutional investors interested in meeting with senior management may contact their respective Canaccord Genuity or Piper Sandler representative.
  • MIMEDX is a transformational placental biologics company, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare.
  • We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts.
  • MIMEDX has supplied over two million allografts, through both direct and consignment shipments.

MIMEDX to Host Third Quarter 2022 Operating and Financial Results Conference Call on November 2

Retrieved on: 
Wednesday, October 19, 2022

MIMEDX is a transformational placental biologics company, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare.

Key Points: 
  • MIMEDX is a transformational placental biologics company, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare.
  • We derive our products from human placental tissues and process these tissues using our proprietary methods, including the PURION process.
  • We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts.
  • MIMEDX has supplied over two million allografts, through both direct and consignment shipments.

MIMEDX Appoints Matt Notarianni as Head of Investor Relations

Retrieved on: 
Tuesday, October 4, 2022

MARIETTA, Ga., Oct. 04, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (NASDAQ: MDXG) (“MIMEDX” or the “Company”), a transformational placental biologics company, today announced the appointment of Matt Notarianni as Head of Investor Relations (IR), effective immediately. Mr. Notarianni joins MIMEDX with over 15 years of healthcare-focused Wall Street and IR experience, most recently serving as head of IR for Cerus Corporation.

Key Points: 
  • MARIETTA, Ga., Oct. 04, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (NASDAQ: MDXG) (MIMEDX or the Company), a transformational placental biologics company, today announced the appointment of Matt Notarianni as Head of Investor Relations (IR), effective immediately.
  • Mr. Notarianni joins MIMEDX with over 15 years of healthcare-focused Wall Street and IR experience, most recently serving as head of IR for Cerus Corporation.
  • I am delighted to welcome Matt to MIMEDX, stated K. Todd Newton, MIMEDX interim Chief Executive Officer.
  • Jack Howarth, MIMEDX Senior Vice President of Investor Relations, will continue to support the MIMEDX IR function until his planned retirement at the end of this year.

MIMEDX Announces Launch of AXIOFILL™

Retrieved on: 
Tuesday, September 20, 2022

MARIETTA, Ga., Sept. 20, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a transformational placental biologics company, today announced the launch of AXIOFILL™, an Extracellular Matrix (ECM) Particulate product derived from human placental tissue.

Key Points: 
  • MARIETTA, Ga., Sept. 20, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (MIMEDX or the Company), a transformational placental biologics company, today announced the launch of AXIOFILL, an Extracellular Matrix (ECM) Particulate product derived from human placental tissue.
  • AXIOFILL is the first and only human placental-derived particulate product available for Surgical Recovery procedures.
  • AXIOFILL provides a cost-effective human collagen scaffold that is conducive for use in large, complex wounds and those of irregular geometries.
  • The launch of AXIOFILL is particularly significant for MIMEDX, said Rohit Kashyap, Ph.D., MIMEDX President, Wound Care & Surgical.

MIMEDX Announces Launch of AMNIOEFFECT™

Retrieved on: 
Monday, September 19, 2022

MARIETTA, Ga., Sept. 19, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a transformational placental biologics company, today announced the launch of AMNIOEFFECT™, a tri-layer PURION® processed human tissue allograft consisting of the amnion, intermediate, and chorion membrane layers of the placenta.

Key Points: 
  • MARIETTA, Ga., Sept. 19, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (MIMEDX or the Company), a transformational placental biologics company, today announced the launch of AMNIOEFFECT, a tri-layer PURION processed human tissue allograft consisting of the amnion, intermediate, and chorion membrane layers of the placenta.
  • During the Limited Market Release (LMR) phase, AMNIOEFFECT was used in over 50 surgical cases.
  • The Surgical Recovery market is an engine of growth for MIMEDX, said Rohit Kashyap, Ph.D., MIMEDX President, Wound Care & Surgical.
  • MIMEDX is a transformational placental biologics company, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare.

MIMEDX EPIFIX® Receives Reimbursement Approval in Japan

Retrieved on: 
Monday, September 12, 2022

MARIETTA, Ga., Sept. 12, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a transformational placental biologics company, today announced that the Japanese Ministry of Health, Labour and Welfare (JMHLW) approved reimbursement of EPIFIX® to treat refractory or hard-to-heal lower extremity diabetic and venous ulcers. The Company is in the last stages of preparing for full product launch, anticipated in the fourth quarter. The Company estimates the Japanese total addressable market associated with the scope of the JMHLW reimbursement decision to be approximately $500 million based on a recently completed third party market study. The study estimated that there are more than 400,000 hard-to-heal wounds that present each year in Japan that can be treated by EPIFIX and which qualify for reimbursement under the JMHLW’s decision.

Key Points: 
  • The study estimated that there are more than 400,000 hard-to-heal wounds that present each year in Japan that can be treated by EPIFIX and which qualify for reimbursement under the JMHLWs decision.
  • Achieving reimbursement was a key pre-requisite to launch EPIFIX in Japan, and we think the awarded rate of 35,100 Yen/cm2 will be very favorable in supporting market adoption, said Rohit Kashyap, Ph.D., MIMEDX President, Wound Care & Surgical.
  • I am very excited to have reimbursement acceptance for EPIFIX in Japan, and I believe many patients and physicians will benefit from having a new treatment option for chronic wounds caused by lower extremity diabetic and venous ulcers.
  • EPIFIX is a PURION processed placental tissue allograft that supports the healing cascade by providing a protective barrier over wounds.

MIMEDX Announces Leadership Transition

Retrieved on: 
Tuesday, September 6, 2022

MARIETTA, Ga., Sept. 06, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a transformational placental biologics company, today announced that K. Todd Newton, a member of the MIMEDX Board of Directors, has been appointed interim Chief Executive Officer (CEO). Mr. Newton replaces Timothy R. Wright, who served as MIMEDX’s CEO since May of 2019.

Key Points: 
  • As we work to accelerate our performance, renew our focus on execution and capitalize on the significant opportunity within our Wound Care & Surgical and Regenerative Medicine & Biologics Innovation businesses, the Board has determined now is the right time for MIMEDX to transition leadership of the Company.
  • Dr. Behrens continued, We are grateful to have Todds support and leadership as the Search Committee conducts its search for MIMEDXs next CEO.
  • Todd is a seasoned executive with close to twenty years of public company senior leadership experience, significant expertise and a proven track record in the med-tech industry.
  • MIMEDX is a transformational placental biologics company, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare.