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Direct Biologics Appoints Dr. Amy Lightner as Chief Medical Officer

AUSTIN, Texas--(BUSINESS WIRE)--Direct Biologics, LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles (EVs) derived from bone marrow mesenchymal stem cells (MSCs), announces the appointment of Amy Lightner, M.D. as Chief Medical Officer. In this role, Dr. Lightner will be responsible for the company’s clinical and medical affairs operations.

“We are delighted to welcome Dr. Lightner to our executive team. With her significant medical and clinical experience, coupled with her substantial understanding of MSC science, we believe Dr. Lightner will contribute substantially to Direct Biologics as we advance our lead product candidate ExoFlo through clinical development,” said Mark Adams, Co-Founder and Chief Executive Officer of Direct Biologics. “ExoFlo represents a potential significant advancement in regenerative medicine as it is designed to reduce inflammation, stimulate immunomodulatory activity and repair tissue by activating self-repair pathways and promote healing at the cellular level.”

“We are entering an era of innovation in regenerative medicine. It is an exciting time for science, medicine and, most importantly, our patients. While working at Cleveland Clinic, I was able to administer ExoFlo to several critically ill transplant patients through a single-patient expanded access program for emergency use authorized by the FDA. I witnessed firsthand ExoFlo’s positive medical effects among very sick patients with no other treatment options,” stated Dr. Lightner. “Direct Biologics is developing a regenerative medicine platform that has significant potential to change the way we treat several diseases, including a passion of mine, inflammatory bowel diseases. As a surgeon, I am able to treat one life at a time; however, I wanted to have an even bigger reach by potentially impacting thousands of lives and help to define a new interchange between academia and industry.”

Dr. Lightner is an accomplished surgeon and researcher with a focus on inflammatory bowel diseases. She completed her undergraduate studies at Stanford University, surgical training at University of California at Los Angeles, postdoctoral work under a California Institute for Regenerative Medicine grant in stem cell therapy at Stanford University and her colorectal fellowship at Mayo Clinic. After completing her fellowship, she stayed on surgical staff at Mayo Clinic and became the Medical Director of the Translation, Implementation and Practice Platforms for the Center for Regenerative Medicine. She was then recruited to Cleveland Clinic to start a Center of Regenerative Medicine and Surgery.

She continues to be an international leader in academia as a member of the editorial board of Inflammatory Bowel Diseases, Colorectal Disease, British Journal of Surgery, Crohn’s and Colitis 360 and Diseases of the Colon and Rectum. She also is the surgical co-chair for the Crohn’s and Colitis Foundation annual meeting, the associate chair of the inflammatory bowel disease committee of the American Society of Colon and Rectal Surgery (ASCRS), vice chair of the national clinical practice guidelines committee for ASCRS and chair of the surgical research committee for ASCRS.

About Direct Biologics

Direct Biologics is a late-stage biotechnology company leveraging a regenerative medicine platform that uses extracellular vesicles, or EVs, secreted from mesenchymal stem cells to address multiple disease indications. Our therapeutic product candidate, ExoFlo, is designed to be a next-generation biologic utilizing our proprietary EV platform technology to reduce inflammation, promote healing at the cellular level, and repair tissues by activating self-repair and regenerative pathways. Direct Biologics is currently conducting a Phase 3 EXTINGuish registrational clinical trial of ExoFlo for the treatment of hospitalized adults with severe or critical COVID-19 induced Acute Respiratory Distress Syndrome (ARDS). In addition, we have initiated Phase 1 clinical trials with ExoFlo for the treatment of ulcerative colitis and Crohn’s disease and expanded access trials in solid abdominal organ transplant and severe COVID-19 ARDS patients. Direct Biologics intends to pursue additional clinical applications including all-cause ARDS. Headquartered in Austin, Texas, Direct Biologics also has an R&D facility at the Center for Novel Therapeutics on the campus of University of California at San Diego, and an operations and order-fulfillment center in San Antonio, Texas. For more information, please visit and follow us on Twitter @directbiologics.


Direct Biologics
Twitter: @directbiologics

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Last Updated: 15-Feb-2023