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February, 2022, New York – AMNICELL’s CEO, Caroline Einaugler, is interviewed by CEOCFO Magazine, https://www.ceocfointerviews.com/amnicell22.html

CEOCFO: Ms. Einaugler, according to your site, “AMNICELL is improving lives through advanced stem cell technology.” In what way?

Ms. Einaugler: AMNICELL leverages technology in the very exciting field of regenerative medicine by being the first company to use amniotic fluid stem cells to improve health and wellness, including COVID-19 and other serious lung diseases. AMNICELL is the first company to recognize the unique capability of human amniotic fluid as an abundant source for novel stem cell products.

CEOCFO: Has this been looked at before? Was there a lightbulb moment, “We should do this?” How did it come about?

Ms. Einaugler: It is really fascinating. Medical and scientific research is very challenging, and it takes a very long time and many brilliant people to get new therapies on the market. The idea began with Dr Young working at the NYU School of Medicine, who realized that the fluid around the baby in the womb, amniotic fluid, contained cells that have potential for groundbreaking therapies. The research was conducted on this amniotic fluid during the last ten years and it showed that amniotic fluid from normal full-term cesarean births contains millions of stem cells for possible clinical use. The amniotic fluid, previously discarded as a waste product, can be safely collected, frozen and stored for later clinical use. Therefore, it is really a long process  from the idea to actually bringing a novel product to the market.

Right now, we are ready to begin our Phase 1 trial of amniotic fluid stem cells to treat serious lung disease for which there is currently no satisfactory treatment. Additional clinical trials will be for chronic non-healing wounds like diabetic foot ulcers and war wounds. We expect clinical trials take at least a year for each of 3 phases, and then be able to get FDA approval to bring the new product to market.   

CEOCFO: When do you collect the amniotic fluid? How would you store it? How do we get stem cells from the fluid?

Ms. Einaugler: At AMNICELL, we have a technique for collecting amniotic fluid and stem cells at the time of scheduled cesarean birth. Because they are natural stem cells we collect and store them frozen after separation from the fluid, and nothing more is needed for clinical use. There are no risks to the mother or baby, and the fluid is considered medical waste and usually thrown out. We foresee the transformative treatment of COVID-19 ventilator patients, respiratory failure from other lung diseases, and non-healing wounds, as well as many other applications for health where there are unmet needs.

CEOCFO: You are new to the role of CEO at AMNICELL, although you were involved with AMNICELL in the past. Why have you chosen to get onboard and what have you found as CEO?

Ms. Einaugler:  Really, what is amazing is that the potential for stem cells is really unlimited and it is the AMNICELL mission that is so exciting. AMNICELL will be at the forefront of the global expansion of regenerative medicine and typically for AMNICELL, by collecting, storing, and providing amniotic fluid and stem cells for health and wellness. The powerful mission of the company is to develop its innovative stem cell technology platform to advance health and wellness and save lives, and that is just very exciting and drew me to the company.  As CEO I find an outstanding dedicated team that makes me proud to have this role at Amnicell.

CEOCFO: Does the fact that you do not have a scientific background make it harder, or in some ways is it easier, as you can be potentially more objective on the business side?  

Ms. Einaugler: It is both. It is harder in the sense that it harder for me to have the deep understanding of the science, but we have our founder and our Chief Science Officer. Both are distinguished professors and teachers with incredible background knowledge and research experience, so they are there to explain and help me with the science component.

In some ways, it is easier in terms of the fact that I do not feel limited in any way, because I can come up with creative suggestions. Sometimes it does not go naturally with the science, but then as we discuss it, we may be able to turn things in a different direction that we might not have thought of if everyone was completely focused on the science.

It also allows me to look at the science and make sure that it is something that can be translated into something that is easy for everyone to understand. As CEO I built on our achievements so far and I am expanding the scope of our platform, aligning research support via grants, and business funding via investors, and coordinating science and business as we make progress.

CEOCFO: Does the mother have to agree to you using the amniotic fluid, or because it is a waste product, is it just up to the hospital?

Ms. Einaugler: The mother has to agree, even though the fluid is waste. Anytime the amniotic fluid is taken from a cesarean birth, the mother is aware and has the consent that we are doing that. We believe there should always be consent.

CEOCFO: Are there challenges from anyone? Are there challenges to using amniotic fluid? Is it accepted as a good means as opposed to something like aborted fetuses? What is the feeling amongst the medical and the “moral” community about using amniotic fluid?

Ms. Einaugler: That is one of the benefits of amniotic fluid. It is not, as you said, stem cells taken from a fetus. It is truly just taken from a waste product. That is one huge advantage as the non-controversial way of obtaining stem cells, in contrast to all other means. Neither the medical nor the moral community have raised any issues about amniotic fluid sourced from normal patients at scheduled cesarean births. Their potential for creating therapies for diseases that have no cure at this time is truly amazing. There is Covid –19, ARDS (Acute Respiratory Distress Syndrome), SARS-2 and other serious lung diseases with respiratory failure. Those are just one aspect of the stem cell therapy platform Amnicell is developing. The medical community recognizes that the hope of the future is through regenerative medicine and stem cells. As I mentioned before, from the amniotic fluid, again, it is really just a waste product, a big advantage oner other stem cell sources.

CEOCFO: You mentioned lung disease. How have you chosen what you to try first?

Ms. Einaugler: I think that we were already looking at lung disease and non-healing wounds, and things like skin related disorders. Because of COVID-19, we did pivot somewhat to focusing more on COVID-19 lung disease. We are hopefully beginning to see some let up of the number of people dying in the United States from COVID-19 and the number of people who are on respirators due to very serious COVID-19 disease. However, new variants continue to emerge, many countries are far behind the US in dealing with the pandemic, and resurgences are occurring in various advanced European countries.

As a result, it is still very timely, and in this country, it is becoming clear that there are likely to be new variants year after year. Therefore, its not just Covid-19. In addition to the COVID-19 lung disease, there is also the existing lung diseases, like the very serious lung disease I mentioned before, the ARDS. The treatment for lung disease alone is likely to help millions of people globally, so the need remains and will persist.

CEOCFO: Funding is always an issue for companies that are developing, particularly in the medical field.  How are you positioned in that regard?

Ms. Einaugler: We are in the process of looking for additional funding. We have gotten a lot of grants, close to 4 million dollars in grants for the research alone. We have had private investors and are looking for, of course, increasing the number of private investors at this point.

CEOCFO: What has been the reception from the medical community that are aware of what you are doing?

Ms. Einaugler: The reception is very positive. A number or research papers have been written on this by our founder, Dr. Bruce Young. The response is really incredible. He has done a number of presentations on the national and international level, about what AMNICELL is doing and research that is going on. It is very exciting, and the medical community is aware of how exciting it is.

CEOCFO: Are other people starting to look at amniotic fluid now? Has it sort of opened the flood gates? It would seem such a natural idea.

Ms. Einaugler: AMNICELL is the first company to recognize the unique capability of human amniotic fluid as an abundant source for novel stem cell products. There are not any other companies, that I am aware of, that are using amniotic stem cells for the same kind of research that we are doing, for non-healing wounds and the serious lung disease. Therefore, at this point there is really not a lot of competition. The scientific community has recognized the importance of the previous research and some scientists have been studying these cells, but no companies have a clinical product.

CEOCFO: How do you spend your time as CEO? What is your focus right now?

Ms. Einaugler: The focus right now is on trying to raise money, trying to come up with succinct ways to describe what our company does, in a way that makes sense to scientist and non-scientists, working on presentations, and then of course, on the operating and just overseeing what direction the company is going in. There is more mundane things of trying to figure out if we want to stay in the same location that we are in, do we want to move and how will we use the additional funding that we hope to receive soon, with the idea that most of it will be focused on going back into the research, but how else will we spend most of the money, to make sure that the research is effective and that the product can be marketed.

CEOCFO: What was learned from the early research that might have been unexpected?

Ms. Einaugler: I think that the early research was actually even more positive than expected. The stem cells have so much potential for so many different ways of being used to help different kinds of diseases where there is very slow progress or no progress and many of the medicines on the market are really just to stop it from getting worse or to keep someone alive, as opposed to really helping them get better.

It became obvious very quickly that, for example, with the non-healing wounds, that even just putting some of these stem cells on the wounds topically had a very quick and rapid effect on healing wounds, which was truly surprising. In the lab, the cells responded so quickly to just being in contact with the stem cells.  

CEOCFO: Will you be pursuing wound care as well now, or is that a little further down the line?

Ms. Einaugler: Right now, we are really focused on severe lung disease, for which there is no treatment, and the chronic non-healing wounds will follow soon afterward. Again, there are millions of people, worldwide, that have both of those conditions. Non-healing wounds is actually very pervasive, in addition to the current widespread lung disease.

CEOCFO: Why should AMNICELL stand out from so many others? Why is the company so important?

Ms. Einaugler: We are really the only company that is using the stem cells from amniotic fluid for regenerative medicine. Our goals are to improve lives, save lives, and use this technology to cure as many diseases as we can. We are already at the Phase 1 trial level for the COVID-19, and other serious lung disease and we have a very well thought our process for going forward with that. That has already been funded through grants, and we are really just looking for additional monies to keep it going past the next 18 months or so, so that we can move into the Phase 2 trials for the serious lung disease, and then also begin Phase 1 trials for the non-healing wounds.

There are also other applications more long-term for things like cosmetics and creams, that also have a lot of potential and do not require the FDA approval. I am really just repeating the same thing, but AMNICELL, once again, is very unique. It is the first company to recognize the capability of human amniotic fluid at the source for novel stem cell products, and has amazing long-term capability, which is a very exciting situation, that really will do a lot of good for many people and save many lives.

January, 2022, New York – AMNICELL awarded ´Stem Cell Company of the Year 2021 Recognized Experts in Amniotic Fluid Stem Cells 2021` by GHP MedTech Award.

We are excited and very pleased to share that AMNICELL is the recipient of the ´Stem Cell Therapy Company of the Year 2021 by GHP MedTech Awards

The GHP recognizes all levels and aspects of the healthcare and pharmaceutical sectors without whom many life changing innovations and developments would not be possible. Their rewards and awards recognize those whose tireless work and dedication change the lives of millions of people each and every day. GHP is dedicated to uncovering and sharing the talented courageous, and innovative people, departments and companies pushing the boundaries of what is possible in the medical world.

AMNICELL, a biotech company recognized as the Stem Cell Company of the Year for 2020 has appointed Caroline Einaugler as CEO.

NEW YORK, NY, USA, October 24, 2021 /EINPresswire.com/ — AMNICELL, a biotech company recognized as the Stem Cell Company of the Year for 2020 has appointed Caroline Einaugler as CEO effective today.

AMNICELL is the first company to use advanced stem cell technology with amniotic fluid to save lives and enhance health. AMNICELL collects, stores and processes amniotic fluid for medical conditions that do not have satisfactory therapies, such as serious lung disease, like COVID-19 and influenza pneumonia, non-healing wounds and diabetes. AMNICELL has a regenerative medicine platform with immense potential growth by developing many products for unmet needs worldwide.

Caroline Einaugler is a highly trained attorney with a background in Law, Medicine and Information Science. She has extensive experience in marketing, operations, information management, and information assurance with both medical and legal information. She helped develop the profitable start-up JuriSearch, the on-line legal research service, as the SVP of Marketing. She was previously the Chief Information Officer at AMNICELL for several years. She is very pleased to take over as the CEO, commenting, “I am very excited to take over my new role as CEO of AMNICELL and to lead the development of products that will save lives and for which there are no satisfactory treatments. I look forward to marketing these products with transformative therapies so that they are accessible to patients and their caregivers worldwide.”

Phyllis L Young, Chairman of the AMNICELL Board of Directors stated, “ I am so thrilled to see Caroline move up from CIO to CEO of AMNICELL. With her previous start-up experience and extensive background in medicine, law and information science, she is the perfect person to move AMNICELL forward and deliver its promise to help cure seriously ill patients with COVID-19 and other serious illnesses, and to develop a worldwide business based on this regenerative medicine platform.”

About AMNICELL
AMNICELL was formed following 10 years of research with amniotic fluid and stem cells by Professor Bruce K. Young at the New York University School of Medicine. It is the first company to use advanced stem cell technology with amniotic fluid stem cells to develop treatment for ventilator patients with COVID-19 and influenza. AMNICELL collects, stores and processes amniotic fluid stem cells for use with a number of conditions of unmet medical need. AMNICELL is headquartered in New York City and is privately owned.

 

April 2021, New York – AMNICELL awarded ´Stem Cell Therapy Company of the Year 2020` by GHP MedTech Awards Link to article

We are excited and very pleased to share that AMNICELL is the recipient of the ´Stem Cell Therapy Company of the Year 2020` by GHP MedTech Awards

The GHP recognizes all levels and aspects of the healthcare and pharmaceutical sectors without whom many life changing innovations and developments would not be possible. Their rewards and awards recognize those whose tireless work and dedication change the lives of millions of people each and every day. GHP is dedicated to uncovering and sharing the talented courageous, and innovative people, departments and companies pushing the boundaries of what is possible in the medical world.


AMNICELL

Stem Cell Therapy Company of the Year 2020

 

January 2021 – AMNICELL’s CEO Helen Ljungdahl Round joined more than 400 companies and 8,000 health care executives and investors at the 39th JPM Healthcare Conference on January 11-14, 2021. This year the conference was held virtually with presentations and 1×1 meetings. She also attended ancillary programs organized by BIO, McDermott & EY and CTIC.

The annual JP Morgan Healthcare Conference is the largest healthcare investment event in the industry, bringing together industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community. The conference started back in 1983 with 20 companies and 200 attendees focusing on the biotech industry. Today, it brings together thousands of investors and companies from around the world. The conference covers the full global healthcare landscape, including start-ups, pharmaceutical and biotech companies, healthcare service providers, profit and not-for-profit organizations, as well as medical device companies.

The JP Morgan Healthcare Conference provides AMNICELL with an important opportunity to meet with potential investors and continuing positioning AMNICELL as the first and leading company working with amniotic fluid cell therapy, and bringing the latest technology in regenerative medicine to overcome unmet medical needs and contribute to health and wellness

April 2020, New York – AMNICELL awarded ‘Best Regenerative Medicine Technology Developers – USA’ by GHP Biotechnology Awards

We are very pleased to share that AMNICELL is the recipient of the ‘Best Regenerative Medicine Technology Developers – USA’ by GHP Biotechnology Awards.

The GHP recognizes all levels and aspects of the healthcare and pharmaceutical sectors without whom many life changing innovations and developments would not be possible. Their rewards and awards recognize those whose tireless work and dedication change the lives of millions of people each and every day. GHP is dedicated to uncovering and sharing the talented courageous, and innovative people, departments and companies pushing the boundaries of what is possible in the medical world.

AMNICELL
Best Regenerative Medicine Technology Developers – USA

 

New York, March 2020 – World renowned Obstetrician and Gynecologist and Founder of AMNICELL, Dr. Bruce K. Young has been awarded the prestigious Albert Nelson Marquis Lifetime Achievement Award in recognition for his outstanding accomplishments throughout his career at New York University Langone Medical Center.  

Dr. Young has held numerous positions while at NYU Medical Center, including Director of Obstetrical Services, Chief of Obstetrics at Bellevue Hospital, Head of Pregnancy Loss Prevention Center and Associate Director of Department, as well as Founder and Director of Division of Maternal and Fetal Medicine. He has continuously trained medical students, residents and fellows as Professor of Obstetrics and Gynecology at New York University School of Medicine, rising to the rank of full Professor in 1980, and Silverman Endowed Professor in 1986.

He is an internationally recognized innovator and leader in his field and his clinical research has resulted in 150 peer review scientific publications. He has edited scientific books, contributed with chapters to 12 books, written 2 books for general public, served as editor for scientific journals, given numerous lectures world-wide and appeared on television programs. He is the recipient of numerous awards and honors, including the Outstanding Achievement Award of American College of Obstetricians and Gynecologists, Outstanding Service in Education and Distinguished Service Award in Fight Against Birth Defects from March of Dimes-National Foundation, and Berson Award in Clinical Science from New York University School of Medicine, among many others.

Dr. Young is a graduate of Princeton University and New York University School of Medicine. Board certified in Obstetrics and Gynecology and Maternal-Fetal Medicine, he was the Director of Examinations for American Board of Obstetrics and Gynecology Division of Maternal-Fetal Medicine for 10 years. Besides the American Board, his professional memberships include the American Gynecological and Obstetrical Society, past President of NY Obstetrical Society, Perinatal Society, NYU School of Medicine Alumni Association, Founder and Director of the Society for Maternal-Fetal Medicine, Royal Society of Medicine in England, and Alpha Omega Alpha Honor Medical Society.

He continues his teaching and research at New York University Langone Medical Center today, while also focusing on the potential of stem cells and regenerative medicine in AMNICELL to heal wounds, treat diabetes, lung fibrosis, and Alzheimer’s Disease.

“I am delighted to receive this award recognizing my achievements. The past is the prologue though; in the present and the future I look forward to building on the past and successfully grow AMNICELL in regenerative medicine, bringing innovation in both therapeutics and cosmeceuticals” says Dr. Bruce K. Young.

San Francisco, January 2020 – AMNICELL’s CEO Helen Ljungdahl Round and Chief Science Officer Dr Bruce K Young joined more than 9,000 health care leaders and investors at the annual JPM Healthcare Conference in San Francisco, January 13-16, 2020.  

The annual JP Morgan Healthcare Conference is the largest healthcare investment event in the industry, bringing together industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community. The conference started back in 1983 with 20 companies and 200 attendees focusing on the biotech industry. Today, it brings together thousands of investors and companies from around the world. The conference covers the full global healthcare landscape, including start-ups, pharmaceutical and biotech companies, healthcare service providers, profit and not-for-profit organizations, as well as medical device companies.

The JP Morgan Healthcare Conference provides AMNICELL with an important opportunity to meet with potential investors and continuing positioning AMNICELL as the first and leading company working with amniotic fluid cell therapy, and bringing the latest technology in regenerative medicine to overcome unmet medical needs and contribute to health and wellness.

 
 

Boston, Sept 2019 – AMNICELL’s CEO Helen Ljungdahl Round and Chief Science Officer Dr Bruce K Young will join 4,500 life science leaders, scientists and innovators at Biotech Week Boston, September 9-12, 2019.

Biotech Week Boston is uniquely positioned to accelerate the development of biotechnology through an exchange of new ideas, science, technology and partnerships, all with the focus on driving a positive impact on health evolution and improving patient health. BioPharm America, taking place on September 11-12, focuses on highlighting innovations as well as promoting new business relationships by bringing companies across the life science ecosystem together to engage in drug development collaborations. Life science executives from around the world will gather to identify, meet and to enter into strategic relationships.

Biotech Week Boston provides an important opportunity to continue positioning AMNICELL as a leader in amniotic fluid stem cell therapy, and bringing the latest technology in regenerative medicine to overcome unmet medical needs and contribute to health wellness.

New York, USA Aug 27, 2019 – AMNICELL, a biotech company focusing on research and development of amniotic fluid stem cells, today announced that Helen Ljungdahl Round has been appointed as CEO, effective July 1, 2019.

AMNICELL is the first company to use advanced stem cell technology, amniotic fluid and pluripotent stem cells to improve lives, health and wellness. The company was formed following 10 years of research with amniotic fluid and stem cells. The amniotic fluid is a unique non-controversial abundant source of stem cells with regenerative properties. AMNICELL collects, stores and processes the amniotic fluid and the stem cells for use in areas of unmet medical need and commercial areas, such as hair and skin care,

Helen Ljungdahl Round is a highly accomplished executive with more than 25 years of experience in international business management, strategy, marketing and sales in the pharmaceutical and medical technology industries, across numerous therapeutic areas, product life cycles and geographic areas. Her wealth of professional and business experience includes positions as Senior Vice President of Global Marketing & Business Development for GN Hearing, and, before that, numerous executive leadership positions of increasing responsibility at Merck & Co, Inc, working in EU, Middle East/Africa, North America, Latin America and Asia. She is a strong commercial leader that has consistently built high performing organizations and delivered profitable and sustainable business results.

Dr Bruce K Young, Professor at NYU School of Medicine, Chairman of AMNICELL Board of Directors, commented: “I am very excited that we have been able to attract someone like Helen Ljungdahl Round as the CEO of AMNICELL. With her experience from the pharmaceutical and medical technology industries, and leading highly successful global commercial organizations around the world, she is the perfect person to lead AMNICELL through the development of our unique technology and product portfolio, as well as delivering strong business results”.

Helen Ljungdahl Round said: “Regenerative medicine holds a lot of future potential, and AMNICELL is uniquely positioned with its advanced technology using amniotic fluid and pluripotent stem cells to contribute to this development. Our initial focus will be on areas of unmet medical need, but also other areas benefiting from the regenerative properties of amniotic fluid and stem cells. I am looking forward to continuing the science, developing our product portfolio, and more importantly bringing these transformative products to the market, enabling people access to novel biological solutions for their health and wellness”.

About AMNICELL

AMNICELL is the first company to use advanced stem cell technology, amniotic fluid and pluripotent stem cells to improve lives, health and wellness. The company is based on more than 10 years research with amniotic fluid and stem cells, and the primary focus on the development and commercialization of transformative therapeutics and innovative cosmeceuticals. AMNICELL is headquartered in New York City and is privately owned.

New York, April 2019 – Dr. Bruce K Young presented as Key Note Speaker at the Global Experts Meeting on Frontiers in Cell & Stem Cell Research on the topic of ‘Clinical Potential of Human Amniotic Fluid Stem Cells’.  

He shared the results of a study designed to characterize full term amniotic fluid stem cells and compare them with previously described mid-trimester amniotic fluid stem cells. Stem cells are undifferentiated cells with the ability to self-replicate without differentiation. Mid-trimester amniotic fluid stem cells have been well-characterized as multipotent, but scant data exist for full term amniotic fluid. With the advent of non-invasive prenatal diagnosis, mid-trimester amniotic fluid will become less available from normal patients. In contrast, term amniotic fluid is available in large quantities from normal pregnancies and might be a resource for clinical transplantation.

The study confirmed that full term and mid-trimester amniotic fluid stem cells demonstrate similar characteristics. The full term amniotic fluid stem cells were indeed multipotent and they differentiated into multiple cell lineages. They also tolerate and remain unchanged during cryostorage. Previous studies on term fluid have demonstrated only mesenchymal cells that required induction to pluripotent stem cells to achieve differentiation to neural lineage. Induced pluripotent cells are genomically unstable and tumorigenic; amniotic stem cells are not. This study demonstrates for the first time that both ectodermal and mesenchymal differentiability are present in term amniotic fluid stem cells. Neural differentiation was achieved without the induction of pluripotency. Term amniotic fluid contains approximately 1 million cells per milliliter, which may represent a readily available, abundant, and noncontroversial source of stem cells with therapeutic potential.

AMNICELL is the first company to develop amniotic fluid and stem cells for treating non-healing wounds, as well as products for skin care and hair growth.

Paris, France March 2019 – Dr. Bruce K Young presented on “Could Trisomy 21 (T21) Brains be Enhanced?” at the 16th Annual Meeting of the Society for Reproductive Investigation (SRI), March 12-16 in Paris, France.

This year the conference theme was “From Innovation to Impact”, highlighting the Society’s dedication to world-class innovation in basic research and translational medicine, as well as to improvements in women’s reproductive health and healthcare.

The study results presented by Dr Young showed the enhancement of neurological differentiation and gene expression specific to neural development by dexamethasone (DX) administration to cultured amniotic fluid stem cells from 1 of 5 trisomy 21 (Down Syndrome) fetuses. Previous studies by Dr Young’s team using human amniotic fluid derived stem cells demonstrated a potential for enhanced fetal brain development by administration of DX to amniotic fluid derived stem cells from euploid fetuses. This study found a specific genome which may identify T21 fetuses whose neurological development could be improved with DX therapy. Down Syndrome children who grow to adulthood suffer from early onset of severe Alzheimer’s Disease due to deposition of amyloid protein in the brain. The gene for amyloid was suppressed in the cells responding to DX, possibly offering some Alzheimer’s patients potential benefit from DX therapy.

This study is the first to discover a gene pattern in Down Syndrome that describes a possible method to treat Down Syndrome in utero as well as Alzheimer’s disease.

Contacts

Caroline Einaugler
Phone : (347) 321-0526
Email: caroline.einaugler@amnicell.com

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