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Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial

Posted: March 7, 2012 at 4:13 pm

ROCKVILLE, Md., March 7, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that the second patient to receive stem cells in the cervical (upper back) region of the spine was dosed on February 29th in the ongoing Phase I trial of its spinal cord neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Patient 14 is also the first woman to be treated in the trial. Stem cell transplantation into the cervical region of the spinal cord couldsupport breathing, a key function that is lost as ALS progresses. The first twelve patients in the trial received stem cell transplants in the lumbar (lower back) region of the spinal cord only.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"This cohort of patients represents another first for our trial, as we transplant cells directly into the gray matter of the spinal cord in the cervical region," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "We are delighted that the surgeries are progressing in a region that could have a significant impact on the quality of life for ALS patients. With the safe transplantation of our 14th patient, we are well are on our way to demonstrating the safety of our novel procedure."

About the Trial The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts. The trial has now progressed to the final six patients. Each is in the cervical (upper back) region of the spine. The entire 18-patient trial concludes six months after the final surgery.

About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include schizophrenia, Alzheimer's disease and bipolar disorder.

For more information, please visit http://www.neuralstem.com and connect with us on Twitter and Facebook.

Cautionary Statement Regarding Forward Looking Information This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2010 and the quarterly report on Form 10-Q for the period ended September 30, 2011.

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Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial

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Cord Blood Registery Helps Families Use Stem Cells – Video

Posted: March 7, 2012 at 9:29 am

29-02-2012 17:57 Learn more at http://www.cordblood.com CBR's team of dedicated professionals is prepared to guide you through every step of the banking process and beyond. Meet Sherry, CBR's transplant coordinator. As Sherry says, her employer is CBR, but she works for the families who need newborn stem cell medicine. She is the voice parents hear over the phone when they need to use their stored cord blood stem cells. Sherry's dedication and passion to deliver exceptional customer service to clients is one example of the many people at Cord Blood Registry who are committed to helping families live longer, healthier lives.

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Influencing stem cell fate

Posted: March 7, 2012 at 9:29 am

Public release date: 6-Mar-2012 [ | E-mail | Share ]

Contact: Megan Fellman fellman@northwestern.edu 847-491-3115 Northwestern University

Northwestern University scientists have developed a powerful analytical method that they have used to direct stem cell differentiation. Out of millions of possibilities, they rapidly identified the chemical and physical structures that can cue stem cells to become osteocytes, cells found in mature bone.

Researchers can use the method, called nanocombinatorics, to build enormous libraries of physical structures varying in size from a few nanometers to many micrometers for addressing problems within and outside biology.

Those in the fields of chemistry, materials engineering and nanotechnology could use this invaluable tool to assess which chemical and physical structures -- including size, shape and composition -- work best for a desired process or function.

Nanocombinatorics holds promise for screening catalysts for energy conversion, understanding properties conferred by nanostructures, identifying active molecules for drug discovery or even optimizing materials for tissue regeneration, among other applications.

Details of the method and proof of concept is published in the Proceedings of the National Academy of Sciences.

"With further development, researchers might be able to use this approach to prepare cells of any lineage on command," said Chad A. Mirkin, who led the work. "Insight into such a process is important for understanding cancer development and for developing novel cancer treatment methodologies."

Mirkin is the George B. Rathmann Professor of Chemistry in the Weinberg College of Arts and Sciences and professor of medicine, chemical and biological engineering, biomedical engineering and materials science and engineering. He also is the director of Northwestern's International Institute for Nanotechnology (IIN).

The new analytical method utilizes a technique invented at Northwestern called polymer pen lithography, where basically a rubber stamp having as many as 11 million sharp pyramids is mounted on a transparent glass backing and precisely controlled by an atomic force microscope to generate desired patterns on a surface. Each pyramid -- a polymeric pen -- is coated with molecules for a particular purpose.

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Influencing stem cell fate

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If Canada's game is hockey, its science is stem cells

Posted: March 7, 2012 at 9:29 am

alan bernstein From Wednesday's Globe and Mail Published Wednesday, Mar. 07, 2012 2:00AM EST

Most Canadians are unaware that two of their own a lanky physics whiz from Alberta and a rumpled Shakespeare-quoting MD from Toronto made a discovery 50 years ago that transformed the understanding of human biology and opened new doors to the treatment of cancer and other diseases.

Toiling away in labs atop Torontos old Princess Margaret Hospital, James Edgar Till and Ernest Armstrong (Bun) McCulloch proved that a single rare cell could produce the red blood cells, white blood cells and platelets needed to make blood, while simultaneously reproducing itself. Dr. Till and Dr. McCulloch originally called the cell a colony-forming unit. Today, its better known as a stem cell.

A great new book, Dreams and Due Diligence, by Joe Sornberger, tells the story. Still, that so few of us know let alone celebrate the fact that the stem cell is a Canadian discovery is baffling. Canada founded the entire field of stem-cell science. We have done much of the heavy lifting for decades: discovering neural stem cells, skin stem cells and cancer stem cells. If hockey is Canadas game, stem-cell science is Canadas science. Not knowing about Dr. Till and Dr. McCulloch is not knowing about Maurice Richard and Wayne Gretzky.

The way it happened didnt help. Their original paper was published in an obscure journal, Radiation Research, in 1961. Public interest went viral only after American James Thomson isolated human embryonic stem cells in 1998, which simultaneously raised hopes that stem cells could be used to repair any damaged cell in the body and ethical concerns that doing so would encourage the destruction of human embryos.

In 2002, the Canadian Institutes of Health Research developed guidelines for all stem-cell research carried out in Canada with its funds. These guidelines have become the gold standard for other countries, including the United States.

Whats even more remarkable is that Canada does such groundbreaking research on a dime. The all in investment in stem-cell research in Canada public, private and charitable funding is about $75-million. This support is provided by Canadians through taxes, donations to health charities and the generosity of community leaders individuals such as Robert and Cheryl McEwen of Toronto and the late Harley Hotchkiss of Calgary. But we still seriously lag behind California, which, with roughly the same population as Canada, has committed $3-billion over 10 years for stem-cell research.

How much further Canadas star scientists can go, however, is in doubt. According to the Stem Cell Network, there are 40 to 50 early-phase clinical trials using transplanted cells ready to roll out over the next four years. All are currently unfunded.

Prime Minister Stephen Harper has said his government will continue to make the key investments in science and technology but bemoaned Canadas less-than-optimal results for those investments. Stem-cell research has already proved itself a sound investment: Dr. Till and Dr. McCullochs work formed the basis of the bone marrow transplantation program at Princess Margaret Hospital that alone has saved thousands of lives. But it will take more than government funding: Private industry and private citizens also need to support life-saving research.

Canadians have good reason to be proud of our countrys contributions to health research and medicine. Two stand out as landmarks: the discovery of insulin in the 1920s and the discovery of stem cells in the 1960s. On Wednesday, at a dinner that brings together many of the countrys leading figures in business, the arts, entertainment, sports and science, the Canadian Stem Cell Foundation will be launched. The event will look back at that great discovery 50 years ago and look forward to ensure that Canadians continue to contribute to stem-cell research and its application to human disease.

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If Canada's game is hockey, its science is stem cells

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Scientists Repair Eyesight Using Human Cornea From Stem Cells

Posted: March 7, 2012 at 9:29 am

Constant shortage of donated corneas have led researchers in Sweden and Spain to explore the possibilities of cultivating corneas from human stem cells.

Two separate studies from the University of Navarra Hospital, Spain and Sahlgrenska Academy University of Gothenburg, Sweden, have attempted to cue in on developing the "epithelial cells" that keep the cornea in its transparent form.

While Swedish scientists have grown stem cells on human corneas, their Spanish counterparts have regenerated the corneal epithelium using cells from the healthy limbus of patients with corneal damage.

A corneal transplant is the only way to prevent total blindness. The result is that nearly 100,000 corneal implants are impacted globally each year. The process calls for replacing the damaged cornea with a healthy and transparent one, relying heavily on donors. Religious or political views have also attacked the medical outcomes of corneal implants adding to long waiting periods for donor-led corneal transplants.

Swedish Scientists Grow Cornea in the Laboratory

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In a first-time effort, scientists at the Sahlgrenska Academy have grown stem cells on human corneas which could perhaps do away with donated corneas in the long run.

The Swedish study published in the journal Acta Ophthalmologica explored ways to develop "epithelial cells" using laboratory cultures for 16 days, which were further cultured on the human cornea for another six days.

Lead scientists Charles Hanson and Ulf Stenevi used defective corneas from the ophthalmology clinic at Sahlgrenska University Hospital in Mlnda for their experiment.

"Similar experiments have been carried out on animals, but this is the first time that stem cells have been grown on damaged human corneas. It means that we have taken the first step towards being able to use stem cells to treat damaged corneas," said Hanson.

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Stem cells 'could repair damaged cornea'

Posted: March 7, 2012 at 9:29 am

Washington, Mar 6 : Researchers have for the first time successfully cultivated stem cells on human corneas, which may eliminate the need for donators in the long run.

The damaged and cloudy cornea that is turning the patient blind is replaced with a healthy, transparent one.

But the procedure requires a donated cornea, and there is a severe shortage of donated material. This is particularly the case throughout the world, where religious or political views often hinder the use of donated material.

Scientists at the Sahlgrenska Academy, University of Gothenburg, have taken the first step towards replacing donated corneas with corneas cultivated from stem cells.

Scientists Charles Hanson and Ulf Stenevi have used defective corneas obtained from the ophthalmology clinic at Sahlgrenska University Hospital in Molndal.

Their study shows how human stem cells can be caused to develop into what are known as 'epithelial cells'after 16 days' culture in the laboratory and a further 6 days' culture on a cornea. It is the epithelial cells that maintain the transparency of the cornea.

"Similar experiments have been carried out on animals, but this is the first time that stem cells have been grown on damaged human corneas. It means that we have taken the first step towards being able to use stem cells to treat damaged corneas," said Charles Hanson.

"If we can establish a routine method for this, the availability of material for patients who need a new cornea will be essentially unlimited. Both the surgical procedures and the aftercare will also become much more simple," said Ulf Stenevi.

The study has been published in the journal Acta Ophthalmologica. (ANI)

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Influencing stem cell fate: New screening method helps scientists identify key information rapidly

Posted: March 7, 2012 at 9:29 am

ScienceDaily (Mar. 6, 2012) Northwestern University scientists have developed a powerful analytical method that they have used to direct stem cell differentiation. Out of millions of possibilities, they rapidly identified the chemical and physical structures that can cue stem cells to become osteocytes, cells found in mature bone.

Researchers can use the method, called nanocombinatorics, to build enormous libraries of physical structures varying in size from a few nanometers to many micrometers for addressing problems within and outside biology.

Those in the fields of chemistry, materials engineering and nanotechnology could use this invaluable tool to assess which chemical and physical structures -- including size, shape and composition -- work best for a desired process or function.

Nanocombinatorics holds promise for screening catalysts for energy conversion, understanding properties conferred by nanostructures, identifying active molecules for drug discovery or even optimizing materials for tissue regeneration, among other applications.

Details of the method and proof of concept is published in the Proceedings of the National Academy of Sciences.

"With further development, researchers might be able to use this approach to prepare cells of any lineage on command," said Chad A. Mirkin, who led the work. "Insight into such a process is important for understanding cancer development and for developing novel cancer treatment methodologies."

Mirkin is the George B. Rathmann Professor of Chemistry in the Weinberg College of Arts and Sciences and professor of medicine, chemical and biological engineering, biomedical engineering and materials science and engineering. He also is the director of Northwestern's International Institute for Nanotechnology (IIN).

The new analytical method utilizes a technique invented at Northwestern called polymer pen lithography, where basically a rubber stamp having as many as 11 million sharp pyramids is mounted on a transparent glass backing and precisely controlled by an atomic force microscope to generate desired patterns on a surface. Each pyramid -- a polymeric pen -- is coated with molecules for a particular purpose.

In this work, the researchers used molecules that bind proteins found in the natural cell environment, such as fibronectin, which could then be attached onto a substrate in various patterns. (Fibronectin is a protein that mediates cell adhesion.) The team rapidly prepared millions of textured features over a large area, which they call a library. The library consisted of approximately 10,000 fibronectin patterns having as many as 25 million features ranging in size from a couple hundred nanometers to several micrometers.

To make these surfaces, they intentionally tilt the stamp and its array of pens as the stamp is brought down onto the substrate, each pen delivering a spot of molecules that could then bind fibronectin. The tilt results in different amounts of pressure on the polymeric pens, which dictates the feature size of each spot. Because the pressure varies across a broad range, so does the feature size.

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Nuvilex Forecasts Vast Partnership Opportunities Using Breakthrough Stem Cell Technology

Posted: March 7, 2012 at 9:29 am

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today pointed out the potential for substantial partnership and licensing opportunities using the companys cell encapsulation technology for applications in stem cell research and medicine. Migration of implanted cells away from the target site and host rejection have been recognized as fundamental challenges faced by the stem cell community regarding their use in therapy, which the companys technology overcomes.

The technology being acquired from associate SG Austria is used to place live stem cells into strong, flexible and permeable capsules. These capsules can then be implanted into animals or humans for specific therapies. Stem cells can then exist at the desired location inside the capsules, prevented from migrating and protected from the immune system that aims to eliminate such foreign cells from the body.

Stem cell therapy is being used by clinicians throughout the world for treating such diverse diseases as spinal cord injury, amyotrophic lateral sclerosis, burns, glioma, multiple myeloma, arthritis, heart disease, stroke, Stargardt's Macular Dystrophy, and age-related macular degeneration, among others, most of which can be found at ClinicalTrials.gov.

Historically, researchers have faced numerous difficulties in succeeding with certain stem cell treatments, because of the problems associated with keeping stem cells alive for significant periods of time, stopping rejection and destruction by the recipients immune system, and keeping stem cells from migrating away from the desired sites. Cells encapsulated in SG Austrias porous beads have been shown to remain alive for long periods of time in humans, surviving intact for at least two years. Once encapsulated, cells are protected from the bodys immune system. Furthermore, encapsulated cells remain within the beads and are unable to migrate to other sites in the body.

In the February 29, 2012 research report, Goldman Small Cap Research stated, The Cell-in-a-Box approach could significantly advance the implementation and utilization of stem cells for a host of debilitating diseases and conditions, making it a uniquely valuable commodity. We believe that by partnering with leading players in the field, Nuvilex could find that companies with deep pockets would be happy to collaborate or license the delivery system and engage in further research which could result in meaningful development and licensing revenue.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, discussed the value for licensing the companys stem cell therapy, adding, By overcoming traditional barriers to effective stem cell therapy, namely viability, migration, and host rejection, we believe these new advances in medical science utilizing stem cells and encapsulation will enable us to take quantum leaps forward now and in the future. As a result of challenges SG Austria has overcome, new advances will be surprisingly close at hand and are part of the driving force behind our desire to work with a number of companies in this endeavor. Our primary goal has been and remains to use our technology to bring life changing treatments to patients on an expedited basis.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

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Stem cells ‘could repair damaged cornea’

Posted: March 7, 2012 at 3:36 am

Washington, Mar 6 : Researchers have for the first time successfully cultivated stem cells on human corneas, which may eliminate the need for donators in the long run.

The damaged and cloudy cornea that is turning the patient blind is replaced with a healthy, transparent one.

But the procedure requires a donated cornea, and there is a severe shortage of donated material. This is particularly the case throughout the world, where religious or political views often hinder the use of donated material.

Scientists at the Sahlgrenska Academy, University of Gothenburg, have taken the first step towards replacing donated corneas with corneas cultivated from stem cells.

Scientists Charles Hanson and Ulf Stenevi have used defective corneas obtained from the ophthalmology clinic at Sahlgrenska University Hospital in Molndal.

Their study shows how human stem cells can be caused to develop into what are known as 'epithelial cells'after 16 days' culture in the laboratory and a further 6 days' culture on a cornea. It is the epithelial cells that maintain the transparency of the cornea.

"Similar experiments have been carried out on animals, but this is the first time that stem cells have been grown on damaged human corneas. It means that we have taken the first step towards being able to use stem cells to treat damaged corneas," said Charles Hanson.

"If we can establish a routine method for this, the availability of material for patients who need a new cornea will be essentially unlimited. Both the surgical procedures and the aftercare will also become much more simple," said Ulf Stenevi.

The study has been published in the journal Acta Ophthalmologica. (ANI)

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Harvard Bioscience Comments on the Passing of Christopher Lyles

Posted: March 7, 2012 at 3:36 am

HOLLISTON, Mass., March 6, 2012 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc. (Nasdaq:HBIO - News), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine is deeply saddened to learn of the passing of Mr. Christopher Lyles. Mr. Lyles was a recent recipient of a tracheal transplant regenerated in a Harvard Bioscience InBreath Bioreactor. Currently, we do not know the cause of Mr. Lyle's death. Our thoughts are with his family at this time. His family has released the following statement:

"We, the family of Christopher Lyles, sorrowfully inform you that Christopher passed away this morning, March 5, 2012. Christopher was a recipient and strong advocate of stem cell therapy. We do not want his journey to be in vain. We hope his bravery will pave the way for further research and development and acceptance of stem cell based therapies in the United States. We would like to thank everyone for their thoughts and prayers throughout Christopher's trailblazing journey."

About Harvard Bioscience

Harvard Bioscience ("HBIO") is a global developer, manufacturer and marketer of a broad range of specialized products, primarily apparatus and scientific instruments, used to advance life science research and regenerative medicine. We sell our products to thousands of researchers in over 100 countries primarily through our 850 page catalog (and various other specialty catalogs), our website, through distributors, including GE Healthcare, Thermo Fisher Scientific and VWR, and via our field sales organization. HBIO has sales and manufacturing operations in the United States, the United Kingdom, Sweden, Germany and Spain with additional facilities in France and Canada. For more information, please visit http://www.harvardbioscience.com.

The Harvard Bioscience, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6426

Forward-looking Statements

The statements made in this press release that are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by our use of such words as "will," "guidance," "objectives," "optimistic," "potential," "future," "expect," "plans," "estimates," "continue," "drive," "strategy," "crucial," "potential," "potentially," "growth," "long-term," "projects," "projected," "produce," "intends," "believes," "goals," "sees," "seek," "develop," "possible," "new," "enabling," "emerging," "opportunity," "pursue" and similar expressions that do not relate to historical matters. Forward-looking statements in this press release may include, but are not limited to, statements or inferences about the HBIO's or management's beliefs or expectations, the field of regenerative medicine, opportunities or potential opportunities in the field of regenerative medicine, HBIO's business strategy, the positioning of HBIO for growth, the market demand and opportunity for HBIO's current products or products it is developing or intends to develop, and HBIO's plans, objectives and intentions that are not historical facts.

These statements involve known and unknown risks, uncertainties and other factors that may cause HBIO's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Factors that may cause HBIO's actual results, performance or achievements to differ materially from those in the forward-looking statements include, but are not limited to, HBIO's failure to successfully expand its product offerings, introduce new products or commercialize new technologies, including in the field of regenerative medicine, decreased demand for the HBIO's products, including products in the field of regenerative medicine, due to changes in our customers' needs, our ability to obtain regulatory approvals, including FDA approval, for our products, including any products in the field of regenerative medicine, the current size or anticipated size of the regenerative medicine market, the existence and size of opportunities in the regenerative medicine market, our financial position, plus risk factors set forth under the heading "Item 1A. Risk Factors" in HBIO's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 or described in HBIO's other public filings. HBIO's results may also be affected by factors of which HBIO is not currently aware. HBIO may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.

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Harvard Bioscience Comments on the Passing of Christopher Lyles

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