BioSpherix reorganizes to grow

PARISH — Randy Yerden, CEO of BioSpherix, Ltd., has reorganized the Oswego County–based company into two divisions: BioSpherix Lab and BioSpherix Medical. The change is a response to the growing demand in the Food & Drug Administration (FDA)-regulated industries by focusing the divisions’ research, sales, and marketing efforts to align with their respective markets.

“BioSpherix designs and builds instruments for optimizing and manipulating critical parameters in the biological environment of cells,” says Yerden. “… [The company] manufactures equipment for the entire cell industry including cell research, cell therapy, cell-based assays, therapeutic modeling, and disease modeling. The business originated by creating unique environments in which the variables such as oxygen, carbon dioxide, and other parameters were better controlled to ensure optimal cell growth and viability. In the early days, the business exclusively retrofitted customers’ existing equipment. I like to say that BioSpherix souped up conventional, standard products to make them more capable of meeting cell needs. The problem with our industry is that the manufacturers are still people-centric and not cell-centric; what we like to call ‘cytocentric.’ In fact, Cytocentric is our brand and our unique claim of distinction in the global marketplace. In layman’s terms, it simply means a quality approach to growing and handling cells. Upgrading other manufacturers’ standard products is still a significant part of our business.”

Frustrated by the handicaps inherent in standard cell equipment, BioSpherix decided to re-think and re-invent cell incubation and processing. The result was an alternative to conventional laboratory equipment, which Yerden calls the Cytocentric-by-design Xvivo System. “We needed to provide a better option for the cells and a safer option for lab technicians who, knowingly or unknowingly, sometimes use cells infected with dangerous transgenes, prions, and viruses, including swine flu, Ebola, and SARS,” the company CEO says. “Currently, short of P4 bio-safety facilities, technicians work in the same open air as these potentially lethal cells carrying infectious agents. The Xvivo System offers not only an unprecedented level of protection for the cells, but also a new, unprecedented layer of protection for the technicians in any facility. It encloses both the cells and any potential pathogen, creating a safety barrier between them and the technician.

“From another perspective,” continues Yerden, “the completely enclosed nature of the Xvivo System has become an attractive alternative to expensive brick-and-mortar clean rooms for producing clinical-grade cells used in new-cell therapies. Our system is not only 10 times less expensive, but it can also be fully operational within weeks; it’s portable, modular, infinitely adaptable for future needs, and produces better cells.”

The explosion in the use of human cells led Yerden to create BioSpherix Medical. 

“We now have this new platform to ensure the best quality-grade, clinical-grade cells safely, but it comes with a catch-22,” laments Yerden. “Unlike the laboratory-research products, which are unregulated and will stay with BioSpherix Lab, regulatory agencies such as the Centers for Disease Control, the FDA, and the National Institute of Standards and Technology (a federal agency within the U.S. Department of Commerce) set strict compliance standards in clinical and bio-safety applications. Without regulatory certifications, customers are discouraged from utilizing the Xvivo System.” BioSpherix Medical received help recently from Congressman Richard Hanna (R–Barneveld) to cut through the bureaucratic red tape of the application process.

BioSpherix serves a variety of cell-industry customers. “Over the years, we have placed our equipment in academic settings, research labs, government agencies, pharmaceutical manufacturers, and biotechnology organizations throughout the world,” asserts Yerden. “Our customers have used our products in the fields of cell biology, stem-cell research, cell therapy, gene therapy, clinical studies, and other FDA-compliant, clinical-grade cell production.”

Growth strategies

In addition to splitting the company in two, Yerden is also expanding sales by synergizing the Cytocentric platform with specialty cell-equipment manufacturers, as exemplified by joining with ACEA Biosciences, Inc., a San Diego–based company that manufactures cellular-assay equipment. 

ACEA, started in 2002, is privately owned and has manufacturing operations in Hangzhou, China. “BioSpherix manufactures the cytocentric, sub-chamber culture system which ACEA integrates with its iCELLigence, real-time, cellular-analysis system,” notes Yerden. “This combination product enhances the quality of the data from ACEA’s powerful, label-free and real-time monitoring of cellular processes, such as cell growth, proliferation, cytotoxicity, adhesion, and other dynamics. We created a partnership in manufacturing the product and in co-promoting the marketing and sales of iCELLigence. We are setting up alliances with many other similar partners which offer synergistic potential.”

Repositioning the company for growth also convinced Yerden not to rely just on direct sales, but also to create a global network of distributors.

“Since the beginning, we have only marketed the company intermittently at trade shows, through some direct mail, our website, and inside telephone sales with no consistent advertising, publicity, catalogs, and in some cases no sales literature,” explains Yerden. “BioSpherix is still an industry secret. All that is now about to change. We are creating catalog and other marketing materials, and we are signing up distributors all over the world. In August, we have invited our new distributors to join us for the first of quarterly, three-day events to introduce them to the company and to train them on our products. We plan to use the Tailwater Lodge in Altmar to house our guests and the showroom here at the plant for training.”

BioSpherix, Ltd. is headquartered in Parish. The company employs 50 people, and generates annual revenue of under $10 million, as estimated by The Business 

Journal. Yerden is the sole stockholder. The two divisions occupy a 38,000-square-foot facility originally built as the Parish Elementary School. Red Ray Properties, LLC, a real-estate company, purchased the building and property in 2013 for $375,000. Yerden holds the stock in Red Ray. In 2014, BioSpherix moved its operation from a 26,000 square-foot facility in Lacona. Yerden, who started his business in 1982 as a sole proprietorship called Reming Bioinstruments Co., incorporated in 2001 as BioSpherix, Ltd.

Yerden’s background

Yerden grew up in Redfield and attended Syracuse University, where in 1975 he received a bachelor’s degree in biology with a minor in chemistry. His first job was at the University of Rochester Strong Memorial Hospital, working as a lab technician in cancer research. “My day was spent peering through a microscope counting stem cells,” recalls Yerden. “I did clonogenic assays, which meant I chopped up the tumor and marrow samples, worked with enzymes and cell media rich in nutrients, plated the cells, and counted the stem-cell colonies for results. The counting was tedious and prone to error, because stem cells didn’t grow well. I heard that an oxygen-controlled atmosphere might improve the cell growth, but incubators then didn’t control oxygen. So, I built an oxygen controller for my incubator, and the improvement was dramatic. I could actually see huge colonies of vibrant, growing cells, which I could count easily and accurately.”

Yerden moved home to Redfield in 1981 and took a job at Bristol Laboratories in Syracuse. The following year, he left his job at Bristol and decided to spend his time selling the incubator oxygen controller he had created. For the next 19 years, Yerden ran Reming Bioinstruments as a one-man shop and developed many additional tools for leading cell scientists. In 2000, he started to realize that the entire cell industry would eventually need these tools, once the industry focused on the need for quality. At the same time, the demand for cells and the value of these cells, especially human cells, started to skyrocket. “A discussion in 2001 with an insurance salesman, who was trying to sell me disability and life insurance, got me thinking about my mortality,” intones Yerden. “How sustainable was a one-man operation? Accepting the challenge to grow, I at first expanded the company to five employees. Over the past 15 years, patiently building a foundation for growth, we are now a team of 50 and almost ready to continue our growth.”

BioSpherix is serving a market that is growing rapidly. The U.S. by itself currently has more than 8,000 biotechnology companies. In the past decade, the number of drug approvals by the FDA has risen steadily. According to the IMS Institute of Healthcare Informatics, the global pharmaceutical industry is expected to continue its growth at a 5-percent to 8-percent annual rate. In the decade between 2002 and 2012, the biologics market, which accounts for 11 percent of total drug sales, nearly quadrupled to $169 billion. And cells are considered the next big thing in health care. Already, more than 4,000 active, cell-therapy clinical trials are in progress. Reports of break-through cures have both government and big pharma finally investing billions in cell therapies. With pharmaceuticals and biologics driving the market growth, bio-safety testing using cells is also becoming big business. According to a Mordor Intelligence industry report, the biological, safety testing market is growing at an annual compounded rate of 12.23 percent, prodded by innovations in the biotechnology industry, drug developments, and government regulations. The report also notes that North America is the global leader in biological safety testing with a 37.5-percent market share.

“We are on the edge of a huge opportunity,” opines Yerden. “To compete in this marketplace, we need capital, two complete management teams, and now more visibility in the marketplace. I believe that BioSpherix is the leader bringing the first and only total-quality approach to the cell industry with our Cytocentric product line. We are poised for substantial growth, and our reorganization is the key to advancing that growth.”        

PARISH — Randy Yerden, CEO of BioSpherix, Ltd., has reorganized the Oswego County–based company into two divisions: BioSpherix Lab and BioSpherix Medical. The change is a response to the growing demand in the Food & Drug Administration (FDA)-regulated industries by focusing the divisions’ research, sales, and marketing efforts to align with their respective markets.

“BioSpherix designs and builds instruments for optimizing and manipulating critical parameters in the biological environment of cells,” says Yerden. “… [The company] manufactures equipment for the entire cell industry including cell research, cell therapy, cell-based assays, therapeutic modeling, and disease modeling. The business originated by creating unique environments in which the variables such as oxygen, carbon dioxide, and other parameters were better controlled to ensure optimal cell growth and viability. In the early days, the business exclusively retrofitted customers’ existing equipment. I like to say that BioSpherix souped up conventional, standard products to make them more capable of meeting cell needs. The problem with our industry is that the manufacturers are still people-centric and not cell-centric; what we like to call ‘cytocentric.’ In fact, Cytocentric is our brand and our unique claim of distinction in the global marketplace. In layman’s terms, it simply means a quality approach to growing and handling cells. Upgrading other manufacturers’ standard products is still a significant part of our business.”

Frustrated by the handicaps inherent in standard cell equipment, BioSpherix decided to re-think and re-invent cell incubation and processing. The result was an alternative to conventional laboratory equipment, which Yerden calls the Cytocentric-by-design Xvivo System. “We needed to provide a better option for the cells and a safer option for lab technicians who, knowingly or unknowingly, sometimes use cells infected with dangerous transgenes, prions, and viruses, including swine flu, Ebola, and SARS,” the company CEO says. “Currently, short of P4 bio-safety facilities, technicians work in the same open air as these potentially lethal cells carrying infectious agents. The Xvivo System offers not only an unprecedented level of protection for the cells, but also a new, unprecedented layer of protection for the technicians in any facility. It encloses both the cells and any potential pathogen, creating a safety barrier between them and the technician.

“From another perspective,” continues Yerden, “the completely enclosed nature of the Xvivo System has become an attractive alternative to expensive brick-and-mortar clean rooms for producing clinical-grade cells used in new-cell therapies. Our system is not only 10 times less expensive, but it can also be fully operational within weeks; it’s portable, modular, infinitely adaptable for future needs, and produces better cells.”

The explosion in the use of human cells led Yerden to create BioSpherix Medical. 

“We now have this new platform to ensure the best quality-grade, clinical-grade cells safely, but it comes with a catch-22,” laments Yerden. “Unlike the laboratory-research products, which are unregulated and will stay with BioSpherix Lab, regulatory agencies such as the Centers for Disease Control, the FDA, and the National Institute of Standards and Technology (a federal agency within the U.S. Department of Commerce) set strict compliance standards in clinical and bio-safety applications. Without regulatory certifications, customers are discouraged from utilizing the Xvivo System.” BioSpherix Medical received help recently from Congressman Richard Hanna (R–Barneveld) to cut through the bureaucratic red tape of the application process.

BioSpherix serves a variety of cell-industry customers. “Over the years, we have placed our equipment in academic settings, research labs, government agencies, pharmaceutical manufacturers, and biotechnology organizations throughout the world,” asserts Yerden. “Our customers have used our products in the fields of cell biology, stem-cell research, cell therapy, gene therapy, clinical studies, and other FDA-compliant, clinical-grade cell production.”

Growth strategies

In addition to splitting the company in two, Yerden is also expanding sales by synergizing the Cytocentric platform with specialty cell-equipment manufacturers, as exemplified by joining with ACEA Biosciences, Inc., a San Diego–based company that manufactures cellular-assay equipment. 

ACEA, started in 2002, is privately owned and has manufacturing operations in Hangzhou, China. “BioSpherix manufactures the cytocentric, sub-chamber culture system which ACEA integrates with its iCELLigence, real-time, cellular-analysis system,” notes Yerden. “This combination product enhances the quality of the data from ACEA’s powerful, label-free and real-time monitoring of cellular processes, such as cell growth, proliferation, cytotoxicity, adhesion, and other dynamics. We created a partnership in manufacturing the product and in co-promoting the marketing and sales of iCELLigence. We are setting up alliances with many other similar partners which offer synergistic potential.”

Repositioning the company for growth also convinced Yerden not to rely just on direct sales, but also to create a global network of distributors.

“Since the beginning, we have only marketed the company intermittently at trade shows, through some direct mail, our website, and inside telephone sales with no consistent advertising, publicity, catalogs, and in some cases no sales literature,” explains Yerden. “BioSpherix is still an industry secret. All that is now about to change. We are creating catalog and other marketing materials, and we are signing up distributors all over the world. In August, we have invited our new distributors to join us for the first of quarterly, three-day events to introduce them to the company and to train them on our products. We plan to use the Tailwater Lodge in Altmar to house our guests and the showroom here at the plant for training.”

BioSpherix, Ltd. is headquartered in Parish. The company employs 50 people, and generates annual revenue of under $10 million, as estimated by The Business 

Journal. Yerden is the sole stockholder. The two divisions occupy a 38,000-square-foot facility originally built as the Parish Elementary School. Red Ray Properties, LLC, a real-estate company, purchased the building and property in 2013 for $375,000. Yerden holds the stock in Red Ray. In 2014, BioSpherix moved its operation from a 26,000 square-foot facility in Lacona. Yerden, who started his business in 1982 as a sole proprietorship called Reming Bioinstruments Co., incorporated in 2001 as BioSpherix, Ltd.

Yerden’s background

Yerden grew up in Redfield and attended Syracuse University, where in 1975 he received a bachelor’s degree in biology with a minor in chemistry. His first job was at the University of Rochester Strong Memorial Hospital, working as a lab technician in cancer research. “My day was spent peering through a microscope counting stem cells,” recalls Yerden. “I did clonogenic assays, which meant I chopped up the tumor and marrow samples, worked with enzymes and cell media rich in nutrients, plated the cells, and counted the stem-cell colonies for results. The counting was tedious and prone to error, because stem cells didn’t grow well. I heard that an oxygen-controlled atmosphere might improve the cell growth, but incubators then didn’t control oxygen. So, I built an oxygen controller for my incubator, and the improvement was dramatic. I could actually see huge colonies of vibrant, growing cells, which I could count easily and accurately.”

Yerden moved home to Redfield in 1981 and took a job at Bristol Laboratories in Syracuse. The following year, he left his job at Bristol and decided to spend his time selling the incubator oxygen controller he had created. For the next 19 years, Yerden ran Reming Bioinstruments as a one-man shop and developed many additional tools for leading cell scientists. In 2000, he started to realize that the entire cell industry would eventually need these tools, once the industry focused on the need for quality. At the same time, the demand for cells and the value of these cells, especially human cells, started to skyrocket. “A discussion in 2001 with an insurance salesman, who was trying to sell me disability and life insurance, got me thinking about my mortality,” intones Yerden. “How sustainable was a one-man operation? Accepting the challenge to grow, I at first expanded the company to five employees. Over the past 15 years, patiently building a foundation for growth, we are now a team of 50 and almost ready to continue our growth.”

BioSpherix is serving a market that is growing rapidly. The U.S. by itself currently has more than 8,000 biotechnology companies. In the past decade, the number of drug approvals by the FDA has risen steadily. According to the IMS Institute of Healthcare Informatics, the global pharmaceutical industry is expected to continue its growth at a 5-percent to 8-percent annual rate. In the decade between 2002 and 2012, the biologics market, which accounts for 11 percent of total drug sales, nearly quadrupled to $169 billion. And cells are considered the next big thing in health care. Already, more than 4,000 active, cell-therapy clinical trials are in progress. Reports of break-through cures have both government and big pharma finally investing billions in cell therapies. With pharmaceuticals and biologics driving the market growth, bio-safety testing using cells is also becoming big business. According to a Mordor Intelligence industry report, the biological, safety testing market is growing at an annual compounded rate of 12.23 percent, prodded by innovations in the biotechnology industry, drug developments, and government regulations. The report also notes that North America is the global leader in biological safety testing with a 37.5-percent market share.

“We are on the edge of a huge opportunity,” opines Yerden. “To compete in this marketplace, we need capital, two complete management teams, and now more visibility in the marketplace. I believe that BioSpherix is the leader bringing the first and only total-quality approach to the cell industry with our Cytocentric product line. We are poised for substantial growth, and our reorganization is the key to advancing that growth.”