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Saturday, November 08, 2003 2:49:26 PM
Gerald Newmin/interview/August 2001
EXTI Chairman and
Chief Executive Officer
Here is an old interview of Gerald Newmins dated August 2001 with a bit of bio on him
http://www.ceocfointerviews.com/interviews/ExtenInd.htm
Healthcare
Biotech
Medical Equipment
OTC BB: EXTI
Exten Industries, Inc.
9620 Chesapeake Dr., Suite 201
San Diego, CA 92123
Phone: 858-496-0173
Gerald Newmin
Chairman and
Chief Executive Officer
Interview conducted by:
Walter Banks, Co-Publisher
CEOCFOinterviews.com
August 2001
BIO OF CEO
Jerry Newmin has managed NYSE and American Exchange-listed Fortune 500 companies and start-ups, specializing in turning around troubled companies and improving revenues, profits and shareholder value. He has been President of HealthAmerica and International Silver Company, CEO of numerous Whittaker Divisions, VP of American Medicorp, CEO of SYS and Chairman of International Forum for Corporate Directors. Additionally, Jerry is Chairman, Treasurer and Director for Xenogenics Corp.
About
Exten Industries, Inc.
Exten Industries, Inc., through its Xenogenics Corporation subsidiary, is engaged in the business of managing the research and development and commercialization of the Sybiol® synthetic bio-liver, an "artificial liver" or liver support system. The Sybiol® liver device is based on technology for continuously circulating liver cells (hepatocytes) through a semi-permeable bio-membrane.
On April 2, 2001, Exten Industries, Inc. announced that they had signed a Letter of Intent to acquire its research and development partner, privately held MultiCell Associates, Inc. (MultiCell) of Warwick, RI in a cash plus stock transaction. Specific details were not disclosed. This acquisition will solidify the working relationship between the two firms in their joint liver assist device program.
MultiCell is a highly respected research company with unique expertise in developing functional cells and cell lines with a special focus on liver derived cells. They have several patents issued on their immortalized hepatocytes or engineered liver cells. MultiCell’s mission, to develop and commercialize cells for diagnosis and treatment of liver diseases, has resulted in an exclusive non-tumorigenic DNA-engineered porcine hepatocyte cell line. Exten has redesigned their device to operate with the MultiCell technology using DNA engineered liver cells.
The Sybiol® liver therapy device is intended to be used as an artificial liver "bridge" for transplant patients when no donor organ is available, and, via regular outpatient treatments, maintain essential liver functions for patients with chronic liver disease or other liver trauma until the human liver heals and is able to resume normal liver functions. It may also increase the quality of life in those patients who are not curable. Lastly, the device may be an effective tool for laboratory testing, veterinary applications, and/or drug testing applications.
CEOCFOinterviews - Mr. Newmin, can you give us a brief history of Exten Industries?
Mr. Newmin: "Exten has been around for a long time, but my involvement began in late 1995. The company acquired the artificial liver device technology from a major medical center in Los Angeles in l993. Exten then stopped all its other activities and concentrated solely on an external biological device to artificially perform some of the basic functions of the human liver. The device is trademarked Sybiol® for synthetic bio-liver.
CEOCFOinterviews - Where is your external liver device in its development?
Mr. Newmin: "The original design of the device was used with liver cells that were extracted from live pigs. We were conducting our research at Loyola Medical Center in Chicago. However, it became apparent that, with both the FDA and the public, dealing with animal retro viruses was going to be a problem. We found a company called MultiCell Associates in Warwick, Rhode Island that developed and patented DNA engineered cells that were manufactured in a laboratory. Therefore, we switched all of our research and development over to MultiCell last year, using DNA engineered pig liver cells. That required redesigning our device. This new device has now restarted testing, and our goal is to use it on large animals, primarily pigs. Following these tests and developing enough hard data, we will file an IND application with the FDA preparatory to initiating Phase 1 safety testing."
CEOCFOinterviews - Do you have any projections as to when clinical trials may start?
Mr. Newmin: "We plan to complete animal trials later this year, and then we plan to start clinical trials in 2002. It is not entirely clear as to exactly how long it will take to get to Phase II and Phase III of the FDA trials. We feel it may take 3 to 5 years. That depends on how many patients the FDA will require to be tested."
CEOCFOinterviews – What will your relationship with MultiCell Associates be going forward?
Mr. Newmin: "MultiCell will be a wholly owned subsidiary of Exten. The owner of MultiCell Associates, an internationally known scientist, unfortunately passed away and his estate decided to sell the company. We have signed a Letter of Intent to acquire the company and are in final stages of closing that transaction. Acquiring MultiCell will allow us to keep all of our research in house. Moreover, the acquisition also gives us the exclusive right to the cell lines. Multicell has developed a human liver cell that they can manufacture in laboratories. Therefore, our hope is to test the device with the human liver cell, which clearly will be a more approvable process than the use of pig liver cells. Since the human liver cell has some significant opportunities for toxicity testing, we think that other products may evolve from these cell lines. Sometime in the future we may consider the merger of MultiCell with our subsidiary Xenogenics Corporation, which owns the artificial liver technology."
CEOCFOinterviews – What changes have you made in the Sybiol® device technology since its acquisition?
Mr. Newmin: "There were certain problems with the technology. Therefore Dr. Brems, the chairman of our advisory board and a member of the staff of the transplant program at the Loyola University came up with some innovative ideas, unique in terms of the way these cells were presented to the patient plasma. That resulted in a patent that is now working it’s way through the patent office. Our objective is to develop a device where the cells stay alive for long periods, therefore extending their viability in terms of their interface with the patient blood. That makes the treatment more efficacious and at the same time drives down the cost per treatment. As an example, the Sybiol® is a device designed to be a "bridge" for transplant patients, when no donor organ is available and, via regular outpatient treatments, maintain essential liver functions for patients with chronic liver disease and other liver trauma until the human liver heals. Our goal is to be able to slow down the rate at which the liver is going to fail or, if we are fortunate, prevent the liver from failing altogether.
The liver is the only organ that will rejuvenate itself, if you allow it. A family member or close relative can literally donate a part of their liver to another family member with a liver failure and the donor's liver will grow back quite quickly. The idea here is to provide “off-line” help to the liver so that it can rejuvenate itself throughout these diseases and allow the patient to lead a normal life.”
CEOCFOinterviews - Can you give us a little more detail on how that would work?
Mr. Newmin: "With kidney dialysis you go for periodic treatments into an outpatient center, where they purify your blood. With our Sybiol device, the patient would go to a similar kind of facility. We do not know exactly how often or how frequently or how long the treatments would be; that would depend on their individual condition. However, you would essentially run a patient’s blood through our device exposing its plasma to the cells contained within our device. There would then be an interaction between the cells in our device and the patient blood plasma where the cells actually perform some of the functions of the liver, including de-toxification. It will probably happen at an outpatient dialysis center, because everything you need for this type of dialysis is already there. We probably would have liver dialysis departments, just as there are kidney dialysis departments."
CEOCFOinterviews – How will you approach the market place?
Mr. Newmin: "We believe the market is very large. The market is not just transplants - there are only about four thousand transplants a year done in the United States. However, because Hepatitis, particularly Hepatitis C, is on the rise all over the world, the business opportunity for a liver assist device is probably as large as or larger than kidney dialysis, which is in the hundreds of millions. We will talk to some of the key players in the major pharmaceutical companies as soon as we have good hard data and are in FDA trials. We will attempt to partner with someone who has much better resources to put our device out to the market than we do."
CEOCFOinterviews – Can you give us an idea of the current cost in treating liver disease?
Mr. Newmin: "It is a very expensive process. For example, it costs over $300,000 for a liver transplant. Our goal is to get the outpatient treatment with dialysis down to close to what kidney dialysis runs. That could be in the thousands of dollars per treatment, yet it is certainly is not in the hundreds of thousands, which is what a transplant would cost. There are a number of treatments that can help the diseased liver, yet they are all very expensive."
CEOCFOinterviews - What other revenue generating possibilities are there for the MultiCell Company?
Mr. Newmin: "MultiCell has a potential to be in the business of selling cells to the pharmaceutical industry. We have already held discussions with several companies and they were very excited about this product. That business opportunity is probably as great as the liver technology’s potential. We think we will be selling some of these cells within months after we close the acquisition. That should happen this year and will be generating revenues and hopefully profits. This is a very exciting business opportunity for us, selling to pharmaceutical firms and research companies.
MultiCell is the only company that has engineered human liver cells. Other people are growing cells using tumorigenic cells, because they proliferate rapidly. MultiCell developed a line of cells that can be replicated and produced in a laboratory that are non-tumorigenic, DNA engineered in origin."
CEOCFOinterviews – Will you be looking to make any more acquisitions?
Mr. Newmin: "We were looking at acquiring some other companies, for example we would like to acquire a medical device manufacturing company, because we would want to be able to manufacture the device, the Sybiol synthetic bio liver, and the disposable products ourselves. In all, we intend to be selling three products. The device itself, the disposable kit issued to each patient at the time of treatment and the cells that would then be applied to the patient as needed. Therefore, we would like at some point to vertically integrate all those activities."
CEOCFOinterviews - Are there any other companies working on a device for liver dialysis?
Mr. Newmin: "There are companies experimenting with liver dialysis, however, none of them is doing it in the fashion we are. We are truly unique in that we suspend our cells in a solution as opposed to growing or packing them in the device itself. There is also another company, which kills pigs to extract liver cells, freezes them and then puts them into the device. We try to create a friendly environment for the cells. The fact that we manufacture the cells eliminates major concerns of the FDA."
CEOCFOinterviews - Do you have the cash or credit to continue going forward?
Mr. Newmin: "We are always raising money. We raised over a million dollars in the last 12 months from a group in Dallas, and now we are in the process of raising more, both to close the acquisition of MultiCell and to cover operating expenses. Beyond that we will be trying to form an alliance with a major financial partner, a strategic partnership for the major money required for the FDA trials."
CEOCFOinterviews – In closing, what would you like to say to your current shareholders and potential investors?
Mr. Newmin: "I think we are at a very exciting point where the company is clearly about to make a major breakthrough in terms of the new cell line and the way the cells work in our device. We also have a patent for our technology that, we hope, will be issued shortly. We have additional patentable processes that are evolving in our new design concept. We believe that we are in a good position looking forward.
This company has been around for a long time. Since I have been involved, I have never questioned or doubted any of our doctors or scientists, and have always believed that we could develop a device that would work. I think that the addition of MultiCell is the most exciting thing that could happen to us. Where we are today was once only a dream, and we have done it quite rapidly. I think that the MultiCell acquisition is an incredible opportunity, and if we can do even a part of what we think we can, our shareholders will be very happy."
EXTI Chairman and
Chief Executive Officer
Here is an old interview of Gerald Newmins dated August 2001 with a bit of bio on him
http://www.ceocfointerviews.com/interviews/ExtenInd.htm
Healthcare
Biotech
Medical Equipment
OTC BB: EXTI
Exten Industries, Inc.
9620 Chesapeake Dr., Suite 201
San Diego, CA 92123
Phone: 858-496-0173
Gerald Newmin
Chairman and
Chief Executive Officer
Interview conducted by:
Walter Banks, Co-Publisher
CEOCFOinterviews.com
August 2001
BIO OF CEO
Jerry Newmin has managed NYSE and American Exchange-listed Fortune 500 companies and start-ups, specializing in turning around troubled companies and improving revenues, profits and shareholder value. He has been President of HealthAmerica and International Silver Company, CEO of numerous Whittaker Divisions, VP of American Medicorp, CEO of SYS and Chairman of International Forum for Corporate Directors. Additionally, Jerry is Chairman, Treasurer and Director for Xenogenics Corp.
About
Exten Industries, Inc.
Exten Industries, Inc., through its Xenogenics Corporation subsidiary, is engaged in the business of managing the research and development and commercialization of the Sybiol® synthetic bio-liver, an "artificial liver" or liver support system. The Sybiol® liver device is based on technology for continuously circulating liver cells (hepatocytes) through a semi-permeable bio-membrane.
On April 2, 2001, Exten Industries, Inc. announced that they had signed a Letter of Intent to acquire its research and development partner, privately held MultiCell Associates, Inc. (MultiCell) of Warwick, RI in a cash plus stock transaction. Specific details were not disclosed. This acquisition will solidify the working relationship between the two firms in their joint liver assist device program.
MultiCell is a highly respected research company with unique expertise in developing functional cells and cell lines with a special focus on liver derived cells. They have several patents issued on their immortalized hepatocytes or engineered liver cells. MultiCell’s mission, to develop and commercialize cells for diagnosis and treatment of liver diseases, has resulted in an exclusive non-tumorigenic DNA-engineered porcine hepatocyte cell line. Exten has redesigned their device to operate with the MultiCell technology using DNA engineered liver cells.
The Sybiol® liver therapy device is intended to be used as an artificial liver "bridge" for transplant patients when no donor organ is available, and, via regular outpatient treatments, maintain essential liver functions for patients with chronic liver disease or other liver trauma until the human liver heals and is able to resume normal liver functions. It may also increase the quality of life in those patients who are not curable. Lastly, the device may be an effective tool for laboratory testing, veterinary applications, and/or drug testing applications.
CEOCFOinterviews - Mr. Newmin, can you give us a brief history of Exten Industries?
Mr. Newmin: "Exten has been around for a long time, but my involvement began in late 1995. The company acquired the artificial liver device technology from a major medical center in Los Angeles in l993. Exten then stopped all its other activities and concentrated solely on an external biological device to artificially perform some of the basic functions of the human liver. The device is trademarked Sybiol® for synthetic bio-liver.
CEOCFOinterviews - Where is your external liver device in its development?
Mr. Newmin: "The original design of the device was used with liver cells that were extracted from live pigs. We were conducting our research at Loyola Medical Center in Chicago. However, it became apparent that, with both the FDA and the public, dealing with animal retro viruses was going to be a problem. We found a company called MultiCell Associates in Warwick, Rhode Island that developed and patented DNA engineered cells that were manufactured in a laboratory. Therefore, we switched all of our research and development over to MultiCell last year, using DNA engineered pig liver cells. That required redesigning our device. This new device has now restarted testing, and our goal is to use it on large animals, primarily pigs. Following these tests and developing enough hard data, we will file an IND application with the FDA preparatory to initiating Phase 1 safety testing."
CEOCFOinterviews - Do you have any projections as to when clinical trials may start?
Mr. Newmin: "We plan to complete animal trials later this year, and then we plan to start clinical trials in 2002. It is not entirely clear as to exactly how long it will take to get to Phase II and Phase III of the FDA trials. We feel it may take 3 to 5 years. That depends on how many patients the FDA will require to be tested."
CEOCFOinterviews – What will your relationship with MultiCell Associates be going forward?
Mr. Newmin: "MultiCell will be a wholly owned subsidiary of Exten. The owner of MultiCell Associates, an internationally known scientist, unfortunately passed away and his estate decided to sell the company. We have signed a Letter of Intent to acquire the company and are in final stages of closing that transaction. Acquiring MultiCell will allow us to keep all of our research in house. Moreover, the acquisition also gives us the exclusive right to the cell lines. Multicell has developed a human liver cell that they can manufacture in laboratories. Therefore, our hope is to test the device with the human liver cell, which clearly will be a more approvable process than the use of pig liver cells. Since the human liver cell has some significant opportunities for toxicity testing, we think that other products may evolve from these cell lines. Sometime in the future we may consider the merger of MultiCell with our subsidiary Xenogenics Corporation, which owns the artificial liver technology."
CEOCFOinterviews – What changes have you made in the Sybiol® device technology since its acquisition?
Mr. Newmin: "There were certain problems with the technology. Therefore Dr. Brems, the chairman of our advisory board and a member of the staff of the transplant program at the Loyola University came up with some innovative ideas, unique in terms of the way these cells were presented to the patient plasma. That resulted in a patent that is now working it’s way through the patent office. Our objective is to develop a device where the cells stay alive for long periods, therefore extending their viability in terms of their interface with the patient blood. That makes the treatment more efficacious and at the same time drives down the cost per treatment. As an example, the Sybiol® is a device designed to be a "bridge" for transplant patients, when no donor organ is available and, via regular outpatient treatments, maintain essential liver functions for patients with chronic liver disease and other liver trauma until the human liver heals. Our goal is to be able to slow down the rate at which the liver is going to fail or, if we are fortunate, prevent the liver from failing altogether.
The liver is the only organ that will rejuvenate itself, if you allow it. A family member or close relative can literally donate a part of their liver to another family member with a liver failure and the donor's liver will grow back quite quickly. The idea here is to provide “off-line” help to the liver so that it can rejuvenate itself throughout these diseases and allow the patient to lead a normal life.”
CEOCFOinterviews - Can you give us a little more detail on how that would work?
Mr. Newmin: "With kidney dialysis you go for periodic treatments into an outpatient center, where they purify your blood. With our Sybiol device, the patient would go to a similar kind of facility. We do not know exactly how often or how frequently or how long the treatments would be; that would depend on their individual condition. However, you would essentially run a patient’s blood through our device exposing its plasma to the cells contained within our device. There would then be an interaction between the cells in our device and the patient blood plasma where the cells actually perform some of the functions of the liver, including de-toxification. It will probably happen at an outpatient dialysis center, because everything you need for this type of dialysis is already there. We probably would have liver dialysis departments, just as there are kidney dialysis departments."
CEOCFOinterviews – How will you approach the market place?
Mr. Newmin: "We believe the market is very large. The market is not just transplants - there are only about four thousand transplants a year done in the United States. However, because Hepatitis, particularly Hepatitis C, is on the rise all over the world, the business opportunity for a liver assist device is probably as large as or larger than kidney dialysis, which is in the hundreds of millions. We will talk to some of the key players in the major pharmaceutical companies as soon as we have good hard data and are in FDA trials. We will attempt to partner with someone who has much better resources to put our device out to the market than we do."
CEOCFOinterviews – Can you give us an idea of the current cost in treating liver disease?
Mr. Newmin: "It is a very expensive process. For example, it costs over $300,000 for a liver transplant. Our goal is to get the outpatient treatment with dialysis down to close to what kidney dialysis runs. That could be in the thousands of dollars per treatment, yet it is certainly is not in the hundreds of thousands, which is what a transplant would cost. There are a number of treatments that can help the diseased liver, yet they are all very expensive."
CEOCFOinterviews - What other revenue generating possibilities are there for the MultiCell Company?
Mr. Newmin: "MultiCell has a potential to be in the business of selling cells to the pharmaceutical industry. We have already held discussions with several companies and they were very excited about this product. That business opportunity is probably as great as the liver technology’s potential. We think we will be selling some of these cells within months after we close the acquisition. That should happen this year and will be generating revenues and hopefully profits. This is a very exciting business opportunity for us, selling to pharmaceutical firms and research companies.
MultiCell is the only company that has engineered human liver cells. Other people are growing cells using tumorigenic cells, because they proliferate rapidly. MultiCell developed a line of cells that can be replicated and produced in a laboratory that are non-tumorigenic, DNA engineered in origin."
CEOCFOinterviews – Will you be looking to make any more acquisitions?
Mr. Newmin: "We were looking at acquiring some other companies, for example we would like to acquire a medical device manufacturing company, because we would want to be able to manufacture the device, the Sybiol synthetic bio liver, and the disposable products ourselves. In all, we intend to be selling three products. The device itself, the disposable kit issued to each patient at the time of treatment and the cells that would then be applied to the patient as needed. Therefore, we would like at some point to vertically integrate all those activities."
CEOCFOinterviews - Are there any other companies working on a device for liver dialysis?
Mr. Newmin: "There are companies experimenting with liver dialysis, however, none of them is doing it in the fashion we are. We are truly unique in that we suspend our cells in a solution as opposed to growing or packing them in the device itself. There is also another company, which kills pigs to extract liver cells, freezes them and then puts them into the device. We try to create a friendly environment for the cells. The fact that we manufacture the cells eliminates major concerns of the FDA."
CEOCFOinterviews - Do you have the cash or credit to continue going forward?
Mr. Newmin: "We are always raising money. We raised over a million dollars in the last 12 months from a group in Dallas, and now we are in the process of raising more, both to close the acquisition of MultiCell and to cover operating expenses. Beyond that we will be trying to form an alliance with a major financial partner, a strategic partnership for the major money required for the FDA trials."
CEOCFOinterviews – In closing, what would you like to say to your current shareholders and potential investors?
Mr. Newmin: "I think we are at a very exciting point where the company is clearly about to make a major breakthrough in terms of the new cell line and the way the cells work in our device. We also have a patent for our technology that, we hope, will be issued shortly. We have additional patentable processes that are evolving in our new design concept. We believe that we are in a good position looking forward.
This company has been around for a long time. Since I have been involved, I have never questioned or doubted any of our doctors or scientists, and have always believed that we could develop a device that would work. I think that the addition of MultiCell is the most exciting thing that could happen to us. Where we are today was once only a dream, and we have done it quite rapidly. I think that the MultiCell acquisition is an incredible opportunity, and if we can do even a part of what we think we can, our shareholders will be very happy."
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