August 24, 2016
An unusually hot summer in Florida created delays in the production scale-up of the Company’s proprietary algal strain as cultivation pond water temperatures exceeded the optimal growth range. Heat exchangers were built and a chiller system was installed by mid-July, and testing resumed in early August. The pilot facility is where the commercial production protocols are developed, forming a significant part of the final product specifications required by the FDA compliance process under regulations promulgated by that agency.
The production protocols become part of the “current Good Manufacturing Practices” or “cGMP” documentation, which is a pharmaceutical manufacturing standard now being applied to dietary supplements and food ingredients. These protocols must be formalized before safety testing can begin, so that the FDA is assured that the same manufacturing practices are observed during commercialization as those used during initial safety testing.
July 11, 2016
Researchers at the University of Georgia’s Center for Complex Carbohydrate Research concluded the most recent phase of analytics to determine the composition of the culture supernatant, the liquid in which the ZIVO algal strain is produced. The supernatant has demonstrated bioactive properties over dozens of in vitro and in vivo experiments and presents a less complex analytical undertaking than the algal biomass itself. The general consensus within the Company is that the biomass and supernatant both hold measurable quantities of bioactive compounds.
The isolated and separated fractions of the supernatant will be tested for bioactivity at Southern Research, a contract research organization located in Atlanta, Georgia, and an established scientific resource for ZIVO Bioscience, Inc., sometime in early September. The Company is not making public the identification or characterization of the bioactive compounds pending the publication of patent applications.
June 14, 2016
ZIVO Bioscience, Inc. has advised its potential customers and strategic partners of an exceptional nutritional profile offered by the proprietary algal biomass the Company has optimized over the last 3 years. 100 grams of dried algal biomass yields 43 grams of high-quality protein and 24 grams of dietary fiber with more Vitamin A than 3 ounces of beef liver and more Vitamin C than a medium-sized orange. 100 g of Zivo algae (freeze dried, non-concentrated natural form) outperforms soy flour, fish protein powder and concentrated whey powder in 20 essential amino acids.
May 25, 2016
Orlando, Florida-based FDA consulting firm Burdock Group executed documents to assist in the development of product specifications, safety study design and supervision thereof, as well as management of the GRAS compliance process on behalf of ZIVO Bioscience, Inc., working with R&D Director Dr. Amy Steffek and Chief Medical Officer Dr. Scott Freeman.
Burdock Group has successfully concluded dozens of GRAS and NDI applications for dietary supplement, food ingredient, feed ingredient and additive manufacturers, and is a recognized leader in the field of FDA compliance consulting.
April 1, 2016
Two 50,000 liter ponds are slated to begin construction at an oceanfront facility in Vero Beach, FL to produce the Company’s proprietary, optimized algal strain for use in FDA compliance studies, customer evaluations, and commercialization. The facility will be supervised by Arizona Center for Algae Technology and Innovation (AzCATI) laboratory manager Dr. Thomas Dempster. Its primary purpose is to develop and refine commercial production protocols necessary to comply with FDA regulations covering dietary supplements and dietary ingredients, as well as to provide algal biomass for testing in animals and humans.
March 15, 2016
ZIVO Bioscience, Inc. announced today that it has accepted the resignation of director Mr. Thomas Cox and invited Mr. Robert Rondeau to join the board of directors and serve in this capacity until his successor is appointed and qualified, or until his term expires.
Mr. Rondeau, 50, is the chief executive officer of PRZ, LLC, a financing company focused on used-car floor plan financing, retail financing and leasing, a position he has held since 2013. Mr. Rondeau is also the chief executive officer of Bran Financial, a credit card processing company, a position he has held since 2010. Prior to that, Mr. Rondeau was an executive director of Flagstar Bank, focusing on commercial, consumer and warehouse lending from 2004 through 2009. Mr. Rondeau received a Bachelor of Arts degree from Northwestern University and an Executive M.B.A. from Michigan State University.
February 1, 2016
Dr. Amy Steffek, Director of R&D, received formal notice from GreenWater Laboratories, based in Palatka, FL, that samples of the Company’s proprietary algal strain and the culture supernatant tested negative for the presence of Microcystin, Cylindrospermopsin, Saxitoxin, Anatoxin-a, Lyngbyatoxin-A, Debromoaplysiatoxin/Aplysiatoxin and β-N-methylamino-L-alanine, which are known bacterial toxins and neurotoxins. The samples were produced in the Company’s ponds and photo-bioreactors housed at the Arizona Center for Algae Technology and Innovation (AzCATI), which is located at the Mesa campus of Arizona State University. The Company’s ponds and bioreactors are operated and managed by AzCATI scientists directly supported by the Company as part of a sponsored research fellowship.
KEEGO HARBOR, MI – (January 30, 2015) – ZIVO Bioscience, Inc. (OTCQB: ZIVO), formerly Health Enhancement Products, Inc., released today expanded results of its pilot bovine mastitis study. Dairy Experts, Inc., based in northern California, conducted the months-long study on behalf of the Company, and specifically targeted mycoplasma bovis, an infective pathogen that afflicts dairy cows.
Mycoplasma refers to a genus of bacteria lacking a cell wall, making it resistant to many common antibiotics. This particular pathogen, mycoplasma bovis, is highly contagious and cows must be quarantined immediately once mycoplasma is detected. There is no approved treatment available.
ZIVO test products were administered orally, by injection and intra-mammary intubation over the course of several days once the mycoplasma infection was confirmed in the test subjects. The cows were examined daily to check the condition of udders, eyes, ears, vaginas and general condition. Further, twice-daily milk samples were tested and evaluated for infective pathogens, appearance scoring, somatic cell count, pH, and electrical conductivity, among other parameters.
Preliminary results indicate that the number of mycoplasma organisms in the udders of cows treated with the intra-mammary intubation product was noticeably decreased when compared to an untreated control group infected with the same pathogen.
Further, milk appearance, as judged by texture, color and consistency, returned to normal in 7 of 9 cows treated with intra-mammary intubation, as compared to 1 of 8 in the untreated group – a six-fold difference. Cows treated with injections and oral doses also demonstrated improvement when compared to the untreated group.
“Returning to normal milk production after a bout of mastitis is very important to dairy farmers,” states ZIVO R&D Director Dr. Amy Steffek. “Every day that a dairy cow is held back from producing milk is an operating loss to the producer. Even when antibiotics or antimicrobial treatments are used to combat the infection directly, it takes some time for milk quality and appearance to return to normal. Any product that can speed up the recovery process has considerable value. As we’ve mentioned previously on many occasions, bovine mastitis and the resulting losses in milk production cost US dairy producers almost $3 billion a year. Considering that the US dairy herd represents only 3% of the world’s 244 million dairy cows, the positive impact of speeding up recovery and improving milk quality has global economic implications.”
The Company will continue testing its products, even as it contemplates registration of its processed algal biomass as a potential feed ingredient and finalizes a formulation for a natural intra-mammary product. Specifically, the Company intends to move forward with the primary arm of its bovine mastitis research study, but focus on intra-mammary administration of candidate formulations in cows with bovine mastitis caused by the staph pathogen. The staph pathogen is a common cause of bovine mastitis that can be treated with antibiotics, but does not necessarily hasten the return of quality milk production, which can lag days or weeks after an infection has cleared up. The study would also include more work on a feed ingredient candidate, as the Company determines a minimum daily requirement necessary to promote a healthy immune response.
“We want to make sure our product isn’t specific to combatting the effects of mycoplasma only, even though that’s a pretty significant development in its own right,” continues Steffek. “Our position is that the candidate formulations promote a healthy immune response, rather than functioning like an antibiotic or antimicrobial. It’s one of the reasons why the primary arm of the larger study has been re-focused toward testing a few groups infected with staph. We’ve already demonstrated in concept that our product can be beneficial even with an untreatable pathogen like mycoplasma, but we want to establish that it demonstrates a broader range of healthy immune response.”
Over the last few months, the Company has activated its product registration and production strategy, approaching potential production partners and financing sources to ramp up commercial-scale production. A particular focus has been the prospective conversion of floundering algae biofuel facilities to high-value nutrition/therapeutics products derived from proprietary algae strains, such as those optimized by ZIVO. The Company already holds two US patents for its proprietary phyto-percolate processing, and has filed another twelve patent applications for various uses and methods of production.
“Algae-to-biofuel producers enjoyed a funding bonanza a few years ago, with the DoD, the DoE and private investors placing millions into algae startups,” states ZIVO President & CEO Andrew Dahl. “Some have come to realize that making biodiesel at a cost of $18 per gallon can’t compete successfully with fossil-based diesel that costs $3 to produce. Our goal is to approach these facilities with production contracts, leasing offers or an earn-out/buyout proposition. To us, these bio-fuel ponds represent a cost-efficient means to ramp up production in what is a capital-intensive production process.”
About ZIVO Bioscience, Inc.
ZIVO Bioscience, Inc. (OTC: ZIVO.QB) is a Michigan-based biotech company engaged in the investigation of the health benefits of bioactive compounds derived from its proprietary algal cultures, and the development of natural bioactive compounds for use as dietary supplements and food ingredients, as well as biologic and synthetic candidates for medicinal and pharmaceutical applications in humans and animals, specifically focused on autoimmune and inflammatory response modulation.
Safe Harbor Statement
Except for any historical information, the matters discussed in this press release contain 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. These forward-looking statements involve risks and uncertainties. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including the timing of completion of a trial, actual future clinical trial results being different than the results the company has obtained to date, and the company's ability to secure funding. Such statements are subject to a number of assumptions, risks and uncertainties. Readers are cautioned that such statements are not guarantees of future performance and those actual results or developments may differ materially from those set forth in the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, whether as a result of new information or otherwise.
RedChip Companies, Inc.
Jon Cunningham, 800-733-2447, ext. 107
December 12, 2014
ZIVO will attend the exclusive J.P. Morgan Healthcare Conference on January 12-15, 2015. The San Francisco-based conference draws investors from around the globe to witness the latest breakthroughs in health science, healthcare, and biotechnology.
October 20, 2014
HEPI's presentation at the RedChip Global Online CEO Conference is now available for re-play. View it here.
October 16, 2014
The RedChip Global Online CEO Conference moved Health Enhancement Products presentation to Wednesday, October 15. We apologize to all of those who missed the presentation yesterday due to anticipation that the conference would take place today, October 16, at 2:30 PM ET. RedChip will archive HEPI's presentation and it will be available online in the next few days. We will provide a link in our Project Updates section.
October 10, 2014
Health Enhancement Products, Inc. will hold its Annual Shareholder Meeting and Conference Call on Tuesday, October 14th, 2014 at 10:00 am Eastern Time.
Conference participants can use the following information to dial in:
CONFERENCE ID NUMBER: 7516788
August 14, 2014
HEPI is pleased to announce the official issuance of its patent titled â€œComposition and use of phyto-percolate for treatment of diseaseâ€, publication number US8791060 B2. The official issuance aligns with HEPIâ€™s goals of utilizing its proprietary algal compounds to generate high-value intellectual property, and the Company looks forward to continued progress.
Jul 18, 2014
An article published earlier this month on Nutraceuticalsworld.com outlines the progress and initial test results of HEPIâ€™s canine joint health study, taking place at a renowned research facility in Canada. The article can be found here.
Jul 18, 2014
An article published on Nutraingredients-USA.com discusses the ongoing research at AzCATI, along with the center's collaboration with HEPI. The article can be found here.
Jul 14, 2014
HEPI is starting follow-up experiments for the application of its bioactive compounds to canine joint health in order to further validate the initial, positive findings. The follow-up experiments will test the Companyâ€™s products against glucosamine and chondroitin, the most popular canine joint health supplements on the market. Furthermore, the Company has concluded a pre-pilot study examining the compoundâ€™s effects on cow immune health, and will commence a formal pilot study later this week.
Jun 17, 2014
HEPI's partnership with AzCATI has paved the way for the mass culturing of HEPI's algal compounds, which have been shown to have a positive effect on canine and bovine health. Recently, AzCATI finished the installation of a positive pressurized greenhouse cover (PPGC) to improve the production methodology for HEPI's biomass scale-up. Production cycles have been compressed from three months to two weeks. The increased efficiency in production cycles aligns with HEPI's goals for upcoming scale-up and commercialization, and the company looks forward to its continued partnership with AzCATI.
A sunset view of the PPGC at the AzCATI facility, in Tempe, Arizona.
Photo courtesy of Thomas A. Dempster, PhD, Arizona Center for Algae Technology and Innovation (AzCATI) © 2014
May 15, 2014
An article published by Feed Navigator features an interview with HEPI CEO Andrew Dahl, covering transition cow syndrome and the companyâ€™s innovative technology. The article is available here.
Apr 08, 2014
An article published yesterday on Nutraingredients-usa.com outlines some of HEPI's revenue strategies and recent developments for both the HEPI and WellMetris sides of the business. The article is available here.
Mar 17, 2014
Please see our latest press release covering the kickoff of a canine joint health study with Charles River. The article can be found here.
Mar 3, 2014
Please see our latest press release covering the kickoff of a canine joint health study with Charles River. The article can be found here.
Feb 7, 2014
HEPI's partnership with the University of Missouri (UMO) has yielded research results that indicate an opportunity to positively affect the health of aging dogs. One out of every five dogs suffers from osteoarthritis at some point in their lives, and they experience stiffness, pain, inflammation, and a reduction in their quality of life. Aging animals drive the pet dietary supplement industry, and according to the Journal of the American Veterinary Association, a study conducted by a global animal health company indicated that over a quarter of pet owners surveyed reported that their pets appear to experience stiffness, lameness, and reluctance/difficulty in doing some activities. Furthermore, of those who owned dogs ages 13 and older, two-thirds reported observing these signs of discomfort. HEPI and UMO's results showed that HEPI algae compounds have the ability to prevent the loss of a major structural component of cartilage in joints, glycosaminoglycan. Intact glycosaminoglycan is also an indicator of overall cartilage health, and healthy cartilage means healthy joints.
This news puts HEPI on the map as a potential new market entry, with the ability to capitalize on what the canine health market needs â€“ an innovative product, backed by sound research, which effectively supports canine joint health. Dogs could greatly benefit from such a product, because the two most popular joint health supplements on the market today, chondroitin and glucosamine, have little to no research to back up claims asserting a positive affect canine joint health. The top five U.S. pet food companies use one or both of these ingredients in their products, too, despite the lack of sound research. HEPI is paving the way towards developing a natural alternative, supported by research.
Pet supplement sales are projected to reach over $1.5 billion by 2017 (a 27% rise from 2010), and furthermore, in 2012, the top-selling supplement group was joint health, with sales of $690 million, equal to 45% of total category sales. Given that dogs have an average life span of 10-12 years, it's no wonder people are looking for options to mitigate age-related complications. HEPI looks forward to the opportunity to contribute to this booming industry. Read more about the pet supplement industry, and the market opportunities therein,Â here.
Jan 20, 2014
HEPI is in the process of conducting a canine whole blood assay with Covance Inc., a major drug development and animal testing organization. The research is underway to determine the beneficial bioactivity of HEPI compounds on canine osteoarthritis, which is characterized by stiffness, joint pain, and inflammation. The results will be announced publicly in the next few weeks.
Covance Inc. is based in Princeton, New Jersey, and the company is a significant contributor to the animal prescription medicine market. Learn more about the company here.
Jan 20, 2014
HEPI is pleased to announce that NutraIngredients.com recently published a summary of the company's cholesterol research, which was performed in conjunction with Wayne State University. The cholesterol study recently appeared in the Journal of Nutrition & Metabolism, and the NutraIngredients summary can be found here.
Jan 02, 2014
Health Enhancement Products, Inc. is pleased to announce the official issuance of their patent for â€œComposition and Use of Phyto-Percolate for Treatment of Disease.â€ The patent is available for download here.
Dec 27, 2013
Health Enhancement Products, Inc. recently entered into a collaborative agreement with an unnamed global animal health company. The partnership will commence with an in vivo validation study of the Companyâ€™s natural compound, the proprietary refined algal extract, and the synthetic molecules developed by HEPI, all of which address bovine mastitis, a condition prevalent among dairy cows. Upcoming validation and product development initiatives will be a result of this joint partnership with scientists from the animal health company. This initial agreement may culminate in a final licensing arrangement, with more details to be made public as they become available.
Dec 20, 2013
Health Enhancement Products, Inc. (OTC.BB:HEPI.OB â€“ News), in conjunction with Wayne State Universityâ€™s Department of Nutrition and Food Science in the College of Liberal Arts and Sciences, announces the publication of a scientific article in the Journal of Nutrition & Metabolism, â€œProAlgaZyme sub-fraction improves the lipoprotein profile of hypercholesterolemic hamsters, while inhibiting production of betaine, carnitine, and choline metabolites.â€
The paper describes the beneficial effects of the Companyâ€™s proprietary algal culture in supporting healthy cholesterol balance. The fractions and isolates derived from the Companyâ€™s proprietary algae culture â€œPAZâ€ (formerly referred to as â€œProAlgaZymeâ€) were shown to be a viable candidate for supporting healthy cholesterol balance, in sharp contrast to the control group. The project, led by Smiti Gupta, Ph.D., associate professor of nutrition and food science at Wayne State University, involved monitoring lipid metabolism in a widely accepted animal model for investigating human lipid metabolism.
Nov 18, 2013
While the validation of bio activity from various algae-based production methods is being conducted at the University of Wisconsin-Madison, a synthetic version of the bioactive molecule found in HEPIâ€™s algal co-culture is also under development at an unnamed research laboratory.
Recently, an intermediate of the synthetic product was tested for anti-inflammatory properties in a primary bovine mammary epithelial cell (pBMEC) culture at the University of Wisconsin. The synthetic intermediary inhibited the release of a pro-inflammatory cytokine, which is a signaling molecule involved in a variety of biological processes, including the inflammatory and immune responses. These preliminary results suggest that, like the natural product, the synthetic version, or homolog,may be useful for reducing chronic inflammation, a characteristic of bovine mastitis.
Further testing will be required to determine whether the finished synthetic product retains the bioactive properties of the native molecule. Alternative production methods such as these are a starting point for creating synthetic variations of the natural molecules for OTC or prescription applications in both humans and animals.
Nov 14, 2013
The University of Missouri recently began investigating the effects of HEPI compounds on osteoarthritic changes that are common to older and larger breed dogs. Approximately 11 million dogs in the U.S. suffer from osteoarthritis, which is characterized by stiffness, inflammation, and joint pain.
Researchers at the University of Missouri developed a well-regarded model to study osteoarthritis using cartilage explants, which consist of donor canine joint tissue harvested after euthanasia performed for reasons unrelated to this study. A previous informal in vivo study and related in vitro findings suggest that HEPI compounds may help protect the cartilage explants, in part, by reducing cell damage cause by prolonged inflammation.
In addition, HEPI has reviewed proposals from several research laboratories for a canine whole blood assay. This is a research method that experimentally induces a state of inflammation in a test tube that mimics the conditions observed in dogs with osteoarthritis to investigate the anti-inflammatory properties of HEPIâ€™s compounds. Covance, one of the largest contract research organizations in the US,has been selected to perform this study, which will launch shortly, pending funding.
With 80% of dogs over the age of eight affected by osteoarthritis, HEPI compounds may provide a natural alternative to help many dogs live pain-free lives.
Nov 1, 2013
The University of Wisconsin-Madison recently began a second round of experiments to assess the potential health benefits of HEPI compounds for cows with mastitis (an infection of the mammary gland). Mycoplasma bovis causes a highly contagious and potentially fatal form of this mammary gland infection.
During lactation, mammary epithelial cells form an immunological barrier to protect the space where milk production takes place. When bacteria or other pathogens break through this barrier, it allows milk to leak out of this space and grants entrance to the infective agents. Transwell experiments model the physiological characteristics of the mammary gland of cows using a specialized type of cell culture.
The first Transwell experiment tested three HEPI compounds with different combinations of the naturally-occurring bioactive molecules from HEPIâ€™s algal co-culture. One of these compounds showed promising results for restoration of the immunological barrier in less than 48 hours after a Mycoplasma bovis infection.
The second round of Transwell experiments is a more robust and larger-scale examination of this compoundâ€™s abilities to protect and/or restore the immunological barrier. In addition, a synthetic intermediate will be tested alongside the natural product.Large-scale reproduction of the initial findings with either compound would be of great clinical significance, as there is currently no cure or treatment for mycoplasma-induced mastitis.