Dear Doctor,
We welcome the opportunity to speak with you at your convenience regarding implementing Regenerative Medicine therapies into your practice. The clinical efficacy of stem cell therapy has barely begun to scratch the surface of its potential, but unfortunately, legitimate stem cell vendors with a long term commitment to quality, transparency and efficacy are few and far between. It is therefore critical to engage in a due diligence process whereby the relative merits of various stem cell sources and providers are evaluated for safety, efficacy, consistency and transparency.
The good news is that we have already done that on your behalf! Our commitment to excellence and the advancement of best clinical practices and outcomes is second to none, and the manufacturers we have chosen to work with have the same commitment and approach. While the leadership of our manufacturing partners is by necessity entrepreneurial, they are first and foremost scientists, and as you will see, the attention to detail in the production and delivery of their products is exemplary. Nowhere is this more important than with the use of live stem cell allografts.
Live Stem Cell Allografts
Our vendors of choice for live cell allografts manufacture the highest quality Umbilical Cord Tissue derived live Stem Cell products currently available in the United States. These labs excel in four critical areas pertaining to allograft quality controls, manufacturing practices and marketability:
1. Safety:
Allografts are manufactured exclusively under the company’s proprietary protocols in their own lab facility in sterile and fully certified ISO Class 100 Clean Rooms to ensure patient safety from exposure to microbial contamination or viral transmissions. Each laboratory is CGMP certified, FDA registered, AATB registered, and ISO clean room certified.
Sterility testing is the most extensive that is currently available and includes both gram positive and gram negative species. With each order, physicians receive a copy of the original allogeneic batch sterility report (from an independent third party lab). Original reports are included in packaging and are also sent electronically with each order confirmation (with the donor name blacked out for HIPAA compliance).
Finally, they offer qualifying clinics the opportunity to treat patients under an approved IRB. This is very significant because if the powers that be have their way, there will soon come a time that the only way one will be able to access live stem cells is through a clinical trial. We can set up a meeting for you with our stem cell providers to discuss clinical trial opportunities.
2. Viability:
The viability of all of our allografts is independently tested and the labs include not only the batch viability test data with your cells, but also identify relevant cell markers and targeted secretions (full characterization).
3. Integrity:
Our vendor labs are fully dedicated to keeping their code of ethics, standards, and compliance far above current industry standards. They have a team of PhD’s, MD’s, research scientists, and laboratory technicians who are completely dedicated to producing and manufacturing the safest and most effective allogenic product available on the market.
The transparency of the donor serological records and original third party sterility reports that they provide with every vial shipped should be standard practice in manufacturing and distributing biological materials, but instead they are prima facia evidence of our manufacturing partners' commitment to excellence and their prioritization of efficacy/patient outcomes (substance over sizzle).
4. Efficacy:
Our carefully vetted laboratory partners produce absolute Gold Standard allografts that enable practitioners to effectively treat a wide variety of conditions:
Best in Class Autografts
Bone Marrow - We have recently partnered with a rapidly emerging leader in the autograft space - especially in the area of innovation in Orthopedics. Specifically, they have invented a superior mousetrap for bone marrow aspiration. Surgeons using bone marrow derived materials in conjunction with scaffolds or bone grafts love this unique technology which requires only a single puncture and eliminates the need for centrifuging the aspirate and removing it from the sterile field. This saves valuable time and radically lowers the risk of infection while multiplying the yield of endogenous progenitor cells that mediate vasculogenesis and orchestrate the transition from the inflammatory phase of the healing cascade to the proliferation and remodeling phases.
Unlike perinatally sourced allografts, bone marrow derived MSC’s do engraft and do have trilineage differentiation potential. This new marrow aspiration technology avoids manipulation of the cells entirely… no centrifuging, no freezing or thawing, no DMSO or cryopreservation agents, and several times more progenitor cells capable of forming CFU’s than traditional marrow aspiration technology.
In conjunction with their revolutionary BMAC kit, this company also offers an FDA cleared (and fully reimbursable) nontoxic, biocompatible and biodegradable synthetic bone graft substitute. This is a cohesive, suturable, moldable carbohydrate scaffold that provides a three-dimensional structure for cell attachment, distribution and migration and resorbs as the healing process occurs. The combination of these technologies works wonders with non-unions and has been shown to achieve a spinal fusion rate of 90% in as little as three months without any comorbidity!
This company has clearly devised a better mouse trap for harvesting bone marrow, but equally impressive is their strategic combining of very lucrative potentiating technologies like the bone grafting scaffold and an FDA approved (and also fully reimbursable) ultra-high resolution single use advanced imaging system which is not only invaluable as a diagnostic tool, but a very powerful sales tool in helping the patient clearly see the problem.
Adipose - We are also contracted with two of the leading providers of lipo-processing technology which gives our clients access to a comprehensive array of regenerative (allograft and autograft) options for their patients.
Platelet Rich Plasma (PRP) - We also offer PRP kits which gives the physician greater flexibility in clinical applications and may be used in combination with cellular therapy or as a lower cost treatment alternative.
Hyaluronic Acid (Non-Avian Sourced)
Prized for its lubricating and soothing effects, HA injections are a popular treatment in orthopedic and pain management centers to increase the volume and viscosity of synovial fluid in a joint. We have contracted to represent one of the largest suppliers of non-avian sourced HA available today, now approved in 64 countries with over 45 Million dosages administered worldwide. This product is manufactured using a bacterial biofermentation technology that eliminates the risk of avian allergies and sensitivities. Studied in over 30 investigational clinical trials, it is also FDA approved and enjoys the highest reimbursement rate in the industry.
Logos Nutritionals Regenerative Support for Stem Cell Therapy
Logos Nutritionals is an Atlanta based Nutriceutical company that was responsible for developing the Burgstiner Wellness Protocol, a comprehensive nutrient support system designed to restore integrity to the bioterrain. We have leveraged their expertise to develop supplements that offer critical nutrients to enhance Regenerative Medicine treatment outcomes by making available the raw materials needed for tissue repair and regeneration. The company offers a Regenerative Support Kit for Orthopedic Applications and a Regenerative Support Kit for Non-Orthopedic Applications along with many other valuable nutriceuticals.
An Irresistible Value Proposition
Hopefully by now the reasons we have chosen to affiliate with and recommend our superior stem cell and other Regenerative Medicine vendors are clear. It boils down to enhanced safety, efficacy, integrity, and variety in a value proposition that is difficult to ignore… especially in the “Wild West” environment we see today in the Regenerative Medicine space.
Stem cells properly derived from neonatal sources - and the amazing secretome of proteins they produce - represent the cutting edge and future of Regenerative Medicine. You will consistently see profound improvements in your patients using these amazing products, but the financial opportunity before you is similarly profound.
We have all the tools and information needed to help you get started with this incredible opportunity to change many lives together… injection training and certification, practice and patient marketing support, patient financing programs, cryo-storage solutions, malpractice solutions, clinical protocols, supporting nutriceuticals, and most importantly - top shelf regenerative materials.
To receive a product overview consultation, please fill out the form below. We look forward to hearing from you.
Warm Regards,
John M. Burgstiner
Founder and CEO
Securative Health Care Solutions LLC
[email protected]
Stem cells and cell based therapies have shown tremendous promise; yet controlled studies are still needed in order to confirm their long term safety and explore their profound potential. Professional judgment and expertise is needed in using these therapies for any therapeutic use, and we urge anyone embarking on the use of stem cell therapies or any regenerative medicine product to consult the national health data bases to evaluate current information from clinical trials. The FDA websites on human tissue should also be consulted to get its current evaluation of any regenerative therapy.
Dear Doctor,
We welcome the opportunity to speak with you at your convenience regarding implementing Regenerative Medicine therapies into your practice. The clinical efficacy of stem cell therapy has barely begun to scratch the surface of its potential, but unfortunately, legitimate stem cell vendors with a long term commitment to quality, transparency and efficacy are few and far between. It is therefore critical to engage in a due diligence process whereby the relative merits of various stem cell sources and providers are evaluated for safety, efficacy, consistency and transparency.
The good news is that we have already done that on your behalf! Our commitment to excellence and the advancement of best clinical practices and outcomes is second to none, and the manufacturers we have chosen to work with have the same commitment and approach. While the leadership of our manufacturing partners is by necessity entrepreneurial, they are first and foremost scientists, and as you will see, the attention to detail in the production and delivery of their products is exemplary. Nowhere is this more important than with the use of live stem cell allografts.
Live Stem Cell Allografts
Our vendors of choice for live cell allografts manufacture the highest quality Umbilical Cord Tissue derived live Stem Cell products currently available in the United States. These labs excel in four critical areas pertaining to allograft quality controls, manufacturing practices and marketability:
1. Safety:
Allografts are manufactured exclusively under the company’s proprietary protocols in their own lab facility in sterile and fully certified ISO Class 100 Clean Rooms to ensure patient safety from exposure to microbial contamination or viral transmissions. Each laboratory is CGMP certified, FDA registered, AATB registered, and ISO clean room certified.
Sterility testing is the most extensive that is currently available and includes both gram positive and gram negative species. With each order, physicians receive a copy of the original allogeneic batch sterility report (from an independent third party lab). Original reports are included in packaging and are also sent electronically with each order confirmation (with the donor name blacked out for HIPAA compliance).
Finally, they offer qualifying clinics the opportunity to treat patients under an approved IRB. This is very significant because if the powers that be have their way, there will soon come a time that the only way one will be able to access live stem cells is through a clinical trial. We can set up a meeting for you with our stem cell providers to discuss clinical trial opportunities.
2. Viability:
The viability of all of our allografts is independently tested and the labs include not only the batch viability test data with your cells, but also identify relevant cell markers and targeted secretions (full characterization).
3. Integrity:
Our vendor labs are fully dedicated to keeping their code of ethics, standards, and compliance far above current industry standards. They have a team of PhD’s, MD’s, research scientists, and laboratory technicians who are completely dedicated to producing and manufacturing the safest and most effective allogenic product available on the market.
The transparency of the donor serological records and original third party sterility reports that they provide with every vial shipped should be standard practice in manufacturing and distributing biological materials, but instead they are prima facia evidence of our manufacturing partners' commitment to excellence and their prioritization of efficacy/patient outcomes (substance over sizzle).
4. Efficacy:
Our carefully vetted laboratory partners produce absolute Gold Standard allografts that enable practitioners to effectively treat a wide variety of conditions:
- Cellular Wharton’s Jelly Allograft - The outstanding clinical value of their Umbilical Cord Tissue product lies in the unique composition of its extracellular matrix, scaffolding, growth factors, collagen and proteins (chemokines and cytokines) - all of which provide a solid foundation for structural regeneration and making it an excellent choice for orthopedic applications.
- Amniotic Fluid/Tissue Based (No live cells) Preparations - Our vendor of choice for non-live cell allografts has developed a full complement of FDA cleared, fully reimbursable regenerative preparations with an impressive array of bioactive proteins and growth factors and 73 Billion exosomes per cc verified on the nanosite. Their Wound Care Kits are state of the art and their new autologous skin graft system is beyond amazing.
- Exosomes are extracellular vesicles loaded with MRNA, MiRNA, and a wide variety of specialized proteins (growth factors and cytokines) and peptides that influence cell communication, differentiation and regeneration. Exosomes may be supplemented to both allografts listed above or used alone. Unlike other exosome products, ours is not a cultured product but rather is purified directly from perinatally sourced tissues (250 Billion per cc). Therefore it is free of potential unintended consequences related to phenotypic shifts (due to genetic drift) or xenogeneic responses to zoonotic serums. The company uses a sophisticated biopolymer filtration process that yields the cleanest and purest exosome product on the market today.
Best in Class Autografts
Bone Marrow - We have recently partnered with a rapidly emerging leader in the autograft space - especially in the area of innovation in Orthopedics. Specifically, they have invented a superior mousetrap for bone marrow aspiration. Surgeons using bone marrow derived materials in conjunction with scaffolds or bone grafts love this unique technology which requires only a single puncture and eliminates the need for centrifuging the aspirate and removing it from the sterile field. This saves valuable time and radically lowers the risk of infection while multiplying the yield of endogenous progenitor cells that mediate vasculogenesis and orchestrate the transition from the inflammatory phase of the healing cascade to the proliferation and remodeling phases.
Unlike perinatally sourced allografts, bone marrow derived MSC’s do engraft and do have trilineage differentiation potential. This new marrow aspiration technology avoids manipulation of the cells entirely… no centrifuging, no freezing or thawing, no DMSO or cryopreservation agents, and several times more progenitor cells capable of forming CFU’s than traditional marrow aspiration technology.
In conjunction with their revolutionary BMAC kit, this company also offers an FDA cleared (and fully reimbursable) nontoxic, biocompatible and biodegradable synthetic bone graft substitute. This is a cohesive, suturable, moldable carbohydrate scaffold that provides a three-dimensional structure for cell attachment, distribution and migration and resorbs as the healing process occurs. The combination of these technologies works wonders with non-unions and has been shown to achieve a spinal fusion rate of 90% in as little as three months without any comorbidity!
This company has clearly devised a better mouse trap for harvesting bone marrow, but equally impressive is their strategic combining of very lucrative potentiating technologies like the bone grafting scaffold and an FDA approved (and also fully reimbursable) ultra-high resolution single use advanced imaging system which is not only invaluable as a diagnostic tool, but a very powerful sales tool in helping the patient clearly see the problem.
Adipose - We are also contracted with two of the leading providers of lipo-processing technology which gives our clients access to a comprehensive array of regenerative (allograft and autograft) options for their patients.
Platelet Rich Plasma (PRP) - We also offer PRP kits which gives the physician greater flexibility in clinical applications and may be used in combination with cellular therapy or as a lower cost treatment alternative.
Hyaluronic Acid (Non-Avian Sourced)
Prized for its lubricating and soothing effects, HA injections are a popular treatment in orthopedic and pain management centers to increase the volume and viscosity of synovial fluid in a joint. We have contracted to represent one of the largest suppliers of non-avian sourced HA available today, now approved in 64 countries with over 45 Million dosages administered worldwide. This product is manufactured using a bacterial biofermentation technology that eliminates the risk of avian allergies and sensitivities. Studied in over 30 investigational clinical trials, it is also FDA approved and enjoys the highest reimbursement rate in the industry.
Logos Nutritionals Regenerative Support for Stem Cell Therapy
Logos Nutritionals is an Atlanta based Nutriceutical company that was responsible for developing the Burgstiner Wellness Protocol, a comprehensive nutrient support system designed to restore integrity to the bioterrain. We have leveraged their expertise to develop supplements that offer critical nutrients to enhance Regenerative Medicine treatment outcomes by making available the raw materials needed for tissue repair and regeneration. The company offers a Regenerative Support Kit for Orthopedic Applications and a Regenerative Support Kit for Non-Orthopedic Applications along with many other valuable nutriceuticals.
An Irresistible Value Proposition
Hopefully by now the reasons we have chosen to affiliate with and recommend our superior stem cell and other Regenerative Medicine vendors are clear. It boils down to enhanced safety, efficacy, integrity, and variety in a value proposition that is difficult to ignore… especially in the “Wild West” environment we see today in the Regenerative Medicine space.
Stem cells properly derived from neonatal sources - and the amazing secretome of proteins they produce - represent the cutting edge and future of Regenerative Medicine. You will consistently see profound improvements in your patients using these amazing products, but the financial opportunity before you is similarly profound.
We have all the tools and information needed to help you get started with this incredible opportunity to change many lives together… injection training and certification, practice and patient marketing support, patient financing programs, cryo-storage solutions, malpractice solutions, clinical protocols, supporting nutriceuticals, and most importantly - top shelf regenerative materials.
To receive a product overview consultation, please fill out the form below. We look forward to hearing from you.
Warm Regards,
John M. Burgstiner
Founder and CEO
Securative Health Care Solutions LLC
[email protected]
Stem cells and cell based therapies have shown tremendous promise; yet controlled studies are still needed in order to confirm their long term safety and explore their profound potential. Professional judgment and expertise is needed in using these therapies for any therapeutic use, and we urge anyone embarking on the use of stem cell therapies or any regenerative medicine product to consult the national health data bases to evaluate current information from clinical trials. The FDA websites on human tissue should also be consulted to get its current evaluation of any regenerative therapy.