NBI History and Heritage

Nutritional Biochemistry, Inc. (NBI) was founded in 2006 by Drs. John Neustadt and Steve Pieczenik. From the beginning they established a company that uniquely combines their respective medical, research and entrepreneurial backgrounds. NBI was founded in true entrepreneurial fashion by two people who invested their own money, countless hours and vision into creating a company and products to help others improve their health. The company's unique products, such as Osteo-K™ and Osteo-K Minis™ dietary supplements, are based on years of medical and scientific research, human clinical trials and basic research. Osteo-K and Osteo-K Minis are the only natural products in the United States with calcium and Vitamin D, plus the amount of MK4 (45 mg per day) approved as a medication in Japan for osteoporosis and the pain of osteoporosis, and shown to help people with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), hepatocellular carcinoma (HCC, liver cancer) and promyelocytic leukemia.

NBI and MK4 Milestones


1995 Japanese Ministry of Health approves MK4™ as a medication to treat osteoporosis and osteoporosis pain. Since then more than 6000 people have taken MK4 for up to eight years, some even with liver and kidney failure, without any dangerous side effects reported in the medical literature. See MK4 studies.
1997
MK4 kills lekeumia cells in study published in the journal Leukemia.
1998
Clinical trial in the journal Bone concludes that MK4 (45 mg daily) increases bone density in post-stroke patients with partial paralysis.
1999

The journal Leukemia publishes a case report showing MK4 (90 mg daily) improves blood markers and normalizes platelets in a patient with MDS, and that the improvement is maintained on 45 mg MK4 for the remainder of the treatment follow up of another 8.5 months.

That same year, Leukemia also publishes an article showing that MK4 kills MDS/AML cells by apoptosis.

Maturitas publishes clinical trial showing MK4 (45 mg daily) increases bone density in postemenopausal women with osteoporosis.
International Journal of Haematology publishes a case report of an 80 year old woman with MDS who was given MK4 (45 mg/day) and improved to the point where she no longer needed transfusions 14 months later.
2000

Leukemia journal publishes survey study showing MK4 (up to 135 mg daily) improves 44% of AML patients in the study.

Calcified Tissue International publishes clinical trial of the effect of MK4 (45 mg daily) on bone loss in patients with kidney failure taking prednisone, a steroid drug that causes osteoporosis. The study concludes MK4 prevents bone loss from prednisone.
Journal of Bone Mineral Research publishes clinical trial that concludes MK4 (45 mg daily) "prevents fractures and sustains lumbar bone mineral density in osteoporosis."
 
Leukemia journal features study showing MK4 kills leukemia cells without harming healthy cells, about which the authors write, MK4 "appears to have clinical benefits for the treatment of patients with leukemias and myelodysplastic syndromes."
2001
Endocrine Journal publishes study in children with Juvenile Rheumatoid Arthritis showing that MK4 (2 mg per kg body weight) increases bone density in children on long-term prednisone therapy.
Current Opinion in Clinical Nutrition and Metabolic Care publishes a research review that concludes MK4 "has impressively been used to prevent further bone mineral loss and fracture risk in osteoporotic patients."
2002

Fractures decrease 90% in clinical trial of Parkinson Disease patients with osteoporosis taking MK4 (45 mg daily).

The American Journal of Gastroenterology publishes study showing that MK4 (45 mg daily) preserves bone density in patients with liver cirrhosis compared to those not taking MK4.
Blood markers improve in 56% of patients with MDS taking MK4 (45 mg daily) in a clinical trial.
2003
Pyshiatry Research publishes clinical trial concluding that MK4 (45 mg daily) preserves bone density in women with anorexia nervosa, a condition that causes osteoporosis.
Journal of Vascular Research publishes animal study that concludes MK4 inhibits arterial calcifications.
2004
Journal of the American Medical Association publishes clinical trial showing that MK4 (45 mg daily) reduces by 80% the development of liver cancer in women with Hepatitis C at high risk for cancer.
The American Journal of Kidney Diseases publishes clinicial trial of sixty patients with kidney disease taking prednisone and the ability of MK4 (45 mg daily) plus Vitamin D to stop bone loss. The study concludes MK4 plus Viamin D tstops bone loss and prevents the increase in blood calcium levels seen in people taking vitamin D alone.
2005

MK4 (45 mg daily) decreases fractures 87% in clinical trial of Alzheimer disease patients with osteoporosis.

World Journal of Gastroenterology publishes case report of a patient with hepatocellular carcinoma (HCC, liver cancer) whose tumor regresses with MK4 (45 mg daily), with no signs of cancer after 22 months.
2006
NBI is founded in Bozeman, MT by Drs. John Neustadt and Steve Pieczenik. They create a unique line of natural products sold directly to the public and prescribed by healthcare providers. As entrepreneurs committed to helping people with fomrulas based on human clinical trials, they work tirelessly to create NBI our of internet coffee shops with a vision, with passion and with a dream of building a global A Revolution in Health™.
Haematologica
Haematologica publishes study showing MK4 kills meyloma cells, a finding that prompts the authors to write, MK4 "may be a good candidate for myeloma patients."
Nutrition Reviews publishes study showing that MK4 "improves bone architecture" and "bone strength."
Journal Cancer publishes clinical trial showing MK4 (45 mg daily) "may have a suppressive effect on recurrence of HCC [hepatocellular carcinoma, liver cancer] and a beneficial effect on survival."
2007

Drs. Neustadt and Pieczenik release their first book, A Revolution in Health Through Nutritional Biochemistry, which teaches people about the underlying biochemical causes of diseases and how they can take charge of their own health.

Drs. Neustadt and Pieczenik's ground-breaking article, Mitochondrial Dysfunction and Molecular Pathways of Disease, is published in the journal Experimental and Molecular Pathology. This article becomes a top ten cited articles for two consecutive years, and they are recognized by Elsevier, the world's largest medical publishing company, as being Top Ten Cited Authors for 2007 & 2008. Based on their research for this article the doctors created their MitoForte product to promote healthy memory, energy and mood.
Clinical Cancer Research features an article showing that MK4 slows liver cancer cell growth and decreases inflammatory markers.
Osteoporosis International publishes clinical trial that deteremines MK4 (45 mg daily) "improves hip bone geometry and bone strength indices in postmenopausal women."
2008

A Revolution in Health

Drs. Neustadt and Pieczenik publish their second book, A Revolution in Health Part 2:How to Take Charge of Your Health, which continues their mission of helping people become educated healthcare consumers and teaching them how to take charge of their own health.

The doctors write a two-part, cover article series, Osteoeporosis: Beyond Bone Mineral Density (Part 1, Part 2) for the journal Integrative Medicine: A Clinician's Journal.
A senior FDA researcher requests Drs. Neustadt and Pieczenik write an article on Medication-Induced Mitochondrial Damage and Disease, which is published in the journal Molecular Nutrition and Food Research.
Thrombosis Research publishes study that concludes "MK4 acts as an anti-calcification component in the vessel wall."
2009

Drs. Neustadt and Pieczenik's third book, Foundations and Applications of Medical Biochemistry in Clinical Practice is published. This seminal book teaches healthcare professionals how to test and treat patients using the paradigm of biochemical medicine.

NBI moves its manufacturing into a state-of-the-art, FDA-registered, cGMP-approved, 175,000 square foot facility in Long Island, NY.
Clinical Drug Investigations publishes a review of clinical trials concluding that MK4 (45 mg daily) decreases vertebral and non-vertebral hip fractures.
Study by orthopedic surgeons in Thailand demonstrate that giving MK4 given after hip surgery in avascular necrosis (AVN) to "help with bone mineralization during healing stage" preserves the hip joint.
2010

Based on their research for NBI, Drs. Neustadt and Pieczenik create NBI Pharmaceuticals, Inc to develop products to help people with rare disease, called "orphan diseases." In the following twelve months NBI Pharmaceuticals receives a total of 15 FDA orphan drug designations for cancers, neurological and mitochondrial diseases, all using natural products.

In November, 2010, based on human clinical trials and case reports NBI Pharmaceuticals receives its first orphan drug designation by the FDA for MK4 as a potential treatment of liver cancer (hepatocellular carcinoma).
Leukemia Research
Leukemia Research publishes a clinical trial that shows MK4 plus vitamin D improves MDS and AML in 30% of patients studied.
Journal Hepatogastroenterology publishes clinical trial concluding that MK4 (45 mg daily) inhibits the development of hepatocellular carcinoma (liver cancer) in people with hepatitis C.
2011

NBI Pharmaceuticals receives orphan drug designations from the US FDA for the potential treatment myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) using MK4. Within the next year, the FDA awards NBI Pharmaceuticals 15 FDA orphan drug designations, more than any other company in the history of the FDA's orphan drug program.

Drs. Neustadt and Pieczenik publish the first-ever article on bisphosphonate-related osteonecrosis of the jaw (BRONJ) approved for continuing dental education credits written by a naturopathic doctor and medical doctor. Their BRONJ is the first research providing a unifying hypothesis for how osteoporosis medications such as Fosamax, Actonel and Boniva cause the jaw bone to desintigrate. The article was published online by Dental Aegis publications.
NBI moves into its FDA-registered, climate controlled warehouse facility in Orange, CT that features state-of-the art inventory control systems, order processing and tracking systems, and an Electronic Data Interchange (EDI) system. This shipping hub improves NBI's customer service, decreases shipping times and provides greater package handling and tracking options for both domestic and international shipping.
NBI begins its Cutomer Video program in which NBI customers send in videos they film themselves, without any editing, scripting or compensation by NBI. Customers are motivated to participate because they have experienced incredible benefits from NBI products, such as Osteo-K improving their bone density, stopping their bone pain, or helping people with AML and MDS improve their health.
2012

NBI reaches a company milestone with 10 million capsules sold and shipped to more than 15 countries.

NBI Oncology Support

NBI launches its Oncology Support section of its website to showcase the clinical trials, basic research and customer stories of how nutrients in Osteo-K and Osteo-K Minis promotes healthy cellular function in people with cancers.

 

Anticancer Research publishes clinical trial showing MK4 (45 mg daily) has a "suppressive effect on HCC [hepatocellular carcinoma; liver cancer] recurrence."

The Upsala Journal of Medical Sciences publishes case reports of four women with pregnancy-associated osteoporosis whose bone pain completely went away, fractures healed and bone density improved after taking MK4 (45 mg daily).
2013
Expert Opinion in Pharmacotherapy publishes research review concluding the MK4 (45 mg daily) decreases osteoporosis fracture risk.
Customer Video Update submitted from AML patient. John Rohan is still alive 1.5 years after his daughter found the research on MK4 conducted in Japan for people with MDS and AML and purchased Osteo-K for her father to take (then Osteo-K Minis after that product launched) after his doctors sent him home to die. His case is now the subject of a case report at an integrative oncology conference.
59-year old AML cancer patient submits a customer video from Poland discussing how Osteo-K helped her recover from a completely debilitated state when her doctors told her that there was nothing else they could do to help her.
Human Mutation publishes seminal article showing MK4 may play an important role in corneal (eye) health and in maintaining healthy vision.

Watch customer video of Percy Allan, of Sydney, Australia, discuss his journey with osteoporosis and the osteoporosis medications. And how after years of drug therapy his osteoporosis was finally reversed with Osteo-K. One of his doctors called his results "remarkable."

Modern Rheumatology
Clinical trial published in the journal Modern Rheumatology concludes that MK4 (45 mg/day) plus alendronate (Fosamax) increased lumbar spine and hip bone density. MK4 by itself was not tested.
2014 Watch the customer video of John Walker, a 71-year old cancer patient, talk about myelodysplastic syndrome (MDS) and how Osteo-K Minis helped him.
Dr. Neustadt speaks on "MK4 for MDS and AML: Molecular Mechanisms, Clinical Trials and Case Reports" at the largest integrative oncology medical conference in the country. Watch the webinar of Dr. Neustadt's talk.
Watch the customer video of James Malone discuss is experiences at being diagnosed with myelodsyplastic syndrome (MDS) and how Osteo-K Minis finally helped him. He took charge of his health and "proved them wrong."
Journal of Nutritional Science and Vitaminology MK4 shown to increase bone strength independent of bone density in a study using an animal model of osteoporosis.
Journal Nutrients A review of randomized controled clinical trials published in the journal Nutrients concluded that MK4 was effective at decreasing fractures in postemenopausal women with osteoporosis.

Watch customer video of Dr. Amy Whittington discuss how Osteo-K Minis has helped improve her patients' bone density scans and decrease their pain. In her medical clinic "Osteo-K Minis has been a wonderful tool."

Clinical Interventions in Aging A clinical trial published in the journal Clinical Interventions in Aging and conducted in China concluded that MK4 "is an effective and safe choice in the treatment of postmenopausal osteoporosis in Chinese women."