Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Effect of BTI320 in Addition to Current Treatment With Metformin and/or Sulfonylureas on Glycemic Control in Subjects With Type 2 Diabetes

The objective of the current study is to investigate the efficacy and safety of BTI320 compared to placebo in addition to metformin and/or sulfonylureas on glycemic control over 12 weeks in subjects with type 2 diabetes mellitus. This is a randomized, placebo-controlled, double-blind, multi-center study with two treatment arms. Study duration will be approximately 12 weeks. Participants will ingest 4 g BTI320 or matching placebo approximately 10 minutes before starting a meal, 3 times per day, at breakfast, lunch, and dinner. Eight study visits will be scheduled after the Screening visit: Baseline (day 0), weeks 3, 6, and 12 (Visits 2, 4, 6, and 8 respectively) for safety and efficacy assessments and Visits 3, 5, 7 and 9 to remove the Continuous Glucose Monitoring System.

Start Date19 Sep 2018

Sponsor / Collaborator

Boston Therapeutics, Inc.

[+1]

NCT03374501 / CompletedNot Applicable

Determination of the Glycemic and Insulinemic Index Values of Soft Drink and Two Test Meals Containing Soft Drink Consumed With Sugardown™

This study was a partly controlled laboratory-based study comparing the glycemic and insulinemic indices of 3 test meals containing soft drink alone or with SUGARDOWN™ (Galactomannan) in overweight adults.

Start Date01 Nov 2014

Sponsor / Collaborator

Boston Therapeutics, Inc.

NCT02135549 / CompletedNot Applicable

Randomized, Dose-Ranging, Cross-over, Placebo-controlled Study of the Effectiveness and Safety of SugarDown vs. Placebo in Type 2 Diabetic Subjects Treated With Metformin

To assess the safety and effectiveness of two doses of SugarDown in two different doses vs. placebo on serum glucose levels after meals in subjects with Type 2 Diabetes treated with metformin alone. There will be five visits, a screening visit, baseline visit, and 3 treatment visits. The study duration will be five weeks. Subjects will all receive placebo tablets at the baseline visit, eat a standard rice meal, and then serum glucose levels will be measured in frequent intervals over four hours immediately following the meal. Subjects will be randomized to one of the six treatment sequences. Patients will take in an unknown order one week of placebo, one week of 4 g dose and one week of 8 g dose of SugarDown immediately before breakfast, lunch and dinner meals. Patients will continue their usual metformin regimen during the trial period.

Start Date01 May 2014

Sponsor / Collaborator

Boston Therapeutics, Inc.

100 Clinical Results associated with Boston Therapeutics, Inc.

0 Patents (Medical) associated with Boston Therapeutics, Inc.

Literatures (Medical) associated with Boston Therapeutics, Inc.

01 Mar 2021·Archives of Pathology & Laboratory MedicineQ3 · MEDICINE

Enhancing Military Burn- and Trauma-Related Acute Kidney Injury Prediction Through an Automated Machine Learning Platform and Point-of-Care Testing

Q3 · MEDICINE

Article

Author: Albahra, Samer ; Fang, Lei ; Tran, Nam K. ; Makley, Amy ; Palmieri, Tina L. ; Rodriquez, Dario ; Yamaguchi, Kensuke ; Rashidi, Hooman H. ; Gerlach, Travis ; Loegering, Julia

Context.—Delayed recognition of acute kidney injury (AKI) results in poor outcomes in military and civilian burn-trauma care. Poor predictive ability of urine output (UOP) and creatinine contribute to the delayed recognition of AKI.Objective.—To determine the impact of point-of-care (POC) AKI biomarker enhanced by machine learning (ML) algorithms in burn-injured and trauma patients.Design.—We conducted a 2-phased study to develop and validate a novel POC device for measuring neutrophil gelatinase-associated lipocalin (NGAL) and creatinine from blood samples. In phase I, 40 remnant plasma samples were used to evaluate the analytic performance of the POC device. Next, phase II enrolled 125 adults with either burns that were 20% or greater of total body surface area or nonburn trauma with suspicion of AKI for clinical validation. We applied an automated ML approach to develop models predicting AKI, using a combination of NGAL, creatinine, and/or UOP as features.Results.—Point-of-care NGAL (mean [SD] bias: 9.8 [38.5] ng/mL, P = .10) and creatinine results (mean [SD] bias: 0.28 [0.30] mg/dL, P = .18) were comparable to the reference method. NGAL was an independent predictor of AKI (odds ratio, 1.6; 95% CI, 0.08–5.20; P = .01). The optimal ML model achieved an accuracy, sensitivity, and specificity of 96%, 92.3%, and 97.7%, respectively, with NGAL, creatinine, and UOP as features. Area under the receiver operator curve was 0.96.Conclusions.—Point-of-care NGAL testing is feasible and produces results comparable to reference methods. Machine learning enhanced the predictive performance of AKI biomarkers including NGAL and was superior to the current techniques.

01 Dec 2018·BMC Endocrine Disorders

A proof-of-concept study to evaluate the efficacy and safety of BTI320 on post-prandial hyperglycaemia in Chinese subjects with pre-diabetes

Article

Author: Chan, Juliana C N ; Ozaki, Risa ; Rausch, Carl W ; Kong, Alice P S ; Chow, Francis C C ; Ma, Ronald C W ; Chan, Michael H M ; Luk, Andrea O Y ; Zee, Benny C Y ; Chong, Marc

BACKGROUNDGalactomannan(s) are plant-derived fiber shown to reduce post-prandial blood glucose by delaying intestinal absorption of carbohydrates and slowing down gastric emptying. We examined glucose-lowering effects of BTI320, a propriety fractionated mannan(s) administered as a chewable tablet before meal in a proof-of-concept study in Chinese subjects with prediabetes.METHODSSixty Chinese adults aged 18-70 years with either impaired fasting glucose, impaired glucose tolerance, or glycated haemoglobin 5.7-6.4% (39-46 mmol/mol), were randomly assigned in 2:2:1 ratio to either BTI320 8 g (high dose), BTI320 4 g (low dose) or matching-placebo three times daily before meal for 16 weeks. The primary endpoint was change in fructosamine in subjects treated with BTI320 compared with placebo from baseline to week 4. Indices of glycaemic variability based on continuous glucose monitoring (CGM) and standard meal tolerance test were explored in secondary analyses.RESULTSOf 60 subjects randomized, 3 subjects discontinued study treatment prematurely. In intention-to-treat analysis, no significant differences in change in serum fructosamine between low or high dose BTI320 and placebo were observed. Using random effect models, adjusted for variability by meals, treatment with low dose BTI320 was associated with reduction in 1-h (p < 0.01), 2-h (p = 0.01) and 3-h (p = 0.02) post-prandial incremental glucose area-under-curve and post-meal maximum glucose (p = 0.03) compared with placebo. Subjects receiving low dose BTI320 had greater body weight reduction than placebo group.CONCLUSIONSBTI320 did not change fructosamine levels compared with placebo. BTI320 reduced glycaemic variability based on CGM indices.TRIAL REGISTRATIONThe study was registered at www.clinicaltrials.gov , reference number NCT02358668 (9 February 2015).

01 Sep 2014·Journal of Diabetes Science and Technology

Treatment With Novel Galactomannan Derivative Reduces 2-Hour Postprandial Glucose Excursions in Individuals With Type 2 Diabetes Treated With Oral Medications and/or Insulin

Article

Author: Trask, Laura E. ; Platt, David ; Chaidarun, Sushela S. ; Parkin, Christopher G.

Background: Galactomannan is an insoluble polysaccharide that has been shown to reduce postprandial excursions. We assessed the impact of a novel galactomannan derivative (PAZ320) on the magnitude of 2-hour postprandial glucose excursions in individuals with type 2 diabetes who were being treated with oral medication and/or insulin. Methods: Investigators recently reported findings from a single-center, open-label, prospective study that evaluated the efficacy of PAZ320 in 24 subjects with type 2 diabetes who were treated with oral antidiabetic agents and/or insulin. End points included adverse events and area under the curve during 3-hour postprandial glucose excursion (gAUC). Subjects consumed a test meal without PAZ320 at baseline and then ingested low-dose (8 g) and high-dose (16 g) PAZ320 with test meals at subsequent intervention visits. A post hoc analysis was conducted to determine changes in 2-hour postprandial glucose excursions. Results: Among the 20 subjects for whom data were available for all clinic visit test meals, 15 (75%) responded to low-dose, high-dose, or both medication dosages. Low-dose responders (n = 8) experienced clinically significant improvements in 2-hour postprandial glucose excursions from baseline excursions compared with nonresponders (–28.00 ± 25.97 mg/dL vs 23.42 ± 11.45 mg/dL, P = .005). Similar differences were seen in high-dose responders (–28.82 ± 24.26 vs 33.89 ± 20.56 mg/dL, P < .0001). Conclusions: PAZ320 was shown to be safe in all patients studied and effective in controlling postprandial glucose in a large portion of the study population. Additional studies are needed to determine its long-term effects on HbA1c and to further define which subpopulation(s) may respond to PAZ320 therapy.

News (Medical) associated with Boston Therapeutics, Inc.

29 Nov 2022

·www.biospace.com

Nanomix Enters into Distribution Agreement for the eLab System with Gepa Srl in Italy

SAN LEANDRO, Calif., Nov. 29, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care (POC) diagnostics, today announced that it has entered into a distribution agreement with Gepa Srl (“Gepa”), a distributor and supplier of diagnostic products in Italy. John Hardesky, Chief Commercial Officer of Nanomix, stated, “Gepa has significant experience in this increasingly complex and important segment of critical infections, sepsis, and antibiotic stewardship. Over the last decade, their team has actively implemented clinical diagnostic solutions to help caregivers improve patient outcomes and positively impact hospital performance. We are excited to support and align with Gepa on an ambitious execution plan to bring our technology to a competitive market like Italy.” Riccardo Figus, Business Manager of Gepa, commented, “The GEPA team is very excited to develop the Italian market for the new eLab, a true Point of Care device. The agreement with Nanomix enables us to offer our customers an innovative solution for the fight against sepsis. This is a big step forward for the Italian healthcare system to bring reliable results from sample to result wherever the emergency is.” Sepsis is a recognized global health crisis. Early identification and treatment is a need and a challenge for healthcare professionals around the globe. For many reasons, sepsis can be difficult to identify and is frequently under-diagnosed in the earliest stages. It affects as many as 50 million people every year, leading to approximately 11 million deaths annually. The Nanōmix eLab® system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanōmix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. Furthermore, the S1 Panel Cartridge was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for procalcitonin (PCT), C-reactive protein (CRP) and lactate (LAC) from a single venous whole blood or plasma sample type. The assay runs on the eLab® Analyzer with results available in approximately 12 minutes from sample to answer, versus the current diagnostic solutions which can take hours to provide a test result. The S1 Panel assay has received the CE marking in Europe and has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration. About Gepa Srl Gepa isan ISO 9001:2015 certified company specializing in the research and distribution of analyzers for the simple and rapid determination of appropriate tests at the Point of Care. About Nanomix Corporation Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanōmix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit . Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Relations Contact: Natalya Rudman Crescendo Communications, LLC Email: NNMX@crescendo-ir.com Tel: (212) 671-1020 Ext.304

License out/inDiagnostic Reagents

04 Nov 2022

·www.biospace.com

Nanomix Enters into Multi-Country Distribution Agreement for the eLab System with Mast Group Limited

SAN LEANDRO, Calif., Nov. 04, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care (POC) diagnostics, today announced that it has entered into a multi-region distribution agreement with Mast Group Limited (“Mast”), an independent world class manufacturer and supplier of diagnostic products for clinical, industrial and veterinary testing. Mast is headquartered in the United Kingdom and has subsidiary companies in Reinfeld, Germany (Mast Diagnostica GmbH) and Amiens, France (Mast Diagnostic). Mast will market and distribute the Nanōmix eLab® system in the United Kingdom, Germany, France, Ireland and South Africa. Thomas Schlumpberger, Chief Executive Officer of Nanomix, stated, “This new agreement with Mast Group becomes our largest expansion to date within Europe for the Nanomix eLab® system. The Nanomix solution is a unique, breakthrough technology that offers mobile, timely diagnostic capability from a whole blood sample. The eLab system will help expedite sepsis and pneumonia diagnosis leading to more informed treatment decisions, thus improving patient outcomes and hospital clinical collaboration.” John Hardesky, Chief Commercial Officer of Nanomix, stated, “It has been a pleasure working with The Mast Group to bring this agreement to fruition. Mast has significant experience and presence in this increasingly complex and important area of critical infections, sepsis, and antibiotic stewardship. Their team is experienced and is actively participating in clinical conversations and solutions to improve patient outcomes and impact hospital performance. We are excited to actively align with Mast on an aggressive execution plan to bring our technology to multiple markets throughout Europe.” Sandy Daun, Sales and Marketing Director of Mast Group, commented, “The Mast Group has always been proud of its commitment and ability to offer innovative diagnostic products that help our customers. We are pleased to begin this long-term, strategic relationship with Nanomix which reinforces that commitment. The platform technology provides the right foundation for assay expansions which will complement the growth areas important to Mast and our customers.” Sepsis is a recognized global health crisis. Early identification and treatment is a need and a challenge for healthcare professionals around the globe. For many reasons, sepsis can be difficult to identify and is frequently under-diagnosed in the earliest stages. It affects as many as 50 million people every year, leading to approximately 11 million deaths annually. The Nanōmix eLab® system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanōmix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. Furthermore, the S1 Panel Cartridge was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for procalcitonin (PCT), C-reactive protein (CRP) and lactate (LAC) from a single venous whole blood or plasma sample type. The assay runs on the eLab® Analyzer with results available in approximately 12 minutes from sample to answer, versus the current diagnostic solutions which can take hours to provide a test result. The S1 Panel assay has received the CE marking in Europe and has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration. About Mast Group Ltd. Mast Group Ltd, is an independent world class manufacturer and supplier of diagnostic products for clinical, industrial, and veterinary testing. Mast manufacturing includes microbiology, molecular biology, as well as infectious disease and autoimmune diagnostics. The Mast product portfolio has been greatly expanded and supplies worldwide to customers including hospital, private clinical, and public health. Mast Group Ltd. offers its specialized product range through its own companies plus a global network of distributors. About Nanomix Corporation Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanōmix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit . For the latest insights, follow Nanomix on Twitter and LinkedIn. Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Relations Contact: Natalya Rudman Crescendo Communications, LLC Email: NNMX@crescendo-ir.com Tel: (212) 671-1020 Ext.304

Collaborate

20 Oct 2022

·www.biospace.com

Nanomix Enters into Distribution Agreement for the eLab System with Diaclinic SpA in Chile

SAN LEANDRO, Calif., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care (POC) diagnostics, today announced a new distribution agreement with Diaclinic SpA (“Diaclinic”), a medical distributor headquartered in Santiago, Chile. Diaclinic will market and distribute the Nanōmix eLab in the Republic of Chile. “We continue to expand our footprint internationally and gain strategic regions due to the unique benefits of the eLab system,” stated Thomas Schlumpberger, Chief Executive Officer of Nanomix. “In approximately 12 minutes, the eLab system can provide healthcare professionals accurate and quantitative results without sending samples to a central lab. Time to diagnosis is critical for patients in sepsis, getting appropriate treatment right away leads to vastly improved survival rates. Additionally, first responders and other healthcare providers can use the eLab for quick, on-the-spot assessment and triage of patients no matter where they are.” John Hardesky, Chief Commercial Officer of Nanomix, commented, “Chile is a fantastic point of entry for expansion into Latin America. We are looking forward to our collaboration with Diaclinic and making an impact in Chile while supporting clinicians in the fight against critical infections and sepsis. We remain laser focused on accomplishing our near-term goal of distribution expansion into new regions and market segments.” Sepsis is a recognized global health crisis. Early identification and treatment is a need and a challenge for healthcare professionals around the globe. For many reasons, sepsis can be difficult to identify and is frequently under-diagnosed in the earliest stages. It affects as many as 50 million people every year, leading to approximately 11 million deaths annually. The Nanōmix eLab® system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanōmix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. Furthermore, the S1 Panel Cartridge was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for procalcitonin (PCT), C-reactive protein (CRP) and lactate (LAC) from a single venous whole blood or plasma sample type. The assay runs on the eLab® Analyzer with results available in approximately 12 minutes from sample to answer, versus the current diagnostic solutions which can take hours to provide a test result. The S1 Panel assay has received the CE marking in Europe and has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration. About Diaclinic SpA Diaclinic is a distribution company in Chile currently representing various medical products and devices to Chile markets including private and public clinical entities. Diaclinic is led by Carlos Jimenez S. who has established successful businesses in this area and who also serves as the Director General for Microbac SpA in Chile. About Nanomix Corporation Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanōmix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit . Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Relations Contact: Natalya Rudman Crescendo Communications, LLC Email: NNMX@crescendo-ir.com Tel: (212) 671-1020 Ext.304

Collaborate

100 Deals associated with Boston Therapeutics, Inc.

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Drug(Targets)	Indications	Global Highest Phase

BTI-320 ( AMY1A x MGAM x Peptide hydrolase )	Diabetes Mellitus, Type 2 More	Discontinued
Human proislet peptide	Diabetes Mellitus, Type 1 More	Pending
CDM-1102	Diabetes Mellitus More	Pending
CDM-1103	Obesity More	Pending

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