Formulations and Availability 900 BILLION 5,319 HIGH POTENCY PROBIOTIC PEDIATRIC ADULT GERIATRIC PROVEN BY RESEARCH. HIGH-POTENCY. NO SHORTCUTS.

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1 Formulations and Availability S TU D I E S PE R D I S E A S E 39 LIVER Liver Disease, Cirrhosis, Liver Failure, Hepatic Encephalopathy S TU D I E S PE R AG E G RO U P Visbiome Regular Product Code: Product Code: GI TRACT Pouchitis, Ulcerative Colitis, IBS, Diarrhea, Crohn s Disease, Diverticulitis, Bowel Movement Nutrition, IBD, Microscopic Colitis OTHER AVAILABLE BY PRESCRIPTION ONLY Bacterial Vaginosis, Sepsis, Dyspepsia, etc. TOTA L N U M B E R O F PATI E NTS E X A M I N E D 12 4 CANADA 9 PEDIATRIC,319 1,682 S TU D I E S PE R R E G I O N ADULTS GERIATRIC (e.g. placebo-controlled, double-blind, cross-over, parallel arm) EUROPE INDIA 3 KOREA TOTA L N U M B E R O F S TU D I E S T Y PE S O F S TU D I E S 43 3 UNKNOWN 3,330 CONTROLLED AND/OR RANDOMIZED USA 7 UNCONTROLLED AND/OR OPEN LABEL (e.g. no control group, open label) PROOF OF CONCEPT (e.g. pilot study, prospective study, case study) 60 Visbiome Extra Strength Product Code: BILLION PEDIATRIC ADULT GERIATRIC 29 Product Code: BILLION HIGH POTENCY PROBIOTIC Product Product Code Bacteria Count (CFU) Dosage Format Counter Per Box/Bottle Billion (2 caps) 60 Visbiome Regular Flavor Visbiome Extra Strength Billion Important Safety Information: Mild abdominal bloating has been reported in the first few days of consuming Visbiome. This is generally a physiological adaptation of the microflora, which usually diminishes within 3-4 days. If bloating persists, the patient should reduce their intake for a few days. This product should not be used in premature infants in the Neonatal Intensive Care Unit (NICU) setting. References 1. Chen et al. Characterization of Fecal Microbial Communities in Patients with Liver Cirrhosis. Hepatology. Vol Rai R, et al. Gut Microbiota: Its Role in Hepatic Encephalopathy. Journal of Clinical and Experiential Hepatology. 201 Mar;(Suppl 1):S Qin N, Yang F, Li A, et al. Alterations of the human gut microbiome in liver cirrhosis. Nature 2014; 13: Bajaj J.S. Review article potential mechanisms of action of rifaxamin in the management of hepatic encephalopathy and other complications of cirrhosis. Aliment Pharmacol Ther 2016; 43.. Agrawal A. et al., Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open-Label, Randomized Controlled Trial American Journal of Gastroenterology. June 2012; doi:.38/ajg Mittal, V.V. et al, A randomized controlled trial comparing lactulose, probiotics, and L-ornithine L-aspartate in treatment of minimal hepatic encephalopathy. European Journal of Gastroenterology and Hepatology. 20, 23: Lunia, M.K.. et al., Probiotics Prevent Hepatic Encephalopathy in Patients With Cirrhosis: A Randomized Controlled Trial. Clinical Gastroenterology and Hepatology Jun;12(6): Maccaferri et al. Rifaximin modulates the colonic microbiota of patients with Crohns disease an in vitro approach using a continuous culture colonic model system. J Antimicrob Chemother 20; Finegold et al. Study of the In Vitro Activities of Rifaximin and Comparator Agents against 36 Anaerobic Intestinal Bacteria from the Perspective of Potential Utility in Pathology Involving Bowel Flora. Antimicrobial Agents and Chemotherapy. Jan 2009 p Fedorak N, J Clin Gastroenterol. 42:S3; S1- (2008).. Camilleri, M. Probiotics and Irritable Bowel Syndrome: Rationale, Putative Mechanisms, and Evidence of Clinical Efficacy. J Clin Gastroenterol. 2006;40: Korpela R, et al. Probiotics and irritable bowel syndrome. Microbial Ecology in Health and Disease Chio et al. Alteration of Gut Microbiotia and Efficacy of Probiotics in Functional Constipation. J Neurogastroenterol Motil. Vol Zandg et al. Effects of probiotic type, dose and treatment duration on irritable bowel syndrome diagnosed by Rome III criteria a meta-analysis. BMC Gastroenterology. 2016; Fedorak R. Probiotics in the Management of Inflammatory Bowel Diseases? Am J Gastroenterol.2007; 2:S22-S Tursi A, et al. Low-dose balsalazide plus high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis. Med Sci Monit. 2004;: Misra et al. Integrative Therapies and Pediatric Inflammatory Bowel Disease The Current Evidence. Children. 2014, 1, Chibbar et al. Probiotics in the Management of Ulcerative Colitis. J Clin Gastroenterol. Vol 49, Supp Shen et al. Effect of Probiotics on Inducing Remission and Maintaining Therapy in UC, Crohn s Disease and Pouchitis Meta-analysis of Randomized Controlled Trials. Inflamm Bowel Dis. 2014;20: Floch, M. Probiotic Therapy for Ulcerative Colitis. J Clin Gastroenterol Ng et al. Immunosuppressive Effects via Human Intestinal Dendritic Cells of Probiotic Bacteria and Steroids in the Treatment of Acute Ulcerative Colitis. Inflamm Bowel Dis Gionchetti P, et al. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: A double-blind, placebo-controlled trial. Gastroenterology. 2000;9(2): Gionchetti P, et al. Prophylaxis of pouchitis onset with probiotic therapy: A double-blind, placebo-controlled trial. Gastroenterology. 2003b;124(): Singh et al. Treatment and prevention of pouchitis after ileal pouch anastomosis for chronic ulcerative colitis. The Cochrane Collaboration Holubar et al. Treatment and prevention of pouchitis after ileal pouchanal anastomosis for chronic ulcerative colitis. The Cochrane Collaboration. 20 Issue 6 (844) FIT-GUTS ( ) VIS PROVEN BY RESEARCH. HIGH-POTENCY. NO SHORTCUTS. Visbiome and Visbiome Extra Strength are medical foods intended for the dietary management of dysbiosis associated with irritable bowel syndrome (IBS), ulcerative colitis (UC), pouchitis, and hepatic encephalopathy (HE). Visbiome is a medical food for the dietary management of dysbiosis associated with: * Irritable Bowel Syndrome (IBS) * Ulcerative Colitis (UC) * Pouchitis * Hepatic Encephalopathy (HE)

2 Formulations and Availability S TU D I E S PE R D I S E A S E 39 LIVER Liver Disease, Cirrhosis, Liver Failure, Hepatic Encephalopathy S TU D I E S PE R AG E G RO U P Visbiome Regular Product Code: Product Code: GI TRACT Pouchitis, Ulcerative Colitis, IBS, Diarrhea, Crohn s Disease, Diverticulitis, Bowel Movement Nutrition, IBD, Microscopic Colitis OTHER AVAILABLE BY PRESCRIPTION ONLY Bacterial Vaginosis, Sepsis, Dyspepsia, etc. TOTA L N U M B E R O F PATI E NTS E X A M I N E D 12 4 CANADA 9 PEDIATRIC,319 1,682 S TU D I E S PE R R E G I O N ADULTS GERIATRIC (e.g. placebo-controlled, double-blind, cross-over, parallel arm) EUROPE INDIA 3 KOREA TOTA L N U M B E R O F S TU D I E S T Y PE S O F S TU D I E S 43 3 UNKNOWN 3,330 CONTROLLED AND/OR RANDOMIZED USA 7 UNCONTROLLED AND/OR OPEN LABEL (e.g. no control group, open label) PROOF OF CONCEPT (e.g. pilot study, prospective study, case study) 60 Visbiome Extra Strength Product Code: BILLION PEDIATRIC ADULT GERIATRIC 29 Product Code: BILLION HIGH POTENCY PROBIOTIC Product Product Code Bacteria Count (CFU) Dosage Format Counter Per Box/Bottle Billion (2 caps) 60 Visbiome Regular Flavor Visbiome Extra Strength Billion Important Safety Information: Mild abdominal bloating has been reported in the first few days of consuming Visbiome. This is generally a physiological adaptation of the microflora, which usually diminishes within 3-4 days. If bloating persists, the patient should reduce their intake for a few days. This product should not be used in premature infants in the Neonatal Intensive Care Unit (NICU) setting. References 1. Chen et al. Characterization of Fecal Microbial Communities in Patients with Liver Cirrhosis. Hepatology. Vol Rai R, et al. Gut Microbiota: Its Role in Hepatic Encephalopathy. Journal of Clinical and Experiential Hepatology. 201 Mar;(Suppl 1):S Qin N, Yang F, Li A, et al. Alterations of the human gut microbiome in liver cirrhosis. Nature 2014; 13: Bajaj J.S. Review article potential mechanisms of action of rifaxamin in the management of hepatic encephalopathy and other complications of cirrhosis. Aliment Pharmacol Ther 2016; 43.. Agrawal A. et al., Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open-Label, Randomized Controlled Trial American Journal of Gastroenterology. June 2012; doi:.38/ajg Mittal, V.V. et al, A randomized controlled trial comparing lactulose, probiotics, and L-ornithine L-aspartate in treatment of minimal hepatic encephalopathy. European Journal of Gastroenterology and Hepatology. 20, 23: Lunia, M.K.. et al., Probiotics Prevent Hepatic Encephalopathy in Patients With Cirrhosis: A Randomized Controlled Trial. Clinical Gastroenterology and Hepatology Jun;12(6): Maccaferri et al. Rifaximin modulates the colonic microbiota of patients with Crohns disease an in vitro approach using a continuous culture colonic model system. J Antimicrob Chemother 20; Finegold et al. Study of the In Vitro Activities of Rifaximin and Comparator Agents against 36 Anaerobic Intestinal Bacteria from the Perspective of Potential Utility in Pathology Involving Bowel Flora. Antimicrobial Agents and Chemotherapy. Jan 2009 p Fedorak N, J Clin Gastroenterol. 42:S3; S1- (2008).. Camilleri, M. Probiotics and Irritable Bowel Syndrome: Rationale, Putative Mechanisms, and Evidence of Clinical Efficacy. J Clin Gastroenterol. 2006;40: Korpela R, et al. Probiotics and irritable bowel syndrome. Microbial Ecology in Health and Disease Chio et al. Alteration of Gut Microbiotia and Efficacy of Probiotics in Functional Constipation. J Neurogastroenterol Motil. Vol Zandg et al. Effects of probiotic type, dose and treatment duration on irritable bowel syndrome diagnosed by Rome III criteria a meta-analysis. BMC Gastroenterology. 2016; Fedorak R. Probiotics in the Management of Inflammatory Bowel Diseases? Am J Gastroenterol.2007; 2:S22-S Tursi A, et al. Low-dose balsalazide plus high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis. Med Sci Monit. 2004;: Misra et al. Integrative Therapies and Pediatric Inflammatory Bowel Disease The Current Evidence. Children. 2014, 1, Chibbar et al. Probiotics in the Management of Ulcerative Colitis. J Clin Gastroenterol. Vol 49, Supp Shen et al. Effect of Probiotics on Inducing Remission and Maintaining Therapy in UC, Crohn s Disease and Pouchitis Meta-analysis of Randomized Controlled Trials. Inflamm Bowel Dis. 2014;20: Floch, M. Probiotic Therapy for Ulcerative Colitis. J Clin Gastroenterol Ng et al. Immunosuppressive Effects via Human Intestinal Dendritic Cells of Probiotic Bacteria and Steroids in the Treatment of Acute Ulcerative Colitis. Inflamm Bowel Dis Gionchetti P, et al. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: A double-blind, placebo-controlled trial. Gastroenterology. 2000;9(2): Gionchetti P, et al. Prophylaxis of pouchitis onset with probiotic therapy: A double-blind, placebo-controlled trial. Gastroenterology. 2003b;124(): Singh et al. Treatment and prevention of pouchitis after ileal pouch anastomosis for chronic ulcerative colitis. The Cochrane Collaboration Holubar et al. Treatment and prevention of pouchitis after ileal pouchanal anastomosis for chronic ulcerative colitis. The Cochrane Collaboration. 20 Issue 6 (844) FIT-GUTS ( ) VIS PROVEN BY RESEARCH. HIGH-POTENCY. NO SHORTCUTS. Visbiome and Visbiome Extra Strength are medical foods intended for the dietary management of dysbiosis associated with irritable bowel syndrome (IBS), ulcerative colitis (UC), pouchitis, and hepatic encephalopathy (HE). Visbiome is a medical food for the dietary management of dysbiosis associated with: * Irritable Bowel Syndrome (IBS) * Ulcerative Colitis (UC) * Pouchitis * Hepatic Encephalopathy (HE)

3 HIGH POTENCY PROBIOTIC Medical food for the dietary management of dysbiosis associated with IBS, ulcerative colitis, pouchitis, and hepatic encephalopathy. Visbiome is a non-drug therapy that addresses distinct nutritional requirements to promote microbial balance in people with IBS, ulcerative colitis, pouchitis, and hepatic encephalopathy which cannot be addressed by modification of diet alone. Eight strains of live bacteria in high concentrations Visbiome capsules are encompassed by the Activ-Vial technology to reduce moisture exposure. Contains original De Simone Formulation probiotic blend, one of the most widely studied probiotics available with over 60 human clinical trials in IBS, UC, Pouchitis, liver disease and more. AVAILABLE IN 4 FORMULATIONS 2. CAPSULES 40 REGULAR POWDER (Lemon Cream Flavor) 40 UNFLAVORED POWDER 900 EXTRA STRENGTH POWDER (available by prescription only) The Beneficial Effects of Probiotics are Highly Strain-Specific Genus Species Strain Reference Number Lactobacillus paracasei DSM Lactobacillus plantarum DSM Lactobacillus acidophilus DSM 2473 Lactobacillus delbrueckii subspecies bulgaricus* DSM Bifidobacterium longum ± DSM Bifidobacterium infantis ± DSM Bifidobacterium breve DSM Streptococcus thermophilus DSM * Recently reclassified as Lactobacillus helveticus ± Recently reclassified as Bifidobacterium lactis

4 Numerous clinical studies have been conducted on the formulation as a medical food in the dietary management of: Dietary Management of: Number of Studies Number of Patients As a medical food the formulation in Visbiome has been associated with: IBS UC Pouchitis PATIENTS PATIENTS PATIENTS Reductions in bloating Reductions in flatulence Reductions in UCDAI scores by up to 0% Achievement of remission Decrease of rectal bleeding 8% patients remained in remission after nine months Decrease bowel frequency RECOMMENDED DAILY INTAKE REGULAR, UNFLAVORED, AND CAPSULES EXTRA STRENGTH (prescription only) Adults For the Dietary Management of Packets Per Day Irritable Bowel Syndrome (IBS) ½ Per Day Adults For the Dietary Management of Irritable Bowel Syndrome (IBS) Packets Per Day ¼ ½ Hepatic Encephalopathy (HE) Ulcerative Colitis Pouchitis 2 4 n/a Active Ulcerative Colitis (flaring) 4 8 n/a Hepatic Encephalopathy (HE) ½ 1 Ulcerative Colitis ½ 1 Pouchitis 1 2 Active Ulcerative Colitis (flaring) 2 4

5 Visbiome in the Dietary Management of Hepatic Encephalopathy Hepatic Encephalopathy (HE) is associated with significant dysbiosis of the bacterial gut flora. 1,2 Standard drug therapy for HE is focused on modulating the gut microbiome through prebiotic and antibiotic activity. 2,4 The Visbiome probiotic, consumed as a monotherapy or concomitantly with standard drug therapy may aid in the dietary management of dysbiosis associated with HE. When used as a medical food, multiple controlled studies have found the De Simone Formulation in Visbiome is associated with: Improved management of overt HE in patients with a prior episode of overt HE. Improvement in abnormal psychometric testing vs. control. Probability of development of HE Adapted from Agrawal et al, 2012 Gp - No Treatment P = Gp - Visbiome Gp - Lactulose Reduction in arterial ammonia levels comparable to lactulose.,7 May be consumed concomitantly with standard drug therapy (lactulose, rifaximin). 8, Follow-up in Months 23 cirrhotic patients who had prior episodes of HE were evaluated after consuming the De Simone Formulation, lactulose or no therapy. There was a significant difference in the development HE in the probiotic vs. no treatment groups (p=0.02) and in the lactulose vs. no treatment group (p=0.001) but no difference between the probiotic group vs. lactulose (p=0.134)

6 Formulations and Availability S TU D I E S PE R D I S E A S E 39 LIVER Liver Disease, Cirrhosis, Liver Failure, Hepatic Encephalopathy S TU D I E S PE R AG E G RO U P Visbiome Regular Product Code: Product Code: GI TRACT Pouchitis, Ulcerative Colitis, IBS, Diarrhea, Crohn s Disease, Diverticulitis, Bowel Movement Nutrition, IBD, Microscopic Colitis OTHER AVAILABLE BY PRESCRIPTION ONLY Bacterial Vaginosis, Sepsis, Dyspepsia, etc. TOTA L N U M B E R O F PATI E NTS E X A M I N E D 12 4 CANADA 9 PEDIATRIC,319 1,682 S TU D I E S PE R R E G I O N ADULTS GERIATRIC (e.g. placebo-controlled, double-blind, cross-over, parallel arm) EUROPE INDIA 3 KOREA TOTA L N U M B E R O F S TU D I E S T Y PE S O F S TU D I E S 43 3 UNKNOWN 3,330 CONTROLLED AND/OR RANDOMIZED USA 7 UNCONTROLLED AND/OR OPEN LABEL (e.g. no control group, open label) PROOF OF CONCEPT (e.g. pilot study, prospective study, case study) 60 Visbiome Extra Strength Product Code: BILLION PEDIATRIC ADULT GERIATRIC 29 Product Code: BILLION HIGH POTENCY PROBIOTIC Product Product Code Bacteria Count (CFU) Dosage Format Counter Per Box/Bottle Billion (2 caps) 60 Visbiome Regular Flavor Visbiome Extra Strength Billion Important Safety Information: Mild abdominal bloating has been reported in the first few days of consuming Visbiome. This is generally a physiological adaptation of the microflora, which usually diminishes within 3-4 days. If bloating persists, the patient should reduce their intake for a few days. This product should not be used in premature infants in the Neonatal Intensive Care Unit (NICU) setting. References 1. Chen et al. Characterization of Fecal Microbial Communities in Patients with Liver Cirrhosis. Hepatology. Vol Rai R, et al. Gut Microbiota: Its Role in Hepatic Encephalopathy. Journal of Clinical and Experiential Hepatology. 201 Mar;(Suppl 1):S Qin N, Yang F, Li A, et al. Alterations of the human gut microbiome in liver cirrhosis. Nature 2014; 13: Bajaj J.S. Review article potential mechanisms of action of rifaxamin in the management of hepatic encephalopathy and other complications of cirrhosis. Aliment Pharmacol Ther 2016; 43.. Agrawal A. et al., Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open-Label, Randomized Controlled Trial American Journal of Gastroenterology. June 2012; doi:.38/ajg Mittal, V.V. et al, A randomized controlled trial comparing lactulose, probiotics, and L-ornithine L-aspartate in treatment of minimal hepatic encephalopathy. European Journal of Gastroenterology and Hepatology. 20, 23: Lunia, M.K.. et al., Probiotics Prevent Hepatic Encephalopathy in Patients With Cirrhosis: A Randomized Controlled Trial. Clinical Gastroenterology and Hepatology Jun;12(6): Maccaferri et al. Rifaximin modulates the colonic microbiota of patients with Crohns disease an in vitro approach using a continuous culture colonic model system. J Antimicrob Chemother 20; Finegold et al. Study of the In Vitro Activities of Rifaximin and Comparator Agents against 36 Anaerobic Intestinal Bacteria from the Perspective of Potential Utility in Pathology Involving Bowel Flora. Antimicrobial Agents and Chemotherapy. Jan 2009 p Fedorak N, J Clin Gastroenterol. 42:S3; S1- (2008).. Camilleri, M. Probiotics and Irritable Bowel Syndrome: Rationale, Putative Mechanisms, and Evidence of Clinical Efficacy. J Clin Gastroenterol. 2006;40: Korpela R, et al. Probiotics and irritable bowel syndrome. Microbial Ecology in Health and Disease Chio et al. Alteration of Gut Microbiotia and Efficacy of Probiotics in Functional Constipation. J Neurogastroenterol Motil. Vol Zandg et al. Effects of probiotic type, dose and treatment duration on irritable bowel syndrome diagnosed by Rome III criteria a meta-analysis. BMC Gastroenterology. 2016; Fedorak R. Probiotics in the Management of Inflammatory Bowel Diseases? Am J Gastroenterol.2007; 2:S22-S Tursi A, et al. Low-dose balsalazide plus high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis. Med Sci Monit. 2004;: Misra et al. Integrative Therapies and Pediatric Inflammatory Bowel Disease The Current Evidence. Children. 2014, 1, Chibbar et al. Probiotics in the Management of Ulcerative Colitis. J Clin Gastroenterol. Vol 49, Supp Shen et al. Effect of Probiotics on Inducing Remission and Maintaining Therapy in UC, Crohn s Disease and Pouchitis Meta-analysis of Randomized Controlled Trials. Inflamm Bowel Dis. 2014;20: Floch, M. Probiotic Therapy for Ulcerative Colitis. J Clin Gastroenterol Ng et al. Immunosuppressive Effects via Human Intestinal Dendritic Cells of Probiotic Bacteria and Steroids in the Treatment of Acute Ulcerative Colitis. Inflamm Bowel Dis Gionchetti P, et al. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: A double-blind, placebo-controlled trial. Gastroenterology. 2000;9(2): Gionchetti P, et al. Prophylaxis of pouchitis onset with probiotic therapy: A double-blind, placebo-controlled trial. Gastroenterology. 2003b;124(): Singh et al. Treatment and prevention of pouchitis after ileal pouch anastomosis for chronic ulcerative colitis. The Cochrane Collaboration Holubar et al. Treatment and prevention of pouchitis after ileal pouchanal anastomosis for chronic ulcerative colitis. The Cochrane Collaboration. 20 Issue 6 (844) FIT-GUTS ( ) VIS PROVEN BY RESEARCH. HIGH-POTENCY. NO SHORTCUTS. Visbiome and Visbiome Extra Strength are medical foods intended for the dietary management of dysbiosis associated with irritable bowel syndrome (IBS), ulcerative colitis (UC), pouchitis, and hepatic encephalopathy (HE). Visbiome is a medical food for the dietary management of dysbiosis associated with: * Irritable Bowel Syndrome (IBS) * Ulcerative Colitis (UC) * Pouchitis * Hepatic Encephalopathy (HE)

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