New FDA Regulations Boost Diabetes Company Revenues May 13, 2020 - Baystreet.ca Amended regulations issued by the Food & Drug Administration (FDA), including in response to the COVID-19 pandemic, are expected to turbocharge revenues for diabetes companies and leading to analyst upgrades. According to the latest 2020 statistics compiled by the Centers for Disease Control & Prevention (CDC), 34.2 million Americans are diagnosed with diabetes. The CDCadvises that persons who are diabetic or obese are at higher risk for contracting COVID-19, than the general population. These amended FDA regulations are creatingoutsized market opportunities for top diabetic nutrition and device companies, Livongo Health, Inc. (NASDAQ: LVGO), Glucose Health, Inc. (OTC: GLUC), Dexcom Inc. (NASDAQ: DXCM) Tandem Diabetes Care Inc. (NASDAQ: TNDM) and Medtronic (NYSE: MDT). In response to COVID-19, FDA issued an emergency authorization for Livongo Health, Inc. (NASDAQ: LVGO) enabling the use of its blood sugar monitoring device in hospitals. The Livongo device is designed for persons to self-monitor blood sugar levels, at home. But,with some hospitals challenged to source PPE (face masks, gowns) due to COVID-19, allowing the Livongo device inhospitals means healthcare workers do not have to be in physical contact with diabetic patients in order to obtain their blood sugar levels. Analysts at Cannacord Genuity issued a buy rating on Livongo May 7th. A ground-breaking resistant dextrin, demonstrated in clinical data submitted to FDA to moderate blood sugar levels, has paved the way for Glucose Health, Inc. (OTC: GLUC) to market its GLUCODOWN® branded diabetic nutritional beverages, direct to consumers at pharmacies nationwide. This resistant dextrin, which is blended intoGLUCODOWN®, has a number of physiological benefits, including stimulating production of pancreatic insulin,thereby helping to keep blood sugar levels in a normal,healthy range. GLUCODOWN® is available without a prescription and is the first of its kind to be sold in the US market. The manufacturer, Glucose Health, Inc. (OTC: GLUC) reported double-digit revenue increases in its most recent annual report, released in February 2020. Another top company gaining recent FDA approval in the area of blood sugar monitoring is Dexcom, Inc. (NASDAQ: DXCM) for its G6 Pro device. The Dexcom device works interoperably with Tandem Diabetic CareInc.’s (NASDAQ: TDNM) Control-IQ technology, which itself received approval in December 2019. The Tandemtechnology adjusts levels of insulin to help manage too high or low blood sugar levels. On April 29, Citigroup increased its stock price targets for both Dexcom and Tandem. Medtronic (NYSE: MDT) also continues to develop its diabetic management technology, which received breakthrough device designation from FDA in 2019. With the recent acquisition of start-up company Klue, Medtronicnow intends to incorporate behavior tracking software into its diabetic management system, in order to provide real-time insights into when a person is consuming food. Medtronic’s full product submission to FDA for the new device, could come as early as Q1 2021. On April 22, Needham and Co. reiterated a buy rating on Medtronic. Other related developments from around the markets include: Livongo Health, Inc. (NASDAQ: LVGO) announced financial results for its first quarter ended March 31, 2020. “Livongo is well positioned to provide assistance to some of the most vulnerable populations during the COVID-19 pandemic - people with chronic conditions - and our remote monitoring, digitally powered and real-time personal coaching capabilities, and access to telehealth services are well suited to track vital signs of interest in maintaining the health of our Members,” said Zane Burke, Chief Executive Officer of Livongo. “The COVID-19 pandemic has accelerated the need for new virtual care delivery models like Livongo. We are pleased to announce our relationship with the Government Employees Health Association, Inc. (GEHA), to provide the Livongo for Diabetes, Hypertension, and Diabetes Prevention solutions for federal employees, retirees, and their dependents that receive GEHA medical coverage.” Glucose Health, Inc. (OTC: GLUC) today reported April 2020 revenues were the best single month sales performance in the Company’s history. For the period April 1, 2020 through April 30, 2020, sales at Amazon and Walmart, were $42,074.05. This sales velocity preliminarily indicates that $500,000 in potential annual revenue, from Walmart and Amazon sales of GLUCODOWN®, is achievable. These record revenues were generated despite GLUCODOWN® supply on Walmart superstore shelves dropping below target for the entire month, in part because of challenges receiving, delivering and restocking, due to the impact of COVID-19. The Company also announced GLUCODOWN® advertising is expanding to satellite TV, for the first time, beginning this month. Expansion to DISH and DIRECT TV means the GLUCODOWN® brand will reach a total potential audience of 35 million households that have never before seen GLUCODOWN® TV advertising. Dexcom Inc. (NASDAQ: DXCM) announced a new patient assistance program to aid current U.S. customers who have lost insurance due to the COVID-19 pandemic. When the program launches for current customers who meet eligibility requirements, Dexcom will Enroll eligible customers in the program during the COVID-19 pandemic; Provide two 90-day supply shipments of Dexcom CGM system supplies, with each shipment including one transmitter and three boxes of three sensors; Reduce customer cost to $45 per 90-day supply shipment. “As unemployment rates continue to rise, we want to help our customers who rely on Dexcom CGM systems to manage their diabetes but have lost insurance coverage due to the impact of the COVID-19 pandemic,” said Kevin Sayer, chairman, president and CEO of Dexcom. “Access to Dexcom CGM systems has never been more important than it is during this pandemic and we are committed to taking care of our customers as best as we can during these challenging and uncertain times.” Tandem Diabetes Care Inc. (NASDAQ: TNDM) announced that John Sheridan, president and chief executive officer, will present a company update at the following virtual investor conferences: BofA Securities 2020 Health Care Conference on Wednesday, May 13, 2020 at 3:00 pm Eastern Time (12:00 pm Pacific Time), and UBS Global Healthcare Conference on Tuesday, May 19, 2020 at 3:50 pm Eastern Time (12:50 pm Pacific Time). The Company update presentations will be webcast live, and archive recordings will be available for 30 days. The link to the live webcast and archive will be accessible on Tandem Diabetes Care’s Investor Center website. Medtronic (NYSE: MDT) announced results from late-breaking clinical trials evaluating the MyCareLink Heart™ mobile app and the Micra® Transcatheter Pacing System (TPS), products that provide needed care for patients and optimal management of their symptoms – while reducing potential exposure between patients and their clinicians. During the current COVID-19 pandemic, procedures and therapies that reduce exposure to other people are important because that also reduces the potential for spreading the virus. The results were presented at the annual Heart Rhythm Society Scientific Sessions, held virtually for the first time. Results from the BlueSync™ Evaluation study demonstrated that patients who used the Medtronic MyCareLink Heart mobile app (MCLH), a remote monitoring application on a patient’s phone or tablet, were more likely to adhere to their pacemaker remote monitoring schedule than patients who used traditional bedside monitors. The study found that patients using the MCLH technology successfully completed 94.6% of scheduled transmissions, which was superior to all three Medtronic bedside monitor control groups (whose results ranged from 56.3% to 87.1%). Higher patient adherence to scheduled transmissions of remote monitoring suggests that patients who use the MCLH app are more likely to benefit from remote monitoring than those with low or no adherence to remote monitoring. Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Glucose Health Inc has paid three thousand five hundred dollars for advertising and marketing services to be distributed by Winning Media. Winning Media is only compensated for its services in the form of cash-based compensation. Winning Media owns ZERO shares of Glucose Health Inc. Please click here for full disclaimer. Contact Information: 2818047972 ty@wallstreetnation.com
New FDA Regulations Boost Diabetes Company Revenues May 13, 2020 - Baystreet.ca Amended regulations issued by the Food & Drug Administration (FDA), including in response to the COVID-19 pandemic, are expected to turbocharge revenues for diabetes companies and leading to analyst upgrades. According to the latest 2020 statistics compiled by the Centers for Disease Control & Prevention (CDC), 34.2 million Americans are diagnosed with diabetes. The CDCadvises that persons who are diabetic or obese are at higher risk for contracting COVID-19, than the general population. These amended FDA regulations are creatingoutsized market opportunities for top diabetic nutrition and device companies, Livongo Health, Inc. (NASDAQ: LVGO), Glucose Health, Inc. (OTC: GLUC), Dexcom Inc. (NASDAQ: DXCM) Tandem Diabetes Care Inc. (NASDAQ: TNDM) and Medtronic (NYSE: MDT). In response to COVID-19, FDA issued an emergency authorization for Livongo Health, Inc. (NASDAQ: LVGO) enabling the use of its blood sugar monitoring device in hospitals. The Livongo device is designed for persons to self-monitor blood sugar levels, at home. But,with some hospitals challenged to source PPE (face masks, gowns) due to COVID-19, allowing the Livongo device inhospitals means healthcare workers do not have to be in physical contact with diabetic patients in order to obtain their blood sugar levels. Analysts at Cannacord Genuity issued a buy rating on Livongo May 7th. A ground-breaking resistant dextrin, demonstrated in clinical data submitted to FDA to moderate blood sugar levels, has paved the way for Glucose Health, Inc. (OTC: GLUC) to market its GLUCODOWN® branded diabetic nutritional beverages, direct to consumers at pharmacies nationwide. This resistant dextrin, which is blended intoGLUCODOWN®, has a number of physiological benefits, including stimulating production of pancreatic insulin,thereby helping to keep blood sugar levels in a normal,healthy range. GLUCODOWN® is available without a prescription and is the first of its kind to be sold in the US market. The manufacturer, Glucose Health, Inc. (OTC: GLUC) reported double-digit revenue increases in its most recent annual report, released in February 2020. Another top company gaining recent FDA approval in the area of blood sugar monitoring is Dexcom, Inc. (NASDAQ: DXCM) for its G6 Pro device. The Dexcom device works interoperably with Tandem Diabetic CareInc.’s (NASDAQ: TDNM) Control-IQ technology, which itself received approval in December 2019. The Tandemtechnology adjusts levels of insulin to help manage too high or low blood sugar levels. On April 29, Citigroup increased its stock price targets for both Dexcom and Tandem. Medtronic (NYSE: MDT) also continues to develop its diabetic management technology, which received breakthrough device designation from FDA in 2019. With the recent acquisition of start-up company Klue, Medtronicnow intends to incorporate behavior tracking software into its diabetic management system, in order to provide real-time insights into when a person is consuming food. Medtronic’s full product submission to FDA for the new device, could come as early as Q1 2021. On April 22, Needham and Co. reiterated a buy rating on Medtronic. Other related developments from around the markets include: Livongo Health, Inc. (NASDAQ: LVGO) announced financial results for its first quarter ended March 31, 2020. “Livongo is well positioned to provide assistance to some of the most vulnerable populations during the COVID-19 pandemic - people with chronic conditions - and our remote monitoring, digitally powered and real-time personal coaching capabilities, and access to telehealth services are well suited to track vital signs of interest in maintaining the health of our Members,” said Zane Burke, Chief Executive Officer of Livongo. “The COVID-19 pandemic has accelerated the need for new virtual care delivery models like Livongo. We are pleased to announce our relationship with the Government Employees Health Association, Inc. (GEHA), to provide the Livongo for Diabetes, Hypertension, and Diabetes Prevention solutions for federal employees, retirees, and their dependents that receive GEHA medical coverage.” Glucose Health, Inc. (OTC: GLUC) today reported April 2020 revenues were the best single month sales performance in the Company’s history. For the period April 1, 2020 through April 30, 2020, sales at Amazon and Walmart, were $42,074.05. This sales velocity preliminarily indicates that $500,000 in potential annual revenue, from Walmart and Amazon sales of GLUCODOWN®, is achievable. These record revenues were generated despite GLUCODOWN® supply on Walmart superstore shelves dropping below target for the entire month, in part because of challenges receiving, delivering and restocking, due to the impact of COVID-19. The Company also announced GLUCODOWN® advertising is expanding to satellite TV, for the first time, beginning this month. Expansion to DISH and DIRECT TV means the GLUCODOWN® brand will reach a total potential audience of 35 million households that have never before seen GLUCODOWN® TV advertising. Dexcom Inc. (NASDAQ: DXCM) announced a new patient assistance program to aid current U.S. customers who have lost insurance due to the COVID-19 pandemic. When the program launches for current customers who meet eligibility requirements, Dexcom will Enroll eligible customers in the program during the COVID-19 pandemic; Provide two 90-day supply shipments of Dexcom CGM system supplies, with each shipment including one transmitter and three boxes of three sensors; Reduce customer cost to $45 per 90-day supply shipment. “As unemployment rates continue to rise, we want to help our customers who rely on Dexcom CGM systems to manage their diabetes but have lost insurance coverage due to the impact of the COVID-19 pandemic,” said Kevin Sayer, chairman, president and CEO of Dexcom. “Access to Dexcom CGM systems has never been more important than it is during this pandemic and we are committed to taking care of our customers as best as we can during these challenging and uncertain times.” Tandem Diabetes Care Inc. (NASDAQ: TNDM) announced that John Sheridan, president and chief executive officer, will present a company update at the following virtual investor conferences: BofA Securities 2020 Health Care Conference on Wednesday, May 13, 2020 at 3:00 pm Eastern Time (12:00 pm Pacific Time), and UBS Global Healthcare Conference on Tuesday, May 19, 2020 at 3:50 pm Eastern Time (12:50 pm Pacific Time). The Company update presentations will be webcast live, and archive recordings will be available for 30 days. The link to the live webcast and archive will be accessible on Tandem Diabetes Care’s Investor Center website. Medtronic (NYSE: MDT) announced results from late-breaking clinical trials evaluating the MyCareLink Heart™ mobile app and the Micra® Transcatheter Pacing System (TPS), products that provide needed care for patients and optimal management of their symptoms – while reducing potential exposure between patients and their clinicians. During the current COVID-19 pandemic, procedures and therapies that reduce exposure to other people are important because that also reduces the potential for spreading the virus. The results were presented at the annual Heart Rhythm Society Scientific Sessions, held virtually for the first time. Results from the BlueSync™ Evaluation study demonstrated that patients who used the Medtronic MyCareLink Heart mobile app (MCLH), a remote monitoring application on a patient’s phone or tablet, were more likely to adhere to their pacemaker remote monitoring schedule than patients who used traditional bedside monitors. The study found that patients using the MCLH technology successfully completed 94.6% of scheduled transmissions, which was superior to all three Medtronic bedside monitor control groups (whose results ranged from 56.3% to 87.1%). Higher patient adherence to scheduled transmissions of remote monitoring suggests that patients who use the MCLH app are more likely to benefit from remote monitoring than those with low or no adherence to remote monitoring. Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Glucose Health Inc has paid three thousand five hundred dollars for advertising and marketing services to be distributed by Winning Media. Winning Media is only compensated for its services in the form of cash-based compensation. Winning Media owns ZERO shares of Glucose Health Inc. Please click here for full disclaimer. Contact Information: 2818047972 ty@wallstreetnation.com