Virtual Care Solution Integrates Critical Data from Popular Continuous Glucose Monitoring Systems

NEW YORK, January 4, 2024 (Newswire.com) - AMC Health is now able to seamlessly integrate critical data from the Dexcom G5, G6, and G7 continuous glucose monitoring (CGM) systems into its industry-leading virtual care solution. This major advance in the remote management of diabetes provides a more comprehensive and timelier picture of a patient’s condition and expands the population of patients who qualify for virtual care. 

“It is very exciting that this enhancement will enable a far greater proportion of patients with diabetes — particularly type 1s — to benefit from the whole-patient, virtual care management enjoyed by enrollees of our solutions,” said Nesim Bildirici, CEO of AMC Health. “Now the care teams of these individuals can more seamlessly marry the remote management of their cardiovascular, behavioral, social, and other comorbid issues with the remote management of their diabetes. We look forward to tracking outcomes to demonstrate how much comprehensive virtual care can further the well-being of patients who use a CGM device.” 

As part of AMC Health’s drive to incorporate a broader array of continuous monitoring technologies, this new capability vastly enhances the breadth and quality of data that AMC Health can collect from patients who have been prescribed CGM, which includes not only patients with type 1 diabetes but also a growing number of type 2 patients. Data collected from CGM devices can now be analyzed in concert with all other information collected and analyzed in CareConsole® — claims and laboratory data, data from other physiometric and medication monitoring technologies, and survey data — to provide a much fuller picture of a patient’s health. 

Integrating the CGM data is seamless for all stakeholders. Summary data for the past 24 hours is automatically fed into CareConsole without any patient intervention needed. Listed below are the data types captured. 

• Daily estimated glucose value (EGV) averages (last 24 hours) 
• High and low EGV readings for the past 24 hours 
• The most recent EGV alert reading 
• Time of the alert reading and its transmission 

The integration helps to improve the delivery of efficient, timely, and informed care through greater detail and context. 

Greater detail: Alerts prompt the remote care manager to work with the patient to access data from the Dexcom Clarity app, which tracks glucose trends in greater detail. 

Greater context: The Clarity report, which the patient can easily share with clinical team members, provides context for clinical coaches to help patients understand how diet, medication, and other behaviors affect glycemic control. 

Greater opportunities: Daily and weekly patterns also can be used to identify mitigation opportunities. 

This product enhancement also significantly increases the number of patients that AMC Health can help at every step of their care journey. Individuals in need of continuous monitoring of their blood sugars, especially those who are insulin-dependent, typically have been excluded from virtual care programs. With this new integration, however, AMC Health can now help these patients heal safely and effectively at home. 

Contact Information:
Marc Kerachsky
Chief Marketing Officer
[email protected]
(877) 262-2240


Original Source: AMC Health Advances the Remote Management of Diabetes Through CGM Data Integration

BERN, Switzerland, January 4, 2024 (Newswire.com) - LEM Surgical AG, an innovative surgical robotics company headquartered in Bern, Switzerland, announces the successful completion of its Series B funding, securing CHF 22 million. The round, which was strongly oversubscribed, reflects the strong investors’ confidence in LEM Surgical’s differentiated approach.

This substantial funding boost is attributed to the enthusiastic participation of new investors from both the United States and Switzerland. The infusion of capital is strategically earmarked to propel the advancement of LEM Surgical’s product development initiatives and readiness for FDA submission in the second half of 2024. With this latest injection of capital, LEM Surgical is well-positioned to achieve its objectives and to further solidify its potential in the field of surgical robotics.

Yossi Bar, founder and CEO of LEM Surgical, expressed the company's vision, stating, "Our goal is to revolutionize the experience for surgeons, clinical teams, and hospitals engaged in robotic surgery. We deeply appreciate the trust and support of our new investors. It underscores the unwavering confidence our investors have in the future success of our groundbreaking technology."

About LEM Surgical AG

LEM Surgical is at the forefront of shaping the future through the creation of the next generation of robotic surgery platforms. The primary focus of its development efforts is centered around surpassing the capabilities of existing robotic platforms for spine surgery. 

The company was founded in 2021 by Prof. Dr. Stefan Weber (CEO, CAScination AG), Marco Matulic (CTO, CAScination AG), Simon Michel (CEO, Ypsomed Group), Prof. Dr. Andreas Raabe (Director, Department of Neurosurgery, Inselspital Bern) and Yossi Bar (previously Director R&D at Mazor Robotics Ltd). 

Follow on LinkedIn www.linkedin.com/company/lem-surgical-ag/

www.lemsurgical.com

Contact Information:
Yossi Bar
Chief Executive Officer
[email protected]


Original Source: LEM Surgical AG Secures CHF 22 Million in Series B Funding to Ready Robotic System for FDA Submission

BRENTWOOD, Tenn., January 4, 2024 (Newswire.com) - Odyssey Behavioral Healthcare, a leading provider of mental health, addiction, and eating disorder treatment services, proudly announces that Clearview Treatment Programs in Southern California has been certified by PsychArmor as a “Veteran Ready Healthcare Organization.” The facility provides needed mental health, PTSD, and addiction services for military Veterans and their families as a participating partner in the VA Community Care Network.

According to recent reports from the U.S. Department of Veteran Affairs and the National Institute of Drug Abuse:

• The Veteran suicide rate has risen over the past 20 years, with 2020 seeing a rate that was 66.2% higher than non-Veteran adults.
• 37-50% of Veterans returning from Afghanistan and Iraq have been diagnosed with a mental health disorder associated with a substance use disorder (SUD), and 63% of those diagnosed with SUDs also met the criteria for post-traumatic stress disorder (PTSD).
• Fewer than 50% of returning Veterans in need receive any mental health treatment.

“Odyssey is committed to addressing the specific challenges faced by military service members by strengthening our understanding of military culture,” said Richard Clark, CEO of Odyssey. “Expanding our partnership with PsychArmor to deepen our understanding plays an important part in how Odyssey provides superior clinical care for those who have served our nation.” 

In collaboration with PsychArmor, a nonprofit organization dedicated to equipping civilian professionals, the team at Clearview Treatment Programs completed comprehensive training to receive the prestigious “Veteran Ready” certification. This facility joins Lifeskills South Florida, Silver Pines, Pasadena Villa Outpatient – McLean, and Pasadena Villa Outpatient – Norfolk as a “Veteran Ready” Healthcare Organization within Odyssey’s network.

Clearview understands the importance of providing culturally competent care to the military community. The partnership with PsychArmor empowers its treatment team to deliver compassionate and effective care that better supports the unique needs of veterans and their families.

Learn more about Clearview Treatment Programs by visiting its website. 

About Odyssey Behavioral Healthcare

Odyssey, formed in 2015, has a diverse clinical network of services treating adults and adolescents for eating disorders, psychiatric disorders, dual diagnosis, and other addictive disorders. Odyssey provides a continuum of care within our Psychiatric Network and Eating Disorder Network, including inpatient, intensive residential, partial hospitalization, outpatient services, detoxification, and transitional living at over 20 locations and affiliated Odyssey Outpatient Network clinics in nine states with over 600 beds.

About PsychArmor

PsychArmor is a California nonprofit public benefit corporation providing education and support to individuals and organizations that work with, live with, and care for American service members, Veterans, and their families.

Contact Information:
Vicki Smith
Chief Marketing Officer, Odyssey Behavioral Healthcare
[email protected]
615-864-8145


Original Source: Clearview Treatment Programs Certified by PsychArmor as a 'Veteran Ready' Organization

GMP-compliant manufacturing puts SR-02 on track to be industry’s second clinical-stage stem cell derived pancreatic islet transplant program. The third-party auditor’s FDA six-system approach yielded no critical nor major observations of Seraxis’ quality system for the production of GMP-grade organs from pancreas-derived stem cells. Dr. William Rust, CEO, will present further data on the development of SR-02 and follow-on immune-cloaked SR-03 on Monday, January 8 at 10:30 a.m. PST at Biotech Showcase in San Francisco.

GERMANTOWN, Md., January 4, 2024 (Newswire.com) - Seraxis, Inc., a regenerative medicine company developing a pancreatic islet replacement therapy to transform the lives of patients with Type 1 and insulin-requiring Type 2 diabetes, today announced the completion of a comprehensive third-party on-site Good Manufacturing Practice (GMP) audit of Seraxis’ QMS, cleanroom, cell growing production process and QC laboratory, conducted in advance of Seraxis’ planned IND submission of the pancreatic clusters candidate SR-02 for the intended treatment of insulin-dependent diabetes. The independent audit followed the FDA six-system approach and concluded that Seraxis’ proprietary manufacturing process is in compliance with GMP audit standards, regulations and internal written procedures. 

“The manufacturing of an exquisite cluster of living cells – essentially the production of a replacement human organ – is a tremendously nuanced and intricate feat of biological engineering,” said Seraxis’ Chief Operating Officer, Carole Welsch, PhD. “We are proud that our team has created a clinical-scale cleanroom production facility and quality system that pass muster with a rigorous audit comparable to a possible future FDA inspection associated with our upcoming IND filings.”

“Seraxis’ stem cell line SR1423 was derived from pancreatic cells and retains the epigenetic fingerprint of islets so, by design, they efficiently expand and generate replacement islet clusters. This characteristic eliminates purification steps, enabling Seraxis to manufacture product on a clinical scale for both the SR-02 program and the follow-on immune-cloaked SR-03 program in our Germantown facility,” added CEO Will Rust. 

Dr. Rust will be presenting Seraxis’ recent candidate development data in a presentation at Biotech Showcase on Monday, January 8, in a 10:30 a.m. (PST) session. The presentation will be posted to www.seraxis.com shortly thereafter.

ABOUT SERAXIS

Seraxis is bringing transformative cures to the millions of people worldwide struggling with the management and life-threatening complications of T1D and insulin-requiring T2D. 

Seraxis’ lead program, SR-02, is a novel, off-the-shelf islet replacement therapy slated to enter clinical testing with immunosuppressive therapy in 2024 in patients with severe recurrent hypoglycemia. A follow-on diabetes program, SR-03, is a version of the Seraxis pancreatic clusters altered to be unrecognized by the immune system for use without chronic immune suppression by the broader population of T1D and insulin-requiring T2D.

Seraxis’ underlying proprietary technology enables the creation of a pipeline of novel stem cell-derived therapies originating from single donated organs for other indications. The company’s lead therapeutic program, SR-02, is manufactured from a stem cell line derived from a human donor pancreas. These cells preferentially re-differentiate into pancreatic clusters containing all the endocrine cells of the native pancreatic islet, and with safety, potency, and manufacturing advantages over embryonic and induced pluripotent stem cells.

Seraxis is backed by Frazier Life Sciences, Polaris Partners, Eli Lilly, the JDRF T1D Fund and independent investors. Seraxis manufactures its best-in-class therapeutic pancreatic clusters using scalable, clinically compliant processes in its cGMP facility located in Maryland’s I-270 Biotech Corridor. 

For more information, please visit www.seraxis.com.

Contact Information:
Ted Hibben
Chief Corporate Development Officer
[email protected]


Original Source: Seraxis’ Manufacturing Suite Completes GMP Quality System Audit Ahead of SR-02 IND Filing and Transplantation of Pancreatic Clusters to Patients With Type 1 Diabetes

Now patients, caregivers and healthcare professionals have an easy and effective way to search for and match with gastric cancer clinical trials.

RALEIGH, N.C., January 3, 2024 (Newswire.com) - Carebox, a leading provider of clinical trial matching solutions, and the Gastric Cancer Foundation (GCF) -- a results-driven national non-profit dedicated to improving the lives of people affected by gastric cancer and working with leading researchers to find a cure -- today announced the launch of the GCF Clinical Trial Finder.

The new web application gives patients, caregivers, and healthcare professionals an easy and effective way to search and match to gastric cancer clinical trials. Patients or caregivers can complete a questionnaire online for their specific gastric cancer and then instantly see which clinical trials are potentially relevant for them. They can then get connected to a trial site for the next steps. 

Alternatively, GCF Clinical Trial Finder clinical trial navigators are available over the phone or email to help with the clinical trial search/matching process and then to help patients and caregivers take the next step with nearby research centers or hospitals where the clinical trials are taking place. 

The GCF Clinical Trial Finder trial database is synchronized daily with the ClinicalTrials.gov clinical trial data maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Applying its human-supervised AI, Carebox converts the unstructured text in ClinicalTrials.gov that describes eligibility criteria for enrollment, into a searchable index of clinical criteria for matching with patient characteristics.  

"Our partnership with Carebox adds an important dimension to our research, education, and advocacy goals. The GCF Clinical Trial Finder makes the latest gastric cancer treatment options more accessible to our community." -Stacie Hershman, Executive Director, Gastric Cancer Foundation

Access to the new web application is available from the Gastric Cancer Foundation website, which also features a Carebox “embedded widget” to allow visitors to request a phone or email appointment with a clinical trial navigator without leaving the website. 

As Stacie Hershman, the Executive Director for GCF explains, “Gastric Cancer Foundation provides hope and support for thousands of patients across the United States and around the world. Our mission is straightforward: to find a cure for gastric cancer. Our partnership with Carebox adds an important dimension to our research, education, and advocacy goals. The GCF Clinical Trial Finder makes the latest gastric cancer treatment options more accessible to our community.” 

As Assaf Levi, VP of Engineering at Carebox notes, “Carebox Connect is the most comprehensive platform available for connecting patients to the treatment options in clinical trials. All the applications, services, modules, and product offerings have a common technology foundation that gives us flexibility to work with every partner in alignment with their preferences and focus.” 

Assaf further explains: “The GCF Clinical Trial Finder is a GCF-branded website, but it’s also a specialized extension to Salesforce™ CRM to allow Carebox clinical trial navigators to support patients and caregivers seamlessly across online and call center services. It’s a referral management solution to ensure patients get connected effectively to research sites. It’s an analytics solution that gives GCF insights into its community’s patient populations and treatment needs to shape the evolution of their programs. And its embedded widget technology makes this an integral part of CGF’s own website. We couldn’t be prouder to partner with and support GCF in its mission to help find a cure for gastric cancer.”

About the Gastric Cancer Foundation 
The Gastric Cancer Foundation provides hope and support for thousands of patients across the United States and around the world. Our mission is straightforward: to find a cure for gastric cancer. We created the first comprehensive Gastric Cancer Registry, and we fund studies that open new paths to better patient outcomes. We’re raising public awareness about gastric cancer and the urgency of expanded research. And we have created a supportive community of patients and caregivers who can share information and experiences, and combat feelings of isolation. For more information, visit gastriccancer.org. 

About Carebox 
Carebox connects patients and physicians seeking treatment options with clinical trials. For patients and families, access to information about the newest and most advanced treatment options is obscure and frustrating to find. For pharma companies, clinical trial recruitment is the primary bottleneck in the $100B+ drug development market now being reshaped by precision medicine treatment specificity, new trial models, diversity requirements, and digital health consumer expectations. Carebox is at the forefront of addressing these challenges for patients and their families, as well as for the ecosystem of companies involved in sponsoring, running, and recruiting for clinical trials. Learn more about Carebox at https://careboxhealth.com. 

About Carebox Connect 
The Carebox Connect cloud platform digitizes Carebox’s two decades of experience in navigating over one million patients seeking clinical trial options. It enables trial sponsors of all sizes to educate, engage, navigate, match, qualify, refer, and enroll patients in their clinical trials. Pharma trial sponsors, hospital research centers, and patient advocacy groups use Carebox Connect to present their clinical trial portfolios to the public, optimize trial recruitment, and enhance participant diversity in support of ongoing clinical research. 

About The Carebox Connect Network 
In addition to customer-branded Carebox Connect solutions for trial sponsors and sites, the Carebox Connect Network brings the power of the platform to patients, families, and caregivers via a rapidly growing network of tens of patient advocacy groups and physician associations. Carebox runs co-branded and branded web applications and/or clinical trial navigation services on behalf of its Carebox Connect Network partners. 

Contact Information:
Madeleine Moench
[email protected]


Original Source: Carebox and Gastric Cancer Foundation (GCF) Announce the GCF Clinical Trial Finder

PillSafe® protects the patient with a patented, innovative pill distribution control system that improves dosage safety, prevents prescription drug misuse, and provides potential solutions for the national opioid epidemic.    

EDMOND, Okla., January 3, 2024 (Newswire.com) - PillSafe® uses new disruptive technology, a groundbreaking economical “smart” pill bottle for prescription drugs, designed by doctors to ensure safety and compliance with medication in the fight against addictive drugs. Conceived to protect the patient, it safeguards the medication and prevents tampering with proprietary technology that tracks and distributes the appropriate amount of medication at the time prescribed by the doctor.

"PillSafe aspires to protect patients and provide a safer way to deliver medication in the healthcare and drug manufacturing industries,” said Dr. John Barr, co-founder of PillSafe. “We firmly believe that every pill that stays within the confines of our system is a life potentially saved from drug abuse."

PillSafe’s medication delivery system secures medications at the source. The pharmacist inserts the pills into the PillSafe container, snaps the lid in place, and programs the bottle to deliver the required dosage on the specific schedule set by the doctor. Each PillSafe pill bottle has a unique, preset three-digit access code entered by the patient to dispense the medication at the time intervals set by the physician. The patient presses down on the lid and rotates it clockwise to access the medication. Then, the device is locked again, and the countdown timer restarts for the next dose.

An electronic net inside each PillSafe container can detect any breach attempt. PillSafe can be programmed to either destroy the medication and or notify the physician or the pharmacy to confirm compliance. With all this technology, PillSafe is still a single-use disposable bottle.

Doctors and pharmacists see the PillSafe bottle as a solution to problems resulting from non-adherence when patients do not take their medications as prescribed. “From my perspective in primary care and as a detox physician, we daily see patients that have become addicted to anything from stimulants to pain relievers, such as opioids, that create dependence and addiction,” said Dr. Edward Mogabgab, M.D.

That can have tragic consequences. According to the Centers for Disease Control and Prevention, there were 80,411 overdose deaths involving opioids, which accounted for 75% of all drug overdose deaths in 2021. To combat the epidemic, President Biden requested a historic funding increase of $46.1 billion for National Drug Control Program agencies, recognizing the urgent need for preventing the misuse of opioids and other dangerous drugs.

Standard pill bottles allow patients to remove the cap and have instant access to many pills, which can lead to overdose, illicit sharing, and trading or selling with other people. According to data from national drug information centers, that costs the United States more than $200 billion each year in insurance diversion and theft from criminal justice costs, health costs, and productivity loss.

PillSafe prevents that uncontrolled access to drugs, which protects the drug manufacturer, pharmacies, doctors and insurers, as well as patients, and guarantees the safe and secure documented delivery of addictive medication as prescribed. PillSafe’s technology can also assist in disrupting drug trafficking, assisting healthcare, law enforcement, and the pharma industry by reducing the supply of illicit drugs.

In the six decades since the creation of a child-proof cap, there have been no major advancements in pill bottles. PillSafe is a revolutionary update, smart bottle system that secures addictive medications from the pharmacy to the patient. The user-specific approach integrates an adult-proof cap, electronic pill counter, a prescription-based time-release feature, and a fail-safe security net to fight prescription drug addiction.

“PillSafe's bold approach propels an innovative way forward, marking a promising stride in the battle against the opioid epidemic,” Dr. Barr said.

For more information, please visit https://pillsafeprotection.com or view this video.

About PillSafe     
PillSafe is a pioneering “smart” technology that shifts the standard of care in the pharmaceutical industry with home delivery and patient compliance in response to the opioid epidemic. The company creates prescription compliance by restricting access to medication to only the patient, keeping medication safe from divergence and abuse. PillSafe's “intelligent” design includes several innovative features that benefit the delivery network from the manufacturer to the pharmacy to the patient. The patented technology includes an electronic label that can increase adherence messaging, two-step verification, or active advertising from the manufacturer to the pharmacy to the patient.

Contact Information:
Michael Albanese
Media Advantage Account Manager
[email protected]
Related Images


Original Source: Introducing PillSafe®, the New ‘Smart’ Pill Bottle for Prescription Medication

PillSafe® protects the patient with a patented, innovative pill distribution control system that improves dosage safety, prevents prescription drug misuse, and provides potential solutions for the national opioid epidemic.    

EDMOND, Okla., January 3, 2024 (Newswire.com) - PillSafe® uses new disruptive technology, a groundbreaking economical “smart” pill bottle for prescription drugs, designed by doctors to ensure safety and compliance with medication in the fight against addictive drugs. Conceived to protect the patient, it safeguards the medication and prevents tampering with proprietary technology that tracks and distributes the appropriate amount of medication at the time prescribed by the doctor.

"PillSafe aspires to protect patients and provide a safer way to deliver medication in the healthcare and drug manufacturing industries,” said Dr. John Barr, co-founder of PillSafe. “We firmly believe that every pill that stays within the confines of our system is a life potentially saved from drug abuse."

PillSafe’s medication delivery system secures medications at the source. The pharmacist inserts the pills into the PillSafe container, snaps the lid in place, and programs the bottle to deliver the required dosage on the specific schedule set by the doctor. Each PillSafe pill bottle has a unique, preset three-digit access code entered by the patient to dispense the medication at the time intervals set by the physician. The patient presses down on the lid and rotates it clockwise to access the medication. Then, the device is locked again, and the countdown timer restarts for the next dose.

An electronic net inside each PillSafe container can detect any breach attempt. PillSafe can be programmed to either destroy the medication and or notify the physician or the pharmacy to confirm compliance. With all this technology, PillSafe is still a single-use disposable bottle.

Doctors and pharmacists see the PillSafe bottle as a solution to problems resulting from non-adherence when patients do not take their medications as prescribed. “From my perspective in primary care and as a detox physician, we daily see patients that have become addicted to anything from stimulants to pain relievers, such as opioids, that create dependence and addiction,” said Dr. Edward Mogabgab, M.D.

That can have tragic consequences. According to the Centers for Disease Control and Prevention, there were 80,411 overdose deaths involving opioids, which accounted for 75% of all drug overdose deaths in 2021. To combat the epidemic, President Biden requested a historic funding increase of $46.1 billion for National Drug Control Program agencies, recognizing the urgent need for preventing the misuse of opioids and other dangerous drugs.

Standard pill bottles allow patients to remove the cap and have instant access to many pills, which can lead to overdose, illicit sharing, and trading or selling with other people. According to data from national drug information centers, that costs the United States more than $200 billion each year in insurance diversion and theft from criminal justice costs, health costs, and productivity loss.

PillSafe prevents that uncontrolled access to drugs, which protects the drug manufacturer, pharmacies, doctors and insurers, as well as patients, and guarantees the safe and secure documented delivery of addictive medication as prescribed. PillSafe’s technology can also assist in disrupting drug trafficking, assisting healthcare, law enforcement, and the pharma industry by reducing the supply of illicit drugs.

In the six decades since the creation of a child-proof cap, there have been no major advancements in pill bottles. PillSafe is a revolutionary update, smart bottle system that secures addictive medications from the pharmacy to the patient. The user-specific approach integrates an adult-proof cap, electronic pill counter, a prescription-based time-release feature, and a fail-safe security net to fight prescription drug addiction.

“PillSafe's bold approach propels an innovative way forward, marking a promising stride in the battle against the opioid epidemic,” Dr. Barr said.

For more information, please visit https://pillsafeprotection.com or view this video.

About PillSafe     
PillSafe is a pioneering “smart” technology that shifts the standard of care in the pharmaceutical industry with home delivery and patient compliance in response to the opioid epidemic. The company creates prescription compliance by restricting access to medication to only the patient, keeping medication safe from divergence and abuse. PillSafe's “intelligent” design includes several innovative features that benefit the delivery network from the manufacturer to the pharmacy to the patient. The patented technology includes an electronic label that can increase adherence messaging, two-step verification, or active advertising from the manufacturer to the pharmacy to the patient.

Contact Information:
Michael Albanese
Media Advantage Account Manager
[email protected]
Related Images


Original Source: Introducing PillSafe®, the New ‘Smart’ Pill Bottle for Prescription Medication