September 14, 2021– JFK Medical Center’s extracorporeal membrane oxygenation (ECMO) program has earned the Silver Level ELSO Award from the Extracorporeal Life Support Organization (ELSO). Achieving the Silver Level Award means that our program has been recognized as on the Path to Excellence in extracorporeal life support.

ELSO is an international nonprofit consortium of health care centers and individuals dedicated to the development, evaluation and improvement of extracorporeal membrane oxygenation (ECMO) and other innovative therapies for support of failing organ systems in infants, children and adult.

JFK Medical Center provides ECMO for support of failing organ systems in adults. ECMO is one of the most advanced forms of life support available to patients experiencing acute failure of the cardio-respiratory system. ECMO is a temporary mechanical support system which pumps and oxygenates a patient’s blood outside the body allowing the heart and lungs time to rest. 

“We are honored to be the recipient of such a prestigious award regarding the critical care services and life support equipment and training provided to our patients,” said Waqas Ghumman, Medical Director of The Advanced Heart Care Center at JFK Medical Center.  “Our accomplishments reflect our dedication to advancing health care that we continuously strive to achieve.”

JFK Medical Center was the first hospital in Palm Beach County to provide this life saving treatment to critically ill patients.  Our ECMO Team is comprised of Surgeons, Intensivists, Respiratory Therapists, Registered Nurses and Perfusionists.

About JFK Medical Center

Founded over 50 years ago, JFK Medical Center has evolved into a multi-campus medical center, with four locations throughout Palm Beach County. Our main campus in Atlantis is a 527-bed facility known for its comprehensive services, including Cardiovascular Care, General and Orthopedic Surgery, Neurosurgery, Stroke Care, Robotics, Cancer Care and Emergency Care. JFK Medical Center North Campus is a 280-bed acute care hospital, with an adjoining 124-bed psychiatric unit and a medical professional office building. JFK also has two off-site Emergency Rooms in Palm Beach Gardens and Boynton Beach.

JFK Medical Center is a facility of HCA East Florida. HCA East Florida is the largest healthcare system in Eastern Florida and an affiliate of HCA Healthcare (HCA). HCA East Florida has 14 hospitals, multiple ambulatory surgery centers, urgent care centers, physician practices, and free standing emergency care facilities, as well as a supply chain center and an integrated regional lab. Together, HCA East Florida employs more than 18,000 employees and has more than 6,600 physicians on staff. For more information, visit HCAEastFlorida.com.

HCA EAST FLORIDA

Aventura Hospital and Medical Center + Highlands Regional Medical Center + JFK Medical Center +

JFK Medical Center North Campus + Kendall Regional Medical Center + Lawnwood Regional Medical Center + Mercy Hospital + Northwest Medical Center + Palms West Hospital + Plantation General Hospital + Raulerson Hospital + St. Lucie Medical Center + University Hospital & Medical Center + Westside Regional Medical Center



Company Achieves Milestone of Dosing First Group of Participants in Six-Month Comparative Study with Lithium-Delivering Ionic Cocrystal Oral Treatment

September 13 2021 – Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that the first group of healthy participants have been dosed in a six-month Phase I relative bioavailability study for AL001 for dementia related to Alzheimer’s disease. The Phase I first-in-human study is for the purpose of determining potential clinically safe and appropriate dosing for AL001 in future studies. AL001 is a lithium-delivering ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer’s disease.

“Advancing AL001 into the clinic as planned marks an important milestone for Alzamend,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We believe AL001 could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million Americans suffering from Alzheimer’s and other neurodegenerative diseases and psychiatric disorders. We look forward to completing the Phase I study and advancing the clinical studies of this promising potential therapeutic.”

Overview of the Phase I Clinical Study
The Phase I study will investigate the pharmacokinetics (the movement of drug through the body) of lithium following a single dose of AL001 (the “study drug”) compared to a typical single dose of a marketed 300 mg immediate-release lithium carbonate capsule (the “comparator” – currently indicated to treat mood disorders) in healthy male and female subjects. The lithium and salicylate components of AL001 will be given within the amounts already approved for use in patients. The purpose of the research study is to test the safety, tolerability, and bioavailability (how much and when drug gets in the body) of the study drug, AL001, compared to the currently marketed formulation of the comparator, lithium carbonate. This is expected to ascertain what AL001 doses should be given, and how often, in subsequent Phase 2 safety and efficacy trials involving Alzheimer’s disease patients. At least 24 healthy male and female human subjects will complete the Phase I trial.

About AL001
AL001 is a patented ionic cocrystal technology delivering lithium via a therapeutic crystal-engineered combination of lithium, proline and salicylate, known as AL001 or LiProSal, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.

Based on preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and has shown an improvement of associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s disease and psychiatric disorders. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially allowing Alzamend to rely upon this existing data, potentially reducing the regulatory burden for safety data.

About Alzamend Neuro
We are an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, including Alzheimer’s disease. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic crystal-engineered combination of lithium, proline and salicylate, and AL002 – a patented therapeutic mutant peptide sensitized cell-based therapeutic vaccine that is targeted to augment the ability of a patient’s immune system to combat Alzheimer’s disease. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.



September 13 2021 – AdvaMed, the leading global trade association for medical technology manufacturers, released the following statement from President and CEO Scott Whitaker on the Administration’s proposal to fully repeal the Medicare Coverage of Innovative Technologies (MCIT) rule that would have allowed immediate access to FDA-designated and -approved “breakthrough” technologies for Medicare patients suffering from debilitating illnesses and conditions that existing treatments and technologies are unable to address:

“It’s unfortunate for patients across the country that the Administration has decided to reject a rule to allow Medicare patients immediate access to breakthrough medical innovations. Any Medicare patient and their doctor who has exhausted all existing medical options should have immediate access to FDA-approved breakthrough medical technologies. That’s what this is all about. Doctors and patients should be trusted to make the right medical decision to treat a life-threatening condition. The federal government should incentivize access to these new breakthrough technologies. Repealing MCIT is the wrong decision for countless Medicare patients, and it’s the wrong decision for American medical innovation. Our goal in this country should be to spur and not inhibit innovation that will change patients’ lives. We will continue to make this important case with the Administration and Congress, and we are hopeful they will make the right decision.”

Under the rule CMS has proposed to repeal, Medicare would have provided immediate national coverage for four years for any new device or diagnostic designated as a “breakthrough” technology and deemed safe and effective by FDA. During that four-year coverage period, manufacturers could continue to provide the additional data needed to maintain coverage after the four-year coverage period expired. Under this rule, if the FDA approved a breakthrough technology, Medicare would have quickly covered it, ensuring immediate national coverage of devices for seniors in need of lifesaving treatments. MCIT ensures the safety and efficacy of breakthrough technologies: After receiving an FDA breakthrough designation, these technologies would still undergo the rigorous FDA review process – the global gold standard for medical safety and effectiveness – to achieve approval.

An op-ed by Whitaker on behalf of the MCIT rule can be found here, and an op-ed by Dr. Anand Shah, an oncologist and former deputy commissioner at the FDA and former chief medical officer at the Center for Medicare & Medicaid Innovation on behalf of the rule can be found here.

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.



HCA Healthcare Broward County facilities honored for clinical excellence in labor and delivery, obstetrics and gynecology, and gynecological surgery in recent Healthgrades analysis

September 13, 2021 – Northwest Medical Center in Margate and Plantation General Hospital in Plantation, part of HCA Healthcare’s East Florida Division, are proud to announce they cumulatively amassed more than 20 awards for excellence in labor and delivery, obstetrics, and gynecology, and gynecological surgery. The national recognition received by the two facilities is for demonstrating exceptional quality in women’s care, according to research released by Healthgrades, a leading online resource connecting patients to information about physicians and hospitals.

The accolades are a testament to the high quality of care available to patients through these connected hospitals offering labor and delivery, postpartum, and gynecological surgery services in Broward County.

Northwest Medical Center was recognized for clinical achievements including but not limited to:
• Recipient of the Healthgrades Gynecologic Surgery Excellence Award™ for 11 Years in a Row (2011-2021) and among the Top 5% of Hospitals Evaluated for Gynecologic Surgery for 4 Years in a Row (2018-2021)
• Five-Star Recipient for C-Section Delivery for 7 Years in a Row (2015-2021)
• Five-Star Recipient for Vaginal Delivery in 2021
• Five-Star Recipient for Gynecologic Procedures for 11 Years in a Row (2011-2021)
• Five-Star Recipient for Hysterectomy for 7 Years in a Row (2015-2021)
“At Northwest, we strive to put our patients at the center of everything we do because we know that is the key to delivering better, safer care,” said Kenneth Jones, Chief Executive Officer at Northwest Medical Center. “These latest Healthgrades recognitions give us even more reason to be proud of our team and the exceptional labor and delivery and gynecological surgery services we offer to the community.”

Plantation General Hospital was recognized for clinical achievements including but not limited to:
• Recipient of the Healthgrades Obstetrics and Gynecology Excellence Award™ for 7 Years in a Row (2015-2021) and among the Top 5% of Hospitals Evaluated for Obstetrics and Gynecology for 7 Years in a Row (2015-2021)
• Recipient of the Healthgrades Labor and Delivery Excellence Award™ for 7 Years in a Row (2015-2021) and among the Top 5% of Hospitals Evaluated for Labor and Delivery for 7 Years in a Row (2015-2021)
• Five-Star Recipient for Vaginal Delivery for 7 Years in a Row (2015-2021)
• Five-Star Recipient for C-Section Delivery for 7 Years in a Row (2015-2021)
• Recipient of the Healthgrades Gynecologic Surgery Excellence Award™ for 8 Years in a Row (2014-2021) and among the Top 5% of Hospitals Evaluated for Gynecologic Surgery for 2 Years in a Row (2020-2021)
• Five-Star Recipient for Gynecologic Procedures for 9 Years in a Row (2013-2021)
• Five-Star Recipient for Hysterectomy for 2 Years in a Row (2020-2021)

“Plantation General Hospital prides itself on providing our patients with the highest quality care,” said Madeline Nava, Chief Executive Officer at Plantation General Hospital. “Earning multiple accolades from Healthgrades demonstrates the dedication and commitment of our team to delivering safe and effective care to all our patients. This is a tremendous accomplishment for our team.”

Healthgrades analyzed patient outcomes data for hospitals across 16 states that provide all-payer state data for years 2017 through 2019 and found that the variation in hospital performance makes a significant difference in terms of clinical outcomes. Specifically, the study found that patients treated in hospitals receiving Women’s Care Excellence Awards and 5-star ratings had a lower risk of experiencing a complication while in the hospital than if they were treated in hospitals that did not receive these awards and ratings.

The complete list of hospital quality awards and detailed report methodologies can be found here.

*Statistics are based on Healthgrades’ analysis of all-payer data for years 2017 through 2019 and represent 3-year estimates for patients in 16 states for which all-payer data was made available

About HCA East Florida Broward Market Hospitals:
Northwest Medical Center and Plantation General Hospital are affiliate facilities of HCA East Florida. HCA East Florida is the largest healthcare system in Eastern Florida and an affiliate of Hospital Corporation of America (HCA). HCA East Florida has 14 hospitals, multiple ambulatory surgery centers, physician practices, and free standing emergency care facilities, as well as a supply chain center and an integrated regional lab. Together, HCA East Florida employs more than 18,000 employees and has nearly 7,000 physicians on staff. For more information, visit HCAEastFlorida.com.

HCA EAST FLORIDA
Aventura Hospital and Medical Center + Highlands Regional Medical Center + JFK Medical Center + JFK Medical Center North Campus + Kendall Regional Medical Center + Lawnwood Regional Medical Center + Mercy Hospital + Northwest Medical Center + Palms West Hospital + Plantation General Hospital + Raulerson Hospital + St. Lucie Medical Center + University Hospital and Medical Center + Westside Regional Medical Center



Bell: Tackling COVID is “most urgent and immediate priority” under hospital’s new ownership

 September 12 2021 – Steward Health Care today announced Michael Bell will become the new president of Florida Medical Center, leading the hospital’s efforts to tackle the regional COVID surge and expand high-quality healthcare to the diverse communities of South Florida. The announcement marks a new era of leadership following Steward’s acquisition of five South Florida hospitals, including FMC and Hialeah Hospital – where Bell previously served as president – from Tenet Healthcare Corporation earlier this month.

“Steward Health Care is thrilled to work closely with Michael as we expand our footprint in South Florida and unlock access to high-quality, compassionate, value-based care in some of the nation’s most vibrant communities,” said Dr. Sanjay Shetty, MD, Steward’s President of North America. “Michael’s track record in the region shows he has what it takes to work closely with this community and tackle the health care challenges we currently face head on.”     

As the CEO of neighboring Hialeah Hospital – also acquired by Steward – Bell previously led an experienced medical staff of more than 800 employees. Prior, he was the chief operating officer of Tenet’s Sierra Vista Regional Medical Center in San Luis Obispo, California, and Group COO for Northern California. 

“I am humbled by the opportunity to lead the team at Florida Medical Center at such a critical moment for the nation’s health care system,” said Michael Bell, president of Florida Medical Center. “Tackling COVID is my most urgent and immediate priority, and I am already working closely with leadership at Steward as they redeploy PPE, ventilators, and other vital supplies needed for care of COVID patients from other facilities throughout the country to FMC and South Florida.”

As president of Florida Medical Center, Bell will lead a team of more than 900 employees directing care at the 459-bed acute care hospital, which has been part of the Fort Lauderdale community for more than 40 years. FMC is home to the Heart Institute of Florida, is a member of the Advanced Neuroscience Network, and has a comprehensive stroke center offering fast, effective stroke care for strong recoveries.

On August 2, Florida Medical Center was one of five hospitals – along with North Shore Medical Center, Hialeah Hospital, Coral Gables Hospital, and Palmetto General Hospital – acquired from Tenet Healthcare by Steward Health Care. Founded by CEO Ralph de la Torre, MD, who grew up in Florida, the son of Cuban immigrants, Steward Health Care’s physician-led model was built to help patients unlock access to high-quality, compassionate, value-based care in more communities across the U.S. and internationally.