August 23, 2021 – Joseph J. Ricotta, MD, MS, DFSVS, FACS,  National Medical Director for Vascular Surgery and Endovascular Therapy for Tenet Healthcare recently completed his 200th Transcarotid Artery Revascularization (TCAR) stroke prevention procedure at Delray Medical Center. Dr. Joseph Ricotta was first in the State of Florida to perform the TCAR procedure in 2018. For patients diagnosed with carotid artery disease, the TCAR procedure is a minimally invasive approach compared with traditional surgical procedures such as carotid endarterectomy. The TCAR procedure is suited for patients who are at a higher risk of surgical complications due to age, medical co-morbidities, or anatomical issues.

In 2020, Dr. Ricotta received the national TCAR Clinical Operator of Experience distinction. Silk Road Medical, manufacturer of the TCAR device for patient procedures, awards select physicians throughout the country with this accolade who have demonstrated clinical excellence and superior quality outcomes using TCAR to treat patients with carotid artery disease.

“TCAR is a new treatment alternative for patients with carotid artery disease aimed to prevent a stroke. Carotid artery disease is the most common cause of stroke and usually occurs when plaque in the carotid artery breaks off and travels to the brain or impedes blood flow which can also cause a stroke,” said Dr. Ricotta.

During a TCAR procedure, Dr. Ricotta makes a small incision above the clavicle to access the carotid artery and insert a pliable sheath. The sheath links to a component temporarily reversing blood away from the brain in an effort to avert any plaque from traveling to the patient’s brain. With this reverse-flow neuroprotection in place, Dr. Ricotta performs balloon angioplasty and implants a stent inside of the carotid artery lesion to achieve long-term plaque stabilization and stroke prevention as well as open blood flow to the brain. Throughout the TCAR procedure, the blood filters removing any plaque or clot before returning to the body via an additional sheath in the femoral vein of the patient’s thigh. Once Dr. Ricotta places the stent in the artery to eliminate the plaque, the reversal flow mechanism switches and blood flows freely to the brain into its intended path free from stroke inducing plaque.

“If you compare TCAR to traditional carotid endarterectomy surgical treatment, TCAR carries a lower risk of stroke, heart attack, and death. TCAR is quicker than a traditional surgery with a shorter hospital stay (<24 hours) and less chance of bleeding, nerve injury, or re-intervention,” said Dr. Ricotta.

Dr. Ricotta performs the TCAR procedure in Delray Medical Center’s Endovascular Hybrid Operating Room Suite. At Dr. Ricotta’s Prime Vascular Institute medical practice in Delray Beach, a non-invasive Doppler ultrasound is available to diagnose a patient’s carotid artery disease.

Prime Vascular Institute is located at 4205 W. Atlantic Ave., Building B, Suite 201, Delray Beach, FL, 33445. For more information visit: PrimeVascular.com or call Dr. Ricotta’s office at 561-303-0013. In addition, Dr. Ricotta is on-staff at Delray Medical Center.

Prime Vascular Institute

Internationally renowned vascular and endovascular surgeon Dr. Joseph Ricotta’s medical practice and office based laboratory (OBL) at Prime Vascular Institute in Delray Beach offers the full spectrum of vascular care with the most up-to-date technology, testing and treatment options tailored to address each patients individual needs.

About Tenet Florida Physician Services

Tenet Florida Physician Services (TFPS), a division of Tenet Healthcare Corporation, is a multi-specialty physician group that has provided care to the Palm Beach County and Treasure Coast communities since 2007. Our award-winning physicians provide a level of expertise that has resulted in regional firsts and outstanding patient outcomes. As an affiliate of the Palm Beach Health Network, one of the largest healthcare networks in Palm Beach County, TFPS specialists, sub-specialists and primary care physicians and staff are committed to delivering the highest quality care to the communities we serve. Today, we are proud to be one of the most respected physician networks in the area.

About the Palm Beach Health Network:

The Palm Beach Health Network is one of the largest healthcare networks in Palm Beach County consisting of, Delray Medical Center, Good Samaritan Medical Center, Palm Beach Children’s Hospital, Palm Beach Gardens Medical Center, St. Mary’s Medical Center and West Boca Medical Center, along with various ambulatory surgery centers, outpatient facilities and urgent care centers. All of our hospitals have received prestigious awards and accolades, national rankings and multiple accreditations. We are dedicated to the standards of excellent patient care that are the hallmark of the Tenet brand.



Approval Signifies Key Achievement for Public Health

August 23 2021 – Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval. 

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. 

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older

The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. 

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population. 

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. 

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Ongoing Safety Monitoring

The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.



WHAT:  The Alzheimer’s Association Brain Bus will make several stops in Broward County from Aug. 30 through Sept. 2.

The Brain Bus is a mobile outreach unit providing local families with access to dementia information and referrals, brain health and risk reduction, and care planning information. Of the six stops planned, three (marked below with an asterisk) will coincide with on-site presentations of the Alzheimer’s Association programs “10 Warning Signs of Alzheimer’s” and “Understanding Alzheimer’s and Dementia” in both English and Spanish.

Joe Baldelomar, program manager for the Alzheimer’s Association Southeast Florida Chapter, said: “We are so excited to bring the Brain Bus to the people of Broward County. The Brain Bus allows us to provide essential information about dementia to those who need it and can also help to facilitate early diagnosis. And as Hispanic Americans are 1 ½ times as likely to develop Alzheimer’s as their White counterparts but less likely to be diagnosed, it is especially crucial that we increase our outreach among the Spanish-speaking community.”

STOPS: 

   Monday, Aug. 30:

Tuesday, Aug. 31:

Wednesday, Sept. 1:

  Thursday, Sept. 2:

WHY: More than 6 million Americans are living with Alzheimer’s disease, a leading cause of death in the United States. Florida has the second-highest prevalence of Alzheimer’s in the nation with more than 580,000 individuals battling the disease and 527,000 family caregivers providing them with daily care. During the COVID-19 pandemic, Alzheimer’s and dementia deaths have increased 16% nationally and 18.5% in Florida.



The Executive Leadership Team now includes Dr. Timothy Long, Chief Clinical Officer; Oscar Perez, Chief Applications & Innovation Officer; and Timothy Weldon, Chief Engagement & Development Officer

August 23, 2021 — Health Choice Network (HCN), a nation-wide collaboration of health centers based in Florida with over 2.2 million unique patient lives across 43 safety-net organizations, has experienced rapid growth to adapt to the continuous evolution and development within the health care community. To best support this growth and HCN’s strategic vision to improve quality care for all, the organization announces a new leadership structure, including three new Associates to the Executive

L­­­eadership Team.

Dr. Timothy Long, who has provided shared services between HCN and AllianceChicago since 2017, takes on the full-time role as Chief Clinical Officer for HCN. Dr. Long coordinates and promotes clinical leadership, clinical engagement, and advancing quality health outcomes on the optimal implementation and use of Health Information Technology. In addition, Dr. Long has practiced as a primary care Internist at Near North Health in Chicago, specializing in preventive and community-based health care, chronic disease management, and HIV/AIDS care for the underserved community since 1997.

Oscar Perez, a dynamic, collaborative, and innovative leader with over 25 years of healthcare IT experience and over 15 years of Epic experience, has been named the Chief Applications & Innovation Officer at HCN. Mr. Perez most recently served as the Vice President, Information Technology for Memorial Healthcare System, and prior to that, as Director of Informatics for Jackson Health System. HCN is excited to see how Mr. Perez will utilize his experience with strategic planning and digital transformation to create more efficient workflows and improve the health status of the community.

Timothy Weldon joins HCN as the Chief Engagement & Development Officer, bringing over 20 years of progressive healthcare experience managing the growth and delivering on organizatio­­­nal strategic plans for value-based care delivery systems. Earlier in his career, Timothy held leadership roles at Canton & Company and Continuum Health. With his strong business acumen, teamwork, and collaborative skills, Mr. Weldon’s leadership will help HCN strengthen and expand their network of Community Health Centers.

“It is exciting and essential to expand our amazing Executive Leadership Team with the talent and experience required to support our ever growing and dynamic health center goals. Our Members are increasing their delivery of services, elevating their quality health care, and demanding more from the network they formed over 27 years ago.  We at HCN invested years of planning for this growth and we are delivering for our health centers.” said Alejandro M. Romillo, President and CEO of Health Choice Network, Inc. and Health Choice Network of Florida, Inc.  

About Health Choice Network 

Health Choice Network, Inc. (HCN) is a successful nation-wide collaboration among health centers, health center-controlled networks and partners. By providing key business services in financial, managed care and billing support, strategic initiatives and the latest in health information technology, participants can improve patient outcomes through increased efficiencies and more accessible care in underserved communities. With 43 safety-net organizations in sixteen states serving approximately 2.2 million patients, HCN is recognized as a leader in the integration of health information technology among health centers and safety net providers. 



Program helps those living with Achromatopsia receive filtered glasses and contact lenses to qualify for bioptic driving

August 19, 2021 – Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare retinal diseases, today announced it will be a sponsor of the Achroma Corp program, No Roadblocks.

No Roadblocks is a program that funds tinted glasses or contact lenses, as well as bioptics, for individuals living with achromatopsia (ACHM), an inherited condition caused by mutations in one of several genes, with the two most common being mutations in either the CNGB3 or CNGA3 genes. ACHM is associated with extremely poor visual acuity, extreme light sensitivity resulting in daytime blindness, and complete loss of color discrimination.

There is no specific treatment for ACHM, although deep red tinted glasses or contact lenses can reduce symptoms of light sensitivity and daytime blindness. These filters are often essential to bioptic driving. Bioptic driving is a method of driving that uses a patient’s general vision and intermittent spotting through a small telescopic system that improves the sharpness of the patient’s vision.

“AGTC understands the unique challenges for those living with achromatopsia and is proud to be a sponsor of the No Roadblocks program and provide support to help these individuals gain independence through bioptic driving,” said Sue Washer, President and Chief Executive Officer of AGTC. “As AGTC diligently works to find a treatment using AAV-based gene therapies for achromatopsia, organizations like Achroma Corp provide an important service of improving quality of life for those living with an IRD.”

“Achroma Corp is excited to be able to launch our No Roadblocks Program with sponsorship support from AGTC,” said Bridget Vissari, President of Achroma Corp. “The goal of this program is to provide those affected with achromatopsia unprecedented access to glasses, contacts, and bioptic systems that they otherwise may have difficulty obtaining. We appreciate AGTC’s commitment to this much needed program.”

About AGTC
AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. AGTC’s most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM B3 and ACHM A3). Its preclinical programs build on the Company’s industry leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders. In recent years AGTC has entered into strategic partnerships with companies including Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, and Bionic Sight, LLC, an innovator in the emerging field of optogenetics and retinal coding.