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Tag: orthobiologics

Hosted by Dr. Scott Sigman – “Dr. Jaime Garza and Dr. Jim Kovach”

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We have on Dr. Jim Kovach and Dr. Jaime Garza, also both NFL alumni, for this episode who are incredibly passionate about research, orthobiologics and cellular mediated therapies. It’s a perfect dovetail episode after our Dr. Scott Bruder episode on the FDA Consumer alert on orthobiologics. We discuss further what you can/can’t do in orthobiologics and discuss an innovation in pre-market approval.

Jim Kovach is MD, JD, Executive Director, Translational Entrepreneurship, UC Davis School of Medicine, where he supports physician training in entrepreneurship; and industry outreach to support translational science. He identifies products that are consistent in formulation and can developed, scaled and distributed to help solve challenges in medicine. Dr. Kovach received his medical degree with distinction from the University of Kentucky while simultaneously playing in the National Football League. Dr. Kovach played 7 years in the National Football League as a middle linebacker for the New Orleans Saints and San Francisco 49ers.

Dr. Jaime R. Garza M.D., D.D.S., F.A.C.S. is a native San Antonian with a focus on academics and clinical trials. He has academic appointments as a professor at the University of Texas Health Sciences Center and at Tulane School of Medicine. He is also the President of the Texas Center for Cell Therapy and Research, LLC. A former college football player before entering medical school, Dr. Garza has served as team or tournament physician for several college and professional teams including the NFL’s New Orleans Saints and the and U.S. Olympic track and field team.

Topics include:

-We hear about their involvement in pivotal investigational device exemption (IDE) studies with GID BIO, Inc.. An IDE allows an investigational device to be used in a clinical study to obtain pre-market approval (PMA) for Class III medical devices. The first study was a safety and feasibility study with the second being a double blind placebo controlled trial at three sites. Tune-in to hear about the technology and the goals of the study outcomes.

-Both are college football and NFL alumni with a passion to educate former players and facilitate outreach to industry. A decade ago, Dr. Garza received emails from NFL alumni about “great stem cell treatments available for free,” yet it wasn’t legitimate.  He has since educated alumni and physicians on how they were being targeted and how to protect the NFL Alumni name. It was a significant organizational wake-up call and is now headed in the right direction with the establishment of NFL Alumni Healthcare Committee, for which Dr. Kovach and Dr. Garza serve as senior medical advisors.

Find out more about Dr. Jim Kovach here and find out more about Dr. Jaime Garza here. Interested in GID BIO, Inc., find out more information here.

For MD’s, capture quick reflections on each learning below & how it applies to your day-to-day to unlock a total of 1 AMA PRA Category 1 CMEs.

Earn CMEs with CMEfy

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Hosted by Dr. Scott Sigman – “FRO ALERT: FDA Consumer Alert”

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Dr. Scott Bruder, MD, PhD., joins us for a “FRO ALERT” episode on the significance of the FDA consumer alert on regenerative medicine therapies. Dr. Bruder is the Founder and CEO of Bruder Consulting & Venture Group. He helps breaks down in orthobiologics what is legal, what’s not, what is compliant, what you can/can’t say and what you can/can’t use. Listen to this episode on this important information that is relevant for all our listeners, including medical sales, orthopedic surgeons and patients.

In this episode, Dr. Bruder breaks down the alert on June 3, 2021 from the FDA on “Important Patient and Consumer Information About Regenerative Medicine Therapies.” This latest alert on June 3rd makes physicians, companies and patients aware of which orthobiologics that are not approved. Other topics include:

-Clarification on terminology such as stem cells, regenerative medicine and orthobiologics

-What it means for FDA clearance vs. FDA approval

-Sage advice to surgeons, medical sales reps and patients seeking counsel on orthobiologics

Follow Dr. Scott Bruder on LinkedIn for more information.

For MD’s, capture quick reflections on each learning below & how it applies to your day-to-day to unlock a total of 1 AMA PRA Category 1 CMEs.

Earn CMEs with CMEfy

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Hosted by Dr. Scott Sigman – “Regenerative Medicine”

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Regenerative medicine is a complicated space and we get key questions answered for our listeners during this episode.

What is PRP? What are stem cells? Does it work? Does it not work? Is it worth the extra money? Who do I go to? We discuss these key questions with Dr. Steven Sampson, one of the nation’s pioneers in regenerative medicine. He’s a top sports medicine doctor in Los Angeles and Beverly Hills and is internationally recognized in the field of non-surgical orthopedics. Dr. Sampson is the physician founder of the Orthohealing Center and physician to Olympic athletes and Los Angeles Clippers. He is also the founder of TOBI, The Orthobiologic Institute, an annual conference which has grown to 1000+ doctors in 40 countries. Discussion topics include:

-Why is regenerative medicine like The Grateful Dead or black licorice? You either love it or hate it. Dr. Sampson discusses how regenerative medicine is changing the way we are doing things and embracing new approaches to care

-Discussion on patient pay model on regenerative medicine. Pricing depends on region, quality, preparation and physician experience. His suggestion is to do your research and reviews on physicians in your area for individuals considering regenerative medicine

-Regenerative medicine crosses multiple specialties and the TOBI conference includes attendees such as plastic surgeons, neurologists, orthopedic surgeons and veterinarians who share best practices to advance the field. TOBI 2021 is slated October 7-9, 2021 as an interactive virtual experience. Check out the conference here

-Wild West claims about what regenerative medicine can do vs. scientific evidence. Dr. Sampson is passionate about the potential of cell based therapies and discusses along with it comes opportunists or rogue physicians taking care of vulnerable patients

-Various types of regenerative medicine with PRP and bone marrow concentrate. His theory is bone marrow is loaded with anti-inflammatory proteins and bone marrow concentrate can neutralize the inflammation. He’s continuing on publishing the outcomes

Find out more about Dr. Steven Sampson here.

Thank you to our partner OrthoLazer for making this episode of The Ortho Show possible.

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