FDA Regulations: What Is and Isn’t Compliant

James Leiber, DO
September 10, 2020

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About The Author

James Leiber, DO

James Leiber, DO, is founder and medical director of Regenexx® at New Regeneration Orthopedics.

James Leiber, DO

James Leiber, DO, is founder and medical director of Regenexx® at New Regeneration Orthopedics.

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Are You a Regenexx® Candidate?

Locations

Regenexx at New Regeneration Orthopedics

Sarasota
2401 University Pkwy, Suite 104
Sarasota, FL 34243
Phone: 941-357-1773
Fax: 941-256-7452

Tampa
8600 Hidden River Pkwy, Suite 700
Tampa, FL 33637
Phone: 813-544-3123

St. Petersburg
100 2nd Ave S, Suite 904S
St. Petersburg, FL 33701
Phone: 941-357-1773

Orlando
1412 Trovillion Ave
Winter Park, FL 32789
Phone: 407-856-3695

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How Can Extracorporeal Shockwave Therapy Help with Lateral Hip Pain?

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Common Hip Issue: Trochanteric Pain Greater Trochanteric Pain Syndrome (GTPS)

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Cartilage Repair in Traditional Orthopedics When it comes to cartilage

Google Rating

4.8

Regenexx Tampa Bay

4.8

Susan Dimeo

I had a medium size rotator cuff tear which in now completely healed with the help of regenexx I am continuing my work lifting patients without any shoulder pain . Going back to get my back taken care of next. Much better alternative than surgery.

L Russell

Dr. Torrence is great!. He not only evaluates the injury/issue from imaging MRI/X-rays/ultrasound, but also takes the time to listen to the specific symptoms of what you’re feeling in the problem joint during his evaluation.

Rebecca Seevers

I am very pleased with the results I have seen from the PRP procedure on my back and one hip. Other orthopedic doctors only offered me medication, surgery, or steroid injections, none of which had any appeal to me. After my PRP injections, I am more active (proven by the health app on my phone) by twice as much over a year ago. I faithfully exercise and walk, but I no longer need the medication, and I no longer limp. The healing PRP brought me is long-lasting, and it was worth the expense. I am so happy about it. Surgery is a serious injury, in my opinion, and I avoid it if at all possible. The fact that this procedure required no anesthesia was a big advantage too. I highly recommend it and the Regenexx office, Dr. Ron Torrance in particular, to anyone who only has the options I did for managing a condition rather than healing it.

Melanie Black

Stem cell therapy for my knees a few years ago and come back yearly for boosters. Dr Leiber is fantastic and I'm still able to enjoy my work and hobbies because of his treatments... highly recommend!

Meagan Skaff

Instead of knee replacement surgery I had Bone Marrow Stem Cell Therapy on my knees and it worked! Within a few weeks I had full range of motion and was walking without pain and better, stronger, faster than I had for at least 10 years. Dr. Ron Torrance knew the latest research for my situation and implemented it: no other orthopedic doctor I saw had a clue. Dr. Torrance is smart, caring, dedicated, and excellent at what he does. The whole team in the Sarasota office was communicative and top-notch. These people really know what they're doing and it's so refreshing to have a positive medical experience with a world-class team! I am grateful for their skills, knowledge, technology, and process. I have my active life back and it feels like a miracle!

Cynthia Mosser

Dr. Leiber is professional, compassionate, he asks questions and he listens. He has a vast knowledge of stem cell therapy and is always studying the field around the globe. I have avoided a knee replacement once with his care and treatment and am about to do the same with the other knee. I highly recommend his practice. Most of all find out all your options for treatment before consenting to surgery. You owe it to yourself.

Cynthia Mosser

Heidi Tuozzolo

Extremely pleased with the care I received before, during and after my knee procedure. Staff was professional and always available to answer questions. Dr. Torrance is very easy to talk to and made me feel comfortable during the procedure. Highly recommend!

Becky Johnson

Finally, a physician who was willing to take the time to properly diagnose and treat my problem instead of just prescribing pain medication! After 10 years of being in constant pain and 3 years of being unable to do even the basic of activities I am back in the gym and able to physically do anything I want. Recovery has been somewhat challenging in my case, but Dr. Torrence and his team have been nothing but helpful and supportive the entire time. I would absolutely recommend them to anyone.

Meghan Finch

Clean office, friendly and helpful staff. Dr. Ron Torrance was great, he took a very long time with me listening and going over everything. Answered most of my questions before I even asked them. I highly recommend him!

Zack

All aspects of my care with Dr. Torrance and his staff have been excellent. I have had several procedures with Dr. Torrance and my most recent experience was no different yet still left me very impressed and recommending him to random people wherever I go. If you are looking for a final solution in order to achieve actual healing and a 100% recovery from spinal disk injuries or avascular necrosis he is your guy.

Mary Guler

I have had torn rotator cuffs on the left and right shoulders repaired with PRP, and neck pain from bulging discs in the cervical spine repaired with PRP and Lysate. Dr Torrance is the best! My first option for any orthopedic problem will always be New Regeneration!

Wolf Weinhold

Clean facilities, responsive staff, and a knowledgeable Doctor who all put you or your issues first. what medicine is supposed to be.

Linda A. Wood

I have been receiving stem cell and prp injections from Dr Leiber since 2016 for various old sports injuries. I wouldn't go anywhere else!

O Harris

Expert and professional. Regenexx has kept me out of the joint replacement crowd for 10 years. The best investment I have ever made is with Dr. James Leiber.

Jean Chaff

I had PRP for a tear in a tendon in my shoulder on 2/15/21....followed by 10 weeks of PT. Today 5/4/21 I am 98% pain free! Only discomfort is when I lay on my shoulder too long while sleeping! I am so grateful for Dr Leiber & his practice for this amazing procedure!

beth owen

It is hard to believe how good this works. At first you wonder and are skeptical. But, being able to use my shoulder full circle is the best feeling in the world! Thanks Dr. Ron Torrance, I am so happy to be active again!!!!

Scott Lane

Great experience from the start Dr. Torrance and the staff reviewed every step of the procedure and followed up several times. Its been six months since my procedure and the results have been amazing! I would highly recommend to explore the Regenexx process before knee replacement, its worth the research!

Angie Rasner

The whole group was very helpful and friendly. Explained things thoroughly. They obviously know their stuff! Felt very confident scheduling a date for procedure.

Jerry Powers

My shoulder was in rough shape. It felt fine as long as I did not do anything with it. Once I had the procedure done and then completed the rehab, my shoulder is really healthy now. It is up to about 95% strength now. I can lift bags of concrete. I can do push ups too. Not a bunch of them, but I couldn't even do 2 before.

*DISCLAIMER: Like all medical procedures, Regenexx® procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our procedures for anyone else. Regenexx® at New Regeneration Orthopedics does not make claims that therapy using any Regenexx® procedure is a cure for any condition, disease or injury. All statements and opinions provided are for educational and informational purposes only. Anyone interested in a possible Regenexx® procedure at Regenexx® at New Regeneration Orthopedics will need to have a consultation with one of the doctors which would include a thorough history, physical examination (which may include an ultrasound and/or Xray diagnostic examination), discussion of various procedure options, and candidacy. Patients receiving a Regenexx® procedure are tracked for side effects and outcomes as part of the largest database registry of its kind in the world. Regenexx® at New Regeneration Orthopedics is compliant with FDA regulations. Individuals interested in regenerative medicine therapy are urged to review all pertinent information and conduct their own research before choosing to participate in procedures utilizing Regenexx® procedures.

Regenexx® procedures are covered by some employers and auto insurance policies. They are not currently covered by Medicare or Medicaid.

FDA Regulations: What Is and Isn’t Compliant

Watch Dr. Leiber present continuing education to Florida doctors.

Your Complete Guide To

About The Author

James Leiber, DO

James Leiber, DO

Related Posts

How Can Extracorporeal Shockwave Therapy Help with Lateral Hip Pain?

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How Can Extracorporeal Shockwave Therapy Help with Lateral Hip Pain?

What Is A Bungee Workout?

I Have A Cartilage Defect In My Knee – Now What?

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How Can Extracorporeal Shockwave Therapy Help with Lateral Hip Pain?

What Is A Bungee Workout?

I Have A Cartilage Defect In My Knee – Now What?

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