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.

Shockwave Therapy For Hand Arthritis: Can It Ease Symptoms?

Ignatios Papas, DO Medically Reviewed By James Leiber, DO February 11, 2026

Hand arthritis is an inflammatory condition that causes joint pain, stiffness, and swelling. These symptoms can make it difficult to perform daily activities. Some non-surgical care options, such as shockwave

Case Study: Kathleen’s Return to Mobility After Severe Sciatica and Disc Degeneration

James Leiber, DO Medically Reviewed By Lisa Valastro, DO February 11, 2026

Part of our Patient Outcomes Series at New Regeneration Orthopedics of Florida Condition: Lumbar Disc Degeneration with Sciatic Pain (L4–L5) Treating Physician: Dr. Leiber Background After Hurricane Milton, Kathleen injured

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Locations

Regenexx at New Regeneration Orthopedics

Sarasota
5630 Marquesas Circle
Sarasota, FL 34233
Phone: 941-357-1773
Fax: 941-256-7452

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

St. Petersburg
625 6th Avenue South, Suite 455
St. Petersburg, FL 33701
Phone: 727-284-5250

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

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Recent Posts

Shockwave Therapy For Hand Arthritis: Can It Ease Symptoms?

Ignatios Papas, DO Medically Reviewed By James Leiber, DO February 11, 2026

Hand arthritis is an inflammatory condition that causes joint pain,

Case Study: Kathleen’s Return to Mobility After Severe Sciatica and Disc Degeneration

James Leiber, DO Medically Reviewed By Lisa Valastro, DO February 11, 2026

Part of our Patient Outcomes Series at New Regeneration Orthopedics

How Shockwave Therapy For Tennis Elbow Works

Gregory Zakas, DO Medically Reviewed By Ron Torrance II, DO FAOASM February 11, 2026

For many active adults, elbow pain can become a frustrating

Google Rating

4.9

Regenexx at New Regeneration Orthopedics of Florida

4.9

Juan Jimenez

20 years in the marine field as a technician was tough on my hands. I was told I needed carpal tunnel release surgery. As an alternative to surgery I had the platelet treatment done on my hands by Dr. Ron Torrance. It’s been over a month since my treatment and I am extremely happy with the results! Would recommend Dr. Torrance and his team to anyone looking for an alternative to surgery.Thank you Dr. Torrance !

Cassandra Carol

Dr Lieber and staff are very knowledgeable and helpful. The stem cell and platelets procedure that Dr Lieber performed has made a big difference in my knee pain. Highly recommend the Regenexx team in Sarasota.

Carolynn Garcia

I needed a torn meniscus on my left knee repaired and after much research decided to go to Regenexx at New Regeneration Orthopedics instead of opting for surgery offered by my regular doctor. I am so glad I did. This is a full disclosure office - no question is stupid and everything, and I mean everything you can think to ask is answered before the procedure. The staff is so accommodating. Front office is great and there is ease in making appointments.I had had very little use of my knee for several months due to an injury by the time I went to Regenexx for my consult. I was not sure what results I would get from stem cell therapy but would have been happy with just 50% better use. The results were much much better. Within 3 weeks of the procedure I was pain free and doing many of my normal activities. I did about 6 weeks of physical therapy to strengthen the ligaments supporting the knee. I did not have to endure months of recuperating from surgery or full on rehab that would have been the case if I had chosen otherwise. It is now 8 months out and I am able to sleep, sit, walk, climb, light jog, dance and participate in all the activities I normally did prior to my injury without any pain. I would say that at 77 years old i am as close to 100% as I am going to get. I highly recommend a consult with Dr. Torrance and his team if you are looking for a non-invasive procedure with excellent results.

Martha Hernandez

It is only "excellent", excellent place, excellent treatment and excellent professionals. I arrived with a limp on my right knee and now I walk like a teenager. Thanks to them, I love them!

Gerri Finch

Last year I fell down stairs and had a severe fracture on my right ankle. Even after surgery for adding titanium extensions to both sides of my ankle I still had nerve pain, and excessive discomfort 7 months later. I returned to Dr James Leiber to discuss my issues and he recommended me to do a PRP protocol to give the area a new start to heal more completely. After the procedure he told me I had a great opportunity for full recovery. It hasn’t been easy but I knew I had tried for PRP procedures in other parts of my body from previous injuries. My husband even did a stem cell procedure on his torn rotator cuff and labrum.I have so much confidence in this dr and in these procedures. After 6-8 weeks I returned to complete pain free mobility. I am continuing to have no nerve pain and endurance to walk unaided. In September I returned to full activity even walking up and down stairs pain free. I see a future again as a 74 year old that will return to traveling , hiking and enjoying life to the fullest. I highly recommend that you try these procedures and believe you to can have a complete recovery to any neuromuscular issue from carpel tunnel, to mobility in your fingers and extremities in your body this really works to restore and repair your abilities to move pain free and successfully return to an active life. Thank you New Regeneration Orthopedics for using our own blood and stem cells to help us to repair our aging and accident ridden parts safely and with great hope!

Nicole Masley

Very professional with thorough instructions on what to expect. I had cervical platelet injections for neck stiffness, pain and positional headaches that have been occurring for the past 5 months. After reviewing my MRI, Dr. Leiber was confident he could safely help me.I did not hesitate because my husband has received positive results from Dr Leibers care and though I was quite anxious, I came out of the procedure a bit whoozy (I was given a muscle relaxant and pain medication), slept in the car and went straight to bed for a 2 hr nap. I can honestly say this was my post op “recovery” experience. My headache is gone, I am a little stiff now (day after) but overall, feel much better than before. I am hopeful this continues to be the case long term. What a relief! I am a healthy 59 yr old and want to stay that way for as long as I can!

Mary Monroe

After years of chronic pain in my shoulder and my cervical spine, I found it time to get serious about feeling better. I had the great fortune of finding Dr Ron Torrance and Regenexx. After a thorough and comprehensive exam, Dr Torrance determined that I was a candidate for both PRP therapy and stem cell therapy. Oh my goodness I am astounded at the results. The decades of chronic pain are GONE! With little to no downtime and physical therapy My cervical spine has improved 100% My shoulder +90% just 8 weeks out. Yes the procedure is pricey but I know I'm worth it if I had it to do over again I would have done it at least 5 years ago. Dr Torrance and his team went above and beyond and explaining the procedure as well as performing. Thank you Dr Ron Torrance because of your expertise this ole gal is getting her groove back.

Perinda Patri

Can’t say enough about Dr. Torrence and his staff. My PRP on my ankle tendons has made me pain free after dealing with this for over three years, podiatrists, and orthopedic surgeons who just wanted surgery. Thank you again Dr. Torrence ????????

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.

Related Posts

Shockwave Therapy For Hand Arthritis: Can It Ease Symptoms?

Case Study: Kathleen’s Return to Mobility After Severe Sciatica and Disc Degeneration

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