COMMON QUESTIONS ABOUT iOBX™ STEM CELL TREATMENTS

The following is a non-exhaustive list of issues we specialize in, which include acute injuries and pain, chronic injuries and pain, and many other types of orthopedic problems:

Acute Orthopedic Problems

• Tendon tears or stretching (examples: rotator cuff tear or Achilles tendon pain)
• Acute Tendon Disease (ex: calcific tendonitis)
• Ligament tears or stretching (examples: shoulder, elbow, hip, knee (ACL, PCL, MCL, LCL), foot and ankle
• Joints (cartilage injury, knee meniscus, wrist meniscus, shoulder and hip labrum, dislocation, etc).

Chronic or Acute on Chronic Orthopedic Problems

• Osteoarthritis (ex: knee arthritis)
• Tendon Disease (ex: “tennis elbow”)
• Ligament Disease (ex: plantar fasciosis)
• Back and Neck Pain (ex: disc pain, facet pain, “sciatica”)
• Fracture Healing (in conjunction with your Orthopedic Surgeon)
• Rheumatoid Arthritis (in conjunction with your Rheumatologist)

In summary, we can deliver biologics with image-guided precision (frequently using a combination of technologies) to virtually any orthopedic-related structure.

Over the last 5-10 years a new field in Orthopedics has begun to blossom, called Orthopedic Restorative/Regenerative Medicine whereby doctors use ultra-minimally invasive techniques to place biological treatments with imaging guided precision. This has been in large part because of technological advancements that are enabling physicians to help facilitate their patients’ own bodies ability to heal itself using their own biological cells, mediators and facilitators. This includes the use of your body’s own stem cells and other “stem-like” cells.

Our model helps the body naturally heal itself. We use FDA-compliant cellular and acellular biologic-based treatments like stem cells and platelet-rich plasma. This allows the body to restore healing in problematic and painful areas or joints. It’s much easier to extract stem cells and spin them around in a machine then it is to manually process a customized stem-cell solution as we do.

Our commitment to quality care has always been about helping others achieve complete healing instead of cutting corners. This is why our board-certified physicians spend 90 minutes during your initial consultation, using state-of-the-art machinery, to fully understand the complexity of your condition and recommend the best treatment option available to you. Our proprietary process results in a success rate of over 90%. Finally, and most importantly, you are our main focus 100% of the time.

Most initial consultations take between 1 hour and 90 minutes. When appropriate, we also offer an ultrasound evaluation of the problematic area, as well as a MRI interpretation in conjunction with the radiologist interpretation. If you have had a MRI prior to seeing us, we will make sure the proper sequences and views have been obtained. If not, we will discuss further steps with you to obtain these. Our doctors have advanced training in Orthopedic MRI and work intimately with high-quality local MRI facilities.

Based on this evaluation, the doctor will provide his recommendation, which could include any of the following or a combination thereof:

• Additional imaging
• Diagnostic injection(s)
• Purpose driven, individualized physical therapy (we work closely with several physical therapy groups to produce optimal results).
• BIOLOGIX based procedure(s), frequently in conjunction with other synergistic modalities.

We also always look forward to working closely with your other doctors or therapists to provide additional information, treatments options, and and maintain a close dialogue with them whenever possible.

The evidence is incredibly strong and continues to be documented in numerous publications. There are dozens of scientific studies (clinical and laboratory-based) that support both the effectiveness and safety of these treatments.

There are many reasons for this such as the newness of the treatment. It’s important to note that insurance reimbursement has nothing to do with the effectiveness of treatment.

From start to finish, all treatments are performed in a 24-hour period. We’ll discuss this with you in more detail for your individual treatment.

Rarely. If this is important to you, we can discuss further.

All procedures at iOBX use stem cells from your own body and fall under the following FDA exemptions

Treatments involving the removal of an HCT/P from a patient and the implantation of that same HCT/P back into the same patient during the same surgical procedure are not subject to FDA regulation; 21 CFR 1271.15(b).

For treatments involving premium bone marrow, minimally manipulated for homologous use is not subject to FDA regulation as a human cell, tissue, or cellular or tissue-based product (HCT/P); 21 CFR 1271.3(d).

For our procedures involving autologous blood (ie: PRP), practitioners who are licensed by law to prescribe or administer drugs and who manufacture blood products solely for use in the course of their professional practice are not subject to FDA regulation; 21 CFR 607.65.

All procedures at iOBX adhere to a stringent level of cleanliness and sterility. We process stem cells from bone marrow and fat tissue utilizing FDA compliant guidelines. The safety standards, focus on patients, and scientific expertise provided by the Advanced Onsite Orthopedic Biologics Laboratory at iOBX™️ make for a unique and outstanding patient experience.

No. This is not permitted in the USA at this time.

The evidence is incredibly strong and continuing to be documented in numerous publications. There are dozens of scientific studies (clinical and and laboratory-based) that support both the effectiveness and safety of these treatments.

Safety is our top priority. There have been literally thousands of orthopedic patients treated with autologous (meaning from your own body) biologics with a proven safety record.

Unfortunately, yes. Even with the lengths that we go to prevent it, any and all medical procedures and treatments have some level of risk involved.

Unfortunately, no. There has never been ANY medical procedure created that is 100% successful. Although proportionally small, there are some people who have no response. We and others in this exciting new field of medicine are diligently working to reduce these number of patients.

Not at this time. The reason for this is because of the planning that takes place to provide you with optimal care. However, please feel free to stop in and say hello and to discuss scheduling an appointment with us. We’d love to meet you.

Call our office or consider coming to one of our catered “Inspired by Bio-Intelligence” Onsite Seminars. This is a no-obligation opportunity to come and hear more about what we do, what we offer, and tour the facility.

A non-exhaustive list of non-orthopedic problems we do not treat at this time:

• Parkinson’s disease
• Multiple Sclerosis
• Alzheimer’s disease
• Fibromyalgia
• Spinal Cord Injury
• Wounds, including diabetic foot ulcers
• Lyme Disease
• Stroke

Of course! Currently, the majority of patients receiving these treatments are not high-level athletes. There are things you can do to optimize results, which will be discussed with you.

We prescribe medications after procedures, as medically appropriate. We do not prescribe medications for long periods of time, including opiates. We do not prescribe pain medications as a stand-alone treatment.

Yes, and we would look forward to discussing these options with you.

In general, biologics-based treatments are not covered by insurance at this time, so we do not accept insurance. However, our model has numerous benefits for our patients including:

• Knowing exactly what you will pay for treatment at the time of final recommendations to include a foresight discussion about possible additional treatments (if any) that may be necessary in the future.
• We have the liberty to make decisions without being influenced by insurance reimbursement algorithms or pre-authorizations.
• 200-300% more time for evaluation, discussions, and treatment.