Studies have found that ultrasound may be a valid and effective way to visualize and evaluate soft tissue.^{1 2}

We provide a tissue analysis, a custom care plan, and a team of providers to help patients overcome pain or restricted mobility.

We believe, from a combination of the clinical studies done on the fascia so far, as well as our experience, that patients suffering from pain and/or restricted mobility due to a soft tissue injury tend to have fascia that appears under ultrasound to have more adhesions, less hydration, and less mobility compared to the fascia of individuals without pain. We often see visual differences in the tissue under ultrasound between patients after a successful RELIEF® treatment that resulted in a reduction of their uncomfortable symptoms, as their fascia may appear expanded, more hydrated, and more mobile.

Some studies have observed consistent differences in the fascial structure around body parts that experienced a soft tissue injury compared to the fascial structure of uninjured subjects. They identified that fascia around areas of injury may tend to be thicker, less mobile, and less hydrated, and that the affected fascia may be a new area of potential treatment for various injuries and painful conditions^{1 2 3 4 5 6 7}

RELIEF® is a treatment that involves hydro-dissecting fascia and injecting sterilized Amnionic Membrane/Umbilical Cord tissue allograft into potentially problematic tissue that could be contributing to pain, discomfort, or restricted mobility.

According to the manufacturer, BioTissue, the AMUC tissue we inject is obtained from fully-screened consenting mothers at the time of delivery from a full-term scheduled cesarean section birth. BioTissue Clarix Flo 100 is used for all RELIEF ® procedures, and there is full compliance with Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP) to preserve extracellular matrix and growth factors/cytokines without any living cells from the donated tissue. All donated tissue is procured and processed according to current FDA standards.

A study has found that AMUC injections may help reduce symptoms of pain and improve physical function in patients with knee osteoarthritis.¹ A study has found that AMUC injections may be a safe and effective way to treat pressure injuries.² A study has found that AMUC injections may safely provide pain relief in Achilles tendinopathy patients with or without partial tendon tear.³ A study has found that AMUC injections may alleviate pain in patients with painful spinal indications of various pathologies.⁴ We believe from the clinical studies done so far, as well as our results so far, that AMUC injections may contain healing benefits for soft tissue injuries.

We purchase the injectible, Clarix Flo, from Biotissue. Their statement on how they acquire it:" Amniox Medical obtains the placental tissue used in all of its products through a voluntary donation program across the US. Donor mothers provide full consent prior to delivery of a full-term, live, newborn baby via a scheduled Cesarean section. The amniotic membrane and umbilical cord, typically discarded at birth, are then processed and preserved at Amniox Medical’s state-of-the-art US-based facility as HCT/P tissues."

Hydrodissection generally refers to introducing liquid under pressure into tissue. It has various use cases.¹ In some surgeries, it may be used to create space within tissue to allow room for operation. Nerve hydrodissection is another common use case that involves using liquid under pressure to release a nerve that is entrapped by surrounding tissue or adjacent structures. ^{2 3}

In recent years, hydrodissection has started to be explored as a treatment for various soft tissue injuries independent of releasing nerve entrapment.¹ This is a new perspective on soft tissue injury treatment and has not been extensively studied in clinical trials. Vitruvia is at the forefront of utilizing hydrodissection to treat non nerve-related pain and injury, and we are launching clinical trials in 2024 for the RELIEF® treatment. We believe from experience that it can be effectively used for soft tissue injuries when done as part of the RELIEF® procedure.

We believe that by hydrodissecting fascia in areas of or related to the patient's pain that show signs of possible reduced mobility, dehydration, or unusual thickness, we may be able to help relieve uncomfortable symptoms by creating hydration and expansion with hydrodissection.

Based on clinical journals and studies across procedures that involve hydrodissection and/or AMUC to treat pain or injury, as well as our experience treating patients, we believe our treatment may be able to help with the symptoms of many painful conditions, including but not limited to:

1. Osteoarthritis^{12 14}
2. Adhesive Capsulitis^{26 27 28}
3. Dupuytren's Contracture⁴
4. Trigger Finger⁴
5. Connective Tissue Lesions⁴
6. Post-Surgical Scar, Pain, or Discomfort^{6 29 30}
7. Carpal and Cubital Tunnel^{7 12 13 18 30}
8. Plantar Fascitis⁸
9. Tendonosis^{8 9}
10. Peripheral Nerve Disorders⁸
11. Tendon Injuries⁹
12. Tendinopathy^{10 24}
13. Nerve entrapment^{11 17 19 20}
14. Facet Joint Syndrome^{14 22}
15. Rotator Cuff Injury¹⁶
16. Sciatica²¹
17. Piriformis Syndrome²³
18. Muscle Injuries²⁵

During the consultation, our providers may use the VALD Performance Measurement System to evaluate a patient's injury across a few measurements that may include range of motion, balance, and force. They will use ultrasound to observe and assess the soft tissue in and around the area of pain.

The consultation is an opportunity for the provider to understand the patient's condition, and for the provider and patient to discuss if and how fascia may possibly be contributing to their pain or discomfort. If the provider feels that the RELIEF® treatment may help, they will create a treatment plan at the end of the consultation.

There may or may not be downtime after the procedure, depending on the patient and their condition. Most patients are able to resume normal daily activities right away but do experience some soreness and/or bruising at the injection site for a few days afterward. Patients may be suggested to avoid certain activities that could be disruptive to the healing process for a period of time after treatment.

We are the only providers of the RELIEF® procedure.

We will be starting our first clinical trial for RELIEF® in 2024.