GENERAL

What Insurance providers are accepted?

Blue Cross Blue Shield, Humana, and UHC Commercial Insurance.

Is the injectable product reimbursed and in what clinical setting?

When submitted for reimbursement correctly, there has been success in reimbursement. However, all payors are different and each case is unique. The greatest opportunity for reimbursement occurs when the product is used in an operating room or surgical center under ultrasound guidance or other imaging assistance.

What criteria must be met for FDA approval?
  • The tissue be minimally manipulated
  • Must be intended for homologous use
  • Must not be combined with a drug or device
  • Not have a systemic effect and not be dependent on the metabolic activity of living cells for its primary function
What are some clinical uses of the injectable product that have had success?
  • Plantar fasciitis
  • Epicondylitis
  • Tendonitis (biceps, triceps)
  • Tendinosis
  • Acromioclavicular joint inflammation
  • Facet osteoarthritis
  • ACL Tears
  • MCL Tears
  • Post-operative pain (orthopedic surgeries and spine)
What is the best way to characterize this product when speaking with a physician?

It is a multipotent tissue matrix used to fill, cover, and protect, a void or defect.

Is there a chance that bone can grow in the canal or migrate if placed in the gutters, like with what happened with Infuse?

No, there is no chance of this because the cells are self-signaling. They will only create or grow what is needed at the site. If there is a need for bone, then the cells will signal and bone will grow. If there is a need for vasculature, then the cells will signal for blood vessels to grow and also create tissue regrowth.

VAMPIRE FACELIFT

What is a Vampire Facelift?

A Vampire Facelift is the popular term for using Platelet-rich plasma (PRP) for facial cosmetic improvement. Blood is taken from your arm and put into a centrifuge to remove the PRP, which is then injected back into your face.

How Long Before I See Improvement After a Vampire Facelift?

Most clients see results over the course of a 5-6 weeks. Immediately after the PRP injections you will see a slight swelling caused by the procedure, which subsides over the course of a few days.

Does the Vampire Facelift Contain Stem Cells?

While there are naturally some stem cells in your plasma, the number is not very significant. More important are the growth factors, which include: PDGF (Platelet Derived Growth Factor), TGF-beta (Transforming Growth Factor Beta), FGF (Fibroblast Growth Factor), IGFs (Insulin-like Growth Factor types 1 and 2), VEGF (Vascular Endothelial Growth Factor), EGF (Epidermal Growth Factor), Interleukins, KGF (Keratinocyte Growth Factor), and connective tissue growth factor.

PRP

How can Platelet-rich plasma PRP rejuvenate the skin?

PRP contains growth factors, which are necessary for healing and tissue regeneration. By injecting growth factors into your skin, we are stimulating rejuvenation.

What is Platelet-rich plasma (PRP)?

PRP (platelet rich plasma) is venous blood that is centrifuged to separate the buffy coat which contains the PRP. The product is used on the same patient as autologous tissue.

This material contains healing growth components from your blood and helps your body to repair itself. PRP therapy is becoming well known, thanks to exposure from famous athletes. PRP therapy has a stimulating effect on the stem cells, making them work harder to heal damaged tissues.

O-SHOT

What is an O-Shot?

The O-Shot is a popular term for injecting platelet-rich plasma (PRP) into vaginal tissue in order to restore and/or heighten sensitivity for more enjoyable sex. The PRP comes from your own blood, which is taken from your arm and put into a centrifuge to remove the PRP.

How long do the effects of an O-Shot last?

The effects of an O-Shot typically last up to a year.

Is an O-Shot painful?

It’s a quick procedure and we use a local anesthetic and ice to numb the area, but there is slight discomfort.

Are there any side effects or down time after the O-Shot?

Typically, there are no side effects or downtime, though a small, superficial bruise may develop at the injection site. Patients can return to work, exercise, and even have sex the same day.

P-SHOT

What is a Priapus Shot (P-Shot)?

The Priapus Shot (P-Shot) is a popular term for injecting platelet-rich plasma (PRP) into penis in order to restore and/or heighten sensitivity for more enjoyable sex. The PRP comes from your own blood, which is taken from your arm and put into a centrifuge to remove the PRP.

Will the Priapus Shot (P-Shot) increase size?

Most men have some increase in the girth of the penis due to the growth of new tissue. Some men have reported an increase in length.

Will the Priapus Shot (P-Shot) help with Erectile Dysfunction (ED)?

The Priapus shot is a great treatment for ED and for men interested in better sexual function. The P-Shot can be used safely with other treatments you may be using for ED.

Are there any side effects or down time after the Priapus Shot (P-Shot)?

Typically, there are no side effects or downtime, though a small, superficial bruise may develop at the injection site. Patients can return to work, exercise, and even have sex the same day.

BOTOX

What is BOTOX?

BOTOX® Cosmetic is a highly purified toxin that can temporarily erase or reduce horizontal forehead lines, vertical frown lines, and crow’s-feet.

How does BOTOX work?

BOTOX works by paralyzing the muscle beneath the unwanted wrinkle, which stops the muscle from moving so that the wrinkle can no longer form.

How long does the BOTOX® Cosmetic procedure take to perform?

Five to ten minutes.

What is the recovery like after a BOTOX injection?

There is minimal recovery or downtime associated with BOTOX, though you may notice some temporary redness and swelling for a few minutes after treatment. However, most patients are readily presentable in public upon leaving the office and can return to work and other normal activities. Avoid prolonged bending and vigorous activity for the rest of the day.

How long do the effects from a BOTOX injection last?

Approximately three to four months.

Are there risks or complications with BOTOX?

If excess BOTOX is injected and/or treatment is done too close to the eyelid, a drooping eyelid can result, though our dermatologists are highly-trained experts with years of experience, so you are in safe hands.

Does insurance cover the BOTOX?

Insurance generally does not cover BOTOX procedures which are performed for cosmetic reasons, though some coverage may be available if BOTOX is used for medical purposes like migraine treatment. You should check with your own insurance carrier.

Do Botox injections hurt?

No. We use a very tiny needle, so all you will feel from Botox injections is a tiny prick. You may see slight swelling and bruising at the injection sites, but those typically resolve in 24 hours. And thanks to the experience and skill of our trained dermatologists, you are in safe hands.

AMNIOTIC

How do amniotic tissue products work?

This tissue is rich with the basic components necessary for tissue regeneration including:

  • Growth Factors
  • Cytokines
  • Collagen
  • Fibrinogen
  • Hyaluronic Acid
  • Messenger RNA
  • Mesenchymal stem cells

 

Amniotic tissues have proven to be multipotent and capable of differentiating into adipogenic, osteogenic, myogenic, endothelial, neurogenic, and hepatic cell lineages. This cellular component may provide and ancillary benefit.

What is amniotic tissue approved for?

Amniotic tissue qualifies as allograft under 21 CFR Part 1271 and section 361 of the Public Health Service Act. It is minimally manipulated (nothing added). This means that the FDA recognizes that the properties of amniotic membranes are approved for use as long as the tissues are for homologous use (which is defined as the product performing the same basic function in the donor and in the recipient.

How long have amniotic tissue based products been used?

Although the popularity in orthopedics and pain management is relatively new, amniotic derived products have a 100 year history of being used in other disciplines for its healing properties.

Why is there no chance of rejection?

Amniotic membrane does not express HLA-A, -B or -DR antigens. The chorion which has been known to cause an antigen response, has been removed from the tissue at processing.

What growth factors are present in the Amniotic Membrane products? How do they work?

The amniotic membrane serves to protect the embryo in utero and possesses many different growth factors that serve to protect the developing fetus. These growth factors regulate a host of different physiologic functions which contribute to cell proliferation, cell migration, and cell growth. Additionally, Amniotic tissue contains collagen substrates, the full range of growth factors, amino acids, carbohydrates, cytokines, hyaluronic acid, fibroblasts, epithelial cells, extra cellular matrix, micronized amniotic membrane and mesenchymal stem cells.

Where do you get the amniotic tissue?

Allograft tissue derived from the amniotic membrane and fluid. Placental tissue is donated by healthy mothers at the time of scheduled cesarean section. Expectant mothers submit their past medical and social history and a detailed risk assessment is performed.

How does Amniotic tissue work in wound care?

Amniotic tissue has been used in wound care and is highly effective in both promoting re-epithelialization and suppressing inflammation. Amniotic tissue provides a new basement membrane that helps in the migration of epithelial cells, reinforces adhesion of basal epithelial cells, promotes epithelial differentiation and prevents epithelial breakdown. It also down-regulates TGF-beta signaling, responsible for fibroblastic activation in wound healing. This inhibits fibroblast proliferation and prevents fibrosis.

How does amniotic tissue differ from bone marrow derived products?

Bone marrow derived products come from recently deceased donors. Two big challenges in the recovery of healthy tissue are the donor age as well as the time of death to recovery. Both have negative consequences on the health of the allograft in general.

We are a nutritional regenerative soup that contains growth factors, cytokines, fibroblasts, keratinocytes, and MSC’s derived from human fetal tissue, we are a human transplant allograft. It is the power of the balanced growth factors that allow our Flow product to be so effective and safe, additionally it is minimally manipulated so that we do not add anything that can cause a reaction as described in attached article.

 

There is a huge difference in the literature between the types of cells we utilize and those that are obtained form autologous harvest and then concentrated and cultured.

How do you screen the amniotic tissue?

Ultimately, approval of the tissue for use is made by the Medical Director following an intensive and complete medical review and pre-natal evaluation prior to delivery.

We examine:

  • Tissue harvest and release criteria
  • Identification of the donor
  • Medical record or hospital chart
  • Treating physician interview
  • Family interview
  • Serologic testing
  • Physical assessment of the donor
  • Tissue evaluation
  • Donor history evaluation
  • Medical director oversight

 

Screening Exclusions:

+ Creutzfeldt-Jakob disease (CJD)

+ Family history of blood relative with CJD

+ Recipients of human pit-hGH from 1963-1985

+ Recipients of non-synthetic dura matter grafts

+ Progressive encephalopathy

+ Encephalitis: active vim1 or of unknown origin

+ Neurologic disease of unestablished diagnosis

+ Progressive multifocal leukoencephalopathy

+ Subacute sclerosing panencephalitis

+ Reyes syndrome

+ Rabies

+ Recreational Drug use

+ Prescription medication use

+ Age below 18 and over 35 years of age

 

Once the placental tissue and fluid is harvested it is sent for serological testing, this same testing is repeated 2 additional times before the product can be released for implantation

serological testing includes:

 

All tissue is held in quarantine until microbiological and blood tests are completed. These tests are required by the AATB and the U.S. Food & Drug Administration (FDA), and include analysis of infectious diseases including HIV, hepatitis B and C, and syphilis.

 

Processing and packaging are performed using sterile techniques in clean room conditions to maintain biological integrity. On occasion, low dose radiation is used to aid in sterilization. Final processed tissues are tested for microbiological contamination in accordance with United States Pharmacopeia (USP) guidelines to ensure compliance with regulatory requirements. Although there is some theoretical risk for disease transmission, the use of allografts that have undergone rigorous donor screening, serological testing, and formal processing has significantly reduced this risk.