BHRT stands for Bio-Identical Hormone Replacement Therapy. The “B” stands for Bio-Identical, not biosimilar. During the development of a therapeutic project, any modification in the manufacturing process can create slight changes in the structure of the resulting drug, thus creating a “biosimilar.” [McCamish, Clinical Pharmacology & Therapeutics 2012 /p409 A]. The term “Bio-Identical,” as defined by experts from The Endocrine Society, is a compound that has exactly the same chemical and molecular structure as the hormones that are produced in the human body. [Files Mayo Clinic Proceedings 2011 /p674 A]

HORMONE IMBALANCE

A simple way to describe hormone imbalance is that it represents any combination of hormone levels that are not within the expected normal range. Because hormones are kept within a certain range to perform specific functions, hormone imbalance can be associated with a variety of symptoms and functional changes in the body.

Hormone imbalance in men and women differs because of the hormones involved and the function of the hormones that are not within the normal range or not fun

HORMONE IMBALANCE IN MEN

Testosterone deficiency is present in a percentage of men age 50–69 years and in an even greater proportion of men 70 years of age and older. Unwanted consequences include decreases in: [Little, Current Diagnosis and Treatment 2014 /p8 B]

• Muscle mass and strength
• Bone mass
• Sexual interest and ability to function sexually
• Cognitive function
• They may also experience increases in fat mass. It is unknown, however, whether these changes can all be attributed to declines in testosterone levels or whether there are other contributing factors. [Little, Current Diagnosis and Treatment 2014 /p8 B]

HORMONE OPTIMIZATION

Optimization in men:

A common form of hormone optimization in men is testosterone replacement therapy. This type of therapy is approved for men who have low levels of testosterone related to certain medical conditions. Examples of these conditions include genetic problems, and chemotherapy or infections that have damaged the testicles. [Khera, Journal of Sexual Medicine 2016 /p1794 A]

Optimization in women:

Hormone optimization in women usually involves some formulation of estrogen, either alone or with progesterone. As with testosterone therapy, estrogen therapy is guided by certain limitations and restrictions. Hormone therapy with estrogens (with or without progesterone) is indicated only for treatment of vasomotor symptoms and vaginal atrophy and for osteoporosis prevention or treatment. [“The Mature Woman,” Williams Gynecology 2016 /p3 A]

The Re3® Advanced Pellet Delivery System for Men & Women is a novel, patented medical device created by a physician with over 20 years experience in Bio-Identical hormone replacement therapy (BHRT) to improve the pellet insertion process – making it easier, safer, and more reliable.

The current procedure most widely used for pellet insertion requires the healthcare provider to clean, autoclave, and reuse the instruments needed for pellet insertion. This method can be cumbersome and expensive and relies on non-standardized procedures at each provider. There are also plastic, single-use kits for pellet insertion, which are not widely used due to poor quality instruments.

Each Pellecome Re3® Advanced Pellet Delivery System for Men & Women includes a sterile tray with peel back lid, an insertion tool, a precision scalpel, and a funnel.

The insertion tool is ergonomically designed with a needle guide to ensure the pellets are always delivered in the target subcutaneous tissue plane. The insertion tool is designed to deposit pellets in a linear retrograde fashion which:

• Reduces amount of anesthesia required
• Reduces risk of pellets bunching or overlapping
• Reduces patient bruising and discomfort

The precision scalpel ensures that the incision is a precise width and depth to facilitate insertion procedure. The scalpel also minimizes risk of extrusion (i.e., this incision is too shallow) or muscle pain (too deep).

The convenient funnel helps prevent loss of pellets during the loading process – a common issue with current methods. The funnel technology secures pellets for safe and efficient use providing an aseptic pellet transfer.