Insights medical devices
Information for professionals
High-quality medical devices: purification and excellent raw materials
Our medical devices are all produced through a purification process that follows excellent standards, with residue limits below the detection limits of analytical instrumentation. The quality of incoming raw materials is our pride: we use only the highest quality raw materials. In addition, our industrial process is at a high technological level, ensuring safe and effective products. Controls are carried out throughout the process: before, during and after production. Endotoxin levels are nonexistent due to working in white rooms, which means sterile environments. The entire product study and implementation process is handled by our highly qualified staff: from design and data collection to packaging, marking and release.
Aesthetic medical devices
Bioformula – Linear Hyaluronic Acid
Sterile, injectable, apyrogenic, resorbable medical device based on linear hyaluronic acid of nonanimal origin, produced by bacterial fermentation. The product is in the form of a colorless gel contained in prefilled, graduated, single-use, sterile glass syringe with Luer Lok fitting.
USAGE PROTOCOLS:
- Linear Hyaluronic Acid 10 mg/mL – Very fine and superficial wrinkles, revitalization of face, neck, décolleté and hands.
In the case of small wrinkle treatment, a linear retrograde injection is recommended, which should trace the superficial course of the wrinkle very precisely. Optimal application requires stretching the skin with the fingers of the hand not holding the syringe, carefully avoiding the capillaries highlighted on the surface. After implantation, it is important to massage the treated surface in order to better distribute the product under the skin. In the case of bio-revitalization, perform the micro-ponfi technique, spacing them about one centimeter apart. - Linear Hyaluronic Acid 15 mg/mL – Superficial perioral and geniene wrinkles or in cases of intense revitalization of the face, neck, décolleté and hands.
The linear retrograde technique is preferred for wrinkle correction, tracing the superficial course of the wrinkle with extreme precision. After implantation, it is important to massage the treated surface. Otherwise, in biorevitalization, the sequential micro-ponfi technique is to be recommended. spacing them about one centimeter apart. - Linear Hyaluronic Acid 20 mg/mL – Medium to deep facial wrinkles such as nasogenic.
The linear retrograde technique is preferred over the sequential micro-ponphase technique. In this case it is recommended to layer the product.
BENEFITS:
- It is safe, effective and highly tolerated;
- Natural results visible from the very first application;
- The product’s simplicity of use and inherent safety make it easier for clinicians to perform treatment.
USAGE GUIDELINES:
- Skin rejuvenation of face, neck, décolleté;
- Correction of forehead wrinkles and superficial wrinkles;
- Hand revitalization.
MECHANISM OF ACTION:
The increase in dermal-epidermal tissue volume is based on the natural ability of hydrophilic hyaluronic acid molecules to bind to many times their weight in water. This allows the intercellular matrix to be integrated, filling the intradermal spaces, imparting turgidity to the tissues.
Bioformula – Cross-linked hyaluronic acid with BDDE
Sterile, injectable, apyrogenic, resorbable medical device based on cross-linked hyaluronic acid of nonanimal origin, produced by bacterial fermentation. The product is in the form of a colorless gel contained in prefilled, graduated, single-use, sterile glass syringe with Luer Lok fitting.
USAGE PROTOCOLS:
- Reticulated Hyaluronic Acid with BDDE 15 mg/mL – Periocular Wrinkles.
The implantation is performed with a linear retrograde injection that should trace the superficial course of the wrinkle very precisely. Overcorrections must be avoided. Optimal application requires stretching the skin with the fingers of the hand not holding the syringe, carefully avoiding the capillaries highlighted on the surface. After implantation, it is important to massage the treated surface in order to better distribute the product under the skin. - Reticulated Hyaluronic Acid with BDDE 20 mg/mL – Lip contour wrinkles.
Implantation is done at the level of the superficial dermis, avoiding overcorrection. Eventual corrections can be made with either the sequential microponfi technique (picotage) or linear retrograde, depending on the operator’s expertise. In the ponfi technique, we suggest starting from the end of the wrinkle toward the operator, “moving up” in the sequence of always contiguous ponfi. It is recommended to firmly massage the treated parts. - Reticulated Hyaluronic Acid with BDDE 25 mg/mL – Deep facial wrinkles.
The linear retrograde technique is preferable to the sequential micro-ponphs technique. It is recommended to inject the product at the level of the deep dermis.
BENEFITS:
- It is highly tolerated, virtually free of endotoxins and other free toxic substances;
- Natural result with an immediate lifting effect;
- The product’s simplicity of use and inherent safety make it easier for clinicians to perform the treatment.
USAGE GUIDELINES:
- Filling superficial and deep wrinkles;
- Correction of skin defects/scars;
- Remodeling of facial contours.
MECHANISM OF ACTION:
The increase in dermal-epidermal tissue volume is based on the natural ability of hydrophilic hyaluronic acid molecules to bind to many times their weight in water. This allows the intercellular matrix to be integrated, filling the intradermal spaces, imparting turgidity to the tissues. The cross-linking technology developed by I.R.A. makes the filling effect more stable and long-lasting.
Bioformula – Polynucleotide Gel.
Injectable, apyrogenic, resorbable medical device based on polynucleotides of animal (fish) origin. By virtue of its hydrophilic and polyanionic characteristics, the polynucleotide-based gel is able to bind water molecules, filling intradermal spaces and imparting hydration and turgor to tissues. The product is in the form of a colorless gel contained in pre-filled, graduated, single-use, sterile glass syringe with Luer Lok fitting.
USAGE PROTOCOLS:
- Polynucleotide Gel 7.5 mg/mL – Fine and superficial wrinkles and minor scars.
In the case of small wrinkle treatment, a linear retrograde injection is recommended, which should trace the superficial course of the wrinkle very precisely. Avoid overcorrections. Optimal application requires stretching the skin with the fingers of the hand not holding the syringe, carefully avoiding the capillaries highlighted on the surface. After implantation, it is important to massage the treated surface in order to better distribute the product under the skin. - Polynucleotide Gel 20 mg/mL – Slightly deep wrinkles such as superficial perioral and cheek wrinkles and medium-sized scars.
In the case of treatment of small wrinkles, either the linear retrograde or the micro-ponfi technique is recommended: both should trace the superficial course of the wrinkle with extreme precision. Avoid overcorrections. After implantation, it is important to massage the treated surface in order to better distribute the product under the skin. - Polynucleotide Gel 25 mg/mL – Medium to deep wrinkles such as naso-genital and for reshaping large areas of the body such as abdomen, thighs and buttock
Linear retrograde technique, to be preferred over sequential micro-ponfiers. It is recommended to inject the product at the level of the deep dermis.
BENEFITS:
- Stimulates skin rejuvenation;
- Intense revitalizing anti-aging action;
- Gives tone and elasticity to the skin.
USAGE GUIDELINES:
Polynucleotide gel is to be used as a temporary filler for the correction of minor skin defects in any skin district.
MECHANISM OF ACTION:
The polynucleotide chain, in addition to attracting water molecules, has an anti-free radical action, acting as a scavenger of hydroxyl radicals that tend to accumulate as a result of stress or through the action of external agents such as UV rays. Moisturizing action and anti-free radical activity help restore tissue elasticity. The three different concentrations allow the treatment of different blemishes.
Seffiline
Numerous studies have identified that adipose tissue is one of the tissues with the highest concentration of adult mesenchymal stem cells (ADSCs) and particularly in its stromal component (SVF Stromal Vascular Fraction).
The proven regenerative capabilities of mesenchymal stem cells (ADSCs) are being exploited in numerous medical branches such as reconstructive surgery, dermatology, vulnology, orthopedics, vascular surgery, cardiology, gynecology, ENT, and proctology as well as in antiaging therapies in the field of Aesthetic Surgery and Medicine.
Such method must have the following characteristics:
- allow tissue to be harvested in the least traumatic way possible for the tissue;
- harvest the adipose tissue in the most superficial plane possible to have a tissue that is richer in terms of mesenchymal stem cells (ADSCs);
- take cell clusters containing adipocytes, stromal tissue (SVF) and mesenchymal stem cells (ADSCs) of small size to promote their rooting at the recipient site;
- minimal handling of the harvested tissue to preserve as much cell viability as possible and avoid the use of tissue fragmentation devices, thus making the method faster and less expensive;
- be as minimally traumatic as possible for the patient and minimize retrieval complications such as hematomas, seromas, infections, and skin irregularities;
- tissue to be implanted should be fluid enough to be grafted with fine needles or cannulas so as to be as minimally traumatic to the recipient site as possible.
In the technique of preparing the tissue to be grafted, the PRELIEVAL part is the one in which Doctors who do not have specific training in the aspiration of subcutaneous adipose tissue encounter the most difficulties: this difficulty very often leads Doctors to use the collaboration of specialists in Plastic Surgery (increasing the costs of the procedure and making the organization of the therapy, which often requires several treatments, more complex) or to forgo regenerative therapy or exposing the patient to possible complications related to incorrect harvesting maneuvers.
S.E.F.F.I. Tissue Implant and MicroS.E.F.F.I. (Superficial Enhanced Fluid Fat Injection)
Since 2015, Gennai et al. have published several studies (see bibliographical references) on new S.E.F.F.I. and MicroS.E.F.F.I. tissue grafting techniques. These techniques aim to graft autologous adipose tissue, including the stromal fraction (SVF) and adipose tissue-derived stem cells (ADSCs) contained therein, in order to achieve trophic tissue improvement and restoration of lost volumes. The authors demonstrated that one can harvest adipose tissue through special cannulas with very small side holes, so that small cell clusters are selected, so there is no need for manipulation to thin the tissue.
SEFFI and MicroSEFFI are now among the most widely used techniques intended for tissue regeneration and volume restoration for rejuvenation of the face and other areas of the body. These techniques are considered minimally invasive surgical procedures, so they require surgical experience, particularly in liposuction, and adequate facilities.
In light of this evidence, Autologous Regenerative Therapy has always been only in the hands of plastic surgeons and has not been open to aesthetic physicians or dermatologists.
Dr. Gennai firmly believes that Autologous Aesthetic Regenerative Therapy should be able to be performed even by Aesthetic Physicians without specific training in liposuction surgery: therefore he has developed, standardized and patented* a special guide, that is, a device aimed at harvesting fat tissue in a safe, easy, effective way, even without any surgical liposuction skills.
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