Since 2012, Dr. Al-Jasim at Apex Medical Device Design LLC. have conducted R&D to design a novel breast implan for a market in which the last market entrant was teardrop shaped implant designed in 1990s.
DefyGravity is the ONLY breast implant under granted United States and International patents valid until 2036. Our granted patent and Trade names are proposed for licensing/sale to a breast implant manufacturing and marketing company interested in expanding their product portfolio
DefyGravity needs minimum R&D expenses and time to be in the market
This is a unique licensing opportunity!
The Apex IP portfolio includes U.S. granted patent, a continustion-in-part of the U.S. patent, and the PCT counterpats that were assigned to Apex Medical Device Design LLC., and the Trade name DefyGravityTM.
Pyramid-Shaped Breast Implant for Breast Augmentation, Breast Reconstruction, or Breast Lift with a Method of Use and Production of the Same.
1) Granted United States Patent # 9,707,073 issued on 07/18/2017 titled “Pyramid-shaped breast implant for breast augmentation and/or breast lift with a method of use and production of the same.” With a legal life extending twenty years from the PCT filing date, to the year 2036.
2) Continuation-in-part applications of the U.S. patent, Application filed on March 5, 2018 # 15/911,979 with broadened claims, and reinstating claims that were withdrawn to keep the "unity of the invention" in response to the Examiner restriction requirements.
3) Allowed International Application # PCT/US16/47635, the patented claims were allowed as per the International Search Report dated Dec. 28, 2016. National phase has been entered in the following national patent offices:
The IP also include Trade names:
DefyGravityTM Breast Implant registered in the USA
The global breast implant market is segmented into four geographic regions, as shown in the graph on the right.
The aesthetic market size of each region can be calculated according to the International Society of Aesthetic Plastic Surgery (ISAPS) annual statistics on the number of procedures performed in participating countries (Canada and UK are non-participants) 1, and on available breast implant market research reports.
Breeast reconstruction procedures will be added to the market size.
Breast implant market geographical regions include:
1. North America, including Canada.
2. Europe and United Kingdom.
3. Asia-Pacific including Australia.
4. South America including Mexico.
DefyGravity implant manufacturing needs only a new MANDREL to manufacture a shell from the established silicone elastomer technology, fill the shell with safe FDA approved silicone gel using current manufacturing protocol, equipments and personnels.
Breast implant manufacturers have the expertise and experience in clinical development and regulatory approval regarding the new breast implant shape.
The risk of complications during clinical development and failure during the manufacturing process is expected to be low.
Then DefyGravity will be marketed along the established marketing channels to reach to the customers within a short time, as seen in the figure below.
Breast implant manufacturing is a manual process.The basic protocol for current breast implant manufacturing techniques was fully described by Barr and Bayat2. The figure below demonstrates a step by step manufacturing process.
Aesthetic Breast procedures are sky rocketing. According to the International Society of Aesthetic Plastic Surgery (ISAPS), in 2017 the number of breast augmentation performed was around 1.5 Million procedures using silicone breast implants, in addition to 657.832 breast lift cases. 3 Accordingto the American Society of Plastic Surgeons, 106,295 breast reconstruction procedures were performed in 2017. 4
Silicone implants dominated the market, with a revenue of $1 Billion in 2016. 5 The breast implant market was over $1.2 Billion in 2016, growing to $1.42 Billion in 2017, and is estimated to account for $1.98 Billion by the end of 2025.
The prominent breast implant manufacturers are Allergan plc, GC Aesthetics, Mentor Worldwide, and Sientra, which account for 85% of the market share. 6 These rivals are committed to product development and innovation in order to broaden their product portfolio and strengthen industry presence.
These innovations consist of changes in silicone chemistry that eventually build up to a significant advancement. Over time, those advancements are incorporated into the latest models. It’s fair to say, then, that innovation in breast implants "tend to build on the trends of the past." 7
Surgeons who might be interested in expanding their breast implant offerings to their patients:
Surgeons who do not provide a textured anatomical implant option in their surgery because of technically demanding and time consuming surgical placement.
Surgeons who want to avoid textured round breast implants and are looking for a safer implant option.
DefyGravity is offered to surgeons looking for an implant with built-in proportionate fill distribution that comply with the advancement of the aesthetic science.
The unmet market needs includes the following underserved patients:
• Women whose aesthetic goals include a fuller upper breast as opposed to the subtle upper breast of a teardrop implant; or the very rounded augmented upper breast of round breast implants.
The goal of the majority of women seeking breast augmentation is a full upper breast. That is why the DefyGravity breast implant has been designed with a fuller upper part than round or teardrop implants.
• Those seeking to avoid the complications of implant shell texturing, including a rare type of blood cancer (Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL) in the local breast tissue or spread systematically.
This cancer type has been tied to textured breast implants by joint research between the World Health Organization and the FDA.
The current surgical trend is: “Go Smooth or Go Home.” 8
• Women undergoing breast implant replacement (revision) surgery have limited choices for their new implant, because textured implants become attached to the surrounding tissue. They are often more difficult to remove during breast augmentation revision surgery, leaving a damaged surgical pocket that can only receive a smooth implants.
Currently about 90% of the implants used are textured.
• Patient undergo implant removals mainly due to dissatisfaction with the implant, including:
As shown in the graph: In 2017 the American Society of Plastic and Aesthetic Surgery found that there were 27,507 breast implants removed out of a total 300,378 augmentation patients – an increase of 3% from 2016, This category does not spare celebrities!
2017 U.S. statistics showed 19,415 breast implants removed out of 106,295 rec. patients, an increase of 3%.
The International Society of Aesthetic Plastic Surgery Statistical Report 2016 showed 155.453 breast implants removed out of the total 1.610,117 breast augmentation patients worldwide.
• Tall patients for whom the tall implant will be placed farther down on the chest wall for better aesthetic results.
• Undecided patients who are seeking an additional option.