IP Licensing Opportunity
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!
Apex IP Portfolio
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.
The Patent Title:
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U.S. patent, Application filed on March 5, 2018 # 15/911,979 with broadened claims, and reinstating claims that were withdrawn to keep the "unity of the invention" in response to the Examiner restriction requirements.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:
- 3.1: EPO on March 29, 2018, application #16842575.9
- 3.2: Costa Rica on April 5, 2018, application #2018-0198
- 3.3: South Korea on April 5, 2018, application #10-2018-7009708
- 3.4: Hong Kong on January 2019, application #19100194.3.9.
The IP also include Trade names:
DefyGravityTM Breast Implant registered in the USA
Patent Licensing / Sale Proposal
Apex LLC. is searching for a breast implant manufacturing and marketing company that have the capabilities to successfully taking DefyGravity invention to the market, and is interested in this invention to expand their product portfolio in the breast aesthetic field.
Under Apex granted patents, the buyer/licensor will establish and protect leadership in breast implant market through 2036.
The proposal contains different options: either to buy the international patent rights, or in-license the patent rights in the agreed geographical region.
It is also possible to manufacture DefyGravity using the services of breast implant Contact Manufacturing Organization (CMO), Regulatory Licensing Firms with the use of available specifically-designed software. When these services are allined, we can submit for FDA Early Feasibility Study (EFS) Program, a limited clinical investigation of a device early in development enrolling a small number of subjects with a goal to evaluate the device design concept, with the results guiding device modification if needed. Initially, it is possible to use a safe saline filled breast implant for a shorter pathway of PMA.
A. Selling the International Patent Rights
This option is preferred by Apex LLC.
An interested breast implant manufacturing and marketing company can acquire the international patent rights of the claimed invention for the whole patent life until 2036, wherein DefyGravity breast implant is claimed for use in breast augmentation, reconstruction and lift-augmentation surgical procedures.
The Trade name DefyGravity is part of this agreement.
B. Regional Exclusive Out-Licensing
The first option for an interested company is to in-license the claimed invention exclusively in the agreed geographic region for the whole patent life until 2036.
The Trade name DefyGravity will be negotiated separately from this agreement, and will go to only one licensee.
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 Further Development
The buyer will undertake further:
manufacturing, approval, and marketing
Is DefyGravity an Early-stage Invention?
DefyGravity invention looks like an early stage innovation, but it only needs minimum R&D spending and is a short time-to-market productsimilar to adding a new implant style..
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.
Breast Implant Market: Competitive Landscape
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
- In November 2015, GC Aesthetics introduced Impleo breast implants.
- In June 2016, Establishment labs received approval from the Korean Food & Drug Administration (KFDA) for Motiva Implants.
- In September 2016, Allergan received the FDA approval of Natrelle Inspira SoftTouch.
- In April 2017 Mentor received the FDA approval for MemoryGel Xtra.
- In March 2018, Establishment Labs received the FDA approval for Motiva clinical trial in the U.S.
- Currently, POLYTECH Health & Aesthetics are manufacturing B-Lite breast implants, the first and only light weight silicone implant, that is considered one of the most significant development in the industry over the last 30 years.
The Unmet Market Need
The innovative DefyGravity implant is designed for the high unmet market needs of surgeons and their patients.
For the surgeons
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.
For the Underserved Patients
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:
- shape and/or size,
- The patient would prefer a different kind of implant,
- Wrinkled or rippled implant,
- And other common local breast aesthetic complications.
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.
Eventually, DefyGravity will compete with round and teardrop shaped implants in primary augmentation, reconstruction and lift-augmentation because consumers are always looking for a new option and improved products.
REFERENCES
- International Society of Aesthetic Plastic Surgery. Global Statistics on Cosmetic Procedures, 2016. https://www.isaps.org/wp-content/uploads/2017/10/GlobalStatistics2016-1.pdf
- Simon Barr, Ardeshir Bayat. Breast Implant Surface Development: Perspectives on Development and Manufacture. Aesthetic Surgery Journal , 2011; 31(1) 56–67 .
- International Society of Aesthetic Plastic Surgery. Global Statistics on Cosmetic Procedures, 2017. https://www.isaps.org/wp-content/uploads/2018/10/ISAPS_2017_International_Study_Cosmetic_Procedures.pdf
- American Society of Plastic Surgeons Statistics 2017, ASPS National Clearinghouse of Plastic Surgery Procedural Statistics. https://www.plasticsurgery.org/documents/News/Statistics/2017/plastic-surgery-statistics-full-report-2017.pdfLast visited December, 2018.
- Global $1 Billion Breast Implants Market 2017-2023: Top Players are Allergan, Mentor Worldwide, GC Aesthetics, and Sientra - Research and Markets. Publishe July, 2017. https://www.marketwatch.com/press-release/global-1-billion-breast-implants-market-2017-2023-top-players-are-allergan-mentor-worldwide-gc-aesthetics-and-sientra---research-and-markets-2017-07-11. Last visited December 2018.
- Global Breast Implants Market 2017-2023 - Top 4 Players Account for 85% of the Market Share. July 11, 2017 /PRNewswire/. https://www.prnewswire.com/news-releases/global-breast-implants-market-2017-2023---top-4-players-account-for-85-of-the-market-share-300486255.html
- Dan Voltz, January 12, 2018. http://plasticsurgeryarticles.com/blog/whats-new-breast-implants-2018y. Last visited October 2018.
- Lisette Hilton. Breast implants uncovered. September 20, 2016. http://cosmeticsurgerytimes.modernmedicine.com/cosmetic-surgery-times/news/breast-implants-uncovered?page=0,1Last visited March 2017.
