Global Leading BiomedicalLifeNet Health announcedCollaborate with Johnson & Johnson to launch a brand-new allograft bone transplantation material, PliaFX Pak, in the U.S. market.

It is reported that,This multifunctional bone graft material combines mineralized bone particles with precisely engineered demineralized bone fibers, designed to fill bone voids and defects caused by trauma or surgery.Suitable for various surgical scenarios such as fractures, fusion, and osteotomy.

As a new member of the PliaFX series, PliaFX Pak will be commercially launched this month by Johnson & Johnson Medical along with the previously introduced PliaFX Prime and PliaFX Strip.

In 1998, Johnson & Johnson acquired DePuy, the world's first orthopedic company, for $3.5 billion.First foray into the orthopedic field.In 2011, Johnson & Johnson spent $19.7 billion to acquire Synthes,One leap becomes one of the largest orthopedic companies in the world.Offering the most comprehensive products in the orthopedic and neuro fields, covering joint reconstruction, trauma, spine, sports medicine, craniomaxillofacial, and power tools.And fields such as biomaterials.

NoSince the announcement of the restructuring of its orthopedic business in 2023, there has been little news of collaborations. At that time, the company only publicly stated that it planned...Move away from "low-profit markets and product lines" and improve the related product portfolio.

So, does this collaboration with LifeNet Health to launch PliaFX Pak mean that Johnson & Johnson's orthopedics division is entering the regenerative medicine field, betting on a vast market?Demineralized Bone Matrix (DBM) Market?

According to the introduction,PliaFX Pak is co-designed by LifeNet Health and Johnson & Johnson Medical Technology.Composed of 100% bone graft material, its unique formula combines mineralized bone particles and demineralized bone fibers, processed through the advanced PliaFX fiber technology. After absorbing water, the material can form a highly malleable and complete graft without the need for any carrier, significantly improving...Improved the operational experience and clinical outcomes during surgery.

At the same time, PliaFX Pak also contains long and coarse cortical fibers, which can provide more attachment points for platelets, effectivelyPromote Coagulation and Hemostasis. Its bone conduction framework, composed of interconnected bone fibers and particles, not only has a large surface area but alsoPromote cell attachment and the formation of bones and blood vessels。

This product is suitable for a variety of clinical applications, such as lumbar interbody fusion, anterior cervical discectomy and fusion (ACDF), open wedge high tibial osteotomy (HTO), distal femoral fractures, calcaneal fractures, and proximal humeral fractures, among others.

Product Features and Advantages

Excellent Operability:The mineralized bone particles and demineralized bone fibers of PliaFX Pak are tightly interlocked, forming a malleable graft that can be easily transferred and adapted to the surgical site without easy displacement.

Excellent bone conduction:The structure of PliaFX Pak provides an ideal scaffold for cell attachment and spreading, helping to promote new bone growth and angiogenesis, supporting rapid bone healing.

100% Pure Bone Material:The product contains no human or xenografts and no synthetic carriers, consisting entirely of mineralized bone particles and demineralized bone fibers, which can naturally remodel during the bone healing process.

Powerful New Bone Generation Potential:The demineralized fibers with PAD® technology retain osteoinductive and angiogenic growth factors, thus having the potential to promote new bone and blood vessel formation in vivo, providing strong support for bone healing.

High Safety:PliaFX Pak is sterilized using proprietary Allowash XG® technology, ensuring extremely high safety. It reduces the risk of infection while maintaining the bone conduction and osteoinductive properties of the graft.

Personalized Customization:The product can be flexibly mixed with autologous bone, allogeneic bone, or a liquid chosen by the surgeon according to needs, meeting various surgical requirements.

PliaFX Pak isPliaFX Bone DefectFiller SeriesThe new member of the series, with earlier products including PliaFX Prime and PliaFX Strip.In the future, PliaFX Pak will be one of the Johnson & Johnson Orthopaedics products globally promoted by Johnson & Johnson Medical Technologies.

The orthopedic business of Johnson & Johnson Medical Technologies comes from its subsidiary DePuy Synthes, which was formed in June 2012 by the merger of DePuy and Synthes, and is one of the top three orthopedic device companies globally.In 2023, the company surpassed Stryker with $8.9 billion in revenue to become the world's largest.

* Revenue growth in Globus Medical's annual report is unclear

It is reported that,In 2023, DePuy Synthes' revenue growth accelerated to 4.4%,Among them, the knee joint business revenue was 1.456 billion US dollars, ranking first in the business sector with a growth rate of 7.1%.

Of course, the growth of DePuy Synthes is inseparable from its restructuring decisions. In2023During the Q3 earnings call, Johnson & Johnson stated it is restructuring its DePuy Synthes orthopedics business.A two-year restructuring plan will separate the orthopedics division from "lower-profit markets and product lines," with specific measures including improvements in the related product portfolio, especially in the orthopedic knee business, where there will be a "more comprehensive portfolio."

During the same period, the company launched the Velys orthopedic robot in Europe for total knee replacement surgeries. Thanks to the European marketThe rapid increase in the field has led to a strong growth in Johnson & Johnson's knee joint business. Notably, Velys has recently received FDA approval for a new indication, allowing its Velys robotic surgery platform to be used for unicompartmental knee replacement.

BesidesDePuy Synthes products also cover areas such as joint reconstruction, trauma, spine, sports medicine, craniomaxillofacial, power tools, and biomaterials, supporting nearly one million orthopedic surgeries worldwide each year.

The launch of PliaFX Pak caters to the rapidly growing demand for Demineralized Bone Matrix (DBM).

According to market research by GlobalData,The U.S. bone grafts and substitutes market was valued at $1.6 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 3.2% over the next decade, reaching $2.2 billion by 2030.

At the same time, other companies in the bone grafting technology field are also picking up the pace.Bone Biologics Corporation, a bone biotechnology company based in Massachusetts, announced that it has successfully treated the first patients in the initial clinical trial of its NB1 bone graft device. Biocomposites, a UK-based medical device company, has also launched two Phase II clinical trials for its pharmaceutical-grade degradable bone graft material, STIMULAN, made from calcium sulfate, further advancing the development of bone grafting technology.

"Astronomical Price" Allograft Bone

It is worth noting that,Allogeneic bone is bone tissue taken from deceased or amputated human bodies.Mainly sourced from allogeneic femur, fibula, humerus, and ilium, which are transplanted into the recipient's body after sterile processing.Due to the limited availability of healthy and compliant cadaveric sources, allogeneic bone graft materials are extremely scarce.The domestic market has already been hyped up to a "sky-high" price of 3,000 yuan per 0.5 grams.

Therefore, some unscrupulous companies in the market profit from the use of allograft bone transplantation materials with unknown origins.. For example, the recent exposure of,Shanxi Aorui Biomaterials Co., Ltd. illegally resold more than 4,000 corpses for the production of "allogeneic bone implant materials" products.It is reported that the company's products have flowed to dozens of medical institutions.

In additionAllogeneic bone has a certain degree of immunogenicity, which may hinder cell adhesion and differentiation, and can lead to complications such as infection, nonunion, refracture, excessive resorption, and immune rejection, or even death. In the United States, there have been two incidents of viral contamination caused by allogeneic bone transplantation.

Johnson & Johnson's collaboration with LifeNet Health has brought new technological options to the market. However, allograft bone materialsThe scarcity and potential risks of materials remain an unavoidable challenge for the industry. Medical device companies need to stay vigilant to ensure the legal and compliant sourcing of materials and prevent infiltration from illegal channels.

So, will DBM be the next niche track that Johnson & Johnson's DePuy Synthes bets on? Medical Device News will continue to follow up.

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