Today, the global spinal implant market is growing at a significant pace. This growth is primarily driven by various factors like increasing incidents of spinal disorders, advancements in spinal surgery technologies, as well as increasing preference towards minimally invasive spinal surgeries. Maximizing the opportunities, several companies are venturing into the market with cutting-edge products.
NanoHive Medical, LLC is one such company making a difference in the spinal implants sector with its best-in-class products. NanoHive is an early-stage commercial company and a pioneer and leading innovator of 3D-printed titanium medical device technology presently focusing on the spinal interbody fusion implants and instrumentation market valued approximately at $2B.
Early Growth Drivers
NanoHive was established in 2016 by two young engineers including the current Vice President of R&D, Ian Helmar. The founders did a great job at bringing innovative technology to the market, securing FDA 510(k) clearance and establishing a very innovative, deep, and wide intellectual property portfolio in an otherwise commoditized and cluttered spinal interbody fusion devices segment.
Patrick O’Donnell , NanoHive’s President and Chief Executive Officer, has also been a vital part of NanoHive’s growth. With over 25 years of experience in the medical device and orthobiologics industries, Patrick has established a successful track record of building and re-building companies. As the C-Level executive officer of several companies, he has built and led the Board of Directors and Executive Management teams and raised over $85M in capital to fund and execute product development and clinical programs toward regulatory milestones and the pathway to liquidity.
When Patrick joined NanoHive in January 2021, it was known as HD Lifesciences. The company only had 3 employees and a few weeks of cash on hand. He saw an opportunity to distinguish NanoHive’s technology from all the others in the crowded interbody fusion device segment of the spine market, create a focused and capital-efficient strategy, build the management team, and drive the adoption of technology to the next level.
Since 2021, NanoHive has raised approximately $6 million of new capital to bring two best-in-class products to market. The company has grown to 20 employees in this period and has tripled its surgeon customer base. Presently, the company deploys multiple distribution channels including a strategic channel as well as it’s own direct channel.
Industry-leading Products
NanoHive has significantly built its corporate and product brand equity in its proprietary Hive™ Soft Titanium® technology for 3D printed titanium interbody fusion devices. The core technology leverages the benefits of 3D printing manufacturing capabilities with titanium surface treatment technologies to distinguish the products by combining the desired biomechanical and biological features that lead to successful clinical experiences. The company provides cervical, posterior lumbar, and anterior lumbar interbody devices in a variety of sizes to accommodate spinal anatomy of their surgeon customers patient’s. Dr. Bridger Cox from Oklahoma City is one such surgeon customer. Dr. Cox has used Allograft and PEEK from Medtronic and some other companies including Titan and Spinal Elements. Talking about NanoHive’s service, he says,
“Titanium is a plus due to its unique combination of strength, stiffness, and osteogenic properties, but NanoHive’s Hive lattice structure and the ability for the bone to grow in and around the cage is a game changer. The portfolio offers implant sizes that fit the vast majority of options and clinical requirements, including high lordosis. And instruments are easy to use and straightforward.
We’ve had no instances of failed fusions or reoperations for pseudarthrosis at this point. Success rates have been exceptional, and early solid bridging bone is seen consistently at 6 months. Overall, we have been very happy with the product and we would definitely recommend it to other surgeons.”
NanoHive’s Anterior Lumbar and Cervical implants consist of both a highly innovative standalone interbody fusion system and a standard interbody system. The standalone ALIF system provides advantages such as maximized porous lattice, streamlined instrumentation, reduced solid titanium structural elements, etc., while the interbody system offers benefits like the proprietary independent endplate design, micro and macro- pore load-bearing lattice core, range of implant sizes and lordotic options, and the proprietary bone graft injection ports to fill the lattice with osteogenic therapies.
The Hive Standalone Cervical system offers advantages like zero profile and plated constructs in one system, variable screw insertion angles, low stiffness, reduced density lattice, etc. The interbody cervical system has the lowest stiffness of titanium interbody fusion cages, hence the Soft titanium branding, reducing subsidence risk while allowing for increased natural loading on the construct.
Additionally, the posterior lumbar implants have PL (straight) and TL (curved) interbody systems. The PL system instrumentation and cage design allow for in-situ rotation. Moreover, these systems have multiple sizes and footprints, including long, wide, and hyperlordotic offerings. The load-bearing lattice core allows for independent endplates, reducing the need for stress-shielding design features.
Commercially, NanoHive’s customers are orthopedic and neurosurgeons specializing in spine surgery. Additionally, its customers include academic and community hospital in-patient and out-patient centers as well as ambulatory care surgery centers throughout the US.
The NanoHive Difference
The Hive™ bioactive titanium interbody devices offer all the benefits of a 3D-printed titanium device without any drawbacks typically associated with some traditional designs. Here are the factors that distinguish NanoHive’s products in the market.
- Soft Titanium® Technology
Unlike a majority of titanium spinal cages on the market, Hive interbody fusion devices were designed from the inside out. The company started with its proprietary Soft Titanium® lattice as the foundation for the Hive portfolio. Thanks to its unique, energy-absorbing rhombic dodecahedron design, the biomimetic lattice is durable enough to support biomechanical loading without the need for solid, stress-shielding elements.
The titanium lattice structure has reduced stiffness, which makes its effective modulus comparable to PEEK materials. The rhombic dodecahedron lattice resembles the base structure of a cancellous bone. Moreover, the lack of solid shielding elements with independent endplates and a load-bearing core reduces the overall implant stiffness.
- Enhanced Bony Ongrowth and Ingrowth
NanoHive’s highly-specific, sub-micron-sized features are shown to interact with cells on a molecular level, starting a biological cascade that supports the adhesion of osteoblasts and drives bone attachment and formation. Additionally, the NanoHive Soft Titanium® lattice provides the optimal balance of strength and porosity for bony ingrowth. Its open pore structure allows the flow of cells and signals and interdigitation of bone growth.
- Superior Imaging
The low-density NanoHive Soft Titanium® lattice provides superior imaging and assessment of fusion on x-ray images or CT scans. Surgeons do not need to compromise on imaging when using the Hive titanium cages. Hive implants are preferred by four out of five surgeons over competitive devices in an independent blind study of visualization characteristics. Moreover, endplate fusion is easily identifiable on x-ray and the bone growth can be easily visualized through the cage.
Furthermore, NanoHive has a robust intellectual property portfolio with 8 Granted US Patents, 9 pending US Patents, 7 International PCTs, and 6 Design Patents issued. Capital-efficient and scalable outsourced production to industry-leading CMOs, a supply chain scalable to global commercialization, and low overhead/average burn are some other factors that distinguish NanoHive from its peers.
Strategic Partnerships
NanoHive has strengthened its commercial reach in the U.S. market and bolstered sales of its Hive™ technology to surgeons, hospitals, and patients by forming strategic partnerships with Accelus and Precision Spine.
NanoHive also partners with 3D Systems for industry leading expertise in the 3D printing of titanium implants.
Prioritizing Patient Clinical Experiences by Focusing on Customer Feedback
Companies that focus on customer feedback and go the extra mile for their satisfaction often come out on top. NanoHive also prioritizes customer satisfaction and its esteemed surgeon and hospital customers heap praises on the company for its responsive services.
Focused on Growth
From a best kept secret to a leading innovator, NanoHive is a company making it’s mark in the industry by combining distinctive innovation with an industry experienced leadership team implementing a focused, stepwise growth strategy.
To learn more about NanoHive Medical, visit the company website at www.nanohive.com.
Quotes:
“NanoHive is addressing the challenges of spinal fusion with bioactive 3D printed titanium interbody devices.”
“NanoHive’s Soft Titanium® technology reduces implant stiffness, making it comparable to PEEK, while providing similar load-bearing strength as bone.”
“NanoHive Medical is committed to selling its products with Distributor organizations that have an established reputation for excellence in hospital and surgeon service and support throughout the U.S.”
