The Food and Drug Administration granted 31 spine- and orthopedic-related medical device clearances in July.
Mazor Robotics received its first follow-up order for the Renaissance robotic spine system from a U.S. hospital corporation, an East Memphis-based full service hospital.
Alphatec Spine closed its acquisition of certain assets of Phygen, which will likely strengthen the company's capabilities.
DSM has partnered with AxioMed Spine to extend an existing licensing and supply agreement for CarboSil Thermoplastic Silicon-Polycarbonate-urethane material for use with AxioMed's Freedom Lumbar and Freedom Cervical Discs.
Medtronic has completed its $755 million acquisition of Chinese orthopedic device company China Kanghui Holdings to strengthen its product portfolio and add new products in trauma, spine and joint reconstruction.
Paradigm Spine and OM HealthCare Logistics signed a multi-year supply chain services agreement for the domestic healthcare marketplace to distribute the recently FDA-approved coflex device.
Smith & Nephew has purchased Texas-based Healthpoint Biotherapeutics for $782 million with the hopes that the acquisition will strengthen its position in the bioactive wound care market.
Spine Wave has completed a definitive agreement to acquire Santa Clara Technology, which develops technology for expandable titanium interbody cage platforms.
Symmetry Medical is partnering with MTG Medical Technologies for exclusive distribution in Europe of Symmetry Surigcal's portfolio.
Symmetry Surgical is partnering with Italian device maker Biocommercial to distribute its portfolio of surgical instruments across Europe and expand the company's global reach.
TranS1 has reached a distribution agreement with Beijing Jiade Sunshine that covers the sale of AxiaLIF products, which were granted a registration certificate by China's State Food and Drug Administration, in most of China.
Wright Medical Group announced it will purchase regenerative medicine company BioMimetic Therapeutics for up to $380 million, pending FDA approval of a new BioMimetic product.
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Question: What factors are driving change and innovation in the spine field today?
Eric Major: Overall, we are seeing an aging population that demands a higher level of activity. From a technology perspective, we are seeing continued focus on minimally invasive approaches for treating diverse pathologies, from degenerative conditions to complex spinal pathologies. Patients and surgeons are demanding minimally invasive alternatives to treatment approaches. From an industry perspective, we are seeing an increased focus on sagittal balance as it relates to spinal deformities and looking at how to treat and maintain balance in deformities such as scoliosis.
Q: How has K2M adapted to the market demands?
EM: Our core competency is in the area of treating the most difficult pathologies. That inspired our product managers, engineers and surgeon designers. From the very beginning, the conceptual approach for our systems was to treat difficult pathologies and deformities. It's very exciting for us to treat challenging scoliosis patients with our minimally invasive SERENGETI® and RAVINE® platforms.
Q: In your experience, what types of procedures and devices are most popular right now?
EM: From an industry perspective, we are seeing better technology across the med tech field. There are enhanced imaging technologies that provide more data input for surgeons and allows them to identify issues earlier and possibly prevent the cascading effects of advanced pathologies. You are able to identify spinal pathologies earlier in the patient's care and obtain more information about their condition; as a result, surgeons can treat them differently than if their pathology had progressed further.
Q: What factors surround the development and release of new technology today?
EM: There continues to be an increasing number of factors that we have to weigh as a medical device innovation company in the development of new technology. This includes:
• Food and Drug Administration regulatory process
• Global financial market — understanding the needs of technology in various markets around the world
• Reimbursement factors that are different around the world
• Geopolitical environments and how that impacts reimbursement
The regulatory process, combined with reimbursement around the world, has an impact on what we develop and where we introduce these technologies. For example, the costs associated with the regulatory approval process in the United States has become cost prohibitive with regard to certain technologies.
We have also seen a continued focus on evidence based medicine, specifically in the area of complex spine surgery and achieving sagittal balance. It's a global issue to address deformities because everyone is challenged with these types of cases.
Q: Where has K2M recently experienced challenges and successes in the market?
EM: In a disproportionate way compared to other companies, we are seeing growth in the United States as well as significant growth in Europe and the Asia Pacific markets. We have been able to provide products that are in demand in these areas and addressing the needs of patients and physicians in each specific market, which drives our growth. We are also adding products to provide surgeons with more versatility in treating a wide variety of individual patients. I'm a firm believer that surgery is a unique decision-making process on a surgeon-by-surgeon basis and we need to provide surgeons with various options because surgeons determine how they want to treat individual pathologies.
It's our job to provide surgeons with the necessary instrumentation to treat those pathologies. We are broadening our surgical fixation profile to provide neurosurgeons and orthopedic spine surgeons with a broader range of options for treating patients who need surgical operations. We are also providing an increased number of alternatives both in the types of implants and types of instrumentation used by the surgeons.
Q: Where do you see the spine device field headed in the future?
EM: The ongoing discussion around healthcare policy is going to impact medical technology everywhere, not just with spine. Regulatory approval and reimbursement rates will impact the ability of companies to bring products to the market. The other thing we are looking at is the aging and active population, which demands innovative technologies at a very competitive price level. It's important to help surgeons treat an increasing number of patients at a competitive price; that is where the industry will move.
I think we'll see a combination of developing innovative technology and making an effort to understand the economics of the situation for all constituents involved. It's important for us to understand hospital reimbursement as we are developing new products and know how insurance company coverage rates impact those hospitals. Those factors effect how we are able to bring technology to hospitals, physicians and insurers. We consider all of them when we are looking at the economics of the spinal med tech market.
Q: What is K2M doing to prepare for the future?
EM: What really drives us is our focus in the area of treating complex spine and the minimally invasive approach for providing those technologies to patients. Sagittal balance is paramount in developing new innovative technologies. Minimally invasive platforms for surgeons are also a critical component for the area of spine. What drives us is treating complex spine through the minimally invasive approach. I'm very bullish on the future of spine and medical technology from an innovation perspective. What excites me the most is knowing that we will continue to discuss, design and introduce new technologies inspired by the needs of surgeons to help them provide new technologies for their patients.
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