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MẌ Orthopedics Receives FDA Clearance on the dynaMẌ™ Nitinol Compression Screw

MẌ Orthopedics Receives FDA Clearance on the dynaMẌ™ Nitinol Compression Screw (press release)

LEXINGTON, Mass., June 7, 2016 /PRNewswire/ — MẌ Orthopedics, Corp. (MẌO), an orthopedic implant company focused on improving implant/bone fixation, is proud to announce the recent FDA clearance (K160427) of the dynaMẌ™ Nitinol Compression Screw.
The dynaMẌ™ Nitinol Compression Screw utilizes the superelastic properties of Nitinol to provide higher levels of compression than contemporary bone screws. During manufacturing, the dynaMẌ™ Nitinol Compression Screw is stretched and held in an elongated position with an internal pin. Following implantation, the internal pin is removed and the Screw attempts to shorten and return to its original unstretched length, thereby providing desirable compression.

“Bone is a living material that remodels with altering stress levels, changing shape and mechanical properties. The dynamic healing process of bone warrants a dynamic implant material. The dynaMẌ™ Nitinol Compression Screw represents the next generation of screw fixation technology as it is engineered to change shape in vivo, enhancing fracture reduction while applying controlled compression to the fracture site,” said Matthew Fonte, Ph.D., Founder and President of MẌO.
More information about the dynaMẌ™ Compression Screw can be found at: http://www.mxortho.com/products/compression-screws/
MẌO’s dynaMẌ™ line of Nitinol fracture fixation implants include superelastic compression screws, staples, plates, and intramedullary implants. MẌO applies sound engineering principles and sophisticated metallurgical know-how to the design of superelastic implants in order to optimize biologic healing. Deleterious implant instability and bone resorption can be minimized through calculated implant internal fixation forces generated between bone segments. The dynaMẌ™ line is designed to provide higher levels of compression at the fracture site as the bone remodels. MẌO’s sophisticated products are Engineered to Heal™.
MẌO will be showcasing the dynaMẌ™ line at:

The National 2016 American Podiatric Medical Association (APMA) Annual Scientific Meeting in Philadelphia, PA (July 14-16). Booth #306.
The American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting in Toronto, ON (July 20-23). Booth #236.

Contact:
MẌ Orthopedics, Corp.
617.207.8602
[email protected]
www.mxortho.com
SOURCE MX Orthopedics, Corp.

When should you use a Retained Search versus a Contingency Search?

2 Questions about choosing the right recruiting method

After writing Hiring is better with a Retained Recruiter, I received a lot of questions on when to use a Contingency recruiter and when to use a Retained recruiter for a specific open position at your company. So, based on 30 years of hiring and placing talent in Ortho and Spine companies, I believe that you can chose the right approach by answering these two questions.

Two Questions
1. Is this a high impact position at our company?
2. Do we need to fill this position immediately?

The Retained recruiting model is designed to find a few “A Players” for your company. Use a Retained recruiter when getting the right person on board is critical to the future of the company. Go Retained when you are adding a transformational person to the team. These high-impact hires are typically at the Director, V or C level. But in startups, a high-impact position can be an individual contributor, such as the first QA/QC hire, who will have a large impact. You will get very few resumes of passive candidates who are not looking for a new job, but these are the A-Players who are doing a great job at your competitor and who are getting promoted quickly. So, if you need an A-Player for a critical position, go with a Retained recruiter.

The Contingency recruiting model is designed to find many many “B and C Players”. The Contingency model is rigged against your company for finding “A Players”. Use a Contingency recruiter when the position is not critical to your company. Go Contingency when you are just trying to fill a chair. You will get many resumes quickly of people who tend to be looking for jobs. The resumes you get will come from the active job seekers who are unemployed or under-employed. These are the B and C-Players. You will get a bunch of these resumes that will let you start to interview quickly. So, if you need speed for a lower level position, go with a Contingency recruiter.

Further Reading… The fundamental Flaw with the Contingency Recruiting model

New FDA guidance for companies that create 3D-printed implants in Orthopedics

More from the FDA on Material Characterization for Additive Manufacturing (ODTMag)
In March, I addressed here recent actions by the FDA to increase the specificity of material characterizations. That article focused on a February FDA Draft Guidance on UHMWPE used in orthopedic devices, and also mentioned a Guidance on blood access devices. Now, the FDA has again weighed in on material characterization, this time in the context of a Draft Guidance Document (DGD) on “Technical Considerations for Additive Manufactured Devices,” which includes 3D printing. The general issue of material characterization is how much needs to be specified to know exactly what material is being used in a medical device, and to address whether one material is identical or similar to another material. If similar rather than identical, how similar is it? Is that degree of similarity sufficient to apply experience with one material to expected performance of the other? These issues apply to both the raw materials and those materials as manufactured into a device.
In the DGD, the FDA “recommends,” or is thinking about recommending (since this is a draft) that material specifications begin with the identity of the starting material used in terms of its common name, chemical name, trade name, CAS number, and material supplier. Note that this goes well beyond merely giving a generic polymer name, and reflects that knowing only the chemical name is not knowing very much. In addition, the DGD asks for the identification of processing aids, additives, and cross-linkers used, also by material or chemical name and incoming specifications, certificates of analysis, and test methods. Specifications may include particle size and distribution for powder; filament diameter and diametric tolerances for filaments; viscosity or viscoelasticity, pH, ionic strength, and pot life for fluids; composition, purity, water content, molecular formula, chemical structure, molecular weight, molecular weight distribution, glass transition temperatures, and melting and crystallization point temperatures for polymers or polymer mixtures; and chemical composition and purity for metals. If any material is recycled from manufacturing back into the starting process, this must also be addressed with respect to potential changes in properties and content.
To read the full feature, see it at ODTmag – More from the FDA on Material Characterization for Additive Manufacturing

Doug Kohrs does it again! Medtronic acquires his low-cost hip and knee startup

I am a big fan of Doug Kohrs. Doug Kohrs is an Orthopedic/Spine startup giant. And Doug did it again! Let’s rewind the tape – He sold SpineTech to Sulzer for 10X sales (I was there) that was the tipping point for the spine bubble, then he built up the urology company, American Medical Systems, and took it public, then he grew Tornier and sold it to Wright, now he self-funded Responsive Orthopedics and sold it to Medtronic. —Tiger
Responsive Orthopedics website
Background story on Responsive Orthopedics (Star Tribune)
Medtronic enters bundled ortho implant space with Responsive Orthopedics buy (MassDevice)
Medtronic snaps up Minnesota company to tackle knees and hips (Minn/St Paul Business Journal)
Medtronic has bought a Twin Cities medical-device startup founded by med-tech vet Doug Kohrs as it dips its toe in the knee- and hip-replacement business.
Medtronic isn’t disclosing terms of its deal to buy Responsive Orthopedics. The acquisition closed in May, a company spokeswoman said.
Medtronic plans to use Responsive’s products to launch a joint-replacement service it detailed during an investor day Monday. Kohrs, formerly CEO of Tornier, launched Responsive Orthopedics to develop low-cost knee and hip implants with a focus on bundled-payment programs, according to a Star Tribune profile. Those programs include not just a surgery itself, but all the services from the time a patient walks into the hospital to 90 days after the procedure is over.
Kohrs and other executives will serve as consultants to Medtronic’s orthopedic implant program.
Medtronic (NYSE: MDT) plans to help hospitals manage bundled-payment programs, providing them with devices and using analytics to track costs and how well patients fare after surgery. If Medtronic reduces costs, it will get a share of the amount saved.
The idea comes as Medicare is making a major bundled-payment push with its comprehensive care for joint replacement program. CJR rewards hospitals that meet its cost and quality goals — and penalizes those who don’t.
The program is part of Medtronic’s broader hospital-services push, which includes managing cath labs. That service has commitments for $2 billion in contracts already, Medtronic said during its investor day.
Even after its mega-deal to buy Covidien, Medtronic didn’t have a foothold in the joint-replacement market, which is dominated by major players like Zimmer Biomet Holdings Inc. While Responsive Orthopedics’ devices don’t come in “47 sizes and different colors,” they should meet surgeons’ needs, said Geoff Martha, Medtronic executive vice president and president of the company’s restorative therapies group during the investor day.
Martha said the program isn’t a “Trojan horse” for selling devices to hospitals. “This offering stands on its own,” he said.
As Medtronic developed the program, it teamed up with physicians who have experience leading successful bundled-payment efforts.
Responsive’s knee product is approved for sale, but regulators have yet to clear the hip version. Medtronic said it wasn’t prepared to offer financial projections for the joint-replacement service, which it expects to launch next year.
Dublin-based Medtronic’s operational headquarters are in Fridley.

Zimmer Biomet acquires LDR Spine for $1B (6 X sales)

Zimmer Biomet to Acquire LDR to Enhance Growth of Spine Business (press release)
This positions the company to capitalize on faster growing spine segments, including cervical disc replacement.
Zimmer Biomet Holdings Inc. and LDR Holding Corporation (LDR), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today announced that both Boards of Directors have approved a definitive agreement under which Zimmer Biomet will commence a tender offer to acquire all of the outstanding shares of LDR for $37.00 per share in cash, which implies a transaction value of approximately $1.0 billion. The transaction is subject to customary closing conditions and is expected to close in the third quarter of 2016.
Founded in France in 2000, LDR designs and commercializes innovative technologies making surgical procedures easier to perform and providing improved clinical outcomes in the treatment of spine disorders. The addition of LDR will bolster Zimmer Biomet’s presence in the global Spine market and provide the Company with an immediate and a leading position in the fast growing cervical disc replacement (CDR) and MIS segments. The combination is expected to meaningfully accelerate the growth of Zimmer Biomet’s Spine business through the incremental revenues associated with entry into the cervical disc replacement market and cross-portfolio selling opportunities to both Zimmer Biomet and LDR customer bases.
Zimmer Biomet also expects the transaction to accelerate the future growth of its overall business. With respect to 2016, the Company reiterates its previously provided revenue guidance, an increase of 2.0% to 3.0% as compared to adjusted pro forma full year 2015 on a constant currency basis. The Company will update its revenue guidance to reflect this transaction at or about the time of closing. Zimmer Biomet is also reiterating its 2016 adjusted diluted EPS guidance of $7.85 – $8.00. The transaction is expected to be neutral to adjusted diluted EPS in 2017 and accretive thereafter.
“This highly strategic and complementary transaction will enhance Zimmer Biomet’s innovation leadership in musculoskeletal healthcare by adding a premier spine platform to our portfolio of solutions,” said David Dvorak, President and CEO of Zimmer Biomet. “This combination is consistent with our goal of driving meaningful growth across all musculoskeletal markets with innovative products, technologies and services that enhance patient outcomes. The talented LDR team uniquely shares our deeply held commitment to innovating in a manner that restores mobility and alleviates pain for patients around the world, and we look forward to welcoming them to Zimmer Biomet. We are confident that the combination of Zimmer Biomet’s Spine division and LDR will create a Spine company with the scale, talent and technology portfolio to become a leader in the $10 billion global Spine market.”
Christophe Lavigne, Co-Founder, Chairman, President and CEO of LDR, said, “We are delighted with this combination, which will further our commitment to improving spine care by providing greater access to our innovative product offerings for patients around the world, while offering our stockholders immediate cash value. We have great respect for the Zimmer Biomet team, who shares our passion for innovation as well as our commitment to patients and providers. We look forward to working closely with Zimmer Biomet to achieve a seamless transition and create lasting value for all of our stakeholders.”
Strategic Benefits of the Transaction

Enhances Zimmer Biomet’s innovative product portfolio: The combination with LDR is a natural expansion of Zimmer Biomet’s Spine business. LDR’s talent, culture and track record of innovation is evidenced by its primary product offerings based on its Mobi-C cervical disc replacement device and MIVo portfolio to support lumbar and cervical fusion procedures, both of which are complementary to Zimmer Biomet’s current portfolio. Combined, Zimmer Biomet and LDR create a differentiated and comprehensive Spine portfolio, improving Zimmer Biomet’s position for sustainable growth.
Positions Zimmer Biomet as a market leader in CDR: CDR represents the fastest growing segment within the $10 billion Spine industry. LDR’s Mobi-C CDR device has been well received in the market as the first and only device FDA approved to treat both one- and two-level adjacent damaged cervical discs. Long-term clinical studies for Mobi-C have demonstrated the efficacy of this unique technology, with Mobi-C showing superiority to fusion for two-level procedures. These excellent clinical outcomes coupled with market-leading ease of use are expected to drive further market penetration as a part of Zimmer Biomet’s Spine portfolio. Finally, the combination positions Zimmer Biomet to leverage its scale and resources to accelerate the development of the CDR market globally.
Significant opportunity to leverage expanded commercial channel: The Company expects to capture cross-portfolio selling opportunities to both Zimmer Biomet and LDR customer bases. Zimmer Biomet anticipates enhancing LDR’s product growth and reach by capitalizing on an expanded combined distribution channel in the U.S. and key international Spine markets. The combination also will create a comprehensive Spine portfolio with innovative surgical solutions that place Zimmer Biomet in an advantaged position to compete for large hospital vendor contracts.

Financing
Zimmer Biomet plans to finance the transaction using cash balances on hand and existing availability under its revolving credit facility and expects to maintain an investment grade profile. Following consummation of the transaction, Zimmer Biomet plans to issue $750 million of senior unsecured notes, the proceeds of which will be used to repay the credit facility. Zimmer Biomet intends to maintain its previously discussed deleveraging strategy.
Organization and Leadership
Upon consummation of the transaction, LDR will be combined with Zimmer Biomet’s Spine & CMF category and will be led by Adam Johnson, Zimmer Biomet Group President, Spine, CMF and Thoracic, and Dental. Christophe Lavigne, Co-Founder, Chairman, President and CEO of LDR and Patrick Richard, Co-Founder of LDR and Executive Vice President and General Manager of LDR Médical, are committed to driving the benefits of this transaction and will remain with the Company in key leadership positions within the global Spine business. To leverage talent and product expertise from both companies, Zimmer Biomet plans to complement the Spine business headquarters in Broomfield, Colorado by maintaining a significant presence in LDR’s strong technology hubs of Austin, Texas and Troyes, France.
Transaction Structure, Approvals and Time to Closing
The transaction is structured as an all-cash tender offer for all outstanding shares of LDR common stock at a price of $37.00 per share, followed by a merger in which each share of LDR common stock that is not tendered pursuant to the tender offer would be converted into the right to receive in cash $37.00 per share.
The transaction is subject to the expiration or termination of the applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the tender of a majority of the outstanding LDR shares in the tender offer and other customary closing conditions. The transaction is expected to close in the third quarter of 2016.
Advisors
Goldman, Sachs & Co. is acting as financial advisor to Zimmer Biomet and White & Case LLP is acting as legal advisor. BofA Merrill Lynch is acting as financial advisor to LDR and Andrews Kurth LLP is acting as legal advisor. – See more at: http://www.odtmag.com/contents/view_breaking-news/2016-06-07/zimmer-biomet-to-acquire-ldr-to-enhance-growth-of-spine-business/#sthash.puiMsxAx.dpuf

MẌ Orthopedics Receives FDA Clearance on the dynaMẌ™ Nitinol Compression Screw

When should you use a Retained Search versus a Contingency Search?

New FDA guidance for companies that create 3D-printed implants in Orthopedics

Doug Kohrs does it again! Medtronic acquires his low-cost hip and knee startup

Zimmer Biomet acquires LDR Spine for $1B (6 X sales)

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