Exactech sells off spine business and restructures

Exactech (EXAC) Divests Spine Assets, Will Restructure (press release)

GAINESVILLE, Fla.–(BUSINESS WIRE)–With the goals of increasing productivity, enhancing profitability of its worldwide business, and strengthening its focus on core competencies, Exactech, Inc., (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for extremities, hip, knee and spine, has announced the restructuring of its Spine and Biologics business segment including the divestiture of its spine products business and restructuring charges related to international operations. The divestiture was executed through a spine asset sale today to ChoiceSpine, a private enterprise headquartered in Knoxville, TN. Terms of the transaction were not released.
“We’re now in a position to dive deeper into our growth strategy by adding and introducing new distribution and surgeon users to our current and future technologies that we plan to launch over the next few months”
Exactech CEO David Petty said, “For nearly a decade, Exactech has driven innovations in spinal surgery and we are pleased to have made meaningful contributions to patient care. We are confident the transfer of these products to ChoiceSpine will provide a continued focus on improving patient care for that population. This divestiture will allow us to sharpen our focus on investments in the core extremities and large joint segments of our business.”
According to Martin Altshuler, who co-founded ChoiceSpine with Rick Henson, “The additional technologies that Exactech has access to, combined with our expanding portfolio, allows us to further solidify our company as a premier, full-line spinal fusion provider in the U.S., with further growth opportunities in select international markets,” said Altshuler.
“We’re now in a position to dive deeper into our growth strategy by adding and introducing new distribution and surgeon users to our current and future technologies that we plan to launch over the next few months,” added Henson.
Exactech stated that the restructuring initiative and losses on the impairment of Spine and Biologics assets, including goodwill and spine assets sold, will result in a pre-tax charge to 2016 earnings in the range of $15-17 million. Looking ahead, the company expects 2017 revenue to be in the range of $264 – $272 million and earnings per share to be in the range of $1.24 to $1.32.
Earnings for 2016 will be released on Tuesday, February 21, 2017 before market open, and additional restructuring details will be reviewed during the company’s 2016 year-end earnings call on Tuesday, February 21, 2017 at 10AM ET.
About Exactech
Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.
A current investment profile on Exactech (Nasdaq: EXAC) is available online at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.
About ChoiceSpine
ChoiceSpine is a privately held spinal implant company located in Knoxville, Tenn., and prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon focused systems that are designed to be safe, efficient, and easy-to-use. By working closely with physicians and maintaining service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to the market.
This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech, Inc.
Investor contacts
Jody Phillips, 352-377-1140
Executive Vice President of Finance &
Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
[email protected]
or
Media contacts
Exactech
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication
or
ChoiceSpine, LP
Anderson Collins, 865-246-3333
Business Development
[email protected]

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ChoiceSpine acquires Exactech’s spine assets

ChoiceSpine acquires Exactech’s spine assets  (press release)
also read All Mergers & Acquisitions in Orthopedics
ChoiceSpine, a privately held spinal fusion device manufacturer based in Knoxville, Tenn., announced today it has acquired the spinal assets of Exactech (Nasdaq:EXAC). Exactech is a developer and producer of bone and joint restoration products for extremities, hip, knee and spine, with corporate headquarters in Gainesville, Fla.
“This is a great addition to our emerging product line,” said Rick Henson, co-owner of ChoiceSpine. “We look forward to building relationships with Exactech distributors and end users, as well as extending our product offering to potential new customers.”
The acquisition will also have beneficial international implications with Exactech having distribution channels in Spain, Portugal and Germany. “We currently have distribution partners in Italy and Mexico, so these new assets will immediately boost our international footprint,” added Marty Altshuler, co-owner of ChoiceSpine.
“This investment will continue to build the momentum behind our pursuit of becoming a prominent, full-line spinal implant provider.”
In addition to today’s acquisition announcement, ChoiceSpine also announced it would be rolling out several new products this year, along with a complete biologics line, set to complement its expanding implant portfolio.
Founded in 2006, ChoiceSpine now has more than 45 employees and is majority-owned by Henson and Altshuler. For more information on the company, visit choicespine.com.
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About ChoiceSpine
ChoiceSpine is a privately held spinal implant company located in Knoxville, Tenn., and prides itself on providing excellent products and exceptional service to meet the needs of their customers.  ChoiceSpine offers a breadth of innovative and surgeon focused systems that are designed to be safe, efficient, and easy-to-use. By working closely with physicians and maintaining service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to the market.
Contact: Carson Barnes
Phone: 865.862.4467
Email: [email protected]

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So far… Zimmer 3, Patients 0 in lawsuits over the NexGen Flex total knee

Zimmer Biomet logs 3rd win in NexGen Flex bellwether trials (MassDevice)
Zimmer Biomet (NYSE:ZBH) last week won its 3rd bellwether trial in the multi-district litigation brought over the NexGen Flex knee implant, after a federal jury in Illinois found against the plaintiff.
The FDA in 2007 cleared the NexGen Flex implant, designed to provide more flexibility than other knee replacement devices. Beverly Goldin is 1 of thousands of product liability plaintiffs in the MDL who allege that the device can’t withstand that extra flexion, despite the Warsaw, Ind.-based company’s marketing claims. The plaintiffs also allege that a design flaw makes the device more prone to premature loosening requiring revision procedures.
Zimmer Biomet denies that the devices are defective and said they have a successful track record; Judge Rebecca Pallmeyer of the U.S. District Court for Northern Illinois, who is overseeing the MDL, and 2 juries have agreed so far.
“Judgment is entered in favor of defendant Zimmer Inc., and against plaintiff Beverly Jemma Goldin,” according to court documents filed Jan. 26 in the most recent trial. Pallmeyer, who did not release the jury verdict form, ordered both parties to submit any post-judgment filings within 30 days.
Zimmer Biomet won the 2nd bellwether last fall when Pallmeyer found that the plaintiff failed to prove that a design defect caused the implant to fail. The jury in the 1st bellwether in November 2015 likewise cleared the company, finding that the plaintiff failed to prove defective design and failure to warn claims.
At least 5,900 NexGen product liability lawsuits have been consolidated into the MDL under Pallmeyer, but the going hasn’t been smooth. It was a challenge to find suitable bellwethers; in June 2015 the judge issued a so-called “Lone Pine” order requiring plaintiffs to prove their cases. Named for a 1986 decision dismissing a mass toxic tort case against a New Jersey landfill, a Lone Pine order requires plaintiffs to show a link between their injuries and the product accused of causing them.

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A “Smart” Patch could detect early OA in knees

“SMART” PATCH COULD DETECT OA IN KNEES (Orthopedics This Week)
A team of researchers from Cardiff University in Wales is working on the development of a smart patch to detect the early onset of osteoarthritis (OA) in patients’ knees. The School of Engineering researchers are making use of sensors from aircraft wings in order to detect cracking sounds in joints!
As indicated in the January 24, 2017 news release, “A smart patch could help save millions of pounds spent on diagnosis via X-ray and MRI [magnetic resonance imaging] scans, as well as improving the lives of patients through targeted, bespoke treatments.”
Davide Crivelli, Ph.D. of the university’s School of Engineering commented to OTW, “I would say that the most exciting part of the project will be to link the inaudible ‘sounds’ generated by early damage in the cartilage (which could lead to osteoarthritis) with live medical imaging (such as dynamic fluoroscopy and motion capture). Once Cardiff School of Engineering musculoskeletal laboratory is commissioned and a prototype patch is developed, we will start investigating the different ‘sounds’ caused by different types of damage, and we will be able to tell at which stage of joint motion they occur.”
“In the future, once the full medical device is validated, it could be used in a range of settings: GP surgery for early and cheap screening, rehabilitation (to assist and compare patient progress) and eventually self rehabilitation to motivate and guide the patient during exercise. A very interesting application could also be in monitoring of joint replacement wear/condition.”

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The 100% biology total knee replacement, the BioKnee

Biology trumps bionics: An alternative to total knee replacement (LinkedIN posting by Kevin R. Stone, M.D. Orthopedic Surgeon at The Stone Clinic)
Dr Stone’s TED Talk
If you have severe knee pain or chronic knee inflammation and swelling which cannot be improved by minor surgery or physical therapy, a doctor may recommend that you have total knee replacement surgery. For many people, after years of agony, this operation is a godsend. The procedure relieves pain and greatly enhances their quality of life, allowing them to return to work and resume activities that they have not been able to enjoy in years.
But artificial knee replacements are not a perfect solution. Studies have shown that up to 50% of recipients still have some pain after the procedure. Surgeons are reluctant to perform knee replacements on younger people because the parts don’t last. Subsequent replacements are more complex and wear out even faster.
Many of the arthritic patients I see are under 70 years old and have years of playing sports and being active ahead of them. Therefore I like to do everything possible to rebuild their knee joint with biologic tissues rather than artificial materials to help delay the time in which an artificial joint replacement is necessary.
This regenerative approach to healing is the new frontier in modern medicine as researchers all over the world look for ways to rebuild and regenerate tissues and organs, harnessing the body’s natural ability to heal itself. In many cases these solutions are a long way off, but in orthopedics, we have been practicing them for years.
A BioKnee is an alternative to an artificial knee replacement. It combines three key procedures that rebuild, regenerate or biologically replace the damaged parts of the knee.
First we fix the articular cartilage, the white shiny surface that covers the ends of the bone. We’ve been doing this for over 20 years with a technique called Articular Cartilage Stem Cell Paste Graft, which permits cartilage to be re-grown inside the knee. We take stem cells from your own bone marrow and mix them with the cartilage cells to form a paste. When the paste is impacted into the damaged area of the joint, it is able to re-grow cartilage repair tissue. Recently, three separate studies have confirmed that the stem cell paste graft produces superior results to other cartilage regeneration techniques. One study, conducted by independent researchers in China, concluded that the reason for the superior results from the paste graft was the presence of stem cells in the paste.
Another BioKnee procedure repairs or replaces the meniscus, the shock absorber in the knee joint. A damaged or missing meniscus leads to increased forces across the knee and causes arthritis. We have developed new techniques to repair the meniscus, bringing in new blood supply to the damaged tissue and often adding growth factors, stem cells, and clot materials to augment healing, even in older people. Where we can’t repair the meniscus, we replace it using a donor transplant.
When we combine these two procedures, we get superb results even in the setting of arthritis. Our long-term studies of meniscus transplantation with articular cartilage grafting show an 80% survival rate with patients ranging from 15 to 70 years old (average age 48.)
The final step in the BioKnee replacement solution is to fix damaged ligaments to properly stabilize the knee. We are able to reconstruct or replace these ligaments using donor tissue.
The goal of a biologic knee replacement is to preserve the biology of the knee, to get the knee moving like it should and provide a buffer to prevent bone-on-bone contact and pain.
With a biologic, rather than artificial knee replacement, we permit our patients to go back to full sports, since there is no artificial material to wear out.
The past two decades have seen a sharp rise in the number of total knee replacements performed in the USA. Latest figures record 600 thousand surgeries a year with demand predicted to increase to three million by 2030. We are certain that many of the knee replacements done in the near future and beyond will be biologic replacements rather than metal and plastic.
Read more from Dr. Stone at StoneClinic.com/blog

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