Exactech Announces Successful First Surgeries with New Equinoxe® Preserve Stem and ExactechGPS® Shoulder Application

June 06, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today a successful first surgery using the new Equinoxe® Preserve stem, a conservative shoulder treatment option designed to preserve humeral bone in shoulder replacement surgery. Additionally, surgeons performed the first U.S. procedures using the ExactechGPS® Shoulder Application.

Orthopaedic surgeon Thomas Wright, MD, performed the first Preserve stem surgery in Gainesville, Fla. “The surgical team and I were pleased with the results of today’s surgery, including the thoughtful implant design, practical instrumentation and relatively simple technique,” Dr. Wright said.

The Preserve stem expands the options offered by the successful Equinoxe®Platform Shoulder System. This new stem is approximately two-thirds the length of the system’s current stem.

“Creating a bone preserving stem that can be used alongside already clinically successful components of our Equinoxe anatomic and reverse implants is an important evolutionary step in our perpetual pursuit of improved clinical outcomes,” said Darin Johnson, Vice President of Marketing, Extremities.

The implant design was developed through the use of CT reconstruction data and clinical studies. Specifically, the implant features a unique polished distal tip to facilitate any need for removal, a straight lateral fin designed for greater rotational stability and plasma coating to aid proximal fixation.

“The technique and implant were created to provide a more bone preserving option within the Equinoxe suite. It was a great pleasure over the last couple of years to collaborate with Drs. Samuel Antuna, Ken Faber, Howard Routman, Joseph Zuckerman and Pierre-Henri Flurin on this innovative improvement. This product demonstrates Exactech’s commitment to working closely with surgeons to improve patient outcomes,” Dr. Wright said.

Dr. Wright and Richard Jones, MD, of Asheville, N.C., also completed the first U.S. surgeries using the ExactechGPS Shoulder Application, a computer-assisted shoulder arthroplasty technology. “This advance in shoulder arthroplasty – being able to execute a preoperative plan in the operating room with real-time visibility into the glenoid vault – has almost limitless possibilities to help patients. Ten years ago, Dr. Sean Grey and I implanted the first Equinoxe reverse shoulder, and that innovation set the pace for the last decade. Now, I believe, ExactechGPS is the breakthrough for the next decade,” Dr. Jones said.

Full U.S. market availability for the Preserve Stem and ExactechGPS Shoulder Application is planned for the beginning of 2018.

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.

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
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
EXAC@hawkassociates.com
or
Exactech
Media contact:
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

Oska® Wellness Teams Up With Arizona Golf Association to Promote the Revolutionary Oska Pulse

CARLSBAD, Calif., May 31, 2017 /PRNewswire/ — Oska Wellness, a technology company committed to developing innovative consumer health and wellness products, is partnering with the Arizona Golf Association to promote Oska Pulse, a breakthrough wearable electromagnetic field device that eases pain.  The AGA is comprised of more than 400 clubs and 75,000 members.

“I used Oska Pulse both prior to and after my hip surgery last year,” said Ed Gowan, Executive Director of the AGA.  “We’re always interested in bringing new products and options to Arizona Golf members. If they can use Oska Pulse to play one more round, then we’re all for recommending it to our community.”

Oska Pulse is a safe, easy-to-use, wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain and increase mobility for people who have acute or chronic pain.

“I met Ed Gowan in 2010 while in the golf industry and am delighted to forge an official relationship with the Arizona Golf Association,” said Steve Collins, COO of Oska Wellness. “The AGA shares our mission for new ways to provide non-invasive, drug-free pain management solutions. Many golfers have told us that they’ve had to cut back on playing due to elbow, hip, wrist, knee, back pain and more. Those who have used Oska Pulse now view the device as just as important to managing their aches and pains as a putter or a driver is to his or her game.”

The Arizona Golf Association was founded in 1923 as a small group of golfers who got together to run the annual Amateur Championship.  The AGA is a volunteer-based organization directed by amateur golfers, dedicated to promoting the game of golf, and providing valuable benefits and services to its members.

During the PGA Merchandise Show in January, Oska Wellness introduced Oska Pulse, a hands-free device that employs safe Pulsed Electromagnetic Field (PEMF) therapeutic technology to help people enjoy more active, pain-free and drug-free lives.  Subsequently, Oska Pulse was named “best in show” by top golf publications, including Golf Digest.

About Oska Wellness
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with more than 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition. The company is headquartered in Carlsbad, California and can be found online at www.oksawellness.com.

CONTACT:
Robin Carr, Oska, Inc.
415-971-3991
162247@email4pr.com

ADD COUPON CODE  “ORTHOSPINECO”  FOR  $55.00 OFF

READ MORE ABOUT OSKA HERE

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/oska-wellness-teams-up-with-arizona-golf-association-to-promote-the-revolutionary-oska-pulse-300465961.html

Dr. Brian Badman is First and Only Indiana Shoulder Surgeon to Offer Breakthrough Treatment for Rotator Cuff Tears

American Health Network today announced that Dr. Brian Badman is the first and only shoulder surgeon in Indiana to treat patients suffering from rotator cuff disease using the Rotation Medical Bioinductive Implant – a new technology that helps tendons heal through the induction of new tissue growth, potentially helping patients resume normal activities quicker than traditional treatment and reducing the likelihood of further degeneration or re-tears.

The minimally invasive system is designed as a new option for people suffering from rotator cuff tendon tears in the shoulder joint, which affect more than 4 million people annually in the U.S. and are the most common source of shoulder pain and disability.

“Rotator cuff injury is common, and many patients avoid surgery because they hear about painful, lengthy postoperative rehabilitation and time away from work,” said Dr. Brian Badman. “The Rotation Medical Bioinductive Implant, which is about the size of a postage stamp, is inserted through a small incision during a minimally invasive arthroscopic outpatient procedure. The Bioinductive Implant induces the formation of new tendinous tissue over the surface of the tendon, resulting in a thicker tendon. Depending on their stage of rotator cuff disease, the Bioinductive Implant can provide patients a range of potential benefits, including shorter rehabilitation, faster recovery, prevention or slowing of disease progression, healing of partial-thickness tears, and decreased risk of developing a subsequent tear.” Several prominent orthopedic shoulder surgeons across the country have helped pioneer this technology including Dr. Jeff Abrams at Princeton and Dr. Buddy Savoie at Tulane University.

Rotator cuff tears are most often caused by chronic wear and tear with degeneration of the tendon. Rotator cuff tears can also occur in people who repeatedly perform overhead motions in their jobs or sports. In fact, more than 50 percent of people over age 60 have symptoms related to rotator cuff partial to full tearing of the tendon. Because traditional treatments do not address the poor quality of the underlying tendon tissue, a significant number of these tendons often develop into larger, more painful and debilitating tears and/or re-tears due to continuing degeneration of the torn tendon. The Bioinductive Implant allows surgeons to intervene early and potentially prevent disease progression by augmenting and healing the tendon before the injury worsens.

The Bioinductive Implant, manufactured by Rotation Medical, is suitable for most rotator cuff disease, from small partial-thickness tears to massive full-thickness tears. The Bioinductive Implant is derived from bovine Achilles tendon and gradually absorbs within six months, leaving a layer of new tendon-like tissue to biologically augment the existing tendon. This treatment can be used for both previously treated and untreated patients. Introduced to the market in 2014, the technology has been used in thousands of rotator cuff procedures in the U.S.

For more information, please visit Indyshoulder.com or to schedule an appointment with Dr. Badman, please call 317-208-3866.

About Dr. Badman
Dr. Badman grew up in South Bend, Indiana. He completed his orthopedic residency training at the University of Florida-Gainesville in 2005 and finished a shoulder and elbow fellowship at the Florida Orthopedic Institute in Tampa in 2006. Dr. Badman joined American Health Network (AHN) in 2011 as the founding member of AHN’s Bone & Spine group. He has subspecialty interest in shoulder and elbow disorders, with specialty training in arthroscopic rotator cuff repair, shoulder instability, total shoulder arthroplasty, reverse shoulder arthroplasty and proximal humeral fracture fixation. He is a member of the American Shoulder and Elbow Society and is only the fourth person from Indiana to be inducted into this prestigious international group of shoulder specialists. Over the past several years, Dr. Badman has consistently been one of the busiest reconstructive shoulder surgeons in the state, performing more than 150 replacement surgeries per year (total and reverse) and over 250 arthroscopic rotator cuff repairs annually.

About American Health Network’s Bone & Spine Group
American Health Network’s bone & spine physicians deal with diagnosis and treatment of diseases and injuries of the musculo-skeletal system, which includes bones, joints, muscles, ligaments, and tendons. The group provides fully integrated state-of-the-art care from diagnosis and treatment to rehabilitation. For more information, visit http://www.indyboneandspine.com

Oska® Wellness Teams With MyTPI to Promote Oska Pulse

CARLSBAD, Calif., May 17, 2017 /PRNewswire/ — Oska Wellness, a technology company committed to developing innovated consumer health and wellness products, is partnering with MyTPI to promote Oska Pulse, a breakthrough wearable electromagnetic field device that eases pain. MyTPI has the largest collection of golf-specific health, fitness and swing advice on the Internet.

“We’re excited to be working with MyTPI, sharing our mission for new ways to provide non-invasive, drug free pain management solutions,” said Greg Houlgate, CEO of Oska Wellness.  “We’ve heard from many golfers who have had to cut back on playing due to pain. But thanks to the use of Oska Pulse, golfers can play one more round, pain free. Oska Pulse is a smart, safe, easy-to-use, wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain, and increase mobility for people who have acute or chronic pain.”

During the PGA Merchandise Show in January, Oska Wellness unveiled the Oska Pulse — a small, portable, hands-free device that employs safe Pulsed Electromagnetic Field (PEMF) therapeutic technology, a longtime therapy used by medical practitioners to help people enjoy more active, pain-free and drug-free lives.  Subsequently, Oska Pulse was named “best in show” by several leading golf publications, including Golf Digest.

“I’ve used Oska Pulse and got great results with mobility and pain relief from this device,” said David Phillips, co-founder of TPI.  “Our partnership with Oska Wellness will allow us be able to promote Oska Pulse to our leadership team, our affiliates, and our athletes. I’m a total believer in this product and I look forward to recommending it to our community.”

Phillips also said there are several ways to use the device. “After a round of golf, if you feel lower back pain or perhaps you have some wrist tendonitis,” he said. “Or prior to play, if you feel a little tightness in the morning. Use Oska Pulse on your way to the course.”  Developed by the experts at the Titleist Performance Institute, MyTPI.com delivers advanced golf-specific information from experts on six continents and 62 countries.

About Oska Wellness
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with over 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition. The company is headquartered in Carlsbad, California and can be found online at www.oksawellness.com.

ADD COUPON CODE  “ORTHOSPINECO”  FOR  $55.00 OFF

READ MORE ABOUT OSKA HERE

CONTACT:

Robin Carr, Oska, Inc.
415-971-3991
160282@email4pr.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/oska-wellness-teams-with-mytpi-to-promote-oska-pulse-300459069.html

Oska® Pulse is a “Best Product” Award Winner at ING Conference

CARLSBAD, CA, June 1, 2017 – Oska Pulse, a breakthrough wearable electromagnetic field device that eases pain, was recently named “Best Product” at the 27th Annual ING Spring Conference. Oska Pulse, the flagship product from Oska Wellness, received the award last month at the World Golf Village & Hall of Fame in St. Augustine, FL.

The ING Spring Conference is an annual gathering of media and golf industry executives conducted by the non-profit networking organization, the International Network of Golf. A group of 130 industry executive and media were in attendance at this years’ event, held May 21- 24.  The Oska Pulse and the Knuth Golf High Heat fairway metals tied in voting by attendees who chose their favorite products which were demoed at the conference.

“We are thrilled to be honored by the folks who attended the ING Conference and who recognize Oska’s mission to provide non-invasive, drug free pain management solutions,” said Greg Houlgate, CEO of Oska Wellness. “It was an inspirational week at the conference, and we heard from golfers who deal with elbow, hip, wrist, knee, back pain and more. With Oska Pulse, golfers can play another round — pain free.”

During the PGA Merchandise Show in January, Oska Wellness introduced Oska Pulse, a hands-free device that employs safe Pulsed Electromagnetic Field (PEMF) therapeutic technology to help people enjoy more active, pain-free and drug-free lives. Oska Pulse was named “best in show” by top golf media outlets who attended, including Golf Digest, Golf Channel, and TravelingGolfer.net.

Oska Pulse is a safe, easy-to-use, portable and wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain and increase mobility for people who have acute or chronic pain.

About Oska Wellness
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with more than 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition. The company is headquartered in Carlsbad, California and can be found online at www.oksawellness.com.

 

ADD COUPON CODE  “ORTHOSPINECO”  FOR  $55.00 OFF

READ MORE ABOUT OSKA HERE

 

 

 

Meta-Analysis Reveals LIPUS as Alternative to Surgery for Established Nonunion Fractures

June 05, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Low-intensity pulsed ultrasound (LIPUS) treatment can be an effective alternative to surgery for nonunions, which are fractures that fail to heal. This according to a systematic review and meta-analysis of 13 published studies that describe nonunions treated with LIPUS. The findings were published in the May 15, 2017 issue of Injury available at http://www.injuryjournal.com/article/S0020-1383(17)30341-8/fulltext.

Nonunions occur in approximately 5% of patient fracture cases each year. Nonunions have little expectation of spontaneous healing and can be corrected with revision surgery, however such procedures typically pose technical challenges and an increased potential for complications. When surgery is optional and patients want to avoid its associated risks, choosing LIPUS has demonstrated a positive healing effect more than 80% of the time, which is comparable to the success rate for surgical treatment.

“This meta-analysis revealed that LIPUS is a viable alternative to surgery for established nonunions,” said Dr. R. Grant Steen, Manager of Medical Affairs, Bioventus. “The heal rate across all primary studies included was 82% and increased to 84% for nonunions that were eight months or older.”

The review and meta-analysis was funded by Bioventus and adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were considered eligible for review if LIPUS was used as an alternative to surgery for non-healing fractures and if the treatment was applied at least three months after the last surgical procedure. In addition, at least one outcome of interest (heal/fail) was required and a clear definition of delayed or nonunion was included.

Authors of this study include Ross Leighton, MD, Dalhousie University; J. Tracy Watson, MD, Saint Louis University School of Medicine; Peter Giannoudis, MD, University of Leeds; Costas Papakostidis, MD, Chapel Allerton Hospital; Andrew Harrison, PhD, Bioventus and R. Grant Steen, PhD, Bioventus.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN® Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC.

Contacts

Bioventus LLC
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

NuVasive Magnetic, Non-Invasive Platforms Featured In The Journal Of Orthopaedic Trauma Supplement

SAN DIEGO, June 5, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the PRECICE® system and PRECICE UNYTE™ platform from NuVasive Specialized Orthopedics (NSO) are featured in the June 2017 supplement of the Journal of Orthopaedic Trauma (JOT), which demonstrates a lower complication rate, greater patient comfort and faster healing in comparison to traditional treatments1.

NSO, a NuVasive division focused on the design and innovation of disruptive orthopedic solutions, developed a proprietary platform of magnetically adjustable implant systems that include:

  • The PRECICE system is an intramedullary device that once implanted utilizes an External Remote Controller (ERC) to non-invasively lengthen the femur and tibia. Through propriety magnetic technology, the PRECICE ERC lengthens the PRECICE device with precision rate control. Each patient’s lengthening is customized based on a physician directed program.
  • PRECICE UNYTE is an intramedullary solution for stabilizing and treating difficult to heal fractures and non-unions. It leverages clinically validated technology based on the proven principles of compression and distraction osteogenesis and uses the ERC magnetic technology to apply non-invasive customized treatment for proper bone healing and restoring natural bone length.

“Our groundbreaking, non-invasive technology platforms from NSO have disrupted the spine and orthopedic markets,” said Gregory T. Lucier, NuVasive chairman and chief executive officer. “The positive outcomes from our early clinical experience with PRECICE UNYTE demonstrate that we are able to treat complex fractures with our magnetic technology, which will help transform the lives of patients that previously lacked a formidable solution.”

PRECICE system and PRECICE UNYTE are featured in the June JOT Supplement, “Intramedullary Limb Lengthening and Compression for Orthopedic Trauma Surgeons“, with five articles authored by leading surgeons Robert Rozbruch, M.D., Mitchell Bernstein, M.D., Stuart Green, M.D., Austin Fragomen, M.D., and Tracy Watson, M.D.

“I’m honored to report on the success of PRECICE UNYTE intramedullary compression implant and share the positive results of our early clinical experience,” said Dr. Green, University of California, Irvine, Department of Orthopaedic Surgery. “The future of this technology is clearly evident in the JOT supplement, which highlights the key role engineering research plays in developing medical device innovation. Patients around the globe will greatly benefit from the new technology created by the collaboration effort of NSO and the surgeon community.”

PRECICE UNYTE WEBINAR

The Company is hosting a webinar on June 6, 2017 titled, “Treating Challenging Fractures and Nonunions,” featuring Austin Fragomen, M.D. from the Hospital for Special Surgery, New York. The webinar will look at traditional treatment options and highlight new technologies in intramedullary compression and distraction devices. Click here for more information and to register.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery and beyond with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

1 Fragomen, Austin T. J Orthop Trauma; Volume 31, Number 6 Supplement, June 2017; S7-S13

 

SOURCE NuVasive, Inc.

Orthopaedic Pediatric Market Draws New Companies, Products

Carolyn LaWell – May 2017

EPOSNA 2017, the combined annual meeting of the European Paediatric Orthopaedic Society and Pediatric Orthopaedic Society of North America, served as an unveiling for new products, brands and companies as a focus on this niche market is drawing in device companies.

Two dozen device, bracing and pharmaceutical companies exhibited at EPOSNA in early May. The way Nick A. Deeter tells it, a decade ago there were three at the North American meeting: OrthoPediatrics (the company that Deeter founded in 2006), Biomet and Smith & Nephew. Attending EPOSNA with WishBone Medical, the pediatric company he founded earlier this year, Deeter said that he believes the pediatric segment is ripe for growth. For one, there is demand. WishBone estimates the market at $1.4 billion, growing at 10% per year. Two, it is one of the few areas in orthopaedics that has yet to gain attention from device companies—though our tracking of announcements in the space suggests that could be changing.

Here’s what’s happened just since 4Q16:

  • Implanet received global regulatory clearance for Jazz Frame connectors for use with the JAZZ Band in the treatment of adult and pediatric spinal deformity.
  • Materialise gained FDA clearance for Surgicase Orthopaedics to assist in pre-op planning for pediatric patients undergoing radius and ulna osteotomies.
  • Medicrea received FDA clearance of specialized posterior fixation and band connector components.
  • Mighty Oak Medical obtained FDA clearance for 3D-printed FIREFLY Pedicle Screw Navigation Guides, reported to be the only patient-specific pedicle screw guide indicated for use in pediatric patients.
  • NuVasive announced that it’s building up a salesforce for exclusive focus on pediatrics to promote its MAGEC rod for early onset scoliosis and PRECICE technology for limb lengthening.
  • Onkos Surgical, focused on the adult and pediatric surgical oncology market, received its first FDA 510(k) for the Eleos Limb Salvage System.
  • Orthofix launched JuniOrtho, a new brand to house services (apps, games, education tools) and products that treat pediatric orthopaedic and congenital deformities, including the TL HEX TrueLok Hexapod system and Guided Growth plates.
  • OrthoPediatrics, a solely-focused pediatric ortho company, launched a new distal femoral osteotomy system.
  • WishBone Medical formed and announced planned launch of single use, disposable implants and instruments for foot and ankle, trauma, spine and sports medicine indications.

 

READ THE REST HERE

Paragon 28® launches PRECISION™ Jones Fracture Screw System

ENGLEWOOD, Colo., May 30, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

The PRECISION™ Jones Fracture Screw System is the latest addition to Paragon 28®’s robust foot and ankle specific portfolio.  The system is comprised of 120 unique screw options spread across four screw families (4.0 mm, 4.5 mm, 5.5 mm, and 6.2 mm).  Solid and cannulated options of each screw length (34-60 mm; 65 mm) are available to address varying anatomies and fracture patterns. The screws are constructed from titanium alloy that is type II anodized for improved fatigue strength. All screws have a short thread and blunt tip to minimize disruption to the cortical bone and to ensure the intended trajectory through the intramedullary canal of the 5thmetatarsal is maintained during insertion. Additionally, the screws have a low profile head to minimize prominence and avoid impingement of the cuboid.

The PRECISION™ Jones Fracture Screw System also includes instrumentation designed to facilitate placement of a K-wire high and inside the proximal portion of the 5th metatarsal.  The patent pending PRECISION™ Jones Curved K-wire Guide has a tip which matches the base curvature of the 5th metatarsal and radius of curvature which aims the handle of the guide away from the lateral malleolus and cuboid.  This guide’s primary function is to aid in positioning a nitinol K-wire into the center of the intramedullary canal simplifying placement which may reduce intraoperative fluoroscopy time. Constructed from nitinol, the K-wire will flex and follow the curvature of the intramedullary canal while limiting the chance of broaching the surrounding cortex.

In addition to the Curved K-wire Guide, the system includes implant specific taps, countersinks, and standard and long drills to aid in implanting the screw through either a traditional or cannulated technique.

Product Page:
http://www.paragon28.com/products/jones-fracture-screw-system/

Contact: Jim Edson, Director of Product Management and Marketing, jedson@paragon28.com

SOURCE Paragon 28

Related Links

http://www.paragon28.com

DJO Global Announces Appointment of Jeffery McCaulley as Global President, DJO Surgical

May 30, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc., a leading global provider of medical technologies designed to get and keep people moving, announced the appointment of Jeffery McCaulley as Global President, DJO Surgical, effective immediately. Mr. McCaulley will succeed Brady Shirley, who was appointed DJO’s President and Chief Executive Officer in November, 2016 after successfully doubling revenue and profitability of DJO Surgical since he joined DJO in 2014.

Mr. McCaulley is an experienced senior executive with more than 25 years in the healthcare industry, most recently serving as President and CEO of Smiths Medical, a $1.2B division of Smiths Group, plc. Before joining Smiths Medical, Mr. McCaulley served as President of the Global Reconstructive Division at Zimmer, where he oversaw five global business units and numerous functions. He held previous roles as President and CEO of the Health Division of Wolters Kluwer and Vice President and General Manager of the Global Diabetes Business Unit at Medtronic. Mr. McCaulley began his career at GE Healthcare, where he held progressively more senior roles during his 13 years there, last serving as President and CEO of GE Clinical Services.

Mr. McCaulley received a Bachelor of Science in Aerospace Engineering from the University of Cincinnati and an Executive MBA from the Owen Graduate School of Management at Vanderbilt University.

“Our Surgical business’ best in market performance has and will continue to be the key transformation catalyst in our company. I am excited to combine Jeff’s talent and experience in the space with our exceptional leadership team. Throughout his career, Jeff has a proven track record of accelerating innovation, improving employee and customer engagement, and delivering results. I look forward to this great next chapter for DJO Surgical!” said Mr. Shirley.

“I am very excited to be joining Brady and the team at DJO,” said Mr. McCaulley. “The growth in recent years has been spectacular and I am convinced that we are positioned to continue to make significant market share gains across our portfolio and have the right internal and external teams to improve key areas of patient care and experience.”

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort®, Bell-Horn® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for continued market performance, sales growth and growth in market share for DJO’s Surgical Segment. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause actual operating results and market growth to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to the successful execution of the Company’s business transformation plans, including achievement of planned actions to improve liquidity, improvements in operational effectiveness, optimization of the Company’s procurement activities, improvements in manufacturing, distribution, sales and operations planning, and actions to improve the profitability of the mix of our product and customers. Other important factors that could cause actual operating results and market growth for our Surgical Segment to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the continued growth of the surgical implant markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 15, 2017. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP, Treasurer and Investor Relations
760.734.3075
ir@djoglobal.com