Bacterin Announces the Launch of OsteoSTX, a Novel Biologic Product

Bacterin International Holdings, Inc. (NYSE MKT: BONE) is pleased to announce the launch of OsteoSTX, a new novel allograft for orthopedic procedures. Utilizing Bacterin's proprietary demineralization technology, OsteoSTX are flexible cortical DBM matchsticks designed for multli-level and deformity spinal applications.

"This is the first product Bacterin has launched since I joined the Company, and I have been very pleased with the process and the results," said Dan Goldberger, Bacterin President and CEO. "We introduced this product to key opinion leaders at the NASS Evidence and Technology Spine Summit and the feedback was astounding. I am looking forward to seeing how distribution of this new product will help support our growth goals, and complement our existing product portfolio."

OsteoSTX is the first product in Bacterin's biologic portfolio designed specifically for addressing multi-level spine procedures and deformity cases. Bacterin is the first company to market a product of this type for single use application. The product will be launched this week at the 2014 AAOS Conference in New Orleans, LA, March 12th - 14th. OsteoSTX has already been implanted in patients with strong surgeon feedback supporting the use of the product and the application.

About Bacterin International Holdings

Bacterin International Holdings, Inc. (NYSE MKT: BONE) develops, manufactures and markets biologics products to domestic and international markets. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries.

Bacterin's Medical Device division develops, employs, and licenses coatings for various medical device applications. For further information, please visit www.Bacterin.com.

Important Cautions Regarding Forward-looking Statements

This news release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as "continue," "efforts," "expects," "anticipates," "intends," "plans," "believes," "estimates," "projects," "forecasts," "strategy," "will," "goal," "target," "prospects," "potential," "optimistic," "confident," "likely," "probable" or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company's ability to meet its existing and anticipated contractual obligations, including financial covenant and other obligations contained in the Company's secured lending facility; the Company's ability to manage cash flow and achieve profitability; the Company's ability to develop, market, sell and distribute desirable applications, products and services and to protect its intellectual property; the ability of the Company's sales force to achieve expected results; the ability of the Company's customers to pay and the timeliness of such payments; the Company's ability to obtain financing as and when needed; changes in consumer demands and preferences; the Company's ability to attract and retain management and employees with appropriate skills and expertise; the Company's ability to remain listed on the NYSE MKT exchange; the Company's ability to successfully conclude government investigations; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. Additional risk factors are listed in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading "Risk Factors." The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Source : The Wall Street Journal , 13th March 2014 

Preoperative Scheuermann’s kyphosis work-up needs to include lateral radiograph, precise neurological exam

There is a place for nonoperative treatment of Scheuermann’s kyphosis in patients whose spine curves are smaller and only reach 70° to 75°, but it is diminishing in favor of surgical treatment, according to a presenter at the American Academy of Orthopaedic Surgeons Annual Meeting, here. 

B. Stephens Richards III

Bracing and casting associated with conservative care of these patients has fallen out of favor with orthopedic surgeons, even though in a recent study it was shown to be successful, B. Stephens Richards III, MD, said during a symposium on the management of sagittal imbalance in these patients.

Richards discussed nonoperative and operative treatments for Scheuermann’s kyphosis, as well as the key considerations for diagnosing the condition.

“Don’t give up on the nonoperative approach,” he said. “It remains a viable option, though for a minority of patients.”

“More commonly the operative approach is used and the indications include rigid deformity that exceeds 70° to 75°, an unacceptable appearance and, unquestionably, persistent pain. Our goals are to obtain a well-balanced sagittal appearance, preserve normal neurological function and avoid a junctional kyphosis,” he said.

He emphasized the need for a precise neurological exam and getting a lateral radiograph preoperatively, and not necessarily an MRI.

“An MRI is debatable in Scheuermann’s kyphosis,” according to Richards, who went on to review the role that preoperative planning, intraoperative neuromonitoring, anterior releases, osteotomies and cantilevering methods can play in successful operative outcomes.

“Curves exceeding 70° with strong cosmetic concerns qualify for operative treatment. MRI is not a routine requirement and posterior compression techniques provide excellent correction without the need for anterior releases,” Richards said. – by Susan M. Rapp.

Reference:

Richards BS. Scheuermann’s kyphosis & roundback: Diagnosis & current treatment guidelines. Presented at: American Academy of Orthopaedic Surgeons Annual Meeting; March 11-15, 2014; New Orleans.

Disclosure: Stephens has stock or stock options with Pfizer and receives royalties, financial or material support from Wolters Kluwer Health-Lippincott Williams & Wilkins. 

Source : Healio , 14th March 2014

Shailene Woodley Covers Marie Claire in Leather Jumpsuit, Talks Scoliosis, Single Life + Miley Cyrus

                                                  Marie Claire


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Divergent’ star Shailene Woodley is earthy and down-to-earth, but she sure glams up on her April 2014 Marie Claire cover, wearing a colorblocked, futuristic leather jumpsuit with cut outs.

She looks majorly sexy for a woman on the verge of superstardom. In her feature, she talks shedding her possessions, the single life, her position on “the one” and Miley Cyrus. She also revealed the spinal condition from which she suffers.

Her big reveals are below.

She has ditched other possessions (not just her cell phone). “I’ve only been home nine days this year, which sort of what inspired me to get rid of everything,” the star, 22, said.

Both her parents are psychologists. Mom is a counselor, and her dad is a family therapist. They are divorced, however.

She thinks teenagers are smarter than we give them credit for. “For so long they were—and still are—depicted in movies and TV shows as codependent whiners or rich, beautiful, diamond-clad daughters or dumb cheerleader types,” she said. “But teenagers are so smart. I was probably smarter as a 16-year-old than I am today. There is a zest for life that you have at that age that is so beautiful.”

She no longer gives a you-know-what about being thin. “My whole life I’ve been so self-conscious about being skinny,” the leggy actress said. “And just recently I don’t care anymore. All insecurities are projected because of what you think others are saying about you, but they don’t really matter at all. My only real insecurities in high school were having such long legs and thick hair—things I’m so very grateful for now.”

She suffers from scoliosis and had to wear a brace for 18 hours a day for two years as a teen. The actress was unfazed, saying, “I was like, ‘Some people have crooked teeth, some people have broken fingers, and I’ve got a back that has my initial on it.’” What an inspiration!

She deleted her Instagram because she felt icky. “Everything I was posting was for a story—like, ‘Look how interesting I am.’ It felt disgusting to me. It feels as though we’re so detached from actual human connection,” Woodley mused about social media.

She has been single for four years, hasn’t met the one and doesn’t know if “he” even exists. “I just haven’t met anyone where I was like, ‘Wow, I could definitely see myself spending a season of my life with you,’” Woodley admitted. “I don’t even know if humans are genetically made to be with one person forever.”

On Miley Cyrus: “I don’t really know anything about twerking,” Woodley declared. “I admire that she’s doing what she wants to do. I wasn’t really a fan of hers before, and now I’m just so fascinated by her. I love how everyone’s throwing a fit about something that isn’t their life.”


Source : Pop Crush , 17th March 2014

The therapy to keep ahead of the spinal curve

When his son was diagnosed with scoliosis, Mark Travers found a little known German spine therapy and brought it to Ireland



 Jake Travers (5) with his physiotherapist Sarah McShane

When Mark Travers went to his local physiotherapy clinic to find help for his toddler son, he could never have guessed that his visit would be the catalyst for the introduction to Ireland of a new treatment which would benefit patients throughout the country.

The story begins when his son Jake was 15 months old and Mark's wife Sarah Feehan noticed something different about his spine – and, she recalls now, that his ribs seemed to be out of alignment.

Five or six months later, after a series of comprehensive tests and medical consultations, Jake was diagnosed with scoliosis, which is curvature of the spine, and, in August 2010, was fitted with a body cast.

"Jake would fall a lot," Sarah recalls. "His balance was very poor and his core muscles were weak, but he always seemed to take it in his stride," she recalls.

Mark started to research scoliosis and investigated the different treatments used for the condition.

About 18 months ago, Mark came across information about Schroth Therapy, a treatment for scoliosis that is very popular in Europe, but was at that stage virtually unknown in Ireland.

Mark visited the Louth Physiotherapy clinic in Dundalk, where the family lives, to see if staff there practised Schroth Therapy – they didn't, but it emerged, they were very open to learning about it.

Schroth Therapy focuses on educating patients about their posture and how to correct it – and then teaches them how to apply their postural changes to functional activities.

It works on the basis that scoliosis always involves asymmetrical muscle groups in the back and elsewhere – which in normal bodies are more evenly symmetrical.

Patients learn exercises which stretch tightened areas and strengthen weakened areas of the body.

The Schroth Method also focuses on educating patients how to breathe more effectively and properly ventilate the lungs.

Sarah McShane (27), a chartered physiotherapist at the clinic, had not heard about Schroth Therapy, but was intrigued by what Mark had to say about it, and immediately started to research it.

"It's very popular all over Europe. There was a lot of research on how this therapy worked and the benefits seemed to be very good," she recalls, adding that it has been used in mainland Europe for more than 40 years.

With the support of her boss, Sarah decided to train in Schroth Therapy and in July 2012, travelled to the tiny German village of Bad Soberheim, where the Schroth Therapy Centre of Excellence was located:

"Schroth therapy looks at the 'asymmetrics' in the body. A curve in the spine will affect the body in different ways," she explains.

"You might have an elevation of a shoulder or hip for example so that one shoulder/hip is higher than the other.

"As part of Schroth Therapy we also identify muscles affected by the curvature of the spine – we look at the back and see what is not in alignment.

"We identify associated problems – for example, a shoulder or a hip and we guide the client into creating a better posture so that these asymmetries are minimised.

"It's about educating the client in how to attain a better posture, thus putting less pressure on certain muscles and on the spine itself."

This is done, she says, through a series of exercises which are very specific to individual clients, depending she explains, on the type of scoliosis they have and the way their condition is affecting them.

"We are effectively identifying ways the scoliosis is affecting the patient, and then teaching them how to correct their posture to improve their spinal alignment."

The exercises, she explains, can be as simple as standing in front of a mirror and putting your arms in a special position so that the shoulder blade is properly positioned.

This exercise also encourages patients to move their ribs into correct alignment and helps teach correct weight-bearing posture:

"Every exercise has multiple components and will have different functions for different parts of the body, so it is very important that they develop the exercises carefully.

"We also teach them how to breathe – Schroth Therapy believes that scoliosis affects the patient's lung capacity so we teach the client how to breath by filling their lungs to maximum capacity which makes exercise easier for them and is also believed to play a role in improving the alignment of the spine.

In February 2013 Jake began to receive a combination of physiotherapy and Schroth Therapy – he now does 20-30 minute exercise sessions four times a week – and the results are significant, says his mother: "It's very much about posture and breathing.

"A year after he started the therapy, his balance has improved, it's really good and he doesn't fall any more.

"His lung capacity is better – he used to get a lot of chest infections, but now his breathing has improved and he doesn't seem to be as vulnerable to the chest infections.

"We're very happy – he will have to be operated on in the future, but the therapy has really improved his quality of life."

"I think this is a very practical therapy – it makes a lot of sense to me," says Sarah.

"The therapy has definitely improve Jake's exercise tolerance and his posture has improved significantly. He wears a cast but the therapy has helped target other areas of the body such as his tummy muscles and head and neck alignment and his shoulder posture."

Jake's not the only one who has benefited from the introduction of Schroth Therapy to the Louth Physiotherapy Clinic.

Says McShane: "Twenty months on, we are up and running successfully, seeing new clients on a weekly basis and managing clients' scoliosis.

"At present we are still the only clinic in the country offering this service and have clients from Kerry to Donegal coming to utilise the service.

"We're getting great results from it – one of our clients was facing surgery when she started with us.

"She has completed six months in treatment and now no longer requires surgery because the severity of the curvature of her spine has reduced."

As a result of the improved posture brought about by the exercises, she explains, clients find their muscles are not as tight and their joints are less stiff – and they're experiencing less pain.

"We also find that clients are able to tolerate more exercise once they start the therapy. The therapy is improving muscle function and helping them breathe better."

Source : Independent , 3rd March 2014

Ardrey Kell senior encourages 'curvy girls'

If you find Brooke Rogers sitting in class at Ardrey Kell High, she won’t be slouched in her seat like other classmates might be.

               John D. Simmons - jsimmons@charlotteobserver.com

Brooke Rogers, 17, formed the Curvy Girls support group after having surgery for scoliosis, which is an abnormal curvature of the spine. Now she encourages other scoliosis patients, telling the girls, “Be confident and know you’re not alone.”

Read more here: http://www.charlotteobserver.com/2014/03/03/4738323/ardrey-kell-senior-with-scoliosis.html#storylink=cpy

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“Everyone says I have really great posture,” she says, laughing. That’s because Brooke has metal rods in her back to keep her spine straight.

After having successful scoliosis surgery a few years ago, Brooke, 17, started the first North Carolina chapter of the support group Curvy Girls, and she spends much of her time mentoring and supporting other girls with the condition.

“She has made a huge difference in the Charlotte scoliosis community,” said Katherine Southard, a spokeswoman and board member for the National Scoliosis Foundation, who lives in Charlotte. (Southard was Miss North Carolina in 2009 in the Miss America pageant, and her platform was scoliosis awareness.)

Brooke was diagnosed with scoliosis, which is an abnormal curvature of the spine, when she was 10, but was told it was a minor condition. But the curvature got worse, and by age 14, doctors told her she’d need surgery.

Eighth and ninth grades were a tough time with an S-shaped spine: “Everything was sticking out and rubbing weird,” she said, adding that she remembers wishing she looked like everyone else. “I felt really alone.”

Brooke had successful surgery the next year, and she was immediately 2 inches taller with a straightened back.

Throughout the surgery process, her doctor, Michael Wattenbarger, said she could reach out to Southard, who was another patient of his. Southard met with her and told her about the international, peer-led support group Curvy Girls, which didn’t have a chapter in North Carolina.

“From there, Brooke just ran with it,” said her mom, Jonnie Rogers.

After her surgery, Brooke had a lengthy phone interview with founding members of Curvy Girls before getting the green light to start a group. “From there, it just blew up,” Brooke said.

There are now about 20 active members in the group, and while most hail from Charlotte, some come from as far as the Triangle area and Asheville. Brooke organizes meetings every couple of months, but she’s in constant contact with the girls, offering support and trading tips.

“She talks to girls I don’t even know about,” Rogers said.

Brooke has given Wattenbarger permission to share her medical information, like X-rays, with girls who have just been diagnosed with scoliosis for comparison. She also talks to them and their families in his office to offer advice and encouragement. Brooke and her mother also visit girls at the hospital who are having or who have had spinal surgery.

“I think it’s a big help to our patients and the families (who are) going through surgery,” Wattenbarger said. “I think it’s a lot more helpful to talk to them.”

Wattenbarger, who performs between 75 and 125 scoliosis surgeries in Charlotte a year, said scoliosis affects girls seven times more than boys. Brooke hopes to intern with him sometime this summer.

At Ardrey Kell, Brooke is mentoring three classmates who have the condition, and she often posts informational fliers in the nurse’s office.

Looking toward the future, Brooke hopes to see a few things happen after she graduates. She’d like to see more Curvy Girl chapters in the state, so meetings are accessible to more girls. For her senior exit project, Brooke researched in-school testing for scoliosis, which has diminished in the Charlotte area. The screening, she said, is as simple as bending over and having someone observe how your spine looks.

“A lot of people are diagnosed later,” she said. “It’s very treatable if it’s diagnosed early enough.” She found that some insurance companies reimburse schools for testing.

Next fall, Brooke is headed to Clemson University, where she’s been accepted into the nursing school. She’d like to be a pediatric nurse, and plans to make time to mentor girls with scoliosis in the future.

Southard said she’s enjoyed watching Brooke transition from being a shy, struggling girl to one of enthusiasm and strength.

“People say some people put others before themselves, but Brooke really does that,” Southard said. “She’s really generous with her time and energy ... and it’s refreshing to see someone her age care so much about other people.” 


Source : Charlotte Observor , 3rd March 2014 

Read more here: http://www.charlotteobserver.com/2014/03/03/4738323/ardrey-kell-senior-with-scoliosis.html#storylink=cpy

Orthotic treatment is successful in adolescent idiopathic scoliosis

                                              Lori Dolan
                                              
Bracing significantly decreased progression of high-risk curves in patients with adolescent idiopathic scoliosis to the threshold for surgery, according to a presenter at the American Academy of Orthotists and Prosthetists Annual Meeting and Scientific Symposium, here.

Lori Dolan, PhD, described results from the Bracing in Adolescent Idiopathic Scoliosis (BrAIST) study.

The goal of the BrAIST study was to produce credible evidence about bracing, primarily with a TLSO, using an improved research design meant to fill in the gaps in the literature, which has shown mixed results, she said. The study also sought to determine the relationship between dose and curve response, and develop a predictive model for curve progression based on patient characteristics at initial presentation and after bracing.

The multicenter, partially randomized study included  high-risk patients between the ages of 10 years and 15 years, Risser 0, 1, 2,  with a Cobb angle of 20° to 40° and apex at or caudal to T7, who received no previous orthopedic treatment. Patients in the treated group received an in-orthosis X-ray 4 weeks to 6 weeks after delivery and an orthotist evaluation at least every 6 months. On average, patients in the treatment group wore the orthosis 12 hours per day. Both treated and observation-only groups completed questionnaires on general health, function, quality of life and appearance. Primary endpoints were skeletal maturity, Risser 4/5.

The trial was stopped early due to treatment success. In 116 patients, 74.5% had treatment success compared with 41.5% in the observation-only group.

Dolan, who is from the department of Orthopedics and Rehabilitation at the University of Iowa, Iowa City, said that as the average hours of orthosis wear increased, so did the success rate, up to a point.

“We found a very strong correlation between average hours per day in the brace and success rate. The kids who were wearing their braces zero to 6 hours a day, they may not have been wearing it at all. But wearing it more than 18 hours a day is unnecessary. We don’t see a huge gain.” — by Carey Cowles

For more information:

Dolan L. Paper OS2. Presented at: American Academy of Orthotists and Prosthetists Annual Meeting and Scientific Symposium. Feb. 26-March 1, 2014. Chicago.

Source : Healio , 1st March 2014 

Factors Most Important in Adult Spinal Deformity Surgical Decisions: Function & Balance

A study published in Spine Deformity: The Official Journal of the Scoliosis Research Society examines the factors influencing adult spinal deformity surgical decision making.

The study authors examined 28 international adult deformity surgeons who completed an online survey of 10 spinal deformity cases. The surgeons answered questions about whether surgical management would be beneficial for each case presented and grade factors influencing decision making.

 

The authors found highest recommendation among surgeons for cases with severe deformities and neurology. Balance was the most important decision making factor among severe deformity cases; in cases with neurologic manifestations, neurology was the most important factor, according to the study abstract.

 

"Agreement between surgeons about the factors influencing surgical decision was good, and about the need for surgery was poor," concluded the authors. "Yet, each surgeon seemed relatively consistent about the consideration given to factors leading to surgical decision for a given ASD patient." 

Source : Becker's Spine Review , 18th Feb 2014

Ten Recent Spine Surgery Studies and Findings

Here are 10 articles on spine surgery study findings within the last two weeks.

1. An article published in the February 2014 edition of the Journal of Neurosurgery: Spine examined the outcomes and cost of spinal cord tumor surgery in the United States. The researchers found the average hospitalization cost increased from $45,452.24 in 2003 to $76,698.96 in 2010.

2. A recent article published in Spine discussed the risk factors for postoperative retropharyngeal hematoma after anterior cervical spine surgery. Researchers gathered data on 2,375 anterior cervical spine procedures from a single institution and found that there were 17 occurrences of postoperative hematoma. It also found that the risk factors include the presence of diffuse idiopathic skeletal hyperostosis.

3. A recent study of 45 consecutive patients undergoing posterior cervical fusion examined the safety and accuracy of freehand pedicle screw placement in the subaxial cervical spine and published the data in Spine. The researchers found 7.8 percent incidences of conversion to lateral mass crews. There were also 14 lateral wall violations from pedicle screws.

4. A new article published in Spine examined trends in blood transfusions after spinal fusion in the United States over the past decade. Researchers found that there was an increasing trend of allogeneic blood transfusion rate and decreasing predonated autologous blood transfusion rate.

5. The Journal of Neurotrauma recently published an article finding the number of spinal cord injuries in the United States is growing, according to a Newswise report. The study also found that emergency room charges for spinal cord injuries totaled $1.6 billion from 2007 to 2009.

 

6. A study published in Spine Deformity: The Official Journal of the Scoliosis Research Society examined the factors influencing adult spinal deformity surgical decision making. Function and balance were found to be the most important decision making factors among spinal deformity cases. 

7. The February issue of Spine included a study examining the impact of surgical planning and neurological outcomes for the anterior approach to remove disc herniation at C7-T1. According to the study authors, an anterior cervical supramanubrial approach was easily accomplished in all patients, and motor deficit was the most common surgical indication.

8. A study recently published in The Journal of Spinal Disorders and Techniques examined the clinical outcomes and fusion rates for patients undergoing anterior cervical discectomy and fusion with and without plates. Researchers found an average subsidence rate of 19.3 percent to 42.5 percent as well as an overall fusion rate of 92.8 percent.

 

9. Researchers published an article based on their study about surgical treatment of lumbar disc herniation in The Journal of Spinal Disorders and Techniques. The study examined 54 patients who received microsurgical fragmentectomy for single-level lumbar disc herniation and found that 88.9 percent reported excellent outcomes.

10. A study recently published in Spine outlined the predictors of postoperative pain in adolescent idiopathic scoliosis patients. The researchers found that pain declined with time and greater confidence in pain control ability predicted quicker declines in pain.


Source : Becker's Spine Review , 25th Feb 2014

Teenage Girls Most Likely to Suffer from Scoliosis

Scoliosis is most common in Korea among teenage girls, the National Health Insurance Service said Sunday based on 2012 data.


Out of all 144,700 patients treated for curvature of the spine, 55,400 or 38 percent were in their teens, 14 percent in their 20s, 10 percent in their 30s, and nine percent in their 50s.


The number of female patients was almost double that of males, and among female teenagers there were four times as many victims at 1,183 per 100,000 as the national average of 291.


Experts attribute the high figures among teens to detection of scoliosis in chest X-rays during regular medical check-up at school.


Lee Choon-sung of the University of Ulsan’s Asan Medical Center said, "The cause of scoliosis is unknown, and it is unclear why it is common among females. The crouched position that many parents are worried about is irrelevant."


Kim Hyoung-seop at the NHIS' Ilsan Hospital said, "Strengthening core muscles like the back and abs and exercise like swimming, fast walking and stretching are the best prevention."


Source : The Chosunilbo , 24th Feb 2014