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Study Shows Patients with MicroPort’s Medial-Pivot Knee Are More Likely to Forget They’ve Had a Joint Replacement

Posted On January 30, 2018 By OrthoSpineNews In Recon, Top Stories /  

January 30, 2018

ARLINGTON, Tenn.–(BUSINESS WIRE)–MicroPort Orthopedics Inc., a medical device company that develops and manufactures cutting edge joint replacement implants designed to help patients achieve full function faster, announced that The Journal of Arthroplasty has published a retrospective, comparative study that evaluated patient satisfaction after total knee arthroplasty (TKA) using the MicroPort Orthopedics’ MicroPort Orthopedics’ Evolution® Medial-Pivot (MP) Knee System. The study showed that patients who underwent the MP-TKA scored significantly better on the Forgotten Joint Score (FJS) than those who underwent the PS-TKA, particularly with regard to deep knee flexion and stability of the prosthesis.

“The goal of TKA surgery is to provide a joint replacement that functions as closely as possible to a normal knee and I believe that this study further validates the superiority of the medial-pivot design over traditional designs with regard to patient outcomes,” says David Backstein, MD, MEd, FRCSC, Head of Orthopaedic Surgery at Mount Sinai Hospital in Toronto, Ontario. “MicroPort’s medial-pivot features an insert designed to promote medial stability and lateral mobility and a femoral component with constant radii of curvature, resulting in greater stability and kinematics that closely replicate the natural motion of the knee.”

The article titled, “A Retrospective Comparison of a Medial Pivot and Posterior-Stabilized Total Knee Arthroplasty with Respect to Patient-Reported and Radiographic Outcomes,” was authored by Drs. David Samy and David Backstein from the Granovsky Gluskin Division of Orthopaedics at University of Toronto. A total of 164 patients, 76 in the MP-TKA group and 88 in the PS-TKA group, were evaluated at one-year follow-up using the FJS, a recently developed, validated measure of patient satisfaction after TKA. The FJS score is based on a 12-item questionnaire related to patients’ ability to forget their artificial joint in everyday life. To date, this study is the first to compare an MP-TKA and a PS-TKA using the FJS as a primary outcome measure.

Studies show that around 20 percent of patients are not satisfied with the outcome of their total knee replacement as a result of residual pain and functional issues that can often attributed to implant design1. Based on the results of this study as well as previous studies showing 95% patient satisfaction and 98.8% survivorship at 17 years, it is clear that the unique design of the MP-TKA can deliver reproducible outcomes that drive patient satisfaction2. Furthermore, it is the only medial-pivot system on the market with a clinically-proven 20-year history.

About MicroPort Orthopedics
Established in January 2014, MicroPort Orthopedics Inc. is a multinational producer of orthopedic products and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative orthopedic reconstructive products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japan, Latin America, and China markets. For more information about MicroPort Orthopedics, visit http://www.ortho.microport.com/.

About MicroPort Scientific
MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 20 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to: http://www.microport.com.

Forward-Looking Statements
Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China.

This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever.

Sources:

1. Thambiah, Matthew Dhanaraj et al. “Patient Satisfaction after Total Knee Arthroplasty: An Asian Perspective.” Singapore Medical Journal 56.5 (2015): 259–263.
2. Macheras, George A. et al. “A long term clinical outcome of the Medial Pivot Knee Arthroplasty System.” The Knee 24 (2017): 447-453.

Contacts

LaVoie HealthScience
Sharon Correia, 617-412-8779
scorreia@lavoiehealthscience.com

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Histogenics Corporation Announces Closing of Underwritten Registered Direct Offering of Common Stock and Full Exercise of Option to Purchase Additional Shares

Posted On January 29, 2018 By OrthoSpineNews In Financial /  

WALTHAM, Mass., Jan. 25, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies, today announced the closing of its previously announced underwritten registered direct offering of 2,691,494 shares of its common stock, which includes 351,064 shares sold in connection with the exercise in full by the underwriter of its option to purchase additional shares. The total net proceeds of the offering are approximately $5.9 million after deducting the underwriting discounts and commissions payable by Histogenics.

Canaccord Genuity acted as the sole book-running manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-216741) relating to the underwritten registered direct offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the SEC) and declared effective by the SEC on March 30, 2017. A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on January 24, 2018 and is available on the SEC’s web site at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus relating to these securities may also be obtained by sending a request to Canaccord Genuity Inc., Attention: Syndicate Department, 99 High Street, 12th Floor, Boston, Massachusetts 02110, by telephone at (617) 371-3900, or by email at prospectus@canaccordgenuity.com.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.




	

		

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Bone Solutions Inc. Reaches 50 Implants Of Its Proprietary Magnesium-Based Bone Void Filler

			


	Posted On January 29, 2018

	By OrthoSpineNews

	In Biologics

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DALLAS (PRWEB)-Bone Solutions Inc. (BSI), an orthobiologics technology company located in Colleyville, TX, is proud to announce it has reached 50 successful implants of OsteoCrete®, its magnesium-based orthopedic medical device. OsteoCrete®, which was launched in September 2017, is a bone void filler designed to assist with bone repair and generation. It’s the first in the U.S. to incorporate magnesium, a critical property for bone health and development.


“This milestone is a huge accomplishment for our company, and we’re excited to continue to introduce our product to surgeons around the country,” says BSI president and CEO Drew Diaz.


The OsteoCrete® implants were performed by various surgeons in the U.S. during BSI’s 90-day launch period, which ran from October 1 to December 31, 2017. The company worked with a network of distributors to deliver and implement the product. BSI will now shift its focus to attaining approvals at various hospital systems in the U.S.


OsteoCrete® is the only bone-repair product in the market made with magnesium. This gives surgeons an advantage as compared to using calcium-based devices, which do not have the unique combination of compressive strength and expandability necessary for optimal binding quality. OsteoCrete® is resorbable, or capable of being assimilated back into the body, as it is replaced with bone as the patient heals. It’s also injectable, moldable, and biocompatible.


“I am confident 2018 will be a banner year for the company, and we look forward to the continued growth of both the market and the use of OsteoCrete® in future surgical applications,” says Diaz.


About Bone Solutions Inc.

Bone Solutions Inc. (‘BSI’) (http://www.bonesolutionsinc.com) is an orthobiologics company with a vision to provide orthopedic surgeons a means to improve clinical outcomes in a number of complex procedures while lowering costs. The company is revolutionizing a new solution for orthopedic surgeons for human uses with their FDA-cleared magnesium-based platform bone void filler.


Media Contact:


Bone Solutions Inc.:

Drew Diaz

President/CEO

817-809-8850

diaz(at)bonesolutions(dot)net


	

		

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New Study on Total Hip Arthroplasty (THA) Outcomes with Anterior Approach Show Less Reported Pain, Fewer Narcotics and Better Hip Function in the First 90 Days

			


	Posted On January 29, 2018

	By OrthoSpineNews

	In Recon

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WARSAW, Ind., Jan. 29, 2018 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies, today announced the first systematic review of prospective studies comparing postoperative outcomes through 90 days of Anterior Approach versus Posterior Approach in primary total hip arthroplasty (THA). The paper, published in The Journal of Arthroplasty, concludes that the Anterior Approach can provide a significant increase in hip function and reduction in pain and narcotics usage compared to Posterior Approach. In addition, the study showed no statistical differences in complication rates between the Anterior Approach and Posterior Approach through 90 days.


Previous comparative reviews of Anterior Approach versus Posterior Approach have predominantly relied on data from retrospective studies. For this meta-analysis, a total of 13 prospective comparative studies (including 7 randomized studies) published between 2006 and 2017 of more than 1,000 patients treated with Anterior Approach or Posterior Approach were included. Focused on perioperative outcomes, the meta-analysis attempted to address each component of the Comprehensive Care for Joint Replacement (CJR) model, which includes complication rate, patient satisfaction, and pain management over a 90-day period. The research was performed by Drs. Friedrich Boettner, Joseph S. Gondusky, and Atul F. Kamath** and well-known meta-analyst Dr. Larry E. Miller. Co-authors of the paper included Samir Bhattacharyya, PhD, MS, MSc, U.S. Head for Health Economics and Market Access (HEMA) DePuy Synthes and Dr. John Wright, Medical Leader DePuy Synthes.


“Our goal with this research was to rigorously evaluate outcomes of Anterior Approach and Posterior Approach from the highest quality prospective studies performed to date,” said lead author Dr. Miller. “We found that THA using the Anterior Approach provided clinically important benefits to patients compared to Posterior Approach over 90 days follow-up.”


The move toward the Anterior Approach is increasing as seen in a 2016 American Association of Hip and Knee Surgeons (AAHKS) survey where 34 percent of surgeons reported they were performing the Anterior Approach compared to 26 percent in a 2015 AAHKS survey. In an effort to gather additional data on this trend, DePuy Synthes, which funded this study, sought to understand the short-term benefits of the Anterior Approach as surgeons look for options in treating their patients. DePuy Synthes has spent more than a decade supporting healthcare providers who are interested in adding the Anterior Approach to their practices through professional education and training, and bringing enabling technologies to market.


“While the Posterior Approach is still the most widely used technique worldwide, we see growing interest in the Anterior Approach,” said Bhattacharyya. “This study builds on the mounting evidence that the Anterior Approach supports the goals of improving outcomes, optimizing the patient experience and reducing the overall cost of care.”


The study, “Does Surgical Approach Affect Outcomes in Total Hip Arthroplasty Through 90 Days of Follow-Up? A Systematic Review with Meta-Analysis,” is available online and will appear mid-2018 in the Journal of Arthroplasty.


About DePuy Synthes


DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies***, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.


*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.


**Drs. Friedrich Boettner, Joseph S. Gondusky, and Atul F. Kamath are consultants to DePuy Synthes Joint Reconstruction.


***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.


©DePuy Synthes 2018. All rights reserved.


DSUS/JRC/0118/2539


SOURCE DePuy Synthes


Related Links


http://www.depuysynthes.com


	

		

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Paradigm Spine Announces Landmark Publication Of coflex® Vs. Decompression Alone In The Journal Of Neurosurgery Spine

			


	Posted On January 29, 2018

	By OrthoSpineNews

	In Spine, Top Stories

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NEW YORK, Jan. 29, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced publication of the ESCADA 2-year trial results (European Study of coflex And Decompression Alone) in the January 2018 issue of the Journal of Neurosurgery Spine (JNS), official journal of the American Association of Neurological Surgeons (AANS). ESCADA reports a prospective, randomized, controlled, multi-center trial comparing decompression alone to decompression with coflex® Interlaminar Stabilization® for treatment of moderate to severe lumbar spinal stenosis.  coflex is the first and only motion preserving minimally invasive treatment for moderate to severe spinal stenosis post decompression.  A total of 225 patients were enrolled in the study with 91% follow up at 2 years.


The study authors concluded that decompression with coflex Interlaminar Stabilization extends the durability and sustainability of a decompression procedure.


“These data strongly validate for the surgical spine community that coflex is a safe and effective protector of a decompression procedure,” said Marc Viscogliosi, President and CEO of Paradigm Spine.  “This means that surgeons treating patients with lumbar spinal stenosis can be more confident than ever in their treatment options, knowing that a randomized controlled trial has demonstrated with statistical significance that nearly twice as many patients with decompression alone have a risk of secondary intervention as compared to coflex patients. coflex is the first and only lumbar spinal device that has produced the highest level of evidence in two separate prospective, randomized, controlled studies against two different control groups – which exhibits the thoroughness and reproducibility of these findings. There is now potentially a more effective surgical option between the two typical treatments for lumbar spinal stenosis, and we are proud to lead the way in changing the standard of care for surgeons and their patients with this diagnosis.”


Highlights of ESCADA results:


    

  • The rate of patients achieving Composite Clinical Success was statistically superior in the coflex group vs. the Decompression Alone group (p=0.017)
    • 

  • Patients who received Decompression Alone experienced significantly more loss of foraminal and posterior disc height maintenance compared to the coflex group (p<0.001)
    • 

  • The Decompression Alone group experienced 228% more subsequent epidural steroid injections compared to the coflex group (p=0.0065)
    • 

  • coflex patients experienced 2.4 times more improvement in walking distance measurements compared to Decompression Alone patients (p=0.062)
    • 

  • At 24 months, the Decompression Alone group was 1.4 times more likely to be taking opioids compared to the coflex group
    • 



The ESCADA trial included seven sites in Europe / Germany with a total of 225 patients who were randomized to either decompression alone (DA, control group) or decompression with coflex Interlaminar Stabilization (coflex, study group). Overall trial success was based on a combined outcome measure called Composite Clinical Success (CCS),  in which all four components must be met: 1) ODI success with improvement > 15 points; 2) survivorship with no secondary surgical interventions or lumbar injections; 3) neurologic maintenance or improvement without worsening; 4) no device-related severe adverse events. This is the same success criteria that was used in the U.S. IDE study of coflex that has published 5-year follow-up, allowing some direct comparisons to be drawn between the cohorts representing 547 patients collectively.  Secondary measures were also collected such as walking distance, foraminal and disc height maintenance, leg and back pain scores, and opioid use.


“With the important work of the ESCADA trial, we can see that coflex extends the success and durability of a decompression procedure for lumbar spinal stenosis, while still allowing natural motion to occur,” says ESCADA author and Principal Investigator Professor Michael Rauschmann. “The U.S. IDE study first investigated and defined the long-term problems with lumbar fusion procedures that can be alleviated with coflex.  And now, through this controlled trial, we can begin to answer the questions of the sustainability of decompression alone, and the need to provide additional stabilization for those patients with coflex at first surgical intervention to avoid future complications.”


Journal of Neurosurgery Spine. January 2018. Volume 28, Issue 1 (http://thejns.org/doi/full/10.3171/2017.11.SPINE17643).


About Lumbar Spinal Stenosis (LSS)

Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion.  Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.


About Paradigm Spine, LLC:

Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis.  The Company’s signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 50 countries worldwide. coflex is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.


 


SOURCE Paradigm Spine, LLC


Related Links


http://www.paradigmspine.com


	

		

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$3.4 Billion Foot And Ankle Devices Market, 2025

			


	Posted On January 26, 2018

	By OrthoSpineNews

	In Extremities

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DUBLIN, Jan. 26, 2018 /PRNewswire/ —


The “Foot And Ankle Devices Market By Product (Bracing & Support, Joint Implants, Soft Tissue Orthopedic Devices, Orthopedic Fixation, Prosthetics), By Application, By Region, And Segment Forecasts, 2014 – 2025” report has been added to ResearchAndMarkets.com’s offering.










Further Key Findings From the Study Suggest:


    

  • Bracing and support dominated the market in 2016. Increasing application of braces drives the market and has resulted in industry players developing and introducing new products in the market. For instance, in October 2017, Vickers Grant Holdings, LLC launched ATHLETICA with an ankle brace as an introductory product for the brand.
    • 

  • Aging results in significant changes in the skeletal and neuromuscular systems, leading to arthritis, weak ligament, and ACL tear. Symptomatic and asymptomatic tears affect more than 50% of the geriatric population. This is one of the key drivers attributed to the accelerated growth of soft tissue orthopedic devices.
    • 

  • Geographically, North America held the largest market share in 2016 and is expected to maintain its position during the forecast period. This large share can be accounted for high adoption rate of new technology and favorable reimbursement scenario.
    • 

  • The companies are tending toward providing novel products by adopting new technology. In February 2016, Zimmer Biomet received FDA approval for its 3D printed foot-and-ankle implantUnite3D Bridge Fixation System. The product is perceived to offer greater stability and rigidity due to its integrated structure.
    • 

  • Some key industry contributors are DePuy Synthes, Zimmer Biomet, Stryker, Integra LifeSciences Corporation, Wright Medical Technology, Inc., Advanced Orthopedic Solutions, Acumed, Bioretec Ltd., and Ossur.
    • 



The global foot and ankle devices market is expected to reach USD 3.4 billion by 2025


The market is expected to observe an exponential growth during the forecast period due to the rising incidence of ankle sprains, hammertoe, bunions, osteoporosis and rheumatoid arthritis.


Ankle fractures are one of the most common types of foot injury. Nearly 170,000 people suffer from ankle fractures per year, which require surgical treatment. It is one of the nine most common fractures. This can be attributed to the relatively small surface area of contact in the ankle and the 1.5 times higher body weight on it at rest & 5.5 times higher forces in case of heavy activity. This makes the long-term viability of ankle joints crucial.


Nearly 50,000 patients are diagnosed with end-stage ankle arthritis per year, wherein the ankle cartilage is worn out, causing painful bone-on-bone contact and disability. These patients are recommended total ankle replacements as opposed to ankle fusion, as it provides higher efficacy, thus driving the market. Favorable reimbursement scenario for joint replacements is one the major contributors to its market growth. Medicare, along with some private insurers, reimburses the procedure.


Key Topics Covered:


Chapter 1 Executive Summary

1.1 Market Snapshot


Chapter 2 Research Methodology

2.1 Information Procurement

2.2 Data Analysis


Chapter 3 Foot And Ankle Devices Market Variables, Trends & Scope

3.1 Market Segmentation and Scope

3.1.1 Market Driver Analysis

3.1.1.1 Increasing expenditure on research and development (R&D) by industry players

3.1.1.2 Increasing geriatric population

3.1.1.3 Increasing prevalence of target disease

3.1.1.4 Rising incidence rate of road accidents

3.1.2 Market Restraint Analysis

3.1.2.1 Uncertainty in regulatory reforms

3.1.2.2 High cost of devices

3.2 Penetration & Growth Prospects Mapping

3.3 Foot and Ankle Devices Market – PESTLE Analysis

3.4 Industry Analysis – Porter’s


Chapter 4 Foot And Ankle Devices :Product Estimates & Trend Analysis

4.1 Foot And Ankle Devices Market: Product Movement Analysis

4.2 Bracing and Support

4.3 Joint Implants

4.4 Soft Tissue Orthopedic Devices

4.5 Orthopedic Fixation

4.6 Prosthetics


Chapter 5 Foot And Ankle Devices: Application Estimates & Trend Analysis

5.1 Foot and Ankle Devices Market: Application Movement Analysis

5.2 Hammertoe

5.3 Trauma

5.4 Osteoarthritis

5.5 Rheumatoid Arthritis

5.6 Neurological Disorders

5.7 Bunions

5.8 Osteoporosis


Chapter 6 Foot And Ankle Devices: Regional Estimates & Trend Analysis, by Product and Application


Chapter 7 Competitive Landscape


For more information about this report visit https://www.researchandmarkets.com/research/gpnt3k/3_4_bn_foot_and?w=5


Media Contact:


Research and Markets

Laura Wood, Senior Manager

press@researchandmarkets.com


For E.S.T Office Hours Call +1-917-300-0470

For U.S./CAN Toll Free Call +1-800-526-8630

For GMT Office Hours Call +353-1-416-8900


U.S. Fax: 646-607-1907

Fax (outside U.S.): +353-1-481-1716


SOURCE Research and Markets


Related Links


http://www.researchandmarkets.com






	

		

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InVivo Therapeutics Announces Purchase Agreement for up to $15 Million with Lincoln Park Capital

			


	Posted On January 26, 2018

	By OrthoSpineNews

	In Financial

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January 26, 2018








CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) today announced that it has entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), a Chicago-based institutional investor, under which the Company has the right to sell up to $15 million in shares of common stock to Lincoln Park over a twenty-four-month period, subject to certain limitations and conditions set forth in the purchase agreement and registration rights agreement, including:


    

  • the company, in its sole discretion, controls the timing and amount of any sales of common stock;
    • 

  • the purchase price is based on prevailing market prices with no warrants;
    • 

  • Lincoln Park cannot require the company to make sales, but is obligated to make purchases as the company directs in accordance with the terms of the purchase agreement;
    • 

  • there are no upper limits on the price per share that Lincoln Park could be obligated to pay for shares of common stock under the purchase agreement;
    • 

  • there are no financial covenants, rights of first refusal, participation rights or liquidated damages; and
    • 

  • the SEC declares effective a registration statement, registering the shares of common stock that Lincoln Park purchases pursuant to the purchase agreement.
    • 



“We are pleased to enter into this purchase agreement with Lincoln Park, which offers us financial flexibility on favorable terms to the company and its shareholders,” said Richard Toselli, M.D., Acting Chief Executive Officer. “We welcome their investment as we pursue our near-term strategic objectives and continue our discussions with the FDA regarding a randomized controlled study in acute complete thoracic spinal cord injury that evaluates the Neuro-Spinal Scaffold™ compared to standard of care.”


In consideration for entering into the purchase agreement, the company has issued shares of common stock to Lincoln Park as a commitment fee. The purchase agreement may be terminated by the company at any time, in its sole discretion.


A more detailed description of the purchase agreement and registration rights agreement is set forth in the company’s Current Report on Form 8-K as filed with the SEC which the company encourages be reviewed carefully.


About InVivo Therapeutics


InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold™ implant received the 2015 Becker’s Healthcare Spine Device Award. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.


Safe Harbor Statement


Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the status of the company’s clinical program. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s discussions and engagement with the FDA; the company’s ability to initiate, conduct and complete clinical trials; the expected benefits and potential efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical trials and future product commercialization; and other risks associated with the company’s business, research, product development, attainment of regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report on Form 10-K for the three months ended September 30, 2017, and its other filings with the SEC, including the company’s most recent Form 10-K, its Form 10-Qs and its current reports on Form 8-K. The company does not undertake to update these forward-looking statements.






Contacts


InVivo Therapeutics Holdings Corp

Heather Hamel, 617-863-5530

Investor Relations

Investor-relations@invivotherapeutics.com










	

		

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Implantable medical devices bolstered by next-gen surface modification

			


	Posted On January 26, 2018

	By OrthoSpineNews

	In Biologics

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January 24, 2018-Credit: University of Sydney


A discovery by University of Sydney researchers could underpin a new class of implantable devices that provide biological signals to surrounding tissue for better integration with the body and reduced risk of infection.




Modern medicine increasingly relies on implantable biomedical devices but their effectiveness is often limited because of unsuccessful integration with host tissue or the development of untreatable infections, necessitating replacement of the device through revision surgery.


The team at the Applied Plasma Physics and Surface Engineering Laboratory has developed practical techniques to guide and attach peptides to surfaces; computer simulations and experiments demonstrated control of both peptide orientation and surface concentration, which can be achieved by applying an electric field like that delivered by a small household-sized battery.


The findings are published today in Nature Communications.


Corresponding author Professor of Applied Physics and Surface Engineering Marcela Bilek said biomaterial coatings can mask the implanted devices and mimic surrounding tissue.


“The holy grail is a surface that interacts seamlessly and naturally with host tissue through biomolecular signalling,” said Professor Bilek, who is a member of the University of Sydney Nano Institute and the Charles Perkins Centre.


Robust attachment of biological molecules to the bio-device surface is required to achieve this, as enabled by unique surface modification processes developed by Professor Bilek.


“Although proteins have successfully been used in a number of applications, they don’t always survive harsh sterilisation treatments — and introduce the risk of pathogen transfer due to their production in micro-organisms,” Professor Bilek said.


Professor Bilek — together with Dr Behnam Akhavan from the School of Aerospace, Mechanical and Mechatronic Engineering and the School of Physics and lead author PhD candidate, Lewis Martin from the School of Physics — are exploring the use of short protein segments called peptides that, when strategically designed, can recapitulate the function of the protein.


Mr Martin said the team was able to tune the orientation of extremely small biomolecules (less than 10 nanometres in size) on the surface. “We used specialised equipment to perform the experiments, but the electric fields could be applied by anyone using a home electronics kit,” he said.


Dr Akhavan said that assuming industry support and funding for clinical trials, improved implants could be available to patients within five years.


“The application of our approach ranges from bone-implants to cardiovascular stents and artificial blood vessels,” Dr Akhavan said.


“For the bone implantable devices, for example, such modern bio-compatible surfaces will directly benefit patients suffering from bone fracture, osteoporosis, and bone cancer.”


Because of their small size, the peptides can be produced synthetically and they are resilient during sterilisation. The main difficulty in using peptides is ensuring they are attached at appropriate densities and in orientations that effectively expose their active sites.


Using applied electric fields and buffer chemistry, the researchers discovered several new levers that control peptide attachment. Charge separation on peptides creates permanent dipole moments that can be aligned with an electric field to provide optimal orientation of the molecules and the amount of peptide immobilised can also be tuned by the electrostatic interactions when the peptides have an overall charge.


The paper said this knowledge is being used to design strategies to create a new generation of synthetic biomolecules.


“Our findings shed light on mechanisms of biomolecule immobilisation that are extremely important for the design of synthetic peptides and biofunctionalisation of advanced implantable materials,” the paper states.







Story Source:


Materials provided by University of Sydney






Journal Reference:


    

  1. Lewis J. Martin, Behnam Akhavan, Marcela M. M. Bilek. Electric fields control the orientation of peptides irreversibly immobilized on radical-functionalized surfaces. Nature Communications, 2018; 9 (1) DOI: 10.1038/s41467-017-02545-6
    2. 









University of Sydney. “Implantable medical devices bolstered by next-gen surface modification: Synthetic peptides could integrate seamlessly with host tissue.” ScienceDaily. ScienceDaily, 24 January 2018. <www.sciencedaily.com/releases/2018/01/180124111239.htm>.






	

		

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AANA, VirtaMed Collaboration to Set New Standards for Arthroscopy Training

			


	Posted On January 26, 2018

	By OrthoSpineNews

	In Recon, Top Stories

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SCHLIEREN, Switzerland and ROSEMONT, Illinois, Jan. 25, 2018 /PRNewswire/ — The Arthroscopy Association of North America (AANA) and VirtaMed have signed a two-year collaboration agreement making VirtaMed the preferred and exclusive partner for virtual reality simulation training. AANA and VirtaMed will work together to advance and improve the training of arthroscopic surgery skills and standards for proficiency-based training curricula by leveraging the latest virtual reality simulation technology and AANA’s expertise in Arthroscopic Surgery education.


The most immediate result of the contract, signed in January 2018, is that the Orthopedic Learning Center (OLC) in Rosemont, IL, will be equipped with VirtaMed ArthroS™ simulators for knee, shoulder and hip arthroscopy training, as well as FAST basic skills training. “We are excited about the opportunity to add high-fidelity simulation into our selection of educational tools. VirtaMed’s top-notch virtual reality simulators are a perfect match to the new OLC with upgraded facilities and state-of-the-art technologies,” says AANA President Robert E. Hunter, M.D.


“We have assessed all virtual reality arthroscopy simulators on the market, and VirtaMed was clearly the best fit to partner with AANA,” says AANA CEO Laura Downes, CAE. “The combination of lifelike anatomic models, high-fidelity graphics and original tools adapted for simulation make the VirtaMed ArthroS™ the closest thing to real surgery.”


AANA and VirtaMed will create new content for the simulator in all its disciplines, as well as a learning curriculum that fully leverages competency-based simulation training and assessment. The two organizations will begin with creating curriculums and proficiency exams shortly after they have collected data from course participants as well as faculty and the more experienced members of AANA early this year.


VirtaMed simulators enable proficiency-based learning as well as skills assessment. VirtaMed and AANA want to use these tools to create standards and best practices for arthroscopic training and assessment across the United States. “Our goal is to improve patient care by advancing education in arthroscopy, and we want to ensure all arthroscopic surgeons have access to high-quality skills training and continuous education. Working with VirtaMed’s first-rate simulators, experienced developers and dedicated education specialists will help us reach that goal,” explains AANA Learning Center Committee Chair, Joseph C. Tauro, M.D.


“We are honored to have been selected as the preferred and exclusive partner by such an influential organization,” says Rick Hoedt, General Manager at VirtaMed Inc. “With the various medtech customers and other societies we have as partners, it is further proof that our product and services lead the market in realism and that VirtaMed really is the go-to partner for surgical simulation. We share the same goals as AANA regarding education and training and are excited to join forces officially to enhance arthroscopy education. We’re also looking forward to working together with residency programs and simulation centers around the country and world to implement the new standard and to share best practices and standardization for improving patient safety.”


About AANA


The Arthroscopy Association of North America (AANA) is an international professional society of more than 4,000 orthopaedic surgeons and other medical professionals who are committed to advancing the art and science of arthroscopy and minimally invasive surgery through education, skills assessment and advocacy.  Our vision is be a global leader in arthroscopy and advancing minimally invasive surgical education, advocacy and skills assessment to improve patient care.


About VirtaMed


VirtaMed is the world leader in high-fidelity virtual reality simulators for instructional training of minimally invasive diagnostic and therapeutic interventions in orthopedics, urology and women’s health. VirtaMed also creates customized simulators for medical associations and medical device companies using original instruments and anatomic models for realistic feedback.


Contact:


AANA

Arthroscopy Association of North America

9400 West Higgins Road, Suite 200

Rosemont, IL 60018, United States

www.aana.org


Christine Nogal

Director of Marketing and Member Services

christinen@aana.org

Tel. +1(847)993-2063


VIRTAMED

VirtaMed AG

Rütistrasse 12

8952 Schlieren, Zurich, Switzerland


VirtaMed Inc.

16144 Churchview Drive

Lithia, FL 33547, USA

www.virtamed.com


Angina Herrmann

Head of Marketing

angina.herrmann@virtamed.com

Tel. +41-44-542-91-20


SOURCE VirtaMed


Related Links


http://www.virtamed.com


	

		

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Amedica Provides Business Update

			


	Posted On January 26, 2018

	By OrthoSpineNews

	In Financial

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SALT LAKE CITY, UT, Jan. 25, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride for biomedical applications, today provided a business update related to its business strategy and certain recent developments.


BUSINESS UPDATE AND RELATED DEVELOPMENTS


Commercialization Report


In 2017, Amedica successfully launched its updated Taurus™ Pedicle Screw System, a pedicle screw system designed for degenerative spine surgery.  With over 250 procedures performed, this product has generated almost $1.3 million in new revenue since its introduction to the market. The company released additional instrument sets in the fourth quarter of 2017 to meet surgeon demand.


Other commercialization highlights include:


    

  • 40% increase in surgeon users during 2017, predominantly from surgeons performing lumbar fusion surgeries utilizing Valeo II silicon nitride implants and Taurus pedicle screws.
    • 

  • 14 new sales agents added in 2017, primarily to establish representation in underrepresented areas of the United States.
    • 

  • The hire of a new Area Vice President for the Western Region, resulted in all members of the sales team having significant experience in spine surgery related sales.
    • 

  • The product pipeline was prioritized and defined for 2018 and beyond, with the goal of launching several new products in 2018.
    • 

  • Year-over-year revenue growth in Brazil from 2016 to 2017.
    • 

  • Expanded sales channel in the UK in 2017.
    • 

  • Identification of potential distribution partners in Australia.
    • 

  • Progress toward regulatory clearance in Japan.
    • 



The company has received feedback from the FDA on its 510k submission for the “C+CSC with Lumen” spinal implant and is submitting a response.


Clinical


With over 33,000 silicon nitride spinal interbody implants implanted since 2008, Amedica is comprehensively reviewing its large-scale clinical outcomes – a requirement under the new European Medical Device Regulation.  The resulting data will be published later in 2018.


The company has completed the data collection associated with its Level 1 SNAP lumbar spine clinical trial.  Initial review supports the efficacy of silicon nitride as a spine fusion material, consistent with a large volume of data already published by Amedica.  Results of the SNAP trial are expected to be published during 2018.


The company is planning several international clinical investigations during 2018 to strengthen clinical evidence of the advantages of silicon nitride, i.e., ease of imaging, improved spinal fusion, and antibacterial properties.  These studies are expected to build upon the existing foundation of extensive material science data supporting the use of silicon nitride in spine fusion surgery.


Research and Development


During 2017 the company had 20 peer-reviewed publications, 10 published conference proceedings, and participated in 27 presentations at conferences and scientific meetings. These R&D efforts have validated the underlying science of silicon nitride, and contributed to increased company visibility that has attracted inquiries and collaborations in areas outside of spine surgery.  Scientific and clinical data are critical toward attracting new surgeons to silicon nitride implants, both in the United States and overseas markets.


Financial Update


The company continues to focus on stabilizing its finances, having substantially reduced its monthly cash burn during 2014-2017.  On January 3, 2018, Amedica paid off its loan with Hercules Capital via a debt exchange transaction with other accredited investors – a significant step in reducing costs.


Strategic Direction


“Our strategic priorities are three-fold. The first priority is revenue growth, while controlling expenses, with the goal of financial self-sufficiency.  Second, we will continue to investigate the full potential of silicon nitride ceramic and build collaborations with external partners.  Third, while we consider ourselves to be a leader in the scientific knowledge of silicon nitride, the company is focused on building a strong portfolio of clinical evidence.  Taken together, revenue growth, external collaborations, and clinical validation of our products are necessary to support product acceptance, and long-term sales growth,” said B. Sonny Bal, MD, MBA, JD, PhD; Chairman and CEO of Amedica.


About Amedica Corporation


Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its FDA registered and ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, as well as OEM and private label partnerships.


For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.


Forward-Looking Statements


This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements, which include statements regarding the company’s goal to release several new products in 2018, anticipated future revenues, FDA clearance of our products, addition of new surgeon users, and, results of clinical studies are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K/A, filed with the Securities and Exchange Commission (SEC) on December 27, 2017, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.


Contacts:
Amedica IR
801-839-3502
IR@amedica.com


	

		

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