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Current Issues in Spine

February 2-4, 2017

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March 28, 2017 OrthoSpineNews

March 28, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, announces its annual results for the financial year to December 31, 2016, as approved by the Board on March 24, 2017.

Ludovic Lastennet, CEO of Implanet, says: “2016 sales growth, notably with +70% in the U.S. market, combined with diligent cost control enabled us to improve our gross margin and operating results. We are confident in our ability to record further strong growth in JAZZ sales in 2017 by continuing to focus on clinical benefits for the patient, making JAZZ technology a benchmark in spine surgery. The Company’s structure is optimized for future growth, we should continue to realize a significant reduction in our cash requirements.

In € thousands – IFRS 2016 2015 Change
Revenue 7,825 6,653 +18%
of which: Spine 4,102 2,806 +46%
Cost of products sold -3,844 -4,070 -6%
Gross margin 3,981 2,583 +54%
Gross margin % 50.9% 38.8%
Research & Development -870 -732 +19%
Regulatory matters, Quality control -916 -940 -3%
Sales, distribution, marketing -5,105 -4,480 +14%
Operating costs -1,089 -792 +38%
General costs -2,883 -3,271 -12%
Operating P/L -6,881 -7,632 +10%
Net P/L -7,288 -8,008 +9%

NB: Consolidated accounts have been audited, and the auditor’s report is pending.

Revenue: significant JAZZ growth

The Company’s revenue, up +18% in 2016 vs. 2015, totaled €7,825 thousand, driven by the +46% increase in JAZZ activity. This segment’s solid growth was a result of the growing adoption of JAZZ technology in markets in which the Company operates directly (+70% in the United States and +33% in France), with growth of +142% in the high-potential degenerative bone disorder segment (surgical treatment of elderly patients).

Strong gross margin increase, operating cost control

The strong growth in JAZZ activity in France and the U.S., where spinal implant pricing is higher, had a positive impact on Implanet’s gross margin. It improved by 12.1 percentage points to 50.9% of sales in 2016 (vs. 38.8% in 2015).

The Company chose to focus on direct distribution in its priority markets via a network of independent sales agents, resulting in a variable cost increase of +€550 thousand (including +€464 thousand in commissions), in line with the growth in JAZZ revenue.

The Company held the remaining operating expenses at a stable level (+0.9%), despite a +19% increase in R&D, mainly due to the cost of protecting its IP. These costs should remain stable, as the Company believes it has an adequate structure to cope with its medium-term growth.

Implanet thus recorded a 10% improvement in its operating loss to -€6,881 thousand as of December 31, 2016 (vs. -€7,632 thousand in 2015), and a 9% improvement in its net loss to -€7,288 thousand (vs. -€8,008 thousand in 2015).

Cash position and financial investments

2016 cash burn (free cash flow minus loan repayments) improved by 28%, to -€6.3 million versus -€8.8 million in 2015.

As of December 31, 2016, Implanet had cash and financial placements of €7.4 million (vs. €7.1 million as of December 31, 2015).

Implanet also has the option of exercising, under certain conditions, 340 convertible bonds coupled with equity warrants (OCABSA) with L1 EUROPEAN HEALTHCARE OPPORTUNITIES FUND for €3.4 million.

Significant milestones and events

Throughout 2016 and early 2017, Implanet experienced substantial growth in its primary development focus, the JAZZ technology platform. This continued growth was driven by conclusive results, notably in the U.S. and France.

Commercial development:

  • 127 surgeons are users of JAZZ technology in France and the U.S. (vs. 82 as of December 31, 2015);
  • success of the first surgical procedures in France, Italy and the U.S. with the new JAZZ Lock® implant, a major innovation and the first component of a product range devoted to degenerative bone disorder surgery;
  • success of a first idiopathic scoliosis surgical procedure in Brazil;
  • signature with Device Technologies of distribution partnership in Australia and New Zealand.

Innovation and regulatory:

  • U.S. (510k) and European (CE) regulatory clearance granted for the new JAZZ Lock®, JAZZ Claw® and JAZZ Frame® implants;
  • additional key patents granted in the US and Europe for the JAZZ® tensioning system;
  • patent granted for the JAZZ Lock® in France.

Clinical development

  • launch of a multicenter clinical study designed to document the outcomes of JAZZ technology in adult degenerative and adult deformity indications;
  • White Paper publication documenting clinical results of JAZZ technology in hypokyphotic idiopathic scoliosis surgery.

Financing

  • listing on the OTCQX® International market in the U.S.;
  • issuance of the remaining bonds convertible into stock and stock warrants within the framework of the financing put in place in October 2015;
  • zero-interest innovation loan of €800 thousand agreed with Bpifrance;
  • success of Implanet’s capital increase with preferential subscription rights for €6.9 million.

Appointments

  • appointment of Brian T. Ennis as President of Implanet America;
  • appointment of Mary E. Shaughnessy, Senior VP Finance & Planning, Partners Continuing Care, as an independent Board member.

Next financial press release: Q1 2017 revenue, on April 18, 2017

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net


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March 27, 2017 OrthoSpineNews

Mar 23, 2017 – By , Staff reporter Cincinnati Business Courier

Surgeons at Mercy Health-Cincinnati’s Anderson Hospital and St. Elizabeth Healthcare in Edgewood are among the first in the nation to offer a total knee replacement using the Mako Robotic Arm-Assisted Surgery System.

Dr. Suresh Nayak performed Ohio’s first total knee replacement procedure using the robotic-arm-assisted technology together with the Stryker Triathlon Total Knee System at Anderson Hospital on March 7, according to Mercy Health.

Dr. Matthew Hummel of Commonwealth Orthopaedic Centers performed a similar total knee replacement surgery using the new robotic-arm-assisted technology at St. Elizabeth in Northern Kentucky on March 22.

The technology is available at only a handful of medical centers in the nation, a St. Elizabeth spokesman said. The U.S. Food & Drug Administration approved the robotic-arm-assisted technology for total knee replacement in August 2015, but the equipment won’t be available to most health systems until 2018.

The procedure is less invasive than traditional surgery, meaning patients often experience less pain after surgery, less hospitalization and more rapid recovery, according to St. Elizabeth. Patients also often feel better motion and a more natural-feeling knee after the surgery.

READ THE REST HERE


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March 27, 2017 OrthoSpineNews

Press release from: Market Research Engine Research Reports

New York, March 24: Market Research Engine has published a new report titled as “Sports Medicine Devices Market By Product Analysis (Accessories, Body Evaluation and Monitoring, Body Repair and Reconstruction, Support and Recovery Products, Orthopedic Products); By Application Analysis (Hand-wrist, Ankle-foot, Shoulders, Arm-elbow, Back-spine, Knee, Hip-groin) and By Regional Analysis – Global Forecast by 2016 – 2022”

How Big is the Global Sports Medicine Devices Market?

The Global Sports Medicine Devices Market is expected to exceed more than US$ 9.3 billion by 2022 and will grow at a CAGR of more than 8% in the given forecast period.

www.marketresearchengine.com/reportdetails/sports-medicin…

Sports medicine is a branch of medication that offers with the prevention and treatment of injuries incurred at some point of sports activities sports, physical activities or bodily fitness education. Sports activities medicine devices consequently, consist of a huge range of goods applied for the prevention, recovery and treatment of accidents related to the above physical sports. Those injuries encompass fractures, sprains, tender tissue harm, joint dislocation, strain and musculoskeletal injuries. The increased global adoption of western sports has given upward thrust to accidents that power the market for sports medicinal drug devices.

The major driving factors of Global Sports Medicine Devices Market are as follows:

• Increasing demand for outpatient
• Increasing awareness regarding the maintenance of an active lifestyle
• Minimally invasive surgeries
• Changing re-imbursement landscape for new surgical technologies

 

READ THE REST HERE


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March 27, 2017 OrthoSpineNews

CARLSBAD, Calif., March 24, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today the addition of two new executives with proven track records in the spine industry, naming Brian Snider as Executive Vice President, Strategic Marketing and Product Development, and Chris Ryan as Area Vice President of Sales in the U.S. Central Region.  Drawing on their deep commercial spine experience, Mr. Snider and Mr. Ryan will focus on building brand awareness with surgeon customers and driving market demand for Alphatec’s differentiated product solutions.

Brian Snider Named EVP Strategic Marketing and Product Development

“I am pleased to welcome Brian to the Alphatec Senior Leadership Team,” said Terry Rich, Alphatec Spine’s Chief Executive Officer.  “Brian’s arrival completes our efforts over the past few months to restructure Alphatec leadership by adding individuals with significant spine and orthopedic experience. Brian brings an unquestioned track record of building strong surgeon relationships, product innovation, and commercialization, having brought to market over 30 innovative spine products and procedures.  We look forward to leveraging his energy and expertise, as we launch our new products, including Battalion™ Lateral and Arsenal™ Deformity, deepen our engagement with surgeons, and aggressively build our brand.  I look forward to partnering with Brian and believe his contributions will help take Alphatec to the next level of innovation and growth.”

As Alphatec’s Executive Vice President, Strategic Marketing and Product Development, Mr. Snider will lead all aspects of the Company’s go-to-market strategy, including product development, marketing, brand awareness and driving market adoption.

Mr. Snider has spent the past 11 years focused on marketing, brand and product development, and global product management in the spine and medical device industries.  Prior to joining Alphatec Spine, Mr. Snider spent nine years at NuVasive, Inc., where he most recently served as the Business Lead of Thoracolumbar Anterior, and had substantial responsibility over the anterior column business, including XLIF® and Anterior Column Realignment (ACR®).  Prior to NuVasive, Mr. Snider held marketing leadership roles at Alveolus, Inc., a medical device company focused on interventional stent technologies.  He started his career at KPMG consulting in various business units, including Life Sciences.

Mr. Snider holds an MBA from the Fuqua School of Business at Duke University and a Bachelor’s degree in Business Administration from The George Washington University.

Chris Ryan Named AVP Sales, Central Region

“I’m excited to bring Chris onboard as the first of our new regional area sales vice presidents,” said Mr. Rich.  “Given the recent launch of our three new products— Arsenal Deformity, Battalion Lateral and XYcor® Expandable Interbody—this is a perfect time for Chris to join the Alphatec team.  Chris brings a combination of high-performing sales leadership and distribution channel transformation experience that will be crucial to leading our sales agent relationships and accelerating our growth.  His reputation for high integrity, his deep understanding of the spine industry and his proven ability to drive significant revenue will make him an asset to our organization.”

As Alphatec’s Area Vice President, Sales, Central, Mr. Ryan will be responsible for expanding the Company’s presence in the Central United States, including building dedicated sales agent relationships, targeting new customer and market opportunities, as well as providing service and support for existing surgeon customers.

Mr. Ryan brings more than 20 years of progressive spine sales leadership experience to Alphatec.  Prior to joining Alphatec, Mr. Ryan held multiple sales leadership roles over a six-year period with Zimmer Biomet Spine, including as its Vice President of U.S. Sales and a member of the Zimmer Spine Leadership Team. Under Mr. Ryan’s leadership, Zimmer’s U.S. Spine Sales channel underwent a substantial, strategic change in distribution, yielding significant annual revenue growth.  Prior to Zimmer, Mr. Ryan served in a number of leadership capacities during his 14-year career at Medtronic, including Regional Vice President of Medtronic Spinal and Biologics business unit, responsible for Medtronic’s Central Region.

Mr. Ryan holds a Bachelor of Science in Economics from Western Michigan University.

Inducement Awards Granted

As an inducement to entering into employment with the Company and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”), on March 16, 2017, the Compensation Committee of the Board of Directors approved the following inducement awards:

  • Mr. Snider: 75,000 restricted stock units (RSUs) (with the grant of such RSUs made subject to, and effective on, the date on which Alphatec files a Registration Statement on Form S-8 registering the shares of common stock issuable upon settlement of the RSUs, which filing is expected to occur later this month) and an option to purchase 75,000 shares of common stock.
  • Mr. Ryan: 25,000 restricted stock units (RSUs) (with the grant of such RSUs made subject to, and effective on, the date on which Alphatec files a Registration Statement on Form S-8 registering the shares of common stock issuable upon settlement of the RSUs, which filing is expected to occur later this month) and an option to purchase 25,000 shares of common stock.

The RSUs and stock options were granted pursuant to the Plan.  Collectively, the RSUs and options were granted as inducements material to the new employees entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of the first date of employment, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant (March 20, 2017). The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company markets products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors.  Forward-looking statements include the Company’s ability to launch new products, deepen surgeon engagement, build brand awareness and accelerate growth. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainty of success in launching new products and developing new products or products currently in the Company’s pipeline; the failure to achieve acceptance of the Company’s products by the surgeon community; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; the Company’s ability to compete with other competing products and with emerging new technologies; and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement.  Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K.  Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer 
Investor Relations 
Alphatec Spine, Inc. 
(760) 494-6610 
czedelmayer@alphatecspine.com

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March 27, 2017 OrthoSpineNews

KIRKLAND, QC, March 24, 2017 /CNW Telbec/ – Ortho Regenerative Technologies Inc. (“Ortho RTi” or the “Company”), an emerging Orthopaedic and Sports Medicine Technology company, today announced that the results of four key scientific studies validating its product’s ability to improve the repair of three distinct joint tissues – the rotator cuff tendons, the meniscus and articular cartilage – were presented at the Annual Orthopaedic Research Society (“ORS”) (http://www.ors.org) meeting.

The ORS Annual Meeting attracts over 3,000 attendees with an interest in Orthopaedic research including clinicians, surgeons, residents, veterinarians, basic scientists, and engineers who present the latest innovative and cutting-edge musculoskeletal research. This year’s ORS Annual Meeting was held this week in San Diego, CA.

The first presentation described a pilot study designed to examine the feasibility of applying the Company’s proprietary Ortho-R implants in conjunction with suturing to improve rotator cuff repair. The researchers found that Ortho-R implants in conjunction with transosseous suturing improved histological structure at the supraspinatus tendons insertion site compared to suturing alone.

The second presentation was entitled “Freeze-dried chitosan-PRP injectable surgical implants for meniscus repair: results from pilot ovine studies.” This presented study findings that the Company’s proprietary Ortho-R implants showed superior regenerative effect over wrapping the meniscus with a collagen membrane or PRP alone, indicating that Ortho-R implants have the potential to overcome some of the current limitations of meniscus repair.

The third presentation, entitled “Freeze dried chitosan/platelet-rich-plasma implants improve marrow stimulated cartilage repair in rabbit chronic defect model”, described a study that was designed to evaluate the augmentation of Bone Marrow Stimulation (“BMS”) with the Company’s proprietary Ortho-R implants. This presentation concluded that augmentation by Ortho-R implant improves the highly variable and less than adequate repair elicited by BMS augmented with PRP, especially in challenging and hard to treat sites.

A fourth presentation highlighted scientific results related to how various surgical procedures in the knee joint may lead to changes in meniscus inter-tie coil morphology and, thereby, affect peripheral pain.

“We believe that increasing researcher and clinician awareness of our proprietary biopolymer platform through our participation in important scientific meetings like ORS will go a long way towards advancing the technology’s development and eventual product adoption,” said Dr. Michael Buschmann, CSO of Ortho RTi. “This type of third-party scientific validation, where four of our studies were reviewed by external experts and selected for broad exposure at this, the most important event of its kind worldwide, is incredibly energizing.”

Dr. Buschmann concluded, “It attests to the progress and excitement we are making towards validating our product for use in healing these types of injuries.”

Forward-Looking Statements

This news release may contain certain forward-looking statements regarding the Corporation’s expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

About Ortho Regenerative Technologies Inc.

Ortho RTi is an emerging Orthopaedic and Sports Medicine technology company dedicated to the development of novel therapeutic tissue repair devices to dramatically improve the success rate of sports medicine surgeries.  We are committed to improving patients’ lives through increasing the success rates of surgeries for soft tissue injuries. Our proprietary biopolymer has been specifically designed to increase the healing rates of sports related injuries to ligaments, tendons and cartilage. The polymer can be directly placed into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention.  Visit us on the internet at www.orthorti.com.


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March 27, 2017 OrthoSpineNews

 News Release – March 16, 2017

HAYWARD, Calif.–(Healthcare Sales & Marketing Network)–Moximed®, Inc., developer of unicompartmental load absorber implants for active patients with painful knee osteoarthritis (OA), announced today an oversubscribed Series C round of $50MM with new investors Advent Life Sciences and Future Fund joining existing investors NEA, Morgenthaler Ventures, Gilde Healthcare, GBS Venture Partners, and Vertex Healthcare. As part of the financing, Shahzad Malik, M.D., General Partner at Advent Life Sciences, and Brigitte Smith, Managing Director at GBS Venture Partners, will join the Board of Directors.

Moximed created the category of shock absorbing implants for knee OA, with treatment durability now established to nearly nine years on the initial patients. The Moximed implants do not require bone cutting or bone removal, and, importantly, they absorb excess joint load rather than shift load to other areas of the joint. Moximed has fully enrolled its FDA pivotal clinical study of the KineSpring® System and is currently enrolling an FDA IDE clinical study of the Atlas® System.

“This financing round is timely, as we are completing the primary endpoint follow-up for our FDA pivotal study this month,” said CEO Kevin Sidow. “We expect this investment to fully fund the company through FDA approval and early US commercialization of our products. There is a massive demand for new treatment options by patients who want to maintain an active lifestyle until they are ready for a knee replacement. The tremendous patient interest and surgeon enthusiasm we are witnessing in our current Atlas IDE study is validating our effort to address this clinical need.”

“Patients between the ages of 35 and 65 years old represent the fastest growing segment of the knee OA population,” added Shahzad Malik, of Advent Life Sciences. “These patients are often considered too young for traditional joint replacement and are desperate for a treatment alternative. We are excited to support Moximed’s effort to address this opportunity.”

About Osteoarthritis

Osteoarthritis (OA), the most common form of arthritis, is a degenerative disease affecting the hands, knees, hips, feet and spine. According to a 2017 Centers for Disease Control and Prevention (CDC) report, OA affects 54 million adults (1 in 4) in the US. It is caused by changes in cartilage, the soft tissue that cushions and protects bone, leading to pain and changes in the shape of the joint. In knee OA, as the cartilage wears away, the bone ends may begin to rub against each other, causing severe pain. While often regarded as a disease of the elderly, patients between the ages of 35 – 65 years of age represent the fastest growing segment of knee OA patients.

About Moximed

Moximed, Inc. is dedicated to improving the standard of care for patients with osteoarthritis (OA). OA, the most common form of arthritis, leads to a breakdown of the joint’s cartilage and often results in joint pain and loss of motion. Moximed is supported by world-leading venture investors including NEA, Morgenthaler Ventures, Gilde Healthcare, GBS Venture Partners, Vertex Healthcare, Advent Life Sciences, and Future Fund. More information can be found at www.moximed.com.

About the Atlas System

The Atlas System is designed as an implantable joint unloader for patients with unicompartmental knee osteoarthritis. Placed subcutaneously alongside the knee joint, the Atlas System incorporates advanced biomaterials designed to provide a clinically beneficial 30 lbs. of unloading. Importantly, the Atlas System absorbs excess joint load rather than shift load to otherwise healthy areas of the joint. This is important because load shifting has been shown in clinical studies to accelerate degeneration of otherwise healthy joint tissues. The Atlas System features a streamlined surgical technique that uses the patient’s own anatomy and allows the surgeon to visually confirm device function during the procedure. Finally, treatment with the Atlas System does not require any bone cutting or bone removal, and patients maintain all future treatment options should their osteoarthritis become more severe.

The Atlas System is CE Marked in Europe and is currently only being made available to select centers. The Atlas System is an investigational device in the United States, where it is limited by US law to investigational use.

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France. For more information, please visit www.AdventLS.com

About Future Fund

The Future Fund is Australia’s sovereign wealth fund and invests for the benefit of future generations of Australians. The Future Fund was established in 2006 and has taken on management of additional public asset funds, including the Disability Care Australia Fund, the Medical Research Future Fund, and two Nation-building Funds. The Fund’s role is to generate high, risk-adjusted returns over the long-term. The Fund operates independently from Government and tailors the management of each fund to its unique investment mandate.

Source: Moximed

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.


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March 24, 2017 OrthoSpineNews

March 23, 2017

LEXINGTON, Mass.–(BUSINESS WIRE)–CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, announced today it has published safety and efficacy data at one year showing that percutaneous intramedullary fixation can provide for stabilization of bone fractures while avoiding the need for open surgery. Results of this study have been published in the Journal of Orthopaedic Research.

“Our study further evaluates the percutaneous application of the IlluminOss System, which is a light-curable photodynamic bone stabilization device developed by IlluminOss Medical as a safe and biocompatible treatment for fracture stabilization and repair in load-bearing bones, such as the long bones of the leg,” said co-investigator Brett G. Zani, Ph.D., Director of Applied Sciences, CBSET.

“Local biocompatibility evaluations comparing the IlluminOss System to standard K-wire implants showed no significant long-term local tissue reactions associated with either implant, and good systemic biocompatibility of the IlluminOss System over the course of a year,” added co-investigator and CBSET scientist Amanda L. McSweeney.

The IlluminOss System is commercially available in international markets under a CE Mark for approved clinical applications through both a direct sales force and distribution networks. It combines the use of proven medical polymers and traditional balloon catheter technology to provide a completely new technology for patient-specific, percutaneous orthopedic implants. The implant begins as a liquid monomer that is completely contained within a Dacron or PET balloon. Once inside a patient’s bone, it conforms to the geometry of that patient’s intramedullary canal, whereas traditional rigid intramedullary rods have only small discrete contact points. Now, international surgeons have the option to use the IlluminOss product alone or in conjunction with traditional hardware and screws for multiple types of fractures.

“CBSET’s high-quality preclinical evaluation continues to substantiate the application of our bone stabilization system and its potential to be a truly disruptive alternative to traditional fracture repair,” said Robert Rabiner, Chief Technical Officer & Founder of IlluminOss Medical.

“CBSET strives to help innovative companies such as IlluminOss to develop new and disruptive technologies that foster paradigm-shifting improvements in patient care. In this case, for patients requiring fracture-fixation in an orthopedic trauma care unit, access to a new solution that is metal-free and can be performed in a minimally invasive manner, and not open surgery, is exciting, and our organization is proud to have contributed,” said Peter Markham, President, CEO and a co-founder of CBSET.

To learn more about these results and the services provided by CBSET, please contact: Michael Naimark, Director, Business Development: +1-970-988-5273, mnaimark@cbset.org.

* The IluminOss™ System is approved for sale in Europe and for investigational use in the U.S.

About CBSET
CBSET Inc. — 500 Shire Way, Lexington, Mass. — is the preclinical research leader in therapeutic fields such as interventional cardiology, renal disease and dialysis, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical device and drug-eluting products. Learn more about CBSET’s expert biomedical research services.

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108


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March 24, 2017 OrthoSpineNews

Albany, NY — (SBWIRE) — 03/24/2017 — Global Extremity Reconstruction Market: Overview

The increasing incidence of injuries, abnormalities, and congenital defects in the upper or lower extremity of human body has fuelled the demand for reconstructive surgical procedures. Implant devices for the shoulder, wrist, ankle joints, digits, elbow, and foot are part of the extremity reconstruction market.

The primary driver of the global extremity reconstruction market is the large pool of geriatric population. According to the Centers of Disease Control and Prevention, with a rise in the geriatric population in the U.S., by the year 2040, the number of patients affected by arthritis is expected to increase to 78 million. Since aged people are more prone to injuries, growth in geriatric population is expected to fuel the demand for reconstructive surgical procedures.

Obtain Report Details @ https://www.tmrresearch.com/extremity-reconstruction-market

Global Extremity Reconstruction Market: Key Trends

The rising incidence of joint disorders such as rheumatoid and osteoarthritis arthritis, coupled with the globally increasing incidence of diabetes and obesity, and rising geriatric population are driving the global extremity reconstruction market. Moreover, growing awareness among patients about the advantages of small joint reconstruction implants and enhanced technology such as development of reverse shoulder implants, stemless shoulder implants, and ankle reconstruction implants, which aid in recovering ankle mobility are projected to boost the market. The zest to get back to the active lifestyle, post-injury or trauma will supplement the demand for extremity reconstruction surgeries.

 

READ THE REST HERE


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March 24, 2017 OrthoSpineNews

March 23, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that Health Canada has approved the company’s Investigational Testing Authorization application to commence a clinical study of the Neuro-Spinal Scaffold™ in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries (SCIs). InVivo currently is in late stage conversation with several site Research Ethics Boards and expects to announce its first Canadian site in the coming weeks.

“This approval is an important step towards our goal of redefining the life of the spinal cord injury patient,” said Mark Perrin, InVivo’s CEO and Chairman. “We are dedicated to helping as many SCI patients as we can, and this approval helps us to evaluate our investigational product in the most severe spinal cord injury cases, with neurologically complete cervical injuries involving impairment of the arms, hands, trunk, and legs. As I explain further in my CEO’s Perspective, moving into the cervical spinal cord is exciting, since each level of the cervical spinal cord has a substantial functional impact. If the Neuro-Spinal Scaffold were able to preserve, remyelinate and/or regenerate just a small area of spinal cord, we believe this could have significant functional consequences. We look forward to bringing sites onboard in Canada to commence enrollment and ultimately to expanding our study of cervical patients to the United Kingdom and the United States.”

A new CEO’s Perspective discussing the differences between thoracic and cervical spinal cord injuries can be found on the InVivo Therapeutics website: http://www.invivotherapeutics.com/about-invivo/ceo-perspective/

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury.

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 Scaffoldreceived 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 safety and effectiveness of the Neuro-Spinal Scaffold, the ability of the company to open a site in Canada or enroll patients in Canada, and the ability to expand the trial to the United Kingdom and the United States. 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 ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the impact of achieving the OPC on the FDA approval process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and 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 studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2016, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com


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March 24, 2017 OrthoSpineNews

CARLSBAD, Calif., March 23, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today that it has entered into a definitive securities purchase agreement to raise approximately $18.9 million in a private placement of common stock, Series A Convertible Preferred Stock and warrants exercisable for common stock. The private placement is being led by new healthcare dedicated institutional investors, with participation by directors and executive officers of Alphatec and other existing investors. The private placement is expected to close on or about March 28, 2017, subject to the satisfaction of customary closing conditions. Alphatec expects to use the net proceeds from the private placement for general corporate and working capital purposes.

“We appreciate the support of our new and existing investors and the confidence this conveys in our strategy to build a high-growth spine company,” said Terry Rich, Alphatec Spine’s Chief Executive Officer.  “We believe the additional capital will allow us to execute on our plans to expand our surgeon customer base, drive growth through the launch of our new products—Arsenal Deformity™, Battalion™ Lateral and XYcor® Expandable Interbody—as well as support the transformation of our distribution channel.”

H.C. Wainwright & Co., LLC, is acting as the exclusive placement agent in connection with this private placement.

Pursuant to the terms of the securities purchase agreement, Alphatec has agreed to sell 1,809,628 shares of common stock at a price of $2.00 per share.  In addition, Alphatec has agreed to sell approximately 15,245 shares of newly created Series A Convertible Preferred Stock, which shares of preferred stock are convertible into approximately 7,622,372 shares of common stock, subject to limitations on conversion until the approval by Alphatec’s stockholders as required in accordance with the NASDAQ Global Select Market rules. Purchasers will also receive warrants to purchase up to approximately 9,432,000 shares of common stock at an exercise price of $2.00 per share. The warrants will be exercisable following approval by Alphatec stockholders, and will expire 5 years from the date of such stockholder approval.

Certain directors and executive officers of Alphatec agreed to purchase an aggregate of $2.35 million of shares of Series A Convertible Preferred Stock, which shares are convertible into approximately 1,175,000 shares of common stock, and warrants to purchase up to 1,175,000 shares of common stock at a price of $2.00 per share.

The securities to be sold in the private placement will not have been registered under the Securities Act of 1933, as amended, or state securities laws as of the time of issuance and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Alphatec has agreed to file one or more registration statements with the SEC registering the resale of the shares of common stock purchased in the private placement and the shares of common stock underlying the warrants and issuable upon conversion of the Series A Convertible Preferred Stock.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops, manufactures and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward looking statements include statements regarding: Alphatec’s expectations on the completion, timing and size of the private placement and the anticipated use of proceeds therefrom, including such proceeds allowing Alphatec to accelerate its plans to expand its surgeon customer base, drive growth through the launch of new products and support the transformation of its distribution channel.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to, risks and uncertainties associated with: market conditions and the satisfaction of customary closing conditions related to the private placement; the uncertainty of success in launching new products; the uncertainties in Alphatec’s ability to execute upon its strategic operating plan; failure to achieve acceptance of Alphatec Spine’s products by the surgeon community; continuation of favorable third-party payor reimbursement for procedures performed using Alphatec Spine’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or Alphatec’s ability to successfully control its costs or achieve profitability; Alphatec’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement; and other risks and uncertainties inherent in Alphatec’s business, including those detailed from time to time in Alphatec’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, and its Amended Annual Report Form 10-K/A filed on April 29, 2016, as well as other filings on Form 10-Q and periodic filings on Form 8-K. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com