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Four-Year Data from the UK National Joint Registry Highlights High Survivorship in Patients Treated with the Conformis iTotal CR

Posted On March 9, 2018 By OrthoSpineNews In Recon /  

BILLERICA, Mass., March 07, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants designed and manufactured to fit and conform to each patient’s unique anatomy, today announced new data showing that patients treated with the Conformis iTotal CR knee implant experienced a cumulative revision rate of 0.5% at four years compared to a 1.9% cumulative revision rate at the same time-point, among all patients who underwent knee replacement.1Results are summarized in a February 2018 report from Beyond Compliance, based on data available in the National Joint Registry (NJR) in the U.K.

In total or partial knee arthroplasty, revision surgery may be required to address problems, including loosening, instability, and infection following an original implant procedure. The summary data in this report includes 576 iTotal implant procedures in 504 patients treated at 46 different centers in the U.K.1 Among all patients treated with Conformis iTotal implants, only three patients (0.5%) required revision surgery up to four years following surgery.1

“The new four-year data highlighting the low risk of revision surgery for patients treated with Conformis iTotal implants provides strong clinical evidence reinforcing survivorship of our implant technology,” said Mark Augusti, President and CEO of Conformis. “We are pleased to add this data summary to our growing body of clinical evidence supporting the many benefits our product provides to patients. Announcement of this new safety data is on the heels of our most recent announcement that the Orthopaedic Data Evaluation Panel (ODEP) in the U.K. awarded the Conformis iTotal CR knee replacement system a ‘3A’ rating. This positive 3A rating is based on strong evidence of implant performance over a three-year period; including low revision rates noted in this report.”    http://www.odep.org.uk/product.aspx?pid=4305

“When adopting new technology, surgeons must assess how the new technology maintains established standards for safety and efficacy, “said Raj Sinha, MD, PhD from S.T.A.R. Orthopedics in Rancho Mirage, CA. “This recent data from the UK demonstrates that the Conformis iTotal CR provides excellent survivorship, evidenced by the low revision rates. This continues to prove the considerable benefits of treating my patients with the Conformis iTotal Knee Replacement System.”

Conformis iTotal is the only patient-conforming total knee replacement for which the implant design and manufacture is based on each patient’s anatomy and offers effective patient based advantages compared to standard off-the-shelf implants, including patient conforming sizes and better bone preservation. Study results from Levengood et. al. published in the peer-reviewed orthopedic journal, The Journal of Knee Surgery, in December 2017 showed that 100% of patients treated with iTotal CR achieved mechanical alignment in the target range of +/-3%. Neutral mechanical limb alignment (alignment within +/-3 °) has previously been linked to better long-term survivorship in TKA, while poor alignment has been linked to higher rates of implant failure.

“As a surgeon, we always strive to provide the best alternatives for our patients,” said Mr. Ian McDermott, MB BS, MS, FRCS (Tr&Orth), FFSEM(UK) affiliated with London Bridge Hospital in London, United Kingdom. “This 4-year National Joint Registry data confirms the positive early results I am seeing with my Conformis patients with respect to survivorship, in addition to published studies that continue to show effective positive outcomes I am seeing with faster recovery, improved kinematics and overall patient satisfaction.”

About Conformis, Inc.

Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are designed and manufactured to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of patient conforming total and partial knee systems that include sterilized single-use instruments delivered in a single package to the hospital. Conformis owns or exclusively in-licenses approximately 420 issued patents and pending patent applications that cover patient-specific implants and instrumentation for all major joints.

For more information, visit www.conformis.com.

1 Implant Summary Report for the iTotal G2 XE and iTotal G2 (Bicondylar tray).  Beyond Compliance database February 11, 2018, pages 19-20. This report has been produced by Northgate Public Services (UK) Ltd. (NPS) based on data collected by the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Conformis, including statements about the ability to offer implants to patients in the United Kingdom, that potential clinical benefits or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Conformis views as of the date hereof. Conformis anticipates that subsequent events and developments may cause Conformis’s views to change. However, while Conformis may elect to update these forward-looking statements at some point in the future, Conformis specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Conformis’ views as of any date subsequent to the date hereof.

MEDIA CONTACT

Kelly Wakelee
Berry and Company Public Relations
kwakelee@berrypr.com
212.253.8881

INVESTOR RELATIONS CONTACT

Oksana Bradley
Investor Relations
ir@conformis.com
781.374.5598
www.conformis.com

Image courtesy of Conformis

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Tyber Medical Announces the Full Launch of TyFix™, An All-in-One Extremity System

Posted On March 9, 2018 By OrthoSpineNews In Extremities /  

BETHLEHEM, Pa., March 8, 2018 /PRNewswire/ — Tyber Medical, LLC, a privately held company focusing on developing innovative medical devices for private label opportunities and advancing the science of bioengineered surfaces, announces the launch of TyFix™, an all-in-one extremity joint fixation system.

Tyber Medical is excited to announce the completion of the limited release for the TyFix™ System.  Dr. Michael Gentile, DPM, FACFAS, at Cornell Surgery Center in Beaverton, OR, performed one of the first procedures utilizing the TyFix™ System.  Dr. Gentile commented, “The instrumentation design is efficient and intuitive. A versatile implant with a myriad of sizes and angle options for a reliable fit and natural toe position.”

The company received 510(k) clearance in July 2017 for the innovative system that reduces the need for ancillary instrumentation for a wide range of bone fixation procedures.  The TyFix™ System, designed for a variety of procedures, including correction of Hammertoe deformities, allows realignment to relieve pain and discomfort.  The integrated implant/instrument design, first of its kind, creates value by minimizing the number of procedure steps, improving operating room efficiency, and significantly reducing procedure time. In addition, the all-in-one sterile packed device eliminates traditional reprocessing costs.

The TyFix™ screw combines a highly-optimized bone thread with a barbed head to maximize bone purchase and compression in both the proximal and distal phalanges. The system delivers intraoperative flexibility by offering solid and cannulated implants with diameters ranging from Ø1.5 – 4.0mm in multiple lengths as well as a straight and an angled 10o option.

“The TyFix™ System is designed to deliver a construct at the speed of a k-wire and the holding strength of a screw, while also delivering an efficient OR process through the patented fully integrated implant and instrument design.” commented Jeff Tyber, CEO of Tyber Medical. He added, “Tyber Medical continues to focus and enhance our distal extremity platform, is dedicated to accelerating the path to market for our private label customers, and is always striving to add value through innovative solutions.”

Visit Tyber Medical’s Booth #333, at ACFAS in Nashville, TN where the company will showcase the TyFix™ System as well as other innovative products available for private labeling.

About Tyber Medical, LLC.
Tyber Medical, LLC is an orthopedic device manufacturer providing rapid access to portfolio enhancing, regulatory approved, orthopedic implants within the spine and extremity/trauma markets.  While focusing on rapid product commercialization, the company distributes products via private labeling; releasing 14 spine and 25 extremity/trauma systems since its founding in 2012.  Tyber Medical utilizes the differentiated, bioengineered technology such as TyPEEK® osteoconductive coatings and BioTy™, a new antimicrobial nano-textured surface modification to enhance the company’s growing portfolio.

Contact:
Eric Dickson
83 South Commerce Way, Suite 310
Bethlehem PA 18017
(610) 849-1710
edickson@tybermed.com

 

SOURCE Tyber Medical, LLC

Related Links

http://www.tybermedical.com

 

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DermaPace Technology Suggests Promising Outcomes of Acoustic Pressure Shockwave Treatment for Venous Leg Ulcers (VLU)

Posted On March 9, 2018 By OrthoSpineNews In Biologics /  

SUWANEE, GA, March 08, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, announces the publication of research that investigated the use of the dermaPACE® System in the treatment of Venous Leg Ulcers (VLU) in a case study series.  The study, titled “Treating venous leg ulcers with Extracorporeal Shockwave Technology (ESWT)” by Charne Miller (LaTrobe University), Suzanne Kapp (University of Melbourne), Jade Green (LaTrobe University), William McGuiness (LaTrobe Alfred Health Clinical School), and Michael Woodward (Austin Health/University of Melbourne), appeared in Wounds International 2017, Volume 8 Issue 3.  The case series was implemented at a medical professional lead, multidisciplinary outpatient wound clinic in Melbourne, Australia.

The case study series consisted of 6 patients, meeting eligibility criteria, presenting with venous leg ulcers (VLU) and who agreed to receive the dermaPACE treatment.  In order to better understand wound response to dose and energy, treatment selection used the two highest energy settings on the dermaPACE System, delivered at a frequency of 240 pulses/min. The shockwave pulse count was a function of wound area (cm2) with larger wounds requiring more shockwaves for treatment and thus longer time per therapy session than smaller wounds. The protocol used recommended one treatment delivered each week for 10 weeks.

Positive wound healing effects were observed for the majority of patients receiving ESWT.  At the conclusion of the case series the majority of wounds were either healed or healing was anticipated in a subsequent visit.

  • Patient 1 received 5 treatments over the course of 5 weeks, the wound reduced in size from 7 cm2 to 1 cm2 at the final treatment.
  • Patient 2 received 8 treatments over the course of 11 weeks, the wound, with an initial area of 2.5 cm2 at the time of the first treatment, was completely closed by week 16.
  • Patient 3 received 4 treatments over approximately 2 months.  Within 2 weeks of the first treatment, the wound had new areas of epithelialization tissue.  By the end of two months, the wound had epithelialized 100%.
  • Patient 4 received 4 treatments over a 6 week period.  By seven weeks post-initial treatment, the wound was documented as near-closure.
  • Patient 5 received only 1 treatment but continued to receive alternative modalities for treatment over a 5 week period.  In this time, the wound reduced in size from 2.5 cm2 to 1.5 cm2.
  • Patient 6 received a total of 3 treatments over a 3 week period.  The wound size at the first treatment was 1.5 cm2 and increased to 2.5 cm2 in the first two weeks.  By the last treatment, the wound presented with a reduction in the extent of hypergranulation and healthier wound margin.

The purpose of this case series was to expand evidence regarding the viability and the concurrent healing outcomes when using ESWT to treat venous leg ulcers.  The capacity to deliver the scheduled weekly treatments was not, however, achieved in any instance. Participants did find the treatment to be acceptable. Pain was reported only twice and was concurrent to reports of wound pain.

The active treatment itself would typically last for only 2-3 minutes with preparation and clean up also requiring only approximately additional five minutes of time, making ESWT an extremely practical therapy to implement in a busy clinic environment. However, the capacity to see patients weekly was difficult to realize for a variety of reasons.  This case study series is one of the first to document the use of dermaPACE in “real-life” conditions and not under the controlled settings seen in typical clinical investigations.  This study represents a low level of evidence regarding the viability and effect of ESWT in treating venous leg ulcers. The method which is characterized by a small sample and the absence of a comparison group represent limitations in comparison to more rigorous research methodologies. However, the case series is an appropriate research design for a burgeoning area of clinical enquiry, where questions regarding feasibility, acceptability, and effectiveness remain.

Suzanne Kapp (Visiting Academic, The University of Melbourne/ Honorary Clinical Study Coordinator, Wound Clinic Austin Health) commented, “The treatment can be easily implemented for clinicians, and was generally acceptable for patients.  We were pleased to see positive wound healing outcomes for the majority of participants.  We see the results from this small sample study as the first step in an evolving program of scientific study that will refine the treatment regimen and adopt more rigorous research designs.”  Adds Charne Miller, Senior Lecturer, LaTrobe University, “The results from this small sample are very encouraging.  It is one of the most promising case series we’ve conducted in terms of wound progress and feasibility. dermaPACE certainly warrants further investigation.”

Kevin A. Richardson II, CEO of SANUWAVE, stated, “We initiated this small case series study to attempt to better understand the response of VLUs to varied energy and shock count delivery.  The results were much better than anticipated, especially where adherence to the defined protocol was limited.  This small example is the first to document the vast series of issues clinicians face in real-life clinical settings.  This furthers our strong belief that dermaPACE will fill an unmet need in the wound care community to provide safe, effective, and fast treatment of wounds.  Enhancing wound management will help to improve the patient’s quality of life, reduce the medical risks associated with uncontrolled wounds, and also reduce health management costs.  SANWUAVE is excited to work with Dr. Kapp and the rest of the team in Melbourne to determine the next steps in developing a full treatment regimen.”

The dermaPACE System received US FDA clearance in late December for the treatment of Diabetic Foot Ulcers (DFU).  The DFU market is 1.5 million cases per year in the US.  The VLU market is larger at 2.5 million cases per year, but the overall costs are similar to the market size of DFU.  This is a natural extension as SANUWAVE expands its indications in the wound category.  This is a first step in preparing clinical work to expand our indication into VLU’s.  We are looking forward to expanding our clinical work with the folks in Australia and launching some work in the US later this year.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, received US FDA clearance in December 2017 for the treatment of Diabetic Foot Ulcers.  dermaPACE is the only Extracorporeal Shockwave Technology (ESWT) device cleared or approved in the US for the treatment of DFUs.  Internationally, dermaPACE is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand, and South Korea.  SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

For additional information about the Company, visit www.sanuwave.com.

Contact:

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com
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InVivo Therapeutics Receives FDA Approval for Pivotal, Randomized, Controlled Trial of the Neuro-Spinal Scaffold™ in Patients with Acute Spinal Cord Injury

Posted On March 8, 2018 By OrthoSpineNews In Regulatory /  

March 08, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that the company has received supplemental Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for a second pivotal clinical study of the company’s Neuro-Spinal Scaffold™ in patients with acute spinal cord injury (SCI). The 20-patient (10 subjects in each study arm), randomized, controlled trial is designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold™ from the company’s single-arm INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury). The definition of study success is that the difference in the proportion of subjects who demonstrate an improvement of at least one grade on AIS assessment at the six-month primary endpoint follow-up visit between the Scaffold Arm and the Comparator Arm must be equal to or greater than 20%.

InVivo recently reported that seven of 16 (43.8%) evaluable patients in the INSPIRE study experienced an improvement in AIS grade from baseline at six months compared to the Objective Performance Criterion (study success definition) of 25% of patients. Of these seven patients, three of five individuals who had converted from AIS A SCI (complete) to AIS B SCI (sensory incomplete) in the first six-month period of follow-up subsequently further improved to AIS C SCI (motor incomplete) within 12 to 24 months, including a recent patient who converted from AIS B to AIS C at the 12-month exam in January 2018.

Richard Toselli, M.D., President and Chief Executive Officer of InVivo, commented, “We are pleased to announce the FDA’s approval of this randomized, controlled trial and appreciate the agency’s collaboration with us on the development of a protocol to address the substantial unmet needs in this patient population. We believe this now sets us in a direction towards a clear and efficient path to approval under the HDE regulatory program, and we are focused on engaging with the investment community and exploring financing mechanisms to support this approved randomized study. We look forward to providing further updates as we obtain clarity on financing and the timing for our second pivotal trial.”

“InVivo has achieved important milestones with the FDA over the past seven months under Dr. Toselli’s leadership,” stated Ann Merrifield, InVivo’s Chair of the Board of Directors. “I wish to commend Rich and his team in their continuing interactions with the FDA and their strategy for advancing this important program in the clinic.”

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 January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. 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 of 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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Alphatec Spine Disrupts Market with Acquisition of SafeOp Surgical, ~$50M Equity Financing, and Strategic Leadership Appointments

Posted On March 8, 2018 By OrthoSpineNews In Spine, Top Stories /  

CARLSBAD, Calif., March 08, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec” or the “Company”) (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, announced today that it has acquired SafeOp Surgical, Inc. (“SafeOp”).  SafeOp is a privately-held provider of advanced neuromonitoring technology designed to prevent the intraoperative risk of nerve injury with automated assessment that obviates the need for a technician or other neuromonitoring professional in most surgeries.  The Company also announced a $50 million capital raise, the proceeds of which were used, in part, to fund the acquisition.

Additionally, the Company announced several leadership updates. Pat Miles has assumed the role of Chief Executive Officer. Terry Rich has been appointed President and Chief Operating Officer.  Both will retain their existing Board positions.  Dr. Luiz Pimenta has been appointed Chief Medical Officer.

SafeOp Acquisition

SafeOp has developed patented technology that automates SSEP’s (Somatosensory Evoked Potentials), designed to provide surgeons with unprecedented, objective feedback during surgery.

“This strategic acquisition of SafeOp marks a transformational moment for the new ATEC,” said Pat Miles. “Our answer to the need for better neuromonitoring is investing in technology that automates information to enable objective clinical decision making and eradicate non-critical operating room personnel. The integration of this key technology into our spine procedures will address unmet clinical needs and improve surgical outcomes in spine.  We expect the combination to accelerate our business by increasing procedural revenue and driving pull-through across our entire portfolio.”

In consideration for SafeOp, Alphatec will pay $15 million in up-front cash, a $3 million convertible note, and the issuance of 3.3 million shares of common stock and warrants to purchase 2.2 million shares of common stock at an exercise price of $3.50 per share.  SafeOp will be eligible to receive an additional 1.3 million shares of common stock, subject to the achievement of performance milestones.  The issuance of the shares of common stock in the merger, including at closing, upon achievement of milestones, conversion of the notes and exercise of the warrants is subject to limitations until required stockholder approval is obtained in accordance with the NASDAQ Global Select Market rules.

Leadership and Board Appointments

The Company also announced the following leadership and board appointments.

Dr. Luiz Pimenta will advise Alphatec as Chief Medical Officer.  Pimenta is a world-renowned spine surgeon with over 30 years of expertise, and is widely credited with pioneering innovative surgical techniques and developing new technologies to improve spine surgery.  His broad contributions have been commercialized via numerous industry partners.  Dr. Pimenta will enhance the ATEC strategy by focusing on spine innovation and medical education.

Miles continued, “I am honored and thrilled to work again with Dr. Pimenta. His decision to assume a key role in our mission is pivotal.  It speaks volumes of the surgical community’s perception of ATEC’s visceral dedication to improved outcomes through eXtreme innovation.”

Richard O’Brien, M.D., and Robert Snow, the scientific principals of SafeOp, with over 50 years of combined neurophysiology expertise will join Alphatec as executives. Prior to serving as Vice President of Development and Chief Medical Officer of SafeOp, Dr. O’Brien, a renowned inventor and neurologist, was Medical Director of Impulse Monitoring, Inc., a neuromonitoring provider. Before joining Impulse Monitoring, O’Brien spent over two decades in the neurophysiology field, as both a physician and consultant. Mr. Snow, a neurophysiologist, was SafeOp’s Vice President, Marketing for 5 years, following an 11-year tenure as co-founder and Senior Vice President of Marketing at Impulse Monitoring.

“I could not be more excited to join the ATEC family and to engage in the creation of automated tools that provide objective information for better clinical decision making,” said O’Brien.

The SafeOp development and integration effort will be led by Jim Gharib, an electrical engineer with more than 20 years of experience in the field of neurophysiology. Gharib was the technical lead of NuVasive’s neurophysiology platform from the company’s inception to its achievement of billion-dollar revenue levels. Gharib is a named inventor on more than 20 patents in the fields of neuromonitoring, spine surgery, IV infusion, and blood chemistry.

“I am exceptionally pleased to work again with Rob, Richard, and Jim, the new leaders of our adjunctive technology team,” said Terry Rich, President and Chief Operating Officer of Alphatec.  “They each have a proven history of successfully creating value in the neurophysiologic and spine marketplace. I look forward to working with each of these new leaders as we evolve into a leading spine market player.”

Three new members have joined the Alphatec Board of Directors, in connection with the above transactions:

  • James Tullis, the founder and Chief Executive Officer of Tullis Health Investors, a healthcare investment firm, has over 40 years of experience in healthcare-focused investments.  Prior to establishing his firm in 1986, Tullis served as an award-winning healthcare investment research analyst and Principal at Morgan Stanley, focusing on pharmaceuticals and medical devices.
  • Jason Hochberg a partner with L-5 Healthcare Partners, and the Founder and CEO of SJS Beacon, an investment company, has over 20 years of business and legal experience.  Prior to founding SJS Beacon, Hochberg held various leadership roles throughout a 15-year tenure at LS Power, an energy investment and innovation company, serving most recently as Chief Operating Officer and as a Principal in LS Power’s private equity fund advisor.  He started his professional career at the law firm of Latham & Watkins in 1996.
  • Evan Bakst, a partner with L-5 Healthcare Partners, and the Founder of and Portfolio Manager at Treetop Capital, a healthcare investment firm. He has over 25 years of experience in healthcare-focused investments.  Prior to founding Treetop Capital, Bakst was a partner for 7 years at Tremblant Capital, an equity hedge-fund manager, where he led the global healthcare group and held various other leadership roles.

Equity Financing Transactions

The Company announced that it has entered into financing transactions to raise an aggregate of $50 million, through a private placement of Series B Convertible Preferred Stock and warrants exercisable for common stock, and a warrant exchange agreement with a holder of an existing warrant for an aggregate consideration of $4.8 million. The private placement was led by L-5 Healthcare Partners, LLC, a healthcare-dedicated institutional investor, and included certain directors and executive officers of Alphatec, as well as other new and existing institutional and independent investors.  The Company used a portion of the net proceeds from the private placement and warrant exercise to fund the $15 million cash purchase price for SafeOp, and expects to use the remainder for general corporate purposes.

Raymond James & Associates, Inc., is acting as placement agent in connection with the private placement and financing advisor in connection with the SafeOp acquisition.

Additional information and legal disclosures about the transaction are contained in the Company’s Current Report on Form 8-K to be filed with the Securities and Exchange Commission.

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 B 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.

Inducement Award 

As an inducement to accepting employment with the Company, and in accordance with applicable NASDAQ listing requirements, the Board of Directors has also approved an award, collectively, to these new additions of 45,000 restricted stock units (RSUs) and 45,000 stock options (Options).

The RSUs and options will be granted following registration of the common stock underlying the RSUs and Options.  The RSUs will vest in equal annual installments on each of the first four anniversaries of date of employment, and the options will vest 25 percent on the first anniversary and in equal monthly installments of 1/36th of the balance of the Options, provided the recipient remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs and Options will fully vest upon a change in control of Alphatec.

The Board approved an amendment to Alphatec’s 2016 Employment Inducement Award Plan to increase the shares reserved for issuance thereunder by 600,000 shares, effective March 6, 2018.

Investor Conference Call

Alphatec will hold a conference today at 1:30 p.m. PT / 4:30 p.m. ET to discuss the strategic acquisition, in conjunction with fourth quarter and full year 2017 results. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. The conference ID number is 7887979. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.atecspine.com.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, 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 providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

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

About Safe-Op Surgical

SafeOp is a privately-held provider of automated neuromonitoring technology.  The Company’s EPAD device was approved by the FDA in January 2014, intended for use in monitoring neurological status by automating & recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).  Functionality, including free run EMG and triggered EMG will be added later this year.

Forward Looking Statements 
This press release contains “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. The Company 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 references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  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 regarding the Company’s ability to recognize the expected synergies and other benefits of the SafeOp acquisition; the difficulties in the integration of SafeOp post-closing; the diversion of management time to address transaction-related issues; the uncertainties related to litigation involving the acquisition of SafeOp or the private placement or limitations or restrictions imposed by regulatory authorities; the uncertainties related to unanticipated integration costs or undisclosed liabilities assumed; the uncertainties related to the acceptance of the SafeOp acquisition and its products by third parties; the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable fourth party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. 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.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the Securities and Exchange Commission. 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.

Investor/Media Contact:

Carol Ruth
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
ir@atecspine.com

 

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Phoenix Spine Announces Participation in the INTRACEPT Study for the Treatment of Chronic Low Back Pain

Posted On March 8, 2018 By OrthoSpineNews In Spine /  

SCOTTSDALE, Ariz., March 8, 2018 /PRNewswire/ — Phoenix Spine today announced participation in a clinical study comparing the Intracept Procedure, developed by Relievant Medsystems, to conservative care for patients with chronic low back pain (CLBP). Phoenix Spine will be among 20 centers across the U.S. participating in the INTRACEPT study with up to 150 patients enrolled.

The INTRACEPT study’s primary efficacy endpoint is the mean change from baseline to 3 months post- treatment in the Oswestry Disability Index (ODI). This study will build on the recently presented results of the Level I SMART trial, which demonstrated significant improvements in function and pain, and reduction of opioid consumption.

“Low back pain—whether coming from the disc or the vertebral body— can be agonizing and debilitating,” said Dr. Dan Lieberman, a neurosurgeon and Medical Director of Phoenix Spine Surgery Center. “Surgery has previously been the only real treatment available to these patients who fail conservative treatment. At Phoenix Spine, our goal is to treat back pain in the least invasive way possible. I look forward to participating in the INTRACEPT study and am hopeful that the outcomes of the Intracept procedure will compare favorably to conservative care and will provide appropriate clinical context for patients and physicians seeking options for the treatment of chronic low back pain.”

The Intracept System is based on ground breaking anatomic research that identified and demonstrated the role of the basivertebral nerve (BVN) in transmitting low back pain from the vertebral body endplates. The procedure uses a transpedicular, minimally invasive approach to reach the BVN near the center of the vertebral body and uses radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals.

Patients will undergo the procedure in an ambulatory surgery setting and return home the same day of the surgery.  The procedure uses image guidance and does not require stitches or general anesthesia.

For more information on the INTRACEPT study, please visit http://intraceptstudy.com.

If you or someone you know is interested in joining the study, please call the Phoenix Spine Surgery Center at (602) 644-9107.

About Phoenix Spine
Phoenix Spine specializes in treating back pain with a patient-centered approach using ultra-minimally invasive options including Direct Visual Rhizotomy. For more information, visit https://www.phoenixspine.com.

About Relievant Medsystems
Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from CLBP. Relievant’s Intracept® System delivers targeted energy into the spine and blocks the transmission of pain signals from the BVN.  This minimally invasive procedure provides orthopedic surgeons, neurological surgeons and interventionalists with a new way to provide clinically proven, lasting pain relief for CLBP.  As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure.  Please see www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.

FDA has cleared the Intracept System for the following Indications for Use:   The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)

Contact: Stan Miele, 602-256-2525, stan@phxspine.com

 

SOURCE Phoenix Spine

Related Links

http://www.phoenixspine.com

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Benvenue Medical to Present Positive Luna 3D Interbody Fusion System Data at Spine Summit 2018

Posted On March 8, 2018 By OrthoSpineNews In Spine /  

March 08, 2018

SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive expandable implant solutions for spine repair, today announced that positive interim results of a retrospective analysis of its Luna® 3D Multi-Expandable Interbody Fusion System will be presented at the Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves (Spine Summit) taking place March 14-17 in Orlando. The single center minimally invasive study evaluated the safety and efficacy of the Luna device when placed from a standard minimally invasive transforaminal lumbar interbody fusion (TLIF) approach.

“The brilliance of Luna is its ability to engage the disc space through a minuscule annulotomy, and then expand to cover the greatest expanse of any intervertebral device available,” said Richard Fessler, M.D., study investigator and professor of neurosurgery at Rush University. “In our analysis, minimally invasive TLIF placement of the Luna device was shown to be safe and effective, improving pain and disability scores as well as consistently restoring disc height, reducing spondylolisthesis and increasing lumbar lordosis.”

The retrospective analysis evaluated 31 patients treated with the Luna 3D System who had at least six months of post-operative follow up. All but one patient experienced improvement in pain scores from baseline, and disability scores improved for all patients. When present, spondylolisthesis was reduced significantly. No instances of graft subsidence or hardware failure occurred.

“These safety and efficacy results lay the groundwork for our ongoing evolution of the Luna 3D Interbody Fusion System,” said Robert K. Weigle, CEO of Benvenue Medical. “We are currently developing a 2.0 version of the system that leverages our original platform and vision, improves the user experience and is designed to be minimally invasive to improve outcomes for patients and for use in the growing, emerging outpatient ambulatory spinal surgery center setting. We expect to submit for FDA clearance on Luna 2.0 later this year.”

“Minimally invasive spinal surgery and procedures in the outpatient setting are forecasted to grow considerably in the near term, and we see Luna as an important technological advancement in advancing patient care, quality and economic outcomes for the patient suffering from degenerative disc disease,” said Luke Düster, managing director and partner at CRG, an investor in Benvenue Medical.

Dr. Fessler will present the analysis, “Minimally invasive transforaminal lumbar interbody fusion with a multi-directional expandable device,” in the sponsored What’s New 2 session on Thursday, March 15, from 2:52-3:02 p.m. Benvenue is also exhibiting at Spine Summit in booth #311.

About the Luna 3D Interbody Fusion System

The Luna 3D Interbody Fusion System is one of the largest footprint yet least invasive devices for posterior lumbar interbody spinal fusion. The Luna 3D System is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space, first in footprint, second in height and third in lordosis, allowing surgeons to effectively restore sagittal balance and height via a MIS posterior approach while providing the stability of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 3D Implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, it is then expanded in height and lordosis with the insertion of a middle section. When the cannula is removed, a large volume of bone graft is placed in the middle of the implant to facilitate an interbody fusion.

About Benvenue Medical, Inc.

Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by CRG. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $9 billion globally. For more information, visit www.benvenuemedical.com.

About CRG LP

CRG is a premier healthcare-focused investment firm that has committed over $3.0 billion of capital across more than 50 investments. The firm seeks to commit between $20 to $300 million in each company and invests across the healthcare spectrum, including: medical devices, biopharmaceuticals, tools and diagnostics, services and information technology. CRG provides growth capital in the form of long-term debt and equity to support innovative, commercial-stage healthcare companies that address large, unmet medical needs. The firm partners with public and private companies to provide flexible financing solutions and world-class support to achieve exceptional growth objectives with minimal dilution. CRG maintains offices in Boulder, Houston and New York. For more information, visit www.crglp.com.

Contacts

MEDIA CONTACT:
Merryman Communications
Betsy Merryman, 310-560-8176
betsy@merrymancommunications.com

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joimax® Presents Its New Generation 4K Camera Light Source and Documentation Command System, Camsource® LED, and Vitegra® at AAOS

Posted On March 8, 2018 By OrthoSpineNews In Spine /  

March 08, 2018

KARLSRUHE, Germany–(BUSINESS WIRE)–joimax®, the German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery, presents its newest combined 4K resolution camera and LED light source system, Camsource® LED, and its fully integrated documentation and command system, Vitegra® Docu and Command. Both systems are introduced for the first time at the Annual Meeting of the American Association of Orthopedic Surgeons (AAOS), currently taking place in New Orleans, LA, where joimax® is represented at booth no. 4020.

The Vitegra® Docu and Command system opens a new era of documentation, control and hospital integration. The device comes with numerous flexible control options including a wireless tablet PC, live video streaming and a live voice commenting option, in-surgery image and video review function, voice control capabilities and easy data export solutions. The Vitegra® offers with its command mode to control all other devices that are part of the joimax® endoscopic tower. An optimized monitoring of the endoscopic devices during the surgical procedures by live review and control of all important device parameters is also provided. An initial, limited market launch is planned for Q2/2018 within European and U.S. markets.

“Our new 4K LED Visualization Systems are the next important components of our steadily growing endoscopic product portfolio. These developments demonstrate our continued leading position in the fast-growing endoscopic spine surgery market worldwide,” states Wolfgang Ries, Founder and CEO of joimax®.

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® (for facet and sacroiliac joint treatment) or with EndoLIF® and Percusys® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

Press Contact USA :
joimax® Inc.
Melissa Brumley
Melissa.brumley@joimaxusa.com
001 949 859 3472

(Graphic: Business Wire)

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LimaCorporate Awarded With Two New ODEP Ratings for the SMR Reverse

Posted On March 8, 2018 By OrthoSpineNews In Recon /  

SAN DANIELE DEL FRIULI, Italy, March 7, 2018 /PRNewswire/ —

LimaCorporate is proud to announce that the SMR Shoulder System has recently been awarded by the Orthopaedic Data Evaluation Panel (ODEP) in the UK, with the following two ratings (ODEP ratings can be found on odep.org.uk):

  • 10A ODEP Rating – SMR Reverse with Uncemented Fixation (Metal Glenosphere / Polyethylene Liner Combination);
  • 5A ODEP Rating – SMR Reverse HP with Uncemented Fixation (Polyethylene Glenosphere / Metal Liner Combination).

The Orthopaedic Data Evaluation Panel (ODEP) was set up in the United Kingdom in 2002 and provides ongoing assessment of arthroplasty implants to benchmark Hip, Knee and Shoulder implants, providing a standard rating for their survivorship and data submission quality.

Shoulder ratings are provided at benchmarks of 3, 5, 7 and 10 years of follow-up alongside a ‘A’ or ‘B’ rating dependent upon the strength of evidence and the quality of the data provided. The main criteria are the survivorship of the implants, the number of patients and the length of follow-up. Many countries outside the United Kingdom now use these ratings to assist in their approval of products into the market place. ODEP ratings provide a simple, independently verified assessment of the performance of an implant, assessed against Clinical best practice guidelines.

LimaCorporate is proud to remark that the SMR Reverse (Uncemented with Metal Glenosphere) was awarded an ODEP 10A rating in 2017 and it is currently the only Shoulder replacement system to be awarded with a 10A benchmark. This achievement, together with the celebration of its 15th Anniversary last year, is a further evidence of the outstanding Clinical heritage of the SMR System. The SMR System was the first Shoulder modular platform to be launched on the market in 2002, and it has since then encountered the appreciation of a wide number of surgeons world-wide.

“I am very happy for the high ODEP rating for the SMR Reverse and HP implants, it matches perfectly with my surgical experience and the satisfaction of my patients,” said Dr. Alessandro Castagna.

To reinforce the strong position held by the SMR System, during the second half of 2018, the SMR TT Hybrid Glenoid will be launched in the US. The SMR TT Hybrid Glenoid features LimaCorporate’s core 3D printed technology, Trabecular Titanium, offering to surgeons an innovative solution for Glenoid replacement. Thanks to its modularity, the SMR TT Hybrid Glenoid is the first convertible Hybrid Glenoid implant on the market that allows to convert from anatomic to reverse implant design without the need to remove the TT centralpeg. The SMR TT Hybrid Glenoid offers an optimized range of sizes, mismatch and thicknesses options to allow an appropriate soft tissues management.

“The achievement of the ODEP 10A rating for the SMR Reverse is yet another recognition for our remarkable technology. On behalf of all of LimaCorporate, I would like to thank the surgeon community that believed in the SMR System from the beginning”, said Luigi Ferrari, Chief Executive Officer of LimaCorporate.

About LimaCorporate

LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation.

For additional information on the Company, please visit: limacorporate.com

Limacorporate S.p.A.
Via Nazionale, 52
33038 Villanova di San Daniele del Friuli
Udine – Italy
T: +39-0432-945511
E: info@limacorporate.com

SOURCE Limacorporate S.p.A

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ulrich medical USA® Delivers Seventh Consecutive Year of Profitable Double-Digit Growth

Posted On March 8, 2018 By OrthoSpineNews In Financial /  

ST. LOUIS, March 7, 2018 /PRNewswire/ — ulrich medical USA, Inc., a medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, today reported 2017 financial results with 10% annual revenue growth for the year ending December 31, 2017 and a 15%, 5-year compound annual growth rate (CAGR) in their U.S. spine market business.

“2017 was a strategic building year for us,” said Hans Stover, President and Chief Executive Officer, ulrich medical USA. “I am very proud of our performance. We experienced record organic growth in the U.S. spine market in 2017 amidst many of our competitors who reported a flat or declining spine business.”

The company also reported a 22% growth in annual case volume for 2017, and a record 131% growth in case volume for the prior 5-year period.

“We are very appreciative of our growing U.S. market acceptance and we are extremely grateful to our customers for their continued confidence in our company and our implant technologies,” said Erika Laskey, Chief Commercial Officer, ulrich medical USA.

For more information, please visit www.ulrichmedicalusa.com.

About ulrich medical USA, Inc.
ulrich medical USA is a subsidiary of ulrich medical®, an innovative medical technology company headquartered in Ulm, Germany.

Company Contact: e.laskey@ulrichmedicalusa.com

 

SOURCE ulrich medical USA, Inc.

Related Links

http://www.ulrichmedicalusa.com

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