News – Page 225 – Selby Spine

RAYNHAM, Mass., March 13, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today the first clinical use of a novel robotic tissue balancing device for use with OMNI’s market-leading OMNIBotics® robotic-assisted total knee replacement technology platform. The successful initial procedure took place in Sydney, Australia and was performed by Dr. Brett Fritsch, MD, FRACS, who is also a member of OMNI’s surgeon clinical evaluation and research team. The device has received the CE Mark and a 510(k) has been submitted to FDA for clearance in the United States.

The OMNIBotics system enables optimized knee implant placement using robotics driven by OMNI’s proprietary ART™ software. With more than 13,000 OMNIBotics procedures performed to date worldwide, it provides patient-specific procedures and eliminates the need for preoperative CT scans or x-rays. Intraoperative adjustments are easily made, and the precise alignment of the implant may lead to a more rapid recovery and a more natural feeling total knee replacement.¹ This new robotic tissue balancing device takes patient-specificity one step further and customizes the procedure not only from a skeletal perspective but also from a soft tissue perspective.

“The OMNIBotics tissue balancer provides dynamic real time feedback on the interplay between the soft-tissue envelope and bone cuts in Total Knee Replacement,” said Dr. Brett Fritsch. “Providing a quantitative tool to actively manage soft tissue in combination with the accuracy of a robotic bone cutting guide has the potential to be a significant step forward towards a more natural feeling knee replacement for the patient.”

“The main objective of the OMNI robotics development program is to leverage the capabilities of robotics to assist orthopaedic surgeons in improving patient outcomes at a lower overall cost for the episode of patient care,” said Rick Randall, OMNI CEO. “Our surgeon customers believe a properly aligned and balanced knee throughout the entire range of motion will lead to optimized patient outcomes. The unique capability of robotic-assisted soft tissue balancing, added to the OMNIBotics alignment of the APEX Knee™ is an exciting breakthrough that further advances our value-based outcomes goals.”

ABOUT OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

CONTACT
Cindy Holloway, Director of Marketing Communications Phone: (508) 824-2444
cholloway@omnils.com

¹Ritter, Et al. “The Effect of Alignment and BMI on Failure of Total Knee Replacement”. J Bone Joint Surg, 2011; 93- A:1588-96.

SOURCE OMNIlife science, Inc.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

March 13, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI)(Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, today announced it will exhibit its full EOSapps software suite at the upcoming American Academy of Orthopedic Surgeons (AAOS) Annual Meeting, being held March 14 – 18 in San Diego, California. The AAOS academic program also includes ten oral podium presentations featuring the EOS imaging technology and software solutions.

EOS imaging will particularly showcase hipEOS, a fully integrated pre-op and post-op 3D simulation and planning software which enables enhanced 3D personalized care for patients. hipEOS addresses several key areas of concern for total hip arthroplasty (THA):

Prevention of implant wear, impingement and dislocation risks through personalized implant positioning rather than generic “safe zone” as well as incorporation of functional parameters from standing and seated exams.
Prevention of leg length discrepancy, an important area of concern for patient satisfaction and one of the most common reasons for litigation, through the utilization of weight-bearing 3D data to plan length and position.

Marie Meynadier, CEO of EOS imaging, said: “We are pleased to see increasing acknowledgement in the orthopedic field of the value of EOS 3D imaging and planning, as compared to using higher cost, higher dose, supine CT scanning. The podium presentations highlighting EOS system and applications at this year’s AAOS, along with the significant increase in EOS-related publications in peer-reviewed journals in 2016, which doubled from 2015, support this momentum.”

EOS imaging will be onsite at Booth #4933 (Hall G), where the company will showcase the EOS low dose imaging system and its full suite of FDA cleared surgical planning EOSapps solutions, which includes hipEOS, along with spineEOS and kneeEOS. The EOSapps are online 3D surgical simulation and planning solutions, based on unbiased, weight-bearing EOS images and an accurate 2D/3D patient-specific data set.

In addition to the activities at its booth at AAOS, the Company is scheduled to present at the Canaccord Genuity Musculoskeletal Conference on March 14, 2017 at 10:30 am PST. The conference provides the opportunity for institutional investors to meet with the Company.

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS^®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2016 revenues of €30.8 million and employs 132 people at December 2016, including an R&D team of 43 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Anne Renevot
CFO
Ph: +33 (0)1 55 25 61 24
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent / Valentine Brouchot
Ph: +33 (0)1 44 71 94 96
eosimaging@newcap.fr
or
The Ruth Group (US)
Press relations / Joanna Zimmerman
Ph: 646-536-7006
jzimmerman@theruthgroup.com

SAN DIEGO – March 14, 2017 – Bioventus, a leader in orthobiologic solutions, today announced its plans for the Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) March 13-18 in the San Diego Convention Center. Among the products clinicians visiting Bioventus in booth #5223 can learn more about is GELSYN-3™ the company’s next generation, three-injection hyaluronic acid (HA).

GELSYN-3 helps relieve pain associated with knee osteoarthritis (OA) and is the company’s latest portfolio addition joining its five-injection knee OA solution called SUPARTZ FX^®, and its single-injection OA product known as DUROLANE^®.Both GELSYN-3 and SUPARTZ FX are available exclusively in the US while DUROLANE is available in OUS markets. Bioventus will also feature the EXOGEN^® Ultrasound Bone Healing System and the associated volume of clinical evidence for efficacy that underscores its position as the #1 prescribed bone healing system in the US.

In addition, Bioventus Surgical will highlight its suite of allograft, cell & marrow and synthetic bone graft solutions including: OSTEOAMP^®, a uniquely processed allograft bone graft substitute; CELLXTRACT^™, a novel cell and bone marrow extraction tool; and SIGNAFUSE^™ a bi-phasic mineral composite combined with a patented bioactive glass and resorbable polymer carrier.

“Since it was established in 2012, Bioventus has expanded its portfolio to include 13 offerings for bone healing, osteoarthritis and bone grafts,” said Tony Bihl, CEO, Bioventus. “Our singular and unique focus is on orthobiologics that provide positive outcomes to benefit patients, surgeons, hospitals and payers. We invite AAOS attendees to visit with us and learn more about our solutions which are not only effective, but are backed by clinical and technical data.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN Ultrasound Bone Healing System is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Media Contact:
Thomas Hill, +1 919-474-6715, thomas.hill@bioventusglobal.com

Bioventus, the Bioventus logo, DUROLANE, OSTEOAMP and EXOGEN are registered trademarks and GELSYN-3, CELLXTRACT and SIGNAFUSE are trademarks of Bioventus LLC of Bioventus LLC. SUPARTZ FX is a registered trademark of Seikagaku Corp.

Summary of Indications for Use

OSTEOAMP may be used in situations where an autograft is appropriate. It should be restricted to homologous use for the repair, replacement or reconstruction of musculoskeletal defects. Please see OSTEOAMP instructions for use for complete list of contraindications, warnings, and precautions. Full prescribing information can be found in product labeling at BioventusSurgical.com or by contacting customer service at 1-800-637-4391. It is available in the US only.

SIGNAFUSE is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). SIGNAFUSE can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process. Full prescribing information can be found in product labeling at BioventusSurgical.com or by contacting customer service at 1-800-637-4391. It is available in the US only.

CELLXTRACT is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe. Full prescribing information can be found in product labeling at BioventusSurgical.com by contacting customer service at1-800-637-4391.

SUPARTZ FX is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. You should not use SUPARTZ FX if you have infections or skin diseases at the injection site or allergies to avian (bird) products (feathers and eggs). SUPARTZ FX is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found at www.SupartzFX.com or by contacting customer service at 1-800-836-4080.

GELSYN-3 is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). GELSYN-3 is not to be administered to patients with known hypersensitivity (allergy) to sodium hyaluronate preparations and should not be injected into the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site. Full prescribing information can be found at www.GelSyn3.com or by contacting customer service at 1-800-836-4080.

EXOGEN

Summary of Indications for Use: In Canada, the EU, Australia and New Zealand

EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) including:

Treatment of delayed union and non-unions†
• Accelerating the time to heal of fresh fractures
• Treatment of stress fractures
• Accelerating repair following osteotomy
• Accelerating repair in bone transport procedures
• Accelerating repair in distraction osteogenesis procedures
• Treatment of joint fusion

† A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.

There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling at www.exogen.com.

Summary of Indications for Use in the US

*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions* excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization.

There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080.

*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

DUROLANE

European Union and Chile:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been approved in the EU for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, shoulder, elbow, wrist, fingers, and toes.

DUROLANE SJ (1ml): Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, elbow, wrist, fingers, and toes.

Both DUROLANE and DUROLANE SJ are also indicated for pain following joint arthroscopy in the presence of osteoarthritis within 3months of the procedure.

Full prescribing information can be found in product labeling, or at www.durolane.com.

Canada:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been licensed for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, fingers and toes.

DUROLANE SJ (1ml): Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, fingers and toes.

Both DUROLANE and DUROLANE SJ are also indicated for pain following joint arthroscopy in the presence of osteoarthritis within 3months of the procedure. There are no known contraindications. You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site.

Full prescribing information can be found in product labeling, or at www.durolane.com.

Australia/New Zealand/Mexico:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee osteoarthritis.

There are no known contraindications. You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site. Full prescribing information can be found in product labeling, or at www.durolane.com.

India, Indonesia, U.A.E., Saudi Arabia, Jordan, Hong Kong, Russia:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee and hip osteoarthritis.

Taiwan:

DUROLANE (3ml): Treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

March 13, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced the launch of the AltiVate Anatomic Shoulder System. The system features a short, bone sparing humeral stem anatomically designed through morphologically-based fit analysis to optimize metaphyseal fit and stability. The stem also features P², DJO’s proprietary “porous porous” coating that provides superior bone ingrowth. Coupled with the stem is a glenoid component with patent-pending “Drop and Go™” technology encompassing trilobe features on the peripheral pegs for immediate fixation upon implantation. This data-driven result is a truly anatomic reconstruction with fixation you can feel.

“The AltiVate Anatomic system allows the surgeon to use a short or standard length humeral stem with the same instrument system and introduces a new glenoid component with outstanding initial fixation. The glenoid instrumentation is low profile and user friendly,” states Dr. Gerald Williams of the Rothman Institute and a leading designer of the system. In summary, “this system provides the humeral length you want; the glenoid fixation you need.”

Brady Shirley, President and CEO of DJO Global states, “The release of this new system strengthens our Upper Extremity portfolio, which is already known for its market-leading AltiVate Reverse shoulder system. We believe this will help us sustain our above market growth in this segment. The AltiVate Anatomic is the first of many advancements to come from DJO Global’s developers consisting of world recognized leaders in shoulder arthroplasty.”

This new system will be showcased at this year’s Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS booth #1733) in San Diego, CA.

About DJO Global

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

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for the success of this product family and its Upper Extremity product portfolio. The words “believe,” “will,” “should,” “expect,” ”target,” “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. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause the results of the Company’s new product family and Upper Extremity product portfolio to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the complexities and uncertainties associated with the development of new products; the uncertainties associated with acceptance of the new products by surgeons and patients; new product introduction and other business strategies relative to our Surgical Implant segment; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on March 25, 2016. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP and Treasurer
760-734-3075
ir@djoglobal.com

March 10, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the year ended December 31, 2016.

Mark Perrin, InVivo’s CEO and Chairman, said, “2016 was a year marked by meaningful and significant progress. In 2016, we:

received approval for converting the Neuro-Spinal Scaffold™ pilot study to the pivotal INSPIRE study;
received approval to initiate the INSPIRE study in Canada (1^st global step for InVivo);
added 13 new clinical sites, including our first ex-U.S. sites (both in Canada);
enrolled seven new patients, with three of those patients achieving the primary endpoint of conversion to partial paralysis by six months post-injury¹;
continued our spinal cord injury (SCI) thought leadership by attending and presenting at international conferences, where we presented 13 scientific abstracts to renowned leaders within the neurosurgical, neuroscience, and SCI communities;
raised $32 million (gross), which is the company’s largest fund raising to date;
successfully developed a preclinical prototype of the TrailMaker™ for the chronic spinal cord injury market and filed two patent applications;
garnered unique media coverage about InVivo and the Neuro-Spinal Scaffold in 18 widely-read outlets resulting in nearly 30 million media impressions;
and continued to make great strides in strengthening our research and intellectual property portfolio.

We ended the year with approximately $33 million in cash, cash equivalents, and marketable securities that we project will fund us into the second quarter of 2018, by which time we expect to be able to submit the HDE application for marketing approval of the Neuro-Spinal Scaffold. Over the coming quarters, we will continue to make progress toward this goal by enrolling more patients, increasing sites, expanding into the U.K., and completing enrollment of the INSPIRE study, which we are now projecting will occur in the third quarter of 2017.

In addition to the progress with INSPIRE, we also plan to initiate our first study in cervical SCI in Canada in the coming months. Cervical SCI represents a higher risk, higher reward indication in which the effects of neural preservation, regeneration or remyelination may be more dramatically demonstrated. I am excited at the prospect of building upon last year’s advances and continuing our journey to redefine the lives of patients with spinal cord injuries.”

Financial Results

For the year ended December 31, 2016, the Company reported a net loss of approximately $23,438,000, or $0.76 per share, compared to a net loss of approximately $33,314,000, or $1.26 per share, for the year ended December 31, 2015. Included in results for the years ended December 31, 2016 and 2015 were non-cash gain of $593,000 and a non-cash loss of $10,804,000, respectively, reflecting changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the year ended December 31, 2016, was $24,031,000, or $0.78 per share, compared to an adjusted net loss of $22,510,000, or $0.85 per share, for the year ended December 31, 2015. The Company ended the year with $33,041,000 of cash, cash equivalents, and marketable securities as of December 31, 2016.

Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the impact of the items noted. A reconciliation of these measures to the comparable GAAP measures is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors, enabling them to better understand the Company’s operations, on a period-to-period comparable basis, with financial amounts both including and excluding these identified items.

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 thoracic complete (AIS A) traumatic acute 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” and similar expressions, and include statements regarding expected enrollment in its pivotal INSPIRE study in 2017, expansion of clinical sites into the UK and Canada, initiation of a cervical spinal cord injury study, and the benefits of the Neuro-Spinal Scaffold.. 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 Company’s ability to obtain FDA approval 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 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.


InVivo Therapeutics Holdings Corp.

Consolidated Balance Sheets
(In thousands, except share and per-share data)

	December 31,
	2016	2015
ASSETS:
Current assets:
Cash and cash equivalents	$21,464	$14,920
Restricted cash	361	361
Marketable securities	11,577	5,274
Prepaid expenses and other current assets	451	184
Total current assets	33,853	20,739
Property, equipment and leasehold improvements, net	510	938
Other assets	421	115
Total assets	$34,784	$21,792
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable	$1,011	$521
Loan payable, current portion	423	395
Derivative warrant liability	1,314	1,907
Deferred rent, current portion	141	115
Accrued expenses	1,959	374
Total current liabilities	4,848	3,312
Loan payable, net of current portion	852	1,275
Deferred rent, net current portion	135	276
Total liabilities	5,835	4,863
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.00001 par value, authorized—100,000,000 shares, issued and outstanding 32,044,087 shares at December 31, 2016; and authorized 50,000,000 shares, issued and outstanding 27,555,948 shares at December 31, 2015	1	1
Additional paid-in capital	185,955	150,497
Accumulated deficit	(157,007)	(133,569)
Total stockholders’ equity	28,949	16,929
Total liabilities and stockholders’ equity	$34,784	$21,792


InVivo Therapeutics Holdings Corp.

Consolidated Statements of Operations
(In thousands, except share and per-share data)

	Years Ended December 31,
	2016	2015	2014
Operating expenses:
Research and development	$12,557	$10,058	$10,273
General and administrative	11,506	12,340	7,566
Total operating expenses	24,063	22,398	17,839
Operating loss	(24,063)	(22,398)	(17,839)
Other income (expense):
Interest income	187	60	5
Interest expense	(155)	(172)	(136)
Derivatives gain (loss)	593	(10,804)	(376)
Other income (expense), net	625	(10,916)	(507)
Net loss	$(23,438)	$(33,314)	$(18,346)
Net loss per share, basic and diluted	$(0.76)	$(1.26)	$(0.83)
Weighted average number of common shares outstanding, basic and diluted	31,025,585	26,461,374	22,080,761


Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp.
(In thousands, except share and per share data)

	Three Months Ended				Year Ended
	December 31,				December 31,
	2016		2015		2016		2015
Reported GAAP net income (loss)	(5,435	)	(4,733	)	(23,438	)	(33,314	)
Derivative (gain)/loss	(1,381	)	(544	)	(593	)	10,804
Adjusted net loss	(6,816	)	(5,277	)	(24,031	)	(22,510	)

Reported GAAP net loss per diluted share	(0.17	)	(0.17	)	(0.76	)	(1.26	)
Derivative (gain)/loss per diluted share	(0.04	)	(0.02	)	(0.02	)	0.41
Adjusted net loss per diluted share	(0.21	)	(0.19	)	(0.78	)	(0.85	)

¹ two patients passed away and one unconverted patient has less than six months of follow-up.

Contacts

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

1200px-Acumed_headquarters_-_Hillsboro_Oregon-1200x798.jpg

HILLSBORO, OREGON (PRWEB) MARCH 10, 2017

Acumed LLC, a member of the Colson Associates, Inc. group of companies and a global leader of innovative orthopaedic medical solutions, today announced the appointment of Sharon Wolfington as president and chief executive officer, effective immediately. Ms. Wolfington succeeds Robert Johnson, who had served as Acumed’s president since 2013.

“We are extremely pleased that Sharon Wolfington is joining Acumed as president and chief executive officer,” said Louhon Tucker, president and chief executive officer of Colson Associates, Inc. “Acumed is an outstanding and highly respected company in the orthopaedic implant market. Sharon’s deep orthopaedic industry experience and her broad market knowledge—combined with her successful leadership roles, her focused approach to market-based product innovation, quality and customer service, her record of building successful and effective sales and distribution networks, and her demonstrated belief in and adherence to ethics, accountability, and employee support and mentoring—makes her the ideal individual to lead Acumed forward. I am confident that Sharon will achieve the company’s objectives of sustainable above-market profitable growth and increasing the pace of providing innovative new products for Acumed’s existing and new customers within the orthopaedic market. As always, it is our intent to ease the burden on orthopaedic and trauma surgeons and further improve the standard of patient care.”

Wolfington joins Acumed after most recently serving as president of DJO Recovery Sciences, a Blackstone company. Previously, Wolfington held a number of significant leadership positions with Stryker Corporation, including president of Stryker Performance Solutions and vice president and general manager of Stryker Global Trauma and Extremities. Wolfington is a graduate of the Advanced Management Program of the Harvard School of Business with an undergraduate degree from Miami University in Oxford, Ohio. She is an honorary founding member of the Foundation of Orthopaedic Trauma.

“I am honored to join the Acumed organization and continue the legacy of high ethics and integrity, quality manufacturing, and new product innovation with the goal of delivering an outstanding customer experience. Acumed is 100% dedicated to serving the foot and ankle, trauma, sports medicine, and hand and upper extremity health care professionals. Acumed has the ability to achieve market-leading growth as an agile, fast moving innovator with highly engaged employees and a best-in-class distributor network,” said Wolfington.

About Acumed

Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over two decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. Acumed was founded in 1988 by Randy and Mary Huebner and became a member of the Colson Associates group of companies in 1999. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.

3-10-2017 – Health & Medicine, Press release from: TMR

Lateral lumbar interbody fusion (LLIF) is a minimally invasive technique and is in demand for surgical spinal fusion procedure. LLIF is an effective and safe surgical procedure that makes post-operative recovery quicker and less painful. The incision is made from the side through psoas muscle that allows surgeons to access more surface area with less damage to the tissue and reduced blood loss.

Lateral lumbar interbody fusion is a surgical procedure used to treat specific types of disorders of lumbar spine, such as degenerative disc disease, low grade spondylolisthesis, degenerative scoliosis (asymmetric disc degeneration) and deformity, and some recurrent lumbar herniated disc and lumbar stenosis. Developments in magnification and illumination associated with surgical instrumentation have led to increased applicability of minimally invasive technique for spinal fusion. High device cost and various procedure levels are likely to boost the growth of the market.

Obtain Report Details @www.transparencymarketresearch.com/lateral-lumbar-interbo…

The minimally invasive lateral lumbar interbody fusion has certain advantages such as enhanced spine alignment and easier spine access in several cases such as degenerative diseases and correction in sagittal and coronal deformities. Large number of surgeons prefer this procedure, as it results in less blood loss and lower damage to the tissues around the surgical area. Reduced time for operation and length of hospital stay, greater fusion, and lesser infection rates are the other advantages of this procedure.

Increased incidence of degenerative diseases and rising prevalence of lower back pain in the population above 45 years drive the global lateral lumbar interbody fusion market. Higher visualization resulting in easy and precise operation with less tissue sparing practice are other factors that propel the global lateral lumbar interbody fusion market. However, high cost of operation and risks associated with lateral lumbar interbody fusion such as psoas muscles or neural network injury and bone graft fusion complication restrain the market.

READ THE REST HERE

By Remedy Partners – February 1, 2017

A significant study published in the JAMA Internal Medicine at the beginning of the year demonstrates how a health system effectively reduced episodic expenditures through bundled payments by 20 percent. Notwithstanding the rising national costs of joint replacements, Baptist Health System (BHS) saved $20 million over seven years with bundled payments.

The study, from the Perelman School of Medicine at the University of Pennsylvania, co-authored by Dr. Ezekiel Emanuel, combines hospital and Medicare data to evaluate the costs and care quality for nearly 4,000 hip and knee replacement episodes from July 2008 to June 2015. The five-hospital Baptist Health System in San Antonio, Texas saved more than $5,000 per episode, or $20 million in total savings. BHS also improved outcomes during the study by reducing readmissions, emergency department visits, and inpatient prolonged lengths of stay.

Remedy Partners has achieved similar results in a shorter period of time with engaged, aligned, and motivated provider partners across the country. Our experience has shown that hospitals and physician group practices can replicate this success by developing local, focused networks of cooperating providers and committing to optimized workflows.

READ THE REST HERE

March 1, 2017 – By Nick Bluhm, Director of Strategy & Government Policy at Remedy Partners

When Secretary Price said “people have coverage, but they don’t have care,” he underscored his commitment to one of the core values of bundled payments: patient-centered care. Dr. Price believes that “patients and doctors should be in control of healthcare”; which is why he does not support mandatory pilot programs.” He understands that providers need flexibility, not dictations, to accommodate the needs of their patients.

Dr. Price knows that physicians will need Medicare to accommodate their diverse, local needs in designing payment models. Notably, Secretary Price sees value in voluntary pilot programs, especially the Bundled Payments for Care Improvement initiative (BPCI). During his confirmation hearing, Secretary Price expressed support for voluntary bundled payment models and highlighted the role of the CMS Innovation Center in sponsoring pilot programs, saying that “for certain patients, bundled payments make a lot of sense.”

Expansion and extension of the framework of the BPCI initiative could create a more competitive and long-term approach to bundled payments. Voluntary models should be agnostic to the sponsoring provider; physician groups, post-acute providers and third-party risk-bearing entities have proven highly successful in government and private sector bundled payment programs. For instance, Accountable Care Organizations can use voluntary bundled payments to improve relationships with hospital-based physicians and integrate acute care management into their population health strategy.

READ THE REST HERE

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