News – Page 129 – Selby Spine

WATERLOO, ON, Nov. 1, 2017 /PRNewswire/ – Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received FDA Clearance for revision Total Hip Arthroplasty (THA) with its intellijoint HIP® System. A 3D Mini-Optical Navigation System, intellijoint HIP® provides surgeons with precise measurements for cup position, leg length and offset for THA. Requiring no pre-operative or intra-operative imaging, intellijoint HIP can be used with any implant manufacturer, and for any primary or revision THA.

The revision indication provides surgeons with the ability to evaluate existing THA components to inform intra-operative decision making. The possibility to leave existing components in place can greatly reduce risk to the patient and can contain cost for the hospital. Other image based technologies are not suitable for revision THA as existing components create distortion to pre-operative images, making them unusable for critical patient registration.

“intellijoint HIP for revision gives me accurate positioning information about the existing cup. I can then determine which acetabular components need to be removed due to the component being malpositioned,” explained said Dr. Wayne Paprosky, Midwest Orthopaedics at Rush and a member of Intellijoint’s scientific medical advisory board. “I can document the position to defend why I removed or retained the component. When I am able to leave the cup in place, particularly in high risk patients, the risk of complication is greatly reduced and the procedure is significantly shortened.”

intellijoint HIP is available for Anterior, Posterior and Lateral approaches and can be used on primary and now revision THA. This milestone supports Intellijoint Surgical’s mission of making intellijoint HIP accessible to every surgeon and every patient.

“Our core technology is well suited for revision surgery as it provides accurate intra-operative information without relying on pre-operative x-rays or imaging of any kind,” added Intellijoint Surgical CEO Armen Bakirtzian. “Image-based robotics and navigation systems rely heavily on pre-operative imaging, which could result in significant inaccuracies due to image distortion by metal from the existing components”.

Visit Intellijoint Surgical at the upcoming American Association of Hip and Knee Surgeons (AAHKS) annual meeting (booth 100) in Dallas, Texas from November 3^rd to 4^th to learn about the cutting-edge technology behind intellijoint HIP.

About Intellijoint Surgical:

Intellijoint Surgical® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

SOURCE Intellijoint Surgical Inc.

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October 30, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today provided a general business update and reported financial results for the quarter ended September 30, 2017.

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the third quarter, we focused our resources solely on reopening enrollment into the clinical study of the Neuro-Spinal Scaffold™ in complete thoracic spinal cord injury (SCI). As part of this focus, we reduced our workforce by 39%, which is expected to result in 2018 operating expense savings of approximately $7.3 million.”

Mr. Perrin continued, “Enrollment into the INSPIRE study is currently on hold as we engage with the United States Food & Drug Administration (FDA) to determine the most appropriate clinical path forward. We continue to engage in discussions with the FDA regarding our clinical program and will provide appropriate updates as we obtain further clarity on the issue. We remain wholly committed to our mission of redefining the life of the spinal cord injury patient and progressing the Neuro-Spinal Scaffold in the clinic toward a Humanitarian Device Exemption (HDE) submission.”

INSPIRE Update

Of the 19 patients implanted in The INSPIRE Study to date, 16 patients are in follow-up, 14 of whom have reached the six-month primary endpoint visit. Six of these 14 (42.9%) have improved from complete AIS A SCI to incomplete SCI (one patient to AIS C and five patients to AIS B) at the six-month primary endpoint visit and eight had not converted at that visit. Two of the six patients who converted and were assessed to have AIS B SCI at the six-month primary endpoint were later assessed to have improved to AIS C SCI at the 12 and 24-month visits, respectively. Two of the patients in follow-up have not yet reached the six-month primary endpoint visit although one of these patients was assessed to be AIS C at one month and two months and AIS B at three months. Three patients in the INSPIRE study have died, with the cause of death in each case determined to be unrelated to the Neuro-Spinal Scaffold or implant procedure by the respective site Principal Investigator.

Financial Results

For the three-month period ended September 30, 2017, the Company reported a net loss of approximately $9.4 million, or $0.28 per diluted share, compared to a net loss of $6.2 million, or $0.19 per diluted share, for the three-month period ended September 30, 2016. The results for the three-month period ended September 30, 2017 were unfavorably impacted by increases in general and administrative operating expenses of $804,000 and by a derivative loss of $3.1 million, due primarily to the impact of the August 2017 warrant exchange, partially offset by decreases in research and development operating expenses of $366,000. Excluding the impact of the derivative warrant liability, adjusted net loss for the three-month period ended September 30, 2017 was $6.3 million, or $0.19 per diluted share, compared to adjusted net loss of $5.9 million, or $0.18 per diluted share, for the three-month period ended September 30, 2016.

The Company ended the quarter with $17.2 million of cash, cash equivalents, and marketable securities.

For the nine-month period ended September 30, 2017, the Company reported a net loss of approximately $22.1 million, or $0.68 per diluted share, compared to a net loss of $18.0 million or $0.59 per diluted share, for the nine-month period ended September 30, 2016. The results for the nine-month period ended September 30, 2017 were unfavorably impacted by increases in research and development operating expenses of $863,000, $1.8 million in general and administrative operating expenses and by a non-cash loss on the derivative warrant liability of $2.3 million, due to the impact of the August 2017 warrant exchange and the change in the fair market value of the warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the nine-month period ended September 30, 2017 was $19.8 million, or $0.61 per diluted share, compared to adjusted net loss of $17.2 million, or $0.56 per diluted share, for the nine-month period ended September 30, 2016.

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

About The INSPIRE Study

The 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, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval.

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 repair within and around 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 Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury.

About InVivo Therapeutics

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

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the status of the clinical program, the timing for re-opening enrollment in the INSPIRE Study and the submission of an HDE application to the FDA, and the impact of the restructuring and the reduction in force on the Company’s balance sheet, financial position and cash burn. 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 re-open clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended September 30, 2017, 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
Unaudited

	As of
	September 30, 2017		December 31, 2016
ASSETS:

Current assets:
Cash and cash equivalents	16,434		21,464
Restricted cash	361		361
Marketable securities	734		11,577
Prepaid expenses and other current assets	475		451
Total current assets	18,004		33,853
Property, equipment and leasehold improvements, net	190		510
Other assets	402		421
Total assets	18,596		34,784

LIABILITIES AND STOCKHOLDERS’ EQUITY:

Current liabilities:
Accounts payable	1,270		1,011
Loan payable, current portion	444		423
Derivative warrant liability	41		1,314
Deferred rent, current portion	30		141
Accrued expenses	1,784		1,959
Total current liabilities	3,569		4,848
Loan payable, net of current portion	516		852
Deferred rent, net of current portion	208		135
Other liabilities	52		—
Total liabilities	4,345		5,835

Stockholders’ equity:
Common stock, $0.00001 par value, authorized 100,000,000 shares; 34,234,580 shares issued and outstanding at September 30, 2017; 32,044,087 shares issued and outstanding at December 31, 2016	1		1
Additional paid-in capital	193,493		185,955
Accumulated deficit	(179,243	)	(157,007	)
Total stockholders’ equity	14,251		28,949
Total liabilities and stockholders’ equity	18,596		34,784

InVivo Therapeutics Holdings Corp. Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

	Three Months Ended September 30,				Nine Months Ended September 30,
	2017		2016		2017		2016
Operating expenses:
Research and development	2,928		3,294		9,522		8,659
General and administrative	3,388		2,584		10,389		8,573
Total operating expenses	6,316		5,878		19,911		17,232
Operating loss	(6,316	)	(5,878	)	(19,911	)	(17,232	)

Other income (expense):
Interest income	43		50		152		133
Interest expense	(18	)	(32	)	(58	)	(117	)
Derivatives gain (loss)	(3,059	)	(336	)	(2,264	)	(788	)
Other income (expense), net	(3,034	)	(318	)	(2,170	)	(772	)
Net loss	(9,350	)	(6,196	)	(22,081	)	(18,004	)
Net loss per share, basic and diluted	(0.28	)	(0.19	)	(0.68	)	(0.59	)
Weighted average number of
common shares outstanding, basic and diluted	33,445,002		31,968,357		32,516,190		30,687,263


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

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2017		2016		2017		2016
Reported GAAP net income (loss)	(9,350	)	(6,196	)	(22,081	)	(18,004	)
Add Back: Derivative (Gain)/ Loss	3,059		336		2,264		788
Adjusted Net Loss	(6,291	)	(5,860	)	(19,817	)	(17,216	)

Reported GAAP net loss per diluted share	(0.28	)	(0.19	)	(0.68	)	(0.59	)
Derivative loss per diluted share	0.09		0.01		0.07		0.03
Adjusted net loss per diluted share	(0.19	)	(0.18	)	(0.61	)	(0.56	)

Contacts

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

WARSAW, Ind., Oct. 30, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market, announced today that the Company plans to release its third quarter 2017 financial results on Wednesday, November 8, 2017 after the market closes.

OrthoPediatrics will host a conference call on Thursday, November 9, 2017 at 8:00 a.m. ET to discuss the results. The dial-in numbers are (855) 289-4603 for domestic callers and (614) 999-9389 for international callers. The conference ID number is 9169647. A live webcast of the conference call will be available online from the investor relations page of the OrthoPediatrics’ corporate website at www.orthopediatrics.com.

A replay of the webcast will remain available on OrthoPediatrics’ website, www.orthopediatrics.com, until the Company releases its fourth quarter and full year 2017 financial results. In addition, a telephonic replay of the call will be available until November 16, 2017. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the replay conference ID number 9169647.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is the only diversified orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market. The Company is dedicated to the cause of improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 22 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contact
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

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DALLAS & THORNTON CLEVELEYS, UK (PRWEB) OCTOBER 31, 2017

Pinnacle Spine Group, LLC, the pioneer of in situ graft delivery in spinal fusion, today announced it has filed an application with the Food and Drug Administration (FDA) seeking 510(k) clearance to market its lateral InFill® Lumbar Fusion Systems with PEEK-OPTIMA HA Enhanced polymer from Invibio Biomaterial Solutions (Invibio).

Pinnacle Spine Group pioneered and commercialized the novel concept of delivering bone graft material in situ into an implanted device in order to fill the biologic void that remains with other spinal fusion systems. Invibio’s PEEK-OPTIMA HA Enhanced polymer is an implantable biomaterial grade that combines two clinically proven advanced biomaterials for enhanced bone apposition: PEEK-OPTIMA and Hydroxyapatite (HA), a well-known osteoconductive material. PEEK-OPTIMA HA Enhanced encourages bone on-growth on all surfaces of a device while providing the strength, versatility and performance advantages of its proven predecessor, PEEK-OPTIMA Natural.

“We are excited about the possibility of combining the proven clinical benefits of Invibio’s PEEK-OPTIMA HA Enhanced with the benefits of Pinnacle Spine’s patented InFill technology,” said Zach Sowell, President of Pinnacle Spine Group. “Once cleared we believe the combination of these two technologies will provide surgeons with an ideal solution for improved outcomes in lumbar fusion, one of the more challenging approaches to achieve successful fusion.”

“Pinnacle Spine Group and Invibio share a passion for trying to improve the effectiveness of bone growth in the graft space,” said John Devine Medical Business Director, Invibio Biomaterial Solutions. “The combination of Pinnacle’s technology with our own pioneering materials feels like an obvious collaboration.”

Invibio´s PEEK-OPTIMA HA Enhanced biomaterial offers all the clinical advantages of PEEK-OPTIMA Natural including a modulus similar to cortical bone, reduced stress shielding and artifact-free imaging that allows for clear fusion assessment. Developed by Invibio, a leading provider of biomaterial solutions, this innovative high performance polymer for spinal fusion implants eliminates the extra processing time and expense of alternative bone on-growth technologies, such as coatings. Implant devices made of the novel PEEK-OPTIMA HA Enhanced have already been cleared by regulatory bodies in both the US (FDA 510(k) clearance) and Europe (CE mark approval).

Pinnacle Spine Group was recently granted a new patent related to the delivery of graft material to fill the internal chamber(s) of a spinal fusion device, while allowing for graft material to be in flush contact with the endplate surfaces of the adjacent vertebral bodies. In addition, Pinnacle was recently awarded a new patent related to the architecture of the lateral implant. These latest patents follow the receipt of three earlier U.S. patents covering Pinnacle Spine’s innovative InFill® fusion technology. The company also owns several non-U.S. applications, including applications in Australia, Canada and Europe.

Pinnacle Spine’s InFill® Fusion Systems include an array of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting area, and compatibility with the InFill® graft delivery system. The backbone of the technology is predicated on controlled and precise in-situ placement of bone graft material directly into the implanted device, to achieve maximum contact with the adjacent vertebral endplates.

About Pinnacle Spine Group, LLC

Based in Dallas, Texas, Pinnacle Spine Group, LLC is a privately held medical device company that develops and markets innovative technologies to improve spinal fusion procedures. The Company’s family of FDA-510(k) cleared InFill® Fusion systems provides for superior endplate-to-endplate contact of bone graft material and a complete fill of the disc space, achieved by post-filling the implants after they have been delivered into a targeted intervertebral disc space.

About Invibio Biomaterial Solutions

Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in ~9 million implanted devices worldwide. Further information is available on Invibio´s new website: https://invibio.com
INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

Contact:
Mr. Zach Sowell, President
Pinnacle Spine Group, LLC
214-466-1428

Contacts
Invibio Biomaterial Solutions
Barbara Pasciak, Marketing Communications Manager
barbara.pasciak(at)invibio(dot)com, Phone +1 484-342-6041

Victrex media contact
Beate Sauer, PR & Marketing Communications Manager
bsauer(at)victrex(dot)com, Phone +49 61 92 / 96 49 19

Victrex: Group media or Investor Relations enquiries
Andrew Hanson, Director of Investor Relations & Corporate Communications
ahanson(at)victrex(dot)com, Phone +44 12538 98121

November 1, 2017

Thousand Oaks, CA.—ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting instruments and surgery-ready procedural kits for the medical industry and surgeons worldwide, has launched the Cervical-One™ single-procedure instrument set for use in one and two-level cervical spine implant procedures. The novel instrument set is available for tailoring and branding by spine implant OEMs for securing both plates and screws and interbodies commonly used to treat spine degeneration and deformity cases.

ECA markets and sells its single-use instruments and complete procedural kits to medical device OEMs for private labeling and branding, saving them significant R&D investment and accelerating time to market for new product introduction or legacy product refresh. Tailored to implant manufacturer specifications the Cervical-One™ kits can be branded in different colors, handle shapes and sizes. The instrument sets are ready for rapid adoption across the marketplace to reduce operating cost, eliminate instrument cleaning and re-sterilization, improve patient safety and provide perfect fixation of implants while reducing risk of surgical site infection.

“Cervical-One™ offers spine implant OEMs essentially an off-the-shelf and surgery ready solution that provides them differentiated instrumentation to both clinically and economically meet the growing demand for cervical spine degeneration repair,” said Lane Hale, president and CEO of ECA Medical Instruments. “The simplicity of design and modular instrument approach allows for easy branding and modification to meet surgeon needs for implant fixation, navigation, procedural stack up and OR efficiency gains,” he said.

ECA is marketing the fully disposable instrument kits in three configurations: 1) instrument set for anterior cervical plate and screw fixation, 2) interbody implant fixation kit, and 3) a combined anterior cervical discectomy fusion (ACDF) kit combining instrumentation.

The kits include the full complement of instruments needed by surgeons and OR teams including precision torque-limiters and drivers. All the instruments use state of the art medical grade polymers for strength and durability, are validated and packaged in sterile-pack fully recyclable trays.

An early adopter of the Cervical-One™ instrument kit is Zavation Medical, Jackson, MS. Zavation is collaborating with ECA to develop a family of kits for stand-alone and combined fixation of one and two-level plating and also interbody cages (artificial discs). Zavation expects to launch their new SteriCerv™ line of products in early 2018. Both Zavation and ECA demonstrated the new instrument kits to neurosurgeons and orthopaedic surgeons at the North American Spine Society (NASS) 2017 conference last week in Orlando.

“Single-use instrument kits coupled with sterile packed implants are clearly the way of the future for high volume and relatively low complexity spine surgeries in both the hospital and outpatient setting,” Hale said. “We’re excited to partner with both large and small/medium enterprise OEMs across the spine industry and bring these new instrument kits to market.”

Single-procedure instruments and procedural kits are providing surgeons and patients alike with a pristine set of ready for surgery instruments for securing a wide range of medical device implants. Sustained benefits include elimination of reprocessing costs, improved OR efficiency, reduced risk of surgical site infection and reduction in hospital and ASC inventory management.

ECA is a one stop shop OEM instrument company providing implant firms with complete product design and development, product and packaging validations, CE Mark and dock to stock operations. This reduces OEM costs and accelerates time to market.

About ECA Medical Instruments

ECA Medical Instruments®, a LongueVue Capital Partners company, was founded in 1979 and located in Thousand Oaks, CA. ECA is the industry leader in single-procedure torque-limiting instruments and surgical fixation kits. The company has manufactured and delivered over 35 million precision torque instruments to the world’s leading producers of CRM, neuromodulation, cardiovascular and orthopaedic and spine implants resulting in over 500 million precision surgical actuations. Every 20 seconds of every day an ECA torque instrument or procedural kit is used to secure a medical implant—one patient at a time. ECA is an ISO 13485, CE Mark certified and FDA registered company and was named Business of the Year 2017 by LivaNova. www.ecamedical.com

Media Contact: James Schultz

Phone: +1 805-990-6177

Email: jschultz@ecamedical.com

Jupiter, Florida., October 31, 2017 (PR NEWSWIRE) — Atlas Spine, Inc., a high technology, spinal implant and instrumentation company based in Jupiter, Florida, today announced that the Ortus™ Expandable Posterior Lumbar Interbody System has been 510(k) cleared by the U.S. Food and Drug Administration (FDA). The device is designed to be delivered using either minimally invasive or open surgical approach. The Ortus™ PL is clearly differentiated from other expandable technology. For example it has one of the smallest starting heights (6.5mm) of any expandable device on the market, and relies on a unique, patented design that allows for implant expansion while restoring natural anatomic alignment in a single step. The device also features an open architecture that allows the surgeon to pack ample graft material after the device is deployed and expanded. This is the first implant in a comprehensive line of expandable interbody intellectual property that utilizes anterior, PLIF, oblique, and minimally invasive approaches and devices that the company plans on launching.

“Atlas has a deep pipeline of expandable technology and the Ortus™ 510(k) clearance presents a tremendous opportunity to establish our company as an expandable interbody technology market leader. The Ortus™ platform provides options and capabilities for surgeons focused on restoring spinal balance that is yet to be provided by other devices and companies. Paired with a minimally invasive surgical approach, Ortus™ PL is a powerful tool for spine surgeons seeking reliable fusions with minimal complexity and post-operative morbidity. Furthermore, the Ortus™ PL platform is well suited for anterior, posterior, lateral and oblique approaches, in addition to MIS,” notes Atlas Spine’s co-founder and CTO Matthew Baynham.

Atlas Spine’s CEO Douglass Watson adds, “We are thrilled to be in the expandable posterior lumbar interbody market. The response from key, opinion-leading surgeons is tremendous. We are preparing to launch the Ortus™ PL interbody device with our distributor network in the near future and look forward to numerous additional differentiated device clearances over the next several quarters.”

The U.S. FDA notified the company on the first day of the North Atlantic Spine Society (NASS) meeting. This is Atlas Spine, Inc’s 12^th product to receive 510(k) clearance by the U.S. FDA and allows the Company to access distribution channels and gain measurable market share. It also allows the company to focus on commercializing other significant projects in the pipeline.

About Atlas Spine, Inc.

Our mission is to create spinal implants and instrument systems that treat a variety of pathologies combining the highest level of performance with ease of use which translate to physician satisfaction and enhanced patient outcomes. The company has over 50 issued and pending patents and currently distributes a number of interbody and posterior stabilization systems and has also licensed technology to other companies in the spinal device market.

For more information about Atlas Spine, please visit atlasspine.com.

Contact: Matthew Miller, Atlas Spine Inc., (561) 741-1108 or mmiller@atlasspine.com. Atlas Spine Inc., 1555 Jupiter Park Drive, Suite 1; Jupiter, Florida 33458.

RAYNHAM, Mass., Oct. 31, 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 that they have begun clinical evaluations of their exclusive OMNIBotics Active Spacer robotic tissue balancing device at three U.S. sites. This technology received 510(k) clearance from the FDA on September 1, 2017.

The OMNIBotics Active Spacer, in clinical use since March in Australia, provides the surgeon with a quantitative tool to actively manage the soft tissue envelope with dynamic real-time feedback. When combined with the accuracy of alignment and bone cuts provided by the OMNIBotics system, the result is a completely customized procedure from both a skeletal and a soft tissue perspective.

“I believe that the active spacer technology is the tool we have been looking for to create even better predictability and reproducibility for knee replacement surgery,“ said Jeffrey M. Lawrence, M.D. Viroqua, WI. “I’m very excited to offer this system to my patients.”

Of his early experience, John M. Keggi, MD, Middlebury, CT said, “The active spacer technology is a great step forward that brings the most advanced measurement and analysis tools directly to each patient and surgeon right in the operating room. It’s an unprecedented, real-time evaluation of the knee that optimizes each step of the procedure.”

Studies indicate that a significant percentage of knee replacement patients do not achieve full satisfaction even with well-placed implants. One potential contributing factor is sub-optimal soft tissue balancing.

“The active spacer is an amazing new technology for knee replacement. It actually shows your surgeon, in real time, how tight or loose your knee is on each side as it bends. This information is then fed into a robot, which plans how your knee is replaced on an individual basis for optimum results,” said Amber Randall, MD an orthopedic surgeon in Arizona.

OMNI, a pioneer in robotic-assisted total knee replacement, now offers the only robotic technology that quantitatively drives the total knee replacement surgical procedure with both alignment and ligament balancing. Dr. Randall continues, “I believe that this revolutionary, never before seen technology will get us not one–but several–steps closer to the Holy Grail of knee replacement: the freely moving, perfectly stable and pain free knee.”

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

SOURCE OMNIlife science, Inc.

October 30, 2017

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix^® Orthopaedics today announced the publication of three new studies in the journal Arthroscopy Techniques supporting the use of the company’s NovoStitch^®Plus device for the repair of horizontal cleavage meniscal tears:

Horizontal Cleavage Meniscus Tear Treated With All-Inside Circumferential Compression Stitches, by lead author Jarret M. Woodmass, M.D., of the Department of Orthopedic Surgery and the Sports Medicine Center, Mayo Clinic and Mayo Foundation, Rochester, Minn.
Circumferential Suture Repair of Isolated Horizontal Meniscal Tears Augmented With Fibrin Clot, by lead author Michael S. Laidlaw, M.D., of the Department of Orthopaedic Surgery of the University of Virginia in Charlottesville, Va.
Vertical Lasso and Horizontal Lasso Sutures for Repair of Horizontal Cleavage and Horizontal Oblique Meniscal Tears: Surgical Technique and Indications, by Kenneth R. Brooks, M.D., of Houston Methodist Orthopedics and Sports Medicine in Nassau Bay, Texas

“These publications illustrate the growing recognition that horizontal meniscus tears, previously deemed irreparable, can in fact be repaired with advanced technology,” said Dr. Kenneth Brooks, orthopaedic surgeon and author of one of the reports. “The NovoStitch Plus has given surgeons increased flexibility to develop advanced meniscal repair techniques specifically designed to treat horizontal tears. This allows us to preserve the meniscus in more patients, reducing the likelihood of developing arthritis or requiring knee replacement surgery later in life.”

Patients with meniscus tears often undergo meniscectomy – total or partial removal of the meniscus – due to the difficulty of access and limitations of current arthroscopic instruments. However, meniscectomy significantly increases the risk of arthritis or total knee replacement later in life.¹ In contrast, meniscus repair, a procedure in which the tear is sutured and allowed to heal naturally, is associated with improved long-term outcomes and overall cost savings relative to meniscectomy.² Meniscus surgery is the single most common arthroscopic procedure in the United States, with roughly one million performed annually.

The NovoStitch Plus device allows orthopaedic surgeons to address horizontal, radial, and other complex meniscal tears in ways not previously possible. The system enables the placement of a circumferential compression stitch around the meniscus, which provides uniform compression during healing and allows orthopaedic surgeons to treat these complex injuries.

About Ceterix Orthopaedics

Ceterix^® Orthopaedics develops surgical tools that expand and improve what is possible for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch Plus meniscal repair system has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif. and is backed by investors Versant Ventures, 5AM Ventures and CRG. For more information, please visit www.ceterix.com.

¹ Papalia, R. et. al. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. British Medical Bulletin. 2011; 99:89 – 106.

² Feeley, B. et. al. The Cost-Effectiveness of Meniscal Repair versus Partial Meniscectomy: A Model-based Projection of Clinical Outcomes and Costs in the United States Healthcare System. ISPOR Annual Meeting 2015.

Contacts

For Ceterix Orthopaedics
Jessica Volchok, 310-849-7985
jessica@healthandcommerce.com

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