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InVivo Therapeutics Provides Business Update and Reports 2017 Second Quarter Financial Results

Posted On August 9, 2017 By OrthoSpineNews In Financial /

August 08, 2017

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

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the second quarter, we continued to make significant progress at InVivo. During the quarter, we enrolled four more patients into INSPIRE, and we now have 16 patients in follow-up. One of these patients improved from complete AIS A SCI to motor incomplete AIS C SCI at the one-month visit. We also announced that two patients who had previously converted to AIS B had been assessed to have converted to AIS C at their 12- and 24-month visits, respectively. Of the seven total AIS grade conversions, four are AIS C conversions at this time, meaning these four patients have recovered both sensory and motor function. Given these AIS C conversions and an overall conversion rate of 54.5% (6/11) at the 6-month primary endpoint visit, we remain enthusiastic about the potential of establishing the Neuro-Spinal Scaffold™ as the foundation of a new standard of care for acute spinal cord injury.

“Last week, we announced that the most recent patient to enroll into the INSPIRE study passed away with the cause of death deemed by the Principal Investigator at the site to be unrelated to the Neuro-Spinal Scaffold™ or implantation procedure. This was the third death in the INSPIRE study. Following discussions with the company’s independent Data Safety Monitoring Board (DSMB), we elected to implement a temporary halt to enrollment as we engaged with the FDA to determine whether any changes to the protocol were needed. The FDA responded formally with its recommendations; we are working on assessing the recommendations and formulating a response that will include a protocol amendment. At this time, our primary focus at InVivo is re-opening enrollment in INSPIRE as quickly as possible so that we can continue to make progress toward our goal of redefining the life of the spinal cord injury patient.”

Financial Results

For the three-month period ended June 30, 2017, the Company reported a net loss of approximately $6.3 million, or $0.20 per diluted share, compared to a net loss of $5.2 million, or $0.16 per diluted share, for the three-month period ended June 30, 2016. The results for the three-month period ended June 30, 2017 were unfavorably impacted by increases in operating expenses of $416,000 in research and development and $724,000 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $554,000 for the three-month period ended June 30, 2017 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 three-month period ended June 30, 2017 was $6.9 million, or $0.22 per diluted share, compared to adjusted net loss of $5.8 million, or $0.18 per diluted share, for the three-month period ended June 30, 2016.

The Company ended the quarter with $21.8 million of cash, cash equivalents, and marketable securities.

For the six-month period ended June 30, 2017, the Company reported a net loss of approximately $12.7 million, or $0.40 per diluted share, compared to a net loss of $11.8 million or $0.39 per diluted share, for the six-month period ended June 30, 2016. The results for the six-month period ended June 30, 2017 were unfavorably impacted by increases in operating expenses of $1.2 million in research and development and $1.0 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $795,000 for the six-month period ended June 30, 2017 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 six-month period ended June 30, 2017 was $13.5 million, or $0.42 per diluted share, compared to adjusted net loss of $11.4 million, or $0.37 per diluted share, for the six-month period ended June 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. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.

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 and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882.

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 safety and effectiveness of the Neuro-Spinal Scaffold™ and the status of the clinical program, including the changes to the INSPIRE protocol, the timing for re-opening enrollment in the INSPIRE Study and the submission of an HDE application to the FDA. 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 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 June 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
	June 30, 2017		December 31, 2016
ASSETS:

Current assets:
Cash and cash equivalents	14,322		21,464
Restricted cash	361		361
Marketable securities	7,525		11,577
Prepaid expenses and other current assets	657		451
Total current assets	22,865		33,853
Property, equipment and leasehold improvements, net	305		510
Other assets	409		421
Total assets	23,579		34,784

LIABILITIES AND STOCKHOLDERS’ EQUITY:

Current liabilities:
Accounts payable	878		1,011
Loan payable, current portion	437		423
Derivative warrant liability	519		1,314
Deferred rent, current portion	154		141
Accrued expenses	1,893		1,959
Total current liabilities	3,881		4,848
Loan payable, net of current portion	630		852
Deferred rent, net of current portion	54		135
Other liabilities	45		—
Total liabilities	4,610		5,835

Stockholders’ equity:
Common stock, $0.00001 par value, authorized 100,000,000 shares; 32,175,179 shares issued and outstanding at June 30, 2017; 32,044,087 shares issued and outstanding at December 31, 2016	1		1
Accumulated other comprehensive loss	(1	)	—
Additional paid-in capital	188,862		185,955
Accumulated deficit	(169,893	)	(157,007	)
Total stockholders’ equity	18,969		28,949
Total liabilities and stockholders’ equity	23,579		34,784


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

	Three Months Ended June 30,				Six Months Ended June 30,
	2017		2016		2017		2016
Operating expenses:
Research and development	3,211		2,795		6,595		5,364
General and administrative	3,715		2,991		7,000		5,990
Total operating expenses	6,926		5,786		13,595		11,354
Operating loss	(6,926	)	(5,786	)	(13,595	)	(11,354	)

Other income (expense):
Interest income	52		36		109		91
Interest expense	(20	)	(29	)	(40	)	(92	)
Derivatives gain (loss)	554		595		795		(452	)
Other income (expense), net	586		602		864		(453	)
Net loss	(6,340	)	(5,184	)	(12,731	)	(11,807	)
Net loss per share, basic and diluted	(0.20	)	(0.16	)	(0.40	)	(0.39	)
Weighted average number of
common shares outstanding, basic and diluted	32,185,607		31,907,747		32,115,328		30,039,677

Other comprehensive loss:
Net loss	(6,340	)	(5,184	)	(12,731	)	(11,807	)
Other comprehensive loss:
Unrealized gain (loss) on marketable securities	1		—		(1	)	—
Comprehensive loss	(6,339	)	(5,184	)	(12,732	)	(11,807	)


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

	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2017		2016		2017		2016
Reported GAAP net income (loss)	(6,340	)	(5,184	)	(12,731	)	(11,807	)
Add Back: Derivative (Gain)/ Loss	(554	)	(595	)	(795	)	452
Adjusted Net Loss	(6,894	)	(5,779	)	(13,526	)	(11,355	)

Reported GAAP net loss per diluted share	(0.20	)	(0.16	)	(0.40	)	(0.39	)
Derivative loss per diluted share	(0.02	)	(0.02	)	(0.02	)	0.02
Adjusted net loss per diluted share	(0.22	)	(0.18	)	(0.42	)	(0.37	)

Contacts

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

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100th Patient Enrolled in Clinical Trials for Active Implants’ NUsurface® Meniscus Implant

Posted On August 9, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /

August 09, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants, LLC, a company that develops orthopedic implant solutions, today announced enrollment of the 100^th patient in clinical trials evaluating the NUsurface® Meniscus Implant for the treatment of persistent knee pain caused by injured or deteriorating meniscus tissue. The surgery was performed by orthopedic surgeon Dr. Wayne Gersoff of Advanced Orthopedics & Sports Medicine Specialists in Denver, Co.

“Treating the 100^th NUsurface patient in the U.S. is an important milestone for us as we continue on our mission to fulfill the unmet need in the orthopedic market,” said Ted Davis, president and CEO of Active Implants. “We are pleased that enrollment is going very well and expect to fully enroll all of the patients in the study plan in the coming months. Over the next two to three years, pending FDA clearance, we should be in a position to bring our product to market in the U.S. and fill the gap between minimally invasive meniscus repair and total knee replacement.”

If approved by the Food & Drug Administration, the NUsurface Implant would be the first “artificial meniscus.” The meniscus is a tissue pad between the thigh and shin bones, and once damaged, the meniscus in middle aged patients has a very limited ability to heal itself. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. It has been estimated that from 700,000 to over 1 million partial meniscectomies are performed annually in the U.S. in an attempt to alleviate pain; however, recent studies have shown that many people who get a meniscectomy continue to experience pain that impacts their quality of life and can eventually lead to knee replacement surgery.

“The NUsurface Implant offers hope for patients who are experiencing persistent knee pain following meniscus injury and surgery, have exhausted non-surgical options and are not yet candidates for total knee replacement,” Dr. Gersoff said. “It’s encouraging to know that with this implant we may be able to alleviate pain and swelling, and delay or even avoid knee replacement surgery – allowing these patients to get back to activities they love.”

The NUsurface Meniscus Implant is made from medical grade polymer and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Implant helps mimic the function of the natural meniscus and redistributes loads transmitted across the knee joint. The NUsurface Meniscus Implant has been used in Europe since 2008 and Israel since 2011.

Active Implants is sponsoring two clinical trials to support regulatory approval from the U.S. Food & Drug Administration (FDA): The VENUS (Verification of the Effectiveness of the NUsurface System) trial is a randomized, controlled study comparing the NUsurface Meniscus Implant compared to non-surgical standard of care and the SUN (Safety Using NUsurface) trial is a single-arm study assessing the safety and effectiveness of the NUsurface Meniscus Implant in restoring function similar to that of a natural, healthy meniscus. The clinical trials are continuing to enroll patients in the following U.S. cities:

VENUS Study

Albany, New York – Capital Region Orthopaedics (Richard Alfred, MD)
Boston, Massachusetts – Brigham and Women’s (Andreas Gomoll, MD) and New England Baptist (Brian McKeon, MD)
Columbus, Ohio – Ohio State University (Christopher Kaeding, MD)
Durham, North Carolina – Duke University Medical Center (William Garrett, Jr., MD and Claude T. Moorman III, MD)
Indianapolis, Indiana – OrthoIndy (Jack Farr, MD)
Memphis, Tennessee – OrthoMemphis (Randall Holcomb, MD)
New York, New York – Lenox Hill Hospital (Elliott Hershman, MD)
Richmond, Virginia – Advanced Orthopaedics (Kenneth Zaslav, MD)
Rochester, New York – University of Rochester Medical (Michael Maloney, MD)

SUN Study

Arlington, Texas – Baylor Orthopedic and Spine Hospital (Joseph Berman, MD)
Baton Rouge, Louisiana – Baton Rouge Orthopaedic Clinic (Brent Bankston, MD and Robert Easton, MD)
Boulder, Colorado – Colorado University Sports Medicine (Eric McCarty, MD)
Denver, Colorado – Advanced Orthopedics & Sports Medicine Specialists (Wayne Gersoff, MD)
Long Beach, California – Memorial Orthopaedic Surgical Group (Peter Kurzweil, MD)
New Orleans, Louisiana – Ochsner Sports Medicine Institute (Deryk Jones, MD)
Phoenix, Arizona – TOCA, The Orthopedic Clinic Association (Tom Carter, MD)
Portland, Oregon – Sports Medicine Oregon (Richard Edelson, MD and John Greenleaf, MD)
Salt Lake City, Utah – Salt Lake Regional Medical Center (Andrew Cooper, MD)
San Diego, California – Grossmont Orthopaedic Medical Group (Scott Hacker, MD)
San Francisco, California – St Mary’s Medical Center (William Montgomery, MD)

About Active Implants LLC

Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

Tissue Regenix Completes Acquisition of CellRight Technologies

Posted On August 9, 2017 By OrthoSpineNews In Biologics /

August 09, 2017

LEEDS, United Kingdom–(BUSINESS WIRE)–Tissue Regenix Group plc, a UK- based regenerative medical company (AIM:TRX) announces completion of the acquisition of CellRight Technologies LLC, a US based specialist in regenerative osteoinductive bone scaffolds.

The acquisition, expands the Group’s presence within the US healthcare market and increases US sales by more than double, bringing together two highly complementary technology and product platforms focused on soft-tissue regeneration and regenerative bone matrices, respectively.

TRX has built a portfolio of soft tissue products for use in wound care, orthopaedics and cardiac applications, based on its patented dCELL® Technology with DermaPure, a decellularized dermal allograft for chronic and acute wound care, currently commercialized. CellRight, brings a complementary regenerative technology which is used to turn allograft bone into various malleable applications including, DBM Putty, strips, blocks and fibres, primarily for use in spine, orthopaedics and dental surgeries.

Leveraging the capabilities of CellRight Technologies’ existing tissue bank in San Antonio, TX, Tissue Regenix is set to launch its OrthoPure™ HT, decellularized human tendon, into the U.S. orthopedics market in early 2018, which will initially address anterior cruciate ligament repair. This facility also provides the Group with a purpose built U.S. base to self-manufacture products utilizing its patented dCELL® process.

“The combination of TRX and CellRight Technologies is a crucial step in advancing our regenerative medicine capabilities for patients worldwide,” said Antony Odell, CEO, Tissue Regenix Group. “CellRight’s team have exceptional talent and experience, and their regenerative technology is highly complementary to our own dCELL® soft tissue platform. The benefits of the combined, broad portfolio of innovative soft tissue and bone products is clinically recognised. CellRight and TRX share a common goal and vision. Together, we can expedite and expand our research and development pipelines, increase our market presence both in the US and internationally and create more value for our stakeholders, both clinical and financial. I am pleased to welcome Jesus Hernandez and his team to the Tissue Regenix Group.”

Jesus Hernandez, Founder and CEO, CellRight Technologies: “I am excited to join the TRX team and continue the evolution of the CellRight Technologies products and brand. In TRX we have found a partner that shares our values and commitment to innovation and clinical outcomes. Our combination will allow us to bring our innovative products to a wider patient population and together, commercialise a pipeline of differentiated regenerative treatments.”

Important notice

The information contained herein is not for release, directly or indirectly, in or into Australia, Canada, Japan or the Republic of South Africa. This document (and the information contained herein) does not contain or constitute an offer of securities for sale, or solicitation of an offer to purchase securities, in the United States, Australia, Canada, Japan or the Republic of South Africa or any other jurisdiction where such an offer or solicitation would be unlawful. The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States unless the securities are registered under the Securities Act, or pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. No public offering of the securities will be made in the United States.

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds, UK. The company’s patented decellularisation (‘dCELL®’) technology removes DNA and other cellular material from animal and human soft tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body and can then be used to repair diseased or worn out body parts. Current applications address many critical clinical needs such as sports medicine, heart valve replacement and wound care.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States – ‘Tissue Regenix Wound Care Inc.’, January 2016 saw the establishment of joint venture GBM-V, a multi- tissue bank based in Rostock, Germany.

In August 2017 Tissue Regenix acquired CellRight Technologies®, a biotech company that specializes in regenerative medicine and is dedicated to the development of innovative osteoinductive and wound care scaffolds that enhance healing opportunities of defects created by trauma and disease. CellRight’s human osteobiologics may be used in spine, trauma, general orthopedic, foot & ankle, dental, and sports medicine surgical procedures.

Contacts

Tissue Regenix Group plc
Caitlin Pearson, 07920 272 441
Corporate Communications Director
or
Racepoint Global
Jeff Stoecker, +1-617-624-3424

In2Bones USA Announces FDA Clearance on Two Key Implant Systems

Posted On August 9, 2017 By OrthoSpineNews In Extremities, Regulatory /

August 08, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced that its In2Bones USA, LLC subsidiary has received U.S. Food and Drug Administration (FDA) clearance for its new Fracture and Correction System. The System will be marketed under the 5MS™ Fracture Repair System and the CoLag™ Locking Compression Screw System brand names.

The 5MS Fracture Repair System is a comprehensive plate and screw system that addresses both fractures and deformities of the 5^th metatarsal bone (5^thtoe) of the foot. Unlike competitive systems, the 5MS System features an array of anatomically contoured plates and fracture-specific screws that provides surgeons more options to customize the needed repair.

The new System offers surgeons multiple design and performance improvements compared with traditional plate products, plus the versatility of interchangeable screws and plates, and specially designed surgical instruments – all to enhance surgical technique and treatment efficacy.

“Fractures of the 5^th metatarsal are the most common in athletes of all skill levels. The 5MS™ System’s unique plantar fracture plate design may address many of the healing complications seen from other methods of treatment,” says Kevin Varner, M.D. of Houston Methodist Orthopedics and Sports Medicine.

The CoLag Locking Compression Screw System is an entirely new concept in orthopaedic bone fixation. Differential, dual-pitch screw threads combined with a low-profile head create a compression lock between the bone fragment and fracture, significantly improving compression compared with competitive headless screws.

“Bone fragment stability and compression are important factors in healing. The CoLag System creates the compression of current headless screws while offering the stability, fixation and ease of removal of screws with heads,” says Keith Heier, M.D., Past President of OrthoTexas Orthopedics & Sports Medicine. “This design may be one of the most significant advances in screw fixation in the past 25 years.”

As is true with all In2Bones USA products, the 5MS and CoLag implants are delivered in individual, pre-sterilized packaging, and are UDI compliant and fully traceable.

The past twelve months have been busy for the company. In August 2016, In2Bones USA, LLC and In2Bones, SAS (Lyon, France) merged to form In2Bones Global, Inc., a Delaware corporation headquartered in Memphis. Since the merger, and in addition to these two new Systems, the company has launched several innovative products including the NeoView^® PEEK Distal Radius Plate, the NeoSpan^® SuperElastic Compression Staple, the Reference Toe System™, AlloAid^® PIP, AlloAid^® Nail and the CoLink™ Forefoot Plating System.

“At In2Bones, our goal is to advance the science of extremity surgery,” says Alan Taylor, President and CEO of In2Bones Global. “Our development pipeline is robust and will provide growth opportunities for us around the world.”

For more information about In2Bones Global, Inc. extremity products in the U.S., please contact 844.602.6637, or visit www.i2b-USA.com. In France, visit www.In2Bones.com.

Contacts

Element-R Partners
Susan Duensing, CBC
847.639.8300
susan@rurelevant.com

Lane Hale Named President & CEO of ECA Medical Instruments

Posted On August 9, 2017 By OrthoSpineNews In Extremities, Spine, Top Stories /

Thousand Oaks, CA – ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits for the medical industry and surgeons worldwide, has named Mr. Lane Hale as President & Chief Executive Officer. The Board of Directors tapped Mr. Hale to build upon the 38-year foundation ECA enjoys in the medical device industry and accelerate growth and market adoption of the company’s novel and proprietary disposable instruments and procedural kits for the cardiac rhythm management, neuromodulation, orthopaedic and spine implant market segments.

Mr. Hale joins ECA from Surgical Frontiers, where he was Executive Vice President and helped launch and operate start-up medtech companies to develop advanced surgical technologies focused on improving surgical outcomes. In the medical device industry since 2005, he spent much of his career partnering with many of today’s leading medical device companies developing new technologies, launching new products, and sustaining manufacturing. Mr. Hale has held leadership roles in business development, operations, and finance at Surgical Frontiers, Insightra Medical, CoorsTek Medical, IMDS and MedicineLodge. Mr. Hale has worked in investment banking for Goldman Sachs and in management consulting focused on process improvement. He received a B.A. and M.B.A. from Brigham Young University.

“Over the past four months, ECA’s Board led an extensive CEO search which included dozens of candidates, and Lane was the Board’s top choice given his experience, background, and personality,” said Rick Rees, Chairman of the Board. “The Board is absolutely confident that Lane is the right leader to guide ECA through its next chapter of transformation and growth. With Lane as CEO, ECA is poised to capitalize on an incredible market opportunity and solidify its first mover advantage and leading market position designing and manufacturing orthopedic and spine disposable instruments and sterile-packed instrument sets. We could not be more excited for Lane, ECA, and our customers.”

“I am very excited to join the ECA team and partner with its customers to provide innovative solutions to the clinical challenges and increasing cost pressures they are facing,” said Mr. Hale. “ECA has been a leader in disposable instruments and sterile-packed procedural kits for many years. We have launched these products, which includes proprietary ECA technology, with market leading orthopedic, cardiovascular, cardiac rhythm management and neuromodulation implant OEMs throughout the world. As more OEM’s, hospitals, and ambulatory surgery centers have begun realizing and pursuing the important benefits of single use instrumentation, including operating room efficiency, cost savings, and patient safety, we are poised to be their preferred strategic partner.”

Mr. Hale will be based at ECA’s headquarters in Thousand Oaks, CA, which includes its design center of excellence and turnkey precision-machining, injection molding and clean room operations. ECA operates out of two buildings consisting of over 40,000 square feet of sales and marketing, manufacturing, engineering, quality assurance and administrative space.

ECA’s disposable instruments and procedural kits are gaining increased popularity and demand by
medical device implant OEMs given their ability to eliminate instrument life cycle costs by over $1,000 per procedure, reduce the risk of surgical site infection, provide perfect implant fixation with calibrated torque-limiters, and improve operating room efficiency. They are used widely by the world’s top medical device firms for securing trauma, extremity, and spine implants and are the industry standard for installing every pacemaker, defibrillator and neurostimulation device.

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 32 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 2012 by the Pacific Coast Business Times. www.ecamedical.com

Former Quadriplegic Enrolled in Asterias’ SCiStar Study to Throw Ceremonial First Pitch at Major League Baseball Game

Posted On August 8, 2017 By OrthoSpineNews In Biologics, Neuro /

FREMONT, Calif., Aug. 08, 2017 (GLOBE NEWSWIRE) — Asterias Biotherapeutics, Inc. (NYSE MKT:AST) today announced that Lucas Lindner of Eden, Wisconsin, a quadriplegic patient who has regained functional use of his fingers, hands and lower arms after receiving the company’s investigational stem cell therapy for complete cervical spinal cord injury, AST-OPC1, will throw out the ceremonial first pitch of a Major League Baseball game in Milwaukee on Sunday, August 13th.

“Lucas has been an inspiration to our employees at Asterias who have worked so hard to bring AST-OPC1 to where it is now being administered to patients in a clinical trial, as well as to thousands of others who have seen his story on the internet or on television,” said Mike Mulroy, President and CEO of Asterias. “We are excited about the progress he has made since receiving 10 million cells of AST-OPC1 and look forward to cheering him on as he takes the field before the game.”

Lucas suffered a severe spinal cord injury when his car swerved off the road into a tree to avoid hitting a deer in May 2016. He was flown to the hospital and received immediate surgery to stabilize his spine. He was left without the ability to move his limbs below the neck and upper arms.

In June 2016, Lucas received 10 million cells of AST-OPC1 in Asterias’ ongoing SCiStar Phase 1/2a clinical study by Shekar N. Kurpad, MD, PhD, Sanford J. Larson Professor and Chairman, Department of Neurosurgery at the Medical College of Wisconsin and Director of the Froedtert & Medical College of Wisconsin Spinal Cord Injury Program. Lucas has since regained the ability to move triceps, hands and fingers.

As of his latest follow-up visit (12 months following administration of AST-OPC1), Lucas has achieved two motor levels of improvement on one side of his body. As suggested by existing research, patients with severe spinal cord injuries that show two motor levels of improvement on at least one side may regain the ability to perform daily activities such as feeding, dressing and bathing, which significantly reduces the overall level of daily assistance needed for the patient and associated healthcare costs.

“Throwing out the first pitch at a Major League game is not something I could have imagined a year ago,” said Lucas. “I want to show everyone that there is hope that spinal cord injury patients can regain function. I am looking forward to going back to school, pursuing my dream of working in the IT field and living independently someday.”

“When I first met Lucas about a year ago, he had some use of his arms and little to no use of his hands or fingers,” said Dr. Kurpad. “The fact that he is throwing out the first pitch at a Major League Baseball game is amazing. It illustrates the strides medical science is starting to make in helping paralyzed patients regain useful function. I’m very encouraged by the early results we are seeing with AST-OPC1 and am grateful for the improvement Lucas has made.”

Asterias has now completed enrollment and dosing in four of the five planned SCiStar study cohorts and enrolled twenty-two patients in the SCiStar study. Twenty-seven patients have been administered AST-OPC1 after including patients from a previous Phase 1 safety trial and results-to-date continue to support the safety of AST-OPC1. In June 2017, Asterias reported 9 month data from the AIS-A 10 million cell cohort that showed improvements in arm, hand and finger function observed at 3-months and 6-months following administration of AST-OPC1 were confirmed and in some patients further increased at 9-months. The company intends to complete enrollment of the entire SCiStar study later this year, with multiple safety and efficacy readouts anticipated during the remainder of 2017 and 2018.

To view a video on Lucas’ story, click on the following link: https://youtu.be/1DerDpM_FO4.

Broadcast quality b-roll footage is available for news media use by request by contacting mark@reachthenextlevel.com.

About the SCiStar Trial

The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with subacute, C-4 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may have retained some minimal sensory function below their injury site. AST-OPC1 is being administered 21 to 42 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.

The study is being conducted at eight centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) jointly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago, Santa Clara Valley Medical Center in San Jose jointly with Stanford University, Thomas Jefferson University Hospital, in partnership with Magee Rehabilitation Hospital, in Philadelphia, and UC San Diego Health in San Diego.

Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.

Additional information on the Phase 1/2a trial, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells originally isolated in 1998, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with cervical spine injuries in the current SCiStar study, which represents the first targeted population for registration trials. Asterias has completed enrollment in the first four cohorts of this study. Results to date have continued to support the safety of AST-OPC1. Additionally, Asterias has recently reported results suggesting reduced cavitation and improved motor function in patients administered AST-OPC1 in the SCiStar trial.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company’s proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS

Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

Contacts:
Investor Relations
(510) 456-3892
or
EVC Group, Inc.
Michael Polyviou/Greg Gin
(646) 445-4800

Media
Thomas D. Gibson
GIBSON Communications, LLC
(201) 476-0322 – Main
(201) 264-3646 – Mobile

RTI Surgical® Announces 2017 Second Quarter Results

Posted On August 8, 2017 By OrthoSpineNews In Financial /

August 08, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, reported operating results for the second quarter of 2017. RTI has delivered two consecutive quarters of revenue growth as its initiatives to transform the business continue to yield improving operating performance.

In the second quarter 2017, as described in greater detail below, each of RTI’s businesses generated top-line growth, including its commercial business, which continues to show signs of stabilization. RTI also delivered double-digit revenue growth across its direct business, including its spine, surgical specialties and cardiothoracic segments, as well as continued revenue growth in its sports medicine and orthopedics segment and its International business.

“We are making tangible progress toward our plan to transform RTI and return it to a path of solid, predictable and sustainable growth,” said Camille Farhat, chief executive officer, RTI. “While we are still in the early phase of this effort and there is more work to do, we are beginning to accomplish what we set out to achieve. Our Commercial business continues to stabilize, our direct business delivered another quarter of strong performance and our Spine business continues to grow at above-market rates. We are encouraged by our strong second quarter results and remain laser-focused on implementing our strategic initiatives and generating value for our employees, customers and shareholders.”

As previously announced, RTI’s management has been implementing a series of initiatives to reduce complexity, drive operational excellence, and accelerate growth to position the company for long-term and sustainable profitability. As part of these initiatives, RTI has appointed Paul Montague as Head of Human Resources and Enrico Sangiorgio to lead the company’s international operations. Mr. Montague brings more than 15 years of global experience in senior human resources roles to RTI and Mr. Sangiorgio’s nearly two decades of leadership positions with European healthcare organizations will be instrumental in growing RTI’s International platform. The company is also actively recruiting for its top two R&D positions.

As part of its focus to reduce complexity, RTI recently completed the previously announced sale of substantially all the assets of its cardiothoracic closure business to an affiliate of A&E Medical Corporation for total consideration of up to $60 million in cash. Concurrent with the sale of the business, RTI entered into a multi-year Contract Manufacturing agreement whereby RTI will continue to support the cardiothoracic business under A&E Medical’s ownership through the manufacturing of existing products and the engineering, development and manufacturing of potential new products in the future.

RTI used the majority of the proceeds from the sale, net of transaction fees and anticipated taxes, to reduce its term loan, as it extended the maturity of its existing credit facilities. The transaction was made possible by RTI’s success growing its cardiothoracic closure business by a compounded annual growth rate of more than 25% over the last five years, through a focused R&D and disciplined direct channel strategy, and demonstrates RTI’s proven ability to create value in OEM product lines. The sale of the cardiothoracic closure business represents an important action toward RTI’s stated goals to reduce complexity in its business and devote resources to those businesses, products and markets with the greatest growth potential.

“Longer-term, our focus will continue to be to: 1) simplify our business to manage costs, specifically in tissue acquisition and processing, 2) deepen our investments in our people with a focus on R&D to accelerate growth and innovation, and 3) ensure a culture of disciplined execution to achieve sustainable profitability,” said Mr. Farhat. “The sale of our cardiothoracic closure business during the quarter was an important first step toward our effort of enhancing RTI’s platform for operational excellence. We are committed to further streamlining our business and evaluating strategic growth opportunities so that we can devote resources to the areas that align best with our long-term growth aspiration. With our talented team, dedication to our customers and innovative products, I am optimistic that RTI is on the right path to success.”

Second Quarter 2017

RTI worldwide revenues were $72.1 million for the second quarter of 2017, an increase of 7 percent. Direct revenues were $43.6 million for the second quarter of 2017, an increase of 10 percent compared to the second quarter of 2016, with double-digit growth reported in RTI’s spine, surgical specialties and cardiothoracic direct business segments. Commercial/other revenues were $28.6 million for the second quarter of 2017, an increase of 2 percent compared to the second quarter of 2016.

Net loss applicable to common shares of $2.6 million in the second quarter of 2017, or $0.04 per fully diluted common share, primarily due to a previously disclosed pre-tax charge for severance-related expenses totaling $3.4 million. As outlined in the reconciliation tables that follow, excluding these charges, adjusted net income applicable to common shares was $965,000 and adjusted net income per fully diluted common share was $0.02.

Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA) were $8.3 million, or 11 percent of second quarter revenue.

Fiscal 2017 Outlook

The company has developed its guidance based on its ongoing restructuring and operational improvement program, its current business profile and existing market conditions.

Within this context, based on second quarter results and the transition of the cardiothoracic closure business from a direct business to a commercial business as a result of the sale, RTI expects full year revenues for 2017 to be between $274 million and $280 million compared to prior guidance of between $274 million and $285 million, with direct revenues anticipated to grow low-to-mid single digits on a percentage basis compared to 2016, while commercial/other revenues are expected to be relatively flat on a percentage basis.

As detailed in the reconciliation provided later in this release, excluding the severance-related expenses in the first half of 2017, the expected third quarter 2017 gain on the sale of the cardiothoracic closure business, and including the transition of the cardiothoracic closure business from a direct business to a commercial business as a result of the sale, RTI expects adjusted full year net income per fully diluted common share to be between $0.04 and $0.08 compared to prior guidance of between $0.05 and $0.10, based on 60 million fully diluted shares outstanding.

RTI will continue to evaluate its operating platform throughout the year and will update its top and bottom line guidance as its actions might warrant.

Conference Call

RTI will host a conference call and simultaneous audio webcast to discuss its second quarter 2017 results at 8:30 a.m. ET today. The conference call can be accessed by dialing (877) 383-7419. The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on the RTI website following the call.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.


RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)


	For the Three Months Ended						For the Six Months Ended
	June 30,						June 30,
		2017			2016			2017			2016
Revenues	$	72,120		$	67,620		$	142,059		$	134,971
Costs of processing and distribution		35,157			33,671			69,317			64,997
Gross profit		36,963			33,949			72,742			69,974

Expenses:
Marketing, general and administrative		29,496			28,402			59,167			55,954
Research and development		3,740			4,084			7,428			8,245
Severance charges		3,400			711			7,803			711
Restructuring charges		–			1,107			–			1,107
Contested proxy expenses		–			2,372			–			2,680
Total operating expenses		36,636			36,676			74,398			68,697
Operating income (loss)		327			(2,727	)		(1,656	)		1,277
Total other expense – net		(990	)		(424	)		(1,789	)		(738	)
(Loss) income before income tax (provision) benefit		(663	)		(3,151	)		(3,445	)		539
Income tax (provision) benefit		(1,026	)		859			(116	)		(430	)
Net (loss) income		(1,689	)		(2,292	)		(3,561	)		109
Convertible preferred dividend		(924	)		(870	)		(1,834	)		(1,728	)
Net loss applicable to common shares	$	(2,613	)	$	(3,162	)	$	(5,395	)	$	(1,619	)

Net loss per common share – basic	$	(0.04	)	$	(0.05	)	$	(0.09	)	$	(0.03	)
Net loss per common share – diluted	$	(0.04	)	$	(0.05	)	$	(0.09	)	$	(0.03	)
Weighted average shares outstanding – basic		58,935,786			58,215,477			58,715,791			58,065,185
Weighted average shares outstanding – diluted		58,935,786			58,215,477			58,715,791			58,065,185


RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of Net (Loss) Income Applicable to Commons Shares to Adjusted EBITDA
(Unaudited, in thousands)


	For the Three Months						For the Six Months
	Ended June 30,						Ended June 30,
	2017			2016			2017			2016
Net (loss) income	$	(2,613	)	$	(3,162	)	$	(5,395	)	$	(1,619	)
Interest expense, net		915			386			1,734			746
Provision for income taxes		1,026			(859	)		116			430
Depreciation		2,652			3,454			5,324			6,836
Amortization of intangible assets		909			930			1,805			1,858
EBITDA		2,889			749			3,584			8,251
Reconciling items for Adjusted EBITDA
Preferred dividend		924			870			1,834			1,728
Non-cash stock based compensation		974			600			1,808			1,100
Foreign exchange gain		75			38			55			(8	)
Other reconciling items(1)
Severance charges excluding stock based compensation		3,400			711			7,470			711
Restructuring charges		–			1,107			–			1,107
Contested proxy expenses		–			2,372			–			2,680
Adjusted EBITDA	$	8,262		$	6,447		$	14,751		$	15,569
Adjusted EBITDA as a percent of revenues		11	%		10	%		10	%		12	%


(1)See explanations in Use of Non-GAAP Financial Measures section later in this release.


RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of Net Loss Applicable to Common Shares and Net Loss Per Diluted Share to
Adjusted Net Income (Loss) Applicable to Common Shares and Adjusted Net Income (Loss) Per Diluted Share
(Unaudited, in thousands, except per share data)

	For the Three Months Ended
	June 30, 2017						June 30, 2016
	Net Income Applicable to Common Shares			Amount per Diluted Share			Net Income Applicable to Common Shares			Amount per Diluted Share



As reported	$	(2,613	)	$	(0.04	)	$	(3,162	)	$	(0.05	)
Severance charges		3,400			0.06			711			0.01
Restructuring charges		–			–			1,107			0.02
Contested proxy expenses		–			–			2,372			0.04
Tax effect on adjustments		178			0.00			(1,237	)		(0.02	)
Adjusted *	$	965		$	0.02		$	(209	)	$	(0.00	)

	For the Six Months Ended
	June 30, 2017						June 30, 2016
	Net Income Applicable to Common Shares			Amount per Diluted Share			Net Income Applicable to Common Shares			Amount per Diluted Share



As reported	$	(5,395	)	$	(0.09	)	$	(1,619	)	$	(0.03	)
Severance charges		7,803			0.13			711			0.01
Restructuring charges		–			–			1,107			0.02
Contested proxy expenses		–			–			2,680			0.05
Tax effect on adjustments		(1,304	)		(0.02	)		(1,355	)		(0.02	)
Adjusted *	$	1,104		$	0.02		$	1,524		$	0.03


* See explanations in Use of Non-GAAP Financial Measures section later in this release.
Amount Per Diluted Share may not foot due to rounding.

Fiscal 2017 Outlook

Full year net income per fully diluted common share is expected to be in the range of $0.00 to $0.04, based on 60 million fully diluted shares outstanding. Excluding severance charges taken in 2017, full year net income per fully diluted common share is expected to be in the range of $0.04 to $0.08.


RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP Guidance Net Income Per Common Share – Diluted to
Adjusted Non-GAAP Guidance Net Income Per Common Share – Diluted
(Unaudited)


		Twelve Months Ended
		December 31, 2017
		$ Amount
		Per Common
		Share – Diluted
GAAP Guidance Net Income Per Common Share – Diluted		$ 0.00 – 0.04
Severance charges, net of tax effect		0.04
Adjusted Non-GAAP Guidance Net Income Per Common Share – Diluted		$ 0.04 – 0.08

Use of Non-GAAP Financial Measures

To supplement the Company’s unaudited condensed consolidated financial statements presented on a GAAP basis, the Company discloses certain non-GAAP financial measures that exclude certain amounts, including Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share – Diluted. The calculation of the tax effect on the adjustments between GAAP net (loss) income applicable to common shares and non-GAAP net income applicable to common shares is based upon our estimated annual GAAP tax rate, adjusted to account for items excluded from GAAP net (loss) income applicable to common shares in calculating Adjusted Net Income Applicable to Common Shares-Diluted. A reconciliation of the non-GAAP financial measures to the corresponding GAAP measures is included in the tables listed above.

The following is an explanation of the adjustments that management excluded as part of adjusted measures for the three and six month period ended June 30, 2017 and 2016 as well as the reason for excluding the individual items:

(1) Severance charges – This adjustment represents charges relating to the termination of former employees. Management removes the amount of these costs from our operating results to supplement a comparison to our past operating performance.

(2) Restructuring charges – This adjustment represents the closure of our French distribution and tissue procurement office. Management removes the amount of these costs from our operating results to supplement a comparison to our past operating performance.

(3) Contested proxy expenses – This adjustment represent charges relating to contested proxy expenses. Management removes the amount of these costs from our operating results to supplement a comparison to our past operating performance.

Material Limitations Associated with the Use of Non-GAAP Financial Measures

Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share – Diluted should not be considered in isolation, or as a replacement for GAAP measures.

Usefulness of Non-GAAP Financial Measures to Investors

The Company believes that presenting Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share – Diluted in addition to the related GAAP measures provide investors greater transparency to the information used by management in its financial decision-making. The Company further believes that providing this information better enables the Company’s investors to understand the Company’s overall core performance and to evaluate the methodology used by management to assess and measure such performance.


RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Revenues
(Unaudited, in thousands)


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2017		2016		2017		2016

Revenues:
Spine	$	19,419	$	17,645	$	39,757	$	34,739
Sports medicine and orthopedics		12,997		12,562		25,893		25,082
Surgical specialties		1,456		802		3,236		1,817
Cardiothoracic		3,673		2,905		6,824		5,439
International		6,005		5,663		11,662		11,180
Subtotal direct		43,550		39,577		87,372		78,257
Global commercial		25,837		24,769		49,418		50,099
Other revenues		2,733		3,274		5,269		6,615
Total revenues	$	72,120	$	67,620	$	142,059	$	134,971


RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)

	June 30,			December 31,
	2017			2016
Assets
Cash and cash equivalents	$	13,675		$	13,849
Accounts receivable – net		39,099			41,488
Inventories – net		116,773			119,743
Prepaid and other current assets		6,177			5,213
Assets held for sale		1,750			–
Total current assets		177,474			180,293

Property, plant and equipment – net		84,379			83,298
Goodwill		54,887			54,887
Other assets – net		49,854			49,553
Total assets	$	366,594		$	368,031

Liabilities and Stockholders’ Equity
Accounts payable	$	27,745		$	26,112
Accrued expenses and other current liabilities		25,668			26,772
Current portion of long-term obligations		5,779			6,080
Total current liabilities		59,192			58,964

Deferred revenue		6,176			6,612
Long-term liabilities		75,201			77,523
Total liabilities		140,569			143,099

Preferred stock, including accrued dividends		61,941			60,016

Stockholders’ equity:
Common stock and additional paid-in capital		417,886			416,570
Accumulated other comprehensive loss		(6,903	)		(8,316	)
Accumulated deficit		(246,899	)		(243,338	)
Total stockholders’ equity		164,084			164,916
Total liabilities and stockholders’ equity	$	366,594		$	368,031


RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited, in thousands)

	For the Three Months						For the Six Months
	Ended June 30,						Ended June 30,
	2017			2016			2017			2016
Cash flows from operating activities:
Net (loss) income	$	(1,689	)	$	(2,292	)	$	(3,561	)	$	109
Adjustments to reconcile net (loss) income to net cash
provided by operating activities:
Depreciation and amortization expense		3,561			4,384			7,129			8,694
Stock-based compensation		974			600			1,808			1,100
Amortization of deferred revenue		(1,186	)		(1,217	)		(2,460	)		(2,434	)
Other items to reconcile to net cash provided by operating activities		(624	)		5,311			7,697			5,740
Net cash provided by operating activities		1,036			6,786			10,613			13,209
Cash flows from investing activities:
Purchases of property, plant and equipment		(3,877	)		(4,766	)		(7,160	)		(9,403	)
Patent and acquired intangible asset costs		(1,526	)		(195	)		(1,845	)		(1,391	)
Net cash used in investing activities		(5,403	)		(4,961	)		(9,005	)		(10,794	)
Cash flows from financing activities:
Proceeds from long-term obligations		2,000			4,000			4,000			7,000
Net payments from short-term obligations		–			(600	)		–			(849	)
Payments on long-term obligations		(3,125	)		(4,166	)		(7,375	)		(8,299	)
Other financing activities		1,467			14			1,433			(94	)
Net cash provided by (used in) financing activities		342			(752	)		(1,942	)		(2,242	)
Effect of exchange rate changes on cash and cash equivalents		102			(47	)		160			(33	)
Net (decrease) increase in cash and cash equivalents		(3,923	)		1,026			(174	)		140
Cash and cash equivalents, beginning of period		17,598			11,728			13,849			12,614
Cash and cash equivalents, end of period	$	13,675		$	12,754		$	13,675		$	12,754

Contacts

RTI Surgical Inc.
Robert Jordheim
Chief Financial Officer
rjordheim@rtix.com
or
Roxane Wergin, 386-418-8888
Director, Corporate Communications
rwergin@rtix.com

FH Orthopedics, Inc. announces successful initial implantations of the Arrow® Prime Dual-Platform Total Shoulder System in the U.S.

Posted On August 8, 2017 By OrthoSpineNews In Recon, Top Stories /

(PR NewsChannel) / August 8, 2017 / CHICAGO

FH Orthopedics, Inc. (FH Inc.), a designer and manufacturer of sports medicine, trauma and joint reconstruction products, announced today the successful first total shoulder arthroplasty using the novel Arrow®Prime cementless glenoid baseplate. Supported by 14 years of successful clinical history, Arrow®Prime offers surgeons unparalleled intraoperative flexibility, dual-platform interchangeability, and addresses the continuum of indications for shoulder arthroplasty in an efficient, 4-tray instrument system.

The Arrow®Prime was cleared by the FDA in April 2017 and has been implanted successfully in multiple centers across the U.S.

Patrick Noud, MD (Lansing, MI) implanted the first Arrow®Prime cementless glenoid baseplate in the U.S. “My initial experience was very satisfying. Relative to traditional cemented polyethylene glenoid implants, the Arrow®Prime anatomic metal-backed glenoid and instrumentation were seamless and efficient, the press-fit of the porous implant impressive, and the procedure was quicker, as no bone cement was required.”

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The ApiFix Spinal Implant Receives TGA Certification

Posted On August 8, 2017 By OrthoSpineNews In Spine, Top Stories /

MISGAV, Israel, Aug. 8, 2017 /PRNewswire/ — ApiFix, a portfolio company of The Trendlines Group, received TGA certification through its distributor Orthotech Pty. Ltd. to begin marketing the ApiFix system in Australia for the treatment and correction of Adolescent Idiopathic Scoliosis (AIS) using an innovative, minimally invasive surgical approach.

The ApiFix system represents a breakthrough treatment for Adolescent Idiopathic Scoliosis (AIS) as it is a minimally invasive, non-fusion spinal implant system which dramatically improves the quality of life of patients who undergo scoliosis surgery. Additionally, it saves hospitalization and OR time, and is considerably more cost-effective than current scoliosis surgery.

“Incorporating the ApiFix system into our portfolio of products fits our mission to bring exceptional, unique, state-of the-art orthopedic products into the Australian market. The ApiFix system provides game-changing technology for AIS patients and surgeons alike and we’re proud to include them in our suite of products,” commented Sam Scott-Young, Managing Director of Orthotech.

Standard scoliosis surgical correction is a highly invasive, lengthy procedure involving a long recovery period, and resulting in a rigid spine due to fusion of the vertebrae. The ApiFix approach brings an ingenious solution with its minimally invasive, non-fusion spinal implant system, inserted in a short procedure, followed by a brief recovery period, and maintains spine flexibility.

ApiFix CEO Eran Feldhay, M.D. remarked: “The certification for the ApiFix product by the TGA through our distribution partnership with Orthotech allows us to expand our reach and provide treatment for AIS patients in Australia too. We look forward to working with a company like Orthotech who are committed to innovative orthopaedic solutions for their customers.”

About ApiFix

ApiFix is an innovation-driven medical device company focused on providing less invasive solutions for scoliosis patients. ApiFix’s leading product for non-fusion treatment of adolescent idiopathic scoliosis (AIS) is used today in Europe. ApiFix is led by a team of highly-regarded spine surgeons and veteran spine specialists. The company has CE clearance and is marketed in Germany, Italy, Greece, The Netherlands, Spain and Israel.

ApiFix principals will attend the annual meeting of the Scoliosis Research Society, (SRS) in Philadelphia, USA on September 5-8 to present the ApiFix system, clinical cases and their follow-up to potential users from all over the world.

Contact: Saar Wollach, ApiFix Sales & Marketing Manager, +972-54-4511512, Philadelphia saar@apifix.com

MiMedx Updates The Status Of Its More Than 5,400 U.S. Hospitals Under Contract

Posted On August 8, 2017 By OrthoSpineNews In Recon /

MARIETTA, Ga., Dec. 7, 2015 /PRNewswire/ — MiMedx Group, Inc., the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today an update of its total portfolio of National Account contracts.

The Company’s National Account contracts are primarily with Group Purchasing Organizations (“GPOs”) and Integrated Delivery Networks (“IDNs”) which provide valuable financial and efficiency-related services for healthcare providers, including the major hospital networks in the U.S. Through these National Account relationships, MiMedx currently has over 5,400 U.S hospitals under contract for the Company’s allografts.

Parker H. “Pete” Petit, Chairman and CEO, said, “We are pleased to partner with the many GPOs and IDNs in our National Account portfolio. These organizations bring both clinical and cost effectiveness resources to the hospitals, ambulatory surgery centers, physician practices and other facilities and entities they serve. Our allografts are recognized for improving patient outcomes, reducing costs and eliminating waste. We share a common goal with these organizations to improve patient outcomes while controlling costs. Our mutual focus to this cause has contributed to our rapid success in establishing our robust National Account network.”

Bill Taylor, President and COO, commented, “We currently have the nation’s four largest GPOs under contract for our allografts. Our contracts cover approximately 95% of the hospitals in the U.S. today, and include our full line of dehydrated human amnion/chorion membrane (dHACM) allografts. In addition, we now have more than 50 IDN systems under contract with MiMedx. Some of our IDNs under contract are also affiliated with the GPOs we have under contract. Many of the IDN Systems have entered into a committed level with MiMedx for our allografts.”

“We continue to have on-going negotiations with additional IDNs to be included in our National Account network. We want to be certain our clinically effective and cost effective allografts can be accessed by the greatest number of patients that can benefit from them. Our vast relationships with GPOs and IDNs are a critical element in achieving that goal,” added Petit.

About MiMedx
MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues. “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies are AmnioFix®, EpiFix®, CollaFix™ and OrthoFlo. AmnioFix and EpiFix are our tissue technologies processed from human amniotic membrane derived from donated placentas. Through our donor program, a mother delivering via scheduled full-term Caesarean section birth can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 500,000 allografts to date for application in the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. The Company has recently introduced OrthoFlo, an amniotic fluid derived allograft for homologous use. Amniotic fluid is donated by consenting mothers delivering healthy babies by scheduled full-term Caesarean section births. CollaFix™, our next technology platform we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair. CollaFix™ is the only biological, biodegradable, biomimetic technology that matches human tendon in strength and stiffness.

Month: August 2017

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