Kuros Biosciences Reports Financial Results for First Half-Year of 2017

Posted On September 26, 2017 By OrthoSpineNews In Financial /

26 Sep 17

Kuros, an orthobiologic company with several commercial-stage products, today announced the financial figures for the first six months of 2017. The Company reported significantly lower net operating costs of CHF 7.5 million and a substantial reduction of net loss of CHF 7.0 million (first half-year 2016: CHF 13.3 million) mainly due to the absence of non-recurring, non-cash charges. Cash reserves by mid-year 2017 amounted to CHF 21.4 million.

Summary of progress since the beginning of the year:

• All-share strategic acquisition of Xpand accelerates Kuros’ transition to commercial stage and provides an EU hub for future distribution, pre-clinical and manufacturing operations.

• Newly appointed CEO Dr. Ivan Cohen-Tanugi prepares Kuros for late-stage clinical development of Fibrin-PTH candidates and for product launches and commercialization in the United States of America and the European Economic Area.

• MagnetOs received clearance for commercialization in the Unites States as well as in Europe, while Neuroseal received clearance in Europe.

• Portfolio extension into new formulations and indications is well underway with MagnetOs Putty receiving market clearance in the United States and filing the product for CE marking in Europe.

• Successful placement of new shares strengthens Kuros’ equity base to fund future commercial activities and Fibrin-PTH development programs.

Dr. Ivan Cohen-Tanugi, Chief Executive Officer of Kuros, said: “The smooth integration of Xpand represents an important shift towards commercialization resulting in a orthobiologics company with commercial-ready products in the US and the EU.” He continued: “Kuros is focusing on differentiated biologics and devices, which improve patient and surgery outcomes. We strongly believe that our commitment to scientific evidence will differentiate our products and benefit patients and payers once our orthobiologics become available to surgeons next year.“

Key figures

in TCHF, IFRS	Six months ended June 30, 2017	Six months ended June 30, 2016
Revenue	534	1,055
Research and development	(2,211)	(5,215)
General and administrative	(6,777)	(11,054)
Other income	1,522	1,161
Net operating costs	(7,466)	(15,108)
Key figures (ctd.)
Net financial result	(247)	955
Net loss	(6,970)	(13,255)
Cash reserves	21,417	17,446
Number of employees (FTE)	34	14

The Interim Report 2017 can be downloaded at www.kuros.ch/investors/reports-presentations.html.

In an all-share strategic business combination, Kuros acquired Dutch-based Xpand Biotechnology effective January 23, 2017. For accounting purposes Xpand has been identified as the acquiree. The total equity consideration is estimated at CHF 30.6 million, including contingent consideration of CHF 9.4 million. As part of the provisional purchase price allocation, Kuros identified currently marketed products with a preliminary fair value of CHF 7.3 million and in-process research and development with a preliminary fair value of CHF 19.2 million. The provisional purchase price allocation results in a goodwill of CHF 9.9 million.

Higher cash reserves due to capital increase

Funds available for financing the operations of Kuros amounted to CHF 21.4 million as per June 30, 2017. This is CHF 9.0 million higher than on December 31, 2016 (CHF 12.4 million). Cash levels decreased due to cash spent in operations and increased due to the proceeds from the rights offering conducted in June 2017.

The gross cash burn for operating activities, as calculated on the cash flow statement, was CHF 5.10 million during the first six months of 2017 or CHF 0.9 million in average per month, compared to CHF 3.8 million and CHF 0.6 million, respectively, in 2016.

Expenses for CE mark drive net result

Operating expenses decreased to CHF 7.5 million (first half-year 2016: CHF 15.1 million) primarily due to significantly lower non-cash expenses in connection with share-based payments occurred in the first six months of 2017. Expenses for research and development of CHF 2.2 million reflect costs for filing preparations, while expenses for general and administrative of CHF 6.8 million contained costs for personnel (CHF 4.2 million) and, among other expenses, costs associated with the business combination with Xpand. Revenues amounted to CHF 0.5 million (first half-year 2016: CHF 1.1 million) and originated primarily from a milestone payment for the CE mark certification of Neuroseal. Other income was CHF 1.5 million (first half-year 2016: CHF 1.1 million) and included proceeds from sub-lease agreements.

The net financial result was CHF –0.2 million (first half-year 2016: CHF 1.0 million). The net loss as per June 30, 2017 amounts to CHF 7.0 million compared to CHF 13.3 million in the corresponding period in 2016. The primary reason for the substantial decrease of CHF 6.3 million are the substantial one-time, non-recurring, non-cash-relevant charges occurred in conjunction with the business combination of Cytos Biotechnology AG and Kuros Biosurgery Holding AG in the first half-year 2016.

Key figures

in TCHF, IFRS	Six months ended June 30, 2017	Six months ended June 30, 2016
Revenue	534	1,055
Research and development	(2,211)	(5,215)
General and administrative	(6,777)	(11,054)
Other income	1,522	1,161
Net operating costs	(7,466)	(15,108)
Key figures (ctd.)
Net financial result	(247)	955
Net loss	(6,970)	(13,255)
Cash reserves	21,417	17,446
Number of employees (FTE)	34	14

The Interim Report 2017 can be downloaded at www.kuros.ch/investors/reports-presentations.html.

Higher cash reserves due to capital increase

Expenses for CE mark drive net result

Status and Outlook

Kuros’ products are advancing according to plan with MagnetOs Putty having received clearance for commercialization in the United States and being filed for CE marking in Europe. The CE certification of the novel sealant Neuroseal in the European Union was obtained in June 2017. In light of the Company moving to commercial stage with MagnetOs and late-stage clinical with Fibrin PTH, Kuros has decided to streamline its organization and to make the position of Chief Technology Officer, currently held by Dr. Jason Schense, redundant. Therefore, the employment relationship with Dr. Schense has been terminated in accordance with the contractual notice period of six months and he ceases to be a member of the Executive Committee. Kuros thanks Jason Schense for his great contribution during these years.

For further information, please contact:

Kuros Biosciences Ltd

Harry Welten, MBA

Chief Financial Officer

Tel +41 79 750 15 64

harry.welten@kuros.ch

About Kuros Biosciences

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kuros.ch for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

DiscGenics Raises $14 Million in Series B Financing

Posted On September 26, 2017 By OrthoSpineNews In Financial /

SALT LAKE CITY, Sept. 26, 2017 /PRNewswire/ — DiscGenics, Inc., a clinical stage regenerative medicine company focused on developing regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced it has closed a $14 million Series B financing.

The round brings DiscGenics’ total funding to $21.7 million, and was jointly led by the Company’s Board of Directors, existing long-term investors and new investment partner and observer Mitsubishi UFJ Capital Co. Ltd.

“The success of this financing round demonstrates the high level of confidence our investors have in our vision of transforming the way millions of patients suffering from the debilitating effects of chronic back pain are treated, beginning with our first product candidate, IDCT, an injectable cell therapy for degenerative disc disease,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. “As we pursue dual regulatory tracks in the U.S. and Japan for IDCT, the addition of Mitsubishi UFJ Capital, one of the world’s leading financial groups, as an investment partner will be invaluable.”

“DiscGenics’ revolutionary approach to treating degenerative diseases of the spine by introducing therapeutic cells that originate from the exact cell type they are intended to regenerate, presents a significant clinical opportunity to address a major unmet need, and with it, a very compelling investment opportunity,” said Najeeb Thomas, MD, a practicing neurosurgeon and Managing Partner at Southern Brain & Spine in New Orleans, LA and an investor in DiscGenics. “I believe in the potential of this technology to change the way we care for patients with chronic back pain and in the DiscGenics team to execute on its mission of bringing this product through the clinic to market.”

“The global market for low back pain is immense and we see an incredible opportunity for DiscGenics to be a major disruptive player in the space,” said Junichi Masuda, Managing Director and Director at Mitsubishi UFJ Capital Co. Ltd. “Our investment in DiscGenics enables us to play an important role in the development of a potentially game-changing technology while continuing to build our biotechnology investment portfolio.”

DiscGenics is using the proceeds from this round to support clinical development of IDCT in the U.S. and Japan, ramp up translation of its cell therapy manufacturing process for Phase III clinical and commercial production, and to fund ongoing operations.

About DiscGenics
DiscGenics is a privately held, clinical stage regenerative medicine company focused on developing regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics is harnessing the restorative potential of cells native to the intervertebral disc to develop what we hope will be a profound therapeutic option for millions of patients suffering from the debilitating effects of back pain. DiscGenics’ first product candidate, IDCT, is a homologous, allogeneic, injectable cell therapy for the treatment of patients with mild to moderate degenerative disc disease.

SOURCE DiscGenics, Inc.

Nov 03, 2016, 08:00 ET

Preview: DiscGenics Fortifies its Intellectual Property Portfolio with 9 Additional Patents

Medicrea Partners with Orthopaedic Surgeon in World’s First 360-Degree Personalized Spine Surgery

Posted On September 26, 2017 By OrthoSpineNews In Spine, Top Stories /

September 26, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD ASI™ technology, announced today the successful completion of a 360-degree spinal surgery using a bespoke combination of patient-specific implants generated by Medicrea’s proprietary UNiD ASI™ system technology.

The complex two-stage operation took place in London at the Wellington Hospital and was performed by Orthopaedic Surgeon, Dr. Benjamin Taylor, MB, BS, MCh(ortho), FRCS, FRCS(Ed). Dr. Taylor partnered with Medicrea’s UNiD LAB™ team of specialized biomedical engineers to strategically plan the operation and design four custom implants to be precisely manufactured in titanium at the company’s new ultra-modern facilities, all within a tight deadline before surgery. The successful outcome was the result of patient-specific spinal instrumentation being implanted from the front and back to create the first-ever 360-degree personalized spinal surgery.

“The ability to strategically plan and manufacture personalized implants in a controlled iterative process generated by Medicrea’s proprietary UNiD ASI™ system technology was a key element in the success of this operation, helping me to simplify and expedite the procedure. Because the implants are scientifically designed using clinical data, I am confident that this patient will continue to see improvements in their quality of life due to the sophisticated outcome-based technology that UNiD ASI™ injects throughout the process,” stated Dr. Taylor following the operation.

Medicrea’s UNiD ASI™ systems technology was used to create a fully personalized solution for the operation that was adapted to both surgeon and patient requirements. The process began with the Company’s UNiD LAB™ engineers using proprietary planning software to turn Dr. Taylor’s surgical plan into a fully digital simulation using patient imaging. The optimal surgical strategy was then identified by Dr. Taylor who was able to draw on the technology’s Adaptive Spine Intelligence™ to directly answer to his and his patient’s needs. Medicrea’s engineering team took this strategy and translated the digital plans into patient-specific implants, using its proprietary manufacturing techniques to create bespoke spinal rods and interbody devices for the operation.

On the day of the surgery, the implants were already at the hospital, prepared to be placed in two stages. First, Dr. Taylor addressed the patient’s spine through an anterior approach where three custom UNiD™ Cages were inserted between the patient’s lumbar vertebrae to restore the exact height to the spine according to the patient’s unique anatomy. The implants were also perfectly sized to form an exact fit between the patient’s vertebrae, leading to a marked reduction in the operation time required to size and place standard off-the-shelf implants.

In the second stage of the operation, the patient’s spine was approached posteriorly. Here, Dr. Taylor inserted two patient-specific UNiD™ Rods to stabilize the patient’s spine in a predetermined patient-specific alignment. Sagittal alignment of the spine is well known to be directly correlated with the long-term success of a spinal surgery, and as such, matching the rod’s shape with the patient’s unique spinal curvature is a critical component of the surgery and was previously only achieved by manually bending the rod during the operation.

Denys Sournac, President and CEO of Medicrea, stated, “Our partnership with Dr. Taylor in this case demonstrates the power of UNiD ASI™’s system-based approach. We offer true collaboration with surgeons to deliver outcome-based data science that is adapted to surgeon and patient in each spine surgery. The result has been to drive improved outcomes and efficiencies in more than 1,500 UNiD ASI™ cases to date. ”

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 100,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com

Stryker’s Serrato Pedicle Screws Implanted by More Than 100 Surgeons in First Month, Prior to Full Commercialization

Posted On September 26, 2017 By OrthoSpineNews In Spine, Top Stories /

September 26, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that Serrato™ Pedicle Screws have been implanted by more than 100 surgeons across the U.S. during the first 30 days since release, prior to full commercialization.

The Serrato Pedicle Screw is the first dual-thread screw with enhanced cutting flutes (serrations) that are designed to reduce work by lowering the insertion torque, and True-tip geometry, which allows for precise insertion and immediate bone engagement. Stryker’s design innovations elevate one of the most basic spinal surgery tools, with the goal of reducing work, increasing speed, and enhancing surgeon efficiency.

“We are very excited by the initial response to Serrato from our early users,” said Bradley Paddock, President of Stryker’s Spine division. “The feedback from surgeons is exceeding expectations.”

“Game-changing screw,” said Roderick Sanden, M.D., an orthopedic surgeon with Advanced Neurospinal Care and Sutter Roseville Medical Center in Northern California. “I never thought a pedicle screw made that much of a difference until I put in a Serrato screw.”

“The Serrato screw insertion was exactly what I was hoping for,” said Scott Luhmann, M.D., Head of Surgery, Pediatric Orthopaedics at Shriners Hospital for Children in St. Louis. “It allowed for easy initiation of the screw, good tactile feedback, and excellent purchase!”

The Serrato pedicle screw, intended for use in the non-cervical spine as part of the company’s Xia^® 3 Spinal System, received 510(k) clearance from the U.S. Food and Drug Administration in May 2017. Serrato leverages the broad portfolio of the Xia 3 Spinal System, an orthopedic spinal system comprised of a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae or the spinal column for purpose of stabilization. The screws accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6.0mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.

Intended Use

The Xia 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. For the full Indications for Use, please refer to the Xia 3 Spinal System Instructions for Use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Content ID: TLSER-PR-2_15523

Dr. Luhmann is a paid consultant of Stryker. His statements represent his own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Contacts

Sullivan & Associates
Barbara Sullivan, 714-374–6174
bsullivan@sullivanpr.com

Paxeon Reconstruction Proves It Saves Hospitals Significantly Through the Results of a Retrospective Study Performed by Dr. Christian Christensen

Posted On September 26, 2017 By OrthoSpineNews In Financial, Recon /

Paxeon Reconstruction, a manufacturer of best-in-class orthopedic products including derivative and emerging products, announces that Dr. Christian Christensen has completed a retrospective study that included 147 patients that underwent total hip arthroplasty in an outpatient surgery center.

Total hip arthroplasty has traditionally been performed in hospitals with a 3-5 day hospital stay. More recently, these surgeries have been done in outpatient surgery centers. These surgery centers have allowed higher levels of surgeon control and increased patient satisfaction. Performing traditionally inpatient procedures in an outpatient arena has allowed the opportunity for cost savings that can be shared by patients, surgeons, and surgery center owners. Cost savings are experienced by decreasing the length of facility stay and also by decreasing the material expenses associated with performing total hip arthroplasty.

Dr. Christensen of Lexington, Kentucky has compared the cost of performing total hip arthroplasty with a Paxeon product versus performing the procedure with both a Stryker and a Biomet product. Over a calendar year, these 147 cases were performed with a savings of more than $2,700 per Biomet hip and $1,040 per Stryker hip.

Since Dr. Christensen used the value based Paxeon product, an annual savings of over $400,000 per Biomet hip and over $150,000 per Stryker hip was realized. All hips were uncemented and included a ceramic head and a cross-linked polyethylene.

Kyle Sineath, President of Paxeon Reconstruction said: “We are thankful to Dr. Christensen for bringing to light the fact that our implants can result in massive savings to the healthcare system.”

______

About Paxeon Reconstruction

Paxeon Reconstruction builds best-in-class orthopaedic products, including derivative and emerging products. We collaborate with hospitals, health systems and physicians to create alignment and utilization of value-based solutions combined with efficiency models for today’s changing healthcare environment. Paxeon Reconstruction offer the world’s most comprehensive portfolio of orthopaedic products and services for joint reconstruction. Paxeon Reconstruction has a celebrated clinical history, and has evolved to meet the needs of the changing orthopaedics marketplace. The history that weaves the fabric of the Paxeon Reconstruction is one that is rich with innovation and demonstrates sustained leadership in an ever-changing landscape of patient and professional needs.

LifeLink Tissue Bank Announces New Taiwan Distribution Partnership

Posted On September 25, 2017 By OrthoSpineNews In Biologics /

Tampa, FL – (September 23, 2017) – LifeLink Tissue Bank, a division of LifeLink Foundation, Inc. headquartered in Tampa, FL, announced a new partnership with Taiwan-based HCT Regenerative, in which LifeLink will provide allografts for patients suffering from sports, orthopedic and/or spine injuries.

HCT Regenerative was established in July 2016, and is the first company in Taiwan to focus on processing human tissue to produce regenerative biomaterials for clinical use. LifeLink will procure and provide to HCT certain bone and tissue for HCT’s use in its operations, while both parties will collaborate to assist HCT in the growth and development of its operations.

Jean Davis, President and CEO of LifeLink Foundation, Inc. said, “LifeLink is pleased to work with HCT Regenerative, which will provide tissue for reconstructive procedures to save and heal lives, and increase donation opportunities for donors and their families. This is a great opportunity for LifeLink to make an impact in Taiwan and across Asia.”

James Tsai, Ph.D., HCT cofounder and Managing Director, said, “It is a great honor to partner with LifeLink Foundation. Together we are dedicated to providing high quality allografts to improve patients’ quality of life in the Asia-Pacific region.”

About LifeLink:

LifeLink Foundation, an independent, non-profit community service organization is dedicated to the recovery and transplantation of organs and tissue. The Foundation is made up of five divisions: LifeLink Tissue Bank, which recovers and processes tissue for patients in need, LifeLink of Florida, LifeLink of Georgia, and LifeLink of Puerto Rico, three federally-certified organ procurement organizations; and LifeLink Transplantation Immunology Laboratory, which supports 15 organ-specific transplant programs. Additionally, the LifeLink Legacy Fund supports the LifeLink Foundation mission through transplant patient assistance, research and programmatic grants to improve organ and tissue donation, and transplantation. Learn more about LifeLink Foundation at www.LifeLinkFoundation.org, or LifeLink Tissue Bank at www.LifeLinkTB.org.

About HCT Regenerative:

HCT Regenerative is devoted to developing advanced human cellular and tissue based products (HCT/Ps) to improve patients’ quality of life. The company aims to cultivate relationships with American tissue banks as well as hospitals and medical device companies in Taiwan to help achieve the goals. Additionally, HCT Regenerative will develop and manufacture high quality tissue allografts for surgeons throughout the Taiwanese market to benefit patients in need. For more information visit www.HCTRegenerative.com.

JointPoint, Inc. Signs Exclusive Agreement with DePuy Synthes to Co-Market JointPoint’s Non-Invasive Computer Navigation System for Hip Replacement

Posted On September 25, 2017 By OrthoSpineNews In Recon, Top Stories /

BELLEAIR BLUFFS, Fla., Sept. 25, 2017 /PRNewswire/ — JointPoint, Inc., providers of non-invasive computer navigation, preoperative digital templating, case planning, and intra-operative feedback, is announcing that it has signed an exclusive agreement with DePuy Synthes to co-market its proprietary software platform. JointPoint™ integrates easily into the Direct Anterior Approach hip replacement technique.

“With over 1,000 cases completed over the last several months, surgeons are enjoying the benefits of JointPoint’s non-invasive hip navigation,” said Noah Wollowick, President and Co-Founder of JointPoint. “We are excited to solidify this co-marketing agreement with DePuy Synthes, a worldwide leader in orthopaedics, to gain better access to surgeons across the country that want to use our innovative technology.”

JointPoint’s intraoperative software streamlines fluoroscopic use while providing the surgeon significant data on cup position, leg length and offset. Additionally, JointPoint’s OneTrial™ technology incorporates implant specific data that has the potential to reduce trialing during surgery.

“I used to rely on multiple fluoroscopic images and trials to confirm a patient’s leg length and offset,” said Dr. Charles Decook, MD. “With the OneTrial™ technique from JointPoint, I am able to trial and shoot one fluoroscopic image, that is it. It tells me my offset and leg length and I am able to clearly pick the neck and head that works best for that patient. It has not only made me more efficient but also more accurate. I wouldn’t even think of interpreting a fluoroscopic image now without JointPoint.”

Adding the JointPoint software to a surgeon’s protocol may help reduce leg length discrepancy and complications related to inaccurate cup placement and final implant selection – two of the most important considerations in hip replacement surgery – by providing pre-surgical digital templating and real-time, data-driven surgical decision making in the operating room.

JointPoint’s navigation system minimizes adoption challenges of the anterior approach surgical method for hip replacement by providing cup position, leg length and offset data for a surgeon using as few as 3 radiographic images.

“One of the major benefits of anterior approach hip replacement is the power of intraoperative fluoroscopy and its ability to improve implant positioning, something all surgeons strive for consistently,” said Andrew J. Cooper, M.D., JointPoint’s Chief Medical Officer and Co-Founder. “JointPoint harnesses the potential of fluoroscopy and allows surgeon to meet this goal efficiently with minimal images.”

About JointPoint, Inc.

JointPoint, Inc. develops and markets software-driven medical technology for orthopaedics. The JointPoint™ software solution and OneTrial™ technology is a completely non-invasive navigation system for hip replacement surgery that provides intraoperative data and guides component selection while also optimizing efficiency within a surgical workflow. For more information, visit http://www.jointpoint.com

SOURCE JointPoint, Inc.

Warding Off Decline, Hospitals Invest in Outpatient Clinics

Posted On September 25, 2017 By OrthoSpineNews In Financial, Top Stories /

By Melanie Evans/September 25, 2017

Some of the hospital industry’s most active investing these days is happening outside the hospital.

Giant U.S. hospital operators, including Tenet Healthcare Corp., Dignity Health and HCA Healthcare Inc., are investing heavily in surgery centers, emergency rooms and urgent care clinics located outside hospitals, chasing after patients who increasingly want cheaper and more convenient care.

Insurers and employers that pay for health care are helping drive the change as they shift more Americans to high-deductible insurance plans, which require patients to pay more of their medical bills before insurance kicks in. That has pushed more patients to seek lower-cost options, says RBC Capital Markets managing director Frank Morgan, a hospital analyst.

Hospital demand slumped during the last recession, a trend that has continued even as the economy recovers, American Hospital Association data through 2014 show. Admissions growth at HCA hospitals has slowed in recent quarters to 1% to 2%, as a boost from the Affordable Care Act faded, while Tenet’s admissions have been flat or down 1% to 3% most quarters since late 2015.

In an effort to strengthen their hold on their markets and prevent rivals from siphoning off patients, hospitals are investing outside their own walls. They are “following the patient,” Mr. Morgan said.

The strategy also places hospital satellites closer to where patients live and work, which executives say they hope will win over new, loyal customers.

In July, Ashley Hammack rushed to a new free-standing ER in Spring Hill, Tenn., after growing weak from vomiting. The facility, a satellite of TriStar Centennial Medical Center, is a 10 minute drive from her home, about 20 minutes closer than the hospital where she delivered her daughter five months before.

Doctors saw her quickly. “I never even sat down,” Ms. Hammack recalled. She was treated for severe dehydration from what doctors suspected was food poisoning and sent home with medication.

Trevor Fetter, Tenet’s outgoing chief executive, says company executives have pursued rapid outpatient expansion partially out of necessity. Slumping admissions contributed to Tenet and HCA lowering their earnings estimates for 2017, which in turn hit stock prices.

It’s unclear how the shift to out-of-hospital care will affect long-term earnings. Non-hospital operations typically generate lower revenue than hospitals but produce higher profit and require less capital to build and run.

But “it’s happening anyway,” Mr. Fetter said. “Somebody else is going to do it to us if we don’t do it ourselves.”

READ THE REST HERE

SI-BONE Announces Publication of iMIA – a 2nd Multicenter Randomized Controlled Trial of the iFuse Implant System®

Posted On September 25, 2017 By OrthoSpineNews In Spine /

SAN JOSE, Calif., Sept. 25, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company which pioneered the use of the iFuse Implant System^® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of one-year results from iMIA (iFuse Implant System Minimally Invasive Arthrodesis; ClinicalTrials.gov ID NCT01741025). iMIA is a randomized controlled trial, conducted at 9 hospitals in 4 countries in Europe, that assessed the safety and effectiveness of SI joint fusion with the iFuse Implant compared to conservative management (CM) in patients with chronic SI joint dysfunction. This Level 1 study was published in Pain Physician, the official journal of the American Society of Interventional Pain Physicians and titled 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint¹. The study showed that for patients with chronic low back pain (LBP) due to certain types of SI joint dysfunction, minimally invasive SI joint fusion with the iFuse Implant was safe and more effective than CM in relieving pain, reducing disability, and improving patient function and quality of life at one year. The full article can be found at the following link: http://www.painphysicianjournal.com/current/pdf?article=NDYwOQ%3D%3D

The study included 109 subjects enrolled between June, 2013 and May, 2015 and follow-up for this publication extends through October, 2016. Mean age was 48.1 years, 75 subjects (72.8%) were women and mean SI joint pain duration was 4.7 years. Most (72.8%) had undergone prior SI joint steroid injections, a minority (16.5%) had had prior radiofrequency ablation and about 1/3 (35.9%) had undergone prior lumbar fusion, a known risk factor for SI joint pain. Patients in the surgical arm of the study were treated with the iFuse Implant, which has been commercially available in the United States since 2009.

As shown in the figures below, at one year, mean LBP improved by 41.6 VAS points (0 – 100 VAS pain scale) in the SI joint fusion group compared to 14.0 points in the CM group (Figure 1), and the mean Oswestry Disability Index (ODI) improved by 25.0 points in the SI joint fusion group compared to 8.7 points in the CM group (Figure 2). Also, mean improvements in leg pain and EQ-5D-3L were large after SI joint fusion and superior to those after CM. CM subjects were allowed to cross over to SI joint fusion after six months and subjects who crossed over to surgical treatment had no pre-crossover improvement in pain and ODI scores. After crossover, improvements in most measures were as large as those patients originally assigned to SI joint fusion.

“It’s been most gratifying to be a part of this important trial to help identify the value and benefits of the use of the iFuse Implant for SI joint patients who no longer benefit from conservative therapies,” said Bengt Sturesson, MD, from Ängelholm Hospital, Ängelholm, Sweden and one of the study authors. “The one-year results from iMIA clearly show consistent outcomes with the previously published U.S. RCT, INSITE, thus further validating the applicability of the iFuse Implant to patients across a broad spectrum of clinical practitioners.”

Aaron Calodney, MD of Texas Spine & Joint Hospital in Tyler, TX said, “as a member and past president of the American Society of Interventional Pain Physicians, I am delighted to see such a high-quality study be published in the Pain Physician journal. In addition, I continue to be impressed with both the quantity and quality of the clinical evidence being generated that clearly separates the iFuse Implant from all other SI joint surgical options.”

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain^2-5, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.⁶ Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs. Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes. Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections to confirm the diagnosis.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions. The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution. The iFuse Implant™ was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. Patients with certain types of sacroiliac joint dysfunction experience pain that can be debilitating. SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

1.        Dengler J, Kools D, Pflugmacher R, et al. 1-Year Results of a Randomized Controlled Trial of Conservative Management vs.
Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain. Pain Physician. 2017;20:537-50.
2.        Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res.
1987;217:266–80.
3.        Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
4.        Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in
54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
5.        Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
6.        DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain
Med. 2011;12:732–9.

SOURCE SI-BONE, Inc.

Amedica Releases First and Second Quarter 2017 Preliminary Unaudited Earnings Report and Business Update

Posted On September 22, 2017 By OrthoSpineNews In Financial /

SALT LAKE CITY, UT–(Marketwired – Sep 22, 2017) – Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, today announced its preliminary earnings report for the first and second quarters ended March 31, 2017 and June 30, 2017, respectively, and provided a business update related to its business strategy and certain recent developments.

2017 Q1 PRELIMINARY EARNINGS REPORT — UNAUDITED

Amedica reported preliminary unaudited revenue of $2.6 million for the first quarter of 2017 as compared to revenue of $4.2 million for the first quarter of 2016. Preliminary unaudited GAAP net loss for the first quarter of 2017 was $0.07 per share, compared to net loss of $0.30 per share in the first quarter of 2016. The company’s cash and cash equivalents were $6.9 million at March 31, 2017, a decrease of $1.0 million from March 31, 2016.

2017 Q2 PRELIMINARY EARNINGS REPORT — UNAUDITED

Amedica reported preliminary unaudited revenue of $3.2 million for the second quarter of 2017 and $5.8 million for the six month period ending June 30, 2017, as compared to revenue of $4.0 million for the second quarter of 2016 and $8.2 million for the six month period ending June 30, 2016. Preliminary unaudited GAAP net loss for the second quarter of 2017 was $0.05 per share, compared to net loss of $0.40 per share in the second quarter of 2016. For the six month period ended June 30, 2017, the company reported preliminary unaudited GAAP net loss of $0.12 per share, compared to a net loss of $0.71 per share in for the six month period ending June 30, 2016. The company’s cash and cash equivalents were $3.5 million at June 30, 2017, a decrease of $1.7 million from June 30, 2016.

BUSINESS UPDATE AND RELATED DEVELOPMENTS

Unaudited Financial Update

As of September 1, 2017, the company has approximately $2.4 million of term debt payable to Hercules, down from $24.3 million of total debt owing in July 2015. The Hercules debt, being currently amortized, will retire by January 2018, or sooner. The company also has $2.7 million of debt payable to North Stadium Investments, without prepayment penalties, back-end fees, debt covenants, or other restrictions. The North Stadium Investments debt is currently being amortized and will retire by July 28, 2018, or sooner.

Commercialization Report

The Alpha launch of Amedica’s Taurus™ Pedicle Screw System, a spine fixation product line that received FDA clearance in November 2016, has now shifted to the Beta launch phase with the release of additional sets to the field. Over 125 new surgeries have been performed with the system generating over $750,000 in new revenue year-to-date. The company plans to release additional sets in the fourth quarter of 2017 to provide increased access to the system to meet new surgeon demand.

In August 2017, the company continued a trend of month-on-month increasing sales of the Taurus system and had its highest monthly revenue year to date. The August sales were led by high demand for the Taurus and Preference pedicle screw systems.
Other commercialization highlights include:

38% increase in surgeons users since the end of 2016.
14% increase in sales agents representing our products versus end of 2016, with many of these agents in parts of the United States that presently had no representation of the company’s products.
A new Area Vice President for the Southeast region has been hired. His 20+ years of spine sales experience is consistent with the experience of other AVP and VP leadership team members.

Research and Development

Recent Research and Development Highlights:

During 2017, Amedica’s R&D group has published 15 peer-reviewed journal articles and 7 scientific proceedings on various aspects of silicon nitride. 5 additional manuscripts are in preparation or are at various stages of submission and peer review.
There have been a total of 19 presentations made at scientific conferences to date. More recently, a presentation entitled, “Osteoinductive Properties of Silicon Nitride, Alumina, and Titanium,” given at the ORS Midwest Musculoskeletal Workshop at Washington University Medical School in July won the “Best Poster” Award.
The company has completed an initial friction and wear test of polished silicon nitride against native cartilage. Preliminary data show that silicon nitride is at least non-inferior in its friction and wear performance as compared to typical cobalt chrome alloys that are currently used in this application.
Initial characterization and cell adhesion studies on silicon nitride, PEEK, and titanium performed under the company’s multi-year agreement with Texas A&M University’s School of Dentistry are consistent with prior independent studies showing favorable ionic, hydrophilic, and surface texture properties of silicon nitride.
Scientific data from the University of Rochester show resistance of silicon nitride to infection with Methicillin-Resistant Staphylococcal Aureus (MRSA), a major pathogen of concern in health care systems. These data, accepted for publication, are consistent with a number of internal and independent studies that have shown similar antimicrobial properties of silicon nitride against a variety of bacterial species, including those implicated in dental infections.

Clinical and Regulatory

As previously announced, in December 2016, Amedica re-filed an application with the FDA with a modified porous (cancellous structured ceramic) cervical implant. After a 510(k) pre-submission meeting, the company remains on track to file a 510k submission with a modified porous (cancellous structured ceramic) cervical implant in October 2017 based on FDA feedback.

In July 2017, Amedica’s Quality Management System was audited by its notified body (BSI) and was certified to the ISO 13485:2016 standard.

Participation at Ladenburg Thalmann 2017 Healthcare Conference
The Company also announced that Dr. Bal will make a presentation at the Ladenburg Thalmann 2017 Healthcare Conference on Tuesday, September 26, 2017, at 10:30 a.m. Eastern time in New York, NY.

A webcast of the presentation will be available during the presentation in the Investors section of the company’s website at http://wsw.com/webcast/ladenburg3/amda/, and will be archived and available at that site for 14 days.

Nasdaq Listing Status
The company has received notice from The NASDAQ Stock Market LLC (“NASDAQ”) indicating that a NASDAQ Hearings Panel (the “Panel”) had granted the company’s request to extend the stay of the suspension of trading in the company’s common stock pending the company’s scheduled hearing on October 12, 2017 before the Panel and a final determination regarding the company’s listing status.

At the October 12, 2017 hearing, the company will present its plan to evidence compliance with NASDAQ’s listing requirements. The company is diligently working to evidence compliance with NASDAQ’s listing requirements as soon as possible; however, there can be no assurance that the Panel will grant the company’s request for continued listing and a further stay of suspension. The delisting of the company’s common stock from the NASDAQ Capital Market could have a material adverse effect on the company’s business and on the trading of its common stock.

Strategic Direction

“Our focus at Amedica is three-fold. First, we are focused on product sales, i.e., increasing revenue so that the company is self-sustaining. Second, we will continue engagement with a number of major, external partners, developing biomedical applications of silicon nitride outside spinal implants. Third, we will continue to strengthen our leadership position in the science and data related to silicon nitride and its biomedical applications,” said B. Sonny Bal, MD, MBA, JD, PhD; Chairman and CEO of Amedica.

Amedica continues to add new U.S surgeons to their customer base while remaining engaged with revenue opportunities in Brazil, Europe, and Australia, all markets where its silicon nitride implants are approved for commercialization.

About Amedica Corporation

Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and OEM and private label partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements, which include statements regarding preliminary unaudited financial results, anticipated future revenues, FDA clearance of our products, addition of new surgeon users, and, results of clinical studies are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on September 20, 2017, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

CONTACT INFORMATION

Contacts:
Amedica IR
801-839-3502
IR@amedica.com

Month: September 2017

Contacts

Contacts

CONTACT INFORMATION