SYNOSTE Ltd raises €5.1 million to launch its smart skeletal deformation correction technology

(Helsinki, October 18, 2018) – SYNOSTE Ltd, a Finnish medical device company creates smart solutions for patient-friendly bone-lengthening and bone-deformation correction. The company has raised over five million euros to start clinical investigations and to develop new clinical applications. SYNOSTE’s patented technology platform provides the basis for further disruptive changes in the treatment of congenital, trauma- and tumor-related limb discrepancies, adult and pediatric deformities, and craniomaxillofacial deformations.

The new funding was provided by Lifeline Ventures, a specialist early investor in game-changing technologies and AO Invest, an investment fund backed by the AO Foundation, the world’s largest community and network of musculoskeletal surgeons and scientists.

“We are excited to gain funding from two complimentary groups – Lifeline’s forward-thinking mindset and strong entrepreneurial experience combined with AO’s expertise and access to a global network of our target surgeons will empower our development of an expanded portfolio of cutting-edge solutions and enable us to transition them into clinical practice faster”, says SYNOSTE’s Managing Director and co-founder Harri Hallila.

 “SYNOSTE is exactly the type of company that interests AO Invest; they have created not just a product but a platform that will enable various intelligent solutions from traditional intramedullary nails to flat plates that can be used in the treatment of extremely painful and psychologically debilitating conditions” comments Michel Orsinger, Chairman of AO Invest.

The €5.1M Lifeline and AO investment raises the total equity invested in SYNOSTE to ten million euros. SYNOSTE’s other investors include strategic and financial investors: Evonik Venture Capital, a German materials company; High-Tech Gründerfonds, Germany’s largest seed investor; Innovestor Ventures, with the largest portfolio of venture backed companies in Finland; and Mectalent, a partner company that provides SYNOSTE component manufacturing and precision mechanics.

For further information about SYNOSTE, this investment, and our market opportunities, please contact Harri Hallila (hallila@synoste.com).
About AO Invest
AO Invest is a newly established investment fund focused on start-ups active in the field of musculoskeletal disorders. The fund is backed by the AO Foundation, a 60-year old non-profit organization, which boasts the world’s largest network of more than 19’000 surgeons and scientists in orthopedics and trauma. The goal of AO Invest is to invest in start-ups related to the AO Foundation’s core expertise, and use the Foundation’s unique reach and expertise to help their companies achieve their full potential.

About Lifeline Ventures
Lifeline Ventures is a team of serial entrepreneurs who invest in the sectors where they have explicit and comprehensive knowledge, know how, and experiences. As start-up specialists the team at Lifeline start working with a fledgling companies before they have launched their first products. The company credo is to be “FIRST” in the heart and mind of the partnering entrepreneur to support them in both times of trouble and joy. Lifeline’s notable investments include e.g. Supercell (acquired by Softbank), Moves (acquired by Facebook), Oncos Therapeutics, ZenRobotics and Applifier (acquired by Unity). For more information, please visit http://www.lifelineventures.com

Centric Medical™ Announces 510(k) Clearance of the SATURN™ External Fixation System

October 18, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine®, Inc., which focuses on developing surgical implants for the treatment of lower distal extremity pathology, announced today That the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the SATURN External Fixation System which consists of rings, struts, threaded rods, pins, wires and connectors intended to be used as a means to stabilize the foot, ankle and long bone segments.

“I am excited to continue the expansion of our foot and ankle portfolio with more complex solutions like the SATURN External Fixation System. The system has a wide variety of components to allow for a unique anatomical construct for each patient. The key features were designed with the intention to reduce operating time and provide greater ease of use for the surgical team,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine and Centric Medical, “because the procedure involves so many moving pieces, it is crucial for the design to be simple, efficient and user-friendly.”

The external fixation system is the tenth 510(k) clearance for Life Spine in the last year and can be utilized for fusions, fractures, deformity reconstructions, tumors and Charcot Reconstructions.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.centricmedical.com.

Contacts

For Centric Medical
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

The Orthopaedic Implant Company Launches Semi-Extended Tibial Nail Platform

VISEON, Inc. Announces FDA Clearance of the Voyant System for Minimally Invasive Spine Surgery Access, Visualization, and Illumination

October 18, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Viseon, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their Voyant System for Minimally Invasive Spine Surgery, featuring proprietary HD imaging sensor and illumination technology. The Voyant System is composed of a sterile single-use, disposable retractor device with integrated state-of-the-art visualization technology, and a reusable controller enabling digital intraoperative manipulation of the surgical site image, displayed on existing operating room HD flat-panel display monitors. The sterile device also allows the surgeon to adjust intraoperative depth of focus.

Viseon President and CEO Jeffrey Valko stated, “We believe the primary factor contributing to spine surgeons’ slow adoption of minimally invasive spine surgery has been inconsistent outcomes driven by the limited or lack of direct access to and visibility of the surgical anatomy. Traditional capital-intensive surgical microscopes and loupes have been in use for many years, and Viseon is offering state-of-the-art technology as a simple alternative.”

John Liu, MD, professor of clinical neurological surgery at the Keck School of Medicine of USC commented, “This system offers an alternative to surgical microscope and surgical loupes visualization for many minimally invasive spine surgery procedures, eliminating ergonomic consequences and multiple scope repositioning maneuvers and refocusing. It also is useful teaching in the OR, since everyone can see and learn from the procedure.”

About Viseon, Inc.

Viseon has developed a platform technology that has multiple opportunities for technological expansion, including wireless, neuro-monitoring and navigation, fluorescence, sensor integration and complementary robotic applications. The company has demonstrated clinical utility in posterior lumbar decompression and interbody fusion procedures and is expanding into lumbar lateral access and anterior cervical decompression fusion applications. The privately held medical device company is located in Irvine, California, founded in 2017, and recently completed an oversubscribed follow-on financing in October 2018.

For further information, please visit www.viseon-spine.com.

Contacts

Viseon, Inc.
Jeffrey J. Valko, (949) 662-3959

Kuros Biosciences Advances its Fibrin-PTH (KUR-113) Spinal Fusion Product Candidate Program

SCHLIEREN (ZURICH), Switzerland, Oct. 18, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences AG (SIX: KURN) announced today that the Company has reached a key milestone in its Fibrin-PTH (KUR-113) spinal fusion product candidate development program with the submission of a 510(k) regulatory package for its enabling lumbar intervertebral body fusion device to the U.S. Food and Drug Administration (FDA).

Kuros Biosciences will include this news in its program update to the North American Association of Spinal Surgeons (NASS) orthobiologics course ‘2018 Biologic Interventions for Spinal Pathologies: Stem Cells, Growth Factors & Novel Therapeutics’ being held in Chicago on Friday October 19.

“The submission of this US FDA 510(k) regulatory package keeps our KUR-113 spinal fusion product candidate development on track. Completion of the lumbar intervertebral body fusion device development is an important corporate milestone as the device will be used in the upcoming clinical trials in combination with Kuros’ spinal fusion product candidate KUR-113,” said Joost de Bruijn, CEO of Kuros.  “Coupled with the invitation to present an update at such a highly focused spine meeting of acknowledged experts in orthobiologics science marks the successful progress of our Company.”

About KUR-113
KUR-113 consists of a natural fibrin-based healing matrix with an immobilized targeted bone growth factor (truncated human parathyroid hormone (PTH) analog). KUR-113 is designed to be applied directly into and around an intervertebral body fusion device as a gel, where it polymerizes in situ. KUR-113 will be combined with the interbody spacer device in the upcoming clinical trial for interbody spinal fusion.

About the NASS ‘2018 Biologic Interventions for Spinal Pathologies’ Meeting
The field of spinal biologics is rapidly evolving as patients, researchers, and clinicians are recognizing its potential to treat challenging painful conditions. While the roles of both nonoperative and surgical treatment are relatively well-defined in the spine care treatment landscape, the indications, risks, and concerns regarding biologics for a variety of spinal conditions have not been agreed upon. Because of the differences in regulatory pathways for many of these products, the availability of data is variable making administrative decision-making difficult. This meeting will bring together exciting minds from academia and industry to discuss pertinent technologies and relevant issues in biologics use for spinal conditions.

For further information, please contact:
Kuros Biosciences AG Media & Investors
Michael Grau Hans Herklots
Chief Financial Officer LifeSci Advisors
Tel +41 44 733 47 47 +41 79 598 7149

About Kuros Biosciences AG 
Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com 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.

Simplify Medical Appoints IP Attorney Veteran to VP, General Counsel

SUNNYVALE, Calif., Oct. 18, 2018 (GLOBE NEWSWIRE) — Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced that it has appointed Cindy Lynch to Vice President, General Counsel. Ms. Lynch has nearly 15 years of experience providing strategic legal and intellectual property advice to medical device startups.

Ms. Lynch’s appointment comes at a time when Simplify is expanding commercial efforts in Europe and nearing completion of its two-level U.S. IDE clinical trial for the implantation of its cervical artificial disc. The Company completed enrollment of its one-level trial in February 2018 with 166 patients enrolled at 16 U.S. sites and anticipates complete enrollment of 200 patients at 18 centers in its two-level study by the end of 2018.

David Hovda, Chief Executive Officer of Simplify Medical, commented, “Cindy has led our intellectual property program for years, and we are very excited she has joined our team as General Counsel.  While continuing to lead our IP program, which we believe is the largest and most impactful portfolio in cervical spine motion preservation, she will lead our overall legal strategy and continue to ensure our technology remains fully protected.”

Ms. Lynch specializes in intellectual property law and business venture advising. Prior to consulting for companies including Simplify Medical as in-house Counsel, she worked as the VP of Intellectual Property at Elixir Medical Corporation, Moximed, Inc., SpinalMotion, Inc., Conor Medsystems, Inc., and as a partner at Burns, Doane, Swecker & Mathis, LLP. Lynch will complete her M.B.A. from San Francisco State University in 2018 and earned her J.D. from George Mason University School of Law in 1995.

“I am thrilled to be part of the Simplify Medical team,” Cindy Lynch, J.D., said. “This is an exciting time to be working with Simplify as we near completion of the two-level Simplify Disc IDE trial enrollment and work toward the highly-anticipated commercial launch of the Simplify Disc, which will provide patients an innovative option for cervical disc replacement. As we continue to expand our commercial efforts, the protection of Simplify’s legal and IP interests is critical, and I look forward to working closely with the management team in these efforts.”

About Simplify Disc
Simplify® Disc is a motion preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, and better match patients’ anatomies and kinematics. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI and may eliminate the need for CT/Myelogram and CT imaging in order to minimize patient exposure to radiation. The Simplify Disc is anatomically designed, offering a broader range of disc heights including low height implant options to better fit patients’ anatomies. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Simplify Medical Contacts:

Investor Contact:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Email: bjohnston@theruthgroup.com

Media Contact:
Kirsten Thomas, The Ruth Group
Tel: +1 508-280-6592
Email: kthomas@theruthgroup.com

TransEnterix CEO, Todd Pope Named One of TIME Magazine’s 50 Most Influential People in Health Care 2018

October 18, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, congratulates its President and Chief Executive Officer, Todd M. Pope, for being named to TIME Magazine’s 50 Most Influential People in Health Care for 2018. In this inaugural list, Pope is highlighted for his role as one of those leaders whose work right now is transforming health care.

“Being named one of TIME Magazine’s 50 Most Influential People in Health Care for 2018 is a tremendous honor,” said Todd M. Pope, TransEnterix president and CEO. “It’s humbling to be recognized alongside other talented, boundary-pushing individuals across the spectrum of health care. This recognition reflects the efforts of our global team at TransEnterix who work every day to deliver innovative solutions that help surgeons achieve better outcomes for their patients.”

As Chief Executive Officer, Mr. Pope sets the company’s strategic vision and oversees its continuing growth. Mr. Pope has spent more than 25 years working in key leadership positions within the medical-device industry. Prior to joining TransEnterix, Mr. Pope served as worldwide president of Cordis, a multi-billion-dollar division within Johnson & Johnson’s medical-device sector. He previously held a number of senior leadership positions within Johnson & Johnson and Boston Scientific.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to the Senhance Surgical System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the delivery of TransEnterix’s innovative solutions help surgeons achieve better outcomes for their patients. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018, and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

TransEnterix, Inc.
Investor Contact:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media Contact:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com

Amplitude Surgical – 2017-18 Annual Results: Sales of over €100 Million, up +8% Like-for-Like, and Solid EBITDA Growth of +17%

October 17, 2018

VALENCE, France–(BUSINESS WIRE)–Regulatory News:

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, announces its 2017-18 annual results.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “Our strong growth, with annual sales exceeding €100 million, and the improvement in our profitability demonstrate the relevance and quality of execution of Amplitude Surgical’s strategy. The strengthening of our structures, following substantial industrial and commercial investments, supports our ambition of doubling our sales in 5 years thanks to, in particular, our ongoing development on the American market and the enrichment of our portfolio of innovative products”.

Over the 2017-18 financial year to June 30, 2018, Amplitude Surgical continued to implement its strategy targeting high-potential countries, particularly the United States, and recorded further significant growth in activity. Sales exceeded €100 million, up +7.5% in actual terms and +8.2% like-for-like (constant currency and scope). Despite the negative currency effect and the increase in the workforce, the Group’s EBITDA grew by +17% to €18.1 million, giving a +140 bp improvement in the margin to 18%.

Key events:

  • During the past year, Amplitude Surgical:
    • in France, continued the strengthening of its sales force and intensified its market coverage with the integration of several independent sales agents, in eastern France and the Paris area;
    • strengthened its industrial integration with the acquisition of the remaining 50% stake in the Sofab Orthopédie group, which specializes in high-precision manufacturing for implants;
    • completed work on a state-of-the-art ISO 5 clean room, on its Valence site, that has been operational since June 2018.
  • Since the end of the financial year, the Group:
    • in early September, recorded the first arthroplasty performed with an ANATOMIC® knee prosthesis in the United States, the world’s largest market, at a hospital in Champaign, Illinois. Since then, the growth of the US market has started with new client surgeons and new distributors choosing Amplitude Surgical;
    • further strengthened its presence on the French market with the creation of its Amplitude Sud subsidiary;
    • and strengthened its organization with the appointment of Mrs. Muriel Benedetto Marmilloud to the newly-created position of Chief Operations Officer (COO). Reporting directly to the Chairman and CEO, she will be responsible for steering the R&D, Supply chain and Quality assurance & Regulatory affairs departments, in order to ensure total control over the entire logistics value chain and to continue the structuring of operations in order to accompany Amplitude Surgical international development while complying with future regulatory changes.

Financial summary (actual currency):

€ thousands – IFRS 2017-18

2016-17

Δ
Sales 100,336 93,356 +7.5%
Gross margin 75,743 70,519 +7.4%
as a % of sales 75.5% 75.6%
Sales & Marketing costs 39,933 38,626 +3.4%
General & Administrative costs 10,958 9,321 +17.6
Research & Development costs 6,784 7,072 -4.1%
EBITDA 18,068 15,500 +16.6%
as a % of sales 18.0% 16.6%
Core operating profit 2,264 17
Net non-core operating expenses -2,503 -1,063
Operating profit/loss -239 -1,046
Financial profit/loss -8,129 -8,510
Attributable net profit/loss -9,446 -12,052
Net financial debt 93,697 80,043
Net cash position 29,338 41,610

EBITDA of €18.1 million and +140 bp improvement in the margin to 18%, despite the negative currency effect

During the 2017-18 financial year, Amplitude Surgical continued to record solid growth in activity with sales totaling €100.3 million, up +7.5% in actual terms and +8.2% like-for-like (constant currency and scope).

This performance was the result of a sustained commercial momentum both on the French market, +9.4% to €63.6 million, where the Group is continuing to significantly outperform the market, and at international subsidiary level, +12.5% at constant currency to €26.6 million. Sales of Novastep products – innovative solutions for lower-limb (foot and ankle) surgery – have really begun to take off, and totaled €6.6 million over the year with growth of +50% overseas, notably on the American market.

The gross margin was 75.5%, a similar level to that recorded in 2016-17, with the benefits of the industrial integration, following the acquisition of Sofab, offseted by the negative currency effect, notably vis-à-vis the Brazilian real and the Australian and US dollars.

During the year, the Group continued its investments, notably human investments, to conquer and develop its target markets. Thus, at June 30, 2018, Amplitude Surgical had a workforce of 428 staff, compared with 368 at end-June 2017; a third of this increase is related to staff at companies acquired by the Group over the period. Personnel costs thus increased by +14% to €26.6 million. Simultaneously, for R&D, Amplitude Surgical stabilized the budget at €6.8 million and teams at 64 staff.

Given the stabilization of overheads, Group EBITDA was up +16.6% at €18.1 million, giving a +140 bp increase in the EBITDA margin to 18%. The weakening of the main currencies affected EBITDA to the tune of €0.4 million. Restated for the costs associated with the launch of the Japanese and US subsidiaries, EBITDA would be €19.9 million, a +21.3% improvement, i.e. 19.8% of sales.

The annual Core Operating Profit was €2.2 million, compared with a figure close to zero in 2016-17, despite non-recurring elements. There was a slight Operating Loss of €0.2 million, versus a loss of €1.0 million in 2016-17, following the writing down of a further €2.6 million provision of to cover the entire risk associated with its dispute with URSSAF (social security contribution collection authority) regarding tax on medical devices.

There was a financial loss of €8.1 million. Beyond a €6.5 million cost of debt, this figure also reflects net currency impacts of €2.8 million, due to the strengthening of the euro versus the US and Australian dollars and Brazilian real, and financial income of €1.2 million associated with the completion of the Sofab group’s acquisition at a lower price than anticipated.

The tax burden was essentially the result of tax on overseas subsidiaries.

The attributable net loss was €9.4 million, versus a loss of €12.1 million in 2016-17.

Operating cash flow surplus of €4.9 million – Net cash position of €29.3 million at end-June 2018

Net cash flow generated by operating activity doubled over the year, to €4.9 million, thanks to a good EBITDA level and fine control over working capital requirements, almost stable despite the growth in activity. Half of the €4.5 million increase in instrument and implant inventories was attributable to the launch of the American subsidiary’s commercial activity.

Investments totaled €13.8 million, down on the previous year’s figure of €32.3 million, notably attributable to the acquisition of agents in France for €5.4 million and the completion of the clean room on the Valence site for €2.0 million. Furthermore, the Group paid out €2.4 million to settle two disputes, entirely provisioned.

Thus, at the end of June 2018, the Group had a solid financial structure with Cash and Cash Equivalents of €29.6 million. The Group’s Net Financial Debt was €93.7 million, giving gearing (Net Financial Debt over Shareholders’ Equity) of 0.99, versus 0.77 at end-June 2017.

Next financial press release: Q1 2018-19 sales, on Thursday November 22, 2018, after market.

About Amplitude Surgical

Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2018, Amplitude Surgical had a workforce of 428 employees and recorded sales of over 100 million euros.

Contacts

Amplitude Surgical
Philippe Garcia, +33 (0)4 75 41 87 41
CFO
finances@amplitude-surgical.com
or
NewCap
Investor Relations
Marc Willaume, +33 (0)1 44 71 00 13
amplitude@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 98 55
amplitude@newcap.eu

SI-BONE Announces Pricing of Initial Public Offering

SANTA CLARA, Calif.Oct. 16, 2018 /PRNewswire/ — SI-BONE, Inc. (Nasdaq: SIBN) (“SI-BONE”), a medical device company that pioneered the minimally invasive surgical treatment of the sacroiliac joint with the iFuse Implant System®, today announced the pricing of its initial public offering of 7,200,000 shares of common stock at a price to the public of $15.00 per share. In addition, SI-BONE has granted the underwriters a 30-day option to purchase up to an additional 1,080,000 shares of common stock, at the initial public offering price less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Market under the ticker symbol “SIBN” on October 17, 2018.

Morgan Stanley and BofA Merrill Lynch are acting as joint book-running managers. Canaccord Genuity LLC and JMP Securities LLC are acting as co-managers.

The offering is being made only by means of a prospectus.  When available, a copy of the final prospectus may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 or from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC  28255-0001, Attn: Prospectus Department, or email at dg.prospectus_requests@baml.com.

A registration statement relating to these securities has been filed with, and declared effective by, the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

Two new studies demonstrate INTERTAN™ Intertrochanteric Antegrade Nail improves patient outcomes and lowers healthcare costs when treating hip fractures

LONDONOct. 17, 2018 /PRNewswire/ — Smith & Nephew (LSE: SN,NYSE: SNN), the global medical technology business, today announced at the Orthopaedic Trauma Association Annual Meeting in Orlando, FL USA two new studies showing positive clinical results and cost savings through using its INTERTAN Intertrochanteric Antegrade Nail.

Patients recovering from a hip fracture often deal with various complications, including decline in mobility and daily living activities, and reduced ability to walk following fracture union. More than 6% will require reoperation due to complications and approximately 1 in 4 patients over the age of 65 die within 12 months of fracture.1,2,3

In a meta-analysis published in Rheumatology and Orthopedic Medicine, the INTERTAN implant, which uses the Smith & Nephew proprietary “Integrated Compression Screw”, was compared to other intertrochanteric nails using a customary “single screw”. The results showed that INTERTAN significantly reduced the risk of implant related failures by 81% (p<0.00001) and revision surgery by 65% (p<0.0001) when compared to single screw nails.4

According to a further study, published in Journal of Orthopaedic Surgery and Research, the improved clinical outcomes from the meta-analysis also led to a cost savings of $2700 USD per patient when using the INTERTAN nail compared to single screw nails.5

“Hip fractures and their sequelae in elderly patients can be debilitating, and potentially life threatening, and contribute a significant portion to overall health care expenditure. These new studies demonstrate that the Integrated Compression Screw used in the INTERTAN nail not only improved the clinical outcomes for these patients studied, but also reduced the cost to the overall health economic system by reducing the revision rates, compared to those that have been demonstrated in prior studies,” commented J. Tracy Watson MD, Orthopaedic Traumatologist,  Phoenix, Arizona and co-author for both papers.

“Smith & Nephew is dedicated to developing products that will improve patient lives. The INTERTAN nail is a prime example of the type of game-changing technology we at Smith & Nephew strive to create. These two publications show how true innovation can both make clinical improvement and provide economic benefits,” said Andy Weymann MD, Chief Medical Officer, Smith & Nephew.

For more information on the INTERTAN nail, please visit us at the Orthopaedic Trauma Association Annual Meeting, Booth #805 or online at hipfx.com.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic ReconstructionAdvanced Wound ManagementSports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN,NYSE: SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.comfollow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

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References:

1. American Academy of Orthopaedic Surgeons. Hip fractures in seniors: a call for health system reform. Position Statement 1144. Rosemont, IL: 1999.

2. Mundi S et al. Similar mortality rates in hip fracture patients over the past 31 years: A systematic review of RCTs. Acta Orthopaedica 2014; 85(1): 54-59.

3. Bentler SE, Liu L, Obrizan M, Cook EA, Wright KB, Geweke JF, et al. The aftermath of hip fracture: discharge placement, functional status change, and mortality. Am. J Epidemiol. 2009 Nov 15;170(10):1290-9. doi: 10.1093/aje/kwp266.

4. Nherera LM, Trueman P, Horner A, Johnstone AJ, Watson JT. A meta-analysis of integrated compression screw compared to single screw nails using a single lag screw or single helical blade screw for intertrochanteric hip fractures. Rheumatol Orthop Med 2018; 3(4): 1-10. doi: 10.15761/ROM.1000156

5. Nherera LM, Trueman P, Horner A, Johnston AJ, Watson JT, Fatoye FA. Comparing the costs and outcomes of an integrated twin compression screw (ITCS) nail with standard of care using a single lag screw or a single helical blade cephalomedullary nail in patients with intertrochanteric hip fractures. Journal of Orthopedic Surgery and Research (2018) 13:217. doi: 10.1186/s12018-018-0923-x

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