Financial

Implanet Reports 2018 Nine-Month Revenue

October 09, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

Implanet (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral and knee surgery implants, is today announcing its revenue for the third quarter and for the nine-month period ended September 30, 2018.

Implanet is holding a conference call at 9:30am this morning.
To join the call, please dial in on +33 (0)1 70 71 01 59 followed by the participant PIN code: 38620165#.

Ludovic Lastennet, Implanet’s Chief Executive Officer, commented: “Jazz® revenue increased 10% in France and 8% at constant exchange rates in the United States. Our strategy of building closer relationships with surgeons is paying off as the number of repeat surgeries has improved in key hospitals, including in the United States. This direct sales model has been up and running since early September in the United Kingdom, with Implanet UK and Jazz® now listed by the NHS. In Germany, Implanet GmbH subsidiary has been created and a sales director hired. This strategic realignment enables us to remain confident in our prospects for the coming months. The Jazz® activity did not offset the scheduled shutdown of the Arthroscopy business, impacting our total revenue by a decrease of 13% in the third quarter and by 10% at constant exchange rates over the last nine months.”

Revenue (in thousands of euros – IFRS*) 2018 2017 Change

Change at constant
exchange rates

First-quarter revenue 1,867 2,048 -9% -6%
Second-quarter revenue 1,765 2,071 -15% -12%
Spine (Jazz) 1,056 1,104 -4% -4%
Knee + Arthroscopy 491 671 -27% -27%
Third-quarter revenue 1,548 1,774 -13% -13%
Spine (Jazz) 3,254 3,506 -7% -4%
Knee + Arthroscopy 1,926 2,387 -19% -19%
Nine-month revenue 5,179 5,894 -12% -10%

*Unaudited data

Implanet recorded a fall of 12% in its total revenue over the nine-month period ended September 30, 2018. to €5.2 million (down 10% at constant exchange rates). The sales reorganization of the spine activities in Europe and the scheduled halt of the Arthroscopy business were the key factors.

Jazz® sales were stable to €1.1 million in the third quarter of 2018 and were down 7% over the first nine months of the year to €3.2 million (down 4% at constant exchange rates). They contributed 63% of total revenue, up from 59% in the same period of 2017.

Over the first nine months of the year, Implanet sold 6,579 units (vs. 6,296 in 2017).

Vibrant growth in Jazz® sales was evident over the first nine months of the financial year in France where they rose 10% to €1.2 million. In the United States, Jazz® sales grew to €1.6 million, up 8% at constant exchange rates.

As previously announced, Implanet intends to replicate the direct sales model, based on close surgeon relationships, which has proven its worth in France and the United States in order to accelerate the commercialization of Jazz® in the principal European markets.

Sales of the proprietary Madison product (knee prosthesis) were stable in France over the first nine months of the year and rose 11% during the third quarter. In the Rest of the World, the scheduled shutdown of the Arthroscopy business was the key factor behind the top-line contraction.

Implanet will be attending the following scientific conferences during Q4 2018:

SOFCOT in Paris from November 12 to November 15, 2018, stand F07
BSS (British Scoliosis Society) in Belfast from November 29 to November 30, 2018, stand 9
DWG in Wiesbaden (Germany) from December 6 to December 8, 2018, stand 102

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 16, 2018 under number D.18-0337 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

1 NHS: National Health Service

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net

Ossur Hf : Share buyback program completed

Reykjavík, 8 October 2018

On 6 March 2018, Össur hf. initiated a share buy-back program, see Company announcement no. 16/2018.

The purpose of the share buyback program was to reduce the Company’s share capital and adjust the capital structure by distributing capital to shareholders in line with the Company’s Capital Structure and Dividend Policy. The program would end no later than 28 February 2019. The Company could purchase up to 5,000,000 shares under the program, corresponding to 1.2% of the current share capital. The total consideration for shares purchased under the program could not exceed USD 10 million.

Össur acquired 2,130,549 shares under the program at the average price of DKK 30.05. The total consideration amounted to USD 10 million (approx. DKK 65 million) and thus the program has been completed. Össur currently holds 6,143,780 own shares, corresponding to 1.4% of the Company’s total share capital.

The share buyback program was carried out in accordance with Regulation No. 596/2014 of the European Parliament and of the Council on market abuse (“MAR”), and the Commission delegated regulation No. 2016/1052.

Contact persons:

Jón Sigurðsson, President & CEO     Tel: +354 515 1300

Sveinn Sölvason, CFO     Tel: +354 515 1300

Össur press releases by e-mail: If you wish to receive Össur press releases by e-mail please register at the following web-site: http://www.ossur.com/investormailings

About Össur Össur (NASDAQ: OSSR) is a global leader in non-invasive orthopedics that help people live a life without limitations. Its business is focused on improving people’s mobility through the delivery of innovative technologies within the fields of braces, supports and prosthetic limbs. A recognized “Technology Pioneer”, Össur invests significantly in research and product development; its award-winning designs ensuring a consistently strong position in the market. Successful patient and clinical outcomes are further empowered via Össur’s educational programs and business solutions.  Headquartered in Iceland, Össur has major operations in the Americas, Europe and Asia, with additional distributors worldwide. www.ossur.com

Forward-Looking Statement This press release includes “forward-looking statements” which involve risks and uncertainties that could cause actual results to differ materially from results expressed or implied by these statements. Össur hf. undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.

Additive Orthopaedics Announces Receipt of NJ CoVest Fund Award

LITTLE SILVER, N.J., Oct. 8, 2018 /PRNewswire/ — Additive Orthopaedics, LLC., the leader in 3D printed orthopaedic foot and ankle devices, today announced it has been approved for the NJ CoVest Fund through the New Jersey Economic Development Authority (EDA). The Fund is designed to help emerging technology companies bridge the funding gap between product development and commercialization.

According to Greg Kowalczyk, President of Additive Orthopaedics, “This is a tremendous honor and opportunity that we are privileged to accept from the State of New Jersey. We are now able to add additional corporate resources to provide even more limb salvage solutions to patients that were previously unavailable.”

EDA Chief Executive Officer Tim Sullivan noted the important role the Fund plays in fostering innovation across the Garden State and furthering the EDA’s ability to support businesses throughout their growth lifecycle.

“Ensuring that pioneering companies like Additive Orthopaedics have access to critical capital between product development and commercialization is a pivotal step in re-establishing New Jersey as a leader in innovation,” Sullivan said. “We are especially pleased that Additive Orthopaedics plans to use the funding from its NJ CoVest loan to expand its workforce.”

Additive Orthopaedics has already seen a growing market need in 2018 for 3D printed orthopaedic complex reconstruction, limb salvage, and revision implants, and will continue to address patient conditions where there are no commercially available devices on the market.

Recent Updates from Additive Orthopaedics, LLC.
Additive Orthopaedics recently became the leading sponsor in the American Society of 3D Printing. Launched in 2017, the mission of the society is to provide an educational forum for surgeons involved in clinical treatments leveraging 3D printing and to support patients in need.

About Additive Orthopaedics, LLC.
Additive Orthopaedics is an early stage orthopaedic company focused on the integration of advanced manufacturing and biologics to improve patient outcomes.

About the NJ CoVest Fund
The NJ CoVest Fund provides funding to New Jersey technology and life sciences companies to further commercialize their technology and scale revenues. Investments made through the NJ CoVest Fund align with the EDA’s ongoing strategy of supporting New Jersey’s entrepreneurial ecosystem.

Contact:
Greg Kowalczyk
732.882.6633
greg@additiveorthopaedics.com

SOURCE Additive Orthopaedics, LLC.

Related Links

http://www.additiveorthopaedics.com

Corin signs binding agreement for the acquisition of Global Orthopaedic Technology

Cirencester, UK Corin, backed by the Permira Funds is pleased to announce the signing of a binding agreement for the acqusition of Global Orthopaedic Technology Pty Ltd (“GOT”), the largest Australian-based orthopaedic implant designer and manufacturer.

The acquisition will strengthen Corin’s position as a global leader in the hip and knee joint replacement market and is a testament to Corin’s accelerated global expansion and focus on innovation. Corin’s R&D Hub in Australia is a key pillar of its global innovation capabilities and differentiated product offering. The combination with GOT provides significant scale to Corin’s operations in Australia – one of the world’s most attractive orthopaedics markets, as well as additional R&D expertise.

Global Orthopaedics Technology formed 19 years ago, offers an extensive range of orthopaedic implants including knee and hip products with enabling robotics and navigation technologies. The company has a significant Australian footprint and an export business in the USA.

Stefano Alfonsi, Chief Executive Officer of Corin, commented, “This agreement will further strengthen our presence in the sophisticated and competitive Australian market. The combination of Corin and GOT capabilities creates a leading player in Australia with stronger ability to fulfill the needs of hip and knee surgeons. I look forward to welcoming the talented GOT team into the Corin global family.”

Andrew Fox-Smith, Chief Executive Officer of GOT said, “Our acquisition by Corin represents a fantastic next step for both our people and our customers. Corin has an excellent track record in the total joint replacement market and their dynamic and innovative culture is a natural fit to how we have been operating over the last 4 years. We’re very excited about what the combined business can achieve, not only here in Australia but also via faster expansion internationally of GOT’s Australian developed product portfolio.”

Silvia Oteri, Partner with Permira, commented, “The Permira funds backed Corin and its outstanding management team as it is a strong and ambitious leader in its market with a clear vision to revolutionise orthopaedics. The GOT acquisition represents an important step forward in building a leading and innovative successful platform in the space.”

Media Enquiries
For Corin
Elvio Gramignano, Global Strategic Marketing Director
+44 (0) 1285 884 725
+44 (0) 7769 883 675
elvio.gramignano@coringroup.com

Vaughan Bonny Managing Director, Australia and New Zealand
+61 (0)2 94977400
Mobile: +61 (0)437 777 121
vaughan.bonny@coringroup.com

For Permira 
James Olley (Montfort Communications)
+44 203 770 7909
jolley@montfort.london

Notes to Editors

About Corin 

Headquartered in Cirencester, UK, Corin is an international orthopaedic company with a direct presence in a majority of the world’s orthopaedic markets and a track record of strong double-digit growth. Corin’s vision is to revolutionise orthopaedics by gaining, understanding and sharing insight at every stage of the arthroplasty experience. The unique combination of shared knowledge and clinically-proven implants delivers better outcomes and maximises healthcare value for patients, surgeons and healthcare providers.

About Global Orthopaedic Technology 
GOT was formed 19 years ago and is the largest Australian-owned orthopaedic implant designer and manufacturer. It has a significant footprint throughout Australia and an export business in the USA, with plans to expand to Asia and Europe. It offers an extensive range of orthopaedic implants including knee and hip products, as well as providing enabling technologies such as robotics and navigation methodologies.

About Permira 
Permira is a global investment firm. Founded in 1985, the firm advises private equity funds with a total committed capital of over €33bn and makes long-term majority and strategic minority investments in companies with the objective of transforming their performance and driving sustainable growth. The Permira funds have made over 250 private equity investments in five key sectors: Consumer, Technology, Industrials, Healthcare and Financial Services.

Permira employs over 200 people in 14 offices across Europe, North America and Asia. For more information please visit www.permira.com.

K2M Group Holdings, Inc. Announces Record Date and Meeting Date for Special Meeting of Stockholders

LEESBURG, Va., Oct. 05, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq: KTWO) (the “Company” or “K2M”), announced today that it has set a record date and meeting date for a special meeting of its stockholders to, among other things, consider and vote on a proposal to adopt the previously announced Agreement and Plan of Merger, dated as of August 29, 2018, by and among Stryker Corporation (“Stryker”), Austin Merger Sub Corp. (“Merger Sub”) and K2M, pursuant to which, on the terms and subject to the conditions set forth therein, Merger Sub will merge with and into K2M, with K2M surviving the merger as a wholly owned subsidiary of Stryker (the “Merger”). At the special meeting, K2M stockholders will also vote on a non-binding advisory proposal to approve the compensation that will or may become payable to K2M’s named executive officers in connection with the consummation of the Merger.

K2M stockholders of record as of the close of business on Thursday, October 4, 2018 will be entitled to receive notice of the special meeting and to vote at the special meeting.  The special meeting will be held on Wednesday, November 7, 2018 at 8:00 a.m., Eastern Time, at K2M’s headquarters, 600 Hope Parkway SE, Leesburg, VA 20175.

Upon the completion of the Merger, K2M stockholders will be entitled to receive $27.50 in cash, without interest and less any applicable withholding taxes, for each share of common stock, par value $0.001 per share, of K2M that they own as of immediately prior to the effective time of the Merger.  The Merger is expected to close in the fourth quarter of 2018, subject to customary closing conditions, including approval by K2M’s stockholders and the receipt of certain regulatory approvals.

K2M also announced today that it has filed a definitive proxy statement with the U.S. Securities and Exchange Commission on October 5, 2018 with respect to the special meeting.  K2M expects to commence mailing the definitive proxy statement to its stockholders on or about October 9, 2018.

Any stockholder questions about the merger, including how to vote shares of K2M common stock, should be directed to K2M’s proxy solicitor, Broadridge Financial Solutions, Inc. at 51 Mercedes Way, Edgewood, NY 11717, or to K2M at IR@K2M.com.

About K2M Group Holdings, Inc.

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS®, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enables K2M to compete favorably in the global spine surgery market. For more information, visit www.K2M.com and connect with us on FacebookTwitterInstagramLinkedIn and YouTube.

Forward-Looking Statements

The foregoing contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend for these forward-looking statements to be covered by the safe harbor provisions of the federal securities laws relating to forward-looking statements. These forward-looking statements include statements relating to the expected timing, completion and effects of the proposed merger, as well as other statements representing management’s beliefs about, future events, transactions, strategies, operations and financial results, including, without limitation, our expectations with respect to the costs and other anticipated financial impacts of the merger; future financial and operating results of K2M Group Holdings, Inc. (“K2M”); K2M’s plans, objectives, expectations and intentions with respect to future operations and services; required approvals to complete the merger by our stockholders and by governmental regulatory authorities, and the timing and conditions for such approvals; the stock price of K2M prior to the consummation of the transactions; and the satisfaction of the closing conditions to the proposed merger. Such forward-looking statements often contain words such as “assume,” “will,” “anticipate,” “believe,” “predict,” “project,” “potential,” “contemplate,” “plan,” “forecast,” “estimate,” “expect,” “intend,” “is targeting,” “may,” “should,” “would,” “could,” “goal,” “seek,” “hope,” “aim,” “continue” and other similar words or expressions or the negative thereof or other variations thereon. Forward-looking statements are made based upon management’s current expectations and beliefs and are not guarantees of future performance. Such forward-looking statements involve numerous assumptions, risks and uncertainties that may cause actual results to differ materially from those expressed or implied in any such statements. Our actual business, financial condition or results of operations may differ materially from those suggested by forward-looking statements as a result of risks and uncertainties which include, among others, those risks and uncertainties described in any of our filings with the Securities and Exchange Commission (the “SEC”). Certain other factors which may impact our business, financial condition or results of operations or which may cause actual results to differ from such forward-looking statements are discussed or included in our periodic reports filed with the SEC and are available on our website at www.K2M.com under “Investor Relations.” You are urged to carefully consider all such factors. Although it is believed that the expectations reflected in such forward-looking statements are reasonable and are expressed in good faith, such expectations may not prove to be correct and persons reading this communication are therefore cautioned not to place undue reliance on these forward-looking statements which speak only to expectations as of the date of this communication. We do not undertake or plan to update or revise forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections, or other circumstances occurring after the date of this communication, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. If we make any future public statements or disclosures which modify or impact any of the forward-looking statements contained in or accompanying this communication, such statements or disclosures will be deemed to modify or supersede such statements in this communication.

Additional Information and Where to Find It

This communication does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval. This communication relates to a proposed acquisition of K2M by Stryker Corporation. In connection with this proposed acquisition, K2M has filed a definitive proxy statement and has filed or may file other documents with the SEC. This communication is not a substitute for any proxy statement or other document K2M has filed or may file with the SEC in connection with the proposed transaction. INVESTORS AND SECURITY HOLDERS OF K2M ARE URGED TO READ THE PROXY STATEMENT AND OTHER DOCUMENTS THAT HAVE BEEN (OR MAY BE) FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN IMPORTANT INFORMATION. The definitive proxy statement will be mailed to stockholders of K2M on or about October 9, 2018. Investors and security holders may obtain free copies of these documents and other documents filed with the SEC by K2M through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by K2M are available free of charge on K2M’s internet website at www.K2M.com or upon written request to: Secretary, K2M Group Holdings, Inc., 600 Hope Parkway SE, Leesburg, Virginia 20175, or by telephone at (703) 777-3155.

Participants in Solicitation

K2M, its directors and certain of its executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information regarding the persons who may, under the rules of the SEC, be deemed participants in such solicitation in connection with the proposed merger is set forth in the definitive proxy statement filed with the SEC on October 5, 2018. Information about the directors and executive officers of K2M is set forth in its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, which was filed with the SEC on March 1, 2018, its proxy statement for its 2018 annual meeting of stockholders, which was filed with the SEC on April 20, 2018, its Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2018 and June 30, 2018, which were filed with the SEC on May 2, 2018 and August 2, 2018, respectively, and its Current Reports on Form 8-K or Form 8-K/A, which were filed with the SEC on January 8, 2018, January 9, 2018, February 28, 2018, March 29, 2018, May 1, 2018, June 11, 2018, June 14, 2018, June 18, 2018, August 1, 2018, and August 30, 2018.

These documents can be obtained free of charge from the sources indicated above. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the definitive proxy statement and other relevant materials filed with the SEC.



Histogenics Corporation Announces Proposed Public Offering of Common Stock and Warrants

WALTHAM, Mass., Oct. 04, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies, today announced that it intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of common stock in an underwritten public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.  All of the securities in the offering are to be sold by Histogenics.

Histogenics intends to use the net proceeds from the offering to complete the submission of the NeoCart® biologics license application and prepare for commercialization of NeoCart following approval by the U.S. Food and Drug Administration, if at all, and for general corporate purposes.

Canaccord Genuity LLC and BTIG, LLC are acting as the joint book-running managers for the offering.

A shelf registration statement on Form S-3 (File No. 333-216741) relating to the public offering of the shares of common stock and the accompanying warrants to purchase shares of common stock described above was filed with the Securities and Exchange Commission (the SEC) and declared effective by the SEC on March 30, 2017. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and made available on the SEC’s web site at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may also be obtained by contacting Canaccord Genuity LLC, 99 High Street, Suite 1200, Boston, MA 02110, Attn: Equity Syndicate Department, by telephone at (617) 371-3900 or by e-mail at prospectus@canaccordgenuity.com, or BTIG, LLC, 825 Third Avenue, 6th Floor, New York, NY, 10022, or by telephone at (212) 593-7555 or by e-mail at equitycapitalmarkets@btig.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

About Histogenics Corporation

Histogenics (Nasdaq: HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.

Forward-Looking Statements

This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the proposed public offering of Histogenics’ common stock and warrants. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ, including completion of the proposed public offering on the anticipated terms, or at all, market conditions and the satisfaction of customary closing conditions related to the proposed public offering, as well as other factors, are discussed in the risks and uncertainties detailed from time to time in Histogenics’ filings with the SEC, including without limitation, under Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Histogenics undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.



SeaSpine – Growing Strong

October 03, 2018 / By RTT News

(RTTNews.com) – Shares of SeaSpine Holdings Corp. ( SPNE ) have returned more than 60% year-to-date, clearly outpacing the 12% gain of the iShares Nasdaq Biotechnology index.

SeaSpine is a medical technology company focused on developing and commercializing surgical solutions namely, orthobiologics and spinal implants, for the treatment of patients suffering from spinal disorders.

Between 2012 and 2017, Company launched a total of 30 products, thanks to increased annual research and development spending. This year, more than 6 products are expected to be launched, of which 4 products have already been launched.

SeaSpine reports revenue in two product categories namely orthobiologics and spinal implants.

The orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. The spinal implant portfolio consists of an extensive line of products to facilitate spinal fusion in MIS, complex spine, deformity and degenerative procedures.

The Company generates 90% of its revenue from the U.S. spine market. Apart from the U.S., the Company’s products are sold in over 30 countries worldwide.

 

READ THE REST HERE

 

CORRECTING and REPLACING – SeaSpine Announces Preliminary Results for Third Quarter 2018

CARLSBAD, Calif., Oct. 02, 2018 (GLOBE NEWSWIRE) — In a release issued under the same headline earlier today by SeaSpine Holdings Corporation (NASDAQ: SPNE) please note that in the fifth paragraph of the release under 2018 Financial Outlook the growth should be 7% to 8% over full-year 2017 revenue, not 6% to 9% over full-year 2017 revenue as previously stated. The corrected release follows:

SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today preliminary financial results for the three-months ended September 30, 2018.

Preliminary and unaudited revenue for third quarter 2018 is expected to be in the range of $35.5 to $36.0 million, reflecting approximately 12% to 13% growth compared to the prior year period.  Compared to third quarter 2017, total U.S. revenue is expected to increase between 12% to 13% to approximately $31.5 to $31.8 million, with both U.S. Orthobiologics and U.S. Spinal Implants revenue expected to increase more than 10%.  International revenue is expected to increase between 14% and 20% to approximately $4.0 to $4.2 million.

Cash and cash equivalents at September 30, 2018 are expected to be approximately $11.5 million.  The Company borrowed $3.0 million of cash under its credit facility during the third quarter of 2018 and had $7.3 million of outstanding borrowings under the credit facility as of September 30, 2018. The Company has not sold any shares of its common stock under its $50 million “at the market” equity offering program.

“We are pleased by our revenue results for the third quarter, which reflect solid revenue growth across all portfolios,” said Keith Valentine, President and Chief Executive Officer. “This momentum is driven by increasing market penetration from our recently launched products, a more engaged and increasingly exclusive distributor network, and from a deeper commitment in our organization to customer experience and medical education and training. We are confident that we are well positioned to sustain this growth as we continue to deliver cost effective procedural solutions to surgeons and hospitals to improve the quality of patient lives.”

2018 Financial Outlook
SeaSpine is increasing its full-year 2018 revenue guidance range to $141 to $142 million, up from $136 to $139 million, reflecting growth of approximately 7% to 8% over full-year 2017 revenue.

Upcoming Investor Conferences
As previously announced, SeaSpine management is scheduled to present at the Ladenburg Thalmann 2018 Healthcare Conference in New York, NY today, October 2 at 3:00pm ET.  SeaSpine management is also scheduled to present at the Cantor Global Healthcare Conference in New York, NY on Wednesday, October 3 at 9:10am ET. A live webcast of both presentations will be available on the Investor Relations page of the Company’s website at www.seaspine.com. A replay of each presentation will be available on the website for 30 days following the event.

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the Company’s preliminary revenue results for the third quarter; the Company’s ability to sustain revenue growth in the future; and the Company’s expectations for full-year 2018 revenue.  In addition, this release contains preliminary financial results for third quarter 2018.  These preliminary results for the third quarter of 2018 are not a comprehensive statement of our financial results for the quarter and provided prior to completion of all internal and external review and audit procedures and therefore are subject to adjustment.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper Lewis
(415) 937-5402
ir@seaspine.com

TransEnterix Provides Corporate Update

October 01, 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, today provided a corporate update, including preliminary unaudited revenue for the third quarter ended September 30, 2018.

“We made significant progress during the third quarter, including the continued adoption of Senhance, driven by the advancement of our sales and marketing strategy, the announcement of the MST acquisition agreement and the expansion of our instrument portfolio,” said Todd M. Pope, President and CEO at TransEnterix. “As we look towards the remainder of 2018 and into 2019, we are focused on increasing the applicability of Senhance to more patients, surgeons, and hospitals and growing on a global basis.”

Third Quarter 2018 Revenue Outlook

For the third quarter ended September 30, 2018, the Company expects to report revenue of approximately $5.4 million. This revenue is primarily driven by the sale of four Senhance systems, as follows:

  • In the US, UPMC purchased a Senhance Surgical System to be utilized at its Magee-Womens Hospital in Pittsburgh. Magee combines a wealth of specialty services with a focus on gynecologic and obstetric services. UPMC is a $19 billion world-renowned health care provider and insurer, which is focused on new models of accountable, cost-effective, and patient-centered care.
  • In EMEA (Europe, Middle East, Africa), three systems were sold:
    • A system was sold to Maxima Medical Center, in Veldhoven, the Netherlands, which is a member of a cooperative association of the 20 largest Dutch teaching hospitals that work together in areas of education and quality control, to guarantee the best level of healthcare.
    • Two systems were sold to distributors, one of which was a demonstration system purchased to support territory marketing and regulatory initiatives.

Balance Sheet

Preliminary unaudited cash and cash equivalents as of September 30, 2018 totaled approximately $82 million. The Company anticipates that it has sufficient cash to fund the business through 2020, assuming the funding of the $20 million in potential future debt tranches available under the Company’s existing debt financing agreements.

Acquisition Agreement with MST

On September 23, 2018, the Company announced that it had entered into an agreement to acquire substantially all of the assets of MST Medical Surgery Technologies Ltd. (“MST”), an Israel medical technology company. MST is a leader in the field of surgical technology, having developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.

The addition of MST’s technology, IP portfolio, and R&D team will support and accelerate TransEnterix’s vision to leverage its Senhance Surgical System to deliver digital laparoscopy, thereby increasing control in the surgical environment and reducing surgical variability. In addition, the acquisition will provide immediate access to an established R&D center in Israel with a core team of experienced engineers. The acquisition is expected to close in the fourth quarter of 2018, and is subject to customary closing conditions.

Instrument Portfolio Expansion

Ultrasonic Instrument System

  • On September 6, 2018, the Company announced that it had filed its application for FDA 510(k) clearance for its Senhance Ultrasonic Instrument System, ahead of expectations. The Company expects to achieve an FDA 510(k) clearance in the first quarter of 2019.
  • As announced on October 1, 2018, the Company received a CE Mark for its Senhance Ultrasonic Instrument System. The Company continues to expect to commercially launch the Ultrasonic Instrument System in CE Mark countries in the fourth quarter of 2018.

3mm Diameter Instrument Set

  • The Company continues to anticipate receiving FDA 510(k) clearance for its expanded instrument set, including 3mm diameter instruments, by the end of 2018.

Articulating Instruments

  • The Company continues to expect to submit its application for FDA 510(k) clearance for its 5mm diameter articulating instruments during the fourth quarter of 2018.
  • The Company continues to expect to receive CE Mark for its 5mm diameter articulating instruments during the fourth quarter of 2018.

Expansion of Geographic Regulatory Approvals

The Company continues to expect to receive Taiwanese FDA approval for the Senhance Surgical System instruments by the end of 2018. In the second quarter of 2018, the Company received approval in Taiwan for the Senhance Surgical System.

Appointment of Chief Commercial Officer

On September 4, 2018, the Company announced that Eric Smith has been named Chief Commercial Officer, effective August 31, 2018. In this newly created role, which reports directly to the Chief Executive Officer, Mr. Smith leads the company’s global commercialization efforts, with a focus on both strategic and tactical execution efforts in sales, upstream and downstream marketing, field clinical support and training with a focus on adoption and clinical excellence.

About TransEnterix, Inc.

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 anticipated third quarter 2018 financial results, the acquisition agreement with MST, the Senhance Surgical System, the Senhance Ultrasonic Instrument System and our current regulatory and commercialization plans for these and our other products. 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 preliminary unaudited 2018 third quarter revenue will be approximately $5.4 million, whether preliminary cash and cash equivalents will be $82 million as of September 30, 2018, whether, for the remainder of 2018 and into 2019, we will be able to increase the applicability of Senhance to more patients, surgeons and hospitals and growing on a global basis, whether the MST transaction will be able to close in the 2018 fourth quarter, whether we will achieve an FDA clearance of the Senhance Ultrasonic Instrument System in the 2019 first quarter, whether we will commercially launch the Ultrasonic Instrument System in CE Mark countries in the 2018 fourth quarter, whether we will receive FDA 510(k) clearance for our expanded instrument set, including 3mm diameter instruments, by the end of 2018, whether we will submit our FDA 510(k) clearance for our 5mm diameter articulating instruments during the 2018 fourth quarter, whether we will receive CE Mark for our 5mm diameter articulating instruments during the 2018 fourth quarter, whether we will receive Taiwanese FDA approval for the Senhance Surgical System instruments by the end of 2018 and whether we will have sufficient cash to fund the business through 2020, assuming the funding of the $20 million in potential future debt tranches available under our existing debt financing agreements. 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

For TransEnterix, Inc.
Investors:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media:
Joanna Rice, + 1-951-751-1858
joanna@greymattermarketing.com

Safe Orthopaedics’ Continues to Improve Results over the First Six Months of 2018

September 28, 2018

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR) (Paris:SAFOR), Safe Orthopaedics (FR0012452746 – SAFOR), a company specialized in the development and marketing of implants and single-use instruments that improve the minimally invasive treatment of spinal fracture conditions, today announced its revenue for the six-month period ending on the 30th June 2018.

Safe Orthopaedics’ 2018 six-month financial report will be available on the company’s website (www.SafeOrtho.com) via Investors > Documentation > Regulatory information, from the 25th September 2018.

Thousands of euros – IFRS Standards 30/06/2018 30/06/2017
Revenue – France 904 803
Revenue – Rest of world 756 841

Total Adjusted Revenue

1 660 1 644
Revenue from discontinued operations 0 0
Total Revenue 1 660 1 644
Purchases and inventory change (844) (839)
External expenses (1 525) (1 221)
Payroll (1 726) (1 659)
Other operational expenses (321) (406)
Ordinary operating income (2 756) (2 481)
Other revenue and operational expenses (154) (49)
Operating income (2 910) (2530)
Financial result 200 (716)
Net Income (2 710) (3 245)

 

In the first six months of 2018, turnover remained stable (+1% at €1.66 million) despite a drop in export sales of 11%. This decreasing resulted from a slow down in sales in the United Kingdom (that coincided with the purchase of British sales force), in Middle Eastern and southern European. These issues known on this period led to corrective actions being taken to revitalise those areas.

The strengthening of our sales force in France, the purchase of a British sales force and the establishment of a partnership with a Japanese group, all constituted major investments in the first six months of 2018, and were all undertaken while maintaining cost control.

Consequently, ordinary operating income dropped by €275,000 over the period (-€2.75 million compared with -€2.48 million in the first six months of 2017). However, after taking into consideration the positive financial result of €200,000, linked to the impact of exchange rates on the intra-group balance sheet (US subsidiary), net income rose by €0.54 million to – €2.7 million compared to -€3.2 million the previous year.

On the 30th of June 2018, Safe Orthopaedics’ cash position was €474,000 compared with €3.74 million at the end of June 2017. However, this amount does not include the €6.95 million fund raised at the beginning of July, in order to boost the development of new minimally invasive technologies; create new strategic partnerships similar to the one established in Japan; launch SteriSpine VATM, a new range dedicated to vertebral augmentation that opens up a new market in 2018 worth €72 million; and, strengthen its direct sales force in France, Germany and the United Kingdom.

“Safe Orthopaedics’ strategy of leading the spinal fracture treatment field has been boosted by our broader product portfolio as well as by the deployment of a direct sales force in France, Germany and the United Kingdom,” said Pierre Dumouchel, CEO and co-founder of Safe Orthopaedics. “The major developments in the first six months of 2018 and our successful fund-raising from institutional investors of reference at the beginning of July both aim to improve Safe Orthopaedics’ financial performance over the six-month periods to come.”

Safe Orthopaedics has also enhanced the expertise of its Executive Board with the appointment of Anne Reiser. Anne Reiser was a member of Mondial RedMed’s board in which she was President of the Emea-Apac-Japan region from 2014 to 2017, having previously been President of the European area. Her entire career has been spent in the medical device field with sector leaders such as Medtronic, Hollister, Zimmer, American Home Product and Mölnlycke. At Zimmer, Anne Reiser managed a traumatology, arthroscopy and spine portfolio. She has lived in France and Germany and is currently based in Dubaï. “I am very excited to join Safe Orthopaedics’ Executive board and I am looking forward to bringing my sectoral and geographic experience.”

At the same time, Kurma partners, an early stage investor in Safe Orthopaedics, has resigned from its position on the board. “Kurma partners may be resigning from the board but we continue to have full confidence in the strategy adopted by Safe Orthopaedics following the appointment of Pierre Dumouchel and his management team.” said Thierry Laugel, president of the board and founder of Kurma Partners.

Forthcoming financial publication: turnover for the 3rd quarter of 2018 on Monday 8th October (after market close).

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to offer the safest technologies for treating spinal fracture. Delivered sterile, all implants and single-use instruments are available to surgeons anytime, anywhere. These technologies facilitate minimally invasive methods which reduce the risk of cross-contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits have CE marking and are FDA cleared. The company is based at Eragny-Sur-Oise (France) and has 37 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
François-Henri Reynaud, Tel.: +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
NewCap
Valentine Brouchot
Investor Relations
or
Nicolas Merigeau
Press Relations
Tel.: +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu
or
Ulysse Communication
Bruno Arabian, +33 (0)6 87 88 47 26
barabian@ulysse-communication.com
or
Nicolas Daniels, +33 (0)6 63 66 59 22
ndaniels@ulysse-communication.com