SpineGuard Reports 23% Revenue Growth to €2.2m for 1Q 2017

Posted On April 4, 2017 By OrthoSpineNews In Financial /

April 03, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, reported today that its first-quarter 2017 revenue grew by 23%, to €2.2 million.

Pierre Jérôme, CEO and co-founder of SpineGuard, said: “In line with former quarters, SpineGuard is starting 2017 with strong growth driven by great momentum in the US and the traction of PediGuard Threaded, the latest addition of our smart, single-use drilling probes. This is very promising given that our DSG integration module for ‘single-step’ screw insertion is in limited release and therefore not yet significantly contributing to our revenue.”

Global revenue in the first quarter of 2017 increased 23% to €2,169k, compared with €1,760k in the first quarter of 2016. At constant exchange rate (cc), the growth rate was 20%.

2,397 PediGuard units were sold in the first quarter of 2017 compared with 2,134 in the first quarter of 2016, including 1,377 (57%) in the United States, where revenue grew 30% (25% cc) to €1,901k compared with €1,377k.


Recent events:
16 Jan. 2017			510(k) clearance from the U.S. Food and Drug Administration (FDA) for new DSG™ (Dynamic Surgical Guidance) integration module to use in combination with Zavation’s spinal fusion system to make its pedicle screws “smart”.

6 Feb. 2017			Patent grant by the US Patent Office for the application of SpineGuard’s Dynamic Surgical Guidance technology for a new application: bone quality measurement.

Next financial press release: 2016 Half-year revenue: July 6, 2017

About SpineGuard®

Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 50,000 surgical procedures have been performed worldwide with DSG enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Pierre Jérôme, +33 (0)1 45 18 45 19
Chief Executive Officer
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1 508-359-4005, x108

Ottobock Buys Boston-Based “Active” Prosthetic Maker BionX

Posted On April 4, 2017 By OrthoSpineNews In Extremities, Robotics /

David Holley, March 29, 2017

BionX Medical Technologies, a Boston-area company that makes a prosthetic foot and ankle product that uses robotics technology, has been acquired by Ottobock, a German prosthetics company with North American headquarters in Austin, TX.

The deal was announced earlier this month. Financial terms weren’t disclosed, so it’s hard to tell how good an outcome it is for investors and shareholders. BionX raised more than $60 million in equity and debt funding since its inception, including $17 million in late 2015. The company’s investors include General Catalyst, WFD Ventures, Sigma Partners, Gilde Healthcare, and ZGC Shiner Investment.

BionX was founded as iWalk in 2006 by Hugh Herr, an MIT Media Lab professor who runs the school’s Center for Extreme Bionics and who himself is a double amputee below the knees. The company’s device, called the Empower Ankle, uses robotics to propel an amputee forward while adapting to his or her walking style; the actively driven ankle joint tries to replace the function of muscles and tendons. Ottobock says the device can give the user more energy while walking.

READ THE REST HERE

Cesca Therapeutics Announces Senior Management Promotions

Posted On April 4, 2017 By OrthoSpineNews In Biologics /

RANCHO CORDOVA, Calif., April 03, 2017 (GLOBE NEWSWIRE) — Cesca Therapeutics Inc. (Nasdaq:KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced the following senior management promotions, effective immediately.

Ms. Haihong Zhu, who most recently served as Director of Sales, has been promoted to the newly-created position of General Manager of ThermoGenesis, Cesca’s device division. Ms. Zhu has been with Cesca since 2004, serving in various technical and sales positions, and contributed significantly to the establishment of Cesca’s commercial presence in China.
Dr. Dalip Sethi, who has served as Director of Clinical Research (USA), has been promoted to the position of Senior Director of Research and Development. Dr. Sethi, who has been with the Company since 2012, will spearhead Cesca’s clinical development of novel cell therapy methods for treating vascular and orthopedic diseases.
Mr. Jeff Cauble, most recently holding the position of Director of Finance, has been promoted to the position of Principal Accounting Officer. Mr. Cauble has been with Cesca since 2010 and has served in various accounting management positions of increasing responsibility.

“These senior team members have contributed greatly to our success in developing and commercializing our proprietary cell-based therapies and devices, and I am delighted to recognize their ongoing leadership and commitment to the company through these promotions,” said Chris Xu, interim Chief Executive Officer of Cesca. “We are fortunate at Cesca to have a deep and seasoned management team, and with these key individuals assuming expanded roles, we believe we have the team in place to successfully shepherd Cesca Therapeutics through its next phase of growth.”

About Cesca Therapeutics Inc.

About Cesca (www.cescatherapeutics.com): Cesca is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics.

Forward-Looking Statement
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics’ forward-looking statements is set forth under the caption “Risk Factors” in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

Investor Contact: 
Rx Communications
Paula Schwartz
917-322-2216
pschwartz@rxir.com

SI-BONE, Inc. Announces 50th Peer-Reviewed Publication for the iFuse Implant System® and 25,000th iFuse Procedure

Posted On April 4, 2017 By OrthoSpineNews In Spine /

SAN JOSE, Calif., April 3, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that the highly respected journal Spine has published the 50^th peer-reviewed iFuse paper titled Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint – a Pooled Analysis¹. Compared to analyses performed in individual trials, pooling data from these three trials allowed a more statistically powerful determination of patient factors that could predict clinical outcomes after either surgery or non-surgical treatment for appropriately diagnosed patients with SI joint dysfunction.

The pooled analysis study included 423 patients from the three combined multicenter prospective trials, two of which were randomized controlled trials, in which 97 patients received non-surgical management (“NSM”) and 326 patients received SI joint fusion with the iFuse Implant™ from 2013 to 2015. Overall, positive effectiveness, durability and opioid user reduction responses were much higher in the iFuse Implant group compared to the NSM group. In the NSM group, there were no predictors of improved outcomes. In contrast, in the iFuse Implant group, smoking and opioid use were predictive of somewhat smaller improvements in pain relief and disability whereas higher patient age and longer duration of pain were predictive of larger improvements. Although statistically significant, the difference in treatment responses in these groups were clinically unimportant; that is, all subgroups had clinically large improvements after SI joint fusion with iFuse Implants.

“These results indicate that SI joint fusion with triangular iFuse Implants leads to better treatment outcomes compared to non-surgical management and that the extent of improvement with SI joint fusion is only modestly associated with smoking, opioid use, patient age and duration of pain,” said Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE and study co-author. “Some surgeons do not offer some treatments to smokers or opioid users; for SI joint fusion with iFuse Implants, however, smokers and opioid users had marked and clinically important responses.”

The company also announced that the iFuse Implant System has been used in more than 25,000 procedures worldwide and continues to be the Method of Choice for SI Joint Fusion^SM. Adoption of the iFuse Procedure™ has continued to grow as surgeons learn to include the SI joint as part of their routine low back pain diagnostic exam and insurance coverage for the procedure has expanded. Recently, Healthcare Service Corporation (HCSC), the 4^th largest commercial health plan in the U.S., established an exclusive coverage policy for iFuse for Blue Cross Blue Shield participants in Texas, Illinois, Montana, New Mexico and Oklahoma.

“These are two remarkable milestones that were made possible with over eight years of relentless dedication by our organization and thousands of health care providers who manage patients with SI joint disorders,” said Jeffrey Dunn, President and CEO of SI-BONE. “Together, we have raised awareness and educated thousands on SI joint diagnosis and treatment and with continued focus on education and clinical evidence, we are hopeful that all those suffering from chronic SI joint dysfunction who fail conservative care are able to obtain the appropriate therapy to help them.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum. The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion. The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth², facilitating long-term fusion of the joint. The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials. Currently, there are 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic benefits of the iFuse Implant (www.si-bone.com/results).

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

Dengler J, Duhon B, Whang P, Frank C, Glaser J, Sturesson B, Garfin S, Cher D, Rendahl A, Polly D, on behalf of the INSITE, iMIA, SIFI study groups. Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint: A Pooled Analysis. Spine. Published Ahead-of-Print March 27, 2017. doi:10.1097/BRS.0000000000002169
MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

SOURCE SI-BONE, Inc.

Planned Transfer of Implanet SA’s Listing to Alternext Market in Paris

Posted On April 3, 2017 By OrthoSpineNews In Financial /

April 03, 2017

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

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, announces that the planned transfer of the listing of its shares from the Euronext regulated market in Paris (compartment C) to the Alternext Paris multilateral trading facility will be submitted to the Shareholders’ Meeting of May 5, 2017 for approval.

The project will allow Implanet to be listed on a more appropriate market for the Group’s size, offering a better regulatory framework and suited to small and midcaps, the market capitalization of the company being approximately € 18 million with a free float of 90%. This planned transfer to Alternext Paris should simplify its administrative burden and reduce its listing costs while providing continued financial market access.

Subject to this project’s approval by shareholders at the upcoming Shareholders’ Meeting, and the consent of Euronext Paris SA, this listing will be carried out via the fast-track admission to trading of the Company’s existing shares without any new shares being issued.

Within the framework of its transfer to Alternext Paris, SwissLife Banque Privée will be Implanet listing sponsor.

In accordance with current regulatory requirements, Implanet would like to inform its shareholders of the possible consequences of a transfer:

In terms of protecting minority shareholders (non exhaustive list):

the protection of minority shareholders, should control change hands, will be ensured by Alternext Paris through the public offering mechanism, if the 50% threshold is exceeded in terms of capital or voting rights, either directly or indirectly and by one party or jointly;
furthermore, companies listed on Alternext Paris are only duty bound to inform the market, in terms of changes in the shareholding structure, of shareholdings moving above or below 50% and 95% of the company’s capital or voting rights;
however, in accordance with regulatory provisions and for a period of 3 months after its listing is removed from the Euronext regulated market in Paris, Implanet will remain subject to the mandatory public offering system and the continuance of information duties regarding the crossing of thresholds and stated intentions applicable to companies listed on the Euronext regulated market in Paris.

Regarding periodic financial information, less restrictive requirements in terms of financial information, including, and again without claiming to be exhaustive, the following:

extension of the timeframe for publishing half-year results – comprising a balance sheet, a P&L statement and comments regarding this period – to 4 months after the half-year ends;
a chairman’s report on the internal audit and corporate governance is no longer mandatory;
the company can choose which accounting system (French or IFRS) it uses when drawing up its consolidated accounts. However, as the Company’s accounts are already drawn up in IFRS, and in order to ensure transparency vis-à-vis its investors and shareholders, Implanet will continue to apply IFRS.

Being a non-regulated market, the transfer to Alternext Paris could lead to a change in the share’s liquidity versus when it was listed on the Euronext regulated market in Paris. The transfer could also lead certain investors, who prefer issuer shares listed on a regulated market, to divest their Implanet shares.

Lastly, Implanet intends to continue publishing accurate, detailed and honest information, making public any news or information liable to have a significant impact on its share price.

Indicative timetable of the transfer

March 27, 2017				The Board decides to submit the planned transfer of Implanet SA’s listing to Alternext to the Shareholders’ Meeting
April 3, 2017				Information published regarding the planned request for admission (1^st press release)
May 5, 2017				Shareholders’ Meeting to approve the transfer to Alternext Paris
May 9, 2017				Information published regarding the definitive transfer decision (2^nd press release)
July 10, 2017				Decision from Euronext Paris SA to admit shares for trading on Alternext Paris, shares
at the earliest				removed from the Euronext regulated market and first listing on Alternext Paris

Next financial press release: Q1 2017 revenue, on April 18, 2017

Annual general meeting: the combined general meeting of Implanet will be held on May 5, 2017 at 10:00 AM CET at the Company headquarters located Technopole Bordeaux Montesquieu, Allée François Magendie, 33650 Martillac, France.

You are invited to participate in the voting of the resolutions. For further information, please send your contact details to the following address: implanet@newcap.eu

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 48 staff and recorded 2016 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 Compartment C of the Euronext™ regulated market in Paris.

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 26, 2016 under number R.16-035 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.

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba
Tel. : +33 (0)1 44 71 94 94
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

Osiris Therapeutics Launches Prestige™ Lyotechnology, a Novel Method for Ambient Storage of Living Cells and Tissues

Posted On April 3, 2017 By OrthoSpineNews In Biologics /

COLUMBIA, Md., March 30, 2017 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (Pink Sheets:OSIR), a leading regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, announced today that it has developed cutting edge technology enabling the preservation of living cells and tissues at ambient temperatures.

Historically, cryopreservation was the only available method that allowed for long-term preservation of living cells and tissues. However, cryopreservation requires ultra-low-temperature freezers and dry ice or liquid nitrogen for storage, which limits the widespread use of cellular therapies. To address this limitation, Osiris has developed Prestige™ Lyotechnology. Unlike all other known lyophilization methods, Prestige™ Lyotechnology enables the preservation of living cells within tissues while stored at ambient temperatures. Moreover, the manufacturing of lyopreserved living tissues with Prestige™ Lyotechnology is scalable and can be applied to many different cell and tissue types. Placental products will be the focus of the Company’s first application of Prestige™ Lyotechnology.

“This novel technology developed by Osiris will benefit the entire field of cellular therapies. It is expected to accelerate development, commercialization and widespread use of living cell and tissue therapies,” said Alla Danilkovitch, Chief Scientific Officer at Osiris. “Through more than two decades of basic and clinical research, Osiris has not only defined the science and potential of cellular regenerative therapies, but has also created a body of work, advancing the medical community’s understanding of cellular technology. With the introduction of Prestige™ Lyotechnology, Osiris is bringing these innovative cellular therapies to more patients to address a wide range of unmet medical needs.”

The Osiris’s Prestige™ Lyotechnology is featured in tomorrow’s online publication of Osiris’s profile in the scientific journal Nature (www.nature.com), entitled “Innovation on the shelf: solving the puzzle of live-cell preservation”. The print version of this article will appear in the special annual “MedTech Dealmakers” issue of Nature Medicine, Nature Biotechnology and Nature Reviews Drug Discovery in May. Nature is the world’s most highly cited international, interdisciplinary science journal.

About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing, and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the Company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine — including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in wound care, orthopedics, and sports medicine, including Grafix®, Stravix™, BIO4 ™, and Cartiform®. Osiris, Grafix, Stravix and Cartiform are trademarks of Osiris Therapeutics, Inc., and BIO4 is a trademark of Howmedica Osteonics Corp. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding the potential uses of Prestige™ Lyotechnology and the publication of Osiris’s profile in Nature (www.nature.com). Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

For additional information, please contact:



Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1834

OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

Month: April 2017

Contacts

Contacts