MiMedx Completes Divestiture Of Its Stability Biologics Subsidiary

MARIETTA, Ga.Oct. 2, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that it has completed the previously communicated divestiture of the Company’s subsidiary, Stability Biologics LLC (f/k/a Stability Inc.), back to the former stockholders of Stability Inc.

The transaction closed on September 30, 2017.  In the Company’s press release of August 18, 2017, MiMedx reported that the consideration included a promissory note issued by Stability Biologics in the principal amount of $3.5 million in favor of MiMedx and a waiver by the former stockholders of Stability Inc. of all claims and rights to any Earn-Out consideration. In that release, the Company also reported that it expects to book a one-time gain on this transaction. The amount of the gain will be disclosed in the Company’s third quarter of 2017 earnings release.

Parker H. “Pete” Petit, Chairman and CEO, said, “When we signed the definitive agreement for the divestiture, we communicated that if the transaction closed in the third quarter, we would maintain our full year revenue guidance, and even without the Stability Biologics revenue contribution in the fourth quarter, we were confident in our ability to meet our revenue guidance for the year. With the transaction’s closing completed within our projected timeline, we remain very confident in that guidance.”

Bill Taylor, President and COO, commented, “Our new ‘private label’ distribution agreement with Stability Biologics whereby we have retained the Stability Biologics key sales relationships for the spine and orthopedics areas of our surgical business, will also be an asset to the Company in our exclusive focus on our biopharma strategy. We are dedicating our efforts to continuing down the Investigational New Drug/Biologics License Application (IND/BLA) regulatory pathways for numerous new therapeutic applications of our human placental-based technology.”

About MiMedx

MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts.   MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the Company’s expectations relative to its revenue guidance for the year and its belief that its distribution agreement with Stability Biologics will be an asset to the Company.  These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that the Company is not able to meet its revenue guidance without the revenue contribution of Stability Biologics or for some other reason, and that the distribution agreement with Stability Biologics does not produce the expected key sales relationships.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

 

SOURCE MiMedx Group, Inc.

NN, Inc. Announces The Acquisition Of DRT Medical

JOHNSON CITY, Tenn., Oct. 2, 2017 /PRNewswire/ — NN, Inc., (NASDAQ: NNBR) a diversified industrial company, today announced it has completed the acquisition of DRT Medical, LLC, a supplier of precision manufactured medical instruments and orthopedic implants, from DRT Holdings, Inc. Financial terms of the transaction were not disclosed.

Richard Holder, President and CEO commented, “We are excited to welcome DRT Medical into the NN family as we continue to grow our life sciences portfolio through the addition of complementary and adjacent technologies. This acquisition aligns perfectly with our strategic plan and long-term objective to further diversify our portfolio and expand into markets that we believe have strong growth potential. DRT Medical’s focus on medical instruments and orthopedic implants is an ideal expansion of our capabilities as we continue to concentrate on doing more for our customers and work to meet their needs by providing them with end to end solutions.”

NN, Inc., a diversified industrial company combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis.  NN has 36 facilities in North AmericaWestern EuropeEastern EuropeSouth America and China.

Except for specific historical information, many of the matters discussed in this press release may express or imply projections of revenues or expenditures, statements of plans and objectives or future operations or statements of future economic performance. These, and similar statements, are forward-looking statements concerning matters that involve risks, uncertainties and other factors which may cause the actual performance of NN, Inc. and its subsidiaries to differ materially from those expressed or implied by this discussion. All forward-looking information is provided by the Company pursuant to the safe harbor established under the Private Securities Litigation Reform Act of 1995 and should be evaluated in the context of these factors. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “assumptions”, “target”, “guidance”, “outlook”, “plans”, “projection”, “may”, “will”, “would”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “potential” or “continue” (or the negative or other derivatives of each of these terms) or similar terminology. Factors which could materially affect actual results include, but are not limited to: general economic conditions and economic conditions in the industrial sector, inventory levels, regulatory compliance costs and the Company’s ability to manage these costs, start-up costs for new operations, debt reduction, competitive influences, risks that current customers will commence or increase captive production, risks of capacity underutilization, quality issues, availability and price of raw materials, currency and other risks associated with international trade, the Company’s dependence on certain major customers, and the successful implementation of the global growth plan including development of new products. Similarly, statements made herein and elsewhere regarding pending and completed transactions are also forward-looking statements, including statements relating to the future performance and prospects of an acquired business, the expected benefits of an acquisition on the Company’s future business and operations and the ability of the Company to successfully integrate recently acquired businesses or the possibility that the Company will be unable to execute on the intended redeployment of proceeds from a divestiture, whether due to a lack of favorable investment opportunities or otherwise.

For additional information concerning such risk factors and cautionary statements, please see the section titled “Risk Factors” in the Company’s periodic reports filed with the Securities and Exchange Commission, including, but not limited to, the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016. Except as required by law, we undertake no obligation to update or revise any forward-looking statements we make in our press releases, whether as a result of new information, future events or otherwise.

SOURCE NN, Inc.

OrthoPediatrics Corp. Announces Launch of Initial Public Offering

WARSAW, Ind., Oct. 02, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”), an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market, announced today the launch of the initial public offering of 4,000,000 shares of its common stock. OrthoPediatrics will grant the underwriters a 30-day option to purchase up to an additional 600,000 shares of its common stock. The proposed offering price is expected to be between $12.00 and $14.00 per share of common stock. OrthoPediatrics has applied to list its common stock on the NASDAQ Global Market under the ticker symbol “KIDS.”

OrthoPediatrics intends to use the net proceeds that it receives from the proposed offering to pay accumulated and unpaid dividends on its Series B preferred stock, to invest in implants and instrument sets for consignment to its customers, to fund research and development activities, to expand its sales and marketing programs, and for working capital and general corporate purposes.

Piper Jaffray and Stifel are acting as joint book-running managers, William Blair is acting as lead manager and BTIG is acting as co-manager, of the proposed offering.

The proposed offering will be made only by means of a prospectus. Copies of the prospectus related to the proposed offering may be obtained from: Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicole Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at prospectus@pjc.com; or from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, via telephone at (415) 364-2720 or via email at syndprospectus@stifel.com.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. 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.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. All statements other than statements of historical facts included in this press release, including statements concerning OrthoPediatrics’ plans, objectives, goals, beliefs, business strategies, future events, business conditions, results of operations, financial position, business outlook and business trends, are forward-looking statements. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “budget,” “goals,” “potential,” “continue,” “design,” “objective,” “would” and other similar expressions. The forward-looking statements are not historical facts and are based upon OrthoPediatrics’ current expectations, beliefs, estimates, projections and assumptions, many of which, by their nature, are inherently uncertain and beyond OrthoPediatrics’ control. OrthoPediatrics’ expectations, beliefs, estimates and projections are expressed in good faith, and OrthoPediatrics believes there is a reasonable basis for them. However, there can be no assurance that such expectations, beliefs, estimates and projections will result or be achieved, and actual results may vary materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ registration statement on Form S-1. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

About OrthoPediatrics Corp.

Founded in 2006, OrthoPediatrics is the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 21 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products to 35 countries outside the United States.

Investor Contacts:
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

OrthAlign Raises $10 Million To Fund Commercial Growth And Product Development

9/27/2017

Aliso Viejo, CA, Sept. 27, 2017 (GLOBE NEWSWIRE) — OrthAlign, Inc., a leading provider of orthopedic surgical navigation solutions, announced today that the company has raised $10 million in a series D financing round. The investment will be used to fuel product development as the company expands from a solution provider for total knee surgery to a platform technology provider for total knee, partial knee, and total hip replacement surgeries. The funds will additionally be used to support continued commercial expansion through investments in hiring and key programs both in the U.S. and International markets.

OrthAlign manufactures and distributes its core technology, KneeAlign®, which is a computer-assisted navigation application for total knee replacement surgery. KneeAlign has powered more than 65,000 surgeries worldwide, and is clinically-supported by more than 15 peer-reviewed published studies. KneeAlign is well positioned as a perfect solution for the future of orthopedic surgery, delivering the accuracy and consistency that users demand while avoiding the unnecessary capital and recurring costs that large-console navigation and robotics bring to the healthcare market. Reducing instrumentation trays and delivering information directly into the surgeon’s hands, the KneeAlign technology is the only computer navigation platform that exists 100% within the sterile field. These same fundamental benefits continue to resonate with expansion into Uni and Hip applications.

“We are pleased to have completed our latest financing round to support our operational goals of strong revenue growth and application expansion,” said Eric B. Timko, Chairman and CEO of OrthAlign. “We continue to invest in developing KneeAlign because we see it as a key component of the total knee replacement technology landscape moving forward, especially considering the importance of delivering solutions in the ambulatory surgery center environment. But we are no longer a single-solution provider, and have rapidly expanded our commercial platform technology to include solutions for partial knee replacement with our UniAlign™ application. Our solution for total hip replacement, HipAlign®, supports both posterior- and direct anterior approaches and is currently in a limited user release with full-commercialization slated for 2018.”

“We are truly excited for the next phase of OrthAlign,” said Gary Henley, board member. “With a new management team in place, the company’s focus on expanding commercial footprint domestically and in key markets around the world, coupled with a focus on research and development, position the business for long-term success in this competitive marketplace.”

This latest financing round was led by existing investors River Cities Capital Funds, California Technology Ventures, Research Corporation Technologies and Mutual Capital Partners who show continued support for the company.

ORTHALIGN, INC.

OrthAlign, Inc. is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit www.orthalign.com or contact Adam Simone (asimone@orthalign.com).

 

 Adam Simone OrthAlign, Inc. asimone@orthalign.com

Safe Orthopaedics Continues to Improve Its Results in the First Half of 2017

September 28, 2017

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR) (Paris:SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments for back surgery, today announces its results for the first half of 2017.

Safe Orthopaedics’ half-year report will be available in the Investors > Documentation > Regulated Information section of the Company’s website (www.SafeOrtho.com) from September 29, 2017.

€ thousands – IFRS 30/06/2017 30/06/2016
Revenues – France 803 599
Revenues – Rest of the world 841 605

Adjusted total revenues1

1,644 1,204
Revenues from discontinued activities 0 99
Total revenues 1,644 1,303
Purchases used and change in inventories (839) (981)
External costs (1,221) (1,362)
Personnel costs (1,659) (2,010)
Other operating expenses (406) (351)
Operating income/(loss) before non-recurring items (2,481) (3,402)
Other operational income and expenses (49) (10)
Operating income/(loss) (2,530) (3,412)
Financial income/(loss) (716) (158)
Net income/(loss) (3,245) (3,559)

In the first half of 2017, adjusted revenues1 saw growth (+37% to €1,644 thousand), driven by an improvement in all zones, France and the Rest of the World, as well as the opening of the first client accounts in Germany. The strengthening of the French sales team has enabled the Company to double its domestic growth. Combined with the regular growth recorded by its longstanding distributors, the commercial launch in South America has helped accelerate export sales.

Subsequently, the operating loss before non-recurring items improved by €900 thousand over the period (-€2.5 million, versus -€3.4 million in the first half of 2016). Once a financial loss of €716 thousand associated with negative currency effects due to the balance intra-group (US subsidiary), is taken into account, there was a net loss of -€3.2 million in H1 2017, compared with -€3.6 million a year earlier.

At June 30, 2017, Safe Orthopaedics had a cash position of €995 thousand, versus €4.25 million at end-June 2016. However, this figure does not incorporate the €5.8 million fundraising operation carried out in early July in order to finance the hiring of new reps in Europe, accelerate its disposable conversion strategy by market segment and extend its international distribution network.

Over the first half of 2017, Safe Orthopaedics continued its transformation from an R&D-centric company to one focused first and foremost on marketing its single-use innovative technologies for emergency spinal surgeries and increasing its sales”, said Pierre Dumouchel, CEO and co-founder of Safe Orthopaedics. “Given this significant improvement in our results and the success of early July’s capital increase, we remain resolutely confident and intent on continuing Safe Orthopaedics’ commercial development and recruiting talented new sales and marketing staff to continue our growth quarter by quarter”.

Next financial press release: revenues for the 3rd quarter of 2017, on Monday October 9 (after market)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally-invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpineTM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com

Revenues adjusted for activities discontinued in the United States since March 1, 2016

Contacts

Safe Orthopaedics
Pierre Dumouchel, Tél.: +33 (0)1 34 21 50 00
CEO
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
Nicolas Merigeau
Media Relations
Tél.: +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

Orthobiologics Market Worth 6.06 Billion USD by 2022

PUNE, IndiaSeptember 27, 2017 /PRNewswire/ —

According to a new market research report Orthobiologics Market by Product (Viscosupplementation, Synthetic Orthobiologics, DBM, BMP, PRP, BMAC, Allograft), Application (Fracture Recovery, Osteoarthritis, Spinal Fusion, Soft Tissue), End User (Hospitals, ASCs, Academia) – Global Forecast to 2022, published by MarketsandMarkets™, the market is projected to reach USD 6.06 Billion by 2022 from USD 4.66 Billion in 2017, at a CAGR of 5.4% during the forecast period.

Browse 60 Market Data Tables and 38 Figures spread through 159 Pages and in-depth TOC on “Orthobiologics Market

http://www.marketsandmarkets.com/Market-Reports/orthobiologics-market-162747970.html
Early buyers will receive 10% customization on this report

The report analyzes and studies the major drivers, restraints, opportunities, and challenges of the Orthobiologics Market in North AmericaEuropeAsia Pacific, and the Rest of the World (RoW). Factors such as rising burden of orthopedic injuries; increasing incidence of sports injuries and road accidents; increasing incidence of spinal fusion surgeries; risk factors associated with increasing aging population, obesity rate, & high incidence of musculoskeletal disorders; and growing patient preference for minimally invasive procedures are driving the Orthobiologics Market. However, high cost pertaining to orthobiologics based treatment is the major factor restraining the market growth to a certain extent.

Download PDF Brochure: http://www.marketsandmarkets.com/pdfdownload.asp?id=162747970

Based on product, the viscosupplementation products segment is estimated account for the largest segment of the market in 2017

On the basis of product, the Orthobiologics Market is segmented into allografts, synthetic orthobiologics, plasma-rich protein (PRP), bone marrow aspirate concentrate (BMAC), demineralized bone matrices (DBM), bone morphogenic protein (BMP), and viscosupplementation products. The viscosupplementation products segment is expected to account for largest share of the Orthobiologics Market in 2017. The large share of this segment can be attributed to the increasing incidence of osteoarthritis of the knee and hip joints among the baby boomer population and lower cost of viscosupplementations.

Based on application, the osteoarthritis and degenerative arthritis segment expected to account for the largest share of the market in 2017

Based on application, the Orthobiologics Market is segmented into fracture recovery, osteoarthritis & degenerative arthritis, spinal fusion, soft tissue injuries, and maxillofacial & dental applications. The osteoarthritis and degenerative arthritis segment is estimated to command the largest share of the global Orthobiologics Market in 2017. The large share of this segment is mainly due to factors such as the significant rise in target patient population across major markets, rising public awareness related to clinical side effects associated with oral medications for pain management, clinical advancements in OA management methodologies, robust healthcare infrastructure & facilities for specific joint replacement surgeries across major markets, and growing clinical evidence validating the efficacy of biologics in OA treatment.

Talk To Our Research Analysts: http://www.marketsandmarkets.com/speaktoanalyst.asp?id=162747970

In 2017, North America is expected to account for the largest share of the Orthobiologics Market

Geographically, the Orthobiologics Market is segmented into North AmericaEuropeAsia Pacific, and the Rest of the World. North America is expected to account for the largest share of the global Orthobiologics Market in 2017. The growth of this region is attributed to rising incidence of orthopedic and spinal disorders; increasing geriatric population coupled with obesity; growing population exposure to key risk factors; rising number of spinal fusion surgeries and rising patient preference for minimally invasive orthopedic therapies over invasive grafting procedures; and growing physician and patient awareness about the newly introduced treatment procedures and technologies.

The major players in the market are DePuy Synthes, Medtronic, Stryker, Zimmer Biomet, Harvest Technologies, Globus Medical, Orthofix International, RTI Surgical, K2M Group, Kuros Biosciences, Bioventus, NuVasive, SeaSpine, Arthrex, and Xtant Medical.

Browse Related Reports:

Bone Growth Stimulator Market by Product (Device, Bone Morphogenetic Protein, PRP), Application (Spinal Fusion, Delay Union & Non-union Bone Fracture, Oral-maxillofacial), End User (Hospitals, Home Care, Academia, CROs) – Global Forecasts to 2022

http://www.marketsandmarkets.com/Market-Reports/bone-growth-stimulator-market-82341383.html

Spine Biologics Market by Product Type (Bone Graft, Bone Graft Substitute, Platelet Rich Plasma, BMAC), Surgery Type (Anterior Cervical Discectomy and Fusion, Posterior Lumbar Interbody Fusion), End User, and Geography-Global Forecast to 2020

http://www.marketsandmarkets.com/Market-Reports/spine-biologics-market-67680943.html

About MarketsandMarkets™

MarketsandMarkets™ provides quantified B2B research on 30,000 high growth niche opportunities/threats which will impact 70% to 80% of worldwide companies’ revenues. Currently servicing 5000 customers worldwide including 80% of global Fortune 1000 companies as clients. Almost 75,000 top officers across eight industries worldwide approach MarketsandMarkets™ for their painpoints around revenues decisions.

Our 850 fulltime analyst and SMEs at MarketsandMarkets™ are tracking global high growth markets following the “Growth Engagement Model – GEM”. The GEM aims at proactive collaboration with the clients to identify new opportunities, identify most important customers, write “Attack, avoid and defend” strategies, identify sources of incremental revenues for both the company and its competitors. MarketsandMarkets™ now coming up with 1,500 MicroQuadrants (Positioning top players across leaders, emerging companies, innovators, strategic players) annually in high growth emerging segments. MarketsandMarkets™ is determined to benefit more than 10,000 companies this year for their revenue planning and help them take their innovations/disruptions early to the market by providing them research ahead of the curve.

MarketsandMarkets’s flagship competitive intelligence and market research platform, “RT” connects over 200,000 markets and entire value chains for deeper understanding of the unmet insights along with market sizing and forecasts of niche markets.

Contact:
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MarketsandMarkets™
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Visit Our Blog@ http://mnmblog.org/market-research/healthcare/medical-devices

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SOURCE MarketsandMarkets

Medicrea Financial Calendar Amendment

September 27, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, will announce its 2017 Half-Year Results on Monday, 2 October, after market.

On the following day, Tuesday, 3 October, Medicrea will participate in a meeting organized by SFAF (French Society of Financial Analysts) to present the Company’s strategy and results.

The upcoming dates announced on the original schedule remain otherwise unchanged:

• 2017 Third Quarter sales

October 12, 2017*

 2017 Annual sales

January 11, 2018*

*Subject to modification. After market.

Next publication: 2017 Half-Year Results on 2 October, after market.

About Medicrea (www.Medicrea.com)

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

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

For further information, please visit: Medicrea.com.

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

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

Contacts

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

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

26 Sep 17

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

Summary of progress since the beginning of the year:

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

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

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

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

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

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

 

Key figures

in TCHF, IFRS

Six months ended
June 30, 2017

Six months ended
June 30, 2016

Revenue

534

1,055

Research and development

(2,211)

(5,215)

General and administrative

(6,777)

(11,054)

Other income

1,522

1,161

Net operating costs

(7,466)

(15,108)

Key figures (ctd.)
Net financial result

(247)

955

Net loss

(6,970)

(13,255)

Cash reserves

21,417

17,446

Number of employees (FTE)

34

14

 

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

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

Higher cash reserves due to capital increase

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

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

Expenses for CE mark drive net result

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

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

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

 

Key figures

in TCHF, IFRS

Six months ended
June 30, 2017

Six months ended
June 30, 2016

Revenue

534

1,055

Research and development

(2,211)

(5,215)

General and administrative

(6,777)

(11,054)

Other income

1,522

1,161

Net operating costs

(7,466)

(15,108)

Key figures (ctd.)
Net financial result

(247)

955

Net loss

(6,970)

(13,255)

Cash reserves

21,417

17,446

Number of employees (FTE)

34

14

 

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

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

Higher cash reserves due to capital increase

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

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

Expenses for CE mark drive net result

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

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

Status and Outlook

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

DiscGenics Raises $14 Million in Series B Financing

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

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

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

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

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

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

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About Paxeon Reconstruction

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