Safe Orthopaedics (Paris:SAFOR) (FR0012452746 – SAFOR), a company specialized in the design and marketing of single-use implants and instruments improving the minimally invasive treatment of spinal fracture conditions, today announces its revenue for the six months to June 30, 2018.
“Following a series of structural changes – the acquisition of a new sales force in the UK, the signature of a strategic partnership in Japan and the success of our capital increase – sales at Safe Orthopaedics are stable. Double-digit growth in France, triple-digit growth in Germany and our new ambitions in the UK all made it necessary to recruit a Global Sales Director. Sjors Hermans has all the qualities and experience in European markets, particularly Germany, needed to support our growth plans. Most recently, he has demonstrated his ability to launch a range of products for use in spinal surgery, reaching sales of €10 million,” noted Pierre Dumouchel, Chief Executive Officer and co-founder of Safe Orthopaedics. “Having refocused on the vertebral fracture segment over the past two years, we are launching our SteriSpine VA vertebral augmentation balloon at the beginning of this second half of the year. On a global level, we are the only manufacturer of single-use, minimally invasive technologies that allow treatment of all vertebral fractures. This will help drive our sales in the second half and enable us to generate growth in 2018 similar to that seen in 2017.”
In the six months to June 30, 2018, Safe Orthopaedics generated stable revenue of €1,657,000, from €1,644,000 in the corresponding period of 2017.
Direct distribution in France continued its steady growth in the first half of 2018, reaching €904,000, from €802,000 in 2017, an increase of 13%.
International sales fell by 11% in the first half of 2018: sales continued to grow in Germany, but sales in the United Kingdom temporarily fell to zero purely as the result of a transfer. It should be remembered that Safe Orthopaedics announced in June 2018 the acquisition of the sales force of its distributor, QSpine, which resulted in the cessation of orders between the two companies during the negotiation period. Sales in the rest of the world were hampered by difficulties experienced in the Middle East and Southern Europe.
Thousands of euros
H1 2018
H1 2017
Change
France
904
802
+13%
Rest of the World
753
842
-11%
Total revenue
1,657
1,644
+1%
In the second quarter of 2018, Safe Orthopaedics’ revenue from the rest of the world was €307,000, a fall of €118,000 (after restating UK sales in 2017), due to the negative contribution from the Middle East and Southern Europe.
On January 15, 2018, Safe Orthopaedics announced that it was facing difficult conditions in the Middle East and was taking action to restore growth in the region. The company has been audited by inspectors from the GCC tender team and is ready to relaunch in the second half, working with new distributors.
Meanwhile, Safe Orthopaedics, seeking to optimize its cash requirements, has decided to strengthen the financial solidity criteria for its distributors, which resulted in the agreement with one of its existing distributors in Southern Europe being put out for competition.
Thousands of euros
Q2 2018
Q2 2017
Change
France
419
382
+10%
Rest of the World
307
499
-39%
Total revenue
726
881
-18%
Key developments
Signature of a strategic partnership agreement in Japan
As announced on June 12, 2018, Safe Orthopaedics has signed a strategic partnership agreement with a group in Japan, the third largest market in the world.
Extension of the dedicated spinal fracture product range
The company has completed its product range with the launch of its kyphoplasty range, from July in countries where it distributes directly, and then in all markets. This so-called ‘balloon cement injection’ method will enable Safe Orthopaedics to offer a full range for emergency fracture treatment, thus increasing the penetration of its products with surgeons as well as enhancing margins.
Strengthening the global sales and marketing teams
Sjors Hermans joined Safe Orthopaedics as Global Sales Director in early July, and has also been appointed to the Executive Committee. An engineer by training, Sjors began his career in 1997 in the field of medical implants, particularly for the spine. His career began with Medtronic, before he joined a start-up company, then Zimmer Spine as Business Director for Germany and Switzerland.
In 2011, Sjors joined Medacta with responsibility for expanding its spinal products business in Europe and the Asia-Pacific region. He contributed to growing this business to around €10 million per year by adapting the product portfolio, managing the approval process for new products and building up highly-effective sales teams in Germany and other countries.
Sven Claes has worked for Safe Orthopaedics for one year, and has now been promoted to Marketing Director. Sven has 10 years’ experience in Marketing and Business Development in an international context in the spinal medical equipment industry. Before joining Safe Orthopaedics he was VP International Business Development at Aurora Spine.
Cash Position
At June 30, 2018, Safe Orthopaedics had cash of €500,000, from €995,000 at the end of June 2017. It should be noted that this does not include the €6.95 million raised at the beginning of July 2018 to allow Safe Orthopaedics to further accelerate the group’s development in the spinal fracture market, notably by strengthening its sales teams in France, Germany and the UK.
Next financial publication: First half 2018 results, September 28, (after market close)
About Safe Orthopaedics
Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 37 employees.
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 second-quarter and first-half periods ended June 30, 2018.
Ludovic Lastennet, Implanet’s Chief Executive Officer, said: “During the first half, the French Jazz® business performed well (+10%), including a record June, and the US business continued to grow (+14% at constant exchange rates). Despite this performance, the first half of 2018 was affected by the commercial reorganisation in Europe that we started early in the year. As previously announced, we now want to duplicate our proven direct sales model in France and the USA based on close ties with surgeons, to achieve growth in other key European markets such as the UK and Germany. We started to roll out our direct sales model by opening a branch in the UK in June, targeting the promising adult degenerative market. To support our development, we maintained the pace of innovation at a rate of one product per quarter, launching Jazz Evo® in the degenerative market in May. As a result, our sales reorganisation is likely to pay off soon. In the current context, we remain confident about our growth prospects and about our ability to improve our recurring operating income, due in particular to ongoing cost control.”
In thousands of euros – IFRS*
2018
2017
Change
Change at constant
exchange rates
Total first-quarter revenue
1,867
2,048
-9%
-6%
Second quarter
Spine (Jazz®)
1,148
1,337
-14%
-10%
Knee + Arthroscopy
617
734
-16%
-16%
Total second-quarter revenue
1,765
2,071
-15%
-12%
First half
Spine (Jazz®)
2,197
2,404
-9%
-3%
Knee + Arthroscopy
1,434
1,716
-16%
-16%
Total first-half revenue
3,632
4,119
-12%
-9%
*Unaudited
In the first half of 2018, Implanet’s revenue fell 12% to €3.6 million, or 9% to €3.8 million at constant exchange rates.
Jazz® sales fell 9% to €2.2 million (down 3% at constant exchange rates). That decline was mainly caused by disappointing sales in the rest of the world region. Jazz® sales now account for 61% of revenue (vs. 58% in 2017).
In markets in which Implanet operates directly, it continued to perform well, with revenue up 10% to €0.9 million in France and up 14% (at constant exchange rates) to €1.1 million in the USA. Despite the exchange-rate impact, US Jazz® sales continued to grow as surgeons implanted these products more frequently.
In the rest of the world, Jazz® sales fell 56% to €0.2 million, mainly because of the Company’s shift away from its distributor-based sales model. As the Company announced when reporting first-quarter revenue, it now wants to roll out its direct sales model, which has proven successful in France and the USA, to achieve growth in other key European markets such as the UK and Germany. This strategy, which began with the opening of a UK subsidiary in June, is likely to pay off soon.
Overall, Implanet sold 4,270 Jazz® units in the first half.
Revenue in the Knee/Arthroscopy business fell 16% to €1.4 million after distribution of arthroscopy implants came to an end.
Next press release: first-half 2018 results, September 19, 2018
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.
Contacts
IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO 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
As announced on 13 June 2018, SPINEWAY, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), finalized a new strategic plan aiming to reposition Spineway on its markets via targeted actions:
– refocus its activities on the most promising areas;
– reorganize its US subsidiary and reinforce R&D to adapt its instruments/implants in order to access additional markets;
– reinforce its innovation strategy via targeted acquisitions;
– refinance growth.
This transformation should allow Spineway to change its scope and set itself on a new path toward profitable growth in the coming years.
To accelerate the implementation of this roadmap, Spineway announces that it has set up financing with Alpha Blue Ocean, Inc.
This financing, representing a maximum of €14.50M, will allow it to carry out this ambitious plan while covering its day-to-day operating needs.
Legal framework
In accordance with the power granted to the Board of Directors and approved by the Ordinary and Extraordinary General Meeting held by the shareholders of Spineway (the “Company“) on 25 June 2018, on 4 July 2018, Spineway’s Board of Directors approved the principle of an issue of 200 tranche warrants (the “Tranche Warrants“) that, upon exercise, results in the issue of 200 bonds convertible into new or existing shares (the “OCEANE“) with attached warrants to subscribe shares (the “Warrants“), representing a bond issue with a total par value of €2M in favor of the European High Growth Opportunities Securitization Fund (the “Investor“), an investment fund managed by European High Growth Opportunities Manco SA, a Luxembourg asset-management company, and empowered the CEO to launch this transaction, approve its final terms and conditions, and issue said Tranche Warrants.
Pursuant to the issuance agreement entered into on this day between the Investor and Spineway (the “Issuance Agreement“), the Investor has agreed to subscribe, within a maximum period of 36 months:
first, through 15 September 2018, up to 200 OCEANE with attached Warrants, representing a total par value of €2M, in two successive €1M tranches (each referred to as a “Tranche“) (the “Initial Commitment“);
second, in accordance with the Issuance Agreement, and subject to approval by an Extraordinary General Meeting to be held by Spineway’s shareholders by 30 October 2018 at the latest of a power in favor of the Board of Directors allowing the pursuit of said financing program to its completion, the Investor has agreed to subscribe, pursuant to the exercise of 800 Tranche Warrants, as from said Extraordinary General Meeting, 800 OCEANE with attached Warrants, representing a total par value of €8M, in two successive €1M Tranches, and then twelve €0.5M Tranches (the “Additional Commitment“).
For its part, the Company has agreed not to initiate the exercise of any tranche warrants issued pursuant to the agreement for the issuance of Notes with attached Warrants entered into with the YA II PN, LTD investment fund on 28 July 2017 until the expiration of the Issuance Agreement. In the event that tranche warrants are exercised at YA II PN, LTD’s initiative before the end of the Issuance Contract, the Company undertakes to implement a Rest Period (as defined below) of 80 trading days, which will have the effect of postponing the Company’s ability to request that the Investor exercise any Tranche Warrants during the term of said Period.
In any event, the Investor shall not remain a long-term shareholder in Spineway’s capital.
Purpose of the transaction
The purpose of the issuance of these OCEANE with Warrants is to provide Spineway with the financial means necessary to carry out its new strategic plan and finance its 2018 operating costs. The transaction (Initial Commitment and Additional Commitment together) could result in a maximum capital investment of approximately €14.50M, broken down as follows:
– €9.5M corresponding to the subscription of all the 1,000 OCEANE to be issued pursuant to the financing program, at a unit subscription price equal to 95% of their par value; and
– €5M corresponding to the exercise of all the attached Warrants.
In 2018, close to €2M will be allocated to the financing of the first steps in the strategic plan, which include the reorganization of the US subsidiary, strengthening the Group’s sales and studying external-growth options. The balance of this new financing will, over the next years, be applied to reinforcing the innovation strategy, financing the WCR and adapting instruments/implants for the redeployment of sales in the United States and China.
Stéphane Le Roux, CEO of the Spineway Group, commented on this potential contribution of €14.50M in additional financial resources: “This transaction will allow us to significantly strengthen the Group’s financial structure and give us the means to carry out our development plan. It was important that we be able to acquire significant resources in order to implement our redeployment and reorganize our subsidiary in the US, as this is an area of strong growth potential for us. Moreover, this financing will allow us to take advantage of any and all external-growth opportunities with respect to the strategic targets we have already identified.”
Pierre Vannineuse, head of European High Growth Opportunities Manco SA, commented as follows: “This partnership between Spineway and Alpha Blue Ocean is part of our global project to invest in players in the field of healthcare. This investment program, which aims to strengthen activity in the short term as well as start developing long-term projects right away, will allow the company to reinforce its role as a leader in severe spinal-column disorders. We are firmly convinced that their international development strategy will be successful, and that this financing will enable them to acquire the market shares necessary for them to establish a lasting presence.”
Characteristics of the Tranche Warrants, OCEANE and Warrants
The main characteristics of the Tranche Warrants, OCEANE and Warrants are as follows:
Main characteristics of the Tranche Warrants
The Tranche Warrants require their bearer, at the Company’s request ([1]) (a “Request“) pursuant to the Initial Commitment and the Additional Commitment or pursuant to the Investor’s call option(1) (the “Investor Option“) exclusively under the Additional Commitment, to subscribe OCEANE with attached Warrants, i.e., one OCEANE per Tranche Warrant exercised, at a price set at 95% of the par value of an OCEANE. The Company can therefore request the exercise of the Tranche Warrants in order to allow the issuance of OCEANE in several tranches. Each exercise date of a Tranche Warrant is a “Tranche Warrant Exercise Date.”
A Request for the issuance of a Tranche pursuant to the exercise of one hundred (100) Tranche Warrants shall be deemed submitted by Spineway to the Investor on the following dates:
9 July 2018 (exercise of 100 Tranche Warrants issued pursuant to the Initial Commitment);
15 September 2018 (exercise of 100 Tranche Warrants issued pursuant to the Initial Commitment);
30 October 2018 (exercise of 100 Tranche Warrants issued pursuant to the Additional Commitment, as the case may be);
1 January 2019 (exercise of 100 Tranche Warrants issued pursuant to the Additional Commitment, as the case may be).
As from the third Tranche under the Additional Commitment and for the following Tranches, a Request for the issuance of a Tranche pursuant to the exercise of the Tranche Warrants shall be deemed submitted by Spineway to the Investor upon expiration of each period of 40 trading days following the exercise of a Tranche Warrant (the “Rest Period“).
The Tranche Warrants are freely transferable to any other fund or company controlling or controlled by European High Growth Opportunities Securitization Fund but cannot be transferred to a third party without the Company’s prior approval. They shall not be the subject of a request for admission to trading on Euronext Growth and therefore shall not be listed.
Main characteristics of the OCEANE
The OCEANE shall be issued in several Tranches. The nominal amount of the two Tranches of the Initial Commitment shall be equal to €1M each. The nominal amount of the first two Tranches of the Additional Commitment shall be equal to €1M each, then the aggregate nominal amount of each of the following Tranches shall be equal to €0.5M.
The OCEANE have a par value of €10,000 each and are subscribed at 95% of par.
The OCEANE have a maturity of 12 years from their date of issuance. In case of an event of default([2]) or if new shares are not delivered in accordance with the Issuance Agreement, the OCEANE that have not been converted shall be redeemed by the Company at par. Upon maturity, the OCEANE shall automatically be converted into shares. The OCEANE do not bear interest.
At its discretion, the Investor may convert all or any of the OCEANE into new and/or existing shares (a “Conversion“). Upon a Conversion, the Investor shall determine the number of OCEANE to be converted and the corresponding aggregate par value so converted (the “Conversion Amount“). The number of shares to be issued to the Investor upon each Conversion shall be equal to the Conversion Amount divided by 95% of the Market Price (as defined below) on the Conversion date.
Upon a Conversion, the Company shall have the right at its sole discretion to remit to the Investor the corresponding new and/or existing shares (as described above).
The market price (the “Market Price“) shall be the lowest daily volume-weighted average price of the Company’s share over the fifteen (15) consecutive trading days immediately preceding the applicable date (the “Pricing Period“). By way of exception, in the case of a Conversion, or upon exercise of Tranche Warrants or Investor Option during the Additional Commitment, the Pricing Period shall mean the last fifteen (15) trading days immediately preceding the applicable date during which the Investor did not sell any shares of the Company on the market.
The OCEANE are freely transferable to any other fund or company controlling or controlled by European High Growth Opportunities Securitization Fund but cannot be transferred to a third party without the Company’s prior approval. They shall not be the subject of a request for admission to trading on Euronext Growth and therefore shall not be listed.
Main characteristics of the Warrants
Each OCEANE shall be issued with a number of Warrants equal to 50% of the par value of an OCEANE divided by the strike price of the Warrants in question (the “Strike Price“). The Warrants shall immediately be detached from the OCEANE and each Warrant shall give its bearer the right to subscribe for one (1) new share in the Company, subject to possible adjustments.
The Strike Price of the Warrants attached to the OCEANE shall be equal to 115% of the average daily volume-weighted price of the Spineway share over the fifteen (15) trading days preceding the Request in question (or on the Tranche Warrant Exercise Date in the event that the Investor Option is exercised during the Additional Commitment), it being specified that, for the first Tranche, the Warrant Strike Price shall be equal to 115% of the lower of (i) the Market Price immediately preceding the signature of the commitment letter (i.e., 1.3641 euros) and (ii) the Market Price immediately preceding the Request to be submitted for the first Tranche.
The Warrants shall be exercisable in new shares for a period of five years from their respective issuance dates.
The Warrants are freely transferable to any other fund or company controlling or controlled by European High Growth Opportunities Securitization Fund but cannot be transferred to a third party without the Company’s prior approval. They shall not be the subject of a request for admission to trading on Euronext Growth and therefore shall not be listed.
For reference, based on the share’s closing price on 6 July 2018 (i.e., €1.45), the theoretical value of a Warrant would be between €0.34 and €0.69 depending on the volatility applied (i.e., between 30% and 60%). The theoretical value of a Warrant is obtained using the Black & Scholes formula based on the following hypotheses:
maturity: 5 years;
risk-free interest rate: 0%;
dividend payout rate: 0%.
New shares resulting from the Conversion of OCEANE or the exercise of Warrants
The new shares issued upon conversion of the OCEANE and/or exercise of the Warrants shall be admitted to trading on Euronext Growth as from their issuance, will carry immediate and current dividend rights and will be fully assimilated to and fungible with the existing shares.
The Company shall update a summary table on its website showing the Tranche Warrants, OCEANE, Warrants and number of shares outstanding.
Theoretical impact of the issuance of the OCEANE with attached Warrants (based on the Company share’s closing price on 6 July 2018, i.e., €1.45)
For reference, assuming the Company decides to remit only new shares upon Conversion of the OCEANE, the impact of the issuance of the OCEANE with attached Warrants would be as follows:
Impact of the issuance on the consolidated net assets per share (based on the shareholders’ equity as at 31 December 2017, i.e., €3.0M, and the number of shares making up the Company’s share capital as at 6 July 2018, i.e., 4,467,371 shares):
Consolidated net assets per share (in €)
Non-diluted basis
Diluted basis(1)
1stTranche
Total
1stTranche
Total
Before issuance of the new shares resulting herefrom
€0.67
€1.12
After issuance of a maximum of 1,080,333 shares (1st Tranche) or of 8,025,340 new ordinary shares (total Tranches) resulting from the reimbursement of the OCEANE in shares
€0.71
€1.00
€1.08
€1.15
After issuance of a maximum of 1,399,065 shares (1st Tranche) or of 11,212,661 new ordinary shares (total Tranches) resulting from the reimbursement of the OCEANE in shares and the exercise of the Warrants
€0.76
€1.12
€1.10
€1.23
(1) assuming the exercise of all the dilutive instruments existing to date that could result in the creation of an indicative maximum of 2,230,088 new shares.
Impact of the issuance on the investment of a shareholder currently holding 1% of the Company’s share capital (based on the number of shares making up the Company’s share capital as at 6 July 2018, i.e., 4,467,371 shares):
Shareholder’s investment (as a %)
Non-diluted basis
Diluted basis(1)
1stTranche
Total
1stTranche
Total
Before issuance of the new shares resulting from this capital increase
1.00%
1.00%
After issuance of a maximum of 1,080,333 shares (1st Tranche) or of 8,025,340 new ordinary shares (total Tranches) resulting from the reimbursement of the OCEANE in shares
0.81%
0.36%
0.57%
0.30%
After issuance of a maximum of 1,399,065 shares (1st Tranche) or of 11,212,661 new ordinary shares (total Tranches) resulting from the reimbursement of the OCEANE in shares and the exercise of the Warrants
0.76%
0.28%
0.55%
0.25%
(1) assuming the exercise of all the dilutive instruments existing to date that could result in the creation of an indicative maximum of 2,230,088 new shares.
The Company specifies that, in the event that the OCEANE are converted, it has the right to remit existing shares instead of new shares in order to limit dilution for its shareholders.
Next communication: Revenue for the first half of 2018 – 11 July 2018 after market closes
SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLAN FOR SMES)
This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.
Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column. Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports. Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent award (2015). ISIN: FR0011398874 – ALSPW
Investor relations David Siegrist – Finance Director Phone: +33 (0)4 72 77 01 52 finance.dsg@spineway.com
([1]) The following conditions must be met on the day the Warrants are exercised:
The issuer must comply with the obligations set forth in the Issuance Agreement;
No event or change causing the representations put forth by the issuer in the Issuance Agreement to become false or incorrect;
No binding commitment has been undertaken by the issuer with respect to a change in control;
No competent authority (in particular the AMF) has taken position against the issuance of the OCEANE or the Warrants, or their conversion or exercise;
No event constituting a case of default as per the Issuance Agreement is occurring and not been resolved during the applicable grace or appeal period;
The commitment period of 32 months as from 30 October 2018 has not expired;
The Spineway shares (i) are listed on the Euronext Growth Paris market and (ii) their listing has not been suspended on the date in question, whether by the AMF or Euronext, on the Euronext Growth Paris market (iii) have not been threatened, as from the date in question, whether (a) in writing by the AMF or Euronext or (b) by failure to meet the minimum requirements to remain listed on the Euronext Growth Paris market;
The issuer must have at least a number of authorized, available and approved shares for the Investor upon conversion of all the OCEANE outstanding, equal to the par value of the OCEANE to be issued upon expiration of the Rest Period in question (plus the par value of any other OCEANE outstanding, as the case may be) divided by the average daily volume-weighted price on the end date of each Rest Period;
The closing price of the Spineway share on the Euronext Growth Paris market must have exceeded 200% of the par value of the Spineway share over a period of over 60 trading days prior to the submission of the Request or prior to the date on which the Request is deemed to have been submitted (or, if this is not the case, an extraordinary general shareholders meeting shall have been held during such period in order to decrease the share capital by dividing the par value of the Spineway share in half or at least lowering it as much as possible).
([2]) Events of default include, in particular:
– continued failure to perform the obligations set forth in the Issuance Agreement for a period of 30 days as from the first of the following dates: (i) the date on which the Company becomes aware of the failure and (ii) the date on which the Investor notifies the Company of said failure;
– the Company’s failure to deliver the shares owed to the Investor within the three trading days following the date the OCEANE are converted or the Warrants are exercised.
Bone cement is used for the fixation of prosthesis to the bone in various orthopedic musculoskeletal surgical procedures for the treatment of osteoporosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, severe joint destruction secondary to trauma, collagen disease, and revision of previous arthroplasty.
In our study, we have segmented the bone cement market by type, application, and end user. Based on type, global bone cement market is segmented as polymethyl methacrylate (PMMA) cement, calcium phosphate cement (CPC), glass polyalkenoate cement (GPC), and others. Based on application, the market is segmented into arthroplasty, kyphoplasty, and vertebroplasty. On the basis of end user, the market is segmented as hospitals, ambulatory surgery centers, and clinics. Geographically, the market for bone cement is segmented into North America, Europe, Asia Pacific (APAC), Middle East and Africa (MEA) and South and Central America (S&CAM).
The bone cement market is estimated to grow at a CAGR of 5.4% during the forecast period from 2018 to 2025. The market for bone cement is projected to reach US$ 1,414.1 Mn in 2025. The market is witnessing a potential growth rate during the past few years and is expected to witness similar trend in the coming years. Factors such as, increasing prevalence of osteoporosis, growing demand for arthroplasty procedures, and growing geriatric population are primarily contributing to the growth of this market. Additionally, major manufacturers in the market are engaged in research and development activities to develop advanced products. Furthermore, rise in umber of osteoporosis cases and increase in number of bone disease cases are expected to boost the demand for bone cement in the coming years. According to a survey conducted by International Osteoporosis Foundation, around 15-30% male and 30-50% females are at a risk of suffering from osteoporotic fracture during their lifetime. Moreover, according to the International Osteoporosis Foundation, approximately one out of five men and one in every three women over the age of 50 would suffer from a fracture owing to osteoporosis. This is expected to stimulate the demand of bone cement market in the coming years. However, availability of substitutes can hamper the growth of this market at a certain extent.
AMPLITUDE SURGICAL (Paris:AMPLI) announces that, following the long-term partnership between NATIXIS and ODDO BHF, the liquidity contract relating to its shares initially allocated to Natixis was transferred to ODDO BHF on July 2, 2018.
At the end of the liquidity contract allocated to Natixis relating to the shares of AMPLITUDE SURGICAL (FR0012789667) the following means appeared in the liquidity account:
– Number of shares: 75,320
– Cash balance of the liquidity account: €89,951.89
In the report at 29 December 2017, the liquidity account stood as follows:
– Number of shares: 62,331
– Cash balance of the liquidity account: €133,983.29
By agreement from June 19, 2018 and for a period of one year, renewable by tacit renewal, AMPLITUDE SURGICAL allocated ODDO BHF and NATIXIS with the implementation of a liquidity and market supervision contract for ordinary shares, in accordance with the AMAFI Code of Ethics of March 8, 2011 approved by the AMF on March 21, 2011.
For the implementation of the liquidity contract, the following resources were allocated to ODDO BHF and assigned to the liquidity account:
– Number of shares: 75,320
– Cash balance of the liquidity account: €89,951.89
Next financial press release: 2017-18 Full-Year Sales, Thursday July 26, 2018
About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. At June 30, 2016, Amplitude Surgical had a workforce of almost 300 employees and recorded sales of over 80 million euros.
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 the announcement of the sale of an additional Senhance system as well as preliminary unaudited revenue for the second quarter ended June 30, 2018.
“We had a strong second quarter as we continued to drive sales of Senhance globally while at the same time making significant progress towards our 2018 goals, including the expansion of Senhance’s indications for use and portfolio of instruments,” said Todd M. Pope, President and CEO at TransEnterix. “We look forward to continuing to build upon the momentum we developed during the first half of the year to drive the widespread adoption of Senhance.”
Second Quarter Senhance System Sales
In June of 2018, the Company sold a Senhance System to an end user hospital through a distributor in the Company’s EMEA (Europe, Middle East, and Africa) region. This sale represents the fourth system sale during the second quarter of 2018, three of which (two in the EMEA region, one in the U.S.) have been previously announced.
Preliminary Second Quarter Revenue
Preliminary unaudited second quarter revenue is expected to be in the range of $6.0 million to $6.3 million, up from $1.5 million in the second quarter of 2017.
Indication Expansion
On May 29, 2018, the Company received FDA 510(k) clearance for expanded indications of its Senhance System for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery. There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S. With this clearance, Senhance System’s total addressable annual procedures in the U.S. has more than doubled to over three million.
Instrument Portfolio Expansion
On June 7, 2018, the Company announced that it had filed an FDA 510(k) submission for additional Senhance System instruments, including 3 millimeter diameter instruments.
Balance Sheet
On May 23, 2018, the Company entered into a loan and security agreement providing the company with up to $40.0 million in term loans. The initial tranche of the term loan, $20 million, was received at closing. The Company will be eligible to draw on the second tranche of $10 million upon achievement of certain Senhance System revenue-related milestones for its 2018 fiscal year, and a third tranche of $10 million upon achievement of designated trailing six months GAAP net revenue from Senhance sales. On the date of closing, the Company repaid all amounts owed under their previous loan provider.
Preliminary unaudited cash and cash equivalents as of June 30, 2018 was approximately $98 million.
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 Senhance Surgical System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether we are making significant progress towards our 2018 goals and whether the preliminary unaudited 2018 second quarter revenue will be in the range of $6.0 million to $6.3 million. 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.
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 spinal device design with UNiD ASI™ (Adaptive Spine Intelligence) technology, announced today sales for the first half of 2018.
Sales for the first half of 2018 amounted to € 16.9 million, up 22% at constant exchange rates compared to the first half of 2017. Second quarter sales reached € 8.8 million, a new historic performance following the previous record of € 8.2 million in the first quarter of 2018.
“We have resumed the path of sustained growth, with the expectation that recent US registrations for two key product families in our development strategy, the top-loading thoracolumbar fixation system PASS TULIP™ and our IB3D™ 3D-printed titanium interbody cages, will further contribute to the turnover from the second half of 2018,” stated Denys Sournac, President and CEO of Medicrea.
The month of June 2018 shows the best performance of the year with:
– Sales for an amount of € 3.4 million, reflecting the resumption of strong growth from the very beginning of 2018;
– Record number of 116 patient-specific UNiD® Rod surgeries performed for the month of June, confirming the adoption of personalized UNID ASI™ services and implants by a growing number of surgeons. In total, 2,500 UNiD® patient-specific surgeries have been performed since the launch of this technology associated with service expertise delivered by the UNiD Lab™.
In the United States, patient-specific UNID® surgeries are reported to be up + 50% in the first half of 2018 compared to the same period in 2017. The reorganization of the sales force at the end of 2017 aimed at refocusing efforts on the UNiD ASI™ platform is starting to bear fruit. The UNiD ASI™ activity represents more than 60% of total sales for the US subsidiary.
Outside of the United States, sales with international distributors grew by 40% following the opening of new countries and the resumption of invoicing in Brazil. The new Belgian subsidiary, Medicrea Belgium, which was incorporated in February 2018, contributed significantly to the half-year turnover, as hospitals are now billed directly. In France, the Company is also continuing its market share gains with a + 3% growth in sales. Medicrea is now also active on the Australian market with a distribution subsidiary operating since June that is expected to represent a significant source of additional revenue in the medium term given the attractive pricing sustained by the local market for premium products.
“In 2018, we have started to see strong growth in the use of our UNiD ASI™ preoperative planning services and patient-specific implants, which confirms that surgeons are interested in this technology and moreover the relevance of our strategic positioning. We believe that this fully personalized approach to treating spinal pathologies will become the standard of care over the coming years as it improves patient outcomes while reducing costs to the healthcare system,” stated Denys Sournac, President and CEO of Medicrea.
“In May of 2018, the Company achieved FDA 510(k) clearance for its 3D-printed patient-specific interbody devices. With this world-first clearance, Medicrea is able to digitally plan, manufacture in-house and supply a 3D-printed device in the United States that has been optimized to follow each patient’s unique spinal anatomy using the Company’s proprietary AI-driven UNiD technology,” Mr. Sournac continued.
“We are confident in pursuing this growth throughout the second half of the year, particularly in the United States, by deploying new services and products for the personalized treatment of spinal pathologies and should be on track to be EBITDA positive during 2018,” Mr. Sournac concluded.
Next publication: Results for the First Half of 2018: Tuesday, September 18, 2018, after-market.
Through the lens of predictive medicine, Medicrea leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company 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 185 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.
LAS VEGAS—The calls for health systems to ditch fee-for-service payment in favor of value-based models were downright urgent at this year’s Healthcare Financial Management Association conference in Las Vegas.
“We can’t afford not to make the change,” David Hammer, a principal in Healthcare Performance Management Consultants’ revenue cycle and managed-care practice in Fort Lauderdale, Fla., told attendees on the conference’s opening day.
It’s been a topic of discussion at the annual conference for years. But this year, conversations seemed to indicate a breaking point. Healthcare costs are unsustainable, and anyone not on the capitation train—or at least without a ticket in their hand—is part of the problem, presenters echoed.
Speakers also acknowledged the real fear C-suite leaders have about taking that leap. When margins are already squeezed, they offered, it can be hard to agree to a change that could decrease revenue further. Indeed, individual discussions with health system leaders revealed more caution than was present in thought leaders’ presentations.
“Honestly, there is too much fear,” said Christer Johnson, health analytics advisory leader with Ernst & Young. “They’re not clear on how they’re going to make money. And that’s why the bundled-payment programs are voluntary today.”
Nonetheless, the resounding theme of this year’s HFMA conference: It’s time to bite the bullet.
In his keynote speech June 25, HFMA President Joseph Fifer urged a packed audience to forge ahead into the value-based unknown, despite a recent study by the HFMA, Leavitt Partners and McManis Consulting that found such models didn’t lower the total cost of care. He attributed the finding to a lack of incentive in those programs to lower the cost of care and too little downside risk and upside opportunity.
The chief financial officers of the future have a different mindset, he said. They’re willing to implement payment models that truly share the risk and use metrics to assess the return on investment.
“If you invest, you’re part of the solution, even if your fee-for-service revenue goes down,” Fifer said. “But if you don’t invest, someone else will. And the revenue could still go down.”
A forward-thinking CFO will also formulate a value-based payment arrangement that fits within his or her specific health system and market, he said. Perhaps that’s why discussions about such programs can begin to sound nebulous, like when you’ve seen one, you’ve seen one.
Health systems at different levels of adoption
Only a very small proportion of the hip and knee replacements performed on commercially insured patients at Providence St. Joseph Health’s hospitals are paid for in bundles, or lump sums regardless of whether the total cost exceeds that amount. On the Medicare side, the Renton, Wash.-based system has seen its costs decrease significantly since it started participating in the CMS’ Comprehensive Care for Joint Replacement bundles, said Kevin Fleming, Providence St. Joseph’s vice president of orthopedics and sports medicine. Twenty of the system’s 50 hospitals are enrolled in the joint replacement program.
“Working with those government bundles really caused us to re-examine what we were doing and take a whole new approach—not being so laser-focused on what’s going on within the four walls of our own hospital and looking at what we’re doing for patients before they come to the hospital and then after discharge,” he said.
Even the system’s markets that aren’t enrolled in the CMS program have adopted some of those hospitals’ value-based strategies, such as using case managers to make sure patients get the right care once they leave the hospital, Fleming said.
Woven Orthopedic Technologies has raised $5.4 million in a new round of equity and options financing, according to an SEC filing posted this week.
Manchester, Conn.-based Woven Orthopedics is developing orthopedic products which aim to improve fixation, specifically for procedures using screws, according to the company’s website.
The company produces the OGmend implant system which uses biotextiles to enhance fixation. The first generation version of the device is designed from a biopolymer intended to increase surface area contact between bone and screw to distribute load transfer and aid in bone healing and remodeling, according to the company’s website.
A total of 64 unnamed investors have joined in the round so far, with the first sale date noted last August 9. The round has a minimum investment of $50,000, according to the filing.
Of the funds raised so far, $469,000 will be used to pay the CEO and six directors of the company for its calendar year 2018. The company is looking to raise an additional $12.6 million in the round, according to the filing.
MiMedx Group, Inc. played a version of, “Can you top that?” on Monday, when the troubled biopharmaceutical company installed an interim CEO and a new board chairman following the latest wave of executive departures.
The company’s stock MDXG, -8.37% tumbled 38% on the news, sending it to its lowest level since September, 2013.
The company appointed Charles R. Evans, previously the company’s lead independent director, as chairman of the board, replacing Parker H. “Pete” Petit who resigned as board chairman and chief executive. It named David Coles to serve as interim CEO, according to a press release.
Chief operating officer William C. “Bill” Taylor also resigned his role and left the board.
The news follows the dramatic announcement on June 7 that the company’s CFO and its controller/treasurer would exit after MiMedx said it would restate more than five years of financial statements, for the period stretching from 2012 through 2016, and the first three quarters of 2017. All communications and financial information, it said at the time, with respect to the fourth quarter of 2017 and the first quarter of 2018 “should no longer be relied upon,” the company said. It withdrew all prior guidance for 2018.
That’s four times more periods reviewed than the average, signaling a substantial and long-standing problem, research firm Audit Analytics wrote in its analysis of the announcement.
“A financial restatement of this magnitude is a significant red flag in respect to a company’s accounting quality,” Audit Analytics wrote in early June.
Coles is taking the assignment on an interim basis, while continuing to act as a Managing Director with Alvarez & Marsal, a global professional services firm that advises and provides turnaround and restructuring services to companies, including providing interim management.
Coles served as the CFO, principal accounting officer, treasurer and controller at Lehman Brothers Holdings, Inc. from September 2008 to February 2009. He worked for Arthur Andersen & Co. in the U.K. and New York before joining Alvarez & Marsal in 1996.
In describing the actions already taken to “promote accountability and strengthen oversight” MiMedx said it had retained “a leading, operationally focused finance and accounting consultancy firm to provide interim leadership for the chief accounting officer, corporate controller and other financial roles.”
Coles’ appointment seems to be part of a larger engagement for Alvarez & Marsal to provide interim staffing to a company that is suddenly bereft of senior management.
