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 that the Company has signed a joint-venture agreement with the Spine division of National Surgical Pty Ltd (“National Surgical”) to introduce the Group’s innovative products and patient-specific technologies in Australia and New Zealand. Other divisions of the National Surgical Businesses will remain unchanged.
Prior to the establishment of the joint-venture, National Surgical was a leading distributor for Medtronic Spine and Biologics in Australia and New Zealand and has developed and maintained excellent relationships for over 14 years with key accounts throughout the territory, which represents the world’s third largest spine market after the United States and Japan and is valued at more than €170 million annually.
Jon Mills, Managing Director of National Surgical, will remain to lead the newly-formed subsidiary with his existing team of highly-trained representatives covering all states and territories of Australia and New Zealand. Mr. Mills stated, “Our history of exceptional service to customers will continue to ensure successful outcomes for patients benefiting from the technology we have supplied since 1997. Moreover, Medicrea’s proprietary UNiD ASI™ (Adaptive Spine Intelligence) technology is especially suited to the Australian market, where surgeons are particularly forward-looking and the healthcare system affords the financial freedom and flexibility to revolutionize spinal surgery. We expect to do nothing less with Medicrea Australia.”
Denys Sournac, President and Chief Executive Officer of Medicrea, added, “We are extremely pleased to have formed this joint venture with National Surgical and to enter Australia’s robust and growing spine market with such a capable partner. Mr. Mills and his team’s experience and long-standing relationships with healthcare professionals at all levels, including key spinal surgeons, hospital administration decision-makers and regulatory contacts, will allow us to rapidly capitalize on a direct sales model and generate new revenue for the Group.”
Medicrea International has been awarded its initial product registrations and holds a 51% majority stake in the Medicrea Australia joint-venture. All revenue generated through the sale of Medicrea products in Australia and New Zealand will be aggregated in Medicrea’s group consolidated numbers.
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.
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.
BELGRADE, MT, July 10, 2018 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced the appointment of Kevin Brandt to the new executive position of Chief Commercial Officer effective July 9, 2018.
“We are excited to have such a talented and experienced executive officer join our team,” said Carl O’Connell, chief executive officer of Xtant. “Kevin’s past accomplishments in the medical device industry show that he is an accomplished business strategist with a unique ability to provide the leadership in sales and marketing to build our Company’s revenues and profitability. I expect his contributions will be transformative for Xtant.”
Brandt brings to Xtant more than 28 years of experience in the medical device industry. As the former executive vice president and chief commercial officer of RTI Surgical, Inc.’s domestic direct business, Brandt led all domestic direct lines of business and R&D for a global surgical implant company marketing biologic, medical and synthetic implants. Prior to joining RTI Surgical in 2012, Brandt spent 18 years at Stryker Corporation from 1994-2012 in various senior commercial leadership positions. Most notably, while at Stryker he served as President of Osteokinetics from 2002-2012 as one of their largest distributors and prior to that he was Senior Director of US Spine sales from 2000-2001 responsible for creating and leading Stryker’s US Spine sales organization.
“I’m thrilled to be joining the Xtant team to lead the development and execution of their commercial strategy”, indicated Kevin Brandt. “Xtant’s legacy portfolio of biologics and fixation products provide a great foundation to build upon in the field of regenerative medicine and medical devices”.
About Xtant Medical
Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.
Important Cautions Regarding Forward-looking Statements
This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as ‘‘continue,’’ ‘‘expects,’’ ‘‘anticipates,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ ‘‘strategy,’’ ‘‘will,’’ “can” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. The Company cautions that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to increase revenue; the ability to achieve expected results; the ability to remain competitive; the ability to innovate and develop new products; the ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals; government regulations; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt and comply with debt covenants; the ability to raise additional financing and other factors. Additional risk factors are listed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without limitation its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.
Contact:
Xtant Medical Holdings, Inc.
Molly Mason
mmason@xtantmedical.com
LEESBURG, Va., July 10, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced it will showcase its 3D spinal balance portfolio and Balance ACS® Platform at the 25th International Meeting on Advanced Spine Techniques (IMAST) in Los Angeles, CA, at Booth #29. Additionally, the Company will host four interactive workshops facilitated by distinguished leaders in spine surgery.
“K2M is excited to attend this year’s IMAST, a prestigious meeting for surgeons to explore the latest topics, technologies, and techniques in spinal deformity,” said John P. Kostuik, MD, Chief Medical Officer and Co-founder at K2M. “Over the past year, we have grown our product offering—as evidenced by our 100th product milestone and our launch of BACS Patient-Specific Rods & Rails at IMAST. We remain committed each day to inventing new solutions that help surgeons improve the lives of people living with spinal disease.”
The Company will also feature Balance ACS (BACS®), which provides solutions to help surgeons achieve balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.
K2M to Host Interactive Workshops in Diamond Salon 6
Techniques for Correcting Cervical Spine Deformities Wednesday, July 11 (4:00–6:00 p.m.)
Christopher Ames, MD; Steven Glassman, MD; Jeffrey Gum, MD
Using Spinopelvic Parameters to Optimize Correction in the Adult Patient Thursday, July 12 (12:30–1:30 p.m.)
Christopher Ames, MD; Shay Bess, MD; Robert Lee, BSc, FRCS
Alternative Fixation Using Band Technology Thursday, July 12 (5:15–6:15 p.m.)
Gregory Mundis, MD; Burt Yaszay, MD
Hybrid Approaches to Deformity Surgery Friday, July 13 (12:00–1:00 p.m.)
Robert Lee, BSc, FRCS
For more information on K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.
About K2M Group Holdings, Inc.
K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.
Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons and hospital customers the merits of our products and to retain their use of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to remediate the material weaknesses in our IT general controls; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects associated with the exit of the United Kingdom from the European Union; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of a fiscal year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.
We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.
MINNEAPOLIS, July 10, 2018 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately-held medical device company developing minimally-invasive solutions for chronic low back pain (CLBP), announced today the successful completion of the first commercial Intracept Procedures. The procedures were performed by Dr. Bradly Goodman at OrthoAlabama Spine & Sports in Birmingham, Alabama and Dr. Erik Bendiks at Georgia Spine & Orthopaedics in Atlanta, Georgia.
Chronic low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30 million people in the US, costing nearly $150 billion each year in medical treatment and lost productivity. Patients suffering from CLBP typically initiate treatment with conservative therapies such as activity modification, medications, bracing, physical therapy, manipulation and steroid injections. Existing therapies fail to provide adequate pain relief for approximately 80 percent of CLBP patients.
The Intracept Procedure is based on groundbreaking research that identified and demonstrated the role of the basivertebral nerve in transmitting low back pain. The procedure utilizes a minimally invasive approach to reach the basivertebral nerve near the center of the vertebral body and delivers radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals. Spine surgeons and interventional pain specialists perform the Intracept Procedure under image guidance in the outpatient setting, with the entire procedure taking 60-90 minutes. Treated patients report nearly immediate relief of their back pain.
The company published the results of the SMART trial, a Level I, sham-controlled randomized controlled trial (RCT) in February 2018 and is currently enrolling patients in a second Level I RCT, the INTRACEPT study, at 20 US sites to expand the portfolio of evidence demonstrating the benefits of the Intracept Procedure.
“We are pleased to initiate the commercialization of Intracept in the United States and to offer this clinically-proven pain relief option to the large segment of chronic low back pain patients who cannot find relief from conservative care and who are not surgical candidates,” said Kevin Hykes, President and Chief Executive Officer. “The ability to intervene early in the disease continuum with this minimally invasive treatment has the potential to significantly improve quality of life and to reduce or eliminate the need for opioids. We are committed to working with patients, physicians and payors to facilitate access to this important new therapy.”
About the INTRACEPT Clinical Study
Relievant is sponsoring the INTRACEPT clinical study to compare outcomes in CLBP patients treated with the Intracept Procedure versus standard medical care. The primary efficacy endpoint is the mean change from baseline to 3 months post-treatment in the ODI, a measurement of the impact of back pain on functional status. The Intracept Procedure will also be evaluated for impact in reducing healthcare costs. The INTRACEPT study will enroll up to 150 patients at up to 20 leading medical centers across the U.S. Patients will be randomized 1:1 between the Intracept Procedure arm vs non-surgical management therapies to treat their CLBP. Patients in the control arm will have the opportunity to receive the Intracept Procedure after 12 months. Please visit www.intraceptstudy.com for more information.
About Relievant Medsystems
Founded in 2006 and with offices in Minneapolis, MN, and Sunnyvale, CA, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from CLBP.
FDA has cleared Relievant’s Intracept System for the following Indications for Use: The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. Please visit www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.
MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the appointment of Brian Burke as Chief Operating Officer (COO). In his role, Mr. Burke will have broad cross-functional responsibility for the Company’s main business functions of sales, marketing, operations, hospital contracting, research and development, human resources, and legal, all to further support the growth of the Company and adoption of its nanoLOCK® surface technology.
nanoLOCK® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.1
Peter Ullrich, MD, Chief Executive Officer of Titan Spine, commented, “As we continue to focus on growth, we identified a need to bring on additional executive talent to the Titan Spine team. Brian has extensive experience driving effective and dynamic functional leadership, brings a wealth of experience in the medtech industry working with both privately and publicly held companies, and has demonstrated a proven track record of implementing operational efficiency. We welcome Brian and believe he will be instrumental in expanding Titan’s strategic positioning in the marketplace.”
Prior to joining Titan Spine, Mr. Burke served as General Manager for Zimmer Biomet Dental in North America where he successfully led the integration of commercial sales and marketing in the United States and Canada following the $13.4B acquisition of Biomet by Zimmer in 2015, which created the second-largest company in the dental implant and oral reconstructive surgery market. He was responsible for leading all North American sales channels that encompassed direct sales, inside sales, and specialty sales. Before Zimmer Biomet, Brian was Group Director of Latin America and Asia for Biomet 3i, where he managed all sales and marketing activities while also managing regulatory compliance and in-country manufacturing in specific global areas.
Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary nanoLOCK® surface technology, which was launched in the U.S. in October 2016 following FDA clearance in late 2014. The nanoLOCK®surface technology consists of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.2,3,4 All Endoskeleton® devices are covered by the company’s risk share warranty.
About Titan Spine
Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S., portions of Europe, and Australia through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.
1 Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.
2 Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.
3 Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.
4 Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.
Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Dublin: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, announces the completion of all implants in ReActiv8-B, its US IDE clinical study.
A total of 204 patients were implanted in the study, reflecting the strength of interest in study participation. The implants were completed in accordance with the Company’s planned timeline and the Company expects to announce a full data readout towards the end of 2018.
Jason Hannon, CEO of Mainstay, said: “Completingall implantsinthe ReActiv8-B study is a significant step for Mainstay and represents continued momentum in our efforts to bring ReActiv8 to patients in the US. We remain on track to have full study data towards the end of 2018. I would like to thank the study participants and investigators for their participation — we look forward to announcing the results of the study later this year.”
ReActiv8-B is an international, multi-centre, prospective, randomized, sham-controlled triple-blinded study with one-way crossover, conducted under an IDE from the US Food & Drug Administration (FDA). The study is intended to gather data in support of a pre-market approval (PMA) application to the FDA, a key step towards the commercialization of ReActiv8 in the US. The study utilizes an adaptive trial design, inclusive of an interim analysis. In December 2017 the Company announced a positive outcome of the interim analysis.
About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands, and is listed on the regulated market of Euronext Paris (MSTY.PA) and the ESM of Euronext Dublin (MSTY.IE).
About Chronic Low Back Pain
One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.
People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.
CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.
Forward looking statements
This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration.
By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialization of ReActiv8, the progress and success of the ReActiv8-B Clinical Trial,general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.
Contacts
PR and IR Enquiries: Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Jessica Hodgson, Nicholas Brown
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com
or FTI Consulting (for Ireland):
Jonathan Neilan
Tel: +353 1 765 0886
Email: jonathan.neilan@fticonsulting.com
or NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr
or AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email : abo@andreasbohne.com
or
Wilhelm Kötting
Tel: +49 69 75913293
Email: wkotting@gmail.com
or Investor Relations: LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com
or ESM Advisers: Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie
ENGLEWOOD, Colo., July 8, 2018 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.
Today, Paragon 28 continues to honor a tradition of comprehensive and innovative solutions with the launch and release of the Bone Graft Harvesting System.
The Bone Graft Harvesting System was created to offer a means to effectively harvest autogenous bone with a straightforward technique, no matter the harvest site chosen.
Common issues that can arise while obtaining autogenous bone includes removal of graft from the harvester, difficulty controlling the amount of bone harvested, and inconsistency of the morselized bone. The Paragon 28® Bone Graft Harvester addresses these concerns by offering three convenient sizes (6 mm, 8 mm, 10 mm) to provide options when choosing the harvest site. The morselizing tip on the harvester allows for control of consistency based on the speed of the drill, while depth markings assist the surgeon with controlling the harvest volume and penetration depth. A 2.3 mm K-wire is also available in this system for use if a pilot hole is desired.
The Bone Graft Harvesting kit disposable trephine and reusable door assemblies are made from medical grades of Stainless Steel. The Bone Graft Harvesting System is delivered in a non-sterile configuration and fits into the Paragon 28® Gorilla® R3CON Plating system. The system is self-contained for a case and can be used in combination with other Paragon 28 systems or in isolation.
About Paragon 28, Inc.
Paragon 28, Inc. was established in 2010 to address the unmet and under-served needs of the foot and ankle community. From the onset, Paragon 28 has made it our goal to re-invent the space of foot and ankle surgery. We believe that through research and innovation we can create new and improved solutions to the challenges faced by foot and ankle specialists.
NEW YORK, July 9, 2018 /PRNewswire-USNewswire/ — Researchers at Hospital for Special Surgery in New York City are launching a new study to identify inflammatory molecules that might help improve treatment of people with certain knee injuries.
The goals of the study, which is now enrolling patients, is to find biomarkers correlated with the development of osteoarthritis of the joint after surgery to fix traumatic tears of the meniscus. This horseshoe-shaped layer of cartilage cushions the bones of the knee during weight-bearing activities like running and jumping.
More than one million Americans annually undergo meniscal surgery, making it among the most common orthopedic procedures performed in the United States. The injuries generally occur in young athletes who experience violent trauma to the knee, although older people can suffer them without such trauma, as well. However, patients who undergo the procedure often develop osteoarthritis of the joint—a painful, degenerative condition that to date has no cure or particularly effective treatment.
“The bottom line is, this is a very common orthopedic surgery and the results are not very good,” said David W. Altchek, MD, sports medicine surgeon and co-chief emeritus of HSS Sports Medicine, and medical director for the New York Mets. “It seems like the surgery makes a small number of people better, some have an indifferent response and, unfortunately, a significant number of people get worse.”
“We don’t really know much about the biology of how the meniscus heals. We kind of let pain be the guide,” added Christopher Mendias, PhD, ATC, associate scientist at HSS, who is helping conduct the study. “We want to be able to say, ‘Is it healing well, and is there a correlation between doing poorly clinically and elevated levels of pro-inflammatory biomarkers or that we can detect with advanced imaging?'”
The HSS study will have several components. Drs. Altchek, Mendias and their colleagues will take samples of synovial fluid–a viscous substance that lubricates joints–from 28 patients (14 men and 14 women) aged 18 to 45 undergoing a procedure called partial meniscectomy in which surgeons shave away frayed pieces of the cartilage. Those samples will be screened for the presence of proteins associated with inflammation, molecules such as interleukin 1 beta, which is known to play a role in osteoarthritis, as well as other previously unidentified substances.
The researchers also will use an advanced form of magnetic resonance imaging to track meniscal healing over time, and will match that information with the biomarker activity to look for patterns of protein activity that predict either successful healing or poor outcomes.
“This whole idea of precision medicine is just kind of catching on in orthopedics now,” Dr. Mendias said. Ideally, a biomarker panel could help surgeons determine which patients will be most likely to benefit from particular meniscal procedures, and what kind of rehabilitation–and even prehabilitation–routine they should undergo. “It could also help us identify therapies to block those inflammatory molecules and reduce the risks of osteoarthritis later in life,” he said.
“The hypothesis is that there is a degenerative effect afterward, as a result of the injury or the surgery, or both—and that biologic therapy might slow that down,” Dr. Altchek said. He added that there is “a tremendous amount of excitement” in the field of orthopedics about new biologic therapies, including platelet rich plasma and stem cells, that are now being used to treat tendon injuries and certain other ailments. Whether they might work to treat or even prevent the development of osteoarthritis after knee surgery is unclear. “This project is an important step in the direction” of answering that question, he said.
Scott A. Rodeo, MD, sports medicine surgeon, co-chief emeritus of HSS Sports Medicine, and co-director of the Tissue Engineering, Regeneration, and Repair Program, will be contributing patients to the study.
“A common clinical observation is that there is tremendous variability in the rate and risk of progressive degenerative changes in patients undergoing surgery for meniscus injury,” said Dr. Rodeo, who also is head team physician for the New York Giants. “Some patients will do well for decades with no further problems, while there is a subset of patients who develop relatively rapid progression of degenerative changes. In addition to biomechanical factors, it is likely that the ‘biologic milieu’ in the joint is a major factor accounting for these discrepant outcomes. In this study we will characterize inflammatory mediators, matrix degrading enzymes, and a host of other cytokines that likely play an important role in joint homeostasis. Such information will not only help us gain a better understanding of the underlying mechanism of joint degeneration in patients with meniscus injury, but, importantly, may suggest therapeutic targets to allow development of innovative treatments.”
Other HSS physicians involved include HSS sports medicine surgeons Answorth A. Allen, MD, New York Knicks team physician; and Riley J. Williams III, MD, medical director of the Brooklyn Nets.
If you have a meniscus tear and are interested in the study, or would like to serve as a healthy control subject, please contact Daniel Edon (edond@hss.edu).
About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the eighth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2017-2018). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients from 80 countries and performed more than 32,000 surgical procedures. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Innovation Institute was formed in 2015 to realize the potential of new drugs, therapeutics and devices; the global standard total knee replacement was developed at HSS in 1969, and in 2017 HSS made 130 invention submissions (more than 2x the submissions in 2015). The HSS Education Institute provides continuing medical curriculum to more than 22.000 subscribing musculoskeletal healthcare professionals in 125 countries. Through HSS Global, the institution is collaborating with medical centers worldwide to advance the quality and value of care and to make world-class HSS care more accessible to more people.
LOMA LINDA, Calif.–(BUSINESS WIRE)–In the fight against hospital acquired infections, Veterans Administration medical centers play a critical role in protecting the health of America’s veterans. At the 159-bed Veterans Administration Loma Linda Healthcare System in California, administrators have adopted the latest technology in fighting airborne bacteria and viruses which contribute to these infections. Recently, the hospital adopted the Illuvia system by Aerobiotix, a unique technology which utilizes ultraviolet energy to eliminate airborne pathogens in the hospital environment. This includes drug resistant microbes such as MRSA. “The hardest place to kill a pathogen is inside the human body. If we can eliminate the danger in the air before it gets a chance to enter the patient, the human and economic benefits are profound,” states Dr. David Kirschman, M.D. founder of Aerobiotix, Inc.
The Veterans Administration Loma Linda has installed the Illuvia systems in ten hospital locations including operating rooms and surgical supply areas. In peer reviewed data, these systems have been shown to significantly reduce airborne bacterial and contamination levels.
About Aerobiotix Inc.
Aerobiotix, Inc. is a company driving leadership in advanced air quality products for the healthcare market. The company develops, manufactures and markets novel technologies to build better healthcare environments worldwide. Our focus is to build awareness of the contribution of air quality issues to hospital-acquired infections and provide safe, effective devices to improve the environments of care. Today, our products benefit patients and caregivers around the globe.
